[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Notices]
[Pages 61630-61664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24206]
[[Page 61629]]
Vol. 86
Friday,
No. 212
November 5, 2021
Part III
Department of Justice
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Larry C. Daniels, M.D.; Decision and Order; Notice
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 /
Notices
[[Page 61630]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 19-33]
Larry C. Daniels, M.D.; Decision and Order
On June 21, 2019, a former Assistant Administrator of Diversion
Control Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause (hereinafter, OSC) to Larry
C. Daniels M.D., (hereinafter, Respondent or Dr. Daniels) of
Shreveport, Louisiana. Administrative Law Judge Exhibit (ALJ-- 1, (OSC)
at 1. The OSC proposed to deny his pending application No. W18024499C
for a DEA Certificate of Registration (hereinafter, COR or
registration) pursuant to 21 U.S.C. 823(f) and 824(a)(1) for the reason
that Respondent's ``registration would be inconsistent with the public
interest,'' and because he ``materially falsified [his] application for
registration.'' Id.
In response to the OSC, Respondent requested a hearing before an
Administrative Law Judge. ALJ-2. The hearing in this matter was held in
Shreveport, Louisiana on November 13-15, 2019. On January 24, 2020,
Administrative Law Judge Charles Wm. Dorman (hereinafter, the ALJ)
issued Recommended Rulings, Findings of Fact, Conclusions of Law and
Decision (hereinafter, Recommended Decision or RD), and on February 11,
2020, the Respondent filed exceptions (hereinafter, Resp Exceptions) to
the Recommended Decision. The Government filed exceptions (hereinafter,
Govt Exceptions) to the Recommended Decision on February 13, 2020. I
address the Government's Exceptions, which were limited to the material
falsification allegations, in the RD at Section Analysis.III. I address
the Respondent's Exceptions, which were focused on the ALJ's finding
that Dr. Daniels had not accepted responsibility and his recommended
sanction, in the Sanction Section, and I issue the final order in this
case following the RD. The ALJ transmitted the record to me on February
19, 2020. Having reviewed the entire record, I adopt the ALJ's rulings,
findings of fact, as modified, conclusions of law and recommended
sanction with minor modifications, where noted herein.\*A\
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\*A\ I have made minor modifications to the RD. I have
substituted initials or titles for the names of witnesses and
patients to protect their privacy and I have made minor,
nonsubstantive, grammatical changes and nonsubstantive, conforming
edits. Where I have made substantive changes, omitted language for
brevity or relevance, or where I have added to or modified the ALJ's
opinion, I have noted the edits with an asterisk, and I have
included specific descriptions of the modifications in brackets
following the asterisk or in footnotes marked with a letter and an
asterisk. Within those brackets and footnotes, the use of the
personal pronoun ``I'' refers to myself--the Administrator.
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Joshua H. Packman, Esq. and David M. Locher, Esq. for the Government
Sam L. Jenkins, Jr., Esq. for the Respondent
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
*B The issue before the Administrator is whether the
record as a whole establishes b a preponderance of the evidence thatg
the DEA should den the application for a Certificate of Registration of
Larr C. Daniels, M.D., Application Number W18024499C, pursuant to 21
UJ.SC. Sec. Sec. 823(f) and 824(a)(1) and (a)(4), because he materiall
falsified his application and because granting him a registration would
be inconsistent with the public interest. ALJ-7.
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\*B\ I have submitted the RD's discussion of the procedural
histor to avoid repetition with m introduction.
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In issuing this Recommended Decision, I have considered the entire
Administrative Record, including all of the testimony, admitted
exhibits, and the oral and written arguments of counsel.
The Allegations
Material Falsification
1. On March 12, 2018, the Louisiana State Board of Medical
Examiners (``the Board'') issued a Consent Order that ``imposed a
continuing restriction on [Dr. Daniels'] ability to practice medicine
and to prescribe controlled substances for pain management or addiction
treatment.'' ALJ-1, at 3-4, para. 8(c). Dr. Daniels' application for a
DEA certificate of registration, dated March 16, 2018, failed to
disclose the restriction imposed by the Board's Consent Order on his
Louisiana state controlled substance license. Id. at 3-4, paras. 8-9.
Dr. Daniels' failure to disclose the restriction imposed by the Board's
Consent Order on his state controlled substance license constitutes a
material falsification of his application for DEA registration, in
violation of 21 U.S.C. 824(a)(1). Id.
Addiction Treatment
2. Between May 2016 and September 2017, Dr. Daniels prescribed
controlled substances to patients AK, CA, MN, JD, SB, and CM. ALJ-1, at
4, paras. 10-12. Dr. Daniels' prescriptions for controlled substances
to these patients exhibited the following deficiencies:
a. Dr. Daniels failed to conduct a physical examination of any of
these patients;
b. Dr. Daniels failed to request these patients' medical records
concerning prior substance abuse or past treatment of substance abuse;
c. Dr. Daniels failed to obtain a report from the Louisiana
Prescription Monitoring Program for any of these patients;
d. Dr. Daniels failed to address in these patients' medical records
the results of abnormal urine drug screens, to include results that
were positive for illicit substances and negative for substances that
Dr. Daniels prescribed;
e. Dr. Daniels failed to document in these patients' medical
records his rationale for his medical treatment of these patients, to
include his reason for initiating buprenorphine treatment at high
dosages. ALJ-1, at 5, para. 12(a)-(e).
3. In addition, Dr. Daniels issued to patients AK, CA, MN, SB, and
CM, prescriptions for both buprenorphine (Subutex) and clonazepam. ALJ-
1, at 5, para. 13. Prescribing these controlled substances to a patient
at the same time can pose potential risks for that patient. Id. Dr.
Daniels failed to document in the patients' medical records any
rationale that justified prescribing buprenorphine and clonazepam at
the same time. Id. Dr. Daniels also failed to document in the patients'
medical records that he discussed with them the risks of taking these
controlled substances at the same time. Id. Specifically, Dr. Daniels
issued the following prescriptions in violation of state and federal
law:
a. Between January 2017 and August 2017, Dr. Daniels prescribed AK
buprenorphine (Subutex) on nine occasions and clonazepam (Klonopin) on
at least eight of those occasions. ALJ-1, at 5, para. 14(a).
b. Between June 2016 and September 2017, Dr. Daniels prescribed CA
buprenorphine (Subutex) and clonazepam (Klonopin) on at least 19
occasions, an amphetamine-dextroamphetamine mixture (Adderall) on 18 of
those occasions. Id. at 6, para. 14(b). Dr. Daniels failed to document
in CA's medical record any rationale for prescribing Adderall to CA.
Id. at 6, para. 14(b)(i).
c. Between May 2017 and August 2017, Dr. Daniels prescribed MN
buprenorphine (Subutex) and clonazepam (Klonopin) on at least five
occasions. Id. at 6, para. 14(c).
d. Between August 2016 and August 2017, Dr. Daniels prescribed JD
buprenorphine (Subutex) on at least 15 occasions. Id. at 6, para.
14(d).
e. Between January 2017 and July 2017, Dr. Daniels prescribed SB
[[Page 61631]]
buprenorphine (Subutex) and clonazepam (Klonopin) on at least seven
occasions. Id. at 6, para. 14(e).
f. Between May 2016 and September 2017, Dr. Daniels prescribed CM
buprenorphine (Subutex) on at least 18 occasions and clonazepam
(Klonopin) on 10 of those occasions. Id. at 6, para. 14(f).
4. For the reasons listed in Allegations 2 and 3, the prescriptions
that Dr. Daniels issued to AK, CA, MN, JD, SB, and CM, were beneath the
standard of care for the practice of medicine in Louisiana, outside the
usual course of professional practice, and not for a legitimate medical
purpose, in violation of 21 U.S.C. 841(a), 842(a); 21 CFR 1306.04(a);
La. Admin. Code tit. 46, Pt. LIII, Sec. 2745(B)(1); La. Admin. Code
tit. 46, Pt. XLV, Sec. Sec. 6919, 6921; and La. Admin. Code tit. 48,
Pt. I, Sec. Sec. 5637, 5647, 5723, 5725, 5731. ALJ-1, at 4-6, paras.
10-15.
Pain Management
5. Dr. Daniels issued controlled substance prescriptions for pain
management to JW that exhibited the following deficiencies:
a. Dr. Daniels' records for follow-up visits with JW lack any
indicia of a meaningful doctor-patient relationship, because the
physical examination records for JW are incomplete, cursory, non-
diagnostic, non-contributory, and/or lack notations of vital signs.
ALJ-1, at 6, para. 16(a).
b. Dr. Daniels duplicated the therapeutic effect of the opioids he
prescribed to JW by prescribing JW oxycodone-acetaminophen (Percocet),
oxycodone extended release (OxyContin), and hydrocodone-acetaminophen
(Lortab), after initially prescribing him methadone. Id. at 6, para.
16(b). Therapeutic duplication increases the risk of unintentional
overdose. Id.
c. Between March 2014 and January 2017, Dr. Daniels prescribed JW
OxyContin and methadone at the same time. Id. at 7, para. 16(c). In
July 2014, Dr. Daniels prescribed JW Percocet and Lortab at the same
time. Id. Dr. Daniels failed to document in JW's medical records any
justification for these prescriptions. Id. at 7, para. 16(d).
d. In addition, Dr. Daniels failed to document in JW's medical
records any justification for increasing JW's monthly methadone
prescription in January 2016 from 150 units of methadone 10 mg to 180
units. Id. at 7, para. 16(d).
e. Between August 2013 and April 2017, Dr. Daniels issued to JW at
least 56 prescriptions for Percocet; 7 prescriptions for OxyContin (5
at the same time as Percocet); and 1 prescription for Lortab. ALJ-1, at
7, para. 17.
f. Between January 2016 and March 2017, Dr. Daniels issued to JW at
least 15 prescriptions for methadone at the increased dosage of 180
units, 5 at the same time as prescriptions for Percocet. Id. at 7,
para. 17.
6. For the reasons listed in Allegation 5, the prescriptions that
Dr. Daniels issued to JW were beneath the standard of care for the
practice of medicine in Louisiana, outside the usual course of
professional practice, and not for a legitimate medical purpose, in
violation of 21 U.S.C. 841(a), 842(a); 21 CFR 1306.04(a); La. Admin.
Code tit. 46, Pt. LIII, Sec. 2745(B)(1); and La. Admin. Code tit. 46,
Pt. XLV, Sec. Sec. 6919, 6921. ALJ-1, at 6-7, paras. 16-17.
Undercover Officer (``TC'')
7. On September 13, 2017, Dr. Daniels prescribed 60 units of
Suboxone (buprenorphine/naloxone) 8/2 mg to TC. ALJ-1, at 7, para. 18.
Among other issues, this prescription exhibited the following
deficiencies:
a. Dr. Daniels failed to conduct a physical examination of TC;
b. Dr. Daniels failed to request any medical records of TC's prior
substance abuse or past treatment for substance abuse;
c. Dr. Daniels failed to obtain a *[Prescription Monitoring Program
(hereinafter,] PMP) report for TC. Id. at 7, para. 19.
8. Furthermore, Dr. Daniels initiated Suboxone treatment for TC at
16/4 mg per day despite TC's negative urine drug screen; TC's report to
Dr. Daniels that he had not taken any opioids for two-to-three weeks;
and Dr. Daniels' recognition that TC's presentment of addiction was not
severe. ALJ-1, at 8, para. 19.
9. Dr. Daniels' medical records for TC fail to provide adequate
information about Dr. Daniels' evaluation and treatment plan for TC,
and are so cursory that they lack credibility. ALJ-1, at 8, para. 19.
10. For the reasons listed in Allegations 7-9, the prescription
that Dr. Daniels issued to TC was beneath the standard of care for the
practice of medicine in Louisiana and outside the usual course of
professional practice, in violation of 21 U.S.C. 841(a) and 842(a); 21
CFR 1306.04(a); and La. Admin. Code tit. 46, Pt. LIII, Sec.
2745(B)(1). ALJ-1, at 8, para. 19.
Witnesses
I. The Government's Witnesses
The Government presented its case through the testimony of three
witnesses. The Government first presented the testimony of a Diversion
Investigator (``the DI''). Tr. 25-72. The DI also testified as a
rebuttal witness. Tr. 588-99.
This witness has been a Diversion Investigator for 11 years. Tr.
26. She briefly testified concerning her work history with the DEA and
her training. Tr. 26-28. The DI became familiar with Dr. Daniels after
the Shreveport Resident Office of the DEA received information that Dr.
Daniels was prescribing excessive amounts of controlled substances. Tr.
28.
The DI reviewed the Consent Order (``the Order'') issued to Dr.
Daniels by the Louisiana State Board of Medical Examiners (``the
Board''), highlighting restrictions placed on Dr. Daniels' ability to
practice medicine by that Order. Tr. 33-34. The DI then reviewed Dr.
Daniels' application for a DEA Certificate of Registration, noting that
he had provided affirmative answers to two of the liability questions
on the application. Tr. 38-39. The DI testified that had Dr. Daniels
provided information that was more consistent with the content of the
Order, that that information would have been relevant in assisting the
DEA when making a decision about what action to take on Dr. Daniels'
application. Tr. 39-41. *[The DI stated that the Order was
``ambiguous'' and that ``it's a requirement for the registrant to
notify DEA that he has specific restrictions as in reference to
controlled substances.'' Tr. 65; see also Tr. 72.] *[The DI testified
that] the application itself, however, does not inform an applicant to
provide the *[incident result] information that the DI asserted was
missing from Dr. Daniels' application, which *[DEA alleged] constituted
a material misrepresentation. [Tr. 70]. The information Dr. Daniels
provided on his application, however, placed the DEA on notice that it
should not summarily approve Dr. Daniels' application, but rather DEA
should investigate it. Tr. 71.
Testifying as a rebuttal witness, the DI identified Government
Exhibit 29 as a subpoena issued to the Louisiana Board of Pharmacy's
Prescription Monitoring Program. Tr. 590. She also identified
Government Exhibit 30 as the response to Government Exhibit 29. Tr.
593. In response to the subpoena, the Board of Pharmacy produced a 20-
page history of Dr. Daniels' logins to the Louisiana PMP from June 2,
2016, through September 9, 2019. Tr. 593, 599. The history showed that
Dr. Daniels had queried the PMP with respect to only two of the named
patients in the OSC, patients TC and CA. Tr. 597. Both inquiries were
made on September 13, 2017. Tr. 598.
[[Page 61632]]
During the Government's case-in-chief, and as a rebuttal witness,
the DI presented her testimony in a professional, clear, and concise
manner, and her demeanor was appropriate. Accordingly, I fully credit
her testimony.
The Government's second witness was Task Force Officer (``TC''), a
detective with the DeSoto Parish Sheriff's Office. Tr. 73-104. TC
provided a brief overview of his law enforcement training. Tr. 74-76.
He became aware of Dr. Daniels during undercover operations, in which
he went to the doctor's office. Tr. 76. TC went to Dr. Daniels' office
twice in September 2017, and made audio and video recordings during
each visit. Tr. 76-77, 80; GE-24, 27. TC testified that Government
Exhibit 24 is a complete and accurate recording of his visit with Dr.
Daniels on September 13, 2017. Tr. 85.
TC detailed what happened during his visit to the clinic on
September 12, 2017. Tr. 77-80. During that visit, TC provided a urine
sample, his vitals were taken, and he talked with a counselor. Id. The
details of what he told the counselor are documented in the counselor's
notes. Tr. 87; GE-23, at 2-6. TC's urine screen was negative. Tr. 89;
GE-23, at 9.
TC also detailed what happened when he returned to the clinic on
September 13, 2017. Tr. 80-85. During that visit, he informed Dr.
Daniels of his prior use of Lortab, Percocet, Adderall, and Suboxone,
which he obtained ``off the street.'' Tr. 82-84. He also told Dr.
Daniels that he drank alcohol. Tr. 82. Dr. Daniels did not caution TC
about combining medications with each other or with alcohol and he did
not physically examine TC. Tr. 82-84; GE-25. TC left the appointment
with a prescription for Suboxone that Dr. Daniels issued to him. Tr.
85; GE-23, at 1.
TC presented his testimony in a professional, clear, and concise
manner. In addition, his testimony was consistent with other evidence
of record. Accordingly, I credit his testimony.
The third witness called by the Government was its expert, Dr. Gene
Kennedy, M.D. He testified during the Government's case-in-chief, Tr.
106-416, and as a rebuttal witness. Tr. 600-04.
Dr. Kennedy currently maintains his own pain practice, Island Pain
Care, on St. Simon's Island, Georgia. Tr. 107. He detailed his
education, training, and professional experience. Tr. 107-111. Dr.
Kennedy graduated from LSU with a degree in biology. Tr. 107. He
obtained his medical degree from New York Medical College, and he then
did a residency in family medicine in Wheeling, West Virginia, and then
practiced family medicine in Ohio for many years. Id. In 2000, Dr.
Kennedy relocated to Georgia. Tr. 109. Dr. Kennedy has been involved in
pain management since his residency because a lot of family practice
deals with pain management. Id. Dr. Kennedy opened his pain management
clinic in 2004-05. Dr. Kennedy also treats patients who have substance
abuse disorders, and he prescribes Suboxone to them. Tr. 109-10. Dr.
Kennedy has a DEA Certificate of Registration, which includes an ``X''
number. Tr. 111. Dr. Kennedy identified Government Exhibit 26 as his
resume. Tr. 111-12. Dr. Kennedy lectures on the differences between
legitimate and illegitimate prescribing of controlled substances. Tr.
114-15. He has also testified as an expert witness at administrative
hearings, and in both civil and criminal cases. Tr. 115. Dr. Kennedy
testified that the standard of care that a doctor needs to meet is, for
the most part, standard across the country, recognizing that individual
states may have individual requirements. Tr. 119-34. *[ He further
testified that ``there are individual variations with states, and
understanding that nobody's medical records are perfect then you
analyze the chart and apply the regulations as best you reasonably can
when doing a review.'' Tr. 120.]
There being no objection *C raised by Dr. Daniels, I
accepted Dr. Kennedy as an expert in the areas of addiction treatment,
pain management, and the standard of care for prescribing controlled
substances for addiction treatment, and for pain management in the
State of Louisiana. Tr. 134, 140.
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\*C\ Despite not raising objections at the hearing, Dr. Daniels
suggests in his posthearing brief that Dr. Kennedy's testimony
should be considered in light of the fact that he ``has never
practiced medicine in the State of Louisiana.'' Respondent's
Posthearing, at 4. In this case, I find that Dr. Kennedy primarily
relied on Louisiana law and regulations to formulate his opinion
regarding the standard of care and usual course of professional
practice and the laws provide extremely strong support for his
testimony. See infra Analysis.V.
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Dr. Kennedy testified that the standard of care for prescribing
controlled substances for the treatment of chemical dependency
requires: An adequate physical examination; obtaining a medical history
and past medical records; obtaining PMP reports; conducting drug
screening; and maintaining complete and accurate medical records. Tr.
141-51. Dr. Kennedy recognized that no doctor can document everything
that occurs during a patient encounter, but the doctor should document
the important, pertinent information such that it will give a picture
of what happened during the encounter to an objective reviewer of those
records. Tr. 151-52. Dr. Kennedy also acknowledged that a reviewer of
medical records must keep an open mind, and, at times, afford the
treating doctor the benefit of the doubt. Tr. 153, 294, 296-98, 336.
In preparation for his testimony, Dr. Kennedy reviewed the medical
records and the PMP reports of the patients identified in the Order to
Show Cause. Tr. 159. In rendering his opinions concerning the
prescriptions he reviewed, Dr. Kennedy noted that ``rarely is [his
opinion] based on a single thing,'' rather it is developed after
reviewing medical records and ``[i]t reaches a point where . . . it's
simply not possible to say that what I'm looking at is credible medical
care.'' Tr. 195. Dr. Kennedy further noted that accidents do happen in
medical records, ``but when you have a repetitive pattern of medical
records missing critical information, it's not excusable.'' Tr. 295.
With respect to treatment plans, Dr. Kennedy testified that he does not
criticize a treatment plan ``as long as I can determine that there is a
rationale behind it.'' Tr. 298.
Dr. Kennedy proceeded to review the patient files contained in this
case, and rendered his opinion that most of the prescriptions
identified in the Order to Show Cause, written by Dr. Daniels, were
issued outside the usual or acceptable course of professional medical
practice and were not issued for legitimate medical purposes. Tr. 191-
92, 206, 220, 231, 238, 244, 255, 261, 266, 278-83, 372-73. As a
rebuttal witness, Dr. Kennedy slightly modified his testimony
concerning Dr. Daniels' treatment of patient TC. Tr. 601-04. While Dr.
Kennedy's opinion had not changed as to whether the prescription that
Dr. Daniels issued to TC was outside the standard of care, and outside
the usual course of professional practice, Tr. 602-03, he testified
that Dr. Daniels may have believed he had a legitimate medical purpose
to issue the prescription. Tr. 602. Concerning the question of
``whether or not it was issued for a legitimate medical purpose,'' Dr.
Kennedy testified that he ``would have to go over everything again to
make a final decision . . . .'' Tr. 602.*D
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\*D\ Ultimately, I find that the distinction that Dr. Kennedy
makes here with regard to whether the prescription had a legitimate
medical purpose is not entirely relevant considering Louisiana law
and the CSA regulations. As explained below, Louisiana law mirrors
the DEA regulations in providing that ``[a]n order purporting to be
a prescription issued not in the usual course of professional
treatment or in legitimate and authorized research is not a
prescription within the meaning and intent of the Controlled
Substances Act.'' La. Admin. Code tit. 46, Pt. LIII, Sec.
2745(B)(1); see also 21 CFR 1306.04(a) (same). Therefore, the fact
that Dr. Kennedy had concluded that this prescription was issued
outside the usual course of professional treatment and beneath the
standard of care, Tr. 602-03, demonstrates that there was a
violation of law for the purpose of consideration under Factor Four
of the public interest factors. See infra Analysis.V (Patient TC);
infra n.27; see also Ester Mark, M.D., 16,760, 16,778 (citing Wesley
Pope, M.D., 82 FR 14,944, 14,967 n.38 (2017) (explaining ``there is
no material difference between'' the dual criteria of Section
1306.04(a).'') Prescribing a controlled substance outside the course
of professional practice is enough to violate DEA's prescription
requirement. Id.
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[[Page 61633]]
Dr. Kennedy presented his testimony in a professional, candid, and
straightforward manner. He also presented his testimony in an objective
manner, and as a witness who had no stake in the outcome of the case.
In addition, the testimony of Dr. Kennedy was sufficiently detailed,
plausible, and internally consistent. Furthermore, Dr. Kennedy's
testimony went unrebutted.\1\ Therefore, I merit it as fully credible
in this Recommended Decision.
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\1\ ``When an administrative tribunal elects to disregard the
uncontradicted opinion of an expert, it runs the risk of improperly
declaring itself as an interpreter of medical knowledge.'' Zvi H.
Perper, M.D., 77 FR 64131, 64140 (2012) (citing Ross v. Gardner, 365
F.2d 554 (6th Cir. 1966)).
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II. Respondent's Witnesses
Respondent presented his case through the testimony of two
witnesses. The Respondent's first witness was LW (``LW''). Tr. 418-69.
LW was the owner of the Medical Clinic (``the Clinic'') where Dr.
Daniels worked. Tr. 419. The Clinic closed on October 3, 2017. Id.
While in operation, the Clinic provided services for patients who had
low, to mid-level incomes, and who were being treated for some kind of
opioid addiction. Tr. 421-22. Between January 2016 and April 24, 2017,
LW was at the Clinic one evening a week. Id. On April 24, 2017, LW
started working at the Clinic full time and oversaw its day-to-day
operations. Tr. 420. LW is a medical assistant. Tr. 445.
LW provided testimony about how the Clinic operated after April 24,
2017. Tr. 430-31. After that date, Dr. Daniels worked at the Clinic
just one evening a week and saw about 25 patients a week. Tr. 424-25.
He was the only doctor who worked at the Clinic. Tr. 427. In addition
to Dr. Daniels and LW, the Clinic employed five other individuals. Tr.
425-26. LW testified about the duties of those employees. Tr. 428-29,
431-34, 436-41. Each of the employees played a part in assembling the
patients' medical records. Tr. 427, 438. LW testified that each new
patient submitted to a urine drug screen and that the Clinic checked
the patient's PMP. Tr. 442-43, 446. Information about the results of
the drug screening and the PMP were provided to Dr. Daniels. Tr. 443.
Although LW testified that after she started working at the Clinic
full-time, Clinic employees always checked the PMP, she did not know if
that information was placed into a patient's medical record. Tr. 448.
In general, I found LW to be a sincere and credible witness who
testified about how she thought the Clinic was running after she took
over the day-to-day operations. It was also obvious that she has a
sincere interest in providing health services to an underserved
community. For someone who was overseeing the day-to-day operations of
the Clinic, however, her testimony was less than clear about when and
how PMPs were run, and how the results of the PMP search and of the
urine drug screens were provided to Dr. Daniels. Although she testified
that the PMP report was run for each patient, Tr. 442, it was not clear
when the clinic ran PMP's on patients. She testified it was run when
the patient came in, and it was run after they saw the social worker,
``it was run constantly.'' Tr. 457-59. Further, LW was not clear on
what information from the PMP was shared with Dr. Daniels. Tr. 460-465.
In that her testimony about running PMP reports on every patient is
directly contradicted by Government Exhibit 30,\2\ I give little weight
to this testimony. Further, while LW testified that urine drug screens
were taken for each patient, Tr. 443, she also testified that the
Clinic discovered that the results of those tests were not always in
the patients' charts. Tr. 427, 439. I find that LW's testimony about
having patients submit to urine drug screening is generally consistent
with other evidence of record, namely the large number of drug
screening reports that are in the patients' medical records. Thus, with
the exception of LW's testimony about PMPs, I give credit to LW's
testimony.
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\2\ Government Exhibit 30, however, gives some support to Dr.
Daniels' position that he was checking the PMP, *[at least with
respect to two of the patients].
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Next, Dr. Larry Daniels, M.D., testified on his own behalf. Tr.
475-586. Dr. Daniels worked at the Shreveport Job Corps Center, the
Diabetes Management Center, and the Clinic. Tr. 475. Dr. Daniels has
practiced medicine in Louisiana since 1983. Tr. 476. He practiced for
one year in Houston, Texas, from 1999 to 2000. Tr. 476-77. Dr. Daniels
received compensation for his services at the Clinic from the Clinic
itself, and not from patients. Tr. 480. Throughout his career, Dr.
Daniels has worked for multiple clinics that provide medical services
to low-income patients, and he has treated patients who had chemical
dependencies. Tr. 482-84. Dr. Daniels worked at the Clinic on Wednesday
evenings. Tr. 488. He would normally see about 10-20 patients on those
evenings. Id.
The Clinic was located in Minden, Louisiana, which is a rural area.
Tr. 480. Dr. Daniels worked at the David Raines Community Health Center
(``Community Health Center'') at the same time that he worked at the
Clinic. Id. Before working at the Clinic, Dr. Daniels had experience in
private practice and at the Community Health Center in treating
chemical dependency. Tr. 482.
Dr. Daniels acknowledged that there is information missing from the
patients' charts. Tr. 487. Dr. Daniels testified that the patient
charts in this case do not include sticky notes and other notes that
would have been on the inside of the manila folder that held the
charts. Tr. 488. Dr. Daniels testified that a doctor learns the
patient's medical history by talking to the patient about his or her
past medical conditions and any current problems, to include the
patient's chief complaint. Tr. 491. He stated that a doctor also
acquires the patient's medical history by discussing the patient's
family and social history. Id.
Dr. Daniels acknowledged that he did not always document the
justification for the prescriptions he wrote. Tr. 523. When Dr. Daniels
saw a patient at the Clinic, some of the patient's medical history was
available on forms that the patient completed before the visit. Tr.
492. He explained that because he has worked in several mental health-
counseling clinics, he has gained familiarity and experience in
treating certain conditions. Id. Dr. Daniels also noted that the Clinic
saw an increase in patients when it received its waiver to treat 100
patients. Tr. 489. Previously it only held a waiver for 30 patients.
Id.
Dr. Daniels agreed with Dr. Kennedy's testimony about physical
examinations. Tr. 492. Dr. Daniels testified that in situations where
there is limited staff and when other patients are waiting, a doctor
sometimes needs to make a ``judgment call'' about examining the
patient, and not inconveniencing the waiting patients. Tr. 493. In
those situations, in Dr. Daniels' view, the doctor performs ``enough of
an exam'' in order to ``move forward'' with the patient, allowing the
doctor time to see other patients. Tr. 493. Dr. Daniels also testified
that a doctor can perform an examination by observing the patient,
[[Page 61634]]
and noting the patient's demeanor, activity, mood, and physical
appearance. Tr. 493-94. Sometimes, Dr. Daniels decided to do a more
thorough physical examination. Tr. 512.
Dr. Daniels testified that in general he would ask each patient:
About his or her medication; whether the medication was working; who
initially prescribed it; and how long the patient had been taking it.
Tr. 517. Similarly, Dr. Daniels testified that the purpose of checking
a patient's PMP report was to see which medications, if any, the
patient has received before, when the patient received those
medications, and the doctors who prescribed them. Tr. 495. Although
there is no requirement to print out a copy of a patient's PMP report,
Dr. Daniels testified that it would be ideal to obtain a printout. Tr.
496.
Dr. Daniels testified that when searching for a patient on the PMP,
he was mostly concerned with looking at the past 30 days. Tr. 496-97.
It is normal to delegate the duty to check the PMP to someone other
than the doctor. Tr. 497. Normally, a staff member of the Clinic would
run a PMP report and provide the results to Dr. Daniels. Tr. 514, 522.
The Clinic did not document the results of the PMP report. Tr. 522.
With respect to urine drug screens, Dr. Daniels testified that in
most cases he addressed abnormalities with the patient but did not
document that fact in the patient's chart. Tr. 498, 502. He
acknowledged it would be best practice to document efforts to address
an abnormal urine drug screen. Tr. 501. He also acknowledged that ``a
couple of patients'' tested negative for their prescribed medications.
Tr. 502. It is unclear, however, whether he was referring to the
patients in this case. Testing negative for a prescribed controlled
substance raises the concern of diversion. Id. When this occurred, he
would refer it to the clinical social worker. Tr. 503. These actions,
in his opinion, should have been better documented. Id.
Dr. Daniels testified that the current standard is not to discharge
a noncompliant patient. Tr. 499-500. It was unclear from his testimony
when this standard began. For example, Dr. Daniels made an analogy to a
diabetic patient whose sugars are elevated after not complying with his
or her prescribed diet. Id. Dr. Daniels said that a doctor would not
discharge this patient simply because the patient failed to comply with
his or her diet. Tr. 500. According to Dr. Daniels, the same is true
for doctors treating patients for chemical dependency. Id. He explained
that it is better for a patient in the long-term to be kept on
medication than to discharge the patient. Id. Discharging a patient
could lead to a relapse or to the patient taking dangerous street
drugs. Id. In Dr. Daniels' opinion, none of the patients in this case
should have been discharged because of a urine drug screen. Tr. 501-02.
Some of the patients who presented with opioid addiction also had
other issues, such as anxiety and depression, and Dr. Daniels had to
formulate a treatment plan for those issues as well. Tr. 506. Most of
the patients also needed counseling. Tr. 501, 504, 506. If Dr. Daniels
was not going to be at the Clinic, he would sometimes write a
prescription for the patient and have the staff check the patient's
vitals and take a urine drug screen. Tr. 508-10. If the patient was
taking Suboxone, Dr. Daniels would discuss the Suboxone treatment
regimen plan with the patient. Tr. 516. He would also ask the patient
if he or she signed the treatment contract, and whether the patient
understood it. Tr. 516. He would only address specific provisions of
the treatment contract if he believed there might be a particular issue
with the patient's ability to comply with the contract. Tr. 516.
When asked about the physical examination he conducted of patient
AK, at AK's first visit on January 18, 2017, Dr. Daniels said he
checked-off neat and clean on the record, and noted AK had a depressed
affect. Tr. 512; GE-6, at 25. Patient AK also took a urine drug screen
at this first visit. Tr. 514; GE-6, at 29. AK's initial urine drug
screen was positive for methamphetamine, but not when he returned to
the next visit. Tr. 515; GE-6, at 29. It was also positive for
marijuana. Id. Dr. Daniels testified that he was not concerned when a
patient tested positive for THC because ``it's so ubiquitous in this
population that I see,'' and he did not believe it would be unsafe for
AK to take marijuana. Tr. 515. Dr. Daniels' treatment plan for AK at
the first visit was to conduct monthly and random urine drug screens,
provide AK counseling, prescribe Subutex 8 mg TID and Klonopin 2 mg,
and have AK return to the Clinic in one month. Tr. 515, 518.
Dr. Daniels could not remember what was found on AK's PMP report,
if anything, because AK's PMP results are not documented. Tr. 514. Dr.
Daniels testified that he was able to conclude that AK had an opioid
addiction based on AK's medical history, the physical examination that
Dr. Daniels described, and AK's urine drug screen. Tr. 515. AK also had
an anxiety disorder and pain. Tr. 517-18. Dr. Daniels did not see pain
recorded in AK's chart. Tr. 517. Dr. Daniels did not see AK's
counseling records in his chart. Tr. 515-16. Dr. Daniels testified that
the Food and Drug Administration has advised that patients should not
be denied Subutex simply because the patient is also taking a
benzodiazepine. Tr. 518. In Dr. Daniels' opinion, he believed it was
justified to prescribe Subutex and Klonopin to AK because AK had pain
and had taken opioids and Klonopin before. Tr. 518. Dr. Daniels
acknowledged, however, that AK's chart does not document that AK had
taken opioids before *[for a pain condition]. Id. Dr. Daniels believed
prescribing a higher dose of Subutex to AK was warranted because in
addition to opioid addiction AK also had pain, and Subutex can be used
to relieve pain. Tr. 517-18. In Dr. Daniels' opinion, the prescriptions
in Stipulation 17 were written to treat AK's substance abuse disorder,
anxiety, and chronic pain. Tr. 520.
On June 22, 2016, patient CA presented with an opioid addiction,
and history of abdominal pain, hand fracture, arthritis, anxiety, ADHD,
and TMJ. Tr. 521. CA had received Subutex from another doctor for
opioid addiction, as well as Adderall for ADHD and Klonopin for
anxiety. Tr. 521-22. When asked about the physical examination he
conducted of CA, Dr. Daniels testified that he looked at CA's person,
place, and orientation; noted that CA's affect was ``blunted and
flat''; and observed that he was ``depressed and anxious.'' Tr. 521.
Dr. Daniels testified that CA's history, his answers, and his demeanor
were consistent with ADHD. Tr. 523. Based on CA's history and Dr.
Daniels' examination of CA, he was able to diagnose CA with an opioid
addiction, anxiety disorder, and ADHD. Tr. 522. Dr. Daniels testified
that CA had received treatment from another provider before CA had seen
him. Tr. 528.
Dr. Daniels' treatment plan for CA included monthly urine drug
screens, counseling, Subutex at his current dosage, Klonopin 1 mg TID,
and Adderall 30 mg. Tr. 523. In Dr. Daniels' opinion, the prescriptions
in Stipulation 22 were written to treat CA's diagnosed conditions of
opioid addiction, anxiety, chronic abdominal pain, ADHD, and TMJ. Tr.
524; GE-10, at 53.
Patient MN's chief complaint was an addiction to Subutex. Tr. 526.
After talking with her, he learned that she had been addicted to other
medications as well. Id. MN had already been prescribed Subutex for
opioid dependence by other doctors before seeing Dr. Daniels. Tr. 528-
29. MN also had anxiety. Tr. 529. Dr. Daniels' chart for MN included a
note that Suboxone
[[Page 61635]]
gave her migraines. Tr. 527; GE-14, at 29. Dr. Daniels described it as
``a very limited note,'' but explained that ``sometimes with
interruptions in the clinic, you get limited information to put in the
chart.'' Tr. 527.
When asked whether he physically encountered MN, Dr. Daniels said
that he did not ``see a document of physical encounter.'' Tr. 527. Dr.
Daniels testified, however, that he did see MN, and he did conduct a
physical examination. Tr. 527-28. MN's chart includes some medical
history collected by the Clinic's staff and the counselor. Tr. 528.
When asked whether he was able to diagnose MN, he stated that he
diagnosed her with an opioid addiction based on her history. Tr. 528-
29. Dr. Daniels' treatment plan for MN included Subutex 8 mg TID and
Klonopin. Tr. 529. In Dr. Daniels' opinion, the prescriptions in
Stipulation 24 were written to treat MN's opioid dependency and
anxiety. Tr. 529-30.
Patient JD presented with a history of back pain and opioid abuse.
Tr. 531. JD had been prescribed Lortab for his back pain by another
physician, but he later began taking Percocet and methadone, which he
bought on the street. Id. A previous physician had also prescribed
Subutex to JD for an opioid addiction, and his urine drug screen was
``consistent with having [taken] Subutex.'' Tr. 532.
Dr. Daniels' treatment plan for JD included Subutex 8 mg TID,
monthly drug screens, and counseling. Id. He additionally testified
that JD remained in the Clinic past this initial visit and that the
Subutex prescription was meant to address JD's back pain as well as his
addiction. Tr. 533.
Patient SB's chief complaint was panic attacks and a history of
recreational drug abuse. Tr. 534. SB had been treated by another
physician with Suboxone, but after experiencing side effects was
treated with Subutex instead. Id. In addition to taking vitals, height,
and weight, Dr. Daniels ordered a urine drug screen for SB. Id. SB
tested positive for methamphetamine, marijuana, and Subutex. Id. While
he did not make a note of it in SB's file, Dr. Daniels testified that
in this situation, his general recommendation would have been for more
frequent counseling. Tr. 535-36. However, he prescribed SB with Subutex
for addiction, and with Klonopin for panic attacks. Tr. 535.
Patient CM came to the Clinic with a history of abusing oxycodone
and roxycodone. Tr. 537. CM had previously been prescribed Subutex by
another physician. Id. Dr. Daniels took CM's vitals, recorded height
and weight, and made some other notes about CM's appearance and habits.
Id. CM did a urine drug screen, which came back positive for marijuana
and Suboxone. Tr. 538. Dr. Daniels also noted that CM ``appeared to
have an anxiety disorder.'' Tr. 540.
Dr. Daniels' treatment plan for CM included Subutex for ``chemical
dependencies,'' and Klonopin for anxiety. Id. When pressed about the
Klonopin prescription, Dr. Daniels testified that Klonopin is what is
usually prescribed for anxiety. Tr. 542. He also recommended
counseling. Tr. 540. According to Dr. Daniels, CM remained a patient
with the clinic for some time and was making progress. Tr. 539-40.
In detailing his treatment of patient JW, Dr. Daniels noted that JW
was a professional colleague of his who owned the Clinic before Ms. LW
took it over. Tr. 543. JW is a professional counselor who has known Dr.
Daniels since 2003. Id. Dr. Daniels testified that JW began developing
chronic pain in 2013, and a local physician was treating him with
methadone. Tr. 544. JW had been referred to a pain specialist in
Shreveport who was unable to see him because of an insurance issue. Id.
Dr. Daniels agreed to see JW temporarily because he was in terrible
pain and ``almost unable to ambulate.'' Id. Though he says it was not
his intent to treat JW long term, he treated him until 2017. Id.
Dr. Daniels determined that JW had hypertension, lumbar disc
disease, chronic back pain, a history of carpal tunnel syndrome, and
multiple surgeries in the past. Tr. 547. The initial plan was to follow
up on medical records. Id.
Dr. Daniels prescribed OxyContin to JW because he had just had knee
surgery, and he was complaining of severe knee pain. Tr. 548. He chose
OxyContin because JW had developed a tolerance to other pain
medications. Tr. 549. He claims that he wrote the prescription for
every 4-6 hours by mistake and that the usual dose is every 12 hours.
Id. He also believes that JW was taking it ``correctly,'' meaning every
12 hours. Tr. 550. Dr. Daniels also prescribed Percocet to JW so that
he could ``rotate [the pain medications] around'' for ``different
options on pain relief,'' because JW described being able to take
certain medications on some days, but not on others. Id. Dr. Daniels
saw JW as a patient at least once per week, but sometimes two or three
times per week, in addition to encountering him professionally on a
regular basis. Tr. 550-51. On cross-examination, Dr. Daniels agreed
that five of the prescriptions he wrote to JW for OxyContin were
written with the wrong dosing instructions. Tr. 577-79.
When Dr. Daniels first saw the undercover agent (``TC'') as a
patient, TC initially told him that he was taking 4-5 pain pills per
day that he had bought off of the street, presuming them to be Lortab.
Tr. 552. Dr. Daniels believed that TC would benefit from counseling.
Id. From further conversation, Dr. Daniels got the impression that TC
was actually taking more pills than he was letting on and that he was
not completely sure that the pills were, in fact, Lortab. Tr. 553. TC
also ``indicated that he was taking Suboxone off the street'' and
``taking maybe Adderall.'' Tr. 554. This led Dr. Daniels to prescribe
Suboxone. Id.
TC took a urine drug screen which tested negative. Tr. 556.
However, based on his understanding of ``the local people that [he] had
been treating for so many years'' and TC's history, Dr. Daniels felt
that the dose of Suboxone he prescribed was appropriate because he
believed it to be one that would prevent a relapse. Tr. 557. Dr.
Daniels testified that the reason why some of his discussions with TC
did not get documented in the medical record was ``because it was
cumbersome.'' Tr. 506.
As to his licensing history, Dr. Daniels testified that he had
never been denied a COR. Tr. 560. Regarding his state authority, Dr.
Daniels entered into a consent order with the state medical board, and
he testified that there had been concerns that he was not properly
monitoring patients or supervising staff. Id. *[He stated that the
state medical board ``felt like that [he], as an individual
practitioner, trusted people too much, that I gave too much confidence
in the people when I would ask them to do things or expect them to
bring things to me.'' Tr. 561.] Citing personal stress, Dr. Daniels
testified that he ``had not be[en] able to really take full advantage
of the opportunity to see these patients'' leading to potential risks
given the areas he was practicing in. Tr. 561. At the state medical
board's recommendation, Dr. Daniels attended continuing medical
education seminars on controlled substance prescribing, ethics, and
boundaries. Tr. 562. After completing these recommendations, the
medical board restored his license, but he was not allowed to practice
in the areas of managing: Addiction; chronic pain; or obesity. Tr. 563.
Dr. Daniels re-applied for a COR once his state license was
reinstated. Tr. 564. In filling out the form, he claims he did not
realize that he ``would have to be more complete'' and that he ``wasn't
aware that the high risk practice areas
[[Page 61636]]
was where they were restricting [him].'' Tr. 565. His understanding was
that the state medical board had fully reinstated his controlled
substance prescribing authority. Id. Dr. Daniels claims that he did not
intend to be evasive or misleading. Id. He additionally testified that
he has been struggling professionally without a COR because he
currently works at a diabetes management clinic where Lyrica, a
Schedule V controlled substance, is an important part of treatment. Tr.
568-69.
* [Dr. Daniels testified that he felt ``like he had made every
attempt to make sure that these patients were getting proper
evaluations, and that the medicines that [he] was prescribing were safe
and effective, and that [he] admit[s] some of the records fall short.
[He] failed. But [he] feel[s] that still the overall diagnoses were
correct, and the treatment plans were good.'' Tr. 570.]
Despite being the witness with the most at stake in these
proceedings, and thus the witness with the strongest motive to
fabricate, Dr. Daniels presented generally as candid and sincere.
However, there were notable inconsistencies between his descriptions of
his prescribing history to various patients and objective data such as
the PMP report for the relevant period. * [Additionally, I note that
regarding the undercover TC, Dr. Daniels stated, ``[a]nd he did tell me
about alcohol and he was drinking. And we talked about some of the
things that needed to be understood about the contract that he signed
that he would not drink alcohol when taking these medicines.'' Tr. 555.
However, the transcript of their recorded conversation does not reflect
any mention of the contract that TC signed or not drinking alcohol when
taking the medicines, despite TC bringing up his alcohol use twice in
the conversation. See GE-25, at 3; see also Tr. Tr. 82-84. I find this
statement to weigh against Dr. Daniels' credibility and to be an
attempt to minimize the egregiousness of his actions.] Thus, I
generally credit Dr. Daniels' testimony, but where his testimony
conflicts with that of other witnesses or record evidence, I consider
it with close scrutiny.
The Facts
I. Stipulations
The Parties agree to 49 stipulations (``Stip.''), which the Parties
have accepted as facts in these proceedings. Tr. 10.
Background
1. Dr. Daniels is a physician licensed to practice medicine by the
Louisiana State Board of Medical Examiners in the State of Louisiana.
2. Dr. Daniels was previously registered with the DEA to handle
controlled substances in Schedules II through V under DEA COR No.
AD2802937 at 1514 Doctors Drive, Bossier City, Louisiana 71111.
3. Dr. Daniels surrendered DEA COR No. AD2802937 for cause on
September 29, 2017.
4. Government Exhibit No. 1 is a true and correct copy of Dr.
Daniels' signed surrender of his DEA COR No. AD2802937, dated September
29, 2017.
5. On September 20, 2017, the Louisiana State Board of Medical
Examiners (``LSBME'') issued a notice partially suspending Dr. Daniels'
medical license and prohibiting him from ``prescribing, dispensing or
administering controlled substances to any patient, effective September
21, 2017.''
6. Government Exhibit No. 2 is a true and correct copy of the
notice issued by the LSBME on September 20, 2017.
7. Dr. Daniels filed a new application for a DEA COR on or about
March 16, 2018.
8. Government Exhibit No. 3 is a true and correct copy of Dr.
Daniels' March 16, 2018 application for a DEA COR.
9. Government Exhibit No. 4 is a true and correct copy of the
Certification of Registration History showing Dr. Daniels' answers to
the liability questions in his March 16, 2018 application for a DEA
COR.
Consent Order
10. On March 12, 2018, the LSBME issued a Consent Order for
Reprimand to Dr. Daniels that, among other things, did the following:
a. The Consent Order recalled the suspension of Dr. Daniels'
authority to prescribe, dispense, or administer controlled substances
issued on September 20, 2017.
b. The Consent Order accepted Dr. Daniels' representations to the
LSBME that he would permanently refrain from prescribing controlled
substances for chronic pain or obesity and refrain from associating
himself with a drug treatment clinic.
c. The Consent Order imposed continuing restrictions on Dr.
Daniels' authority to prescribe, dispense, or administer controlled
substances, namely that it required Dr. Daniels to meet with the LSBME
or a designee in advance and to abide by any suggestions or conditions
the LSBME might recommend if Dr. Daniels ever wished to resume the acts
he promised to discontinue.
11. Government Exhibit No. 5 is a true and correct copy of the
Consent Order for Reprimand issued by the LSBME on March 12, 2018.
12. Dr. Daniels referenced the Consent Order, a public document, in
his application for the COR.
Patient AK
13. Government Exhibit No. 6 is a true and correct copy of Dr.
Daniels' patient file for Patient AK.
14. Government Exhibit No. 7 is a true and correct copy of a DEA
subpoena issued to the CVS Pharmacy located at 2735 Beene Boulevard,
Bossier City, Louisiana, regarding Dr. Daniels' prescriptions to
Patient AK.
15. Government Exhibit No. 8 is a true and correct copy of various
prescriptions that Dr. Daniels issued to Patient AK and that DEA
obtained from the CVS Pharmacy located at 2735 Beene Boulevard, Bossier
City, Louisiana.
16. Government Exhibit No. 9 is a true and correct copy of a DEA
subpoena issued to Super One Pharmacy located at 745 Shreveport
Barksdale Highway, Shreveport, Louisiana, regarding Dr. Daniels'
prescriptions to Patient AK, and the response that DEA received from
Brookshire Grocery Company, Pharmacy Operations, 1600 WSW Loop 323,
Tyler, Texas, containing copies of prescriptions Respondent issued to
Patient AK
17. As listed below, Dr. Daniels issued prescriptions for
controlled substances, including Subutex (buprenorphine) and Klonopin
(clonazepam), to Patient AK on at least the following occasions:
------------------------------------------------------------------------
Date issued Prescription
------------------------------------------------------------------------
1/16/2017.............................. 15 units of Subutex 8 mg.
1/18/2017.............................. 90 units of Subutex 8 mg; 30
units of Klonopin 2 mg.
2/23/2017.............................. 90 units of Subutex 8 mg; 30
units of Klonopin 2 mg.
3/22/2017.............................. 90 units of Subutex 8 mg; 30
units of Klonopin 2 mg.
4/18/2017.............................. 90 units of Subutex 8 mg; 30
units of Klonopin 2 mg.
5/18/2017.............................. 90 units of Subutex 8 mg; 30
units of Klonopin 2 mg.
[[Page 61637]]
7/28/2017.............................. 90 units of Subutex 8 mg; 30
units of Klonopin 2 mg.
8/25/2017.............................. 90 units of Subutex 8 mg; 30
units of Klonopin 2 mg.
------------------------------------------------------------------------
Patient CA
18. Government Exhibit No. 10 is a true and correct copy of Dr.
Daniels' patient file for Patient CA.
19. Government Exhibit No. 11 is a true and correct copy of a DEA
subpoena issued to Benzer Pharmacy located at 2951 E. Texas Street,
Bossier City, Louisiana, regarding Dr. Daniels' prescriptions to
Patient CA.
20. Government Exhibit No. 12 is a true and correct copy of various
prescriptions that Dr. Daniels issued to Patient CA and that DEA
obtained from Benzer Pharmacy located at 2951 E. Texas Street, Bossier
City, Louisiana.
21. Government Exhibit No. 13 is a true and correct copy of a
response to a DEA Subpoena from Walgreen's Pharmacy located at 9209
Mansfield Road, Shreveport, Louisiana, containing a prescription that
Dr. Daniels issued to Patient CA.
22. As listed below, Dr. Daniels issued prescriptions for
controlled substances, including Subutex, Klonopin, and Adderall
(amphetamine-dextroamphetamine mixture), to Patient CA on at least the
following occasions:
------------------------------------------------------------------------
Date issued Prescription
------------------------------------------------------------------------
6/9/2016............................... 90 units of Subutex 8 mg; 30
units of Klonopin 1 mg.
6/22/2016.............................. 90 units of Klonopin 1 mg; 30
units of Adderall 30 mg.
7/6/2016............................... 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
8/31/2016.............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
9/28/2016.............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
10/26/2016............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
11/16/2016............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
12/14/2016............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
1/11/2017.............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
2/8/2017............................... 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
3/8/2017............................... 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
4/5/2017............................... 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
5/3/2017............................... 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
5/31/2017.............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
6/29/2017.............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
7/26/2017.............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
8/23/2017.............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
9/13/2017.............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg; 30
units of Adderall 30 mg.
------------------------------------------------------------------------
Patient MN
23. Government Exhibit No. 14 is a true and correct copy of Dr.
Daniels' patient file for Patient MN.
24. As listed below, Dr. Daniels issued prescriptions for
controlled substances, including Subutex and Klonopin, to Patient MN on
at least the following occasions:
------------------------------------------------------------------------
Date issued Prescription
------------------------------------------------------------------------
5/3/2017............................... 90 units of Subutex 8 mg; 60
units of Klonopin 2 mg.
5/31/2017.............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg.
6/28/2017.............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg.
7/28/2017.............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg.
8/29/2017.............................. 90 units of Subutex 8 mg; 90
units of Klonopin 2 mg.
------------------------------------------------------------------------
Patient JD
25. Government Exhibit No. 15 is a true and correct copy of Dr.
Daniels' patient file for Patient JD.
26. Government Exhibit No. 16 is a true and correct copy of a
response to a DEA Subpoena from Brookshire's Pharmacy located at 1125
Highway 80, Haughton, Louisiana, containing prescriptions that Dr.
Daniels issued to Patient JD.
27. As listed below, Dr. Daniels issued prescriptions for
controlled substances, including Subutex, to Patient JD on at least the
following occasions:
------------------------------------------------------------------------
Date issued Prescription
------------------------------------------------------------------------
8/3/2016............................... 90 units of Subutex 8 mg.
8/31/2016.............................. 90 units of Subutex 8 mg.
9/28/2016.............................. 90 units of Subutex 8 mg.
10/26/2016............................. 90 units of Subutex 8 mg.
11/16/2016............................. 90 units of Subutex 8 mg.
12/14/2016............................. 90 units of Subutex 8 mg.
1/18/2017.............................. 90 units of Subutex 8 mg.
2/8/2017............................... 90 units of Subutex 8 mg.
3/8/2017............................... 90 units of Subutex 8 mg.
[[Page 61638]]
4/5/2017............................... 90 units of Subutex 8 mg.
5/3/2017............................... 90 units of Subutex 8 mg.
6/7/2017............................... 90 units of Subutex 8 mg.
7/5/2017............................... 90 units of Subutex 8 mg.
8/2/2017............................... 90 units of Subutex 8 mg.
8/30/2017.............................. 90 units of Subutex 8 mg.
------------------------------------------------------------------------
Patient SB
28. Government Exhibit No. 17 is a true and correct copy of Dr.
Daniels' patient file for Patient SB.
29. As listed below, Dr. Daniels issued prescriptions for
controlled substances, including Subutex and Klonopin, to Patient SB on
at least the following occasions:
------------------------------------------------------------------------
Date issued Prescription
------------------------------------------------------------------------
1/18/2017.............................. 60 units of Subutex 8 mg; 60
units of Klonopin 1 mg.
2/15/2017.............................. 60 units of Subutex 8 mg; 60
units of Klonopin 1 mg.
3/15/2017.............................. 60 units of Subutex 8 mg; 60
units of Klonopin 1 mg.
4/12/2017.............................. 60 units of Subutex 8 mg; 60
units of Klonopin 1 mg.
5/10/2017.............................. 60 units of Subutex 8 mg; 60
units of Klonopin 1 mg.
6/24/2017.............................. 60 units of Subutex 8 mg; 60
units of Klonopin 1 mg.
7/19/2017.............................. 60 units of Subutex 8 mg; 60
units of Klonopin 1 mg.
------------------------------------------------------------------------
Patient CM
30. Government Exhibit No. 18 is a true and correct copy of Dr.
Daniels' patient file for Patient CM.
31. As listed below, Dr. Daniels issued prescriptions for
controlled substances, including Subutex and Klonopin, to Patient CM on
at least the following occasions:
------------------------------------------------------------------------
Date issued Prescription
------------------------------------------------------------------------
5/4/2016............................... 90 units of Subutex 8 mg.
6/1/2016............................... 90 units of Subutex 8 mg.
6/29/2016.............................. 90 units of Subutex 8 mg.
7/27/2016.............................. 90 units of Subutex 8 mg.
8/24/2016.............................. 90 units of Subutex 8 mg.
9/21/2016.............................. 90 units of Subutex 8 mg.
10/19/2016............................. 90 units of Subutex 8 mg.
11/16/2016............................. 90 units of Subutex 8 mg.
12/14/2016............................. 90 units of Subutex 8 mg; 60
units of Klonopin 2 mg.
1/11/2017.............................. 90 units of Subutex 8 mg; 60
units of Klonopin 2 mg.
2/22/2017.............................. 90 units of Subutex 8 mg; 60
units of Klonopin 2 mg.
3/20/2017.............................. 90 units of Subutex 8 mg; 60
units of Klonopin 2 mg.
4/19/2017.............................. 90 units of Subutex 8 mg; 60
units of Klonopin 2 mg.
5/17/2017.............................. 90 units of Subutex 8 mg; 60
units of Klonopin 2 mg.
6/14/2017.............................. 90 units of Subutex 8 mg; 60
units of Klonopin 2 mg.
7/12/2017.............................. 90 units of Subutex 8 mg; 60
units of Klonopin 2 mg.
8/9/2017............................... 90 units of Subutex 8 mg; 60
units of Klonopin 2 mg.
9/5/2017............................... 90 units of Subutex 8 mg; 60
units of Klonopin 2 mg.
------------------------------------------------------------------------
Patient JW
32. Government Exhibit No. 19 is a true and correct copy of Dr.
Daniels' patient file for Patient JW.
33. Government Exhibit No. 20 is a true and correct copy of a DEA
subpoena issued to the CVS Pharmacy located at 1118 Homer Road, Minden,
Louisiana, regarding Dr. Daniels' prescriptions to Patients CA, JD, CM,
and JW.
34. Government Exhibit No. 21 is a true and correct copy of various
prescriptions that Dr. Daniels issued to Patients CA, JD, CM, and JW,
and that DEA obtained from the CVS Pharmacy located at 1118 Homer Road,
Minden, Louisiana.
35. As listed below, Dr. Daniels issued prescriptions for
controlled substances, including methadone, Percocet (oxycodone-
acetaminophen), OxyContin (oxycodone extended release), and Lortab
(hydrocodone-acetaminophen), to Patient JW on at least the following
occasions:
------------------------------------------------------------------------
Date issued Prescription
------------------------------------------------------------------------
7/5/2013............................... 90 units of methadone 10 mg.
7/22/2013.............................. 150 units of methadone 10 mg.
8/9/2013............................... 30 units of Percocet 10/325 mg.
8/16/2013.............................. 150 units of methadone 10 mg.
8/23/2013.............................. 60 units of Percocet 10/325 mg.
[[Page 61639]]
9/6/2013............................... 60 units of Percocet 10/325 mg.
9/13/2013.............................. 150 units of methadone 10 mg.
10/11/2013............................. 150 units of methadone 10 mg.
10/18/2013............................. 60 units of Percocet 10/650 mg.
11/8/2013.............................. 150 units of methadone 10 mg;
60 units of Percocet 10/325
mg.
12/6/2013.............................. 150 units of methadone 10 mg;
60 units of Percocet 10/325
mg.
12/20/2013............................. 60 units of Percocet 10/325 mg.
1/3/2014............................... 150 units of methadone 10 mg;
90 units of Percocet 10/325
mg.
1/17/2014.............................. 90 units of Percocet 10/325 mg.
1/31/2014.............................. 150 units of methadone 10 mg;
90 units of Percocet 10/325
mg.
2/14/2014.............................. 90 units of Percocet 10/325 mg.
2/28/2014.............................. 90 units of Percocet 10/325 mg.
3/14/2014.............................. 30 units of OxyContin 10 mg.
3/19/2014.............................. 90 units of Percocet 10/325 mg.
3/21/2014.............................. 150 units of methadone 10 mg.
3/28/2014.............................. 20 units of OxyContin 10 mg; 90
units of Percocet 10/325 mg.
4/11/2014.............................. 20 units of OxyContin 10 mg; 90
units of Percocet 10/325 mg.
4/17/2014.............................. 150 units of methadone 10 mg.
4/25/2014.............................. 20 units of OxyContin 10 mg;
120 units of Percocet 10/325
mg.
5/9/2014............................... 20 units of OxyContin 10 mg;
120 units of Percocet 10/325
mg.
5/16/2014.............................. 20 units of OxyContin 10 mg;
120 units of Percocet 10/325
mg.
5/23/2014.............................. 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
6/6/2014............................... 120 units of Percocet 10/325
mg.
6/20/2014.............................. 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
7/10/2014.............................. 60 units of Lortab 10/325 mg.
7/16/2014.............................. 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
8/8/2014............................... 120 units of Percocet 10/325
mg.
8/22/2014.............................. 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
9/5/2014............................... 120 units of Percocet 10/325
mg.
9/19/2014.............................. 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
10/17/2014............................. 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
11/14/2014............................. 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
12/5/2014.............................. 120 units of Percocet 10/325
mg.
12/12/2014............................. 150 units of methadone 10 mg.
12/23/2014............................. 120 units of Percocet 10/325
mg.
1/5/2015............................... 120 units of Percocet 10/325
mg.
1/12/2015.............................. 150 units of methadone 10 mg.
1/23/2015.............................. 120 units of Percocet 10/325
mg.
2/6/2015............................... 120 units of Percocet 10/325
mg.
2/20/2015.............................. 120 units of Percocet 10/325
mg.
3/6/2015............................... 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
3/20/2015.............................. 120 units of Percocet 10/325
mg.
4/2/2015............................... 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
4/17/2015.............................. 120 units of Percocet 10/325
mg.
5/1/2015............................... 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
5/15/2015.............................. 120 units of Percocet 10/325
mg.
6/1/2015............................... 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
6/15/2015.............................. 120 units of Percocet 10/325
mg.
7/1/2015............................... 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
7/30/2015.............................. 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
8/14/2015.............................. 120 units of Percocet 10/325
mg.
8/31/2015.............................. 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
9/14/2015.............................. 120 units of Percocet 10/325
mg.
9/26/2015.............................. 150 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
10/14/2015............................. 180 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
11/24/2015............................. 180 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
12/9/2015.............................. 120 units of Percocet 10/325
mg.
12/19/2015............................. 120 units of Percocet 10/325
mg.
12/30/2015............................. 180 units of methadone 10 mg.
1/12/2016.............................. 120 units of Percocet 10/325
mg.
1/27/2016.............................. 180 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
2/24/2016.............................. 180 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
3/16/2016.............................. 120 units of Percocet 10/325
mg.
3/23/2016.............................. 180 units of methadone 10 mg.
4/6/2016............................... 120 units of Percocet 10/325
mg.
4/27/2016.............................. 180 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
5/18/2016.............................. 120 units of Percocet 10/325
mg.
5/25/2016.............................. 180 units of methadone 10 mg.
6/8/2016............................... 120 units of Percocet 10/325
mg.
6/22/2016.............................. 180 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
7/20/2016.............................. 180 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
8/10/2016.............................. 120 units of Percocet 10/325
mg.
8/24/2016.............................. 180 units of methadone 10 mg.
8/31/2016.............................. 120 units of Percocet 10/325
mg.
[[Page 61640]]
9/21/2016.............................. 180 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
10/5/2016.............................. 120 units of Percocet 10/325
mg.
10/26/2016............................. 180 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
11/9/2016.............................. 120 units of Percocet 10/325
mg.
12/14/2016............................. 120 units of Percocet 10/325
mg.
12/21/2016............................. 180 units of methadone 10 mg.
1/4/2017............................... 120 units of Percocet 10/325
mg.
1/6/2017............................... 30 units of OxyContin 10 mg.
1/18/2017.............................. 180 units of methadone 10 mg.
1/30/2017.............................. 120 units of Percocet 10/325
mg.
2/13/2017.............................. 120 units of Percocet 10/325
mg.
2/21/2017.............................. 180 units of methadone 10 mg.
3/1/2017............................... 120 units of Percocet 10/325
mg.
3/22/2017.............................. 180 units of methadone 10 mg;
120 units of Percocet 10/325
mg.
4/5/2017............................... 120 units of Percocet 10/325
mg.
------------------------------------------------------------------------
Patient TC
36. Government Exhibit No. 23 is a true and correct copy of Dr.
Daniels' patient file for Patient TC.
37. On September 13, 2017, Dr. Daniels issued a prescription to
Patient TC for 60 units of Suboxone (buprenorphine/naloxone) 8/2 mg.
38. Government Exhibit No. 24 is a true and correct video recording
of Dr. Daniels' interaction with Patient TC on September 13, 2017.
39. Government Exhibit No. 25 is a true and correct transcript of
Dr. Daniels' interaction with Patient TC on September 13, 2017.
40. Government Exhibit No. 27 is a true and correct video recording
of Patient TC's visits to Dr. Daniels' office on September 12 and 13,
2017.
Controlled Substances
41. DEA lists Subutex (buprenorphine) as a Schedule III controlled
substance under 21 CFR 1308.13(e)(2)(i).
42. DEA lists Klonopin (clonazepam) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(11).
43. DEA lists Adderall (amphetamine-dextroamphetamine mixture) as a
Schedule II controlled substance under 21 CFR 1308.12(d)(1).
44. DEA lists methadone as a Schedule II controlled substance under
21 CFR 1308.12(c)(15).
45. DEA lists Percocet (oxycodone-acetaminophen) as a Schedule II
controlled substance under 21 CFR 1308.12(b)(1)(xiii).
46. DEA lists OxyContin (oxycodone extended release) as a Schedule
II controlled substance under 21 CFR 1308.12(b)(1)(xiii).
47. DEA lists Lortab (hydrocodone-acetaminophen) as a Schedule II
controlled substance under 21 CFR 1308.12(b)(1)(vi).
48. DEA lists Suboxone (buprenorphine/naloxone) as a Schedule III
controlled substance under 21 CFR 1308.13(e)(2)(i).
49. Respondent's Exhibit No. 2 is a true and correct copy of a
March 9, 2018 letter from Dr. Daniels' counsel to Cecilia Mouton, M.D.,
the Director of Investigations for the Louisiana State Board of Medical
Examiners, and which is countersigned by Cecilia Mouton, M.D., on
behalf of the Louisiana State Board of Medical Examiners.
II. Findings of Fact
The Application
1. Dr. Daniels has never been denied a COR. Tr. 560.
2. Dr. Daniels entered into a consent order with the State Medical
Board (``the Board''), following concerns that he was not properly
monitoring patients or supervising staff. Tr. 560.
3. At the Board's recommendation, Dr. Daniels attended continuing
medical education seminars on controlled substance prescribing, ethics,
and boundaries. Tr. 562. After completing those seminars, the Board
restored Dr. Daniels' medical license, but he was not allowed to
practice in the areas of managing: Addiction; chronic pain; or obesity.
Tr. 563.
4. Dr. Daniels re-applied for a COR once his license was
reinstated. Tr. 564. In filling out the application, he did not realize
that he ``would have to be more complete'' and that he was not ``aware
that the high risk practice areas was where they were restricting
[him].'' Tr. 565. His understanding was that the Board and the State
Pharmacy Board had fully reinstated his controlled substance
prescribing authority. Id.
5. The application for a COR does not inform an applicant to
provide the detailed information that the DEA asserted was missing from
Dr. Daniels' application. Tr. 70.
6. The information Dr. Daniels provided on his application placed
the DEA on notice that it should not summarily approve Dr. Daniels'
application, but rather that DEA should investigate it. Tr. 70-71.
7. Dr. Daniels did not intend to be evasive or misleading when he
submitted his application for a Certificate of Registration. Tr. 565.
8. Dr. Daniels is struggling professionally without a COR because
he currently works at a diabetes management clinic where Lyrica, a
Schedule V controlled substance, is an important part of treatment. Tr.
568-69.
The Clinic
9. The Clinic was located in Minden, Louisiana, which is a rural
area. Tr. 480.
10. LW had full control of the Clinic from April 2017 to September
2017. Tr. 479.
11. The Clinic provided services for low, to mid-level, income
individuals, but it focused its service on those with low incomes. Tr.
421. The Clinic provided services to a wide array of patients including
those suffering from drug addiction and those with mental health
problems. Tr. 421-22. Most of the patients had some type of opioid
addiction. Tr. 424. The Clinic stayed open late on Wednesdays to make
it convenient for patients to seek treatment. Tr. 422-23.
12. Dr. Daniels would see patients at the Clinic one day a week,
arriving around 5:00 p.m., and staying until 9:00 to 10:00 p.m. Tr.
424-25. Dr. Daniels was scheduled to see 25 patients a week, but
sometimes he saw more. Tr. 425.
13. Dr. Daniels was the only physician who worked at the Clinic.
Tr. 425. Most of the patients he saw had some kind of opioid addiction.
Tr, 427.
14. The Clinic also employed a licensed practical nurse, a
registered nurse, a licensed clinical social worker, a receptionist,
and a phlebotomist. Tr. 425-26.
15. The Clinic struggled with establishing a reliable system for
[[Page 61641]]
ensuring the patients' charts were complete and accurate. Tr. 486-87.
16. The entire staff of the Clinic worked on medical records, but
the Clinic brought in an RN to work on the records because the Clinic
had seen a lot of deficiencies in the records. Tr. 427. These changes
were made after LW began working full-time in the Clinic. Tr. 428. As
of April 2017, the Clinic was attempting to organize and re-structure.
Tr. 435.
17. Various employees at the Clinic inserted documents into the
patients' charts as well as taking the patient's vital signs. Tr. 437-
38. The office staff as a whole was responsible for making sure the
documents got into the patient's medical record. Tr. 438.
18. The registered nurse was hired to audit the medical records,
and she was also in the office with Dr. Daniels when he saw patients.
Tr. 436.
19. When a patient came into the Clinic, the licensed clinical
social worker would conduct a clinical/behavioral assessment to
determine whether the patient met the criteria to be treated at the
Clinic. Tr. 429, 443.
20. Most of the Clinic's patients had previously been seen at other
clinics. Tr. 429.
21. All new patients were required to submit urine samples for drug
screening. Tr. 432, 443. The results of the screening were passed on to
the licensed clinical social worker. Id.
22. The phlebotomist did the urine drug screens and bloodwork. Tr.
441.
23. If a patient met the Clinic's requirements, the patient was
scheduled to see Dr. Daniels. Tr. 432.
24. Dr. Daniels wanted to see the patients' vitals, as well as
their drug screens. Tr. 438.
25. The work that the Clinic employees performed was at Dr.
Daniels' request. Tr. 441. Information gathered in the assessments was
provided to Dr. Daniels. Tr. 441-42.
26. Generally, PMPs were tracked for each patient and if anything
was out of line Dr. Daniels was informed. Tr. 442, 446. Of the patients
named in the Order to Show Cause, however, Dr. Daniels' PMP account was
used to check the prescriptions filled by only two patients, CA and TC.
Tr. 597-99; GE-30. The PMP was checked for both of these patients on
September 13, 2017, which was the last day CA received a prescription
from Dr. Daniels, and the only time he issued a prescription to TC. Tr.
598; GE-30, at 2; Stip. 22, 37.
27. The Clinic's default setting used for reviewing PMPs was one
year, but Dr. Daniels was more concerned about what a patient had
received within the last 30 days. Tr. 496-97.
28. Normally a staff member of the Clinic would run a PMP report
and provide the results to Dr. Daniels. Tr. 448, 497, 514, 522. The
results of the PMP report would not be documented. Tr. 522.
29. Ideally, a doctor gets a print-out of a patient's PMP report,
but there is no requirement to print it out. Tr. 496.
30. The Clinic did not check a patient's PMP when the patient came
in to pick up a prescription. Tr. 451.
Dr. Daniels' Clinic Practices
31. Dr. Daniels used Suboxone and Subutex to treat opioid
addiction. Tr. 506.
32. Dr. Daniels did not put together the patient charts at the
Clinic. Tr. 485-86.
33. Dr. Daniels acknowledged that there is information missing from
the patients' charts. Tr. 487. Dr. Daniels testified that the patient
charts in this case do not include sticky notes and other notes that
would have been on the inside of the manila folder that held the
charts. Tr. 488.
34. When Dr. Daniels saw a patient at the Clinic, some of the
patient's medical history was available on forms that the patient
completed before the visit. Tr. 492.
35. In general, Dr. Daniels would ask each patient: About his or
medication; whether the medication was working; who initially
prescribed it; and how long the patient had been taking it. Tr. 517.
36. Dr. Daniels testified that a doctor can perform an examination
by observing the patient, and noting the patient's demeanor, activity,
mood, and physical appearance. Tr. 493-94. Sometimes Dr. Daniels
decided to do a more thorough physical examination. Tr. 512.
37. Dr. Daniels testified that in situations where there is limited
staff and other patients are waiting, a doctor sometimes needs to make
a ``judgment call'' about examining the patient, and not
inconveniencing waiting patients. Tr. 493. In that situation, in Dr.
Daniels' view, the doctor performs ``enough of an exam'' in order to
``move forward'' with the patient, allowing the doctor time to see
other patients. Tr. 493.
38. With respect to urine drug screens, Dr. Daniels testified that
he was provided the results of the screens. Tr. 510. He testified that
in most cases he addressed abnormalities with the patient, but did not
document that fact in the patient's chart. Tr. 498, 502, 510. He
acknowledged it would be best practice to document efforts to address
an abnormal urine drug screen. Tr. 501.
39. Dr. Daniels testified that the current standard is to not
discharge a patient who is noncompliant with the treatment plan. Tr.
499-500.
40. In Dr. Daniels' view, it is better to keep a long-term patient
on medication than to discharge the patient. Tr. 500. Discharging a
patient could lead to a relapse, or to the patient taking dangerous
street-drugs. Id.
41. If the new patient was already taking Suboxone, Dr. Daniels
would discuss the Suboxone treatment regimen plan with the patient. Tr.
516. He would also ask the patient if he or she signed the treatment
contract, and whether the patient understood it. Id. He would only
address specific provisions of the treatment contract if he believed
there might be a particular issue with the patient's ability to comply
with the contract. Id.
42. Dr. Daniels reviewed the PMP to: See what medications a patient
has been on; determine previous providers; and, determine when the
patient received medications. Tr. 495.
43. When one of Dr. Daniels' substance-abuse patients tested
positive for marijuana he did not address the issue with the patient
because it was ``so ubiquitous in the population'' that Dr. Daniels
treated. Tr. 515.
44. While working at the Clinic, Dr. Daniels was under quite a bit
of personal stress and he ``had not be[en] able to really take full
advantage of the opportunity to see these patients,'' which lead to
potential risks given the areas in which he was practicing. Tr. 561.
General Facts Derived From Expert Testimony
45. Klonopin (clonazepam) is a benzodiazepine. Tr. 177.
46. To prescribe controlled substances in Louisiana for the
treatment of chemical dependency, the standard of care requires the
treating physician to: conduct an adequate physical examination; obtain
past medical records; obtain PMP reports; conduct drug screening; and
maintain medical records. Tr. 141-42, 492.
47. The standard of care requires that a patient's medical record
be ``complete and accurate.'' Tr. 151.
48. A doctor need not document everything that occurred during a
patient encounter, but the doctor should document the important,
pertinent information that will give an objective viewer a picture of
what happened during the encounter. Tr. 151-52.
49. Changes in medical treatment, and the reasons for those
changes, must be documented. Tr. 150. The treatment plan is updated
over time. Id.
[[Page 61642]]
50. When there is a consistent absence of pertinent information in
a patient's medical records such as: PMP reports; a credible physical
examination; past medical records; resolution of abnormal drug screens,
the records reach a point where it is not possible to say that the
treatment has been within the scope of acceptable medical practice or
that the prescriptions are legitimate. Tr. 154; see also Tr. 384.
51. Because the application of medicine needs to be individualized,
a sufficiently adequate physical examination would not necessarily be
the same for every patient. Tr. 144-45, 492.
52. In conducting a physical examination for a patient who has
chemical dependency the doctor should: Look for track marks; note how
the patient's pupils look and whether the patient's mucous membranes
are dry; look for goosebumps; look for signs of withdrawal such as
whether the patient is sweaty and/or shaky, and/or whether the patient
is obtunded. Tr. 143, 289, 492. Much of this information can be
obtained through a discussion with the patient. Tr. 290, 492. If the
chemical dependency originated following treatment of an injury to a
part of the body, the physical examination should also include an
examination of that body part. Tr. 388-89, 492.
53. As part of a physical examination for a patient who has a
chemical dependency, a doctor should ask the patient questions such as:
What are you using?; How long have you been using?; Why did you start
using?; Are you around people who are using?; and, How do the drugs
affect your life? Tr. 144, 492.
54. It is possible to treat a patient even without obtaining prior
medical records; however, contained within the patient's medical
records should be a documented good-faith effort to obtain the prior
records, and an explanation of why treatment has begun without those
prior records. Tr. 292.
55. Obtaining past medical records is important because such
records contain an abundance of information that a treating doctor
needs to know. Tr. 145. Obtaining past medical records is mandatory.
Tr. 146. Even if the patient presents with medical documentation, the
physician is not relieved of the obligation to attempt to obtain past
medical records. Tr. 291.
56. A physician also needs to take a medical history and/or look
for past medical records upon the patient's initial visit. Tr. 146. It
is also important to update the patient's medical history. Tr. 147.
57. The failure to take a medical history, and/or to obtain past
medical records, makes it difficult to argue that the doctor knows what
he or she is doing at any particular instance of the patient's care.
Tr. 147.
58. In Louisiana, the treatment plan must talk about what is being
done for a patient, and why. Tr. 148, 503. The treatment plan allows
another physician to pick up the patient's record and understand the
treatment. Tr. 148-49. The treatment plan assists with continuity of
care. Tr. 149.
59. For a patient with a chemical dependency, the treatment plan is
dependent on what has been done in the past, and where the medical
treatment is intended to take the patient. Tr. 149. *[For opioid
addiction, Dr. Kennedy testified that in a treatment plan, he ``would
expect there to be goals as far as where it is that we're heading with
this. In other words, is this somebody that we expect that we're going
to wean and discharge from this medication eventually? What are the
likelihood of doing dosage adjustments if it works or if it doesn't
work? What are we going to do if the patient has problems with some
social issue . . . . All of the other kind of things that would go into
any treatment record, where you're hoping that the patient is going to
have an improved life.'' Tr. 301]
60. Informed consent is not obtained by having a signature on a
form. Tr. 306. Informed consent is obtained by a conversation between
the physician and the patient in which the doctor explains the dangers,
the side effects of treatment, and that the treatment might not work.
Id.
61. A prescription itself is not sufficient documentation of
medical treatment. Tr. 234.
62. In Louisiana, a doctor who is treating a patient for addiction
or chemical dependency is required to document the results of an
abnormal urine drug screen, and the actions the physician took in
response to it. Tr. 173, 225-26. If the test is abnormal, the results
must be documented, as well as documenting the type of action that was
taken in response to the abnormal test. Tr. 310-11, 318, 336, 378.
Ignoring an abnormal urine drug screen, or saying nothing about it, is
outside the course of acceptable medical practice in Louisiana. Tr.
378. *[Regarding the standard of care for chemical dependency, Dr.
Kennedy stated, ``If we're talking about treating patients with
chemical dependency, with the way that the regulations, the way the
systems are designed, there's a reason we have to check PDMP reports
and there's a reason that we have to get drug screens and there's a
reason that we have to get past medical records and all of these other
things, and it's not because we're counting on the patients being
compliant, it's because of the likelihood of patients being
noncompliant.'' Tr. 299.]
63. For a doctor to treat a diagnosis there must be supporting
information. Tr. 323. A diagnosis alone is not sufficient to support a
prescription for controlled substances. Tr. 371.
64. A clinical licensed social worker cannot make a diagnosis. Tr.
408. Thus, the diagnosis made by the social worker contained in
Government Exhibit 14, pages 31-39, is not a valid diagnosis. See also
Tr. 380 (no evidence that Dr. Daniels reviewed the diagnosis).
65. Prior to 2018, doctors in Louisiana were not required to check
a patient's PMP before writing a prescription for a controlled
substance, but it was considered the standard of care. Tr. 393.
66. The use of multiple pre-signed medical forms and/or identical
copied handwritten treatment notes do not support a finding of
legitimate medical care and are not credible in medical records. Tr.
190, 196; cf. GE-6 at 12, GE-14, at 14, and GE-18, at 26; and GE-6, at
26, and GE-10, at 57.
67. Signed forms do not provide sufficient advice concerning the
dangers of combining alcohol with buprenorphine when the patient had a
history of abusing drugs, and an abnormal urine drug screen. Tr. 400. A
discussion needs to occur because the patient is starting a program of
regular scheduled medications. Tr. 401. If, later, it is determined
that the patient is still abusing drugs, it is clear the original
discussion was not enough, and the doctor needs to revisit the issue
with the patient. Id.
68. Signed forms are not sufficient to constitute a treatment plan.
Tr. 374.
69. A Patient Treatment Contract does not establish a physician/
patient relationship. Tr. 304.
70. None of the patients' medical records in the Administrative
Record contained sufficient documentation to support a prescription for
Klonopin. Tr. 399-400.
The Patients
Patient AK
71. On January 16, 2017, AK signed a Patient Treatment Contract
with Dr. Daniels. Tr. 161, 303-04; GE-6, at 30. In paragraph one of
that contract, AK agreed to keep, and be on time, for all of his
scheduled appointments, and in paragraph two he agreed to the payment
policy of Dr. Daniels' office. Id. In paragraph 13 of the contract, AK
agreed
[[Page 61643]]
to abstain from alcohol, opioids, marijuana, cocaine, and other
addictive substances. Id. This contract was signed by Dr. Daniels on
January 18, 2017. Tr. 162; GE-6, at 30.
72. Paragraph 10 of the Patient Treatment Contract that AK signed
on January 16, 2017, reads as follows: ``I understand that mixing
buprenorphine with other medications especially benzodiazepines (for
example, Valium, Klonopin, or Xanax), can be dangerous. I also
recognize that several deaths have occurred among persons mixing
buprenorphine and benzodiazepines (especially if taken outside the care
of a physician, using a route of administration other than sublingual
or in higher than recommended therapeutic doses).'' GE-6, at 30.
73. On January 16, 2017, AK signed a Patient Agreement to
Participate in Suboxone Treatment. Tr. 161, 308; GE-6, at 31. At the
end of each paragraph is a space for the patient's initials, but there
are no initials there. Tr. 308; GE-6, at 31.
74. On January 16, 2017, AK signed a Patient Information and
Consent to Treatment with Buprenorphine and Suboxone. GE-6, at 41. The
fourth paragraph of that information sheet advises that combining
buprenorphine with alcohol or other sedating medications is dangerous,
and that combining buprenorphine with benzodiazepines has resulted in
deaths. Id.
75. The prescription that Dr. Daniels wrote for AK on January 16,
2017, for 15 tablets of 8 mg Subutex predates any written documentation
of Dr. Daniels actually seeing AK. Tr. 160-61; GE-9, at 10; Stip. 17.
Because this prescription was written prior to Dr. Daniels initially
seeing AK, this prescription was issued outside of the course of
medical practice in the state of Louisiana, and it was not issued for a
legitimate medical purpose. Tr. 162-63, 401-02.
76. The initial Physician Intake Note for AK, dated January 18,
2017, indicates that AK had a history of multiple fractures, secondary
to a fight and a motor vehicle accident. Tr. 162, 511; GE-6, at 25. The
Note also indicates that AK had an opioid addiction issue, and that he
previously took prescriptions for 8 mg Subutex, three times a day, and
for 2 mg Klonopin, once a day. Tr. 165, 302, 511; GE-6, at 25; see also
GE-6, at 43. The treatment history indicated that AK had previously
been treated by another provider. Tr. 165, 511; GE-6, at 25. It does
not appear that Dr. Daniels obtained treatment records from that
provider. Tr. 165-66; GE-6. The Authorization to Release Healthcare
Information in AK's file was not completed. Tr. 167; GE-6, at 47.
77. Dr. Daniels testified that he was able to conclude that AK had
an opioid addiction based on AK's medical history, the physical
examination that Dr. Daniels described, and AK's urine drug screen. Tr.
515.
78. Dr. Daniels testified that, even though the documentation is
limited, AK also had an anxiety disorder and pain, and that the pain
was related to AK's fractures. Tr. 517-18. Dr. Daniels did not see pain
recorded in AK's chart.\3\ Tr. 517.
---------------------------------------------------------------------------
\3\ Assuming that AK was in pain, a physical examination should
have included an examination of AK's body parts that had been
fractured. Tr. 388-89, 492. No such examination, however, is
documented in AK's medical record. GE-6.
---------------------------------------------------------------------------
79. Dr. Daniels testified that the Food and Drug Administration has
advised that patients should not be denied Subutex simply because the
patient is also taking a benzodiazepine. Tr. 518. In Dr. Daniels'
opinion, he believed it was justified to prescribe Subutex and Klonopin
to AK because he had pain and had taken opioids and Klonopin before.
Tr. 518. Dr. Daniels acknowledged, however, that AK's chart does not
document that AK had taken opioids before *[for a pain condition]. Id.
80. Dr. Daniels believed prescribing a higher dose of Subutex to AK
was warranted because in addition to opioid addiction, AK also had pain
and Subutex can be used to relieve pain. Tr. 517-19.
81. The initial Physician Intake Note for AK, dated January 18,
2017, contains a treatment plan that reads, ``Monthly and random drug
screens. Counseling with LW Medical Multi Care Clinic 801 Shreveport
Rd. Minden, La. One group monthly 6:00-7:30 p.m. Meet with LPC 20
minutes prior to doctor visit.'' \4\ Tr. 169, 302-03; GE-6, at 25. The
treatment plan also includes the medications prescribed, but it does
not include a rationale as to why the medications were prescribed. Id.
Dr. Daniels testified that AK's treatment plan developed on January 18,
2017, was to conduct monthly and random urine drug screens, provide AK
counseling, prescribe Subutex 8 mg TID and Klonopin 2 mg, and have AK
return to the Clinic in one month. Tr. 515, 518; GE-6, at 25.
---------------------------------------------------------------------------
\4\ This treatment plan will be referred to as the ``boilerplate
treatment plan'' throughout the remainder of this Recommended
Decision.
---------------------------------------------------------------------------
82. Contained in AK's medical file is a Physician Assessment form
dated January 18, 2017. Tr. 164; GE-6, at 45-46. Although this
assessment is contained in AK's patient file, his name is not on the
form, and the form is not signed by a doctor. Id. The form also does
not document that Dr. Daniels performed a physical examination of AK.
Id.
83. The only portion of a physical examination documented in AK's
medical record for his first visit on January 18, 2017, was that AK
appeared neat and clean, and that he had a depressed affect. Tr. 512;
GE-6, at 25.
84. Dr. Daniels did not know whether the Klonopin AK reported he
had been taking had been prescribed to him, or if he was taking it
``off the street.'' Tr. 511-12.
85. AK's PMP was not checked at the Clinic. Tr. 168, 597-99; GE-30.
86. On January 18, 2017, AK's urine drug screen was positive for
benzodiazepines, methamphetamine, THC, and Subutex. Tr. 169-70, 514;
GE-6, at 29. In his ``MD Notes'' for that day, Dr. Daniels wrote that
AK's drug screen was positive for Subutex and negative for opioids.\5\
Id. at 26. This was an abnormal drug screen because it was positive for
methamphetamine and THC (``marijuana''). Tr. 170-72. In that AK had
indicated that he had not used crystal methamphetamine, the results of
the urine drug screen should make a physician very suspicious that AK
was lying. Tr. 171-72; GE-6, at 39. There is no indication in AK's
medical record that Dr. Daniels took any action in response to AK's
abnormal drug screen. Tr. 174.
---------------------------------------------------------------------------
\5\ This note makes little sense, however, because Subutex is an
opioid. Tr. 177.
---------------------------------------------------------------------------
87. On February 23, 2017, and March 22, 2017, AK's urine drug
screens were positive for benzodiazepines, THC and Subutex. GE-6, at
27-28. In his treatment notes for those days, Dr. Daniels wrote that
AK's drug screen was positive for Subutex and negative for opioids. Id.
at 26.
88. On a Pharmacy Prior Authorization Form, dated April 3, 2017,
Dr. Daniels notes that AK had reported adverse reactions to Suboxone.
GE-6, at 24.
89. On June 20, 2017, AK's urine drug screen was positive for
benzodiazepines and Subutex. Tr. 309; GE-6, at 6.
90. On September 25, 2017, Dr. Daniels discharged patient AK for
failing to keep agreed appointments every 28 days, and/or for not
paying in full for his office visits in a timely manner. GE-6, at 6.
91. A review of Dr. Daniels' medical records of AK reveals no
documentation that Dr. Daniels ever conducted a physical examination of
AK, and those records provide no justification for Dr.
[[Page 61644]]
Daniels' prescription of Klonopin to AK. Tr. 396-97; GE-6, at 1-49.
92. The prescriptions that Dr. Daniels wrote for AK on January 18,
2017, for Klonopin and Subutex were not issued for a legitimate medical
purpose because: action taken on the abnormal urine drug screen, if
any, was not documented; the PMP was not checked; there were no past
medical records; and there was no documentation of a significant
physical examination. Tr. 177; GE-30.
93. A Physician Intake Note dated June 20, 2017, is contained in
AK's patient file. Tr. 180; GE-6, at 12. This is the only other intake
note contained in AK's patient file. Tr. 182; GE-6, at 12. Prior to
this date, Dr. Daniels issued prescriptions to AK on six occasions, and
after this date on two more occasions. Tr. 181; Stip. 17.
94. The Physician Intake Note of June 20, 2017, does not document:
A physical examination; AK's response to prior treatment; a rationale
for the prescriptions; or the response to abnormal drug screens. Tr.
182-84; GE-6, at 11, 12, 27-28.
95. Although the Physician Intake Note of June 20, 2017, is signed,
it is not dated, and the signature is identical to that contained on an
intake note of patient MN, dated June 28, 2017, and an intake note of
patient CM, dated August 9, 2017, and the signatures on both of those
intake forms are not dated. Tr. 186-89; GE-6 at 12; GE-14, at 14; GE-
18, at 26.
96. Dr. Daniels also used identical copied handwritten
``boilerplate'' notes concerning patients' monthly counseling
appointments. Tr. 193-95; cf. GE-6, at 26, and GE-10, at 57. Such notes
are not credible in medical records. Tr. 196.
97. The prescriptions that Dr. Daniels issued to AK between January
16, 2017 and August 25, 2017, identified in Stipulation 17, were issued
outside the course of acceptable medical practice and were not issued
for a legitimate medical purpose because Dr. Daniels did not: conduct a
sufficient medical history of AK; conduct a physical examination of AK;
formulate a treatment plan with a rationale that supported the
prescriptions; document resolution of abnormal urine drug screens;
obtain prior medical records or conduct a review of AK's PMP; or
maintain accurate medical records. Tr. 191-92.
Patient CA
98. On June 9, 2016, CA signed a Patient Treatment Contract with
Dr. Daniels. GE-10, at 56. In paragraph 13 of the contract, CA agreed
to abstain from alcohol, opioids, marijuana, cocaine, and other
addictive substances. Id.
99. Paragraph 10 of the Patient Treatment Contract that CA signed
on June 9, 2016, reads as follows: ``I understand that mixing
buprenorphine with other medications especially benzodiazepines (for
example, Valium, Klonopin, or Xanax), can be dangerous. I also
recognize that several deaths have occurred among persons mixing
buprenorphine and benzodiazepines (especially if taken outside the care
of a physician, using a route of administration other than sublingual
or in higher than recommended therapeutic doses).'' GE-10, at 55.
100. On June 9, 2016, CA signed a Patient Information and Consent
to Treatment with Buprenorphine and Suboxone. GE-10, at 76. The fourth
paragraph of that information sheet advises that combining
buprenorphine with alcohol or other sedating medications is dangerous,
and that combining buprenorphine with benzodiazepines has resulted in
deaths. Id.
101. On June 9, 2016, CA's urine drug screen tested positive for
only buprenorphine. GE-10, at 93-95. This was abnormal based on the
medications that CA reported he was taking. Tr. 217-18.
102. The prescriptions that Dr. Daniels wrote for CA on June 9,
2016, for Klonopin and Subutex predate any written documentation of Dr.
Daniels actually seeing CA. Tr. 204; Stip. 22. Because these
prescriptions were written prior to Dr. Daniels initially seeing CA,
these prescriptions were issued outside of the course of medical
practice in the State of Louisiana, and they were not issued for
legitimate medical purposes. Tr. 204, 401-02.
103. On June 22, 2016, an assessment was completed for CA. Tr. 196;
GE-10, at 51-53. The assessment indicates that CA had an opioid
(oxycodone) addiction, and that another doctor had given CA a
prescription for Subutex. Tr. 197, 521; GE-10, at 51. The assessment
indicates that CA became addicted to oxycodone while being treated for
abdominal pain, a hand fracture, and arthritis. Tr. 196, 521; GE-10, at
51. The assessment also indicates that CA had a history of ADHD for
which he was taking Adderall, and he was taking Klonopin for anxiety.
Tr. 196, 521-22, 524; GE-10, at 51. CA also had a history of TMJ. Tr.
521; GE-10, at 51. The assessment does not document a physical
examination that would support prescriptions for controlled substances.
Tr. 196-97; GE-10, at 53. The assessment also does not document a
rationale for the controlled substances that Dr. Daniels prescribed.
Tr. 198-99; GE-10, at 51-53. Because CA's chart does not support a
diagnosis of ADHD, there is nothing in CA's chart that justified a
prescription for Adderall. Tr. 322, 377.
104. The comments' section of the June 22, 2016 assessment is a
handwritten partial treatment plan.\6\ Tr. 406-07; GE-10, at 51-53.
What is missing is a notation of follow-up, anticipated reaction to
things that may go wrong or if the patient needs more medication. Tr.
407; see also Tr. 503. In addition, Louisiana law details specific
information that must be contained in a treatment plan. See La. Admin.
Code tit. 46, Pt. XLV, Sec. 6921(A)(3).
---------------------------------------------------------------------------
\6\ This partial treatment plan is the same plan that is
preprinted on Physician Intake Forms-the boilerplate treatment plan.
See, e.g., GE-6, at 25; GE-10, at 23.
---------------------------------------------------------------------------
105. Although the June 22, 2016 assessment indicated that another
doctor had treated CA, there are no prior medical records in CA's
medical file, nor was there a request for those records in the file.
Tr. 197-98.
106. Dr. Daniels viewed CA's history, his answers, and his demeanor
as being consistent with ADHD. Tr. 523. Based on CA's history and Dr.
Daniels' examination of CA, he diagnosed CA with an opioid addiction,
anxiety disorder, and ADHD. Tr. 522.
When asked about the physical examination he conducted of CA, Dr.
Daniels testified that he looked at CA's person, place, and
orientation; noted that CA's affect was ``blunted and flat''; and
observed that he was ``depressed and anxious.'' Tr. 521. This
information was obtained from CA's mental status examination, however,
not from a physical examination. Tr. 582; GE-10, at 52.
107. Dr. Daniels' treatment plan for CA included monthly urine drug
screens, counseling, Subutex at his current dosage, Klonopin 1 mg TID,
and Adderall 30 mg. Tr. 523; GE-10, at 53. Dr. Daniels acknowledged,
however, that the justification for these prescriptions is not
contained in CA's medical records. Id. He further testified these
prescriptions were written to treat CA's medical condition he had
diagnosed: Opioid addiction, anxiety, chronic abdominal pain, TMJ, and
ADHD. Tr. 524; GE-6, at 53.
108. CA's medical file contains a Physician Intake Note dated July
26, 2017. Tr. 199; GE-10, at 34. The intake note contains the
boilerplate treatment plan. GE-10, at 34. The intake note does not
document: A physical examination; CA's responses to past treatment; or
a
[[Page 61645]]
rationale for the prescriptions that Dr. Daniels issued to CA. Tr. 199;
GE-10, at 34. In addition, the length of time between this documented
encounter with CA and the previous documented encounter (more than a
year), during which CA continued to get the same three prescriptions
every month, is not consistent with the standard of care. Tr. 205-06;
Stip. 22.
109. CA's medical file contains a Physician Intake Note dated
September 13, 2017. Tr. 200; GE-10, at 23. The intake note contains the
boilerplate treatment plan. GE-10, at 23. The intake note does not
document: A physical examination,\*E\ or a rationale for the
prescriptions that Dr. Daniels issued to CA. Tr. 201; GE-10, at 23. It
does have a comment that CA reported zero problems with current meds.
Id. That comment, however, does not provide sufficient follow-up or
history of his prior treatment with Dr. Daniels. Tr. 201-202.
---------------------------------------------------------------------------
\*E\ Although vital signs were taken for CA, Dr. Kennedy
testified that they are not adequate to support the provision of
controlled substances. Tr. 376-77; GE-10, at 51.
---------------------------------------------------------------------------
110. On June 9, 2016, CA's urine drug screen was positive for only
buprenorphine. Tr. 217; GE-10, at 93-94. This was an abnormal urine
drug screen because it was inconsistent with the medications he told
the doctor he had been previously prescribed. Tr. 217-18.
111. On September 29, 2016, CA's urine drug screen was positive for
only Subutex. Tr. 212; GE-10, at 87. This was an abnormal urine drug
screen because it was inconsistent with the medications he was
prescribed, whereas earlier tests were positive for those same
medications. Tr. 212-13.
112. On October 18, 2016, November 16, 2016, December 7, 2016, and
January 4, 2017, CA's urine drug screens were positive for
benzodiazepines, Subutex, and methamphetamine. Tr. 208-212; GE-10, at
72-74, 97. *[Although CA was taking amphetamines, Dr. Kennedy testified
that this would not make the urine drug test positive for
methamphetamines. Tr. 209. Additionally, he testified that ``this is an
inconsistent result and we have to send it out to disprove that
notion.'' Tr. 210.]
113. A treatment note of January 11, 2017, indicates that CA was
receiving a prescription of Adderall for ADHD, and a prescription of
Klonopin for anxiety. GE-10, at 64. Someone other than Dr. Daniels
signed this note. Id.
114. On May 2, 2017, CA's urine drug screen was positive for
Subutex, but negative for Adderall and Klonopin. Tr. 216; GE-10, at 18.
CA had received prescriptions for all of these medications on April 5,
2017. GE-10, at 6. The results of this urine drug screen were abnormal.
Tr. 216. On May 3, 2017, an unsigned, handwritten treatment note for CA
indicates that his drug screen was positive, but does not indicate what
it was positive for. GE-10, at 57. The treatment note also incorrectly
indicates that the drug screen was negative for opioids. Id.
115. On July 26, 2017, CA's urine drug screen was positive for
buprenorphine, but negative for amphetamines and benzodiazepines. Tr.
216-17; GE-10, at 28, 30. CA had received prescriptions for all types
of these medications on June 29, 2017. GE-10, at 3. The results of this
urine drug screen were abnormal. Tr. 216-17.
116. On August 23, 2017, CA's urine drug screen was positive for
buprenorphine, but it was negative for amphetamines and
benzodiazepines. Tr. 214; GE-10, at 11-12. CA had received
prescriptions for all types of these medications on July 26, 2017. GE-
10, at 2. The results of this test were not normal. Tr. 214-15.
117. A review of Dr. Daniels' medical records of CA reveals no
documentation that Dr. Daniels ever conducted a physical examination of
CA, and those records provide no explanation of why Dr. Daniels
prescribed Klonopin to him, other than CA's claim that he had a history
of ADHD and anxiety, which was unsupported by any records. GE-10, at 1-
97, 51; Tr. 322. *[hairsp][The record does contain vital signs for CA,
which Dr. Kennedy described as ``part'' of the physical examination.
Tr. 316; GE-10, at 51.]
118. There are no discussions of any abnormal urine drug screens in
CA's medial file. Tr. 214-15, 220. The failure to respond or document
that response to abnormal urine drug screens makes it very difficult to
conclude that the physician is engaged in ``legitimate medical
management in a patient who's receiving scheduled medications for any
reason.'' Tr. 219.
119. Between June 2016 and September 2017, Dr. Daniels was issuing
CA prescriptions for Subutex, Klonopin, and Adderall, an opioid, a
benzodiazepine, and an amphetamine. Tr. 203; Stip. 22.
120. In Dr. Kennedy's opinion, all the prescriptions Dr. Daniels
wrote for CA, identified in Stipulation 22, were issued outside the
course of medical practice and were not issued for a legitimate medical
purpose. Tr. 206-07, 220.
Patient MN
121. On May 2, 2017, MN presented to the Clinic needing help with
withdrawal symptoms due to a history of opioid dependence. GE-14, at
19. She stated that she was addicted to Subutex, which she claimed to
have been taking for two years. Id. MN also reported that she had taken
Klonopin in the past for depression and anxiety and was requesting a
refill. Id.
122. On May 2, 2017, MN signed a Patient Treatment Contract with
Dr. Daniels. Tr. 327-28; GE-14, at 43. In paragraph 13 of the contract,
MN agreed to abstain from alcohol, opioids, marijuana, cocaine, and
other addictive substances. GE-14, at 43. Although MN signed this
contract, it was not signed by Dr. Daniels or anyone else. Id.
123. Paragraph 10 of the Patient Treatment Contract that MN signed
on May 2, 2017, reads as follows: ``I understand that mixing
buprenorphine with other medications especially benzodiazepines (for
example, Valium, Klonopin, or Xanax), can be dangerous. I also
recognize that several deaths have occurred among persons mixing
buprenorphine and benzodiazepines (especially if taken outside the care
of a physician, using a route of administration other than sublingual
or in higher than recommended therapeutic doses).'' GE-14, at 43.
124. MN's medical file contains an assessment completed by a
licensed clinical social worker on May 2, 2017. GE-14, at 19-28, 31-39.
125. On May 3, 2017, MN's urine drug screen was positive for
ecstasy, THC, and Subutex. Tr. 222, 327; GE-14, at 41. The presence of
ecstasy and marijuana indicates that MN was abusing drugs. Tr. 222.
126. On May 3, 2017, Dr. Daniels entered a ``very limited note''
\7\ in MN's medical record that Suboxone gave MN headaches. Tr. 527,
583-84; GE-14, at 29. The note does not include a subjective complaint,
any objective findings, any assessment of MN's conditions, or a medical
treatment plan. GE-14, at 29. That same day, Dr. Daniels wrote
prescriptions to MN for 8 mg Subutex TID, and 2 mg Klonopin BID. Stip.
24; GE-14, at 5. Then on May 31, 2017, Dr. Daniels again wrote a
prescription to MN for 8 mg Subutex TID, but he modified the
prescription for 2 mg Klonopin to TID. GE-14, at 4; Stip. 24. Because
these prescriptions were written prior to Dr. Daniels documenting
sufficient information into MN's medical record, these prescriptions
were issued outside of the usual course of professional practice in
[[Page 61646]]
the State of Louisiana, and not for a legitimate medical purpose. Tr.
163, 401-02.
---------------------------------------------------------------------------
\7\ Dr. Daniels explained that it was a limited note because
``sometimes with interruptions in the clinic, you get limited
information to put in the chart.'' Tr. 527.
---------------------------------------------------------------------------
127. MN's medical file contains a Physician Intake Note dated June
28, 2017. Tr. 221; GE-14, at 14. The intake note contains the
boilerplate treatment plan. GE-14, at 14. The intake note does not
document: A physical examination; MN's responses to past treatment; or
a rationale for the prescriptions that Dr. Daniels issued to MN. GE-14,
at 14. The MD note of May 3, 2017, and this intake note are the only
notes in MN's file that document an encounter between Dr. Daniels and
MN. Tr. 221; GE-14.
128. When asked whether he had a physical encounter with MN, Dr.
Daniels testified that he did not ``see a document of physical
encounter.'' Tr. 527. Although there is no documentation of a physical
encounter, he testified that he did see her and he did conduct a
physical examination.\8\ Tr. 527-28. Dr. Daniels also testified,
however, that he diagnosed MN as having an opioid addiction based on
her history. Tr. 528-29.
---------------------------------------------------------------------------
\8\ Earlier, however, Dr. Daniels testified that, ``After
looking at the notes, I just remember the encounter. I don't
remember from just my memory though.'' Tr. 525.
---------------------------------------------------------------------------
129. There is nothing in Dr. Daniels' medical record concerning MN
that documents that Dr. Daniels diagnosed MN's medical condition. Tr.
582.
130. A treatment plan for MN would have included a discussion of
how Dr. Daniels was going to wean MN off of Subutex, the substance she
claimed she was addicted to. Tr. 408-09. As of May 3, 2017, Dr.
Daniels' treatment plan for MN only included Subutex 8 mg TID and
Klonopin. Tr. 529; GE-14, at 29.
131. On June 28, 2017, MN's urine drug screen was positive for only
Subutex. Tr. 223; GE-14, at 10. This drug screen was abnormal because
it should have been positive for a benzodiazepine, having received a
prescription for Klonopin on May 31, 2017. Tr. 223-24; Stip. 24.
132. On July 28, 2017, MN's urine drug screen was positive for
ecstasy, Subutex, and methamphetamines, and negative for
benzodiazepines. Tr. 224; GE-14, at 8. This is a ``wildly abnormal''
drug screen. Tr. 224-25. *[hairsp][Dr. Kennedy testified that ``to have
a drug screen like this, and to make absolutely no comment in the
medical record, did not make any comment with addressing the patient
about it, or what you plan to do about this, is in my view,
inexcusable.'' Tr. 226. Further, he stated that ``to continue providing
this patient with scheduled medications without comment, in my view, is
not medically legitimate.'' Id.]
133. On August 29, 201[7][hairsp]*, MN received prescriptions for
Subutex and Klonopin, written by Dr. Daniels, but there is no
documentation in MN's medical file of an encounter with Dr. Daniels
that day. Tr. 228; GE-14, at 1; Stip. 24. *[hairsp][Dr. Kennedy
testified that ``every single prescription for a scheduled medication,
in my opinion, must be accounted for.'' Tr. 233. He clarified that when
writing new prescription, there must be something documenting that
prescription in the medical record. Id.]
134. There are no discussions of any abnormal urine drug screen in
MN's medical file. Tr. 226-27; GE-14. The failure to respond or
document a response to abnormal urine drug screens makes it very
difficult to conclude that the physician is engaged in ``legitimate
medical management in a patient who's receiving scheduled medications
for any reason.'' Tr. 219.
135. A review of Dr. Daniels' medical records of MN reveals no
documentation that Dr. Daniels ever conducted a physical examination of
MN, and those records provide no explanation of why Dr. Daniels
prescribed Klonopin to her, other than that she had been prescribed it
in the past, and she had requested a refill. GE-14, at 1-47, 19.
136. In Dr. Kennedy's opinion, all the prescriptions identified in
Stipulation 24, issued to MN, were issued outside the course of
acceptable medical practice and were not issued for a legitimate
medical purpose. Tr. 231. Dr. Kennedy's opinion was based upon: The
absence of drug screening documentation; the absence of medical
records; no documentation that MN's PMP was reviewed; no evidence of a
credible physical examination; and the absence of any documented
discussions with MN that would establish a valid doctor-patient
relationship. Tr. 231-32.
Patient JD
137. On August 3, 2016, JD signed a Patient Treatment Contract with
Dr. Daniels. GE-15, at 30. In paragraph 13 of the contract, JD agreed
to abstain from alcohol, opioids, marijuana, cocaine, and other
addictive substances. Id.
138. Paragraph 10 of the Patient Treatment Contract that JD signed
on August 3, 2016, reads as follows: ``I understand that mixing
buprenorphine with other medications especially benzodiazepines (for
example, Valium, Klonopin, or Xanax), can be dangerous. I also
recognize that several deaths have occurred among persons mixing
buprenorphine and benzodiazepines (especially if taken outside the care
of a physician, using a route of administration other than sublingual
or in higher than recommended therapeutic doses).'' GE-15, at 30.
139. On August 3, 2016, JD signed a Patient Information and Consent
to Treatment with Buprenorphine and Suboxone. GE-15, at 32. The fourth
paragraph of that information sheet advises that combining
buprenorphine with alcohol or other sedating medications is dangerous,
and that combining buprenorphine with benzodiazepines has resulted in
deaths. Id.
140. On August 3, 2016, JD signed a Patient Agreement to
Participate in Suboxone Treatment. Tr. 332; GE-15, at 29. At the end of
each paragraph is a space for the patient's initials, but there are no
initials there. Id. Dr. Daniels did not sign the Agreement; a counselor
signed it instead. GE-15, at 29.
141. On August 3, 2016, JD presented to Dr. Daniels with a history
of back pain, and indicated that he had a prior prescription for
Lortab. Tr. 235, 531; GE-15, at 22. JD also reported that he had taken
Percocet and methadone off the streets, and that he had used Subutex
for two years. Id. Dr. Daniels signed and dated this handwritten
assessment on August 10, 2016. Tr. 235; GE-15, at 22-23. This is the
only documented encounter between JD and Dr. Daniels. Tr. 235; GE-15.
142. A review of Dr. Daniels' medical records of JD reveals no
documentation: That he obtained JD's prior medical records; that Dr.
Daniels ever conducted a physical examination of JD; *F or
that he developed an appropriate treatment plan for JD. Tr. 235-36; GE-
15, at 1-35.
---------------------------------------------------------------------------
\*F\ The JD file does include vital signs, which Dr. Kennedy
testified is part of the physical examination, but not adequate by
itself to meet the standard of care and usual course of professional
practice. Tr. 329; GE-15, at 22.
---------------------------------------------------------------------------
143. Dr. Daniels' assessment of JD does not document a treatment
plan (other than the boilerplate treatment plan) and it does not
provide a rationale for the controlled substances prescribed to JD. Tr.
236, 330, 532; GE-15, at 22-23.
144. On August 3, 2016, JD's urine drug screen was positive for
only Subutex. Tr. 532; GE-15, at 26. A counselor signed this urine drug
screen. Tr. 330; GE-15, at 26. A physician should have signed the urine
drug screen. Tr. 331, 380-81.
145. Over the 13 months that Dr. Daniels treated JD, there is only
one encounter note. Tr. 235, 237; GE-15. Dr. Kennedy testified that one
encounter followed by a year's worth of the maximum dosage of
buprenorphine, is clearly outside the course of acceptable
[[Page 61647]]
medical practice anywhere in the United States. Tr. 238-39.
146. In Dr. Kennedy's opinion, all the prescriptions Dr. Daniels
issued to JD, identified in Stipulation 27, were issued outside the
course of acceptable medical practice and were not issued for a
legitimate medical purpose. Tr. 238. Dr. Kennedy's opinion was based
upon the absence of follow-up care after the initial encounter. Id.
Patient SB
147. On January 17, 2017, SB signed a Patient Treatment Contract
with Dr. Daniels. Tr. 340; GE-17, at 17. In paragraph 13 of the
contract, SB agreed to abstain from alcohol, opioids, marijuana,
cocaine, and other addictive substances. GE-17, at 17.
148. Paragraph 10 of the Patient Treatment Contract that SB signed
on January 17, 2017, reads as follows: ``I understand that mixing
buprenorphine with other medications especially benzodiazepines (for
example, Valium, Klonopin, or Xanax), can be dangerous. I also
recognize that several deaths have occurred among persons mixing
buprenorphine and benzodiazepines (especially if taken outside the care
of a physician, using a route of administration other than sublingual
or in higher than recommended therapeutic doses).'' GE-17, at 17.
149. On January 17, 2017, SB signed a Patient Agreement to
Participate in Suboxone Treatment. Tr. 337-38; GE-17, at 18. At the end
of each paragraph is a space for the patient's initials, but only half
of the spaces were initialed. Id. A counselor signed this Agreement,
rather than Dr. Daniels. GE-17, at 18.
150. On January 17, 2017,*G SB signed a Patient
Information and Consent to Treatment with Buprenorphine and Suboxone.
GE-17, at 31. The fourth paragraph of that information sheet advises
that combining buprenorphine with alcohol or other sedating medications
is dangerous, and that combining buprenorphine with benzodiazepines has
resulted in deaths. Id.
---------------------------------------------------------------------------
\*G\ It appears that the patient mistakenly marked this with the
year 2016 and so I have edited the RD to reflect 2017. In GE-17, at
17, the patient's signature year of ``16'' is crossed out and hand-
edited to state ``17'' and the physician's signature lists 2017. See
GE-17, at 17 and 18. The record demonstrates that SB first came to
the clinic in January 2017. It is logical, based on these other
records, that the patient was simply confused about the new year in
signing this form.
---------------------------------------------------------------------------
151. On a January 18, 2017 Physician Intake Note, Dr. Daniels noted
that SB had a history of recreational drug abuse, heroin abuse, and
severe panic attacks. Tr. 239, 333, 533-34; GE-17, at 15. The Note
states that SB had previously been treated with Suboxone, but developed
hives as a side effect. Tr. 534; GE-17, at 15. This Note is the only
documentation of Dr. Daniels' assessment of SB, other than an undated,
unsigned ``Physician Assessment'' in SB's medical file that does not
bear the name of a patient. Tr. 239-40; GE-17, at 27-28. Neither the
Note nor the Assessment documents a physical examination of SB. Tr.
240, 333; GE-17, at 15, 27-28. In addition, neither the Note nor the
Assessment documents a rationale for the medications Dr. Daniels
prescribed to SB. Tr. 243; GE-17, at 15, 27-28.
152. Although the Intake Note indicates that SB was treated with
Suboxone in Dallas, the medical records request form was not completed
and there are no prior medical records in SB's medical file. Tr. 241;
GE-17, at 29.
153. On January 18, 2017, SB's urine drug screen tested positive
for methamphetamine, THC and Subutex. Tr. 336, 534; GE-17, at 16. Dr.
Daniels did not document any discussions with SB about this abnormal
urine drug screen. Tr. 243. In light of this abnormal drug screen, Dr.
Daniels should have provided a rationale for his decision to treat SB.
Tr. 337. On July 14, 2017, SB's urine drug screen tested positive for
Klonopin, Subutex, fluoxetine, norfluoxetine, and cTHC. GE-17, at 8,
10-11. The lab report indicates that a source for fluoxetine includes
Prozac. Id. at 8. On her patient intake form, SB indicated that she had
previously taken Prozac. Id. at 24-25.
154. While Dr. Daniels did not make a note of it in the file, he
testified that the general recommendation for a drug screening that was
positive for marijuana and methamphetamine would have been more
frequent counseling.\9\ Tr. 534-35.
---------------------------------------------------------------------------
\9\ The medical records in this case, however, do not document
an instance where Dr. Daniels increased the frequency of counseling
based upon an abnormal urine drug screen. Further, although SB had
an abnormal urine drug screen on January 18, 2017, GE-17, at 13, see
supra FF 154, SB's treatment plan with respect to counseling is
identical to those of other patients who had not initially tested
positive for marijuana or methamphetamines. GE-10, at 34; GE-17, at
15; GE-23, at 8. In fact, Dr. Daniels' medical records concerning SB
do not document that she ever returned to the Clinic for follow-up
treatment or counseling, though she did receive monthly
prescriptions of Subutex and Klonopin for another six months after
her initial appointment. GE-17; Stip. 29.
---------------------------------------------------------------------------
155. A review of Dr. Daniels' medical records of SB reveals no
documentation that Dr. Daniels ever conducted a physical examination of
SB, and those records provide no explanation of why Dr. Daniels
prescribed Klonopin to her, other than that she had a history of severe
panic attacks. GE-17, at 1-32, 15.
156. In Dr. Kennedy's opinion, all the prescriptions issued to SB,
identified in Stipulation 29, were issued outside the course of
acceptable medical practice and were not issued for a legitimate
medical purpose. Tr. 244. Dr. Kennedy's opinion was based upon SB being
a young woman of reproductive age, who had a history of heroin abuse,
issues with alcohol, an abnormal drug screen, and an absence of
documentation to explain treatment. Id. *[Dr. Kennedy testified that,
``there was, in essence, in [his] view, no medical care here, simply
the provision of scheduled prescriptions.'' Id.]
Patient CM
157. On May 2, 2016, CM's urine drug screen tested positive for
buprenorphine and cTHC. GE-18, at 34, 36.
158. On May 3, 2016, CM signed a Patient Treatment Contract with
Dr. Daniels. GE-18, at 45. In paragraph 13 of the contract, CM agreed
to abstain from alcohol, opioids, marijuana, cocaine, and other
addictive substances. Id.
159. Paragraph 10 of the Patient Treatment Contract that CM signed
on May 3, 2016, reads as follows: ``I understand that mixing
buprenorphine with other medications especially benzodiazepines (for
example, Valium, Klonopin, or Xanax), can be dangerous. I also
recognize that several deaths have occurred among persons mixing
buprenorphine and benzodiazepines (especially if taken outside the care
of a physician, using a route of administration other than sublingual
or in higher than recommended therapeutic doses).'' GE-18, at 45.
160. On May 3, 2016, CM signed a Patient Information and Consent to
Treatment with Buprenorphine and Suboxone. GE-18, at 41. The fourth
paragraph of that information sheet advises that combining
buprenorphine with alcohol or other sedating medications is dangerous,
and that combining buprenorphine with benzodiazepines has resulted in
deaths. Id. A counselor signed this Agreement, rather than Dr. Daniels.
Id.
161. On May 3, 2016, CM signed a Patient Agreement to Participate
in Suboxone Treatment. GE-18, at 42. At the end of each paragraph is a
space for the patient's initials, but there are no initials there. Id.
A counselor signed this Agreement, rather than Dr. Daniels. Id.
162. A May 4, 2016 nursing assessment indicates that CM had been
abusing oxycodone and Roxicodone, and he had been taking Subutex 8 mg
for three years. Tr. 341, 537; GE-18, at 49. The individual who
completed this
[[Page 61648]]
nursing assessment did not sign or date it.\10\ Tr. 251; GE-18, at 50.
This nursing assessment is not sufficient to support issuing
prescriptions for controlled substances to CM. Tr. 250-51. The nursing
assessment indicates that a different provider had previously treated
CM. Tr. 253, 537-38; GE-18, at 49. The assessment does not contain any
diagnoses or a treatment plan. GE-18, at 50.
---------------------------------------------------------------------------
\10\ Dr. Daniels testified, however, that this was the encounter
note for the initial visit. Tr. 537. There is no Physician Intake
Note concerning CM in the medical file contemporaneous with Dr.
Daniels' initiation of care for CM.
---------------------------------------------------------------------------
163. The prescriptions that Dr. Daniels wrote for CM on May 4,
2016, through May 17, 2017, for Subutex and Klonopin predate any
written documentation of Dr. Daniels actually seeing CM. GE-18; Stip.
31. These prescriptions were issued outside the usual course of medical
practice in the state of Louisiana. Tr. 401-02.
164. On December 14, 2016, Dr. Daniels began prescribing Klonopin
to CM. Tr. 254; Stip. 31. Nothing in Dr. Daniels' medical records
concerning CM supports prescribing Klonopin to him. Tr. 254, 542; GE-
18. In fact, there are no treatment notes concerning CM dated December
14, 2016. GE-18.
165. CM's medical file contains a Physician Intake Note, dated June
14, 2017. Tr. 251, 343; GE-18, at 26. Although the intake note is
signed by Dr. Daniels, the signature appears to be photocopied, and it
is not dated. Tr. 251. The note contains the boilerplate treatment
plan. GE-18, at 26. The note does not document: A physical examination;
CM's responses to past treatment; or a rationale for the prescriptions
that Dr. Daniels issued to CM. Tr. 252-54; GE-18, at 26.
166. CM's medical file contains a Physician Intake Note, dated
August 9, 2017. Tr. 251-52; GE-18, at 20. This note reports that the
patient was doing well on medications. GE-18, at 20. Although Dr.
Daniels signed the note, the signature appears to be a photocopy, and
it is not dated. Tr. 252, 340. The note contains the boilerplate
treatment plan. GE-18, at 20. The intake note does not document: A
physical examination; CM's responses to past treatment; or a rationale
for the prescriptions that Dr. Daniels issued to CM. Tr. 252-54; GE-18,
at 20.
167. There is no completed medical records' release form contained
in CM's medical file. Tr. 253-54; GE-18. There are no prior medical
records contained in CM's medical file. Tr. 253-54; GE-18.
168. On May 17, 2017, July 12, 2017, and September 5, 2017, CM's
urine drug screens tested positive for THC (tetrahydrocannabinol) and
Subutex. Tr. 538-39; GE-18, at 19, 23, 32. Although counseling would
have been Dr. Daniels' normal response, he did not indicate that it was
done, nor is it documented. Tr. 539; GE-18.
169. On September 9, 2017, CM's urine drug screen tested positive
for benzodiazepines, THC, and Subutex. GE-18, at 21.
170. Dr. Daniels testified that CM was prescribed 8 mg Subutex TID,
for his substance abuse issues, and he was eventually prescribed
Klonopin for his anxiety. Tr. 540.
171. In Dr. Kennedy's opinion, all the prescriptions Dr. Daniels
issued to CM, identified in Stipulation 31, were issued outside the
course of acceptable medical practice and were not issued for a
legitimate medical purpose. Tr. 255. Dr. Kennedy's opinion was based
upon: The lack of PMP reports in CM's file; the lack of prior medical
records, the failure to document responses to abnormal urine drug
screen, as well as ``other modalities'' he previously testified about.
Tr. 255-56.
Undercover Patient TC
172. A DEA Task Force Officer (``TFO'') conducted two undercover
visits with Dr. Daniels. Tr. 76-77, 80. The TFO presented himself to
Dr. Daniels as patient TC. Id.
173. TC first visited Dr. Daniels' practice on September 12, 2017.
Tr. 77. TC made an audio and video recording of the visit. Id.; GE-24,
27.
174. When TC went to the Clinic on September 12, 2017, a nurse
instructed him to provide a urine sample. Tr. 77. After TC provided a
urine sample, the nurse checked his vitals, and TC's blood pressure was
found to be about 190/120. Tr. 78. That was the only physical
examination conducted of TC. Id.
175. TC's urine drug screen was negative. Tr. 89; GE-23, at 9. TC
reported he had not used any controlled substances in the prior two-
three weeks. Tr. 89-90; GE-23, at 9; GE-25, at 1-2.
176. After TC's vitals were taken, he met with a counselor for 10
to 15 minutes. Tr. 78-79. The counselor asked him questions about his
family and alcohol/substance use. Id. TC did not record this portion of
the visit to the Clinic. Id. Following the interview with the
counselor, the counselor indicated there was no problem. Tr. 79-80.
177. TC told the counselor that he had an addiction to Lortab and
he wanted to get off it right away. Tr. 87; GE-23, at 2. TC also
informed the counselor that about four years ago he began buying
Lortabs off the street. Tr. 87-88; GE-23, at 2.
178. On September 12, 2017, TC signed a Patient Treatment Contract
with Dr. Daniels. Tr. 90-91; GE-23, at 16. In paragraph 13 of the
contract, TC agreed to abstain from alcohol, opioids, marijuana,
cocaine, and other addictive substances. Tr. 91, 104; GE-23, at 16. No
one at the Clinic discussed the content of the contract with TC, he was
just told to sign it. Tr. 102-03.
179. Paragraph 10 of the Patient Treatment Contract that TC signed
on September 12, 2017, reads as follows: ``I understand that mixing
buprenorphine with other medications especially benzodiazepines (for
example, Valium, Klonopin, or Xanax), can be dangerous. I also
recognize that several deaths have occurred among persons mixing
buprenorphine and benzodiazepines (especially if taken outside the care
of a physician, using a route of administration other than sublingual
or in higher than recommended therapeutic doses).'' Tr. 90; GE-23, at
16.
180. On September 12, 2017, TC signed a Patient Information and
Consent to Treatment with Buprenorphine and Suboxone. Tr. 91-92; GE-23,
at 17. The fourth paragraph of that information sheet advises that
combining buprenorphine with alcohol or other sedating medications is
dangerous, and that combining buprenorphine with benzodiazepines has
resulted in deaths. Id. No one from the Clinic signed this form. Id. No
one at the Clinic discussed the content of the form with TC, they just
told him to sign it. Tr. 102-03.
181. On September 12, 2017, TC signed a Patient Agreement to
Participate in Suboxone Treatment. Tr. 348-49; GE-23, at 19. At the end
of each paragraph is a space for the patient's initials, and TC
initialed each space. GE-23, at 19. Although the form was witnessed,
Dr. Daniels did not sign as the witness. Id.
182. On September 12, 2017, Dr. Daniels' Clinic completed a
Behavioral Health Assessment of TC. GE-23, at 2. The assessment was
conducted by Akee Jackson. Id. at 6. TC's chief complaint was that he
was addicted to Lortab and he wanted to get off it right away. Id. at
2. TC reported that he had last used Lortab two weeks prior to the
assessment. Id.
183. On September 12, 2017, TC's urine drug screen tested negative
for all drugs. Tr. 257, 556; GE-23, at 9. Based on when TC reported
that he had last used an opioid, he would have been an opioid
na[iuml]ve patient on September 12, 2017. Tr. 258.
184. TC returned to the Clinic on September 13, 2017. Tr. 80-81.
When
[[Page 61649]]
TC entered Dr. Daniels' office, he asked to step out for a second. Tr.
81. He momentarily stepped out of Dr. Daniels' office to turn on his
recording devices. Id.
185. On his second visit to the Clinic, no one took TC's vitals or
conducted a physical examination of him before he saw Dr. Daniels. Tr.
81.
186. On September 13, 2017, the Clinic checked the PMP concerning
TC. Tr. 598; GE-30, at 2. The medical records that Dr. Daniels
maintained on TC did not contain a PMP report concerning TC. Tr. 261;
GE-23. Dr. Daniels did not mention the PMP report when he met with TC
on that date. GE-25.
187. On September 13, 2017, Dr. Daniels completed a Physician
Intake Note concerning TC. Tr. 256; GE-23, at 8. Dr. Daniels noted that
TC had a history of recreational drug abuse, and that he had positive
signs of withdrawal, to include: Migraine headaches, elevated blood
pressure, and sweating. GE-23, at 8; see also GE-25, at 4. The Intake
Note does not reflect a diagnosis for TC, or document that Dr. Daniels
conducted a physical examination of TC. Tr. 256-57; GE-23, at 8. In
addition, a review of the video recording of this visit by TC with Dr.
Daniels shows that TC met with Dr. Daniels for 8 minutes, 36 seconds,
and that no physical examination *H was conducted, TC and
Dr. Daniels just talked. Tr. 84; GE-27.
---------------------------------------------------------------------------
\*H\ Dr. Kennedy testified that although he thought that the
interview of TC was appropriate, the physical examination needed to
be done, and that would have included generally ``a heart and lung
exam, and the doctor look in his eyes and notice if there is any
kind of tremoring going on and maybe check peripheral pulses and see
if he's tachycardic, and if not a complete and in-depth physical
exam, at least a checking over of the patient before you embark on
this program of long-term scheduled medications.'' Tr. 389-90.
---------------------------------------------------------------------------
188. During the September 13, 2017 office visit, TC informed Dr.
Daniels that he had provided a drug screen and that he drinks alcohol.
Tr. 82. TC also informed Dr. Daniels that he had taken Suboxone or
Subutex before and that he had taken it ``from people.'' Tr. 82-83; GE-
25, at 2. Dr. Daniels responded by saying ``okay.'' Id. TC told Dr.
Daniels that he had been taking 8 mg Suboxone off the street, and that
he had not had any adverse reaction. Tr. 83; GE-25, at 2.
189. During the September 13, 2017 office visit, TC informed Dr.
Daniels that he had been taking Lortabs, but he had not taken any for
several weeks. Tr. 82, 552; GE-23, at 8; GE-25, at 1. TC also informed
Dr. Daniels that he had taken Adderall before. Tr. 84; GE-25, at 3.
190. During the September 13, 2017 office visit, Dr. Daniels
informed TC several times that he did not think TC's condition was very
severe and that he would like to get TC some counseling. Tr. 93-94,
552; GE 25, at 3-4. TC then gave Dr. Daniels indications that his
condition was more serious than he had previously been telling Dr.
Daniels. Tr. 94-95, 554.
191. During the September 13, 2017 office visit, Dr. Daniels did
not counsel TC about the dangers of using alcohol while taking
Suboxone. GE-25. Combining alcohol with Suboxone could be dangerous.
Tr. 263-64; GE-23, at 17.
192. During the September 13, 2017 office visit, Dr. Daniels did
not counsel TC about the dangers of obtaining drugs off the street, or
the dangers of mixing controlled substances. Tr. 83-84.
193. On September 13, 2017, Dr. Daniels issued TC a prescription
for 60 tablets of 8/2 mg Suboxone, to be taken twice a day. Tr. 261-62;
GE-23, at 1; Stip. 37. *[``8 milligrams twice daily, that would be, as
you said, 16 milligrams a day.'' Tr. 262]
194. Dr. Daniels did not document a rationale for the prescription
for the Suboxone he issued to TC. Tr. 260. Dr. Daniels did, however,
ask TC appropriate questions when he met with him on September 13,
2017. Tr. 261, 349; GE-25.
195. Dr. Daniels testified, however, that based on his
understanding of ``the local people that [he] had been treating for so
many years,'' and TC's history, Dr. Daniels felt that the dose of
Suboxone he prescribed to TC was appropriate because he believed it to
be one that would prevent a relapse. Tr. 556-57.
196. Because TC was opioid na[iuml]ve, if he took the Suboxone as
it had been prescribed to him by Dr. Daniels, TC could have become
quite sick. Tr. 262-63, 399.
197. None of the records that Dr. Daniels maintained concerning TC
document a physical examination of TC. Tr. 257; GE-23. Concerning TC,
Dr. Daniels should have documented a physical examination that
included: Checking heart and lungs, checking for tremors in the eyes,
and checking peripheral pulses for tachycardia. Tr. 389-90.
198. The medical records that Dr. Daniels maintained on TC did not
contain any medical records from TC's prior doctors, but TC also told
Dr. Daniels that he did not have a primary care doctor, and that he had
never been treated for substance abuse. Tr. 261; GE-23; GE-25, at 3-4.
199. In Dr. Kennedy's opinion, the prescription Dr. Daniels issued
to TC, identified in Stipulation 37, was issued outside the course of
acceptable medical practice and was not issued for a legitimate medical
purpose. Tr. 261, 266. Dr. Kennedy's opinion was based upon: The lack
of PMP reports in CM's file; the lack of prior medical records; the
failure to perform a physical examination; giving a high dose of
Suboxone to an asymptomatic patient who has a history of recreational
substance abuse; *[the lack of actual counseling regarding the dangers
of mixing alcohol and Suboxone] and the deficiency of Dr. Daniels'
medical records concerning TC. Tr. 261, 264-66, 386-87, 602.
200. Upon learning that TC's PMP report was checked, and after
listening to Dr. Daniels' testimony, Dr. Kennedy stated that he still
believes that the prescription of 16 mg of Suboxone to an opioid
na[iuml]ve patient was outside the standard of care, however, as to the
question of ``whether or not it was issued for a legitimate medical
purpose, that I would have to go over everything again to make a final
decision on.'' Tr. 602.
Patient JW \11\
---------------------------------------------------------------------------
\11\ With respect to patient JW, the Government's only concern
is with the OxyContin prescriptions that Dr. Daniels issued to JW.
Tr. 547-48. Therefore, the facts concerning JW will focus on just
those prescriptions.
---------------------------------------------------------------------------
201. JW owned the Clinic before LW took it over. Tr. 543. JW is a
professional counselor who Dr. Daniels had known and worked with since
2003. Id.
202. In 2013, JW developed chronic pain and a local physician
treated him with methadone. Tr. 544. JW was referred to a pain
specialist in Shreveport who was unable to see him because of an
insurance issue. Id. Dr. Daniels agreed to see JW on a temporary basis
because JW was in terrible pain and was ``almost unable to ambulate.''
Id. Although Dr. Daniels did not intend to treat JW long term, he
treated JW until 2017. Id.
203. On July 5, 2013, JW presented to Dr. Daniels with complaints
of back, arm, hand, knee, and leg pain. GE-19, at 11, 21.
204. On July 5, 2013, Dr. Daniels conducted a physical examination
of JW. GE-19, at 9-10, 21. JW rated his pain as 8/10, and reported that
he had surgeries performed on his back, shoulder, and a hernia. Id. at
21. JW reported that he was taking 10 mg methadone five times a day for
chronic pain and carpal tunnel syndrome. Id. Following the physical
examination, Dr. Daniels reached the following clinical impressions
concerning JW's conditions: Hypertension; lumbar disc
[[Page 61650]]
disease; chronic back pain; history of carpal tunnel syndrome; and a
history of multiple surgeries. Tr. 547; GE-19, at 9-10, 21; see also
Patient Questionnaire, Id. at 26-32.
205. On July 5, 2013, Dr. Daniels placed a note in JW's medical
file indicating that JW was the former patient of another doctor, but
JW was well-known to Dr. Daniels. Tr. 545-46; GE-19, at 83. The note
indicated that JW needed follow up for medical problems including knee
and leg pain, back pain, and carpal tunnel syndrome, with the pain
rating of 8/10. Id. Dr. Daniels noted that JW's activities of daily
living were poor. Id.
206. A progress note for JW, dated January 31, 2014, indicates that
JW presented with complaints of constant right knee pain, which he
rated as 8/10. GE-19, at 103. Upon examination, Dr. Daniels noted that
JW's pulse was 80, and his blood pressure was 130/82. Id. Dr. Daniels
noted that JW's right knee was swollen, that there was increased pain
with motion, and that JW was walking with a noticeable limp. Id. Dr.
Daniels refilled prescriptions for JW for 90 tablets of 10/325 mg
Percocet, and 150 tablets of 10 mg methadone. Id.
207. On February 20, 2014, JW had a total knee replacement of his
right knee. GE-19, at 101.
208. On March 14, 2014, JW complained of very intense knee pain,
which he numerically rated a 9 out of 10. GE-19, at 99. Upon
examination, Dr. Daniels noted no swelling but a reduced range of
motion, status-post knee surgery. Id. On that date, Dr. Daniels issued
JW a prescription for 30 tablets of OxyContin, to be taken twice a day.
Id.
209. Progress notes from March 28, 2014, for JW reveal complaints
of occasional severe knee pain for which he needs 10 mg OxyContin, but
his routine chronic pain was relieved by 10/325 mg Percocet. Tr. 548-
49; GE-19, at 100. Upon physical examination, JW's pulse was 84, and
his blood pressure was 146/90. Id. JW's knee surgery was healing well,
but there was increased limited range of motion. Id. There was
tenderness over the medial collateral ligament, and the strength was 4/
5. Id. Dr. Daniels gave JW prescriptions for 90 tablets of 10 mg
OxyContin, and 90 tablets of 10/325 mg Percocet. Id.; see also Stip.
35.
210. Dr. Daniels prescribed OxyContin to JW because he had just had
knee surgery and was complaining of severe knee pain. Tr. 548. He chose
OxyContin because JW had developed a tolerance to other pain
medications. Tr. 549. Dr. Daniels claims that he wrote the dosing
instructions for the prescription, to be taken every 4-6 hours, by
mistake, and that he knows that the usual dose is every 12 hours. Id.
Dr. Daniels also believed that JW was taking the OxyContin
``correctly,'' meaning every 12 hours.\12\ Tr. 550, 577-79.
---------------------------------------------------------------------------
\12\ The timing of JW obtaining new prescriptions for OxyContin
lends support to this belief. On March 28, 2014, April 11, 2014,
April 25, 2014, May 9, 2014, and May 16, 2014, JW received
prescriptions for 20 tablets of OxyContin. Stip. 35. If JW had been
taking the tablets four to six times a day, he would have run out of
the medication before he returned to Dr. Daniels for a new
prescription. The intervals between these appointments are 13 days,
14 days, 14 days, and 7 days. Furthermore, the dosing instructions
of the March 14, 2014 prescription of 30 tablets, were to take one
tablet twice a day. GE-19, at 99. Thus, that prescription was a
fifteen-day supply. JW returned 14 days later to obtain a new
prescription. Stip. 35. There are, however, no treatment notes
concerning the stand-alone prescription for 30 tablets of OxyContin
on January 6, 2017. On January 17, 2016, Dr. Daniels noted that JW
``takes meds appropriate.'' GE-19, at 60.
---------------------------------------------------------------------------
211. While JW was taking the OxyContin, Dr. Daniels encountered JW,
either professionally or as a patient, almost daily. Tr. 550-51.
212. OxyContin is a long-acting continuous release medication
indicated for patients who need around-the-clock pain management. Tr.
268. It is not appropriate to prescribe OxyContin to be taken ``as
needed.'' Tr. 272. It is not appropriate to prescribe OxyContin for
breakthrough pain. Tr. 272-73, 372. OxyContin has a ``Black Box
Warning'' that it is not intended to be taken ``as needed,'' and that
it could be dangerous to take it that way. Tr. 273. Any physician
prescribing OxyContin should know that it is not to be prescribed to be
taken ``as needed.'' Tr. 274.
213. The prescription that Dr. Daniels issued to JW on March 14,
2014, for OxyContin, was issued with instructions to take them as the
medications are intended to be used, one tablet every 12 hours. Tr.
275-76; GE-19, at 99; Stip. 35.
214. The prescriptions that Dr. Daniels issued to JW on March 28,
2014, April 11, 2014, April 25, 2014, May 9, 2014, May 16, 2014, and
January 6, 2017, for OxyContin were issued with instructions that the
OxyContin was to be taken every four to six hours for severe
breakthrough pain. Tr. 277-82; GE-19, at 94-97, 174; GE-21, at 75. A
prescription for OxyContin should never be written like this. Tr. 278.
It would be dangerous to issue a patient a prescription like this. Id.
These prescriptions were not issued within the usual course of
professional practice and were not issued for a legitimate medical
purpose. Tr. 278-83, 372-73.
Analysis
To deny an application for a COR, the Government must prove, by a
preponderance of the evidence, that the requirements for registration
are not satisfied. Steadman v. SEC, 450 U.S. 91, 100-02 (1981); 21 CFR
1301.44(d). Under 21 U.S.C. 823(f), the DEA may deny a COR application
if the ``issuance of such registration . . . would be inconsistent with
the public interest.'' The DEA considers the following five factors to
determine whether granting a registration is in the public interest:
(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).
The 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 15,227, 15,230 (2003). Each factor is weighed on a case-by-case
basis. Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 2005). Any one
factor, or combination of factors, may be decisive. David H. Gillis,
M.D., 58 FR 37,507, 37,508 (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, the DEA must consider the totality of the circumstances. See
generally Joseph Gaudio, M.D., 74 FR 10,083, 10,094-95 (2009) (basing
sanction on all evidence of record).
The Government bears the initial burden of proof, and must justify
denial by a preponderance of the evidence. Steadman, 450 U.S. at 100-
03. If the Government presents a prima facie case for denying a COR
application, the burden of proof shifts to the applicant to show that
such action would be inappropriate. Med. Shoppe--Jonesborough, 73 FR
364, 387 (2008); see, e.g., Steven M. Abbadessa, D.O., 74 FR 10,077,
10,078, 10,081 (2009). An applicant may prevail by successfully
attacking the veracity of the OSC's allegations or the Government's
evidence. Superior Pharmacy I &
[[Page 61651]]
Superior Pharmacy II, 81 FR 31,310, 31,340 n.68 (2016); see Hatem M.
Ataya, M.D., 81 FR 8221, 8224 (2016). Alternatively, an applicant may
rebut the Government's prima facie case for denial of the application
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). When assessing the
appropriateness and extent of sanctioning, the DEA considers the
egregiousness of an applicant's offenses and the DEA's interest in
specific and general deterrence. David A. Ruben, M.D., 78 FR 38,363,
38,385 (2013).
In this case, the Government alleged that Dr. Daniels materially
falsified his application for a Certificate of Registration by failing
to disclose a restriction on his Louisiana state controlled substance
license that was imposed on him by a Consent Order issued by the
Louisiana Medical Board, *[which would constitute a ground for
revocation or denial of an application under 21 U.S.C. 824(a)(1). See
Robert Wayne Locklear, M.D., 86 FR at 33,744-45 (collecting cases) (DEA
has consistently used the grounds for revocation in section 824 as a
basis for denial of an application)]. The Government also alleges that
Factors Two and Four of the public interest standard set forth in 21
U.S.C. 823(f) weigh against the Respondent's registration. See ALJ-18.
Additionally, evidence introduced by the Respondent merits
consideration under Factor One.
I. The Government's Position
The Government presented its position in an opening statement, Tr.
16-19, and in its Post-Hearing Brief, which it submitted on January 10,
2020.\13\ I have read and considered the Government's opening
statement, and its Brief, in preparing this Recommended Decision. 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-18, at 4-22. The Findings of Fact in this Recommended
Decision differ from those proposed by the Government, where I have
found the Government's proposed findings to be in error or not relevant
to resolve the issues in this case. [Omitted] *I 14
---------------------------------------------------------------------------
\13\ The Government's Brief has been marked as ALJ-18.
\*I\ I am omitting the paragraph where the ALJ discussed the
Government's position on the material falsification charge, because
the Government abandoned its allegations related to material
falsification in its Exceptions, and therefore, I find that this
issue is no longer relevant. See also infra III.
\14\ [Footnote omitted. See n.I.]
---------------------------------------------------------------------------
With respect to the public interest considerations, the Government
argues that it is relying ``on the testimony of Dr. Kennedy to show
that [Dr. Daniels] issued prescriptions . . . outside the usual course
of professional practice, beneath the standard of care in the State of
Louisiana, . . . and without a legitimate purpose.'' ALJ-18, at 29. The
Government noted that Dr. Kennedy's opinion was informed by numerous
Louisiana Regulations. Id. Informed by those regulations, Dr. Kennedy
testified that the standard of care in Louisiana for the treatment of
addiction patients requires that a physician: Conduct an adequate
physical examination; obtain an adequate medical history through past
medical records or the PMP; create a treatment plan that includes a
rationale for treatment; maintain adequate treatment records; conduct
urine drug screening; and document the response to abnormal screenings
within the patient's medical record. Id. at 30. The Government also
noted that Dr. Daniels did not dispute Dr. Kennedy's testimony
concerning the standard of care. Id. at 30-31.
The Government argues that I should not credit the testimony of Dr.
Daniels, or his witness LW. ALJ-18, at 31-35. It also argues that Dr.
Daniels' evidence concerning the Clinic's use of PMP reports is
``demonstrably false.'' Id. at 35. I note that I have addressed the
credibility of both Dr. Daniels and LW earlier in this Recommended
Decision. Concerning the PMP reports, Government Exhibit 30
demonstrates that the Clinic viewed the PMP concerning only two of the
eight patients identified in the Order to Show Cause. See FF 26.
Nevertheless, that same exhibit shows that between June 18, 2016, and
September 20, 2017, Dr. Daniels checked the PMP 497 times. GE-30.
Next, the Government summarized the evidence it presented with
respect to each allegation contained in the Order to Show Cause, and
argued it had proven its prima facie case for denial of Dr. Daniels'
application. ALJ-18, at 36-40. Finally, the Government argues that Dr.
Daniels has not accepted responsibility, and, thus, his application
should be denied. Id. at 40-41.
II. The Respondent's Position
Dr. Daniels presented his position in an opening statement, Tr. 20-
22, and in his Post-hearing Brief, which he submitted on January 10,
2020.\15\ I have read and considered Dr. Daniels' opening statement,
and his Brief, in preparing this Recommended Decision. In his Brief,
Dr. Daniels' proposed findings of fact are essentially the same as the
Findings of Fact set forth in this Recommended Decision. ALJ-19, at 3-
21. The Findings of Fact in this Recommended Decision differ from those
proposed by the Respondent, where I have found the Respondent's
proposed findings to be in error or not relevant to resolve the issues
in this case.
---------------------------------------------------------------------------
\15\ Respondent's post-hearing brief has been marked as ALJ-19.
---------------------------------------------------------------------------
Regarding the allegation of material falsification, Dr. Daniels
points out that when submitting his application he ``specifically
referenced the Consent Order issued by the [California Board of
Medicine] as further explanation of the suspension.'' Id. at 3. He also
notes that the Government acknowledged that his affirmative answer to
the liability question and his reference to the Consent Order in his
application ``certainly put the DEA on notice to investigate the
application and not to summarily approve it.'' Id.
With respect to whether his registration would be inconsistent with
the public interest, Dr. Daniels argues that the ``case must rest on
the question of whether [he] knowingly prescribed drugs for other than
a medical purpose, and not whether [he] used good judgment or bad
judgment in trying to actually treat a patient.'' Id. at 4. Dr. Daniels
also calls into question the lack of Louisiana specific experience of
the Government's expert, as well as the ``miniscule sampling of six
charts,'' when compared to the number of patients he had treated at the
Clinic. Id. at 4-5.
Dr. Daniels notes that the Government's expert testified that the
standard of care requires that the treating physician: 1. Obtain a
history from the patient; 2. Conduct a physical examination of the
patient; 3. Obtain the patient's past medical records and review the
patient's PMP; 4. Conduct drug screening of the patient; and 5. Develop
a treatment plan for the patient. Id. at 5. Dr. Daniels then proceeds
to review the evidence, patient by patient, arguing that ``the
treatment provided by [him] to each of the subject patients met this
test.'' Id. at 6. Dr. Daniels does acknowledge that ``[r]egarding the
patient charts . . . some information was missing.'' Id. With respect
to reviewing the patient's PMP, Dr. Daniels noted that ``Dr. Kennedy
testified that prescription monitoring as an accepted practice
requirement became effective in 2018. (Trans., pg. 393). The charts
reviewed were for patient visits between 2016 thru 2017 when
prescription
[[Page 61652]]
monitoring was more of a recommendation.'' Id. at 8.
Dr. Daniels argued that when presented with the results of an
abnormal urine drug screen, ``he reacted to the information with
directives for his staff to carry out.'' Id. Dr. Daniels states that
``[c]ounseling to the patient was always appropriate.'' Id.
Furthermore, the Patient Treatment Agreements required drug screening
as part of the recovery plan. Id. Dr. Daniels than addressed each of
the subject patients, essentially reviewing their case files as he did
when he testified. Id. at 9-21. For each patient, except JW and TC, Dr.
Daniels argues that the Government had presented no evidence suggesting
that the patients were somehow engaged in diversion.\16\ Id. at 11, 13,
15, 16, 17, 19.
---------------------------------------------------------------------------
\16\ The Government, however, is not required to prove that
diversion resulted from the unauthorized issuance of prescriptions.
Arvinder Singh, M.D., 81 FR 8247, 8249 (2016) *[(parentheticals
omitted). In fact, Agency decisions have made clear that ``diversion
occurs whenever controlled substances leave `the closed system of
distribution established by the CSA . . . .' '' Id. (citing Roy S.
Schwartz, 79 FR 34,360, 34,363 (2014)). In this case, I have found
that Respondent issued prescriptions without complying with his
obligations under the CSA and Louisiana law. See George Mathew,
M.D., 75 FR 66,138, 66,148 (2010).].
---------------------------------------------------------------------------
In conclusion, Dr. Daniels acknowledges that ``the patient files
needed much improvement.'' Id. at 22. He adds, however, that ``poor
documentation is not evidence that prescriptions were written for
illegitimate purposes.'' Id. Of note, Dr. Daniels does not address
acceptance of responsibility or remedial steps he may have taken.
III. Material Falsification
The DEA alleged that on March 12, 2018, the Louisiana State Board
of Medical Examiners (``the Board'') issued a Consent Order that
``imposed a continuing restriction on [Dr. Daniels'] ability to
practice medicine and to prescribe controlled substances for pain
management or addiction treatment.'' ALJ-1, at 3-4, para. 8(c). The DEA
further alleged that Dr. Daniels' application for a DEA certificate of
registration, dated March 16, 2018, failed to disclose the restriction
imposed by the Board's Consent Order on his Louisiana state controlled
substance license. Id. at 3-4, paras. 8-9. *[I am omitting the RD's
discussion of material falsification,17 18 because the
Government in its Exceptions abandoned the allegation. See Government
Exceptions, at 1 (stating that the Government does not ``take exception
to the ALJ's finding that Respondent did not materially falsify his DEA
COR application.''). Accordingly, I am not including an analysis of
whether the facts here would have amounted to a material falsification,
but instead, I am removing the RD's legal analysis per the Government's
request for me to ``decline to adopt those limited portions of the
Recommended Decision.'' Id. at 8. I find, as did the ALJ, that there is
more than enough support in the record without the material
falsification allegations that Dr. Daniels' registration is
inconsistent with the public interest and that the appropriate sanction
is denial of his application, as further explained below.]
---------------------------------------------------------------------------
\17\ [Footnote omitted regarding material falsification.]
\18\ [Footnote omitted regarding material falsification.]
---------------------------------------------------------------------------
IV. Public Interest Factor One: The Recommendation of the Appropriate
State Licensing Board or Professional Disciplinary Authority
*[In determining the public interest, 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, M.D., 85 FR 15,800, 15,810 (2020); see also Vincent J.
Scolaro, D.O., 67 FR 42,060, 42,065 (2002).]
In this case, it is undisputed that Dr. Daniels holds a valid state
medical license in Louisiana. Tr. 476; Stip. 1; GE-3. 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 20,011, 20,018
(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 15,227, 15,230 (2003). 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 (DC Cir. 2008).\*J\
---------------------------------------------------------------------------
\*J\ I moved the three sentences preceding this footnote from
the RD to provide further analysis of Factor 1 in accordance with
Agency decisions.
---------------------------------------------------------------------------
The record contains no evidence of a recommendation *[to the Agency
regarding whether or not Dr. Daniels' DEA controlled substance
registration application should be granted] by a relevant state
licensing board or professional disciplinary authority. *[See John O.
Dimowo, M.D., 85 FR 15,810. However, as previously discussed, the State
Board issued Consent Order for Reprimand, which was reached following a
notice of Summary Suspension in Part of Dr. Daniels' Medical License
filed by the Louisiana State Board of Medical Examiners (the Board)
against Dr. Daniels based on ``information that he prescribed
controlled substances without sufficient documentation.'' GE-5 and RE-1
(Consent Order); GE-2 (Summary Suspension). Neither the Consent Order,
nor the Summary Suspension Order details the allegations against Dr.
Daniels, so it is difficult to determine whether the State Board
considered the same allegations and the extent of violations that DEA
is considering herein. However, the Consent Order states that ``Dr.
Daniels has surrendered his controlled dangerous substance registration
to federal authorities.'' GE-5, at 1. Therefore, at the time the Board
made its decision, Dr. Daniels was without a DEA registration and the
Board had no reason to know whether he would receive one again. The
Consent Order also included restrictions, which were proposed by Dr.
Daniels, on Dr. Daniels' ability ``to prescribe controlled substances
for chronic pain or obesity, associating himself with a drug treatment
clinic, or serving in any position of responsibility for the health
care services provided by others.'' Id. at 1-2. Therefore, the Consent
Order does not indicate that the Board has a substantial amount of
trust in Dr. Daniels' prescribing. For all of these reasons, the terms
of the Board's Consent Order are not dispositive of the public interest
inquiry in this case, and although I have considered it slightly in
favor of Respondent, it is also minimized by the circumstances
described above. See John O. Dimowo, 85 FR 15,810-11 (citing Brian
Thomas Nichol, M.D., 83 FR 47,352, 47,362-63 (2018)).] \*K\
---------------------------------------------------------------------------
\*K\ It is noted that the ALJ found that this Factor weighed
neither for nor against Dr. Daniels. See RD, at 69. Although I am
weighing the factor slightly in his favor, it does not outweigh the
egregious violations of law and misconduct in prescribing that I am
considering under Factors 2 and 4.
---------------------------------------------------------------------------
[[Page 61653]]
V. Public Interest Factors Two & Four: The Respondent's Experience in
Dispensing Controlled Substances and Compliance with Applicable State,
Federal, or Local Laws Relating to Controlled Substances
\*L\ [ ] Here, the Government alleges that denying Dr. Daniels' COR
application is appropriate under Factors Two and Four because Dr.
Daniels improperly prescribed controlled substances to: Six addiction
treatment patients; a pain patient; and an undercover patient. ALJ-1,
at 4-8, paras. 10-19.
---------------------------------------------------------------------------
\*L\ Omitted content for clarity.
---------------------------------------------------------------------------
It is unlawful for a practitioner to distribute controlled
substances except as authorized under the CSA. 21 U.S.C. 841(a)(1). To
combat abuse and diversion of controlled substances, ``Congress devised
a closed regulatory system making it unlawful to manufacture,
distribute, dispense, or possess any controlled substance except in a
manner authorized by the CSA.'' Gonzales v. Raich, 545 U.S. 1, 13
(2005). To maintain this closed regulatory system, a DEA registrant may
prescribe a controlled substance only by writing a valid prescription.
Carlos Gonzalez, M.D., 76 FR 63,118, 63,141 (2011). As the Supreme
Court explained, ``the prescription requirement . . . ensures that
patients use controlled substances under the supervision of a doctor so
as to prevent addiction and recreational abuse. As a corollary, [it]
also bars doctors from peddling to patients who crave the drugs for
those prohibited uses.'' Gonzales v. Oregon, 546 U.S. at 274 (2006)
(citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)). *
[According to the CSA's implementing regulations, a lawful] controlled
substance prescription is valid only when it is ``issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.'' 21 CFR 1306.04(a). Federal
regulations further provide that ``[a]n order purporting to be a
prescription issued not in the usual course of professional treatment .
. . is not a prescription within the meaning and intent of [21 U.S.C.
829] and . . . the person issuing it[ ] shall be subject to the
penalties provided for violations of [controlled substance laws].'' Id.
Furthermore, 21 U.S.C. 842(a)(1) establishes that it is illegal for a
person to distribute or dispense controlled substances without a
prescription, as is required under 21 U.S.C. 829. [ ]\*M\
---------------------------------------------------------------------------
\*M\ I am omitting some of the ALJ's analysis related to 21 CFR
1306.04(a) for brevity and clarity.
---------------------------------------------------------------------------
The Government presented the expert testimony of Dr. Kennedy, who
testified that Dr. Daniels' prescriptions to the patients in this case
were not issued for legitimate medical purposes and were issued outside
the usual course of professional practice. Second, the Government has
shown through the testimony of its expert witness that Dr. Daniels
violated the Louisiana standard of care *[and Louisiana law]. [ ]\*N\
---------------------------------------------------------------------------
\*N\ Omitted. See supra n.M
---------------------------------------------------------------------------
[Furthermore, Agency decisions highlight the Agency's
interpretation that ```[c]onscientious documentation is repeatedly
emphasized as not just a ministerial act, but a key treatment tool and
vital indicator to evaluate whether the physician's prescribing
practices are `within the usual course of professional practice.' ''
Mark A. Wimbley, M.D., 86 FR 20,713, 20,726 (2021) (quoting Cynthia M.
Cadet, M.D., 76 FR 19,450, 19,464 (2011)); *[see also Kaniz F. Khan-
Jaffery, M.D., 85 FR 45,667, 45,686 (2020) (``DEA's ability to assess
whether controlled substances registrations are consistent with the
public interest is predicated upon the ability to consider the evidence
and rationale of the practitioner at the time that she prescribed a
controlled substance--adequate documentation is critical to that
assessment.''). Here, Respondent's sparse documentation made it
impossible to evaluate his prescribing practices in any meaningful
way.]
In fact, several of the regulatory provisions cited by the
Government and Dr. Kennedy impose specific requirements on
practitioners when practitioners obtain evidence that a patient is
abusing or diverting controlled substances. In addition, Louisiana's
controlled substance regulations also require practitioners to conduct
urine drug screens and check the PMP, precautionary actions designed to
check for abuse and diversion.
Because Dr. Daniels practices medicine in Louisiana, and because
the OSC cites to specific provisions of Louisiana law and regulations,
it is important to review the requirements of Louisiana law as they
relate to professional conduct and the maintenance of medical records.
Louisiana Law
Louisiana law imposes requirements on controlled substance
prescriptions similar to those imposed by the Controlled Substances Act
and its implementing regulations. For example, under Louisiana law,
``[a] prescription for a controlled substance shall be issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.'' La. Admin. Code tit. 46,
Pt. LIII, Sec. 2745(B)(1). Louisiana law further provides that ``[a]n
order purporting to be a prescription issued not in the usual course of
professional treatment or in legitimate and authorized research is not
a prescription within the meaning and intent of the Controlled
Substances Act.'' Id.
Louisiana law provides that treating chronic pain not related to
cancer with controlled substances ``constitutes legitimate medical
therapy when provided in the course of professional medical practice
and when fully documented in the patient's medical record.'' La. Admin.
Code tit. 46, Pt. XLV, Sec. 6919. Louisiana law imposes several
limitations on the use of controlled substances in the medical
treatment of non-cancer related chronic pain. Specifically, Louisiana
law requires that the medical practitioner evaluate the patient;
diagnose the patient; establish a treatment plan; and obtain informed
consent. Id. at Sec. 6921(A)(1)-(4).
To comply with Louisiana law, a medical evaluation must include
``relevant medical, pain, alcohol and substance abuse histories'';
assessment of the pain's impact ``on the patient's physical and
psychological functions''; review of past diagnostic tests; previously
utilized therapies; ``assessment of coexisting illnesses, diseases, or
conditions''; and ``an appropriate physical examination.'' Id. at Sec.
6921(A)(1).
With respect to the requirement to diagnose the patient, Louisiana
law provides that ``[a] medical diagnosis shall be established and
fully documented in the patient's medical record.'' Id. at Sec.
6921(A)(2). The patient's medical record must indicate ``the presence
of noncancer-related chronic or intractable pain'' and ``the nature of
the underlying disease and pain mechanism,'' if possible for the
practitioner to determine. Id.
In addition to the requirement to document a diagnosis, Louisiana
law also requires the practitioner to document in the patient's medical
record a treatment plan that provides medical justification for the use
of controlled substances. Id. at Sec. 6921(A)(3). The treatment plan
must be tailored to each patient's individual needs. Id. The treatment
plan must also ``include documentation that other medically reasonable
alternative treatments for relief of the patient's noncancer-related
chronic or intractable pain have been considered or attempted without
adequate or reasonable success.'' Id. In addition, the treatment plan
must ``specify the intended role of
[[Page 61654]]
controlled substance therapy within the overall plan.'' Id.
Lastly, with respect to informed consent, Louisiana law requires
the practitioner to ensure the patient is informed of the risks and
benefits of controlled substance therapy. Id. at Sec. 6921(A)(4).
Louisiana law requires that ``[d]iscussions of risks and benefits
should be noted in some format in the patient's record.'' Id.
Once a practitioner determines that controlled substance therapy is
justified, Louisiana law imposes several additional requirements, to
include the requirement that the practitioner: Monitor and assess the
treatment's efficacy; conduct urine drug screens if appropriate; assume
primary responsibility for the patient's controlled substance therapy;
refer the patient for further evaluation and treatment if necessary;
document the need for prescribing more than one controlled substance;
maintain complete and accurate medical records; and document specific
information concerning the controlled substance therapy. Id. at Sec.
6921(B)(1)-(7).
Specifically, the practitioner must see the patient ``at
appropriate intervals, not to exceed 12 weeks, to assess the efficacy
of treatment, assure that controlled substance therapy remains
indicated, and evaluate the patient's progress toward treatment
objectives and any adverse drug effects.'' Id. at Sec. 6921(B)(1). The
requirement to monitor and assess the efficacy of controlled substance
therapy includes the requirement to evaluate any ``[i]ndications of
substance abuse or diversion.'' Id. In addition, the practitioner
``should seek evidence of under treatment of pain'' and assess ``the
possibility of decreased function or quality of life as a result of
controlled substance treatment.'' Id.
With respect to urine drug screens, Louisiana law requires that if
the practitioner ``reasonably believes'' the patient is abusing or
diverting controlled substances, the practitioner ``shall obtain a
urine drug screen on the patient.'' Id. at Sec. 6921(B)(2). In
addition, Louisiana law requires that ``[a] single physician shall take
primary responsibility'' for a patient's controlled substance therapy.
Id. at Sec. 6921(B)(3).
In addition, a practitioner treating a patient with controlled
substances ``should be willing to refer the patient as necessary for
additional evaluation and treatment in order to achieve treatment
objectives.'' Id. at Sec. 6921(B)(4). Using controlled substances to
treat patients with a history of substance abuse or with psychiatric
disorders ``may require extra care, monitoring, documentation, and
consultation with or referral to an expert.'' Id. Louisiana law
specifically instructs practitioners to pay special attention to
patients who are at-risk for misusing or diverting their controlled
substances. Id.
Louisiana law also requires that if a practitioner prescribes more
than one controlled substance to a patient, the practitioner must
``document in the patient's medical record the medical necessity for
the use of more than one type or schedule of controlled substance.''
Id. at Sec. 6921(B)(5).
Furthermore, Louisiana law imposes several specific requirements
concerning the information that a practitioner must document in a
patient's medical record. Specifically, Louisiana law provides that
with respect to medical records:
A physician shall document and maintain in the patient's medical
record, accurate and complete records of history, physical and other
examinations and evaluations, consultations, laboratory and
diagnostic reports, treatment plans and objectives, controlled
substance and other medication therapy, informed consents, periodic
assessments, and reviews and the results of all other attempts at
analgesia which he has employed alternative to controlled substance
therapy.
Id. at Sec. 6921(B)(6).
With respect to controlled substance prescriptions, a Louisiana
practitioner must also document in the patient's medical record: ``The
date, quantity, dosage, route, frequency of administration, the number
of controlled substance refills authorized, as well as the frequency of
visits to obtain refills.'' Id. at Sec. 6921(B)(7).
Louisiana law also provides that if a practitioner obtains evidence
of, or if a patient's behavior indicates, abuse or diversion of
controlled substances, the practitioner should taper the patient's
prescriptions and discontinue controlled substance therapy. Id. at
Sec. 6921(C). The practitioner should only reinitiate controlled
substance therapy after an addiction or pain management specialist, or
psychiatrist, provides written support for ``the medical necessity of
continued controlled substance therapy.'' Id.
Louisiana law also imposes requirements on behavioral health
service providers, which includes practitioners who provide substance
abuse or addiction treatment services. La. Admin. Code tit. 48, Pt. I,
Sec. 5603. Among those requirements include the requirement to
maintain a client record ``according to current professional
standards'' and to ensure medical records contain, at minimum, the
treatment provided to the patient; the patient's response to treatment;
initial assessment, diagnosis, and referral information; treatment
plan; results of diagnostic and laboratory tests; and progress notes.
Id. at Sec. 5637(A)-(B). In addition, a practitioner must document in
the patient's medical record the results of the patient's five most
recent urine drug screens, as well as the action the practitioner took
``for positive results.'' Id. at Sec. 5731(A)(2). Providers operating
an opioid treatment program must ``conduct at least eight random
monthly drug screen tests on each'' patient per year. Id. at Sec.
5723(A)(4).
Behavioral Health Service \*O\ providers must also conduct an
initial assessment of a patient admitted for behavioral health
services, to include a physical examination and drug screening. Id. at
Sec. 5647(C)(4)(b)-(c). In addition, the initial assessment must also
contain a biopsycho-social evaluation, which covers, among other
information, the reason for the patient's admission to behavioral
health services; medical history and past treatment; family and social
history; living situation; education level; employment status; and
functioning level. Id. at Sec. 5647(C)(4)(b). A practitioner may only
admit a patient to behavioral health services if the practitioner has
verified that ``treatment is medically necessary,'' and if the patient
has had a complete physical evaluation before admission, and a full
medical examination within 14 days of admission. Id. at Sec.
5725(A)(3)-(5).\*P\
---------------------------------------------------------------------------
\*O\ I made a slight correction here to the RD, because the
regulation appears to apply to all Behavioral Health Service
providers, including outpatient substance abuse or addiction
treatment service providers, such as the Clinic where Dr. Daniels
worked at the time of the allegations. I find that the substantial
record evidence supports a finding that the Clinic was a Behavioral
Health Service provider and that, therefore, these provisions of
Louisiana regulations apply. Tr. 126, 421; La. Admin. Code tit. 48,
Pt. I, Sec. 5603 (defining a Behavioral Health Service provider as
a clinic that ``provides behavioral health services, presents itself
to the public as a provider of behavioral health services.'')
\*P\ In this case, the requirement to adequately address and
document aberrant results of the urine drug screens has been fully
established by Louisiana law and the standard of care as testified
to by Dr. Kennedy, whose expert testimony is unrebutted. See La.
Admin. Code tit. 48, Pt. I, Sec. 5731(A)(2). As discussed herein,
Dr. Kennedy testified that many of the urine drug screens were
aberrant and there was no documentation of their resolution in
violation of state regulations and the usual course of professional
practice. See infra AK, CA, MN, JD, SB, and CM. The ALJ added a
section in the RD here regarding other DEA decisions that considered
a practitioner's failure to address aberrant urine drug screens in
assessing whether a registration was inconsistent with the public
interest. See Hatem M. Ataya, M.D., 81 FR 8221, 8227 (2016); Jacobo
Dreszer, M.D., 76 FR at 19,388, 19,394 (2011); ``[A] practitioner's
failure to properly supervise his patients to prevent them from
personally abusing controlled substances or selling them to others
constitutes conduct `inconsistent with the public interest' and can
support the denial of an application for registration, or the
revocation of an existing registration.'' Bienvenido Tan, M.D., 76
FR 17,673, 17,689 (2011) (quoting Paul J. Caragine, Jr., 63 FR
51,592, 51,601 (1998)); Mireille Lalanne, M.D., 78 FR 47,750,
47,766-68 (2013) (finding that failing to confront a patient about
inconsistent drug screens by itself is sufficient evidence to show
that the registrant acted outside the scope of professional
practice). I have omitted this section of the RD, but included some
of the cited decisions herein. See Kaniz Khan-Jaffery, 85 FR 45,667,
n.71 (2020) (``Even though these Agency decisions are not essential
or controlling in determining the standard of care in New Jersey
that applies to this case, the fact that other medical experts in
other states have testified regarding the importance of documenting
inconsistent urine screens to their applicable standard of care and
that DEA has long highlighted the importance of this aspect of the
standard of care in those states to maintaining registrations under
the CSA lends further support to the findings herein.'') It is noted
that, the decisions cited in the RD and this footnote, relied on
expertise regarding the applicable standard of care and usual course
of professional practice to those particular registrants, as does
this decision.
---------------------------------------------------------------------------
[[Page 61655]]
Addiction Treatment
The Government alleged that between May 2016 and September 2017,
Dr. Daniels prescribed controlled substances to patients AK, CA, MN,
JD, SB, and CM, outside the usual course of professional practice and
not for legitimate medical purposes, in violation of federal and state
law. ALJ-1, at 4, paras. 10-12. Specifically, the Government alleged
that Dr. Daniels' prescriptions to these patients exhibited several
deficiencies, to include Dr. Daniels' failure to conduct physical
examinations; failure to request the patients' past medical records;
failure to obtain PMP reports; failure to resolve aberrant urine drug
screens; and failure to document the rationale for his medical
treatment. ALJ-1, at 5, para. 12(a)-(e).
In addition, the Government alleged that Dr. Daniels prescribed
patients AK, CA, MN, SB, and CM, prescriptions for both buprenorphine
(Subutex) and clonazepam. The Government further alleged that both of
these controlled substances were respiratory depressants, and that Dr.
Daniels failed to document in the patients' medical records any
rationale that justified prescribing buprenorphine and clonazepam at
the same time. ALJ-1, at 5, para. 13. Dr. Daniels also failed to
document in the patients' medical records that he discussed with them
the risks of taking these controlled substances at the same time. Id.
During his testimony, Dr. Kennedy provided guidance concerning the
standard of care in Louisiana. For example, to prescribe controlled
substances in Louisiana for the treatment of chemical dependency, the
standard of care requires the treating physician to: Conduct an
adequate physical examination; obtain past medical records; obtain PMP
reports; conduct drug screening; and maintain medical records. FF 46.
In addition, the standard of care requires that a patient's medical
record be ``complete and accurate.'' FF 47. With respect to the
Louisiana PMP, prior to 2018, doctors in Louisiana were not required to
check a patient's PMP before writing a prescription for a controlled
substance, but it was considered the standard of care. FF 65.
Patient AK
The Government alleged that all of the prescriptions for controlled
substances that Dr. Daniels issued to Patient AK, between May 2016 and
September 2017,\19\ were issued outside the usual course of
professional practice and not for legitimate medical purposes, in
violation of federal and state law. ALJ-1, at 4-5, paras. 12-13. With
respect to AK, the Government alleged that the prescriptions were
issued outside the usual course of professional practice and not for
legitimate medical purposes for the following five reasons. First, Dr.
Daniels failed to conduct a physical examination of AK, as required by
La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5647, 5725. Second, Dr.
Daniels failed to request AK's medical records concerning prior
substance abuse or past treatment of substance abuse, as required by
La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5647, 5725. Third, Dr.
Daniels failed to obtain a report from the Louisiana Prescription
Monitoring Program for AK, as required by La. Admin. Code tit. 48, Pt.
I, Sec. Sec. 5647, 5725. Fourth, Dr. Daniels failed to address in AK's
medical record the results of abnormal urine drug screens, to include
results that were positive for illicit substances and negative for
substances that Dr. Daniels prescribed, as required by La. Admin. Code
tit. 48, Pt. I, Sec. Sec. 5723, 5725, 5731. And fifth, Dr. Daniels
failed to document in AK's medical records his rationale for his
medical treatment of AK, to include his reason for initiating
buprenorphine treatment at high dosages, as required by La. Admin. Code
tit. 48, Pt. I, Sec. Sec. 5637, 5731. ALJ-1, at 5, para. 12(a)-(e).
---------------------------------------------------------------------------
\19\ This includes all of the prescriptions listed in
Stipulation 17.
---------------------------------------------------------------------------
In addition, the Government alleged that Dr. Daniels issued
prescriptions for both buprenorphine and Klonopin to AK at the same
time. Because Dr. Daniels failed to document in AK's medical record any
rationale that justified prescribing buprenorphine and clonazepam at
the same time, and because Dr. Daniels failed to document that he
discussed with AK the risks of taking these controlled substances at
the same time, the prescriptions were beneath the standard of care for
the practice of medicine in Louisiana, outside the usual course of
professional practice, and not for a legitimate medical purpose. ALJ-1,
at 5-6, paras. 13-15.
During the hearing the Government established by a preponderance of
the evidence that Dr. Daniels did not perform, or he failed to document
that he performed a physical examination of AK. FF 78, 82, 83, 91, 92,
94, 97. Dr. Daniels also failed to obtain past medical records
concerning AK. FF 76, 92, 97; Tr. 198. Although the standard of care
dictated that Dr. Daniels check AK's PMP, he did not do so. FF 26, 85,
92, 97. Although Dr. Daniels did conduct some urine drug screens of AK,
there is no documentation of any action he may have taken concerning
screenings that were abnormal. FF 86, 87, 92, 94, 97. Finally, Dr.
Daniels did not document within AK's medical record a rationale for the
controlled substances he prescribed to AK. FF 81, 94, 97. Accordingly,
*[I find based on the unrebutted, credible testimony of Dr. Kennedy,
and as supported by the evidence] that the prescriptions that Dr.
Daniels issued to AK were issued outside the course of acceptable
medical practice and were not issued for a legitimate medical purpose.
FF 97.
While the preponderance of the Government's evidence establishes
that the medical records Dr. Daniels maintained on AK, failed to
provide an adequate justification for Klonopin, it did not establish
the dangers of prescribing buprenorphine and Klonopin together, or that
Dr. Daniels failed to caution AK of the dangers. FF 70. In fact, the
Government presented no evidence that both buprenorphine and Klonopin
are respiratory depressants. In addition, AK's medical records include
a Patient Treatment Contract that AK signed that specifically warned AK
of the dangers of taking buprenorphine and Klonopin together. FF 72.
Nevertheless, the Government established by a preponderance of the
evidence that, for a number of reasons, all of the prescriptions
identified in Stipulation 17 were issued outside the course of
acceptable medical practice and were not issued for a legitimate
medical purpose. FF 97.
Accordingly, the allegations contained in Paragraph 12 of the Order
to Show Cause that Dr. Daniels issued
[[Page 61656]]
prescriptions to Patient AK in violation of La. Admin. Code tit. 48,
Pt. I, Sec. Sec. 5637, 5647, 5723, 5725, 5731 are SUSTAINED. Because
the Government presented no evidence that established that
buprenorphine and Klonopin (clonazepam) are respiratory depressants,
and because the number of prescriptions alleged in the Order to Show
Cause to have been issued by Dr. Daniels to AK is inconsistent with the
Government's proof, the allegations contained in Paragraphs 13-15 of
the Order to Show Cause concerning AK are NOT SUSTAINED. Nevertheless,
by sustaining the allegations contained in Paragraph 12, I have found
that all of the prescriptions that Dr. Daniels wrote for AK, including
those for buprenorphine and Klonopin, identified in Stipulation 17,
were issued outside the course of acceptable medical practice and were
not issued for a legitimate medical purpose. These violations weigh in
favor of denying Dr. Daniels' pending application for a Certificate of
Registration.
Patient CA
The Government alleged that all of the prescriptions for controlled
substances that Dr. Daniels issued to Patient CA, between May 2016 and
September 2017,\20\ were issued outside the usual course of
professional practice and not for legitimate medical purposes, in
violation of federal and state law. ALJ-1, at 4-5, paras. 12-13. With
respect to CA, the Government alleged that the prescriptions were
issued outside the usual course of professional practice and not for
legitimate medical purposes for the following five reasons. First, Dr.
Daniels failed to conduct a physical examination of CA, as required by
La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5647, 5725. Second, Dr.
Daniels failed to request CA's medical records concerning prior
substance abuse or past treatment of substance abuse, as required by
La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5647, 5725. Third, Dr.
Daniels failed to obtain a report from the Louisiana Prescription
Monitoring Program for CA, as required by La. Admin. Code tit. 48, Pt.
I, Sec. Sec. 5647, 5725. Fourth, Dr. Daniels failed to address in CA's
medical record the results of abnormal urine drug screens, to include
results that were positive for illicit substances and negative for
substances that Dr. Daniels prescribed, as required by La. Admin. Code
tit. 48, Pt. I, Sec. Sec. 5723, 5725, 5731. And fifth, Dr. Daniels
failed to document in CA's medical records his rationale for his
medical treatment of CA, to include his reason for initiating
buprenorphine treatment at high dosages, as required by La. Admin. Code
tit. 48, Pt. I, Sec. Sec. 5637, 5731. ALJ-1, at 5, para. 12(a)-(e).
---------------------------------------------------------------------------
\20\ This includes all of the prescriptions listed in
Stipulation 22.
---------------------------------------------------------------------------
In addition, the Government alleged that Dr. Daniels issued
prescriptions for both buprenorphine and Klonopin to CA at the same
time. Because Dr. Daniels failed to document in CA's medical record a
rationale for prescribing buprenorphine and clonazepam at the same
time, and because Dr. Daniels failed to document that he discussed with
CA the risks of taking these controlled substances at the same time,
the prescriptions were beneath the standard of care for the practice of
medicine in Louisiana, outside the usual course of professional
practice, and not for a legitimate medical purpose. ALJ-1, at 5-6,
paras. 13-15. The Government also alleged that Dr. Daniels failed to
document any rationale for prescribing Adderall to CA. ALJ-1, at 6,
para. 14.b.i.
During the hearing the Government established by a preponderance of
the evidence that Dr. Daniels did not perform, or he failed to document
that he performed a physical examination of CA. FF 103, 107, 109, 110,
118. Dr. Daniels also failed to obtain past medical records concerning
CA. FF 105; Tr. 198. The evidence shows, however, that Dr. Daniels
checked CA's PMP, but he did not do so until more than a year after he
first prescribed controlled substances to CA. FF 26. Although Dr.
Daniels did conduct some urine drug screens of CA, there is no
documentation of any action he may have taken concerning screenings
that were abnormal. FF 101, 102, 111-13, 115-17, 119. Finally, Dr.
Daniels did not document within CA's medical record a rationale for the
controlled substances he prescribed to CA. FF 103, 108-10, 118.
Accordingly, *[I find, based on the unrebutted, credible, expert
testimony of Dr. Kennedy, and as supported by the evidence] that the
prescriptions that Dr. Daniels issued to CA were issued outside the
course of acceptable medical practice and were not issued for a
legitimate medical purpose. FF 121.
While the preponderance of the Government's evidence establishes
that the medical records Dr. Daniels maintained on CA failed to provide
an adequate justification for Klonopin, it did not establish the
dangers of prescribing buprenorphine and Klonopin together, or that Dr.
Daniels failed to caution CA of the dangers. FF 70. In fact, the
Government presented no evidence that both buprenorphine and Klonopin
are respiratory depressants. In addition, CA's medical records include
a Patient Treatment Contract that CA signed that specifically warned CA
of the dangers of taking buprenorphine and Klonopin together. FF 99.
*[Additionally, both Dr. Daniels and Dr. Kennedy testified that
prescribing both Klonopin and buprenorphine is not outside the usual
course of professional practice. Tr. 315, 518.] Nevertheless, the
Government established by a preponderance of the evidence that, for a
number of reasons, all of the prescriptions identified in Stipulation
22, were issued outside the course of acceptable medical practice and
were not issued for a legitimate medical purpose. FF 121. With respect
to the prescriptions for Adderall that Dr. Daniels prescribed to CA,
the Government established Dr. Daniels did not document a rationale for
prescribing Adderall to CA. FF 103. In fact, during his testimony, Dr.
Daniels acknowledged that the justification was not contained in CA's
medical records. FF 108.
Accordingly, the allegations contained in Paragraph 12 of the Order
to Show Cause that Dr. Daniels issued prescriptions to Patient CA in
violation of La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5637, 5647,
5723, 5725, 5731 are SUSTAINED. Because the Government presented no
evidence that established that buprenorphine and Klonopin (clonazepam)
are respiratory depressants, and because the number of prescriptions
alleged in the Order to Show Cause to have been issued by Dr. Daniels
to CA is inconsistent with the Government's proof, the allegations
contained in Paragraphs 13-15 of the Order to Show Cause concerning CA
are NOT SUSTAINED. Nevertheless, by sustaining the allegations
contained in Paragraph 12, I have found that all of the prescriptions
that Dr. Daniels wrote for CA, identified in Stipulation 22, including
those for buprenorphine and Klonopin, were issued outside the course of
acceptable medical practice and were not issued for a legitimate
medical purpose. Furthermore, the allegation contained in ALJ-1, at 6,
para. 14.b.i., that Dr. Daniels failed to document a rationale for
prescribing Adderall to CA is not documented in CA's medical record in
violation of 21 U.S.C. 841(a) and 842(a); 21 CFR 1304.04(a); and La.
Admin. Code tit. 46, Pt. LIII, Sec. 2745(B)(1), is SUSTAINED. These
violations weigh in favor of denying Dr. Daniels' pending application
for a Certificate of Registration.
Patient MN
The Government alleged that all of the prescriptions for controlled
substances
[[Page 61657]]
that Dr. Daniels issued to Patient MN, between May 2016 and September
2017,\21\ were issued outside the usual course of professional practice
and not for legitimate medical purposes, in violation of federal and
state law. ALJ-1, at 4-5, paras. 12-13. With respect to MN, the
Government alleged that the prescriptions were issued outside the usual
course of professional practice and not for legitimate medical purposes
for the following five reasons. First, Dr. Daniels failed to conduct a
physical examination of MN, as required by La. Admin. Code tit. 48, Pt.
I, Sec. Sec. 5647, 5725. Second, Dr. Daniels failed to request MN's
medical records concerning prior substance abuse or past treatment of
substance abuse, as required by La. Admin. Code tit. 48, Pt. I,
Sec. Sec. 5647, 5725. Third, Dr. Daniels failed to obtain a report
from the Louisiana Prescription Monitoring Program for MN, as required
by La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5647, 5725. Fourth, Dr.
Daniels failed to address in MN's medical record the results of
abnormal urine drug screens, to include results that were positive for
illicit substances and negative for substances that Dr. Daniels
prescribed, as required by La. Admin. Code tit. 48, Pt. I, Sec. Sec.
5723, 5725, 5731. And fifth, Dr. Daniels failed to document in MN's
medical records his rationale for his medical treatment of MN, to
include his reason for initiating buprenorphine treatment at high
dosages, as required by La. Admin. Code tit. 48, Pt. I, Sec. Sec.
5637, 5731. ALJ-1, at 5, para. 12(a)-(e).
---------------------------------------------------------------------------
\21\ This includes all of the prescriptions listed in
Stipulation 24.
---------------------------------------------------------------------------
In addition, the Government alleged that Dr. Daniels issued
prescriptions for both buprenorphine and Klonopin to MN at the same
time. Because Dr. Daniels failed to document in the MN's medical record
a rationale for prescribing buprenorphine and clonazepam at the same
time, and because Dr. Daniels failed to document that he discussed with
MN the risks of taking these controlled substances at the same time,
the prescriptions were beneath the standard of care for the practice of
medicine in Louisiana, outside the usual course of professional
practice, and not for a legitimate medical purpose. ALJ-1, at 5-6,
paras. 13-15.
During the hearing the Government established by a preponderance of
the evidence that Dr. Daniels did not perform, or he failed to document
that he performed, a physical examination of MN. FF 128-29, 136-37. Dr.
Daniels also failed to obtain past medical records concerning MN. FF
137; Tr. 198. Although the standard of care dictated that Dr. Daniels
check MN's PMP, he did not do so. FF 26, 137. Although Dr. Daniels did
conduct some urine drug screens of MN, there is no documentation of any
action he may have taken concerning screenings that were abnormal. FF
126-27, 132-33, 135, 137. Finally, Dr. Daniels did not document within
MN's medical record a rationale for the controlled substances he
prescribed to MN. FF 128, 137. Accordingly, *[I find based on the
unrebutted, credible, expert testimony of Dr. Kennedy, and as supported
by the evidence] that the prescriptions that Dr. Daniels issued to MN
were issued outside the course of acceptable medical practice and were
not issued for a legitimate medical purpose. FF 137.
While the preponderance of the Government's evidence establishes
that the medical records Dr. Daniels maintained on MN failed to provide
an adequate justification for Klonopin, it did not establish the
dangers of prescribing buprenorphine and Klonopin together, or that Dr.
Daniels failed to caution MN of the dangers. FF 70. In fact, the
Government presented no evidence that both buprenorphine and Klonopin
are respiratory depressants. In addition, MN's medical records include
a Patient Treatment Contract that MN signed that specifically warned MN
of the dangers of taking buprenorphine and Klonopin together. FF 124.
Nevertheless, the Government established by a preponderance of the
evidence that, for a number of reasons, all of the prescriptions
identified in Stipulation 24 were issued outside the course of
acceptable medical practice and were not issued for a legitimate
medical purpose. FF 137.
Accordingly, the allegations contained in Paragraph 12 of the Order
to Show Cause that Dr. Daniels issued prescriptions to Patient MN in
violation of La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5637, 5647,
5723, 5725, 5731 are SUSTAINED. Because the Government presented no
evidence that established that both buprenorphine and Klonopin
(clonazepam) are respiratory depressants, the allegations contained in
Paragraphs 13-15 of the Order to Show Cause concerning MN are NOT
SUSTAINED. Nevertheless, by sustaining the allegations contained in
Paragraph 12, I have found that all of the prescriptions that Dr.
Daniels wrote for MN, including those for buprenorphine and Klonopin,
identified in Stipulation 24, were issued outside the course of
acceptable medical practice and were not issued for a legitimate
medical purpose. These violations weigh in favor of denying Dr.
Daniels' pending application for a Certificate of Registration.
Patient JD
The Government alleged that all of the prescriptions for controlled
substances that Dr. Daniels issued to Patient JD, between May 2016 and
September 2017,\22\ were issued outside the usual course of
professional practice and not for legitimate medical purposes, in
violation of federal and state law. ALJ-1, at 4-5, paras. 12-13. With
respect to JD, the Government alleged that the prescriptions were
issued outside the usual course of professional practice and not for
legitimate medical purposes for the following five reasons. First, Dr.
Daniels failed to conduct a physical examination of JD, as required by
La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5647, 5725. Second, Dr.
Daniels failed to request JD's medical records concerning prior
substance abuse or past treatment of substance abuse, as required by
La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5647, 5725. Third, Dr.
Daniels failed to obtain a report from the Louisiana Prescription
Monitoring Program for JD, as required by La. Admin. Code tit. 48, Pt.
I, Sec. Sec. 5647, 5725. Fourth, Dr. Daniels failed to address in JD's
medical record the results of abnormal urine drug screens, to include
results that were positive for illicit substances and negative for
substances that Dr. Daniels prescribed, as required by La. Admin. Code
tit. 48, Pt. I, Sec. Sec. 5723, 5725, 5731. And fifth, Dr. Daniels
failed to document in JD's medical records his rationale for his
medical treatment of JD, to include his reason for initiating
buprenorphine treatment at high dosages, as required by La. Admin. Code
tit. 48, Pt. I, Sec. Sec. 5637, 5731. ALJ-1, at 5, para. 12(a)-(e).
---------------------------------------------------------------------------
\22\ This includes all of the prescriptions listed in
Stipulation 27.
---------------------------------------------------------------------------
During the hearing the Government established by a preponderance of
the evidence that Dr. Daniels did not perform, or he failed to document
that he performed a physical examination of JD. FF 143. Dr. Daniels
also failed to obtain past medical records concerning JD. FF 143; Tr.
198. Although the standard of care dictated that Dr. Daniels check JD's
PMP, he did not do so. FF 26. Although Dr. Daniels conducted a urine
drug screen of JD, due to the length of time he treated JD, Dr. Daniels
should have conducted additional urine drug screens of JD. FF 145; La.
Admin. Code tit. 48, Pt. I Sec. 5723(A)(4). Finally, Dr. Daniels did
not document within JD's medical record a rationale for the controlled
[[Page 61658]]
substances he prescribed to JD. FF 177. Accordingly, I *[I find based
on the unrebutted, credible, expert testimony of Dr. Kennedy, and as
supported by the evidence] that the prescriptions that Dr. Daniels
issued to JD were issued outside the course of acceptable medical
practice and were not issued for a legitimate medical purpose. FF 147.
Of significance, Dr. Kennedy's opinion concerning the prescriptions
that Dr. Daniels issued to JD was based on the fact that there was no
documented follow-up care of JD after his initial visit with Dr.
Daniels, though JD continued to obtain prescriptions from Dr. Daniels
for more than a year after obtaining his first prescription from Dr.
Daniels. FF 147; Stip. 27.
Accordingly, the allegations contained in Paragraph 12 of the Order
to Show Cause that Dr. Daniels issued prescriptions to Patient JD in
violation of La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5637, 5647,
5723, 5725, 5731 are SUSTAINED. These violations weigh in favor of
denying Dr. Daniels' pending application for a Certificate of
Registration.
Patient SB
The Government alleged that all of the prescriptions for controlled
substances that Dr. Daniels issued to Patient SB, between May 2016 and
September 2017,\23\ were issued outside the usual course of
professional practice and not for legitimate medical purposes, in
violation of federal and state law. ALJ-1, at 4-5, paras. 12-13. With
respect to SB, the Government alleged that the prescriptions were
issued outside the usual course of professional practice and not for
legitimate medical purposes for the following five reasons. First, Dr.
Daniels failed to conduct a physical examination of SB, as required by
La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5647, 5725.
---------------------------------------------------------------------------
\23\ This includes all of the prescriptions listed in
Stipulation 29.
---------------------------------------------------------------------------
Second, Dr. Daniels failed to request SB's medical records
concerning prior substance abuse or past treatment of substance abuse,
as required by La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5647, 5725.
Third, Dr. Daniels failed to obtain a report from the Louisiana
Prescription Monitoring Program for SB, as required by La. Admin. Code
tit. 48, Pt. I, Sec. Sec. 5647, 5725. Fourth, Dr. Daniels failed to
address in SB's medical record the results of abnormal urine drug
screens, to include results that were positive for illicit substances
and negative for substances that Dr. Daniels prescribed, as required by
La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5723, 5725, 5731. And fifth,
Dr. Daniels failed to document in SB's medical records his rationale
for his medical treatment of SB, to include his reason for initiating
buprenorphine treatment at high dosages, as required by La. Admin. Code
tit. 48, Pt. I, Sec. Sec. 5637, 5731. ALJ-1, at 5, para. 12(a)-(e).
In addition, the Government alleged that Dr. Daniels issued
prescriptions for both buprenorphine and Klonopin to SB at the same
time. Because Dr. Daniels failed to document in SB's medical record a
rationale for prescribing buprenorphine and clonazepam at the same
time, and because Dr. Daniels failed to document that he discussed the
risks of taking these controlled substances at the same time with SB,
the prescriptions were beneath the standard of care for the practice of
medicine in Louisiana, outside the usual course of professional
practice, and not for a legitimate medical purpose. ALJ-1, at 5-6,
paras. 13-15.
During the hearing the Government established by a preponderance of
the evidence that Dr. Daniels did not perform, or he failed to document
that he performed, a physical examination of SB. FF 152, 156. Dr.
Daniels also failed to obtain past medical records concerning SB. FF
153; Tr. 198. Although the standard of care dictated that Dr. Daniels
check SB's PMP, he did not do so. FF 26. Although Dr. Daniels did
conduct some urine drug screens of SB, there is no documentation of any
action he may have taken concerning screenings that were abnormal. FF
154-55, 157. Finally, Dr. Daniels did not document within SB's medical
record a rationale for the controlled substances he prescribed to SB.
FF 152, 154, 157. Accordingly, *[I find based on the unrebutted,
credible, expert testimony of Dr. Kennedy, and as supported by the
evidence] that the prescriptions that Dr. Daniels issued to SB were
issued outside the course of acceptable medical practice and were not
issued for a legitimate medical purpose. FF 157.
While the preponderance of the Government's evidence establishes
that the medical records Dr. Daniels maintained on SB failed to provide
an adequate justification for Klonopin, it did not establish the
dangers of prescribing buprenorphine and Klonopin together, or that Dr.
Daniels failed to caution SB of the dangers. FF 70. In fact, the
Government presented no evidence that both buprenorphine and Klonopin
are respiratory depressants. In addition, SB's medical records include
a Patient Treatment Contract that SB signed that specifically warned SB
of the dangers of taking buprenorphine and Klonopin together. FF 149.
Nevertheless, the Government established by a preponderance of the
evidence that, for a number of reasons, all of the prescriptions
identified in Stipulation 29 were issued outside the course of
acceptable medical practice and were not issued for a legitimate
medical purpose. FF 157.
Accordingly, the allegations contained in Paragraph 12 of the Order
to Show Cause that Dr. Daniels issued prescriptions to Patient SB in
violation of La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5637, 5647,
5723, 5725, 5731 are SUSTAINED. Because the Government presented no
evidence that established that buprenorphine and Klonopin (clonazepam)
are respiratory depressants the allegations contained in Paragraphs 13-
15 of the Order to Show Cause concerning SB are NOT SUSTAINED.
Nevertheless, by sustaining the allegations contained in Paragraph 12,
I have found that all of the prescriptions that Dr. Daniels wrote for
SB, including those for buprenorphine and Klonopin, identified in
Stipulation 29, were issued outside the course of acceptable medical
practice and were not issued for a legitimate medical purpose. These
violations weigh in favor of denying Dr. Daniels' pending application
for a Certificate of Registration.
Patient CM
The Government alleged that all of the prescriptions for controlled
substances that Dr. Daniels issued to Patient CM, between May 2016 and
September 2017,\24\ were issued outside the usual course of
professional practice and not for legitimate medical purposes, in
violation of federal and state law. ALJ-1, at 4-5, paras. 12-13. With
respect to CM, the Government alleged that the prescriptions were
issued outside the usual course of professional practice and not for
legitimate medical purposes for the following five reasons. First, Dr.
Daniels failed to conduct a physical examination of CM, as required by
La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5647, 5725. Second, Dr.
Daniels failed to request CM's medical records concerning prior
substance abuse or past treatment of substance abuse, as required by
La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5647, 5725. Third, Dr.
Daniels failed to obtain a report from the Louisiana Prescription
Monitoring Program for CM, as required by La. Admin. Code tit. 48, Pt.
I, Sec. Sec. 5647, 5725. Fourth, Dr. Daniels failed to address in CM's
medical record the results of abnormal urine drug screens, to include
results that were positive for illicit substances and negative for
[[Page 61659]]
substances that Dr. Daniels prescribed, as required by La. Admin. Code
tit. 48, Pt. I, Sec. Sec. 5723, 5725, 5731. And fifth, Dr. Daniels
failed to document in CM's medical records his rationale for his
medical treatment of CM, to include his reason for initiating
buprenorphine treatment at high dosages, as required by La. Admin. Code
tit. 48, Pt. I, Sec. Sec. 5637, 5731. ALJ-1, at 5, para. 12(a)-(e).
---------------------------------------------------------------------------
\24\ This includes all of the prescriptions listed in
Stipulation 31.
---------------------------------------------------------------------------
In addition, the Government alleged that Dr. Daniels issued
prescriptions for both buprenorphine and Klonopin to CM at the same
time. Because Dr. Daniels failed to document in CM's medical record any
rationale that justified prescribing buprenorphine and clonazepam at
the same time, and because Dr. Daniels failed to document that he
discussed with CM the risks of taking these controlled substances at
the same time, the prescriptions were beneath the standard of care for
the practice of medicine in Louisiana, outside the usual course of
professional practice, and not for a legitimate medical purpose. ALJ-1,
at 5-6, paras. 13-15. During the hearing the Government established by
a preponderance of the evidence that Dr. Daniels did not perform, or he
failed to document that he performed, a physical examination of CM. FF
166-67. Dr. Daniels also failed to obtain past medical records
concerning CM. FF 168, 172; Tr. 198. Although the standard of care
dictated that Dr. Daniels check CM's PMP, he did not do so. FF 26, 172.
Although Dr. Daniels did conduct some urine drug screens of CM, there
is no documentation of any action he may have taken concerning
screenings that were abnormal. FF 158, 169, 170, 172. Finally, Dr.
Daniels did not document within CM's medical record a rationale for the
controlled substances he prescribed to CM. FF 166-67. Accordingly, *[I
find based on the unrebutted, credible, expert testimony of Dr.
Kennedy, and as supported by the evidence] that the prescriptions that
Dr. Daniels issued to CM were issued outside the course of acceptable
medical practice and were not issued for a legitimate medical purpose.
FF 172.
While the preponderance of the Government's evidence establishes
that the medical records Dr. Daniels maintained on CM failed to provide
an adequate justification for Klonopin, it did not establish the
dangers of prescribing buprenorphine and Klonopin together, or that Dr.
Daniels failed to caution CM of the dangers. FF 70. In fact, the
Government presented no evidence that both buprenorphine and Klonopin
are respiratory depressants. In addition, CM's medical records include
a Patient Treatment Contract that CM signed that specifically warned CM
of the dangers of taking buprenorphine and Klonopin together. FF 160.
Nevertheless, the Government established by a preponderance of the
evidence that, for a number of reasons, all of the prescriptions
identified in Stipulation 31 were issued outside the course of
acceptable medical practice and were not issued for a legitimate
medical purpose. FF 172.
Accordingly, the allegations contained in Paragraph 12 of the Order
to Show Cause that Dr. Daniels issued prescriptions to Patient CM in
violation of La. Admin. Code tit. 48, Pt. I, Sec. Sec. 5637, 5647,
5723, 5725, 5731 are SUSTAINED. Because the Government presented no
evidence that established that buprenorphine and Klonopin (clonazepam)
are respiratory depressants the allegations contained in Paragraphs 13-
15 of the Order to Show Cause concerning CM are NOT SUSTAINED.
Nevertheless, by sustaining the allegations contained in Paragraph 12,
I have found that all of the prescriptions that Dr. Daniels wrote for
CM, including those for buprenorphine and Klonopin, identified in
Stipulation 31, were issued outside the course of acceptable medical
practice and were not issued for a legitimate medical purpose. These
violations weigh in favor of denying Dr. Daniels' pending application
for a Certificate of Registration.
Undercover Patient TC
The Government alleged that Dr. Daniels issued a prescription to TC
for 60 tablets of 8/2 mg Suboxone on September 13, 2017. ALJ-1, at 7,
para. 18. It also alleges that this prescription was issued beneath the
standard of care for the practice of medicine in Louisiana, and outside
the usual course of professional practice in violation of 21 U.S.C.
841(a) and 842(a); 21 CFR 1304.04(a); and La. Admin. Code tit. 46, Pt.
LIII, Sec. 2745(B)(1). ALJ-1, at 7-8, paras. 18-19. The Government
alleged that the prescription was issued outside the usual course of
professional practice and was beneath the standard of care for the
following reasons. First, Dr. Daniels failed to conduct a physical
examination of TC. Second, Dr. Daniels failed to request TC's medical
records concerning prior substance abuse or past treatment of substance
abuse. Third, Dr. Daniels failed to obtain a PMP report concerning TC.
Fourth, Dr. Daniels prescribed a high dose of Suboxone to TC who
presented as an opioid na[iuml]ve patient. Fifth, Dr. Daniels' medical
record for TC failed to provide an adequate evaluation of TC's
condition or a treatment plan. ALJ-1, at 7-8, para. 19.
During the hearing the Government established by a preponderance of
the evidence that Dr. Daniels did not perform, or he failed to document
that he performed, a physical examination of TC. FF 175, 186, 188, 198,
200. Dr. Daniels also failed to obtain past medical records concerning
TC. FF 199, 200. Contrary to the Government's allegation, Dr. Daniels
did obtain a PMP report concerning TC. FF 26. The results of the PMP
report, however, are not contained in TC's medical record. FF 187. Dr.
Daniels conducted a urine drug screen of TC, which did not reveal any
controlled substances in his body. FF 175-76. During TC's first
appointment with Dr. Daniels, he prescribed 60 tablets of 8/2 mg of
Suboxone, one tablet to be taken twice a day. FF 194. Because TC was an
opioid na[iuml]ve patient, had TC taken the Suboxone as it was
prescribed, *[Dr. Kennedy testified that] he could have become quite
sick. FF 197. Finally, Dr. Daniels' treatment notes for TC do not
document his rationale for the manner in which he initiated his
treatment of TC. FF 195. Therefore, I *[I find based on the unrebutted,
credible, expert testimony of Dr. Kennedy, and as supported by the
evidence] that the prescription that Dr. Daniels issued to TC was
issued outside the standard of care. FF 200-01.
Accordingly, the allegations contained in Paragraph 18-19 of the
Order to Show Cause that Dr. Daniels issued prescriptions to Patient TC
in violation of 21 U.S.C. 841(a) and 842(a); 21 CFR 1304.04(a); and La.
Admin. Code tit. 46, Pt. LIII, Sec. 2745(B)(1) are SUSTAINED. These
violations weigh in favor of denying Dr. Daniels' pending application
for a Certificate of Registration.
Pain Management Patient JW
Lastly, the Government alleged that Dr. Daniels' issuance of
controlled substance prescriptions for pain management to JW exhibited
several deficiencies, to include: The lack of a doctor-patient
relationship; therapeutic duplication; failure to justify co-
prescribing; and failure to justify increasing his methadone dosage.
ALJ-1, at 6-7, paras. 16-17. At the hearing, however, the Government
stated that with respect to Patient JW, it was only concerned with the
prescriptions that Dr. Daniels wrote to JW for OxyContin.\25\ Tr. 547-
48.
---------------------------------------------------------------------------
\25\ Testimony in support of the Government's position is
consistent with the summarization of Dr. Kennedy's testimony
contained in the Government's Prehearing Statement, ALJ-5, at 25-26,
and the Government's Supplemental Prehearing Statement. ALJ-9, at 3-
4.
---------------------------------------------------------------------------
[[Page 61660]]
The Government presented evidence that OxyContin is a long-lasting
continuous release medication indicated for patients who need around-
the-clock pain management. FF 213, 268. It is not appropriate to
prescribe OxyContin to be taken ``as needed.'' Id. It is also not
appropriate to prescribe OxyContin for break-through pain. Id. In fact,
taking OxyContin for break-through pain or on an ``as needed'' basis
could be dangerous. Id.
Dr. Daniels issued seven OxyContin prescriptions to JW. Stip. 35.
The prescription that Dr. Daniels issued to JW on March 14, 2014, for
OxyContin, was issued with instructions to take them as the medications
are intended to be used, one tablet every 12 hours. FF 214. The
prescriptions that Dr. Daniels issued to JW on March 28, 2014, April
11, 2014, April 25, 2014, May 9, 2014, May 16, 2014, and January 6,
2017, for OxyContin were issued with instructions that the OxyContin
was to be taken every four to six hours for severe breakthrough pain.
FF 215. Dr. Daniels acknowledges when he wrote instructions for JW to
take the OxyContin every four to six hours, he did so by mistake. Tr.
211. Nevertheless, he did so five times in 2014, and once again in
2017. FF 215; Stip. 35. Even though Dr. Daniels acknowledges it was a
mistake to issue the OxyContin in the manner that he did, \*Q\ [``just
because misconduct is unintentional, innocent, or devoid of improper
motive, [it] does not preclude revocation or denial. Careless or
negligent handling of controlled substances creates the opportunity for
diversion and [can] justify the revocation of an existing registration
. . .'' Bobby D. Reynolds, N.P., Tina L. Killebrew, N.P., & David R.
Stout, N.P., 80 FR 28,643, 28,662 (2015) (quoting Paul J. Caragine, Jr.
63 FR 51,592, 51,601 (1998).]
---------------------------------------------------------------------------
\*Q\ Altered for clarity.
---------------------------------------------------------------------------
In light of the six separate prescriptions that Dr. Daniels wrote
to JW for OxyContin, with instructions to take the medication once
every four to six hours, *[I find based on the unrebutted, credible
expert testimony of Dr. Kennedy, and as supported by the evidence] that
these six prescriptions were not issued within the usual course of
professional practice and were not issued for a legitimate medical
purpose. Accordingly, the allegation that Dr. Daniels issued these six
prescriptions beneath the standard of care in Louisiana and outside the
usual course of professional practice in violation of Federal and State
laws and regulations is SUSTAINED. Because the Government did not
present evidence to support the specific allegations contained in
Paragraphs 16-17 of the Order to Show Cause, those allegations are NOT
SUSTAINED. The sustained allegation, however, weighs in favor of
denying Dr. Daniels' current application.
Discussion and Conclusions of Law \*R\
---------------------------------------------------------------------------
\*R\ I am omitting the RD's discussion of material falsification
because, as noted above, the Government has explicitly abandoned
that allegation. See supra Analysis.III.
---------------------------------------------------------------------------
Based upon my review of the evidence in this case, I have sustained
the allegations that all of the prescriptions that Dr. Daniels issued
to patients AK, CA, MN, JD, SB, CM, and TC, and six of the
prescriptions Dr. Daniels wrote to patient JW, were issued outside the
usual course of professional practice, and therefore were not issued
for legitimate medical purposes. While these prescriptions were issued
to only eight patients, Dr. Daniels wrote over 140 prescriptions to
these patients during a 17-month period. My independent review of the
medical records that Dr. Daniels maintained on all of these patients,
except for JW, allows me to adopt fully Dr. Kennedy's testimony
concerning the adequacy of those records. *[Based on Dr. Kennedy's
expert testimony and the record evidence in this case] where there is a
consistent absence of pertinent information in a patient's medical
records, such as: PMP reports; a credible physical examination; past
medical records; resolution of abnormal drug screens, the records reach
a point where it is not possible to say that the treatment has been
within the scope of acceptable medical practice or that the
prescriptions are legitimate. FF 50.
Issues Raised by the Respondent
In explaining this Recommended Decision, it is appropriate to
address two issues that Dr. Daniels raised both at the hearing and in
his Post-Hearing Brief. In that Brief, Dr. Daniels repeatedly asserts
that ``the Government presented no evidence that [the patient] was
obtaining the same or similar prescriptions from multiple sources or
obtaining those medications for illicit purposes.'' ALJ-19, at 11, 13,
15, 16, 17, 19. In addition, in his Brief, Dr. Daniels notes that Dr.
Kennedy's opinions were based upon his review of a few charts and that
``[t]his miniscule sampling of six (6) charts hand picked by DEA should
raise serious questions as to the legitimacy of any `pattern' that may
be deduced therefrom.'' Id. at 4-5.
Meaning of Diversion
Some of Dr. Daniels' arguments in his Brief reflect a
misunderstanding of the DEA's definition of diversion. Dr. Daniels
essentially contends that the Government did not present evidence of
diversion. ALJ-19, at 11, 13, 15, 16, 17, 19. One of the CSA's primary
purposes is to protect against ``the diversion of drugs from legitimate
channels to illegitimate channels.'' United States v. Moore, 423 U.S.
122, 135 (1975). To ensure that controlled substances remain in
legitimate channels, the CSA creates a ``closed regulatory'' scheme.
Gonzales v. Oregon, 546 U.S. 243, 250 (2006). The DEA has explained
that diversion occurs whenever controlled substances leave ``the closed
system of distribution established by the CSA . . . .'' Roy S.
Schwartz, 79 FR 34,360, 34,363 (2014). Thus, ``when prescriptions are
issued outside of the usual course of professional practice and lack a
legitimate medical purpose, . . . the drugs are deemed to have been
diverted.'' George Mathew, M.D., 75 FR 66,138, 66,148 (2010).
Contrary to Dr. Daniels' suggestion, the Government does not need
to prove that a patient was seeking medications from multiple sources
or was abusing controlled substances for a finding of diversion.
Rather, when a practitioner violates the CSA's prescription
requirement, set forth in 21 CFR 1306.04(a), by issuing a prescription
without a legitimate medical purpose and outside the course of
professional practice, the DEA [essentially] considers the prescription
to have been diverted. Mathew, 75 FR at 66,146. *[Omitted for brevity.]
Although the DEA has occasionally considered such evidence,\26\ the
Government is not obligated to show, as the Respondent would suggest,
that a patient died, overdosed, or illegally disposed of prescription
medication.
[[Page 61661]]
Waiting for a controlled substance to be found coursing through a
person's bloodstream before holding the registrant accountable is
wholly at odds with the DEA's responsibility to protect the public
interest under 21 U.S.C. 823(f). For these reasons, I reject Dr.
Daniels' suggestion that the Government has not provided enough
evidence to justify denying his application.
---------------------------------------------------------------------------
\26\ See, e.g. Lawrence E. Stewart, M.D., 81 FR 54,822, 54,832,
54847 (2016) (discussing registrant's treatment of patient who
overdosed on prescriptions issued by the registrant); Ibem R.
Borges, M.D., 81 FR 23,521, 23,523 (2016) (suggesting that
registrant's prescribing which caused overdose deaths could result
in ``total revocation based on public interest grounds'', but
deciding the case differently in accord with the allegations
premised on lack of state authority); Samuel Mintlow, M.D., 80 FR
3630, 3646 (2015) (noting expert testimony that respondent
prescribed at such high dosages as to risk ```acute narcotic
overdose'''); Richard D. Vitalis, D.O., 79 FR 68,701, 68,701, 68,707
(2014) (considering evidence that respondent's patient died of
overdose attributable to respondent's over-prescribing); Darryl J.
Mohr, M.D., 77 FR 34,998, 35,010-11 (2012) (discussing three
patients who died due to registrant's prescribing).
---------------------------------------------------------------------------
Size of the Sample
The DEA has made it clear that the Government may proceed to
hearing with only a few allegations. ``[W]here the Government has
seized files, it can review them and choose to present at the hearing
only those files which evidence a practitioner's most egregious acts.''
Jacobo Dreszer, M.D., 76 FR 19,386, 19,387 (2011); see also Cleveland
J. Enmon, Jr., M.D., 77 FR 57,116, 57,126 (2012) (rejecting argument
that the respondent's practice could not be judged based upon a review
of only 19 files). Furthermore, the DEA has held that ``even though the
patients at issue are only a small portion of [a] [r]espondent's
patient population, his prescribing of controlled substances to these
individuals raises serious concerns regarding his ability to
responsibly handle controlled substances in the future.'' Paul J.
Caragine, Jr., 63 FR 51,592, 51,600 (1998).
With respect to consideration given to a practitioner's positive
experience in prescribing, the DEA assumes that all of the
prescriptions a registrant has issued were issued lawfully, except for
those prescriptions that the Government alleges were issued unlawfully.
Wesley Pope, M.D., 82 FR 14944, 14,984 (2017). *[The violations I have
found demonstrate that Dr. Daniels repeatedly violated the applicable
standard of care and state law and that his conduct was not an isolated
occurrence, but occurred with multiple patients and in multiple
contexts over a period of years. See Kaniz Khan-Jaffery M.D., 85 FR
45,667, 45,685 (2020).]
Prima Facie Showing and Balancing
The Government can meet its burden for revocation or denial by
proving ``only a few instances of illegal prescribing.'' Jayam Krishna-
Iyer, M.D., 74 FR 459, 464 (2009). DEA precedent asserts in no
uncertain terms that the public interest inquiry is not a numbers game
in which the Government must prove a certain number of violations.\27\
For instance, in Alan H. Olefsky, M.D., the DEA imposed a revocation
based on evidence of only two fraudulent prescriptions.\28\ 57 FR 928,
928-29 (1992). In James Clopton, M.D., the DEA denied the respondent's
application on evidence that he wrote only four unlawful prescriptions.
79 FR 2475, 2475-77 (2014). Although the record contained additional
evidence of recordkeeping violations, the Administrator viewed the
unlawful prescriptions as ``reason alone to deny [respondent's]
application.'' Id. at 2478.
---------------------------------------------------------------------------
\27\ See Lawrence E. Stewart, M.D., 81 FR 54,822, 54,848 (2016)
(stressing that even though the respondent committed ``far more than
one'' violation, proving only one instance of knowing diversion is
enough to make a prima facie case for revocation); T.J. McNichol,
M.D., 77 FR 57,133, 57,145 (2012) (``[P]roof of a single act of
intentional or knowing diversion is sufficient to satisfy the
Government's prima facie burden . . . .''); Jayam Krishna-Iyer,
M.D., 74 FR 459, 462 (2009) (emphasizing that ``what matters is the
seriousness'' of the misconduct rather than a tallying up of
violations).
\28\ Additionally, in the Olefsky case, the registrant argued in
his exceptions to the ALJ's recommended ruling that suspension of
his license was disproportionate to the proven misconduct, which was
limited to two fraudulent prescriptions presented on one occasion.
57 FR at 929. The Administrator rejected the registrant's exception
and ruled that ``[r]evocation [was] an acceptable remedy.'' Id.
---------------------------------------------------------------------------
Additionally, in Jose Gonzalo Zavaleta, M.D., the Administrator
denied an application where the evidence showed a total of six unlawful
prescriptions written on four occasions. 77 FR 64,128, 64,129-30
(2012). In Gabriel Sanchez, M.D., the DEA based revocation on a total
of seven prescriptions issued to two undercover officers who each had
one appointment with the respondent. 78 FR 59,060, 59,060-61 (2013). In
Clair L. Pettinger, M.D., the Administrator revoked the registrant's
COR based on evidence that he issued nine prescriptions in violation of
21 CFR 1306.04(a), and authorized one prescription while his COR was
suspended. 78 FR at 61,600. In MacKay v. DEA, the Tenth Circuit
affirmed revocation based on 14 unlawful prescriptions. 664 F.3d 808,
811-14, 822 (10th Cir. 2011). In Wesley Pope, M.D., the Administrator
deemed denial the appropriate sanction where the Government proved
violations stemming from 19 unlawful prescriptions. 82 FR at 14,985. In
Lynch v. DEA, the Eleventh Circuit upheld revocation based on evidence
of 19 unlawful prescriptions. 480 Fed. App'x 946, 948 (11th Cir. 2012)
(unpublished) (per curium) (reviewing Ronald Lynch, M.D., 75 FR 78,745
(2010)).
These cases represent only a sampling of DEA final orders, but they
illustrate the point that the Administrator has imposed the DEA's
harshest sanction--revocation or denial--based on evidence of only 2 to
19 unlawful prescriptions. The present case involves over 140
prescriptions.\*S\
---------------------------------------------------------------------------
\*S\ Omitted for brevity.
---------------------------------------------------------------------------
Summary of Factors One, Two and Four
Specifically, the Government bases its case on evidence that
implicates Factors Two and Four of 21 U.S.C. 823(f). The Government did
not advance any evidence under Factors One, Three, and Five. As the DEA
has explained, ``findings under a single factor are sufficient to
support the revocation or suspension of a registration.'' Syed Jawed
Akhtar-Zaidi, M.D., 80 FR 42,962, 42,967 (2015). While I consider all
the factors, the central inquiry ``focuses on protecting the public
interest,'' and misconduct relevant to only one factor can be
sufficient to support a finding that a practitioner's continued
registration threatens the public interest. Id.
[I have found that there is substantial evidence in the record
before me that Dr. Daniels issued controlled substance prescriptions to
eight individuals, including for Schedule II controlled substances, for
no legitimate medical purpose and outside the usual course of
professional practice, that Respondent failed to maintain medical
records pertaining to his prescribing of controlled substances in
violation of state law and the state standard of care. Accordingly, I
conclude that it would be ``inconsistent with the public interest'' for
Dr. Daniels to be granted a registration due to the substantial
evidence of his violations of the CSA and its implementing regulations
and state law. 21 U.S.C. 823(f).]
Based on the evidence in this case, *[I have found that Factor One
weighs slightly] against denying Dr. Daniels' application. Factors Two
and Four, however, weigh for denying his application. Considering the
public interest factors in their totality, I find that the Government
has made a prima facie case showing that Dr. Daniels' registration
would be inconsistent with the public interest.
*T Sanction
---------------------------------------------------------------------------
\*T\ I am replacing portions of the Sanction section in the RD
with preferred language regarding prior Agency decisions; however,
the substance is primarily the same. I will also address Dr.
Daniels' Exceptions herein as noted.
---------------------------------------------------------------------------
Where, as here, the Government has met its prima facie burden of
showing that Dr. Daniels' application for a registration is
inconsistent with the public interest due to his violations of federal
and state law pertaining to controlled substance prescribing, the
burden shifts to the Dr. Daniels to show why he can be entrusted with a
new
[[Page 61662]]
registration. Garrett Howard Smith, M.D., 83 FR 18,882, 18,910 (2018)
(collecting cases).
The CSA authorizes the Attorney General to ``promulgate and enforce
any rules, regulations, and procedures which he may deem necessary and
appropriate for the efficient execution of his functions under this
subchapter.'' 21 U.S.C. 871(b). This authority specifically relates
``to `registration' and `control,' and `for the efficient execution of
his functions' under the statute.'' Gonzales v. Oregon, 546 U.S. at
259. A clear purpose of this authority is to ``bar[ ] doctors from
using their prescription-writing powers as a means to engage in illicit
drug dealing and trafficking.'' Id. at 270. In efficiently executing
the revocation and suspension authority delegated to me under the CSA
for the aforementioned purposes, I review the evidence and argument
Respondent submitted to determine whether or not he has presented
``sufficient mitigating evidence to assure the Administrator that [she]
can be trusted with the responsibility carried by such a
registration.'' Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 (2007)
(quoting Leo R. Miller, M.D., 53 FR 21,931, 21,932 (1988)). ``
`Moreover, because ``past performance is the best predictor of future
performance,'' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.
1995), [the Agency] has repeatedly held that where a registrant has
committed acts inconsistent with the public interest, the registrant
must accept responsibility for [the registrant's] actions and
demonstrate that [registrant] will not engage in future misconduct.' ''
Jayam Krishna-Iyer, 74 FR at 463 (quoting Medicine Shoppe, 73 FR 364,
387 (2008)); see also Jackson, 72 FR at 23,853; John H. Kennnedy, M.D.,
71 FR 35,705, 35,709 (2006); Prince George Daniels, D.D.S., 60 FR
62,884, 62,887 (1995). The issue of trust is necessarily a fact-
dependent determination based on the circumstances presented by the
individual respondent; therefore, the Agency looks at factors, such as
the acceptance of responsibility and the credibility of that acceptance
as it relates to the probability of repeat violations or behavior and
the nature of the misconduct that forms the basis for sanction, while
also considering the Agency's interest in deterring similar acts. See
Arvinder Singh, M.D., 81 FR 8247, 8248 (2016).]
Dr. Daniels 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 15,227,
15,228 (2003). To accept responsibility, a respondent must show ``true
remorse'' for wrongful conduct. Michael S. Moore, M.D., 76 FR 45,867,
45,877 (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 26,208, 26,211 (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
38,363, 38,364 (2013).
Notwithstanding the fact that the Government has made a prima facie
case for sanction, imposing a sanction is a matter of discretion. See
21 U.S.C. 824(a) (``A registration . . . may be suspended or revoked by
the Attorney General . . . .'') (emphasis added); Martha Hernandez,
M.D., 62 FR 61,145, 61,147 (1997) (referring to Administrator's
authority to exercise discretion in issuing the appropriate
sanction).\*T\
---------------------------------------------------------------------------
\*T\ Omitted for brevity.
---------------------------------------------------------------------------
\*U\ [Respondent argues in his Exceptions that he ``acknowledged
responsibility throughout the proceedings.'' Resp Exceptions, at 2. In
support of this statement, he cites to the record \*V\ where he
``agreed with DEA's expert, Dr. Kennedy's testimony about the
importance of physical examinations.'' Id. (citing Tr. 492). Although I
credit Dr. Daniels for agreeing with the Government's expert regarding
the standard of care, he then went on to state that in situations where
there is limited staff and when other patients are waiting, a doctor
sometimes needs to make a ``judgment call'' about examining the
patient, and not inconveniencing the waiting patients. Tr. 493. In
those situations, in Dr. Daniels' view, the doctor performs ``enough of
an exam'' in order to ``move forward'' with the patient, allowing the
doctor time to see other patients. Tr. 493. After agreeing with the
Government's expert that ``a physical examination is certainly very
important,'' Tr. 492, which in this case is required by state law, Dr.
Daniels then proceeded to try to minimize his misconduct in not
conducting the required, self-described ``very important'' physical
examinations by implying that a practitioner could ignore a legal
requirement for one patient in order to not ``inconvenience other
patients who may be waiting.'' Tr. 493. Not only do I find this
statement to minimize any acceptance of responsibility, I find it to be
in blatant disregard of the ``importan[ce]'' of a physical
examination.\*W\ See Stein, 84 FR at 46,972 (finding that a
registrant's attempts to minimize his misconduct weigh against a
finding of unequivocal acceptance of responsibility); see also Ronald
Lynch, M.D., 75 FR 78,745, 78,754 (2010) (Respondent did not accept
responsibility noting that he ``repeatedly attempted to minimize his
[egregious] misconduct''); Michael White, M.D., 79 FR 62,957, 62,967
(2014) (finding that Respondent's ``acceptance of responsibility was
tenuous at best'' and that he ``minimized the severity of his
misconduct by suggesting that he thinks the requirements for
prescribing Phentermine are too strict.''). It does not instill
confidence in me that Dr. Daniels could be entrusted with a
registration when he could so casually dismiss a legal requirement
based on a perception of inconvenience to other patients.
---------------------------------------------------------------------------
\*U\ The ALJ found that thee was ``no evidence that Dr. Daniels
has accepted any responsibility for the 141 prescriptions he issued
to eight different patients. The closest he came to accepting
responsibility was an acknowledgement that `some of the records fell
short.' Tr. 570.'' RD, at 98. Although I agree with the ALJ that
ultimately Respondent did not adequately accept responsibility,
Respondent has taken exception to this finding and therefore I am
evaluating Respondent's additional citations to the record in
support of his statement that he ``acknowledged responsibility
throughout the proceedings.'' Resp Exceptions, at 2.
\*V\ Dr. Daniels also cited to page 11 of the Transcript to
support that he had ``acknowledged that he did not always document
the justification for the prescriptions that he wrote,'' but I could
not find what he was referencing. Resp Exceptions, at 2.
\*W\ I also found above that Dr. Daniels misstated his
conversations with TC regarding alcohol use that he had counseled TC
not to drink alcohol, TR. 555, despite the fact that the record
directly contradicts this statement. Again, I find that this is an
attempt to minimize the egregiousness of his interaction with TC and
weighs against a finding of acceptance of responsibility.
---------------------------------------------------------------------------
Further, when explaining the reasons for his Consent Agreement with
the Medical Board, Dr. Daniels stated that the Board ``felt like that
[he], as an individual practitioner, trusted people too much, that [he]
gave too much confidence in the people when [he] would ask them to do
things or expect them to bring things to [him].'' Tr. 561. If the
violations before the Medical Board were similar to the ones before me,
as the record suggests, I find this to be an outrageously minimized
characterization of his wrongdoing. Dr. Daniels subtly passes the blame
onto his co-workers at the clinic and characterizes himself as too
trusting. Based on this statement, it does not appear to me that Dr.
Daniels
[[Page 61663]]
comprehends the full extent of his wrongdoing in order for me to find
acceptance of responsibility. Furthermore, it demonstrates that, thus
far, he has not learned from his mistakes in order to be deterred from
repeating them.]
[The ALJ found that the] closest [Dr. Daniels] came to accepting
responsibility was an acknowledgment that ``some of the records fell
short.'' Tr. 570. Then in his Brief, Dr. Daniels admits that ``the
documentation of the patient files needed much improvement.'' ALJ-19,
at 22. He adds, however, that ``poor documentation is not evidence that
the prescriptions were written for illegitimate purposes.'' \29\ Id.
*[Again, Dr. Daniels minimizes his misconduct, and additionally, this
statement critically understates the egregiousness of his found
wrongdoing, which is more serious than poor documentation, as explained
below. I agree with the ALJ that these admissions do not amount to
acceptance of responsibility. See Carol Hippenmeyer, M.D., 86 FR
33,748, 33,773 (2021) (``Respondent's admission that she failed to
maintain adequate medical records was not a sufficient acceptance of
responsibility.''); see also Kaniz F. Khan-Jaffery, M.D., 85 FR 45,667,
45,686 (2020) (``Respondent's assertion that she `should have written
more' barely scrapes the surface of these issues, and seems to be an
attempt to minimize the severity of her actions by so lightly
characterizing a substantive documentation requirement.'')
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\29\ This statement demonstrates Dr. Daniels' lack of
understanding of the need to maintain adequate medical records.
First, the State of Louisiana requires it. La. Admin. Code tit. 46,
Pt. LIII, Sec. 6921(B)(6); La. Admin. Code tit. 48, Pt. I, Sec.
5637 (A)-(B). Second, when a practitioner fails to maintain adequate
medical records that practitioner is not acting within the usual
course of professional practice. Third, as noted earlier in this
Recommended Decision, a controlled substance prescription is valid
only when it is ``issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his
professional practice.'' 21 CFR 1306.04(a) (emphasis added).
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I further find that the additional cites to the transcript that Dr.
Daniels references in his Exceptions, also do not amount to adequate
acceptance of responsibility. See Hoxie v. Drug Enf't Admin., 419 F.3d
at 483 (``The DEA properly considers the candor of the physician'' and
``admitting fault'' is an ``important factor[ ] in determining whether
the physician's registration should be revoked''). Although Dr. Daniels
admitted that he made a ``mistake'' on the instructions for JW's
OxyContin prescriptions, Tr. 549, he also stated that he thought JW
``was taking it correctly,'' Tr. 550, based on the fact that he did not
run out between visits; however, Dr. Daniels never acknowledged the
severity of the consequences that could have occurred had JW taken them
pursuant to his mistaken instructions. Tr. 273 (Dr. Kennedy's testimony
that taking OxyContin pursuant to Dr. Daniels instructions would be
``very dangerous'' and that the controlled substance had a ``black
box'' warning regarding those dangers.)
Further, even if Respondent's acceptance of responsibility for his
wrongdoing had been sufficient such that I would reach the matter of
remedial measures, Respondent has not offered adequate remedial
measures to assure me that I can entrust him with a registration. See
Carol Hippenmeyer, M.D., 86 FR 33,748, 33,773 (2021). Dr. Daniels
stated that as a result of the Consent Order, he took ``a controlled
substance prescribing course in Cleveland, Ohio at Case Western Reserve
University, ethics, boundaries, those were recommended. I did complete
those,'' Tr. 562, however, he did not submit any documentation
regarding these courses, and I do not find that he presented any
meaningful evidence regarding actual or proposed remedial measures,
other than the possibility of limiting his registration to Schedule V
controlled substances. See infra n.30.]
``[E]ven though the Government has made out a prima facie case''
for sanction, the registrant remains free to argue that ``his conduct
was not so egregious as to warrant revocation.'' Jacobo Dreszer, M.D.,
76 FR 19,386, 19,387-88 (2011). ``In short, this is not a contest in
which score is kept; the Agency is not required to mechanically count
up the factors and determine how many favor the Government and how many
favor the registrant. Rather, it is an inquiry which focuses on
protecting the public interest; what matters is the seriousness of the
registrant's misconduct.'' Richard J. Settles, D.O., 81 FR 64,940,
64,945 n.17 (2016) (quoting Jayam Krishna-Iyer, M.D., 74 FR 459, 462
(2009)).
\*X\ [ ] The Administrator has noted that ``there may be some
instances in which the proven misconduct is not so egregious as to
warrant revocation . . . and a respondent, while offering a less than
unequivocal acceptance of responsibility[,] nonetheless offers
sufficient evidence of adequate remedial measures to rebut the
Government's proposed sanction.'' Roberto Zayas, M.D., 82 FR 21410,
21429 (2017). This is not such an instance.
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\*X\ Omitted for brevity.
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*[In this case, the ALJ found, and I agree, that there was
substantial record evidence that over 140 prescriptions issued by
Respondent were issued outside the usual course of professional
practice and beneath the standard of care. Specifically, the
Government's credible expert witness testified that certain conduct was
particularly egregious. For example, he described one of the urine drug
screens for Patient MN, which was positive for ecstasy, as ``wildly
abnormal,'' Tr. 225, and he stated that ``to have a drug screen like
this, and to make absolutely no comment in the medical record, did not
make any comment with addressing the patient about it, or what you plan
to do about this, is in my view, inexcusable.'' Tr. 226. Further, Dr.
Kennedy testified regarding Patient SB's records that ``there was, in
essence, in [his] view, no medical care here, simply the provision of
scheduled prescriptions.'' Tr. 244. Dr. Kennedy also testified several
times that there was no medical diagnosis at all in the records to
support controlled substance prescriptions. See e.g., Tr. 396-97; GE-6,
at 1-49 (no justification for Klonopin to AK); Tr. 322, 377 (no
justification for Adderall to CA). Dr. Daniels prescribed controlled
substances to AK and CA without maintaining any records on his visits
with them, if they occurred. He repeatedly failed to conduct physical
examinations, address urine drug screens, and counsel patients about
risks. The Government's expert, Dr. Kennedy, testified that in
addiction treatment, these accountability measures were of particular
importance, ``not because we're counting on the patients being
compliant, it's because of the likelihood of patients being
noncompliant.'' Tr. 299. Although I find Dr. Daniels to be sincere and
laudable in his wish to help an underserved population, it does not
excuse his repeated failure to follow the laws designed to keep these
patients safe.]
In addition to the severity of the proven misconduct, DEA also
considers its interest in specific and general deterrence when
determining the appropriate sanction. Daniel A. Glick, D.D.S., 80 FR
74,800, 74,810 (2015); David A. Ruben, M.D., 78 FR 38,363, 38,364
(2013). Deterrence is an appropriate consideration, and is consistent
with the CSA's purpose of protecting the public interest and the DEA's
broad grant of authority to consider acts inconsistent with the public
interest. Southwood Pharm., Inc., 72 FR 36,487, 36,504 (2007). General
deterrence concerns DEA's
[[Page 61664]]
responsibility to deter conduct similar to the proven allegations
against the respondent for the protection of the public at large.
Glick, 80 FR at 74,810. 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.
Having considered all of the evidence, I find that Dr. Daniels'
violations of federal and state laws and regulations concerning the
prescribing of controlled substances were egregious. I concur with Dr.
Kennedy's assessment of the adequacy of Dr. Daniels' medical records
concerning patients, AK, CA, MN, JD, SB, CM, and TC, not only because
his expert testimony went unrebutted, but also *[because a review of
the sparse medical records demonstrates obvious deficiencies, to
include no records at all related to some of the prescriptions]. I also
find Dr. Daniels' statement that poor documentation is not evidence of
illegitimate prescriptions to be a further indication demonstrating his
continuing lack of understanding of the responsibilities of an
individual who holds a Certificate of Registration.
Further, I find it appropriate to consider both general and
specific deterrence. In light of the extremely poor quality of the
medical records that Dr. Daniels maintained, which were non-existent in
some instances, and the fact that he continues to attempt to portray
his records as adequate to support his prescriptions for controlled
substances, to include Schedule II and III substances, granting his
application would send the wrong message to other medical
practitioners. In addition, granting a Certificate of Registration to
Dr. Daniels, absent his acceptance of responsibility and an
acknowledgement of the responsibilities attached to a registration,
would totally defeat the concept of specific deterrence.
* [Here, there is insufficient evidence in the record to
demonstrate that Respondent can be entrusted with a registration. See
Leo R. Miller, M.D., 53 FR 21,931, 21,932 (1988) (describing revocation
as a remedial measure ``based upon the public interest and the
necessity to protect the public from individuals who have misused
controlled substances or their DEA Certificate of Registration and who
have not presented sufficient mitigating evidence to assure the
Administrator that they can be trusted with the responsibility carried
by such a registration.''). Due to the extent and egregiousness of Dr.
Daniels' misconduct, his failure to adequately accept responsibility,
Dr. Daniels has not given me reassurance that he can be entrusted with
a registration.]
Therefore, I find that granting a Certificate of Registration to
Dr. Daniels, at this time, would be inconsistent with the public
interest.\30\
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\30\ I have given consideration to recommending that Dr.
Daniels' application be granted, but limited to Schedule V, to
accommodate his current medical practice. See supra FF 8. While Dr.
Daniels' continued efforts to provide medical assistance to
underserved communities is commendable, there is insufficient
evidence in the Administrative Record to support such a
recommendation. *[I agree, and I disagree with Respondent's
Exception stating that ``limitation to Schedule V would protect the
public interest since he will not be practicing in high risk
areas.'' Resp Exceptions, at 3. Respondent has not provided me with
adequate reasons to entrust him with a controlled substance
registration at any schedule.]
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Recommendation
Accordingly, I Recommend that Dr. Larry C. Daniels' application for
a DEA Certificate of Registration, Control Number W18024499C, be
Denied.
Dated: January 24, 2020.
Charles Wm. Dorman,
U.S. Administrative Law Judge.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(f), I hereby deny the pending application for a Certificate
of Registration, Control Number W18024499C, submitted by Larry C.
Daniels, M.D., as well as any other pending application of Larry C.
Daniels, M.D. for additional registration in Louisiana. This Order is
effective December 6, 2021.
Anne Milgram,
Administrator.
[FR Doc. 2021-24206 Filed 11-4-21; 8:45 am]
BILLING CODE 4410-09-P