Kansky J. Delisma, M.D.; Decision and Order
| Published date | 29 April 2020 |
| Record Number | 2020-09057 |
| Section | Notices |
| Court | Drug Enforcement Administration,Justice Department |
Federal Register, Volume 85 Issue 83 (Wednesday, April 29, 2020)
[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
