[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35339-35345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14163]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 19-22]


Keith A. Jenkins, N.P.; Decision and Order

    On February 19, 2020, the Drug Enforcement Administration 
(hereinafter, DEA or Government) Administrative Law Judge Mark M. Dowd 
(hereinafter, ALJ), issued a Recommended Rulings, Findings of Fact, 
Conclusions of Law, and Decision (hereinafter, RD) on the action to 
revoke the DEA Certificate of Registration Numbers MJ3401609 and 
MJ4509331 of Keith A. Jenkins, N.P. The ALJ transmitted the record to 
me on March 10, 2020. Having reviewed and considered the entire 
administrative record before me, I adopt the ALJ's RD with 
modifications, where noted herein.\*\\A\
---------------------------------------------------------------------------

    \*A\ I have made minor, nonsubstantive, grammatical changes to 
the RD. Where I have made any substantive changes, omitted language 
for brevity or relevance, or where I have added to or modified the 
ALJ's opinion, I have bracketed the modified language and explained 
the edit in a footnote marked with an asterisk and a letter in 
alphabetical order.
---------------------------------------------------------------------------

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby dismiss the Order to Show Cause issued to Keith 
A. Jenkins, N.P. I further order that any pending applications for 
renewal of DEA Certificates of Registration MJ3401609 and MJ4509331 be 
granted. This Order is effective immediately.

D. Christopher Evans,
Acting Administrator.

Paul Soeffing, Esq., for the Government
Robert W. Liles, Esq. and Meaghan K. McCormick, Esq., for the 
Respondent

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge

    The Assistant Administrator, Diversion Control Division, Drug 
Enforcement Administration (DEA), issued an Order to Show Cause 
(OSC),\1\ dated April 23, 2019, seeking to revoke the Respondent's 
Certificates of Registration (COR), numbers ``MJ3401609 and MJ4509331, 
pursuant to 21 U.S.C. 824(a)(5), and deny any applications for renewal 
or modification of such registration and any applications for any other 
DEA registrations pursuant to 21 U.S.C. 824(a)(5),'' because the 
Respondent has been excluded from participation in a program pursuant 
to section 1320a-7(a) of Title 42. OSC, at 1. The Respondent requested 
a hearing on May 16, 2019,\2\ and prehearing proceedings were 
initiated.\3\ A hearing was conducted in this matter on November 20, 
2019, at the DEA Hearing Facility in Arlington, Virginia.
---------------------------------------------------------------------------

    \1\ ALJ Ex. 1.
    \2\ ALJ Ex. 2.
    \3\ ALJ Ex. 3.
---------------------------------------------------------------------------

    The issue ultimately to be adjudicated by the Acting Administrator, 
with the assistance of this recommended decision, is whether the record 
as a whole establishes by a preponderance of the evidence that the 
Respondent's subject registration with the DEA should be revoked 
pursuant to 21 U.S.C. 824(a)(5).
    After carefully considering the testimony elicited at the hearing, 
the admitted exhibits, the arguments of counsel, and the record as a 
whole, I have set forth my recommended findings of fact and conclusions 
of law below.

The Allegations

    In the OSC, the Government contends that the DEA should revoke the 
Respondent's DEA COR because he has been excluded from participation in 
a program pursuant to section 1320a-7(a) of Title 42.
    Specifically, the Government alleges the following:
    1. Respondent is registered with the DEA as an MLP-nurse 
practitioner in Schedules II through V under DEA Certificate of 
Registration MJ3401609, at 105 Vanner Rd., Mt. Juliet, TN 37122. 
Respondent is also registered with the DEA under DEA Certificate of 
Registration MJ4509331, at 3909 Woodley Rd., Toledo, OH 43606, with a 
mailing address of 105 Vanner Rd., Mt. Juliet, TN 37122. Respondent's 
registrations both expire by their terms on December 31, 2020. Id. 
Prior to the current action, Respondent's DEA Certificates of 
Registration have not been the subject of disciplinary or other adverse 
action by the DEA.
    2. On August 7, 2017, Respondent entered an ``Alford Plea of Guilty 
to a Felony'' to the offense of ``False Statement to Medicaid.'' On 
August 1l, 2017, the Circuit Court of Fairfax County, Virginia entered 
its sentencing Order for Respondent's offense of ``False Statement for 
Payment (F)'' in violation of Va. Code Section 32.1-314(F) FRD 3337F9. 
See Commonwealth of Virginia v. Keith Allen Jenkins, No. FE-2017-
0000711 (Fairfax Cty. Cir. Ct.).
    3. Based on Respondent's conviction, the U.S. Department of Health 
and Human Services, Office of Inspector General (``HHS/OIG''), by 
letter dated February 28, 2018, mandatorily excluded Respondent from 
participation in Medicare, Medicaid and all federal health care 
programs for a minimum period of five years pursuant to 42 U.S.C. 
1320a-7(a), effective March 20, 2018. Notwithstanding the fact that the 
underlying conduct for which the Respondent was convicted had no nexus 
to controlled substances, the Respondent's mandatory exclusion from 
Medicare, Medicaid, and all federal health care programs by HHS/OIG 
warrants revocation of the Respondent's registration pursuant to 21 
U.S.C. 824(a)(5). See, e.g., Richard Hauser, M.D., 83 FR 26308 (2018).

The Hearing

Government's Opening Statement

    The Government outlined its case in its Opening Statement. The 
Government seeks the revocation of the Respondent's registrations 
pursuant to 21 U.S.C. 824(a)(5), as the Respondent has been excluded 
from a program pursuant to Sec.  1320a-7a of Title 2. Tr. 12. The 
Government explained that in 2017, the Respondent entered an Alford 
plea of guilty, to the felony offense of false statement to Medicaid, 
in the Circuit Court of Fairfax County, Virginia. On the basis of that 
conviction, in 2018, the Department of Health and Human Resources, 
Office of Inspector General mandatorily excluded the Respondent from 
participation in Medicare, Medicaid and all federal health care 
programs pursuant to 42 U.S.C. 1320a-7(a). The Respondent's exclusion 
remains in effect. Id.

Respondent's Opening Statement

    In his Opening Statement, the Respondent noted he has stipulated to 
all of the operative facts of the case. Id. at 13. The Respondent 
conceded he was convicted as charged, he was excluded from 
participation from Medicare, Medicaid and all federal health benefit 
programs, as alleged. Acknowledging the evidentiary burden shift to 
him, upon the prima facie showing of these facts, the Respondent argued 
that his

[[Page 35340]]

Registrations should not be revoked as that would be inconsistent with 
the public interest. The Respondent argued that he has accepted 
responsibility for his misconduct, and further that this type of 
conduct can no longer reoccur, as preventive safeguards are now in 
place.
    Referring to the five operative factors under Sec.  823(f), the 
Respondent noted that the Respondent has the ``backing and support'' of 
the state nursing boards. Id. at 14. He is knowledgeable and 
experienced with respect to controlled substances. He has never been 
accused of any violation, state or federal, of controlled substance 
statutes. He has always complied with these statutes. Finally, there is 
no evidence that any of his ``other conduct'' could be a threat to the 
public safety. Thus, in balancing the five factors under Sec.  823(f), 
the retention of his registrations would not be inconsistent with the 
public interest. Id. at 15.

Government's Case in Chief

    Before presenting witnesses, the Government offered the sworn and 
notarized COR history for the Respondent, which was admitted without 
objection. See GX 1. The Government otherwise presented its case in 
chief through the testimony of a single witness. The Government 
presented the testimony of a Diversion Investigator.

Diversion Investigator (DI)

    The DI has worked for the Drug Enforcement Administration for five 
and a half years and holds a Bachelor's Degree in Accounting and a 
Master's Degree in Business Administration. Tr. 16-17. She has 
graduated from the 12-week Basic Diversion Investigator School. Id. at 
17. She has also received advanced diversion investigator training, 
tactical diversion training, and asset forfeiture training. Id. at 18.
    The instant investigation commenced when the DEA learned that the 
Respondent's Tennessee Nursing license had been suspended by the 
Tennessee Board of Nursing. Id. The DI later learned that the 
Respondent had been excluded from Medicare, Medicaid and all other 
federal health care programs by HHS/OIG. The DI obtained a copy of the 
Respondent's Alford plea of guilty to the Virginia felony offense of 
False Statement to Medicaid, a copy of the sentencing order and a copy 
of the Respondent's exclusion letter by HHS/OIG. Id. at 19-22; GX 3, 4, 
5. The DI verified the Respondent's exclusion by accessing the HHS 
website. Tr. 23; GX 6. The DI confirmed on the HHS website the 
exclusion remained active as of the day of the hearing. Tr. 24.
    On cross-examination, the DI conceded the instant case did not 
involve the diversion of controlled substance, nor was she aware of any 
such violations by the Respondent. Id. at 24-25.

Respondent's Case in Chief

Keith A. Jenkins, N.P.

    The Respondent, Keith A. Jenkins, is a licensed Advanced Practice 
Registered Nurse in Tennessee and Ohio. Id. at 33; RX 1, 7. He holds 
DEA registrations in Tennessee and Ohio. Tr. 33, 39-40; RX 4. Other 
than this instant proceeding, the Respondent has never been disciplined 
or cautioned by the DEA. Tr. 39, 61. The Respondent has never been 
admonished, reprimanded or disciplined by any of the state nursing 
boards regarding his prescribing practices. Id. at 61. The Respondent 
has never been convicted of any offense involving controlled 
substances. Id.
    His educational background includes an Associate's Degree in 
Medical Laboratory Technology from Cumberland College in 1997, an 
Associate's Degree in Nursing in 2002, a Master's Degree in Nursing and 
Adult Bariatric Nurse Practitioner in 2014, post-Master's Certificate 
for Family Nurse Practitioner in 2015, and post-Master's Certificate 
for Psychiatric Nurse Practitioner in 2017. Id. at 28. The Respondent 
is currently working on his Doctorate, which he expects to complete by 
January 2020.
    The Respondent is an adjunct faculty member in a nurse practitioner 
program. Id. at 28-29; RX 1. He teaches various courses, including 
Pharmacology. Tr. 41. He works part-time at two clinics, a bariatric 
clinic, and a primary care psychiatric clinic. Id. at 29. The 
Respondent typically prescribed controlled substances, Phentermine and 
Qsymia. At the psychiatric clinic, controlled substances typically 
prescribed include benzodiazepines, such as Clonazepam. Other 
controlled substances prescribed there include Alprazolam, Ritalin, and 
Adderall. Id. at 30. The Respondent also volunteers at a free clinic 
and may prescribe, on average, one opioid per month. Id. at 31, 80.
    The Respondent reported taking precautions in prescribing 
controlled substances, including checking the state database for 
patient drug use pattern or use history. Id. at 32. Additionally, he 
requires drug screens if warranted by the results of the database 
inquiry, as well as randomly. To remain current with obligations 
regarding prescribing controlled substances, the Respondent reported 
that he attends at least two medical conferences per year, a number of 
continuing education courses, and receives regulatory updates. Id. at 
41, 44; RX 9, 10, 11. His adjunct faculty position also requires him to 
stay current with prescribing protocol.
    The Respondent's Ohio APRN includes the authority to prescribe 
controlled substances. Tr. 34; RX 7. At the time of the hearing, the 
Respondent's authority to prescribe in Ohio was unrestricted. However, 
the Respondent's Tennessee license reflected the disciplinary action of 
probation, requiring some continuing education as a result of the 
Virginia state court conviction. Tr. 36; RX 8. The Respondent has 
completed the required continuing education. Tr. 42-43; RX 9, 10, 11. 
His Tennessee prescribing authority remained unrestricted. Tr. 36, 60. 
In September 2019, despite disclosing the circumstances surrounding his 
Virginia conviction, the Respondent obtained South Carolina nursing 
licensure. Id. at 37-38; RX 12. He retains unrestricted prescribing 
authority in South Carolina. Tr. 38.
    As relates to the Respondent's underlying misconduct, the 
Respondent worked for Actera Home Health from 2008-2015, as 
Administrator. Id. at 45. He did not generally provide any clinical 
support or prescribe medication. Id.
    His employment there ended as a result of an audit by state 
authorities. The mother of a child patient of the home health service 
was found to be abusing medication. Id. at 46. In response to actions 
by the service, the mother filed a complaint with state regulators 
against the home health service, resulting in an investigation and 
audit. Id. Although the investigation revealed no wrongdoing by the 
service, the audit disclosed a billing discrepancy. A different child 
patient was signed up for ``personal care'' services. Id. at 47, 71, 
73-74. The service used an Electronic Medical Record system (EMR) to 
maintain treatment records and to bill for services. The Respondent 
explained that the service's EMR system could not directly bill 
Medicaid, so the service used a secondary billing system to bill 
Medicaid, which auto billed weekly. Id. at 48, 70. The secondary 
billing system would automatically ``pull claims over'' to it from the 
EMR. Id. at 48, 70-71. Services for this child were initiated and 
reported in the EMR system, which automatically initiated the Medicaid 
billing through the secondary billing system. Id. at 48, 71, 78. The 
normal checks and balances within the home

[[Page 35341]]

health service involved squaring the care-giver service reports with 
the billing. Id. at 49, 72. If the caregiver reported a cessation of 
care or change in care, the billing would be ceased or adjusted to 
reflect that. Id. at 78-79. However, in this case, the grandmother/
custodian refused to allow care-givers to provide any care at all. As 
there were no care-giver reports generated, the billing to Medicaid 
continued automatically. There were no care-giver reports to prompt the 
review of that patient's billing to Medicaid, [so the audit safeguards 
never caught the error.] Id. at 49, 74-76, 78. The overpayment from 
Medicaid was approximately $80,000. Id. at 48. When the audit revealed 
this overpayment, Medicaid audited every patient the service billed 
Medicaid. No other discrepancies were discovered. Id. at 53, 78.
    The Respondent entered an Alford plea of guilty to false statement 
to Medicaid. Id. at 50, 52. The Respondent understood at the time of 
his plea that, as Administrator of the home health service, he was 
``responsible'' for the improper claims to Medicaid, despite that he 
did not personally enter the claims. Id. at 50, 69. His sentence was 
three years suspended, three years inactive probation, and $83,027.56 
in restitution. Id. at 51-52, 63. I asked the Respondent if he 
realized, at the time he plead guilty, the criminal offense of false 
statement to Medicaid required the intent of intentional or willful. 
The Respondent reported that his criminal attorney handled the plea 
negotiation and recommended the Respondent view the guilty plea as a 
``business decision.'' Id. at 68-69. [Respondent stated, ``Since they 
never got a record on him, it never got caught. In hindsight, it was a 
huge gap on our end or my end, really, that let that slip through.'' 
Id. at 49. His attorney asked, ``So whose fault was it?'' Id. ``Well, 
mine.'' Id.]
    Conceding the Government proved its prima facie case, the 
Respondent argued that he should be permitted to keep his CORs. Id. at 
57. He explained that the incident that gave rise to the felony 
conviction and the resultant HHS exclusion was [``an isolated incident, 
it wasn't intentional but [he does] realize that in [his] acting role 
as administrator, ultimately, it is [his] responsibility.''] Id. at 58, 
67. The Respondent did not have clinical duties at the service. He did 
not supervise the line care providers. They were supervised by the 
nursing director. Id. at 77-78. Although he had access to the billing 
records in the form of an electronic report, his duties did not include 
reviewing the accuracy of the billing report. Id. at 78. The accuracy 
of the billing was insured by periodic audits, which failed them in 
this case. Id. The Respondent did not benefit from the overpayment,\*B\ 
other than his salary.
---------------------------------------------------------------------------

    \*B\ This fact seems to be reasonably inferred from the record. 
The clinic paid restitution ``immediately once it was identified.'' 
Tr. 52.
---------------------------------------------------------------------------

    For his Tennessee APRN, a physician supervisor is required. Id. at 
59. The Respondent has a physician supervisor at each clinic where he 
works. Id. at 63-64. Although supervision is required once a month, he 
works closely with his physician supervisor and sees him weekly. The 
supervisor critically reviews patient charts and must sign off on each 
controlled substance prescription. Id. at 59. The Respondent reported 
that his supervisors have yet to reject any of the Respondent's 
prescriptions. Id. at 65.
    The Respondent reported that he has not used his Ohio nursing 
license. He has not worked in Ohio. Id. at 66.
    The Respondent stated he remains fully compliant with state and 
federal controlled substance laws and regulations. Id. at 61. The 
Respondent noted he was an infrequent prescriber of controlled 
substances. Id. The Respondent believed it is in the public interest 
for him to retain his registrations.

The Facts

Stipulations of Fact

    The Government and the Respondent have agreed to each of the 
following stipulations, which I recommend be accepted as fact in these 
proceedings:
    1. Respondent is registered with the DEA as a MLP-nurse 
practitioner in Schedules II through V under DEA Certificate of 
Registration MJ3401609 at 105 Vanner Rd., Mt. Juliet, TN 37122. 
Respondent is also registered with the DEA under DEA Certificate of 
Registration MJ4509331 at 3909 Woodley Rd., Toledo, OH 43606, with a 
mailing address of 105 Vanner Rd., Mt. Juliet, TN 37122. Respondent's 
registrations both expire by their terms on December 31, 2020. Prior to 
the current action, Respondent's DEA Certificates of Registration have 
not been the subject to disciplinary or other adverse action by the 
DEA.
    2. From 2006 to 2013, Respondent worked in an administrative, non-
clinical, capacity for a Virginia-based home health agency. While 
employed at the home health agency, the agency was audited by state 
Medicaid authorities and Respondent's role in the billing of claims for 
a specific patient were investigated by the state. On August 7, 2017, 
Respondent entered an ``Alford Plea of Guilty to a Felony'' to the 
offense of ``False Statement to Medicaid.'' On August 11, 2017, the 
Circuit Court of Fairfax County, Virginia, entered its sentencing Order 
for Respondent's offense of ``False Statement of Payment(F)'' in 
violation of Va. Code Section 32.1-314(F) FRD3337F9. Commonwealth of 
Virginia v. Keith Allen Jenkins, No. FE-2017-0000711 (Fairfax Cty. Cir. 
Ct.). Mr. Jenkins was sentenced to ``3 years w/all 3 years suspended.'' 
Furthermore, the Court Ordered that all ``3 years [were subject to] 
inactive probation.'' Simply put, Mr. Jenkins was not incarcerated, nor 
is he required to report to a Probation Officer during the period of 
his 3-year suspended sentence.
    3. Based on Respondent's conviction, the U.S. Department of Health 
and Human Services, Office of Inspector General (``HHS/OIG''), by 
letter dated February 28, 2018, mandatorily excluded Respondent from 
participation in Medicare, Medicaid and all federal health care 
programs for a minimum period of five years pursuant to 42 U.S.C. 
1320a-7(a), effective March 20, 2018.
    4. Reinstatement of eligibility to participate in Medicare, 
Medicaid and all federal health care programs after exclusion by HHS/
OIG is not automatic.
    5. Respondent is currently excluded from participation in Medicare, 
Medicaid and all federal health care programs.
    6. Restitution in the amount of $83,027.56 to the Medicaid program 
was ordered by the Court. The restitution was paid in full by the time 
of Respondent's Alford Plea filing.
    7. On April 23, 2019, the Assistant Administrator, Diversion 
Control Division, DEA, issued an Order to Show Cause to Respondent, 
giving Respondent notice of an opportunity to show cause why the DEA 
should not revoke Respondent's DEA Certificates of Registration Nos. 
MJ3401609 (Tennessee) and MJ4509331 (Ohio), pursuant to 21 U.S.C. 
824(a)(5), and deny any pending application(s) as a practitioner for 
registration in Schedules II through V, alleging that Respondent has 
been excluded from participation in all federal health care programs as 
defined in 21 U.S.C. 824(a)(5).
    8. On May 16, 2019, Respondent, through his legal counsel, filed a 
timely request for administrative hearing in the Matter of Keith A. 
Jenkins, N.P.
    9. On May 17, 2019, the Administrative Law Judge (ALJ) assigned to 
this case issued the Court's Order for Prehearing Statements to the DEA 
and Respondent.
    10. On May 29, 2019, counsel for the Government filed the 
Government's

[[Page 35342]]

Prehearing Statement. Concurrent with this filing, counsel also filed 
the Government's Motion for Summary Disposition.
    11. On May 30, 2019, Respondent filed an Unopposed Motion for 
Extension of Time to Submit Respondent's Prehearing Statement and 
Respondent's Response to the Government's Motion for Summary 
Disposition.
    12. On May 31, 2019, the Court issued its Order Granting 
Respondent's Unopposed Motion for Extension of Time until June 21, 2019 
at 2:00 p.m. EST.
    13. Respondent is currently licensed by the Ohio Board of Nursing 
to practice as an Advanced Practice Registered Nurse (APRN), license 
number APRN.CNP.021771. The Respondent's Ohio APRN license includes the 
authority to prescribe.
    14. Respondent is currently licensed by the Tennessee Board of 
Nursing to practice as an Advanced Practice Registered Nurse, license 
no. 19606. Respondent's Tennessee APRN license is currently on 
probation but is unrestricted.
    15. At this time, Respondent's DEA Certificates of Registration in 
Ohio and Tennessee are active and he is authorized to prescribe 
controlled substances in Schedules II through V.

Findings of Fact

    The factual findings below are based on a preponderance of the 
evidence, including the detailed, credible, and competent testimony of 
the aforementioned witnesses, the exhibits entered into evidence, and 
the record before me.
    1. Respondent is registered with the DEA as a MLP-nurse 
practitioner in Schedules II through V under DEA Certificate of 
Registration MJ3401609 at 105 Vanner Rd., Mt. Juliet, TN 37122. 
Respondent is also registered with the DEA under DEA Certificate of 
Registration MJ4509331 at 3909 Woodley Rd., Toledo, OH 43606, with a 
mailing address of 105 Vanner Rd., Mt. Juliet, TN 37122. Stipulation 
(``Stip.'') l; ALJ Ex. 13 at 10. Respondent's registrations both expire 
by their terms on December 31, 2020. Id. Prior to the current action, 
Respondent's DEA Certificates of Registration have not been the subject 
of disciplinary or other adverse action by the DEA. Id.
    2. On August 7, 2017, Respondent entered an ``Alford Plea of Guilty 
to a Felony'' to the offense of ``False Statement to Medicaid.'' Stip. 
2; ALJ Ex. 13 at 10. On August 11, 2017, the Circuit Court of Fairfax 
County, Virginia, entered its sentencing Order for Respondent's offense 
of ``False Statement for Payment (F)'' in violation of Va. Code Section 
32.1-314(F) FRD3337F9. See Commonwealth of Virginia v. Keith Allen 
Jenkins, No. FE-2017-0000711 (Fairfax Cty. Cir. Ct.).
    3. Based on Respondent's conviction, the U.S. Department of Health 
and Human Services, Office of Inspector General (``HHS/OIG''), by 
letter dated February 28, 2018, mandatorily excluded Respondent from 
participation in Medicare, Medicaid and all federal health care 
programs for a minimum period of five years pursuant to 42 U.S.C. 
1320a-7(a), effective March 20, 2018. Stip. 3; ALJ Ex. 13 at 10-11.
    4. Reinstatement of eligibility to participate in Medicare, 
Medicaid and all federal health care programs after exclusion by HHS/
OIG is not automatic. Stip. 4; ALJ Ex. 13 at 11.
    5. Respondent is currently excluded from participation in Medicare, 
Medicaid and all federal health care programs. Stip. 5; ALJ Ex. 13 at 
11.
    6. Restitution in the amount of $83,027.56 to the Medicaid program 
was ordered by the Court. Stip. 6; ALJ Ex. 13, at 11.
    7. On April 23, 2019, the Assistant Administrator, Diversion 
Control Division, DEA issued an Order to Show Cause to Respondent, 
giving Respondent notice of an opportunity to show cause why the DEA 
should not revoke Respondent's DEA Certificates of Registration Nos. 
MJ3401609 (Tennessee) and MJ4509331 (Ohio), pursuant to 21 U.S.C. 
824(a)(5), and deny any pending application(s) as a practitioner for 
registration in Schedules II through V, alleging that Respondent has 
been excluded from participation in all federal health care programs as 
defined in 21 U.S.C. 824(a)(5). Stip. 7; ALJ Ex. 13 at 11.
    8. On May 16, 2019, Respondent, through his legal counsel, filed a 
timely request for administrative hearing in the Matter of Keith A. 
Jenkins, N.P. Stip. 8; ALJ Ex. 13 at 11.
    9. On May 17, 2019, the Administrative Law Judge (ALJ) assigned to 
this case issued the Court's Order for Prehearing Statements to the DEA 
and Respondent. Stip. 9; ALJ Ex. 13 at 11.
    10. On May 29, 2019, counsel for the Government filed the 
Government's Prehearing Statement. Stip. 10; ALJ Ex. 13 at 11. 
Concurrent with this filing, counsel also filed the Government's Motion 
for Summary Disposition. Id.
    11. Respondent is currently licensed by the Ohio Board of Nursing 
to practice as an Advanced Practice Nurse (APRN), license number 
APRN.CNP.021771. Stip. 13; ALJ Ex. 13 at 12.
    12. The Respondent's Ohio APRN license includes authority to 
prescribe. Id.
    13. Respondent is currently licensed by the Tennessee Board of 
Nursing to practice as an Advanced Practice Registered Nurse, license 
no. 19606. Stip. 14; ALJ Ex. 13 at 12. Respondent's Tennessee APRN 
license is currently on probation but is unrestricted. Id.
    14. At this time, Respondent's DEA Certificates of Registration in 
Ohio and Tennessee are active and he is authorized to prescribe 
controlled substances in Schedules II through V. Stip. 15; ALJ Ex. 13 
at 12.
    15. Respondent testified that he works at a bariatric clinic where 
he predominately treats morbid obesity and typically prescribes 
Phentermine and Qsymia to those patients. Tr. 29.
    16. He also works at a primary behavioral health clinic where he 
treats depression, anxiety, schizophrenia, bipolar disorder, 
personality disorders, and substance abuse disorders and prescribes 
benzodiazepines such as Clonazepam and Alprazolam, as well as 
stimulants such as Ritalin and Adderall. Id. at 30.
    17. Respondent testified that at both the bariatric clinic and the 
behavioral health practice where he works, drug screens are performed 
to ensure that diversion doesn't occur. Id. at 32.
    18. Respondent testified that although he holds two DEA 
Certificates of Registration, he does not use his registration for 
Ohio. Id. at 39.
    19. Respondent testified that to remain current in his knowledge 
of, and obligations with respect to, controlled substances and 
prescribing he attends conferences and takes continuing education. Id. 
at 41-42; RX 9; RX 11.
    20. Respondent testified that from 2008 to 2015 he worked at Actera 
Home Health, which was a home health agency that provided skilled care, 
private duty and personal care. Tr. 45.
    21. Respondent testified that he did not generally provide clinical 
support at Actera Home Health, nor did he write prescriptions there. 
Id.
    22. Respondent testified that the mother of a child receiving 
services at Actera Home Health lodged a complaint against Actera Home 
Health. Id. at 46.
    23. Respondent testified that the complaint was not substantiated. 
Id.
    24. During investigation of the complaint by the state of Virginia 
a billing error was discovered for a different patient. Id. at 46, 71.
    25. Respondent testified that the billing error was an overpayment 
of approximately $80,000. Id. at 48.
    26. Respondent testified that the service's billing checks-and-
balance

[[Page 35343]]

system failed to disclose an improper billing to Medicaid. Once the 
initiation of a patient's treatment is entered into the Electronic 
Medical Record (EMR), which triggers automatic billing, in this case to 
Medicaid, that billing continues until a treatment report noting 
cessation of treatment triggers the termination of billing. Here, the 
patient's guardian refused treatment for the patient. So, no treatment 
reports were ever generated and automatic billing to Medicaid 
continued, despite no treatment being provided. Id. at 48, 71, 74.
    27. Respondent testified that ``it was a huge gap on our end or my 
end, really, that let that slip through.'' Id. at 49.
    28. Respondent testified that the fault was ``mine'' and that it 
was ``my responsibility.'' Id.
    29. Respondent testified that he entered an Alford plea regarding 
this incident. Id. at 29; GX 3.
    30. Respondent testified that he entered the Alford plea because 
``I did not personally go enter these claims, but I am responsible for 
it as the administrator.'' Tr. 50.
    31. Respondent testified that he was sentenced to three years, but 
it was suspended and he served no time in jail. Id. at 51.
    32. Respondent testified that he was put on probation for three 
years, which remains in effect for another year. Id. at 51-52.
    33. Respondent testified that the clinic paid restitution of 
$83,027.67. Id. at 42; GX 3.
    34. Respondent testified that his Alford plea resulted in his 
conviction of a felony for a ``false statement to Medicaid.'' Tr. 52.
    35. Respondent testified that he was excluded by the HHS/OIG from 
Medicare and Medicaid. Id. at 54, 57; GX 5.
    36. Respondent testified that his false statement to Medicaid ``was 
an isolated incident,'' ``wasn't intentional'' but that as 
administrator ``it is my responsibility.'' Tr. 58.
    37. Respondent testified that ``[t]he Board of Nursing did not deem 
me a threat to public welfare and safety'' and that he has ``no 
criminal background at all with substances.'' Id.
    38. Respondent testified that he ``absolutely'' accepts 
responsibility for the misconduct. Id. at 58, 67.
    39. Respondent testified that he considers his criminal conviction 
to be a serious violation. Id. at 67.
    40. Respondent testified that he is remorseful for his violation. 
Id. at 58, 67.
    41. Respondent testified that this violation will not happen again 
because he no longer works in administrative roles, but instead 
provides direct patient care and does no billing. Id. at 58.
    42. Respondent testified that he also has a physician supervisor 
who provides oversight. Id. at 58-59. Respondent testified that, under 
Tennessee law, his physician supervisor must sign off on every 
controlled substance prescription that he writes. Id. at 59, 65.
    43. Respondent testified that his Tennessee nursing license is on 
probation, but that he has no restrictions on his practice or on 
prescribing. Id. at 60.
    44. Respondent testified that none of the allegations against him 
from the home health agency involved controlled substances. Id.
    45. Respondent testified that his probation is scheduled to end in 
August 2020. Id. at 64; GX 4.

Analysis

Findings as to Allegations

    The Government alleges that the Respondent's COR should be revoked 
and any pending applications be denied because the Respondent has been 
excluded from all federal health care programs, pursuant to 21 U.S.C. 
824(a)(5). The Agency has held that section 824(a)(5) authorizes the 
revocation of existing registrations, as well as the denial of 
applications. Dinorah Drug Store, Inc., 61 FR 15,972 (1996); Kuen H. 
Chen, M.D., 58 FR 65,401 (1993).
    In the adjudication of a revocation or suspension of a DEA COR, DEA 
has the burden of proving that the requirements for such revocation or 
suspension are satisfied. 21 CFR 1301.44(e) (2010). Where the 
Government has sustained its burden and made its prima facie case, a 
respondent must both accept responsibility for his actions and 
demonstrate that he will not engage in future misconduct. Patrick W. 
Stodola, M.D., 74 FR 20,727, 20,734 (2009). Acceptance of 
responsibility and remedial measures are assessed in the context of the 
``egregiousness of the violations and the [DEA's] interest in deterring 
similar misconduct by [the] Respondent in the future as well as on the 
part of others.'' David A. Ruben, M.D., 78 FR 38,363, 38,364 (2013). 
Where the Government has sustained its burden, that registrant must 
present sufficient mitigating evidence to assure the Acting 
Administrator that he/she can be entrusted with the responsibility 
commensurate with such a registration. Medicine Shoppe-Jonesborough, 73 
FR 364, 387 (2008).
    The burden of proof at this administrative hearing is a 
preponderance-of-the-evidence standard. Steadman v. SEC, 450 U.S. 91, 
100-01 (1981). The Acting Administrator's factual findings will be 
sustained on review to the extent they are supported by ``substantial 
evidence.'' Hoxie v. DEA, 419 F.3d 477, 481 (6th Cir. 2005). The 
Supreme Court has defined `substantial evidence' as such relevant 
evidence as a reasonable mind might accept as adequate to support a 
conclusion. Consolidated Edison Co. of New York v. National Labor 
Relations Board, 305 U.S. 197, 229 (1938). While ``the possibility of 
drawing two inconsistent conclusions from the evidence'' does not limit 
the Acting Administrator's ability to find facts on either side of the 
contested issues in the case, Shatz v. U.S. Dep't of Justice, 873 F.2d 
1089, 1092 (8th Cir. 1989); Trawick v. DEA, 861 F.2d 72, 77 (4th Cir. 
1988), all ``important aspect[s] of the problem,'' such as a 
respondent's defense or explanation that runs counter to the 
Government's evidence must be considered. Wedgewood Vill. Pharmacy v. 
DEA, 509 F.3d 541, 549 (D.C. Cir. 2007); Humphreys v. DEA, 96 F.3d 658, 
663 (3rd Cir. 1996). The ultimate disposition of the case must be in 
accordance with the weight of the evidence, not simply supported by 
enough evidence to justify, if the trial were to a jury, a refusal to 
direct a verdict when the conclusion sought to be drawn from it is one 
of fact for the jury. Steadman, 450 U.S. at 99 (internal quotation 
marks omitted).
    Regarding the exercise of discretionary authority, the courts have 
recognized that gross deviations from past agency precedent must be 
adequately supported, Morall v. DEA, 412 F.3d 165, 183 (D.C. Cir. 
2005), but mere unevenness in application does not, standing alone, 
render a particular discretionary action unwarranted. Chein v. DEA, 533 
F.3d 828, 835 (D.C. Cir. 2008) (citing Butz v. Glover Livestock Comm'n 
Co., 411 U.S. 182, 188 (1973)). It is well-settled that since the 
Administrative Law Judge has had the opportunity to observe the 
demeanor and conduct of hearing witnesses, the factual findings set 
forth in this recommended decision are entitled to significant 
deference, Universal Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951), 
and that this recommended decision constitutes an important part of the 
record that must be considered in the Acting Administrator's decision. 
Morall, 412 F.3d at 179. However, any recommendations set forth herein 
regarding the exercise of discretion are by no means binding on the 
Acting Administrator and do not limit the

[[Page 35344]]

exercise of that discretion. 5 U.S.C. 557(b) (2006); River Forest 
Pharmacy, Inc. v. DEA, 501 F.2d 1202, 1206 (7th Cir. 1974); Attorney 
General's Manual on the Administrative Procedure Act 8 1947).

Exclusion Under 42 U.S.C. 1320a-7(a)

    The Government has alleged that the Respondent has been excluded 
from participation in a program pursuant to section 1320a-7(a) of Title 
42. The Government can meet its burden under Sec.  824(a)(5) simply by 
advancing evidence that the registrant has been excluded from a federal 
health care program under 42 U.S.C. 1320a-7(a). 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/applicant's 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 1320a-7(a). 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 Pillot-Costas, 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 respondent's 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 respondent's ``prescribing practices'').[ 
] \*C\
---------------------------------------------------------------------------

    \*C\ Language omitted for clarity.
---------------------------------------------------------------------------

Government's 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. 824(a).
    It is clear from the stipulations, the Government's evidence, and 
the Respondent's position in this matter that there is no controversy 
between the parties that the Respondent was 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-7(a). The Government's evidence clearly 
demonstrates the necessary elements of proof under 21 U.S.C. 824(a)(5) 
and I find that the Government has established a prima facie case for 
revocation of the Respondent's 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 Government's evidence and the Agency's interest in 
both specific and general deterrence. David A. Ruben, M.D., 78 FR 
38,363, 38,364, 38,385 (2013).[ ] \*D\
---------------------------------------------------------------------------

    \*D\ Analysis of public interest factors omitted for relevance.
---------------------------------------------------------------------------

Acceptance of Responsibility and Rehabilitative Measures

    The Government's 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 Shoppe-Jonesborough, 73 FR 
364, 387 (2008); Samuel S. Jackson, 72 FR 23,848, 23,853 (2007).[ ] 
\*F\
---------------------------------------------------------------------------

    \*E\ Omitted text for clarity.
    \*F\ Omitted additional public interest analysis.
---------------------------------------------------------------------------

    The egregiousness and extent of an applicant's misconduct are 
significant factors in determining the appropriate sanction. See Jacobo 
Dreszer, 76 FR 19,386, 19,387-88 (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 cross-examination 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.
---------------------------------------------------------------------------

    \*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 Respondent's 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 68-69. 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 Respondent's Alford plea, I find that he 
consistently and completely accepted responsibility.
---------------------------------------------------------------------------

    [Moreover, it is noted that Respondent's 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

[[Page 35345]]

paid as a result of his criminal sentence, he answered precisely to the 
cent. Tr. 51. When he talked about the mistake in the billing, he 
corrected himself when he initially said ``we,'' and stated 
unequivocally that it was ``really'' him. Id. 49. In a situation such 
as this one that involved a mistake, it would have been very easy for 
Respondent to have shifted the blame or mitigated the circumstances 
surrounding his crime, but he unfalteringly maintained that it was his 
responsibility.] \*H\
---------------------------------------------------------------------------

    \*H\ Language added.
---------------------------------------------------------------------------

    Additionally, Respondent has consistently demonstrated that he has 
taken the necessary steps to correct the error. The Respondent has 
returned to clinical care, and is not involved in billing or any other 
administrative responsibility. [Respondent recognized that he should 
not hold a management or administrative position and Respondent changed 
his practice area. By doing so, Respondent has made the effort to 
ensure that there is no recurrence of his mistake in the future. I find 
this to be further evidence of his acceptance of responsibility that 
demonstrates that he has taken active steps to prevent future mistakes. 
He also attends a few conferences a year, receives regulatory update 
mailings, and stated that his role as adjunct faculty ``forces [him] to 
stay current.'' Id. at 41.] \*I\
---------------------------------------------------------------------------

    \*I\ Language added.
---------------------------------------------------------------------------

    Although correcting improper behavior and practices is very 
important to establish acceptance of responsibility, conceding 
wrongdoing is critical to reestablishing trust with the Agency. Holiday 
CVS, L.L.C., 77 FR 62,316, 62,346 (2012); Daniel A. Glick, D.D.S., 80 
FR at 74,801. Based upon the evidence presented, I find that the 
Respondent has demonstrated the full measure of acceptance of 
responsibility, and has fully demonstrated that he is remorseful for 
his actions and has taken considerable steps to ensure that this 
conduct will not be repeated.

Loss of Trust

    Where the Government has sustained its burden and established that 
a registrant has committed acts inconsistent with the public interest, 
that registrant must present sufficient mitigating evidence to assure 
the Acting Administrator that he can be entrusted with the 
responsibility commensurate with such a registration. Medicine Shoppe, 
73 FR at 387.
    As demonstrated by the evidence presented in this matter, it is 
clear to me that the Respondent has unequivocally accepted 
responsibility for his conduct. His underlying criminal conduct did not 
relate to his handling of controlled substances and the Government has 
not alleged or demonstrated any deficiencies by the Respondent related 
to controlled substance. [ ] \*J\
---------------------------------------------------------------------------

    \*J\ Language omitted for clarity.
---------------------------------------------------------------------------

    There is no indication that the Respondent has ever improperly 
handled controlled substances or that he represents a danger to the 
public. Based upon the evidence presented, and consistent with Jackson, 
Miller, and Stein, the Respondent has clearly demonstrated that he can 
be entrusted to properly maintain his COR.

Recommendation

    Considering the entire record before me, the conduct of the 
hearing, and observation of the testimony of the witnesses presented, I 
find that the Government has met its burden of proof and has 
established a prima facie case for revocation. However, [ ] \*K\ the 
evidence suggests that the Respondent has unequivocally accepted 
responsibility, is remorseful for his conduct, has withdrawn from any 
responsibilities related to billing or other administrative duties, and 
has presented convincing evidence demonstrating that the Agency can 
entrust him to maintain his COR.
---------------------------------------------------------------------------

    \*K\ Omitted text for clarity.
---------------------------------------------------------------------------

    Therefore, I recommend the Respondent's DEA Certificates of 
Registration MJ3401609 and MJ4509331 should not be revoked and any 
pending applications for renewal or modification of such registration, 
or for additional DEA registrations, be granted.

Signed: February 19, 2020.

Mark M. Dowd,
U.S. Administrative Law Judge

[FR Doc. 2021-14163 Filed 7-1-21; 8:45 am]
BILLING CODE 4410-09-P