[Federal Register Volume 85, Number 83 (Wednesday, April 29, 2020)]
[Notices]
[Pages 23845-23855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09057]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Kansky J. Delisma, M.D.; Decision and Order

    On May 23, 2019, the Drug Enforcement Administration (hereinafter, 
DEA or Government) Administrative Law Judge Charles Wm. Dorman 
(hereinafter, ALJ), issued a Recommended Rulings, Findings of Fact, 
Conclusions of Law and Decision (hereinafter, RD) on the action to deny 
Kansky J. Delisma, M.D.'s application for a DEA Certification of 
Registration. The Government filed exceptions to the RD to which Dr. 
Delisma responded. Having reviewed and considered the entire 
administrative record before me, including the Government's Exceptions, 
I adopt the ALJ's RD with minor modifications, where noted herein.\*A\
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    \*A\ I have made minor modifications to the RD. I have 
substituted initials for the names of witnesses to protect their 
privacy, and I have made minor, nonsubstantive grammatical changes. 
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.
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Government's Exceptions

    The Government filed an exception (hereinafter, Govt Exceptions) to 
the ALJ's interpretation and application of 21 U.S.C. 824(a)(5) and 
that provision's interplay with 42 U.S.C. 1320a-7(a). Govt Exceptions, 
at 2. 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

[[Page 23846]]

``has been excluded (or directed to be excluded) from participation in 
a program pursuant to section 1320a-7(a) of Title 42.'' Id. 42 U.S.C. 
1320a-7(a) provides a list of four predicate offenses for which 
exclusion from Medicare, Medicaid and federal health care programs is 
mandatory and sets out mandatory timeframes for such exclusion. Id.\*B\
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    \*B\ Although the language of 21 U.S.C. 824(a)(5) discusses 
suspension and revocation of a registration, it may also serve as 
the basis for the denial of a DEA registration application. Dinorah 
Drug Store, Inc., 61 FR 15972-03, 15973 (1996).
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    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 respondent is currently 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 has been excluded.'' Govt Exceptions, at 2. As the 
Government noted in its brief, the Government advocated for this 
position in several contemporaneous exclusion cases. Id. at n.2. Since 
the Government filed its brief, I have issued a Decision and Order in 
one of the other exclusion cases, Jeffrey Stein, M.D., that directly 
addressed and rejected the Government's argument. 84 FR 46968 (2019).
    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. 
Stein, 84 FR at 46970-71 (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 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 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 made a prima facie case to suspend or revoke a 
registration based on a mandatory exclusion pursuant to section 1320a-
7(a) of Title 42, I 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 23848, 23853 (2007) 
(quoting Leo R. Miller, M.D., 53 FR 21931, 21932 (1988)).\*C\
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    \*C\ 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 pursuant to section 824(a)(5). 
Stein at 46971-72; see also Narciso Reyes, M.D., 83 FR 61678, 61681 
(2018); KK Pharmacy, 64 FR at 49510 (collecting cases); Melvin N. 
Seglin, M.D., 63 FR 70431, 70433 (1998); Stanley Dubin, D.D.S., 61 
FR 60727, 60728 (1996).
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    As I explained in Stein, the Government's proposed reading of the 
CSA would also ``be a significant departure from past Agency 
decisions.'' 84 FR at 46970; see, e.g., Kwan Bo Jin, M.D., 77 FR 35021, 
35023 (2012); Dinorah Drug Store, Inc., 61 FR 15972, 15974 (1996).
    For the above reasons, I reject the Government's exception and 
issue the Order below adopting the recommendations of the ALJ.

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 W18071098C, submitted by 
Kansky J. Delisma, M.D., is approved. This Order is effective May 29, 
2020.

Uttam Dhillon,
Acting Administrator.

    Paul E. Soeffing, Esq., for the Government.
    Laura Perkovic, Esq. and Jeremy L. Belanger, Esq., C.H.C., for 
the Respondent.

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

    On January 17, 2019, the Drug Enforcement Administration served 
Kansky J. Delisma, M.D. (``Dr. Delisma'' or ``Respondent'') with an 
Order to Show Cause (``OSC''), proposing to deny his application for a 
DEA Certificate of Registration (``COR''), Control Number W18071098C. 
Administrative Law Judge Exhibit (``ALJ-'') 1, at 1. The OSC alleged 
that denial is warranted under 21 U.S.C. 824(a)(5), because Dr. Delisma 
is excluded from federal health care programs pursuant to 42 U.S.C. 
1320a-7(a). In response to the OSC, Dr. Delisma timely requested a 
hearing before an Administrative Law Judge. ALJ-2. The hearing that Dr. 
Delisma requested was held in Pittsburgh, Pennsylvania, on April 18, 
2019.
    The issue before the Acting Administrator is whether the record as 
a whole establishes by a preponderance of the evidence that DEA should 
deny the application for a Certificate of Registration of Kansky J. 
Delisma, M.D., Control Number W18071098C, and deny any pending 
application 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 he has been excluded from federal health care 
programs under 42 U.S.C. 1320a-7(a). ALJ-10, at 1.
    This Recommended Decision is based on my consideration of the 
entire Administrative Record, including all of the testimony, admitted 
exhibits, and the oral and written arguments of counsel.

The Allegation

    1. On May 31, 2016, judgment was entered against Dr. Delisma based 
on his guilty plea to one count of ``Receipt of Kickbacks in Connection 
with a Federal Health Care Program,'' in violation of 42 U.S.C. 1320a-
7b(b)(1)(A). Based on this conviction for health care fraud, the U.S. 
Department of Health and Human Services, Office of Inspector General 
(``HHS/OIG''), by letter dated August 31, 2016, mandatorily excluded 
Dr. Delisma from participation in Medicare, Medicaid, and all federal 
health care programs for the minimum statutory period of five years 
pursuant to 42 U.S.C. 1320a-7(a), effective September 20, 2016. ALJ-1, 
at 2. Despite the fact that the underlying conduct for which Dr. 
Delisma was convicted did not involve controlled substances, his 
mandatory exclusion from Medicare, Medicaid, and all federal health 
care

[[Page 23847]]

programs warrants denial of his application for DEA registration 
pursuant to 21 U.S.C. 824(a)(5). ALJ-1, at 2, paras. 2-3.

Witnesses

I. The Government's Witnesses

    Because Respondent stipulated to the admissibility of all of the 
Government's Exhibits, the Government called no witnesses. Stipulation 
(``Stip.'') 12. Rather, the Government moved the admission of 
Government Exhibits 1-4, and upon their admission into the 
Administrative Record, the Government rested its case. Transcript 
(``Tr.'') 14-15.

II. Respondent's Witnesses

    Respondent presented his case through two witnesses. The Respondent 
was the first witness. Tr. 17-57. In his testimony, Dr. Delisma 
provided background information about his education and training. Tr. 
17-20. He explained that he decided to go into medicine out of a ``true 
calling from inside to serve.'' Tr. 20. As such, after completing his 
medical education, he began his medical practice working at a Veteran's 
Hospital and a public health hospital in Miami, Florida. Id. He first 
obtained a DEA Certificate of Registration in 2004 and kept it until it 
expired in 2016. Tr. 28, 43-44.
    Dr. Delisma went into a private, internal medicine practice in 
2008-09. Tr. 20. While in that private practice, he accepted a kickback 
of $700. for referring a patient to a home-health provider. Tr. 28-29. 
Because of that action, following his guilty plea, Dr. Delisma was 
convicted in Federal Court of a single count of accepting a kickback. 
Id. For that crime, Dr. Delisma was sentenced to eight months 
confinement, to pay a $5,000. fine, fees of $100., and restitution of 
$49,000., and following his confinement, he was placed on one year of 
supervised release. Tr. 29. Dr. Delisma has satisfied all the terms of 
his sentence. Id. Because of his conviction, Dr. Delisma was excluded 
from participation in federal health care programs. Tr. 33-36.
    Although Dr. Delisma allowed his Florida medical license to expire, 
he later obtained licenses to practice medicine in Pennsylvania, 
Montana, New York, and Maryland. Tr. 36-39. At the time he applied for 
a license in each state, he informed the licensing board of his 
conviction and none placed any restrictions on his medical license. Tr. 
38-39. He currently works as the Medical Director at the State 
Correctional Institution in Somerset, Pennsylvania, and he has 
requested a Certificate of Registration for that location. Tr. 20-21, 
49. He is the only full-time physician who works at that facility. Tr. 
50-51. There have been times when his inmate patients have had to wait 
to obtain prescriptions for controlled substances. Tr. 52-54.
    Dr. Delisma has taken three continuing medical education courses, 
all related to medical ethics. Tr. 39-41, 44-45. He also accepted 
responsibility for his actions, and expressed his remorse. Tr. 29, 42.
    Dr. Delisma presented his testimony in a clear, candid, and 
convincing manner. He impressed me as sincere in his acceptance of 
responsibility and his remorse. I find his testimony to be entirely 
credible.
    The Respondent's second witness was Dr. A.D. Tr. 58-70. Dr. A.D. is 
the Regional Medical Director for the Central Region of the 
Pennsylvania Department of Corrections. Tr. 59. He has known Dr. 
Delisma since shortly before Dr. Delisma was hired into his current 
job. Id. Dr. A.D. wanted to meet and interview Dr. Delisma upon 
reviewing his ``remarkable'' credentials. Tr. 60.
    Dr. A.D. testified concerning the fine quality of work Dr. Delisma 
has performed as the medical director at Somerset. Tr. 60, 64, 68. He 
considers Dr. Delisma to be ``one of our top physicians.'' Tr. 60. Dr. 
A.D. also testified that Dr. Delisma's lack of a Certificate of 
Registration adversely impacts the quality of medical care he is able 
to provide to the inmates. Tr. 62-64, 67-68. In fact, it was Dr. A.D. 
who suggested that Dr. Delisma apply for a Certificate of Registration. 
Tr. 70; RE-10, at 1.
    Dr. A.D. presented his testimony in a clear, candid, and convincing 
manner. His testimony also corroborated substantial portions of Dr. 
Delisma's testimony. Accordingly, I find his testimony to be entirely 
credible.

The Facts

I. Stipulations

    The Parties agree to 12 stipulations, which are accepted as facts 
in these proceedings:
    1. Respondent applied to DEA for registration as a practitioner in 
Schedules II through V pursuant to DEA control number W18071098C, with 
a proposed registered address of 1590 Walters Mill Rd., Somerset, PA 
15510 and a proposed mailing address of 600 N 12th Street, Lemoyne, PA 
17043. Respondent submitted his online application on or about July 9, 
2018.
    2. On May 31, 2016, judgment was entered against Respondent in the 
United States District Court for the Southern District of Florida based 
on his guilty plea to one count of ``Receipt of Kickbacks in Connection 
with a Federal Health Care Program,'' in violation of 42 U.S.C. 1320a-
7b(b)(l)(A).
    3. HHS/OIG, by letter dated August 31, 2016, mandatorily excluded 
Respondent from participation in Medicare, Medicaid and all federal 
health care programs for the minimum statutory period of five years 
pursuant to 42 U.S.C. 1320a-7a. The exclusion was effective September 
20, 2016.
    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. Since Respondent's criminal conviction, he has satisfied all 
assessments, fines, and restitution as of August 22, 2017. Tr. 10-11.
    7. On April 24, 2018, the Florida Board of Medicine settled its 
case with Respondent by issuing a Letter of Concern and by requiring 
Respondent to pay a fine.
    8. Respondent was issued a medical license by the Pennsylvania 
Bureau of Professional and Occupational Affairs as of March 22, 2018.
    9. Respondent was issued a medical license by the New York State 
Education Department on July 2, 2018.
    10. Respondent was issued a medical license by the Maryland Board 
of Physicians on June 19, 2018, with terms and conditions. All of those 
terms and conditions were satisfied as of November 21, 2018.
    11. On January 26, 2018, Respondent was issued a medical license by 
the Montana Board of Medical Examiners.
    12. The Government and Respondent stipulate to the admissibility of 
Government Exhibits 1-4.

II. Findings of Fact

Dr. Delisma's Background and Training
    1. Dr. Delisma was born in Haiti, where he completed high school. 
Tr. 17.
    2. At age 19, Dr. Delisma went to the University of Bordeaux in 
France, where he studied for six years. Tr. 17. While in France, Dr. 
Delisma earned four university degrees. Tr. 17-18.
    3. Dr. Delisma immigrated to the United States in 1992, moving to 
South Florida. Tr. 18.
    4. Dr. Delisma attended Howard University Medical School in 
Washington, DC, from 1997 to 2001. Tr. 19.
    5. From 2001 to 2004, Dr. Delisma completed an internship and 
residency

[[Page 23848]]

in internal medicine at the Yale University School of Medicine. Tr. 19. 
Dr. Delisma remained at Yale for another year, as an attending 
physician. Id.
    6. Dr. Delisma had a DEA registration from 2004 until it expired in 
May 2016. Tr. 28, 43-44.
    7. Dr. Delisma received a scholarship to Harvard University in 
2005, where he completed a master's degree in public health and a 
fellowship in health policy in 2006. Tr. 19.
Dr. Delisma's Medical Practice in Florida
    8. Dr. Delisma returned to South Florida in 2006, where he worked 
as an emergency room physician at the Veterans Administration hospital 
in Miami for two years, and for a year at Jackson Hospital, a public 
health hospital in Miami. Tr. 19-20.
    9. In 2008-09, Dr. Delisma began private practice in internal 
medicine in Florida. Tr. 20. He treated about 60% of his patients in 
hospital settings, and about 40% were in an outpatient clinic. Tr. 20
    10. Dr. Delisma let his Florida medical license expire and did not 
renew it. Tr. 36.
Medicare Exclusion
    11. Dr. Delisma's exclusion from federal health care programs is 
the result of his 2016 conviction in Florida for receiving a $700. 
kickback for referring a patient to a home health agency. Tr. 28; 
Government Exhibit (``GE-'') 2, 3. His conviction involved only one 
patient. Tr. 28-29.
    12. Dr. Delisma pled guilty to the offense and took responsibility 
for his actions. Tr. 29. Dr. Delisma offered his apology, and is deeply 
sorry for his actions. Id.
    13. On May 26, 2016, Dr. Delisma was convicted, and sentenced to 
eight months in Federal detention in Miami, Florida, followed by one 
year of supervised release. Tr. 29; GE-2, at 2-3. He was also ordered 
to pay $49,000. in restitution, a $5,000. fine, and $100. in fees. Tr. 
29; GE-2, at 5-6.
    14. The restitution that Dr. Delisma was required to pay was for 
the amount of money the home-health care provider had billed Medicare 
for the patient Dr. Delisma had referred to the home health care 
provider. Tr. 50.
    15. Dr. Delisma satisfied all the conditions of his sentence by 
January 2018.\1\ Tr. 29; RE-1.
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    \1\ The ``Satisfaction of Judgment'' was entered on August 22, 
2017. RE-1.
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    16. Concerning Dr. Delisma's conviction, there were no issues 
regarding the quality of the patient care he rendered to his patients. 
Tr. 31. In addition, there were no allegations concerning prescribing 
any medications. Id.
    17. Because of Dr. Delisma's exclusion from federal health care 
programs, the Florida Board of Medicine (``Board'') reprimanded him and 
imposed a $500. fine, but placed no restrictions on his practice.\2\ 
Tr. 35-36; RE-2, at 4-5. In addition, Dr. Delisma was required to 
reimburse the Board $882.94. to cover the cost of its proceedings 
against him. RE-2, at 1, 6.
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    \2\ Although Dr. Delisma testified that the Florida Board of 
Medicine did not impose any restrictions on his medical license, he 
also testified that his ``license was reinstated after being 
suspended for one year.'' Tr. 36. Nothing in the Final Order of the 
Board, or in the Settlement Agreement with the Board, however, 
indicates that the Board suspended Dr. Delisma's medical license. 
RE-2, at 1-14.
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Dr. Delisma's Current Medical Position
    18. Dr. Delisma is currently licensed to practice medicine in 
Pennsylvania, Montana, New York, and Maryland. Tr. 37-39; RE-3, 4, 7, 
8. When applying for a medical license in each of the states, Dr. 
Delisma informed the licensing board of each state of his criminal 
conviction in Florida. Tr. 38-39. The medical licensing boards of those 
states have not placed any restrictions on Dr. Delisma's ability to 
prescribe medications or to practice medicine. Tr. 39.
    19. Dr. Delisma currently works as the Medical Director at the 
State Correctional Institution in Somerset, Pennsylvania. Tr. 20-21. 
Dr. Delisma is seeking a Certificate of Registration for his work at 
the Somerset Correctional Institution, located at 1590 Walters Mill 
Rd., Somerset, Pennsylvania. Tr. 49.
    20. Dr. A.D. is the regional medical director for the central 
region of the Pennsylvania Department of Corrections (``Department of 
Corrections''). Tr. 59.
    21. At the time Dr. Delisma was hired, Dr. A.D. was aware of Dr. 
Delisma's past legal issues. Tr. 60.
    22. Due to Dr. Delisma's remarkable credentials, Dr. A.D. was very 
interested in seeing and interviewing him. Tr. 60. Although Dr. Delisma 
had no correctional medicine experience, he took to it amazingly well 
and quickly picked-up the nuances required in correctional medicine. 
Id.
    23. In Dr. A.D.'s opinion, Dr. Delisma is one of the top physicians 
within his organization. Tr. 60.
    24. Dr. A.D. suggested to Dr. Delisma that he apply for a 
Certificate of Registration for the reasons Dr. A.D. expounded upon in 
his testimony. Tr. 70.
    25. In Dr. A.D.'s opinion, granting a Certificate of Registration 
to Dr. Delisma ``would vastly improve the quality of care that is 
given'' at Somerset. Tr. 66. Delaying care to a patient can result in 
pain and suffering by the patient. Tr. 67-68. The Department of 
Corrections strives to avoid that. Id.
    26. The standard of care for inmates is no different than the 
standard of care for any patient who is not in prison. Tr. 68.
    27. The Somerset Correctional Institution is where inmates come 
from all over the State of Pennsylvania for surgical procedures, 
oncology care, and end-of-life care. Tr. 22.
    28. For many inmates their first interaction with the medical 
community is when they are in prison. Tr. 68. Many inmates present with 
years of undiagnosed, untreated medical conditions. Id.
    29. There are about 2,600 inmates at Somerset, and Dr. Delisma 
routinely provides medical care to about 300 of them. Tr. 23-24.
    30. On a daily basis, Dr. Delisma sees about 15 patients in the 
correctional facility infirmary, where patients are waiting to go to 
the hospital or have just returned from the hospital. Tr. 21. In 
addition, Dr. Delisma sees up to 30 patients a day in the facility's 
outpatient clinic. Id.
    31. With the patient population at Somerset, it is necessary to 
prescribe controlled substances up to five times a week. Tr. 26. Some 
inmates may require controlled substances to alleviate pain following 
surgery or due to acute injuries. Tr. 26-27. Other patients may require 
a benzodiazepine or a chemotherapy drug. Tr. 27. Because many of the 
inmates have some sort of addiction problem, however, the Department of 
Corrections is ``extraordinarily careful to limit [their] use of any 
type of controlled substance . . . .'' Tr. 66.
    32. It is consistent with the standard of care in internal medicine 
to be able to prescribe necessary medications to a patient. Tr. 44.
    33. When Dr. Delisma evaluates one of his inmate patients and 
determines that the patient needs a controlled substance, Dr. Delisma 
refers the patient to another physician who has a DEA registration. Tr. 
47. That physician also works at the Somerset facility, but he is not 
assigned there full-time. Tr. 47-49. That physician also works at other 
correctional facilities. Tr. 48-49
    34. When Dr. Delisma refers a patient to another doctor for a 
prescription for a controlled substance that doctor independently 
evaluates the patient before issuing a prescription for a

[[Page 23849]]

controlled substance to the patient. Tr. 47.
    35. No full-time medical professional works at the Somerset 
facility who has a DEA Certificate of Registration. Tr. 50-51. In 
addition to a physician who works at other correctional facilities, the 
regional director and a physician's assistant will sometimes help at 
Somerset. Id.
    36. There are times when no one at the Somerset Correctional 
Institution has a DEA registration. Tr. 51.
    37. If Dr. Delisma determines that an inmate requires a controlled 
substance, the patient can normally get a prescription for that 
controlled substance in less than 24 hours. Tr. 52. Over a weekend, 
however, it has taken up to 72 hours for an inmate to obtain a 
prescription for a controlled substance. Tr. 53-54.
    38. Dr. Delisma is the only full-time physician at Somerset. Tr. 
63. Sometimes the inmates, however, need immediate medical attention. 
Tr. 63. Therefore, it is not in the medical interest of the inmates 
when their only full-time physician is unable to deliver the expected 
standard of care because he does not have a Certificate of 
Registration. Tr. 64, 67.
    39. Even though Dr. Delisma does not have a Certificate of 
Registration, the Department of Corrections wants to keep him because 
he has ``already demonstrated himself to be reliable, talented, well 
trained, and always willing to help us out when we need him.'' Tr. 64.
    40. According to Dr. A.D., Dr. Delisma is valuable to the 
Department of Corrections ``because of his experience and training in 
internal medicine, from some of the best institutions in this world.'' 
Tr. 68.
    41. Respondent's Exhibit 10 is a letter of recommendation that Dr. 
A.D. drafted on behalf of Dr. Delisma. Tr. 65.
    42. The State Medical Director for the Department of Corrections 
has endorsed Dr. Delisma's application for a Certificate of 
Registration. Tr. 44-45; RE-11.
No Prior Incidents Concerning Controlled Substances
    43. In Dr. Delisma's entire career as a licensed physician he has 
never received any reprimands for improper or irresponsible prescribing 
of any medications, to include controlled substances. Tr. 42.
    44. Dr. Delisma has never been under investigation by any 
governmental agency for any inappropriate or irresponsible prescribing 
practices. Tr. 42.
Continuing Education
    45. In March 2017, Dr. Delisma completed a continuing education 
course in ``Legal and Ethical Issues in Healthcare,'' and in September 
2017 he completed a course in ``Medical Ethics for Physicians.'' Tr. 
40-41; RE-5, at 44-45.
    46. On November 17, 2018, Dr. Delisma attended the ``Medical Ethics 
and Professionalism'' course in Atlanta, Georgia, presented by the 
University of California, Irvine School of Medicine. Tr. 39-40; RE-6.

Analysis

    To deny an application for DEA registration, the Government must 
prove, by a preponderance of the evidence, that the regulatory 
requirements for denial are satisfied. Steadman v. SEC, 450 U.S. 91, 
100-02 (1981); 21 CFR 1301.44(e). The sole basis for sanction in this 
case is the mandatory exclusion provision of 21 U.S.C. 824(a)(5). DEA 
has held that section 824(a)(5) authorizes the denial of applications 
as well as revocation of existing registrations. Dinorah Drug Store, 
Inc., 61 FR 15972, 15973 (1996); Kuen H. Chen, M.D., 58 FR 65401, 65402 
(1993).
    Under 21 U.S.C. 824(a)(5), DEA may deny an application for 
registration if the applicant ``has been excluded (or directed to be 
excluded) from participation in a program pursuant to section 1320a-
7(a) of Title 42.'' The Government can meet its burden under section 
824(a)(5) simply by advancing evidence that the applicant has been 
excluded from a federal health care program under 42 U.S.C. 1320a-7(a). 
Johnnie Melvin Turner, M.D., 67 FR 71203, 71203-04 (2002); Dinorah Drug 
Store, Inc., 61 FR at 15973. The Administrator has issued sanctions 
where the Government introduced evidence of the applicant's plea 
agreement and judgment for health care fraud, and the resulting letter 
from the U.S. Department of Health and Human Services imposing 
mandatory exclusion. Richard Hauser, M.D., 83 FR 26308, 26310 (2018); 
Johnnie Melvin Turner, M.D., 67 FR at 71203-04.
    Section 1320a-7(a) of Title 42, United States Code, establishes 
four bases for mandatory exclusion that authorize the Secretary of the 
Department of Health and Human Services to exclude individuals or 
entities from Federal health care programs. Those bases include 
conviction of program-related crimes, patient abuse, health care fraud, 
or a felony related to controlled substances. 42 U.S.C. 1320a-7(a)(1)-
(4). These 4 bases are different from the 16 bases that authorize 
permissive exclusion under 42 U.S.C. 1320-7(b). The distinction is 
important because section 824(a)(5) specifically references 42 U.S.C. 
1320a-7(a), the section establishing four bases for mandatory 
exclusion. Thus, to carry its burden under section 824(a)(5), the 
Government must prove that the applicant's exclusion was mandatory (42 
U.S.C. 1320a-7(a)) and not permissive (42 U.S.C. 1320-7(b)). Exclusion 
under one of the 16 permissive grounds listed in section 1320a-7(b) 
does not provide a basis for sanction. Hoi Y. Kam, M.D., 78 FR 62694, 
62697 (2013); Terese, Inc., d/b/a Peach Orchard Drugs, 76 FR 46843, 
46846-47 (2011); James Henry Holmes, M.D., 59 FR 6300, 6301 (1994).
    In addition, DEA has reiterated in numerous final orders that the 
underlying conviction that led to mandatory exclusion does not need to 
involve controlled substances to support sanction.\3\ This long held 
and consistent precedent makes it undisputed that the Government does 
not need to advance any evidence related to controlled substances to 
meet its burden under section 824(a)(5). The absence of evidence 
related to controlled substances, however, can be considered as 
mitigation evidence [to show why the applicant can be entrusted with a 
registration].\*D\ See Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018) 
(noting respondent's conviction ``did not involve the misuse of his 
registration to handle controlled substances''); Kwan Bo Jin, M.D., 77 
FR 35021, 35027 (2012) (highlighting the lack of evidence concerning 
respondent's ``prescribing practices''); Dinorah Drug Store, Inc., 61 
FR at 15944 (``[B]alanced against this basis for denial is . . . the 
lack of any adverse action or allegations pertaining to [respondent's] 
conduct related to controlled substances.''). In the absence of 
evidence involving controlled substances, however, sanction is 
warranted where the Administrative Record presents ``serious questions 
as to the'' registrant's integrity. Anibal P.

[[Page 23850]]

Herrera, M.D., 61 FR 65075, 65078 (1996).
---------------------------------------------------------------------------

    \3\ [Jeffrey Stein, 84 FR at 46971-72 (2019)] * (citation 
added); Mohammed Asgar, M.D., 83 FR 29569, 29571 (2018); Narciso A. 
Reyes, M.D., 83 FR 61678, 61681 (2018); Richard Hauser, M.D., 83 FR 
26308, 26310 (2018); Orlando Ortega-Ortiz, M.D., 70 FR 15122, 15123 
(2005); Juan Pillot-Costas, M.D., 69 FR 62084, 62085 (2004); Daniel 
Ortiz-Vargas, M.D., 69 FR 62095, 62095-96 (2004); KK Pharmacy, 64 FR 
49507, 49510 (1999); Melvin N. Seglin, M.D., 63 FR 70431, 70433 
(1998); Anibal P. Herrera, M.D., 61 FR 65075, 65078 (1996); Stanley 
Dubin, D.D.S., 61 FR 60727, 60728 (1996); Richard M. Koenig, M.D., 
60 FR 65069, 65071 (1995); George D. Osafo, M.D., 58 FR 37508, 37509 
(1993); Nelson Ramirez-Gonzalez, M.D., 58 FR 52787, 52788 (1993); 
Gilbert L. Franklin, D.D.S., 57 FR 3441, 3441 (1992).
    \*D\ Language added.
---------------------------------------------------------------------------

I. The Government's Position

    The Government submitted its ``Proposed Findings of Fact and 
Conclusions of Law'' (``Government's Brief'') on May 17, 2019.\4\ I 
have read and considered the Government's Brief in preparing this 
Recommended Decision.
---------------------------------------------------------------------------

    \4\ The Government's Brief has been marked as ALJ-12.
---------------------------------------------------------------------------

    In its Brief, the Government's proposed findings of fact are 
essentially the same as the findings of fact set forth in this 
Recommended Decision. ALJ-12, at 1-5. The Government also acknowledges 
that it is appropriate to analyze this case under the public interest 
factors of 21 U.S.C. 823(f).\*E\ Id. at 6. The Government also 
acknowledges that Factors 1-4 of 21 U.S.C. 823(f) are not applicable in 
this case, but argues that the Respondent's conviction for accepting a 
kickback and his exclusion from federal health care programs is a 
Factor 5 consideration. Id. at 9.
---------------------------------------------------------------------------

    \*E\ In its Motion for Summary Judgment, which the ALJ properly 
denied, the Government argued that the five public interest factors 
were inapplicable to this case because the Government was seeking to 
deny the application based on section 824(a)(5) (exclusion from 
federal health care programs) and had not alleged grounds under 
section 824(a)(4) (registrant has committed acts that would render 
his registration inconsistent with the public interest) in its Order 
to Show Cause. Govt MSJ at 5, n. 2. In reviewing an application for 
a registration, however, section 823(f) instructs the Agency to 
consider the public interest when determining whether to grant a 
petitioner's application to dispense controlled substances. 21 
U.S.C. 823(f). Accordingly, the Respondent appropriately raised, and 
the ALJ appropriately considered, the public interest in determining 
whether to grant the Respondent's application in this case.
---------------------------------------------------------------------------

    Relying on Richard Hauser, M.D., 83 FR 26308, 26310 (2018), and 
cases cited therein, the Government argues that ``notwithstanding the 
fact that the underlying conduct for which Respondent was convicted had 
no nexus to controlled substances'' his exclusion ``warrants revocation 
(sic) of his registration.'' \5\ ALJ-12, at 7. Continuing, the 
Government argues that ``[i]t would be incongruous and contrary to the 
public interest for DEA to grant Respondent a registration when he has 
not completed the period of his health care exclusion . . . .'' \6\ Id. 
at 10.
---------------------------------------------------------------------------

    \5\ It is accurate to state that Hauser, and the cases cited 
therein, state that where a registrant is excluded from Federal 
health care programs, DEA may revoke a Certificate of Registration 
even if the exclusion is unrelated to controlled substances. Having 
read Hauser and the cases the Government cited, however, all are 
inapposite to the case before me. For example, in four of the cases 
cited by the Government no hearing was held and the underlying 
criminal conviction involved fraud (solicitation) and there is no 
mention of acceptance of responsibility: Orlando Ortega-Ortiz, M.D., 
70 FR 15122 (2005); Juan Pillot-Costas, M.D., 69 FR 62084 (2004); 
Daniel Ortiz-Vargas, M.D., 69 FR 62095 (2004); and KK Pharmacy, 64 
FR 49507 (1999), which also involved controlled substances and a 
materially false application. In Stanley Dubin, D.D.S., 61 FR 60727 
(1996), the respondent had been convicted of Medicare fraud, 
criminal conspiracy, forgery, and tampering with or fabricating 
evidence. In addition, the Administrative Law Judge did not credit a 
portion of Dubin's testimony and there is no discussion of 
acceptance of responsibility. Finally, in Nelson Ramirez-Gonzalez, 
M.D., 58 FR 52787 (1993), the Administrative Law Judge found that 
the registrant had been convicted of nine felony counts, to include 
mail fraud, false claims, and making false statements. There is no 
mention of acceptance of responsibility in the decision.
    \6\ In my view, this argument is contrary to the discretion the 
Administrator has in determining whether to grant an application for 
a registration, or to revoke one. Dan E. Hale, D.O., 69 FR 69402, 
69406 (2004). It also fails to account for the Administrator's 
decisions in Kwan Bo Jin, M.D., 77 FR 35021, 35023 (2012) and 
Mohammed Asgar, M.D., 83 FR 29569, 29572 (2018). In addition, for 
the reasons explained in my ``Order Denying Government's Motion for 
Summary Disposition,'' the Government's reliance on Narciso A. 
Reyes, M.D., 83 FR 61678 (2018) is also misplaced. ALJ-12, at 8; 
ALJ-9, at 4-5.
---------------------------------------------------------------------------

    Finally, the Government notes that Dr. Delisma did not need a 
Certificate of Registration to be hired into his current position, or 
to keep it. ALJ-12, at 10. Without citation to any authority, the 
Government argues that Dr. Delisma's application should be denied 
because ``there is no compelling public interest purpose for Respondent 
to be granted a DEA registration where the public interest is currently 
being served . . . .'' Id.

II. The Respondent's Position

    Respondent submitted his ``Closing Argument & Proposed Findings of 
Fact and Conclusions of Law'' (``Respondent's Brief'') on May 17, 
2019.\7\ I have read and considered the Respondent's Brief in preparing 
this Recommended Decision.
---------------------------------------------------------------------------

    \7\ The Respondent's Brief has been marked as ALJ-13.
---------------------------------------------------------------------------

    In his Brief, the Respondent's proposed findings of fact are 
essentially the same as the findings of fact set forth in this 
Recommended Decision. ALJ-13, at 1-8. While the Respondent notes that 
the Government established a prima facie case, the Respondent also 
argues that the Government failed to prove ``by a preponderance of the 
evidence that the Respondent's application should be denied solely 
based off of the Respondent's exclusion from participation in federal 
health care programs.'' Id. at 9. The Respondent notes that the 
licensing authorities in four states ``do not perceive Dr. Delisma as a 
threat to public safety and believe that [] his unfettered licensure is 
consistent with public interest.'' Id. Like the Government, the 
Respondent acknowledges that it is appropriate to analyze this case 
under the five factors contained in 21 U.S.C. 823(f). Id. In reviewing 
those factors, the Respondent argues that all five factors weigh in his 
favor. Id. at 10-12.
    The Respondent notes that he has accepted responsibility for his 
actions. ALJ-13, at 12. The Respondent also notes that patients at the 
correctional facility where he works have had to wait, at times up to 
72 hours, to obtain needed medication. Id. The Respondent argues that 
by granting him a registration the inmate patients at Somerset will not 
have to ``suffer needlessly while the facility locates a provider that 
(sic) can write a prescription for a controlled substance.'' Id. at 13.

III. 21 U.S.C. 824(a)(5): Mandatory Exclusion From Federal Health Care 
Programs Pursuant to 42 U.S.C. 1320a-7(a)

    Mandatory exclusion from a federal health care program under 42 
U.S.C. 1320a-7(a) serves as an independent basis for denying an 
application for DEA registration. 21 U.S.C. 824(a)(5). The OSC's sole 
allegation is that Dr. Delisma's mandatory exclusion from all federal 
health care programs warrants denying his application under 21 U.S.C. 
824(a)(5). Specifically, the Government alleges that on May 31, 2016, 
judgment was entered against Dr. Delisma based on his guilty plea to 
one count of ``Receipt of Kickbacks in Connection with a Federal Health 
Care Program,'' in violation of 42 U.S.C. 1320a-7b(b)(1)(A). ALJ-1, at 
2. Based on this conviction, the HHS/OIG, by letter dated August 31, 
2016, mandatorily excluded Dr. Delisma from participation in Medicare, 
Medicaid, and all federal health care programs for the minimum 
statutory period of five years pursuant to 42 U.S.C. 1320a-7(a), 
effective September 20, 2016. Id. The Government further alleged that 
although the underlying conduct for which Dr. Delisma was convicted did 
not involve controlled substances, his mandatory exclusion from 
Medicare, Medicaid, and all federal health care programs warrants 
denial of his application for DEA registration pursuant to 21 U.S.C. 
824(a)(5). Id.
    Neither party disputes that Dr. Delisma was mandatorily excluded 
from federal health care programs under 42 U.S.C. 1320a-7(a) for the 
minimum period of five years based on Dr. Delisma's guilty plea to one 
count of receiving a kickback in connection with a federal health care 
program. Stips. 2-

[[Page 23851]]

3, 5. The parties also stipulated to the admissibility of the 
Government's four exhibits. Stip. 12.
    The Government's evidence shows that the United States District 
Court for the Southern District of Florida (``District Court'') entered 
judgment against Dr. Delisma on May 31, 2016, on one count of ``Receipt 
of Kickbacks in Connection with a Federal Health Care Program,'' in 
violation of 42 U.S.C. 1320a-7b(b)(l)(A). GE-2, at 1; Stip. 2. The 
evidence further shows that Dr. Delisma pled guilty to the offense. Id. 
The judgment form indicates that the District Court sentenced Dr. 
Delisma to 8 months imprisonment and 1 year of supervised release. GE-
2, at 2-3. The District Court also ordered Dr. Delisma to pay fines of 
$100. and $5,000., and to pay $49,000. in restitution. Id. at 5-6.
    The Government's evidence also shows that on August 31, 2016, HHS/
OIG issued a letter to Dr. Delisma informing him that HHS was excluding 
him from participation in Medicare, Medicaid, and all federal health 
care programs under section 1128(a)(1) of the Social Security Act 
(codified at 42 U.S.C. 1320a-7(a)). GE-3, at 1; Stip. 3. The letter 
states that HHS excluded Dr. Delisma based on his conviction for ``a 
criminal offense related to the delivery of an item or service under 
the Medicare or a State health care program.'' GE-3, at 1; see 42 
U.S.C. 1320a-7(a)(1) (establishing mandatory exclusion based on 
conviction ``of a criminal offense related to the delivery of an item 
or service under subchapter XVIII or under any State health care 
program''). The letter further states that HHS excluded Dr. Delisma for 
the statutory minimum of five years and the exclusion was effective 
September 20, 2016. GE-3, at 1; Stip. 3. The letter also explains that 
reinstatement in federal health care programs is not automatic. Id. at 
2; Stip. 4.
    The Government's evidence also includes a printout from the HHS/OIG 
website showing that Dr. Delisma was excluded under Section 1128(a)(1) 
(42 U.S.C. 1320a-7(a)(1)) for a program-related conviction effective 
September 20, 2016. GE-4. Lastly, the Government's evidence includes a 
notarized document titled, Certification of Registration Non-
Registration (``Certification''), signed by the Associate Chief of the 
Registration and Program Support Section. GE-1. The Certification 
states that Dr. Delisma submitted an application for DEA registration 
on or about July 9, 2018, and that the Registration and Support Section 
assigned his application Control Number W18071098C. Id.; Stip. 1. The 
Certification further indicates that when Dr. Delisma submitted his 
application, he disclosed his conviction and exclusion from federal 
health care programs. Id.
    Evidence of Dr. Delisma's plea agreement, judgment, and the HHS 
exclusion letter are sufficient to sustain an allegation under 21 
U.S.C. 824(a)(5). Kwan Bo Jin, M.D., 77 FR at 35023; Linda Sue Cheek, 
M.D., 76 FR 66972, 66982 (2011). Based on the Government's documentary 
exhibits, and the parties' joint stipulations, I find that the 
Administrative Record shows by a preponderance of the evidence that Dr. 
Delisma was convicted of receiving a kickback in connection with a 
federal health care program. I also find that based on this conviction, 
he was mandatorily excluded from participation in Medicare, Medicaid, 
and all federal health care programs for five years under 42 U.S.C. 
1320a-7(a). Thus, the Government's allegation that Dr. Delisma's 
application for DEA registration should be denied under 21 U.S.C. 
824(a)(5) because he was mandatorily excluded from Medicare, Medicaid, 
and all federal health care programs pursuant to 42 U.S.C. 1320a-7(a) 
is SUSTAINED. ALJ-1, at 2, paras. 2-3. This allegation weighs in favor 
of denying Dr. Delisma's application for DEA registration.

Discussion and Conclusions of Law

    I sustained the Government's allegation that HHS mandatorily 
excluded Dr. Delisma from federal health care programs based on a 
program-related conviction. This allegation is supported by a 
preponderance of the evidence and the parties' joint stipulations.
    Once the Government makes a prima facie case under 21 U.S.C. 
824(a)(5), the burden shifts to respondent to `` `present[] sufficient 
mitigating evidence to show why he can be entrusted with a 
registration.'' Mohammed Asgar, M.D., 83 FR at 29572; Kwan Bo Jin, 
M.D., 77 FR at 35023; Linda Sue Cheek, M.D., 76 FR at 66982. Stated 
differently, where the Government advances substantial evidence to 
prove that exclusion from a federal health care program justifies 
sanction under section 824(a)(5), the case is not over, but instead 
shifts to respondent to argue that a lesser sanction, or no sanction, 
is appropriate in light of mitigating evidence. Id.; see KK Pharmacy, 
64 FR 49507, 49510 (1999) (revoking where Government carried its burden 
and respondent introduced ``[n]o evidence of explanation or mitigating 
circumstances''); Joseph M. Piacentile, M.D., 62 FR 35527, 35528-29 
(1997) (revoking registration because Government met its burden and 
respondent failed to offer ``any evidence of [his] rehabilitation or 
remorse''). Once the burden shifts to Respondent, Respondent may 
present evidence showing that despite his conviction, he does not pose 
a threat to the public interest. Linda Sue Cheek, M.D., 76 FR at 66982. 
Respondent may rebut the Government's prima facie case by accepting 
responsibility, showing remorse, introducing evidence of 
rehabilitation, and satisfying all terms and conditions of his 
sentence. Kwan Bo Jin, M.D., 77 FR at 35026.
    Even in cases involving the exclusion from federal health care 
programs, DEA analyzes the five public interest factors in 21 U.S.C. 
823(f) in determining whether [granting a respondent's application for] 
\*F\ registration would be inconsistent with the public interest. See 
Dinorah Drug Store, Inc., 61 FR 15972, 15973-74 (1996) (considering all 
five public interest factors); [].\*G\ Those factors are:
---------------------------------------------------------------------------

    \*F\ Language modified.
    \*G\ Citations omitted for relevance.
---------------------------------------------------------------------------

    (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).
    DEA considers these public interest factors separately. Ajay S. 
Ahuja, M.D., 84 Fed Reg. 5479, 5488 (2019); Robert A. Leslie, M.D., 68 
FR 15227, 15230 (2003). Each factor is weighed on a case-by-case basis. 
Morall v. Drug Enf't Admin., 412 F.3d 165, 173-74 (D.C. Cir. 2005). Any 
one factor, or combination of factors, may be decisive. David H. 
Gillis, M.D., 58 FR 37507, 37508 (1993). Thus, there is no need to 
enter findings on each of the factors. Hoxie v. DEA, 419 F.3d 477, 482 
(6th Cir. 2005). Furthermore, there is no requirement to consider a 
factor in any given level of detail. Trawick v. DEA, 861 F.2d 72, 76-77 
(4th Cir. 1988). When deciding whether registration is in the public 
interest, DEA must consider the totality of the circumstances. See 
generally Joseph Gaudio, M.D., 74 FR 10083, 10094-95

[[Page 23852]]

(2009) (basing sanction on all evidence of record).
    With respect to Factors 1 and 3, it is undisputed that Dr. Delisma 
holds valid state medical licenses in Pennsylvania, New York, Maryland, 
and Montana. FF 18. [].\*H\ However, possession of a state license does 
not entitle a holder of that license to a DEA registration. Mark De La 
Lama, P.A., 76 FR 20011, 20018 (2011). It is well established that a 
``state license is a necessary, but not a sufficient condition for 
registration.'' Robert A. Leslie, M.D., 68 FR at 15230. The ultimate 
responsibility to determine whether a DEA registration is consistent 
with the public interest resides exclusively with the DEA, not to 
entities within state government. Edmund Chein, M.D., 72 FR 6580, 6590 
(2007), aff'd Chien v. DEA, 533 F.3d 828 (D.C. Cir. 2008).
---------------------------------------------------------------------------

    \*H\ Sentence omitted.
---------------------------------------------------------------------------

    [In determining the public interest under Factor 1, the 
``recommendation of the appropriate State licensing board or 
professional disciplinary authority . . . shall be considered.'' 21 
U.S.C. 823(f)(1). ``Two forms of recommendations appear in Agency 
decisions: (1) A recommendation to DEA directly from a state licensing 
board or professional disciplinary authority (hereinafter, appropriate 
state entity), which explicitly addresses the granting or retention of 
a DEA COR; and (2) the appropriate state entity's action regarding the 
licensure under its jurisdiction on the same matter that is the basis 
for the DEA OSC.'' John O. Dimowo, 85 FR 15800, 15809 (2020). See, 
also, Vincent J. Scolaro, D.O., 67 FR 42060, 42065 (2002) (``While the 
State Board did not affirmatively state that the Respondent could apply 
for a DEA registration, [the ALJ] found that the State Board by 
implication acquiesced to the Respondent's application because the 
State Board has given state authority to the Respondent to prescribe 
controlled substances.''). Here, Pennsylvania, where Respondent seeks 
registration, acted to grant Respondent a medical license after he 
apprised the licensing authority of his conviction, and the state did 
not place any restrictions on Respondent's ability to prescribe 
medications or practice medicine. FF 18. As the ``appropriate State 
licensing board'' for the purpose of Public Interest Factor One 
determined that Respondent should be licensed with full knowledge of 
his conviction, Factor 1 weighs against denial of his application in 
this matter. See, e.g., Tyson D. Quy, M.D., 78 FR 47412, 47417 (2013); 
Vincent J. Scolaro, D.O., 67 FR 42060, 42064-65 (2002); Kwan Bo Jin, 
M.D., 77 FR at 35023-24 (noting that a state medical board's 
determination that a registrant could maintain his license after his 
Federal conviction for health care fraud ``does weigh against a finding 
that [r]espondent's continued registration would be inconsistent with . 
. . Factor One.'')\*I\].
---------------------------------------------------------------------------

    \*I\ I have replaced the ALJ's Factor One analysis in this case 
to reflect the Factor One legal analysis in John O. Dimowo, 85 FR 
15800 (2020), which was published after the ALJ issued this RD. As 
noted in Dimowo, a state entity's actions are distinct from its 
inactions. 85 FR at 15810, n. M. Where the record contains no 
evidence of a recommendation by a state licensing board, that 
absence does not weigh for or against revocation under Factor 1. See 
Ajay S. Ahuja, M.D., 84 FR 5479, 5490 (2019) (finding that ``where 
the record contains no evidence of a recommendation by a state 
licensing board that absence does not weigh for or against 
revocation.''); see also MacKay v. Drug Enf't Admin., 664 F.3d 808, 
817-819 (10th Cir. 2011) (noting that the Agency decision found that 
the lack of action from an appropriate state entity was not a 
recommendation under Factor One and holding that the Deputy 
Administrator did not misweigh the public interest factors).
---------------------------------------------------------------------------

    As to Factor 3, there is no evidence that Dr. Delisma has been 
convicted of an offense under either federal or state law ``relating to 
the manufacture, distribution, or dispensing of controlled 
substances.'' 21 U.S.C. 823(f)(3). However, there are a number of 
reasons why even a person who has engaged in criminal misconduct may 
never have been convicted of an offense or even prosecuted for one. 
Dewey C. MacKay, M.D., 75 FR 49956, 49973 (2010), pet. for rev. denied, 
MacKay v. Drug Enf't Admin., 664 F.3d 808, 822 (10th Cir. 2011). 
Therefore, DEA has held that ``the absence of such a conviction is of 
considerably less consequence in the public interest inquiry'' and is 
not dispositive. Id. Accordingly, Factor 3 weighs neither for nor 
against revocation in this case.
    DEA often analyzes Factors 2 and 4 together. See, e.g., Fred 
Samimi, M.D., 79 FR 18698, 18709 (2014); John V. Scalera, M.D., 78 FR 
12092, 12098 (2013). Under Factor 2, DEA analyzes a registrant's 
``experience in dispensing controlled substances.'' 21 U.S.C. 
823(f)(2). Factor 2 analysis focuses on a registrant's acts that are 
inconsistent with the public interest, rather than on a registrant's 
neutral or positive acts and experience. Randall L. Wolff, M.D., 77 FR 
5106, 5121 n.25 (2012) (explaining that ``every registrant can 
undoubtedly point to an extensive body of legitimate prescribing over 
the course of [the registrant's] professional career'' (quoting Jayam 
Krishna-Iyer, M.D., 74 FR 459, 463 (2009))). Similarly, under Factor 4, 
DEA analyzes an applicant's compliance with Federal and state 
controlled substance laws. 21 U.S.C. 823(f)(4). The Factor 4 analysis 
focuses on violations of state and Federal laws and regulations 
concerning controlled substances. Volkman v. Drug Enf't Admin., 567 
F.3d 215, 223-24 (6th Cir. 2009) (citing Gonzales v. Oregon, 546 U.S. 
243, 272, 274 (2006)); Gaudio, 74 FR at 10090-91. In this case, 
however, there are no allegations suggesting that Dr. Delisma has any 
negative experience in dispensing controlled substances, or that he has 
failed to comply with any state or federal laws concerning controlled 
substances. In my view, the absence of such allegations weigh in Dr. 
Delisma's favor. Kwan Bo Jin, M.D., 77 FR at 35024; see also Dinorah 
Drug Store, Inc., 61 FR at 15973-74 (noting consideration of the fact 
that the underlying misconduct that led to the exclusion did not 
involve controlled substances).
    Factor 5 allows for consideration of other conduct a registrant may 
have engaged in that may threaten the public health and safety. In this 
case, the Government has not alleged any conduct other than Dr. 
Delisma's conviction of receiving a kickback and his resulting 
exclusion from federal health care programs as a basis to deny his 
application. Thus, in my view, the absence of allegations of any other 
conduct that may threaten the public health and safety weighs in Dr. 
Delisma's favor. Kwan Bo Jin, M.D., 77 FR at 35025.
    Finally, Dr. Delisma has not presented any evidence to rebut the 
underlying misconduct, or his exclusion from participation in Federal 
health care programs. Rather, he stipulated to the accuracy of those 
allegations. In addition, he accepted responsibility for his actions. 
FF 12. He initially did so by pleading guilty to the charge in Federal 
Court (Stip. 2; FF 12), by stipulating to all the elements of the 
Government's prima facie case in these proceedings, and by candidly 
accepting responsibility on the record. Id. Based upon my review of the 
entire Administrative Record and my evaluation of Dr. Delisma's candor 
and demeanor under oath, I find that Dr. Delisma's acceptance of 
responsibility was sincere and unequivocal.

Sanction

    Imposing sanctions under 21 U.S.C. 824(a)(5) is a matter of 
discretion. [Stein, 84 FR at 46971;] \*J\ Kwan Bo Jin, M.D., 77 FR at 
35023. Even when the Government meets its burden, the CSA provides that 
issuing a sanction is ``discretionary.'' Dan E. Hale, D.O., 69 FR 
69402, 69406 (2004). In exercising that discretion, DEA ``should 
consider

[[Page 23853]]

all the facts and circumstances of the case.'' Id.; see also Linda Sue 
Cheek, M.D., 76 FR at 66982 (``[D]enial of an application for 
registration [under section 824(a)(5)] is a matter of discretion.''); 
Melvin N. Seglin, M.D., 63 FR 70431, 70433 (1998) (turning to the issue 
of whether DEA should exercise its discretion to revoke respondent's 
COR after the Government carried its burden); Anibal P. Herrera, M.D., 
61 FR at 65077 (same).
---------------------------------------------------------------------------

    \*J\ Citation added.
---------------------------------------------------------------------------

    The Government bears the initial burden of proof, and must justify 
a sanction by a preponderance of the evidence. Steadman, 450 U.S. at 
100-03. If the Government makes a prima facie case for a sanction, the 
burden of proof shifts to the registrant to show that a sanction would 
be inappropriate. Med. Shoppe--Jonesborough, 73 FR 364, 387 (2008). A 
registrant may prevail by successfully attacking the veracity of the 
Government's allegations or evidence. Alternatively, a registrant may 
rebut the Government's prima facie case for a sanction by accepting 
responsibility for wrongful behavior and by taking remedial measures to 
``prevent the re-occurrence of similar acts.'' Jeri Hassman, M.D., 75 
FR 8194, 8236 (2010) (citations omitted). In addition, when assessing 
the appropriateness and extent of sanctioning, DEA considers the 
egregiousness of the offenses and its interest in specific and general 
deterrence. David A. Ruben, M.D., 78 FR 38363, 38385 (2013).

Prima Facie Showing and Balancing

    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). [Stein, 84 FR 
at 46971-71;] \*K\ Hauser, 83 FR at 26310.
---------------------------------------------------------------------------

    \*K\ Citation added.
---------------------------------------------------------------------------

    The Government based its case on Dr. Delisma's conviction of his 
receipt of kickbacks in connection with a federal health care program, 
and his subsequent exclusion from federal health care programs by the 
Department of Health and Human Services. ALJ-1, at 2, paras. 2-3. 
Citing Hauser, 83 FR at 26308, the Government asserted that even though 
Dr. Delisma's underlying conduct ``had no nexus to controlled 
substances,'' his exclusion warranted the denial of his application for 
a Certificate of Registration. ALJ-1, at 2, para. 3. The Government has 
not advanced any evidence under Factors 1-5 of 21 U.S.C. 823(f), other 
than the exclusion.
    After the Government presents a prima facie case for a sanction, 
the Respondent has the burden of production to present ``sufficient 
mitigating evidence'' to show why he can be entrusted with a DEA 
registration. Med. Shoppe--Jonesborough, 73 FR at 387 (quoting Samuel 
S. Jackson, D.D.S., 72 FR 23848, 23853 (2007)). To rebut the 
Government's prima facie case, the 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 20727, 20734-35 
(2009).
    The Respondent may accept responsibility by providing evidence of 
his remorse, his efforts at rehabilitation, and his recognition of the 
severity of his misconduct. Robert A. Leslie, M.D., 68 FR at 15228. To 
accept responsibility, a respondent must show ``true remorse'' for 
wrongful conduct. Michael S. Moore, M.D., 76 FR 45867, 45877 (2011). An 
expression of remorse includes acknowledgment of wrongdoing. Wesley G. 
Harline, M.D., 65 FR 5665, 5671 (2000). A respondent must express 
remorse for all acts of documented misconduct. Jeffrey Patrick 
Gunderson, M.D., 61 FR 26208, 26211 (1996). 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 at 38364. In this case, I 
have found that Dr. Delisma's acceptance of responsibility was both 
sincere and unequivocal.
    The mere acceptance of responsibility, however, does not end the 
analysis of whether to issue a sanction. ``[T]here are cases in which, 
notwithstanding a finding that a registrant has credibly accepted 
responsibility, the misconduct is so egregious and extensive that the 
protection of the public interest nonetheless warrants the revocation 
of a registration or the denial of an application.'' William J. 
O'Brien, III, D.O., 82 FR 46527, 46527 (2017) (quoting Hatem Ataya, 
M.D., 81 FR 8221, 8244 (2016)) (citation omitted).
    In addition, consideration must be given to both specific and 
general deterrence. Daniel A. Glick, D.D.S., 80 FR 74800, 74810 (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.
    With respect to egregiousness, I do not find the Respondent's 
conduct to be particularly egregious. Furthermore, the Government's 
reliance on Hauser in the Order to Show Cause is misplaced. Dr. Hauser 
was convicted of two counts of health care fraud for overbilling a 
state Medicaid program. Hauser, 83 FR at 26309. Dr. Hauser's fraud 
involved ``executing a scheme with the intent to defraud'' a state 
Medicaid program for payment of ``services that he did not actually 
perform,'' a far more egregious offense than that of Dr. Delisma. Id. 
In addition, Dr. Hauser failed to come forward with any evidence 
explaining or mitigating his overbilling conduct or otherwise 
explaining why his registration should not be revoked, and the record 
reflected no such evidence. Id. at 26,310. Furthermore, Dr. Hauser's 
fraud conviction is significant because a fraud conviction suggests 
that a registrant cannot be trusted to tell the truth except in cases 
where the registrant credibly accepts responsibility. Kwan Bo Jin, 
M.D., 77 FR at 35027. In contrast, Dr. Delisma was convicted of a 
single count of receiving a kickback involving only one patient. In 
addition, Dr. Delisma was not convicted of fraudulent activities,\8\ he 
accepted responsibility, he submitted credible evidence as to why his 
application should be approved, and he submitted some evidence of 
remediation. Further, his misconduct was not related to controlled 
substances.
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    \8\ There are four bases for mandatory exclusion under 42 U.S.C. 
1320a-7(a). They are convictions for: Program-related crimes, 
patient abuse, health care fraud, or a felony related to controlled 
substances. The Government's evidence shows that the Respondent's 
exclusion was for a ``program-related conviction.'' GE-4. Further, 
unlike several of the registrants in cases cited by the Government, 
Dr. Delisma was not convicted of ``soliciting'' a kickback.
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    The Administrator has also considered various circumstances as 
mitigating factors in past exclusion cases. Examples of such 
circumstances include: The fact that misconduct did not involve 
controlled substances; \9\ no evidence that respondent's registration

[[Page 23854]]

threatens the public interest; \10\ respondent accepted responsibility; 
\11\ respondent submitted letters and testimony concerning his good 
character; \12\ HHS found no aggravating factors and therefore excluded 
respondent for the minimum period; \13\ respondent was candid about his 
background with his employer; \14\ and respondent satisfied all terms 
and conditions of his sentence.\15\ All of these circumstances are 
relevant mitigating factors in the case before me. Stip. 3, 6; FF 12, 
16, 18, 21, 31, 33-34, 41-44.
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    \9\ See Mohammed Asgar, M.D., 83 FR at 29573 (declaring it 
significant ``that Respondent's criminality did not directly involve 
his registration or controlled substances''); Dinorah Drug Store, 
Inc., 61 FR at 15974 (weighing in mitigation ``the lack of any 
adverse action or allegations pertaining to [respondent's] conduct 
related to controlled substances'').
    \10\ See Kwan Bo Jin, M.D., 77 FR at 35027 (stressing the lack 
of any evidence that the practitioner's ``registration would be 
inconsistent with the public interest, to include issues with his 
prescribing practices'').
    \11\ See Mohammed Asgar, M.D., 83 FR at 29573 (finding 
respondent accepted responsibility and the Government ``put forward 
no evidence challenging the sincerity of Respondent's acceptance of 
responsibility''); Kwan Bo Jin, M.D., 77 FR at 35026 (highlighting 
the practitioner's ``full acceptance of responsibility''); Melvin N. 
Seglin, M.D., 63 FR at 70433 (holding respondent's attempt to 
explain why he overbilled did not negate his acceptance of 
responsibility).
    \12\ See Anibal P. Herrera, M.D., 61 FR at 65077 (considering 
``letters of support from patients and other doctors''); Suresh 
Gandotra, M.D., 58 FR 64781, 64782 (1993) (considering character 
testimony).
    \13\ See Dinorah Drug Store, Inc., 61 FR at 15974 (considering 
the fact that HHS found no aggravating factors ``to justify imposing 
more than the mandatory minimum period of exclusion'').
    \14\ See Melvin N. Seglin, M.D., 63 FR at 70432-33 (stressing 
that respondent ``was honest and forthcoming regarding his 
background with his current employer'').
    \15\ See Kwan Bo Jin, M.D., 77 FR at 35026 (finding it relevant 
for purposes of mitigation that respondent ``met all terms and 
conditions of his sentence'').
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    It is frequently noted that proceedings concerning an Order to Show 
Cause are non-punitive in nature. Leo R. Miller, M.D., 53 FR 21931, 
21932 (1988). ``The purpose of this proceeding is not to impose 
punishment . . . .'' Jackson, 72 FR at 23853. Rather, these proceedings 
are intended to be `` `a remedial measure, based upon the public 
interest and the necessity to protect the public from those individuals 
who have misused controlled substances or their DEA Certificate of 
Registration, and who have not presented sufficient mitigating evidence 
to assure the Administrator that they can be trusted with the 
responsibility carried by such a registration.' '' Id. (quoting Miller, 
53 FR at 21932) (citing Robert M. Golden, M.D., 61 FR 24808, 24812 
(1996)).
    I have also considered the issue of deterrence, both general and 
specific. With regard to specific deterrence, Dr. Delisma has already 
been held accountable for accepting a kickback, having been sentenced 
to prison, as well as having to pay substantial financial penalties. He 
has fully satisfied all of those imposed requirements by both the 
Federal courts and licensing authorities. FF 15, 17-18. He has also 
completed three continuing education courses concerning medical ethics. 
FF 45-46. In addition, [and importantly,] \*L\ he has demonstrated 
sincere remorse. FF 12. Concerning general deterrence, other 
practitioners would be sufficiently deterred based upon Dr. Delisma's 
criminal conviction and punishment, as well as the fees imposed by 
state licensing authorities. [].\*M\ In this case, where there is no 
allegation or evidence that Dr. Delisma has ever improperly handled 
controlled substances [or engaged in other behaviors that negatively 
implicate his potential future compliance with the CSA and where he has 
been held accountable and expressed sincere remorse],\*N\ denying his 
application would not be remedial in nature, it would simply be added 
punishment.
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    \*L\ Language added.
    \*M\ Sentence omitted.
    \*N\ Language added. Although Dr. Delisma's past history with 
controlled substances weighs in favor of granting his application, 
certain behaviors that do not directly involve controlled substances 
may still weigh against an application if the behaviors are relevant 
to the applicant's potential future compliance with the CSA. See 
Stein, 84 FR 469 (finding a sanction appropriate for deterrence 
where there were no allegations respondent had improperly handled 
controlled substances but respondent had impeded a government 
investigation). Dr. Delisma's single act of accepting a kickback 
does demonstrate a past failure to comply with federal law, which I 
factor into my determination of trust, but his actions since his 
criminal act have been fully compliant and transparent and have 
given me no further reason to doubt his future compliance with the 
CSA.
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    The Administrator has also frequently noted that ``past performance 
is the best predictor of future performance.'' Mohammed Asgar, M.D., 83 
FR at 29572 (internal citations and quotations omitted). In this case, 
there is absolutely no evidence that there has ever been any concern 
about the manner in which Dr. Delisma handled controlled substances. 
While a respondent's past poor performance in handling controlled 
substances is often times cited in decisions revoking a Certificate of 
Registration or denying an application for a Certificate of 
Registration, the reverse should also be true. In this case, I consider 
Dr. Delisma's past performance to be the best predictor of continued 
performance consistent with public health and safety.
    Finally, I note that the Government has argued that Dr. Delisma's 
application should be denied because he did not need a registration to 
secure his position at Somerset, and does not need it to retain the 
position. ALJ-12, at 10. The Government cites no authority for this 
novel proposition. Countering that argument, Dr. Delisma argues that he 
needs a registration to provide the inmates at Somerset the quality of 
care they deserve. ALJ-13, at 12-13. The Respondent cites no DEA 
authority for this novel proposition.\16\ I reject both arguments 
because the analysis of 21 U.S.C. 823(f) focuses on whether granting an 
application for a registration or revoking a registration is in the 
public interest. Jackson, 72 FR at 23853. Nowhere is there a suggestion 
that an application should be approved or denied based upon an 
evaluation, or consideration, of whether the applicant needs the 
registration.\17\ Similarly, while it is commendable that Dr. Delisma 
is using his medical talents in a public service environment, an 
environment cannot entitle a practitioner to a registration, where 
consideration of the five factors of 21 U.S.C. 823(f) might otherwise 
result in denial of that practitioner's application.
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    \16\ It would seem the decision in Garrett Howard Smith, M.D., 
83 FR 18882 (2018) undercuts the Respondent's suggestion. There, the 
Acting Administrator held that testimony about a registrant's 
excellent work performance at a medical facility other than where he 
held his registration and that he was ``providing a valuable service 
to the community'' is not ``relevant in the public interest 
determination.'' Id. at 18897 n.23.
    \17\ However, in Melvin N. Seglin, M.D., 63 FR at 70433, the 
Deputy Administrator found ``it significant that Respondent . . . 
need[ed] to be able to handle controlled substances in order to 
continue treating inmates in the local jail.'' The Deputy 
Administrator decided Seglin in 1998. In the more recent case of 
Gregory D. Owens, D.D.S., 74 FR 36751 (2009), however, the Deputy 
Administrator reasoned ``[w]hether a practitioner treats patients 
who come from a medically underserved community or who have limited 
incomes has no bearing on whether he has accepted responsibility and 
undertaken adequate corrective measures.'' In 2011, the 
Administrator upheld this reasoning in Linda Sue Cheek, M.D., 76 FR 
at 66972. If there ever was a suggestion that DEA should consider 
whether, and to what extent, an applicant needed a registration, as 
DEA considered in Seglin, DEA has since changed course, as 
illustrated by Owens and Cheek. Thus, I find no support for the 
proposition that I should recommend denying Dr. Delisma's 
application because he does not need a COR, or that I should 
recommend granting his application because he might need one.
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Recommendation

    I have considered the entire Administrative Record in this case. 
Other than Dr. Delisma's exclusion from participation in federal health 
care programs and his underlying conviction, which prompted that 
mandatory exclusion, I find absolutely no evidence that Dr. Delisma 
poses any threat to our public health and safety. To the contrary, the 
evidence suggests that granting Dr. Delisma a Certificate of 
Registration would be in the public interest. Accordingly, I recommend 
that

[[Page 23855]]

the Acting Administrator GRANT the application for a Certificate of 
Registration, Control Number W18071098C, submitted by Dr. Kansky J. 
Delisma, M.D., without further delay.
    Dated: May 23, 2019.

Charles Wm. Dorman,
U.S. Administrative Law Judge.
[FR Doc. 2020-09057 Filed 4-28-20; 8:45 am]
BILLING CODE 4410-09-P