Morris W. Cochran, M.D.: Revocation of Registration, 17505-17522 [2012-7107]
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Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices
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Washington, DC 20530.
Jerri Murray,
Department Clearance Officer, PRA, United
States Department of Justice.
[FR Doc. 2012–7190 Filed 3–23–12; 8:45 am]
BILLING CODE 4410–FY–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11–1]
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Morris W. Cochran, M.D.: Revocation
of Registration
On September 22, 2010, I, the thenDeputy Administrator of the Drug
Enforcement Administration, issued an
Order to Show Cause and Immediate
Suspension of Registration to Morris W.
Cochran, M.D. (Respondent), of
Birmingham, Alabama. The Order
proposed the revocation of
Respondent’s DEA Certificate of
Registration BC1701184, and the denial
of any pending applications to renew or
modify his registration, on the ground
that his ‘‘continued registration is
inconsistent with the public interest.’’
21 U.S.C. 824(a)(4).
More specifically, the Order alleged
that while Respondent is authorized to
prescribe Suboxone and Subutex ‘‘for
maintenance or detoxification treatment
pursuant to 21 U.S.C. 823(g)(2) under
DEA identification number
XC1701184,’’ he had ‘‘prescribed
methadone,’’ a schedule II controlled
substance, ‘‘to patients for the purpose
of drug addiction treatment’’ without
the registration required under 21 U.S.C.
823(g)(1). ALJ Ex.1, at 1–2.
Next, the Order alleged that
Respondent had prescribed both
methadone and Suboxone, the latter
being a Schedule III controlled
substance, to numerous patients whose
charts show that he ‘‘did not obtain a
prior medical history,’’ that he ‘‘did not
perform an initial physical exam,’’ that
he ‘‘established little or no basis for the
diagnoses,’’ and that he ‘‘offered no
other treatment other than prescribing
controlled substances.’’ Id. at 2. The
Order further alleged that ‘‘[s]uch
prescribing was not for a legitimate
medical purpose in the usual course of
professional practice in violation of 21
CFR 1306.04(a), and in violation of
Alabama Administrative Code 540–X–
11)(1), which requires that a physician
personally obtain an appropriate
history, perform a physical exam, make
a diagnosis and formulate a therapeutic
plan before prescribing drugs to a
patient.’’ Id. Finally, the Order alleged
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that Respondent had ‘‘continue to
prescribe alprazolam, a schedule IV
controlled substances depressant, to a
patient after [the] patient file explicitly
noted that the patient abused this drug.’’
Id.
Based on the above, I concluded that
Respondent’s continued registration
during the pendency of the proceeding
‘‘constitute[d] an imminent danger to
the public health and safety.’’ Id. I
therefore invoked my authority under
21 U.S.C. 824(d) and immediately
suspended Respondent’s registration.
Respondent requested a hearing on
the allegations and the matter was
placed on the docket of the Agency’s
Administrative Law Judges (ALJs). On
November 2–4, 2010, an ALJ conducted
a hearing in Birmingham, Alabama. ALJ
Decision (also ALJ), at 3.
On January 5, 2011, the ALJ issued
her decision which recommended that
Respondent’s registration be revoked.
Id. at 51. Therein, the ALJ found that the
Alabama Medical Board had not made
a recommendation in the matter (factor
one) and that Respondent has not been
convicted of an offense related to the
manufacture and distribution of
controlled substances (factor three). Id.
at 43, 48.
With respect to factors two
(Respondent’s experience in dispensing
controlled substances) and four
(Respondent’s compliance with
applicable laws related to controlled
substances), the ALJ made extensive
findings. First, the ALJ found that
Respondent violated DEA regulations
because he prescribed drugs other than
Suboxone or Subutex on prescription
forms that used only his Data Waiver (or
X) number. ALJ at 43. The ALJ also
found that Respondent ‘‘improperly
prescribed Suboxone for substance
abuse using his regular DEA registration
number rather than the required ‘‘X’’
number.’’ Id.
Next, the ALJ found that Respondent
prescribed methadone for detoxification
and maintenance treatment without
holding the separate registration
required to do so under Federal law.
ALJ at 43–45. The ALJ specifically
rejected Respondent’s testimony that he
had prescribed methadone to nine
patients to treat pain (which does not
require a separate registration), noting
that Respondent had initially told a
DEA Investigator that he was
prescribing methadone for
detoxification purposes, that several
patients who had received methadone
had told the Investigator that they were
being treated for substance abuse, and
that several of the patients had come to
Respondent’s clinic ‘‘directly after’’
being treated by a methadone clinic
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‘‘where the prescription of methadone
for pain is prohibited’’ and had been
diagnosed by Respondent as being
substance abusers. Id. at 44–45. The ALJ
also found that Respondent had violated
the limitation imposed under Federal
law and regulations which limit to 100,
the number of patients who can be
treated for substance abuse with
Suboxone. ALJ at 46–47 (citing 21
U.S.C. 823(g)(2)(B)(iii) and 21 CFR
1301.28(b)(1)(iii)).
Next, the ALJ found that Respondent
violated both Federal and State
regulations because his medical charts
‘‘fail[ed] to list the source and severity
of pain when chronic pain [wa]s the
diagnosis. ALJ at 47 (citing Ala. Admin.
Code 540–X–4.08; 21 CFR 1306.04(a)
and 1306.07(c)). The ALJ further found
that Respondent’s charts ‘‘fail[ed] to
record when medical examinations were
conducted and the specific results of
those examinations in support of
diagnoses,’’ and that ‘‘[i]n some
instances, patients actually reported that
no examination was conducted.’’ Id.
The ALJ also found that the ‘‘charts
failed to show the use of any treatment
options besides the prescribing of
controlled substances,’’ and that the
‘‘lack of attempts of alternative
treatment modalities prior to
determining that the patient suffers from
chronic pain violates 21 CFR
1306.07(c).’’ Id.
The ALJ further found that
Respondent had post-dated
prescriptions for schedule II controlled
substances in violation of Federal
regulations. Id. at 47–48 (citing 21 CFR
1306.05(a) and 1306.12(b)). In addition,
the ALJ found that Respondent had
admitted to having issued a controlled
substance prescription after he was
served with the Immediate Suspension
Order. Id. at 48. The ALJ then found that
‘‘Respondent testified, and the record
contains no expert evidence to the
contrary, that his treatment of his
patients met the standard of care.’’ Id.
However, based on Respondent’s
improper use of his data-waiver number
on prescriptions, his unauthorized
prescribing of methadone for
maintenance and detoxification
purposes, his incomplete records, his
failure to recommend any treatment
options for his chronic pain patients
besides the prescribing of controlled
substances, and his issuance of a
controlled substance prescription after
his registration was suspended, the ALJ
concluded that these factors supported
the revocation of his registration. Id.
With respect to factor five—such
other conduct which may threaten
public health or safety—the ALJ found
that Respondent lacked candor. More
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specifically, the ALJ noted that
‘‘[p]ractically all of the patient charts in
this record had the same diagnoses:
Chronic pain and substance abuse.
However, when most of the patients
were asked about their treatment by the
Respondent, they stated that they were
being treated for substance abuse.’’ Id. at
49. While the ALJ acknowledged ‘‘that
it may be difficult to accurately
diagnose chronic pain or substance
abuse,’’ she found Respondent’s
testimony that the patients did not
know that they were being treated for
chronic pain to ‘‘lack[] credibility.’’ Id.
The ALJ thus concluded that
Respondent’s ‘‘lack of candor also
threatens public health and safety.’’ Id.
at 49.
The ALJ then turned to Respondent’s
evidence as to his remedial measures.
The ALJ noted that Respondent had
stopped using his X number improperly
(to prescribe drugs other than Suboxone
and for purposes other than substance
abuse treatment), that he had stopped
prescribing methadone, and that at the
hearing, he had ‘‘apologized for the
issuance of prescriptions for controlled
substances without a proper DEA
registration.’’ Id. at 50. However, noting
that upon being served with the
Immediate Suspension Order,
Respondent had stated that he did not
intend to comply with it, as well as his
testimony that while he currently lacks
‘‘authority to handle controlled
substances, he continues to ‘help’ with
the Suboxone at [another] clinic,’’ the
ALJ found that Respondent’s ‘‘actions
do not indicate remorse, but, rather, are
more indicative of a failure to appreciate
the seriousness of the allegations against
him and the responsibility with which
he was charged.’’ Id. The ALJ further
found that ‘‘Respondent, through his
actions, likely facilitated’’ drug abuse.
Id.
The ALJ thus concluded that
Respondent had failed to rebut the
Government’s prima facie case. Id. at 51.
She further recommended that
Respondent’s registration be revoked
and that any pending applications be
denied. Id.
Neither party filed exceptions to the
ALJ’s decision. Thereafter, the record
was forwarded to this Office for Final
Agency Action. Having considered the
record as a whole, I adopt the ALJ’s
findings of fact and conclusions of law
except as otherwise noted herein. I
further adopt the ALJ’s recommendation
that Respondent’s registration be
revoked and that any pending
application be denied. I make the
following findings.
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Findings
Respondent is a physician licensed by
the Alabama State Board of Medical
Examiners (hereinafter, State Board or
Medical Board) and is board certified in
family practice. As of the date of the
hearing, Respondent’s state license
remains current and unrestricted. Tr.
259. The State Board, however, has an
open investigation of Respondent. Id. at
257–58.
Respondent is also the holder of DEA
Certificate of Registration BC1701184,
which prior to the issuance of the
Immediate Suspension Order,
authorized him to dispense controlled
substances as a practitioner in schedules
II through V, with the registered
location of Narrows Health & Wellness,
151 Narrows Parkway, Suite 110,
Birmingham, Alabama.1 ALJ at 4
(stipulated facts). Respondent’s
registration does not expire until August
31, 2012. Id.
Respondent is also authorized to
dispense Suboxone and Subutex, under
the Drug Addiction Treatment Act of
2000 (DATA), for the purpose of treating
opiate addicted patients and is
authorized to treat up to 100 patients;
Respondent has been assigned
identification number XC1701184 for
this purpose. Id.; see 21 U.S.C. 823(g)(2).
Suboxone and Subutex are schedule III
controlled substances (and are the only
schedule III through V drugs) which
have been approved by the Food and
Drug Administration for the treatment of
opiate addiction by a DATA Waiver
physician.
Respondent is not, however,
authorized to dispense methadone, a
schedule II narcotic, for the purpose of
treating opiate addiction as he does not
have the registration required by 21
U.S.C. 823(g)(1). GXs 1 & 2. Respondent
can, however, lawfully dispense
methadone for the purpose of treating
pain.
The Investigation
Respondent first came to the attention
of the authorities when several
pharmacies complained to a State Board
Investigator that he was prescribing
large amounts of methadone using his X
number. Tr. 35–36. The State
Investigator passed this information on
to a DEA Diversion Investigator (DI); on
February 28, 2010, which was a Sunday
morning, the two Investigators went to
Respondent’s Red Bay Clinic and
arrived there at 6:30 a.m. Id. at 37.
While the Investigators were in the
parking lot taking photographs, they
1 Respondent also was practicing at offices in Red
Bay and Russellville, Alabama. ALJ at 4–5
(Stipulated Facts at para. 4); Tr. 35.
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were approached by TS, who said ‘‘[h]e
was waiting to get his methadone from’’
Respondent. Id. at 38. TS also stated
that he paid cash for his visits, that he
was seeing Respondent for an old
football injury, that he did not provide
any medical records to Respondent, and
that he was not asked for identification
when he first registered as a patient. Id.
at 39–40.
Respondent did not arrive at the office
until shortly before 11 a.m., by which
time ‘‘close to 50 people’’ were waiting
to see him. Id. The State Investigator
then went inside to register in an
attempt to see Respondent. Id. However,
when the State Investigator was told
that he would have to wait five to six
hours to see Respondent, the
Investigators decided to identify
themselves and interview him. Id. at 42.
Respondent initially told the
Investigators that ‘‘he was operating a
detox clinic where he was using
methadone to get his patients onto
Suboxone.’’ Id. at 43. Respondent also
said that he accepted cash only, that he
saw an average of 80 patients on
Sundays at the Red Bay clinic, and that
he also treated chronic pain patients on
whom he performed ‘‘range of motion
tests.’’ Id. at 43–44.
With respect to his chronic pain
patients, Respondent told the State
Investigator that he would look for
surgical scars on the patient’s body and
that he sent some of his patients for
X–Rays and MRIs. Id. at 218–19.
Respondent admitted to the State
Investigator that ‘‘he did not’’ follow the
Board’s guidelines for the use of
controlled substances in treating pain.
Id. at 220. In the interview, Respondent
also stated that he would require his
substance abuse patients to undergo
drug screens ‘‘if he felt that they needed
one.’’ Id. at 219.
Respondent also maintained that he
knew the requirements for using his X
number and that he was not prescribing
any other drugs under this number. Id.
at 44–45. The State Investigator then
showed Respondent a methadone
prescription he had written under his X
number; Respondent said that the
‘‘prescription was a mistake.’’ Id. at 45.
The DI then told Respondent that he
had found ‘‘close to 200 prescriptions
* * * written under his X number for’’
drugs other than Suboxone and
Subutex, including Xanax (a schedule
IV depressant) and Adderall (a schedule
II stimulant). Id.; see also id. at 221
(testimony of State Investigator).
The DI then asked Respondent how
many patients he was treating under his
X number. Id. at 46. Respondent said
that he had 60 patients at his Red Bay
clinic and another 50 patients at his
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Birmingham office. Id. When told by the
DI that this exceeded the 100 patient
limit, Respondent claimed that ten of
the patients were actually being treated
with Suboxone for pain. Id. at 46.
During the visit, the DI encountered
JKB in Respondent’s waiting room and
asked to speak with him. Id. at 51. The
DI asked JKB what Respondent was
treating him for; JKB stated that he was
treating him for an addiction to opiates
with methadone. Id. at 52. JKB also told
the DI that he had previously gone to a
narcotic treatment program which used
methadone and that he was going to
Respondent because it was cheaper. Id.
at 53. JKB also stated that he was not
seeing Respondent for chronic pain. Id.
Following this interview, the DI
resumed his interview of Respondent.
Respondent now maintained that he
was prescribing methadone for pain. Id.
When the DI told Respondent that he
had just interviewed a patient who said
he was being treated for opiate
addiction with methadone, Respondent
stated that the patient was mistaken. Id.
at 54. When the DI reminded
Respondent that he had earlier stated
that he was using methadone to transfer
patients onto Suboxone, he stated that
he had previously misspoken and
‘‘[t]hat he was only using methadone for
pain’’ and not to treat addiction. Id. at
55. When the DI asked Respondent
whether it was possible to see eighty
patients in a day and ‘‘provide the kind
of treatment that was necessary for’’
them, Respondent stated that ‘‘he was
overwhelmed and . . . needed some
guidance.’’ Id. at 56–57.
Upon leaving the clinic, the
Investigators observed ‘‘approximately
50 patients inside of [the] office and
probably another 50 to 60 . . . in the
parking lot.’’ Id. at 57. The Investigators
then went to a local CVS pharmacy and
interviewed its pharmacist, who stated
that since the opening of Respondent’s
Red Bay clinic, he had ‘‘seen a
tremendous spiking in the amount of
prescriptions for methadone.’’ Id. at 58.
The pharmacist further stated that
Respondent was writing methadone
prescriptions to treat addiction and that
he would not fill these prescriptions. Id.
at 59; see also GX 7.
On May 17, 2010, the Investigators
(along with a Supervisory DI) went to
Respondent’s Russellville office and
obtained various patients’ files through
either an administrative subpoena or a
warrant. Tr. 48–50, 62–63. The
Investigators again interviewed
Respondent who stated that he was
mainly seeing pain patients. Id. at 63.
The DI then asked Respondent if he had
made any changes to his practice;
Respondent states that ‘‘he had
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switched pretty much everybody from
methadone to Suboxone and that out of
the 85 percent [of his] patients that he
was seeing for pain, 95 percent . . . were
being treated with Suboxone.’’ Id. at 64.
Respondent also stated that he had
stopped prescribing methadone for pain
because he was having more success
using Suboxone. Id. at 65.
During the interview, Respondent
identified AK as a chronic pain patient
who he was treating with Suboxone and
who was waiting to see him. Id. at 65–
66. The DI proceeded to interview AK,
who had yet to see Respondent that day;
AK stated that Respondent ‘‘was treating
her for an addiction to opiates,’’ and
that after the February visit by the
Investigators, he had stopped writing
methadone prescriptions. Id. at 66.
The DI also interviewed another
patient, SH, who was in the parking lot.
Id. at 73–74. SH stated that Respondent
was treating him for opiate addiction
and not for chronic pain. Id. at 74.
The DIs seized 114 patient files which
were selected on the basis of pharmacy
records showing that Respondent had
prescribed either Suboxone or
methadone to the patients. Id. at 171–
72, 174. The files were taken to the DIs’
office where they were reviewed. Id. at
68. Thereafter, the DIs focused their
investigation on approximately 28
patients, whose files were introduced
into evidence.2 During the course of the
investigation, the DIs interviewed most
of these patients by telephone to
determine why they were seeing
Respondent. Id. at 172.
The Patient Files and Interviews
Respondent’s Methadone Patients
TP
On June 1, 2010, the DI spoke with
TP. TP told him that Respondent did
not physically examine her, that she
paid $100.00 for the visit and that he
prescribed methadone to her. Tr. 103–
105; GX 5X. TP went to Respondent
because she had heard that he was using
methadone to treat addiction. Tr. 105.
TP saw Respondent on three
occasions (Feb. 7 and 21, and Mar. 7,
2010). GX 5X. TP completed an intake
form on which she listed her
medications as ‘‘methadone 12 10s a
day’’ and wrote that her pharmacy was
the ‘‘methadone clinic.’’ Id. at 2. At her
first visit, Respondent checked ‘‘YES’’
2 Twenty-six of the patient files were entered into
evidence as Government Exhibit 5; the two
remaining files were entered into evidence as
Government Exhibits 22–23. Respondent also
introduced copies of the same files. See RXS 2, 4–
28. I have carefully reviewed both sets of files and
conclude that there are no material differences
between the two sets.
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for whether TP had pain and listed her
legs and back as the location. Id. at 3.
Respondent diagnosed TP as having
chronic pain, substance abuse and
anxiety. Id.
However, Respondent did not
document the nature and intensity of
the pain, current and past treatments for
the pain, and its effect on TP’s physical
and psychological functioning. Id. at 3,
5. No vital signs were recorded at any
of her visits. Id. In addition, the chart
contains no medical history. See
generally GX 5X.
Moreover, while TP indicated that she
had previously gone to a methadone
clinic, Respondent did not know the
name of the clinic and did not even
attempt to obtain her treatment records.
See generally GX 5X; Tr. 727–28. In
addition, the progress note for TP’s third
visit contains no information other than
her name, date of birth and the date of
the visit.
At each of TP’s three visits,
Respondent prescribed a daily dose of
eleven tablets of methadone 10 mg, with
the first two prescriptions being written
under his X number for 154 tablets each.
See GX 5X. While TP told the DI that
after DEA’s February 28, 2010 visit,
Respondent told her that he was no
longer prescribing methadone, Tr. 105;
on March 7, Respondent again
prescribed 88 tablets of methadone 10
mg to her. GX 5X, at 1. When
Respondent offered TP alternative
medications to methadone, she elected
to return to a methadone treatment
program. Tr. 501, 728.
When asked on cross-examination if
the methadone clinic which TP had
previously gone to was treating her for
abusing narcotics, Respondent testified
that while the only purpose of a
methadone clinic is to treat ‘‘substance
abuse,’’ she was ‘‘going for pain.’’ Id. at
728. While Respondent also diagnosed
TP as having substance abuse, he did
not document the substances that she
was abusing. GX 5X.
DG
DG first saw Respondent on January 3,
2010. GX 5O. On the intake form, DG
listed his medications as ‘‘methadone.’’
Respondent made a diagnosis of chronic
pain even though he checked ‘‘NO’’ for
whether DG had pain and the progress
note for the visit does not document the
nature and intensity of the pain,
whether any treatments had been
previously tried, and the pain’s effect on
his psychological and physical function.
GX 5O, at 4. While Respondent noted
that he performed a physical exam, he
found each of the areas of the
examination to be normal. Id.
Respondent prescribed methadone to
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DG at this visit, as well as on January
12, 19, and February 1, 14, and 28, 2010.
Id. at 5, 7, 9, 11.
On July 9, 2010, the lead DI
interviewed DG. Tr. 106. DG stated that
Respondent had told him on February
28, 2010, that he would no longer
prescribe methadone, but that he would
prescribe Suboxone to DG if he was
having trouble getting off of the
methadone. Id. at 107–08, 386.
Respondent testified that on January
19, 2010, he diagnosed DG as having a
substance abuse problem, yet the
medical chart does not document the
basis for that diagnosis. Id. at 701–02.
Respondent testified that his diagnosis
was based on DG’s demeanor and
‘‘probably . . . also a drug screen.’’ Id.
However, there is no drug screen in the
file. See GX 5O.
DG testified at the hearing. The ALJ
found credible his testimony that he
was also seeing the Respondent for pain
in his shoulder and lower back. ALJ at
23. While DG believed this pain was a
result of masonry work he had done
since he was a teenager, as well as a
snowboarding accident he had when he
had lived in Utah, DG’s chart does not
reflect any of this information. Tr. 367,
374; GX 5O.
According to DG, Respondent
examined him and would spend about
7 to 10 minutes with him during his
visits. Tr. 370. DG also denied having
told the DI that Respondent did not
perform a physical exam on him and
that he was seeing Respondent for
substance abuse. Tr. 371.
Respondent used his X number to
prescribe methadone for DG. GX 5O, at
5, 7, 9, 11. The methadone prescriptions
were for lesser and lesser amounts. GX
5O, at 1. In March of 2010, Respondent
proposed to offer DG an alternative
medication treatment plan. Id. at 11; Tr.
386–87. The medical chart stops at that
point. GX 5O. Respondent stated that he
believed his treatment of DG was
appropriate. Tr. 488.
MB
On July 20, 2010, the lead DI
interviewed MB. Tr. 108; GX 5A. MB
stated that she was seeing Respondent
for an addiction to Lorcet and not for
chronic pain, that she paid cash for her
prescriptions, and that Respondent did
not perform any physical examinations.
Tr. 109–110. MB also commented that
she thought there were too many people
waiting inside and outside the office to
see Respondent. Id. at 109.
On the progress note for MB’s first
visit, Respondent circled ‘‘YES’’ for
whether she had pain and diagnosed her
as having chronic pain due to
headaches. GX 5A, at 7. At the hearing,
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Respondent testified that MB was being
treated for both periodic headaches and
substance abuse. Respondent did not,
however, further document the nature
and intensity of the pain, how it affected
MB’s ability to function, and any prior
treatments for her pain. See id. Nor did
he document the history of MB’s
substance abuse. Tr. 533–37.
Respondent did not obtain information
from MB’s prior physicians. Tr. 533–34.
While Respondent indicated that the
physical examination was normal, he
did not take MB’s vital signs. Tr. 532–
33; GX 5A, at 7.
Respondent described his treatment of
MB as tapering her down on her
methadone prescriptions, and the
prescriptions show that Respondent was
gradually reducing her daily dosage
from 150 mg to 130 mg over the course
of the slightly more than two months in
which he treated her.3 Tr. 463, 545, 550;
GX 5A, at 5–6. At MB’s last visit (Mar.
14), Respondent offered her the option
of using different medication to control
any potential withdrawal symptoms she
may have from the lack of methadone.
Tr. 464–65. However, MB chose to seek
treatment elsewhere. Tr. 551.
Respondent issued MB two
methadone prescriptions on his X
prescription pad. Tr. 541–42; GX 5A, at
6. MB’s file has no entry for her visits
of February 28 and March 14, even
though MB’s drug log notes that a
methadone prescription was issued on
each date for 182 and 106 dosage units
of methadone respectively. GX 5A, at 2–
3.
JC1
Respondent saw JC1 three times in
February and March of 2010. GX 5N. On
his intake form, JC1 listed his
medications as methadone and Xanax.
GX 5N, at 2. On the progress note for
JC1’s first visit (Feb. 9), Respondent
noted that he had been in an automobile
accident and wrote ‘‘back’’ on the chart.
Id. at 4. However, Respondent also
noted that JC1 had ‘‘NO’’ pain and did
not document the nature and intensity
of the pain, details regarding the
accident such as when it occurred, what
treatments had been used, and the
pain’s effect on his physical and
psychological functioning. Id. The
progress note indicated that Respondent
did a physical exam, during which he
did not find any area to be abnormal. Id.
Respondent did not document having
taken JC1’s vital signs. Id. At this visit,
Respondent gave JC1 prescriptions for
3 Respondent issued MB a total of six methadone
prescriptions between January 5 and March 14,
2010. GX 5A, at 2. Some of the prescriptions
indicated that they were ‘‘for pain.’’ Id. at 4, 6.
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210 tablets of methadone 10 mg, with a
daily dose of 15 tablets, and 60 tablets
of Valium, even though he noted that
JC1 was not agitated or moody and did
not have insomnia. Id. at 4–5. These
prescriptions were written under his X
number. Id. at 5.
At JC1’s next visit (Feb. 23),
Respondent again indicated that he had
‘‘NO’’ pain and did a physical exam at
which he found all areas normal. Id. at
4. At this visit, Respondent noted
diagnoses of both chronic pain and
substance abuse. Id. Respondent issued
JC1 a prescription for 210 tablets of
methadone 10 mg, with a daily dose of
15 tablets ‘‘for pain.’’ Id. Respondent
wrote the prescription under his X
number. Id. at 5.
On March 9, Respondent wrote JC1
two more prescriptions, one for another
210 tablets of methadone with the same
daily dose ‘‘for pain’’ as before, and one
for twenty-eight tablets of Valium. Id. at
1, 7. Respondent wrote the prescriptions
under his X number. Id. at 7.
Respondent did not, however, create a
progress note to document the issuance
of the prescriptions. See generally GX
5N.
Respondent testified that JC1 had
been in an automobile accident and had
fractured his back, that he had
developed a tolerance for pain medicine
and was taking more and more, and thus
went to a methadone clinic. Tr. 486.
Respondent further testified that JC1
had come from either the Shoal’s clinic
or a narcotic treatment program in
Hamilton because he ‘‘wanted to take a
cleaner medicine for his pain.’’ Id. at
486, 699. Respondent denied that JC1
had gone to the narcotic treatment
program ‘‘to be treated for addiction’’
and maintained that ‘‘he was going there
to be treated for pain from a fractured
back.’’ Id. at 699.
As for the basis of the substance abuse
diagnosis which he made at JC1’s
second visit, Respondent testified that
‘‘we probably got our February 9 drug
screen back. And he probably had some
[illicit] drug in there.’’ Id. at 700.
However, Respondent acknowledged
that he was speculating about this
because JC1’s chart did not contain any
drug test results. Id.
Respondent prescribed methadone at
a lower dosage amount than the dosage
JC1 reported he had been on. Id. at 486;
GX 5N at 1, 5, 7. However, while
Respondent maintained that JC1
‘‘wanted to take a cleaner medicine for
his pain,’’ Respondent did not taper the
methadone prescriptions for JC1, but
rather prescribed the same daily dose of
150 mg in each prescription between
February 9, 2010, and March 9, 2010.
Tr. 486; GX 5N, at 1, 5, 7. When in
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March, Respondent offered him
alternative medications, JC1 elected to
go to another treatment facility. Tr. 486.
Respondent maintained that his care of
JC1 was appropriate. Id. at 487.
tkelley on DSK3SPTVN1PROD with NOTICES
JB
Respondent treated JB in February
and March of 2010.4 GX 5L. On the
intake form, JB listed his medications as
‘‘methadone,’’ and on the progress note
for his visit, Respondent wrote that JB
had been a patient at the Shoals
Treatment Center, that he had been on
230 mg. of methadone, but that he ‘‘was
kicked out.’’ GX 5L, at 5. Respondent
further wrote that JB ‘‘desires to get off
methadone.’’ Id. In addition,
Respondent noted that JB had foot pain,
back pain and knee pain which had
been caused by ‘‘a four-wheeler
accident.’’ Id.; Tr. 696. Respondent
performed a physical examination and
took JB’s blood pressure and heart rate.
GX 5L, at 5. Respondent also noted that
JB had withdrawal, was agitated/moody,
had insomnia, and had a positive MDQ
(Mood Disorder Questionnaire). Id.
Respondent then issued JB a
prescription for a fourteen-day supply of
methadone 10 mg, at a daily dose of 18
tablets, id., and noted that his plan
included placing JB on his alternative
medication (KCZZU) program. Id.
Respondent issued JB a prescription for
methadone, which was written under
his X number, and wrote on it ‘‘for
pain.’’ Id. at 6. Respondent also wrote JB
a prescription for Ultram, a noncontrolled drug, on the same form,
which listed only his X number. Id.
On February 28, 2010, JB again saw
Respondent. Respondent circled ‘‘YES’’
for whether JB had pain and insomnia,
and made a further notation that his
pain was worse, although the precise
area is illegible. Id. at 5. Respondent
again noted a diagnosis of chronic pain
and issued JB another prescription for
252 methadone 10 mg, with a daily dose
of 18 tablets ‘‘for pain.’’ Id. at 6. This
prescription was also issued under his
X number.
At JB’s final visit (Mar. 14),
Respondent noted that his ‘‘pain
persists’’ and that he was ‘‘anxious
about stopping methadone.’’ Id. at 3.
Respondent issued him a prescription
for 156 tablets of methadone 10 mg with
a daily dose of 17 tablets ‘‘for pain.’’ Id.
at 4. Respondent wrote the prescription
4 It is unclear whether JB is the same person as
JKB, who was interviewed in the waiting room on
February 28, 2010, and who told Investigators that
he had previously gone to a methadone clinic and
that Respondent was treating him for opiate
addiction, as the Government did not establish that
this chart (GX 5L) was JKB’s.
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on a form, which contained both his X
number and regular DEA number. Id.
Respondent testified that JB had been
asked to leave a drug treatment program
before he saw the Respondent. Tr. 482.
Respondent testified that he had done a
drug screen on JB and that he did not
‘‘see anything that bothered [him], such
as cocaine * * * or marijuana at that
time.’’ Id. at 483. However, JB’s file does
not contain the results of a drug screen.
GX 5L.
According to Respondent, JB had been
in a four-wheeler accident, took
narcotics, and went to the drug
treatment program because his other
physician would not write anymore
prescriptions for narcotics. Tr. 696.
Respondent did not, however obtain
JB’s records from the drug treatment
program and Respondent maintained
that the fact that JB was being treated at
a methadone clinic did not tell him that
JB was being treated for opiate
addiction. Id. at 695–96. Respondent
stated that he prescribed methadone in
a tapered amount to prevent JB from
going into withdrawal. Id. at 483; GX
5L, at 1.
Respondent also testified that he had
provided JB with the option of other
treatment medications, but that he
elected to go to another methadone
clinic. Tr. 483. Respondent annotated in
the medical chart that he was treating JB
for back and knee pain. GX 5L, at 5–6.
Respondent did not document the
severity of the pain. GX 5L. Respondent
stated that his treatment of JB was
appropriate. Tr. 483–84.
NB
Respondent saw NB three times in
February and March of 2010. GX 5M. At
her first visit (Feb. 7), Respondent
diagnosed her as having chronic pain
even though he indicated that she had
‘‘NO’’ pain. GX 5M, at 3. Respondent
did not document any further
information regarding NB’s condition
(such as the nature and intensity of the
pain, its history, whether any treatments
had been previously tried, and the
pain’s effect on her psychological and
physical functioning) at any of her three
visits. Id. at 3, 5.
The progress note for NB’s first visit
indicates that Respondent performed a
physical exam. Id. at 3. However,
Respondent noted that all areas were
normal. Id. Respondent did not
document having taken NB’s vital signs.
Id. At this visit, Respondent issued NB
prescriptions under his X number, for
210 tablets of methadone 10 mg (with a
daily dose of 15 tablets) and 30 Xanax.
Id. at 4. Respondent did not diagnose
NB as having anxiety; indeed, he noted
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that she was not agitated/moody and
did not have insomnia. Id. at 3.
On Feb. 21, Respondent issued NB
additional prescriptions for methadone
and Xanax under his X number. Id. at
4. The progress note for this visit,
however, contains no information
regarding her medical condition. Id. at
3. On the progress note for NB’s final
visit (Mar. 7), Respondent circled
‘‘CHRONIC PAIN’’ but made no other
findings. Id. at 5. At this visit,
Respondent issued her prescriptions for
112 tablets of methadone 10 mg, with a
daily dose of 14 tablets ‘‘For Pain,’’ and
for 20 tablets of Klonopin ‘‘for anxiety.’’
Id. at 6. Respondent wrote the
prescriptions on a form which listed
both his X number and his regular
registration number. Id.
Respondent testified that NB told her
at the initial visit that she had been on
180 mg of methadone and that ‘‘she was
taking it for pain.’’ Tr. 484. He then
testified that ‘‘she also had some
anxiety’’ and that she was a ‘‘troubling
patient’’ because she was ‘‘on a
combination of methadone and Xanax’’
which caused him great concern,
especially if ‘‘those two drugs get mixed
with alcohol.’’ Id. at 485. None of this
was documented.
Respondent also testified that he gave
her ‘‘150 methadone,’’ which was
‘‘much less methadone than she was
on,’’ and that he ‘‘gave her 28 tablets of
the Xanax in fear of seizure potential if
we went below that.’’ Id. At her last
visit, Respondent offered NB the option
of alternative medications, after which
she did not return to his clinic. Id. 485;
GX 5M. Respondent believed his care of
NB was appropriate. Tr. 485–86.
KI
Respondent saw KI four times in
February and March of 2010. GX 5T. On
the intake form, KI noted that her
medications included ‘‘methadone,
Xanex[sic], [and] Ambien.’’ Id. at 2.
According to Respondent, KI was
being treated at Shoals, a narcotic
treatment facility, and she wanted out of
the clinic. Tr. 494. Respondent testified
that KI had back pain; however,
Respondent indicated that she had
‘‘NO’’ pain on the progress note for her
first visit. Tr. 494, GX 5T, at 3. Although
Respondent wrote ‘‘Back’’ as the
location, once again, he did not
document the nature and intensity of
the pain, the history of the pain, what
treatments had been used, and the
pain’s effect on KI’s physical and
psychological functioning. GX 5T, at 3;
Tr. 494, 718.
Respondent performed a physical
examination but did not note any
abnormalities; he also did not document
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having taken KI’s vital signs. GX 5T, at
3. Respondent noted the diagnoses of
both chronic pain and substance abuse
and prescribed a lesser dose of
methadone (130 mg per day) than what
KI reported she had been receiving at
Shoals (150 mg). Tr. 494; GX 5T, at 3–
4. However, Respondent did not taper
KI’s methadone prescriptions; rather, he
prescribed 130 mg per day of
methadone to her three times between
February 7, 2010, and March 7, 2010,
with the first two prescriptions being
written under his X number. GX 5T, at
1, 4, 6.
Respondent did not obtain treatment
records from the narcotic treatment
facility and did not know what
substance KI was abusing; he also did
not obtain any records related to her
back pain. Tr. 715–16. Respondent
testified that KI began taking narcotics
to treat her pain, became addicted to
those narcotics, but then denied that she
had told him that she then entered the
methadone clinic to treat her addiction.
Id. at 716–17. Respondent testified that
he offered alternative medications to KI,
that on March 21, 2010, he refused to
prescribe methadone to her, and that
she then ‘‘went to another facility.’’ Id.
at 494–95. Respondent maintained that
his care of KI was appropriate. Id. at
495.
tkelley on DSK3SPTVN1PROD with NOTICES
Respondent’s Suboxone Patients
SS
On June 1, 2010, the DI spoke with SS
by phone. Tr. 96. SS said that he was
being treated for opiate addiction, that
he received a Suboxone prescription
from Respondent, and that he was not
being treated for chronic pain. He also
stated that he paid $100.00 cash directly
to Respondent for his prescription and
that Respondent did not conduct any
examination on him. Tr. 95–98; GX 5H.
SS saw Respondent only on May 2,
2010. GX 5H, at 2–3. On the intake form,
SS listed methadone as his medication
and Respondent noted on the progress
note that he was on 120 mg. Id. at 3.
Respondent diagnosed SS as having
both chronic pain and methadone use;
while Respondent checked ‘‘NO’’ for
SS’s pain, he indicated that SS had disc
surgery at L5S1. Id. at 3; Tr. 475. While
Respondent recalled, and the chart
reflects, that SS had back surgery, SS’s
chart does not contain any copies of
records related to his back surgery and
does not document the date of the
surgery. Tr. 475, 673; GX 5H. SS’s chart
does not document the nature and
intensity of the pain, current and past
treatments for it other than the surgery,
and the pain’s effect on his physical and
psychological functioning. GX 5H, at 3.
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No vital signs were recorded at SS’s
visit. Id.
Respondent testified that SS was on
methadone, which he was getting ‘‘off
the street,’’ but that fact is not annotated
in his chart. Tr. 672. Respondent,
however, refused to prescribe
methadone to SS. Instead, he prescribed
Suboxone and offered SS the choice of
an alternative medical treatment
program for getting off of methadone. Id.
at 475–76, 674. Respondent believed
that he gave SS appropriate care. Id. at
476.
AG
On May 17, 2010, the DI interviewed
AG. Id. at 80. AG stated that she was
seeing Respondent for treatment of her
addiction to Lortab, a schedule III
narcotic containing hydrocodone. Id. at
80–81. AG further explained that she
was not being treated for chronic pain,
although such treatment was indicated
in her chart. AG stated she did not know
why her chart listed this condition. Id.
at 81; see also GX 5P.
According to her chart, Respondent
diagnosed AG as having chronic pain
and substance abuse as a secondary
condition. GX 5P, at 3; Tr. 488–89.
However, the chart does not specify the
basis for this diagnosis and Respondent
checked ‘‘NO’’ for whether AG had
pain. Tr. 704; GX 5P, at 3. In addition,
Respondent did not record any vital
signs at this or any subsequent visit.
Respondent prescribed Suboxone to
AG at both the initial and several
subsequent visits. Tr. 488; GX 5P, at 1,
4, 6, 8, 9. Moreover, at subsequent visits,
Respondent continued to diagnose AG
as having both chronic pain and
substances abuse while checking ‘‘NO’’
for whether she had pain. See id. In
other instances, the progress notes
indicate that AG visited on a certain
date but are otherwise blank even
though Respondent issued AG a
prescription. GX 5P, at 5. At AG’s final
visit, Respondent circled ‘‘YES’’ for
whether she had pain but provided no
further documentation as to the location
of the pain, the nature and intensity of
the pain, current and past treatment for
pain, and its effect on her physical and
psychological functioning. Id. at 7. In
addition, the chart contains no medical
history. See generally GX 5P.
Respondent nonetheless maintained
that he met the standard of care with
respect to AG. Tr. 489.
LM
On June 1, 2010, DI Michael Jones
interviewed LM by telephone. Id. at 82.
LM stated that the Respondent was
treating her for an addiction to pain
killers. Id. at 83. Respondent had been
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treating LM since December 27, 2009, at
the Red Bay clinic. LM confirmed that
she was not being treated for chronic
pain. Tr. 82–83.
LM completed a form in which she
listed her medications as Adderall and
Oxycontin, the latter being a schedule II
narcotic. Tr. 193; GX 5V, at 2. At LM’s
first visit, Respondent diagnosed LM as
having chronic pain, substance abuse,
and bipolar disorder. GX 5, at 3. While
Respondent checked ‘‘YES’’ for whether
LM had pain and listed her ‘‘back’’ as
the location, the chart does not
document the nature and intensity of
the pain, current and past treatments for
pain, and its effect on her physical and
psychological functioning. Id. In
addition, the chart contains no medical
history. See generally id. Respondent
prescribed Suboxone and Adderall on
an X prescription pad. GX 5V, at 4, 6.
Subsequently, he prescribed both
controlled substances using his regular
DEA registration number. GX 5V,
at 6–7.
At subsequent visits, Respondent
continued to list chronic pain as a
diagnosis while checking ‘‘NO’’ for
whether LM had pain.5 Id. at 3.
Respondent testified that he was
treating LM for back pain and for
bipolar disorder. He further stated that
LM was on Oxycontin and wanted to get
‘‘onto a better pain medicine.’’ Tr. 498.
However, when asked on crossexamination as to whether his diagnosis
of substance abuse was ‘‘based on her
abuse of Oxycontin,’’ Respondent
stated: ‘‘I think it had to do with—she
had multiple things. She had stimulants
* * * such as Adderall,’’ and ‘‘I think
she had taken periodically Xanax.’’ Id.
at 723.
LM’s progress notes do not, however,
indicate what substance(s) she was
abusing. GX 5V, at 3 & 5. Moreover,
notwithstanding his testimony that her
substance abuse was based in part on
her use of Adderall, Respondent
prescribed this drug to LM at four of her
subsequent visits. Id. at 4, 6, 7.
Respondent believed his treatment of
LM was within the standard of care. Tr.
498–99.
ET
On June 1, 2010, the DI interviewed
ET by telephone. ET explained that the
Respondent was treating him for an
addiction to pain killers. Tr. 83–84.
Respondent prescribed Suboxone to ET
on an X pad on four occasions between
December 2009 and March 2010; in
5 At LM’s second visit, Respondent listed
substance abuse as a diagnosis; however, at two
subsequent visits, he no longer listed substance
abuse as a diagnosis. See GX 5V.
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April, he prescribed Suboxone to ET on
a prescription pad which listed both his
X number and his practitioner’s
registration number. GX 5Z, at 4, 6, 8.
ET told the DI that he was not being
treated for chronic pain. Tr. 83–84.
The first two progress notes (one of
which is undated but which is above the
note for January 5, 2010 6) indicate a
diagnosis of chronic pain but not
substance abuse, the latter not being
listed as a diagnosis until ET’s third
visit (Feb. 2, 2010). GX 5Z, at 3, 7. Here
again, Respondent noted on the chart
that ET had ‘‘NO’’ pain and the chart
does not indicate the location of the
pain, the nature and intensity of the
pain, current and past treatments for the
pain, and its effect on his physical and
psychological functioning. Id. at 3, 5, 7.
No vital signs were recorded at any of
ET’s visits. Id. In addition, the chart
contains no medical history. See
generally GX 5Z. Respondent
maintained that his care of ET was
appropriate. Tr. 503.
tkelley on DSK3SPTVN1PROD with NOTICES
CT
On June 2, 2010, a DI spoke with CT.
CT stated that Respondent was treating
her for opiate addiction with Suboxone.
Tr. 87–88. On the intake form, CT listed
her medications as ‘‘Suboxone,
methadone, and Zanex [sic].’’ GX 5Y,
at 2.
At CT’s first visit, Respondent
diagnosed her as having both substance
abuse and chronic pain. GX 5Y, at 3.
However, Respondent did not indicate
in the chart what substance she was
abusing. Id. Moreover, Respondent
indicated that she had ‘‘NO’’ pain. Id.
Respondent did not indicate a location
of CT’s pain until the third visit
(approximately two months later) when
he noted its location as her ‘‘back,’’ but
once again checked that she had ‘‘NO’’
pain. Id. at 5. While Respondent listed
a diagnosis of chronic pain at each of
CT’s four visits, he never checked
‘‘YES’’ for pain on any of the progress
notes. Id. at 3, 5. Respondent did not
document the nature and intensity of
the pain, current and past treatments for
the pain, and its effect on CT’s physical
and psychological functioning. Id. Nor
did he record vital signs at any of CT’s
visits. Id.
In his testimony, Respondent
admitted that he did not know what
substance(s) CT was abusing, but added
that ‘‘usually they’re on multiple
medicines to get whatever desired effect
they want.’’ Tr. 729–30. Respondent did
6 For this reason, I conclude that the undated note
was for ET visit of December 8, 2009, at which
Respondent issued him a prescription for
Suboxone. See GX 5Z, at 1 & 4.
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19:32 Mar 23, 2012
Jkt 226001
not obtain any prior treatment records
for CT, whether for pain or substance
abuse. Id. at 731.
Respondent wrote CT prescriptions
for Suboxone on a pad which contained
only his X number, as well as on a pad
which contained both his X number and
his regular DEA registration number. GX
5Y, at 4, 6. Respondent believed his
treatment of CT was within the standard
of care. Tr. 502.
JH
On June 2, 2010, the lead DI spoke
with JH. JH stated that Respondent was
treating him for ‘‘a bad addiction to
Oxycontin’’ with Suboxone and that he
was not being treated for chronic pain.
Tr. 89–90; GX 5R. JH listed his
medications as ‘‘OXY 80 mg x4.’’ GX 5R,
at 9. According to Respondent, JH was
taking ‘‘four [Oxycontin] a day for his
pain,’’ which he was getting off the
street because ‘‘his doctors fired him.’’
Tr. 710.
At JH’s first visit, Respondent
diagnosed him as having substance
abuse, attention deficit disorder and
chronic pain. GX 5R, at 10. While in his
testimony, Respondent maintained that
JH had told him that he needed
OxyContin ‘‘to get by with his pain,’’ on
JH’s chart, Respondent indicated that JH
had ‘‘NO’’ pain and did not document
a cause of the pain. Id. Moreover, while
JH saw Respondent multiple times
thereafter and diagnosed him as having
chronic pain at each visit, Respondent
never checked ‘‘YES’’ in the pain entry
of the progress notes and never
provided a description and location of
the pain. See generally GX 5R.
Moreover, Respondent never recorded
vital signs for any of JH’s visits. See
generally id. Nor does JH’s chart include
a medical history. See generally id.
Respondent obtained a printout of
JH’s prescriptions from the State’s
prescription monitoring program. Id. at
2–8. While the report showed that JH
had also obtained Suboxone from
another physician (Dr. H.), Respondent
neither obtained JH’s records from
Dr. H. nor conferred with him. Tr. 711–
12; GX 5. Respondent wrote JH
prescriptions for both Suboxone and
Adderall under his X number. GX 5R, at
11, 15. However, Respondent required
JH to undergo a drug test; while this test
showed that JH was taking Suboxone
(buprenorphine) and amphetamine
(Adderall), he also tested positive for
marijuana use. GX 5R, at 12.
Respondent believed his care of JH was
appropriate. Tr. 492.
KP
On June 2, 2010, the lead DI spoke
with KP. KP stated that Respondent was
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17511
prescribing Suboxone to treat her opiate
addiction and that she was not being
treated for chronic pain. Tr. 92–94.
While Respondent testified that KP was
on a narcotic which she wanted off of,
KP did not list any medications she was
on. GX 5W, at 2. Moreover, Respondent
did not document the name of the
narcotic in KP’s record. Tr. 499.
Respondent testified that KP had ‘‘a
complaint of pain.’’ Id. At KP’s first two
visits (Dec. 6, 2009 and January 3, 2010),
Respondent diagnosed her as having
only chronic pain. GX 5W, at 3.
However, for both visits, Respondent
checked ‘‘NO’’ for whether KP had pain
and did not list a cause or location of
any such pain. Id.
Respondent did not make a diagnosis
of substance abuse until her third visit
(Jan. 19, 2010); however, none of the
progress notes for KP’s subsequent visits
list a diagnosis of substance abuse.7 See
id. at 5, 7, 9, 11. Moreover, while
Respondent continued to diagnose KP
as having chronic pain, he did not check
‘‘YES’’ for whether she was having pain
on any of the progress notes. See id. Nor
did he document the cause, location or
severity of her pain, or record her vital
signs, at any of her visits. See id.
KP stated that she had to pay cash for
her prescriptions as Respondent would
not file a claim with Medicare for her.
Tr. 94. She also stated that the
Respondent did not perform any
medical examinations on her, although
Respondent indicated on the progress
notes that he had done so and noted that
the various parts of the examinations
were normal (by either checking or
lining through them). Tr. 95, see also GX
5W, at 3, 5, 9.
Respondent prescribed Suboxone and
Xanax for KP on an X prescription pad.
Id. at 499; see also GX 5W, at 4, 6.
Respondent believed his treatment of
KP was within the standard of care. Tr.
500.
TB
On June 10, 2010, the lead DI spoke
with TB. TB stated that Respondent was
prescribing Suboxone to him for both
pain and addiction. Tr. 98–99; GX 5B.
TB wrote on the intake sheet that he had
used Suboxone, but Respondent did not
know who prescribed it, and he
commented that he could not tell from
TB’s chart if the Suboxone had been
prescribed for substance abuse. GX 5B,
at 1; Tr. 580–81.
At the first visit (Dec. 20, 2009),
Respondent diagnosed TB as having
chronic pain and substance abuse. Tr.
7 Respondent also diagnosed KP as having
anxiety, for which he prescribed Xanax. GX 5W, at
5.
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466. Respondent checked ‘‘YES’’ for
whether TB had pain and indicated the
location as the lumbar area. GX 5B, at
6. While Respondent testified that ‘‘[w]e
got him to tell us about his back
problems,’’ if he had undergone any
surgeries and how ‘‘it affect[ed] his
everyday activity,’’ Respondent did not
document the nature and intensity of
the pain, whether any treatments had
been previously tried, and the pain’s
effect on his psychological and physical
function. Id.; Tr. 578–79. Moreover,
Respondent did not know if TB’s back
pain was caused by an injury or a
degenerative condition. Tr. 578–79.
The chart indicates that Respondent
performed an examination at which all
areas including TB’s back were found to
be normal. GX 5B, at 6. However, no
vital signs were recorded. Id. at 6–7.
Respondent prescribed Suboxone to TB,
as well as Ambien. Id. While
Respondent testified that he prescribed
the Suboxone for TB’s back pain, he
issued the prescription under his X
number; he also issued the Ambien
prescription on the same form. Id. at 7.
Respondent also saw TB on January
19, February 16,8 and May 2, 2010. Id.
at 4–7. At both the January and February
visits, Respondent prescribed both
Suboxone and Ambien to TB using his
X number. Id. at 5, 7; Tr. 466–67, 587–
88. Respondent did not obtain TB’s
records from other doctors even though
TB listed Suboxone as one of his
medications. Tr. 578–580; GX 5B. When
asked if he knew the name of the doctor
who had previously prescribed
Suboxone to TB, Respondent testified
‘‘We might have found it out—I just
didn’t document it * * *. It could be a
local doctor there.’’ Tr. 581. When asked
why TB had previously gotten
Suboxone, Respondent could not
definitively answer if it had been for
pain or substance abuse. Id. at 582. With
respect to the Ambien prescriptions,
Respondent admitted that he did not
document an insomnia diagnosis. Id. at
583.
SW
SW’s chart indicates that he was being
treated for chronic pain and substance
abuse. While the chart for SW’s first
visit indicates that he was on Oxy 160
mg, Respondent checked ‘‘NO’’ for
whether SW had pain and did not
document the cause or severity of SW’s
pain. GX 5J at 3, 5. Respondent did not
8 In the progress note for this visit, Respondent
indicated that TB had ‘‘NO’’ pain while continuing
to indicate that he had chronic pain. GX 5B, at 4.
In his testimony, Respondent explained he ‘‘marked
off that [TB’s] pain was controlled under the no
part.’’ Tr. 588. The ALJ did not, however, credit this
testimony. See ALJ at 21–22. Nor do I.
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identify a potential source of SW’s pain
until his third and final visit, when he
noted that SW had a herniated disc in
his back and had undergone surgery. Id.
at 3.
SW testified at the hearing and the
ALJ found credible his testimony that he
had a herniated disc in his back, that he
had been taking Oxycontin for the pain,
and that he had begun treatment with
the Respondent in order to get a
different pain medication. Tr. 346. The
ALJ also found credible SW’s testimony
that he told a DI that Respondent was
treating him for chronic pain and that
the Respondent had performed a
physical examination on him.9
However, the ALJ also found credible
SW’s subsequent testimony that he had
told the DI that he was being treated for
substance abuse because ‘‘it was better
being on Suboxone than it was
Oxycontin.’’ Tr. 363.
Respondent did not know who had
prescribed Oxycontin to SW, and SW’s
chart does not contain any prior medical
records. Tr. 684–85; GX 5J. SW testified
that he was addicted to his pain
medications. Tr. 355. Respondent spent
15 to 20 minutes with SW and
prescribed Suboxone to him. Id. at 351–
52; GX 5J. SW testified that he had an
MRI in 2005 or 2006, and a bone scan
in 2001 or 2002, but these test results
were not part of his patient chart in
evidence. Tr. 346, 349, 353, 357; GX 5J.
SW saw Respondent three times. See
GX 5J.10 At the time of the hearing, SW
was still taking Suboxone, but he was
not getting it from Respondent. Tr. at
364–65. Respondent refused to file an
insurance claim for SW., and required
that he pay $100 cash for the visits. Id.
at 102–103.
CL
CL first saw Respondent on December
20, 2009. See GX 22, at 6. Respondent
made a diagnosis of both chronic pain
and bipolar disorder; however,
Respondent did not document the
nature and intensity of the pain (he did
not check either ‘‘YES’’ or ‘‘NO’’ for
9 The ALJ noted that the testimony of the lead DI
and SW conflicted on this point. ALJ at 22 n.3. The
DI testified that SW told him that Respondent was
not treating him for chronic pain and had not
performed a physical examination on him; SW
testified to the contrary. Compare Tr. 102–03, with
id. at 348–49. The ALJ found, however, that the DI
had difficulty recalling the conversation that he had
with SW and his memory had to be refreshed by
the use of his notes, id. at 101–102, but that SW’s
memory required no similar refreshment. Id. at
345–65. I therefore adopt the ALJ credibility finding
that SW’s testimony is a more reliable account of
the conversation that took place between SW and
the DI.
10 SW testified that he saw Respondent four or
five times. Tr. 364. However, SW’s patient file
documents only three visits.
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whether CL had pain), the history of the
pain, whether any treatments had been
previously tried, and the pain’s effect on
her psychological and physical
function. Id. While Respondent noted
that he had performed a physical exam
and found all areas normal, he did not
record any vital signs. Id. Respondent
did not make a substance abuse
diagnosis at this visit and yet prescribed
Suboxone to CL under his X number. Id.
at 7.
Respondent saw CL again on January
17, 2010. Id. at 6. At this visit,
Respondent again diagnosed CL as
having pain even though he noted that
she had ‘‘NO’’ pain and made none of
the findings as explained above. Id. He
also diagnosed her as having substance
abuse and required that CL undergo a
drug screen, the results of which are not
in her chart. Tr. 127–28, 153–54; GX 22.
Respondent did not, however,
document CL’s history of substance
abuse. GX 22, at 6. Respondent again
provided CL with a prescription for
Suboxone. Id. at 7.
Respondent provided CL with
prescriptions for Suboxone on February
14, March 14, April 10, and May 9,
2010. Id. at 2–3, 5. However, the
progress notes for both February 14 and
March 14 contain no information
besides CL’s name, date of birth and the
date of the visit. Id. at 4. The progress
note for April 10 indicates that CL had
chronic pain even though Respondent
checked ‘‘NO’’ for her pain and no
longer listed substance abuse as a
diagnosis. Id. at 1. Finally, the progress
note for CL’s last visit (May 9) again lists
chronic pain as one of three diagnoses
even though Respondent checked that
she had ‘‘NO’’ pain. Id. While the notes
for both the April 10 and May 9 visits
indicate that CL’s physical exam was
normal, Respondent did not document
having taken any vital signs as either
visit. Id.
CP
The earliest progress note for CP is
dated December 20, 2009, which also
corresponds with the earliest date listed
on the record of CP’s Suboxone
prescriptions. GX 23, at 5, 10. The
progress note indicates a diagnosis of
chronic pain, even though Respondent
checked that CP had ‘‘NO’’ pain and
contains no other documentation (such
as the nature and intensity of the pain,
its history, and its effect on CP’s
functioning) to support this diagnosis.
Id. at 5. Respondent also diagnosed CP
as having substance abuse (with no
supporting findings) and anxiety. Id.
While Respondent performed a physical
exam and found all areas normal, he did
not document having taken CP’s vital
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signs. Id. Respondent prescribed
Suboxone and Xanax at this visit using
his X number.
At the next visit, Respondent again
noted that CP had chronic pain while
indicating that he had ‘‘NO’’ pain. Id.
Respondent, however, made an entry in
the blank for ‘‘EXT’’ and for the
‘‘Location,’’ both of which are illegible.
Id. Respondent did not, however, note
a diagnosis of substance abuse at this or
any subsequent visit. See generally id. at
1,3,5.
At CP’s next visit (Feb. 16),
Respondent again diagnosed him as
having chronic pain while noting that
he had ‘‘NO’’ pain. Id. at 3.
Subsequently, at CP’s April 10 visit,
Respondent again checked that CP had
‘‘NO’’ pain while writing ‘‘knee pain’’ in
the ‘‘Review of Systems’’ section; he
also made a note next to the ‘‘EXT’’
section of the Examination which is
illegible but was not asked about this
during his testimony. Id. Finally, at CP’s
final visit, Respondent again diagnosed
him as having chronic pain but noted
that he had ‘‘NO’’ pain and did not
otherwise document any other findings
regarding CP’s pain. Id. at 1. Moreover,
the Government did not offer any
testimony as to whether it had
interviewed CP.
Respondent issued CP prescriptions
for Suboxone on Dec. 20, 2009, Jan. 17,
Feb. 16, Mar. 16, April 10, and May 9,
2010; he also wrote CP prescriptions for
Xanax on each of these dates except for
April 10. GX 23. Respondent wrote both
the Suboxone and Xanax prescriptions
on Dec. 20, 2009, as well as the Jan. 17,
Feb. 16, and March 16, under his X
number. Id. He also wrote the April 10
Suboxone prescription under his X
number even though he did not list a
diagnosis of substance abuse on any of
CP’s visits after the first visit. Id; Tr.
130–31.
CML
On June 23, 2010, another DI
interviewed CML and asked whether
she was ‘‘being treated for pain or
addiction.’’ Tr. 266–67. CML stated that
she was being treated for addiction to
controlled substances and that the
Respondent was prescribing Suboxone
to her. Id. at 267–68. She paid $100.00
cash for her visits. Id. at 268.
On the progress note for CML’s first
visit (Dec. 8, 2009), Respondent checked
that she had both pain and chronic pain,
as well as insomnia. GX 5F, at 7. While
Respondent noted that her physical
exam was normal in all areas, he did not
record any vital signs and did not
document the nature and intensity of
the pain, the history of the pain,
whether any treatments had been
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previously tried, and the pain’s effect on
her psychological and physical function
at any of her subsequent visits. See GX
5F. Respondent did not document that
CML had back pain until her sixth and
final visit (April 27, 2010), while on the
same note checking that she had ‘‘NO’’
pain. Id. at 3.
Indeed, several of the progress notes
for CML’s visits contain no medical
information whatsoever. With respect to
this, Respondent testified, ‘‘In fact,
there’s some entries I didn’t even put in
on February and March of 2010 and I
don’t know why that’s the case.’’ Tr.
472.
At CML’s second visit, Respondent
noted a diagnosis of substance abuse.
GX 5F, at 7. However, Respondent did
not note this diagnosis at any of CML’s
subsequent visits. See GX 5F. Moreover,
the chart contains no information about
what substances CML was abusing and
her history of substance abuse. GX 5F,
at 7; Tr. 666.
Respondent admitted that the chart
fails to adequately document CML’s
pain. Tr. 472. Respondent also testified
that he was tapering CML’s dosages of
Suboxone to find the appropriate levels
to treat her chronic pain. Id. at 473.
Respondent maintained that his care of
CML was within the standard of care.
Id. Respondent prescribed Suboxone
(and Ambien at the first visit) to CML
under his X number at several of the
visits even though he did not document
that he was treating her for substance
abuse at those visits. See GX 5F.
SJW
On December 29, 2009, SJW made her
initial visit to Respondent.11 GX 5I, at 7.
At the visit, Respondent diagnosed SJW
as having both chronic pain and
substance abuse, although he noted that
she had ‘‘NO’’ pain and did not
document the nature and intensity of
the pain, the history of the pain,
whether any treatments had been
previously tried, and the pain’s effect on
her psychological and physical function
at this or any of her subsequent visits.
Id. While Respondent indicated that all
areas of her physical examination were
normal, he did not record any vital signs
at this visit. Id. Nor did Respondent
make any notes regarding SJW’s history
of substance abuse. There is, however,
no evidence that Respondent prescribed
to SJW at this visit.
Respondent did, however, prescribe
Suboxone (and Xanax) to SJW at her
second visit, which occurred one week
later. Id. at 7–8. On the progress note for
this visit, Respondent listed the
11 SJW’s file includes an intake form in which she
listed her medications as ‘‘Suboxin.’’ GX 5I, at 1.
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17513
diagnoses as chronic pain (while
indicating that she had ‘‘NO’’ pain and
failing to document any other
information regarding her condition)
and substance abuse, again without any
documentation. Id. at 7. Moreover, he
again documented that SJW’s physical
exam was normal but did not record any
vital signs. Id. Nor did Respondent
document that SJW had anxiety, the
condition for which Xanax is typically
prescribed, and, in fact, Respondent
indicated ‘‘NO’’ for whether she was
agitated/moody. Id.
While SJW’s chart shows that she
received prescriptions for Suboxone
(and Xanax) in February and March, the
progress notes for this period contain no
information regarding her medical
condition(s). Id. at 2,—5–6. Regarding
these incidents, Respondent stated: ‘‘I
don’t have an explanation for it unless
I had to zip over and take care of
another patient and I just took care of
her and then took off. I don’t know the
situation.’’ Tr. 681.
On May 9, 2010, SJW made her final
visit to Respondent. GX 5I, at 3. At this
visit, Respondent again diagnosed her as
having chronic pain while indicating
that she had ‘‘NO’’ pain and that her
physical examination was normal in all
areas. Id. at 3. Respondent also
diagnosed her as having anxiety, even
though he indicated ‘‘NO’’ for whether
she was agitated or moody. Id.
Respondent issued her prescriptions for
both Suboxone and Xanax. Id. at 4.
On June 23, 2010, a DI phoned SJW
and interviewed her. SJW told the DI
that Respondent was treating her for her
addiction to controlled substances and
that she paid $100 cash for each visit.
Tr. 268–69. On two occasions (Jan. 5
and Feb. 2), Respondent prescribed both
Suboxone and Xanax to SJW under his
X number. Tr. 269; GX 5I, at 6, 8.
Respondent testified that he was
treating SJW for pain and anxiety. Tr.
477, 679.
As for how he made his diagnosis of
substance abuse, Respondent testified
that ‘‘[i]t could be in her history with
me; it could be a drug screen.’’ Id. at
679. There is, however, no evidence in
SJW’s chart establishing that
Respondent took a history or that he
required her to undergo a drug screen.
See generally GX 5I. Moreover, when
asked ‘‘do we see an indication that
[SJW] complained of pain?,’’
Respondent answered: ‘‘No. I did not fill
that out.’’ TR. at 679–80. As for
Respondent’s failure to note why he
prescribed Xanax, Respondent testified:
‘‘No, I did not put an anxiety there. And
there was a good chance that she was on
Xanax already. Did not give it to her in
the December because she probably
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already had an active prescription for it.
And we probably got that from the drug
monitoring system.’’ Id. at 680.
Respondent believed his treatment of
SJW was appropriate, but that his
documentation was ‘‘terrible.’’ Tr. 478.
LMJ
On her intake form, LMJ listed her
medications as ‘‘Loricets’’ [sic]. GX 5E.
At her first visit (Feb. 16, 2010),
Respondent made diagnoses of both
chronic pain and substance abuse. Id. at
4. However, Respondent noted that LMJ
had ‘‘NO’’ pain, that her physical
examination was normal and did not
document the nature and intensity of
the pain, the history of the pain,
whether any treatments had been
previously tried, and the pain’s effect on
her psychological and physical function
at this visit or her next two visits. Id. at
2 & 4. Respondent did not note a
location of any pain LMJ had until her
final visit; even then, however, he did
not document any information other
than that the pain was in her ‘‘back &
arms.’’ Id. at 2. Respondent did not
document having taken LMJ’s vital signs
at any of her visits. Id. at 2, 4. Moreover,
while at LMJ’s first three visits,
Respondent listed a diagnosis of
substance abuse, the chart contains no
information as to her history of
substance abuse. Id. at 2, 4. At each of
LMJ’s visits, Respondent prescribed
Suboxone to her. Id. at 3, 5.
On June 24, 2010, a DI interviewed
LMJ by phone. Tr. 270. The DI asked
LMJ whether she was seeing
Respondent for pain or for addiction to
controlled substances; LMJ said that she
was seeing Respondent for addiction for
which he was prescribing Suboxone. Id.
LMJ also stated that she paid $100.00
cash for each visit. Id.
The ALJ found that Respondent
credibly testified that he did not ‘‘have
a good grasp on her history and physical
as to, is this chronic pain or substance
abuse, so we put the differential as both
of these right now.’’ Id. at 470. She also
found credible Respondent’s testimony
that LMJ was a patient ‘‘who wanted to
get off Lorcet because she was building
such a tolerance having to take more
and more of this for her pain, but I
could not totally rule out that she had
a substance abuse problem.’’ Id. at 471.
While Respondent testified that he
could sometimes rule out a substance
abuse diagnosis ‘‘later on as [I] get a
grasp on these patients, and periodic
random drug screens help me with this
also,’’ there is no evidence that
Respondent required LMJ to undergo a
drug test. Id. Respondent thought his
treatment of LMJ was within the
standard of care. Id.
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MR
MR first saw Respondent on
December 15, 2009. GX 5G, at 7.
Respondent diagnosed MR as having
chronic pain even though he noted that
MR had ‘‘NO’’ pain. Id. Respondent
documented the pain’s location as MR’s
‘‘Teeth’’ and prescribed Suboxone to
him. Id. at 7–8. Respondent testified
that MR’s pain was in his mouth and
jaw, but the chart does not contain any
other information regarding this
condition. Tr. 474, 668; GX 5G.
Moreover, Respondent continued to list
a diagnosis of chronic pain at MR’s
visits of Jan. 17, Feb. 14, and Mar. 30,
even though on the respective progress
notes, he checked ‘‘NO’’ for whether MR
had pain, did not list a location of the
pain, noted that the physical exam was
normal in all areas, and did not
document having taken any vital signs
Id. at 5, 7. Nor is there any evidence that
Respondent referred MR to a dentist.
On both the January 17 and March 30
progress notes, Respondent also listed a
diagnosis of substance abuse. Id. at 5, 7.
However, Respondent did not document
the basis for his diagnosis. Id. At MR’s
final visit, Respondent no longer listed
a diagnosis of substance abuse.
However, he now documented that MR
had right shoulder pain as the result of
a motor vehicle accident. Id. at 3; Tr.
671. Respondent testified that MR had
gone to the emergency room, but that he
had not obtained those records. Tr. 671.
When asked whether MR’s tooth pain
‘‘was no longer an issue in the
subsequent visits’’; Respondent
maintained that ‘‘I just didn’t enter it.’’
Id. at 672. As for the diagnosis of
substance abuse, Respondent did not
note in MR’s chart the substances he
abused, and Respondent could not
remember during his testimony.12 Id. at
668–69; GX 5G.
On June 24, 2010, a DI phoned MR
and interviewed him. Id. at 271. The DI
asked MR whether he was seeing
Respondent for chronic pain or for
addiction; MR stated that ‘‘he was
addicted.’’ Id. at 271–72. MR also said
that he paid $100.00 cash for each visit.
Id. at 272. MR was treated with
Suboxone, which was written on an X
prescription pad. Tr. 474; GX 5G, at 6,
8. Respondent believed his treatment of
MR was appropriate. Tr. 475.
SHY
SHY first saw Respondent on
December 13, 2009. GX 5D, at 8. On the
intake form, SHY listed his medications
12 The ALJ found credible Respondent’s
testimony that he had also diagnosed MR with
bipolar disorder, but that he had failed to annotate
that in the patient’s chart as well. Tr. 474.
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as Suboxone and Zyprexa. Id. at 1.
Respondent diagnosed SHY as having
chronic pain even though he circled
‘‘NO’’ for whether SHY had pain, did
not note the location of the pain, and
did a physical examination during
which he found all areas normal. Id. at
8. Moreover, Respondent did not
document a history of the pain, whether
any treatments had been previously
tried, and the pain’s effect on his
psychological and physical function at
this visit. Id. Respondent also did not
document having taken SHY’s vital
signs.13 Id.
At SHY’s subsequent visits,
Respondent continued to document that
SHY had chronic pain even though he
repeatedly noted that he had ‘‘NO’’
pain, never found anything that was not
normal during the physical exams, and
never listed a location of any pain. Id.
at 4, 6. Respondent also noted a
diagnosis of substance abuse on two
separate occasions, but did not
document SHY’s history of substance
abuse and what substances he was
abusing. Id. He did, however, require
SHY to undergo a drug screen at the first
visit, the results of which were negative
with the exception of the test for
synthetic opioids, which was consistent
with SHY having indicated that his
medications included Suboxone. Id. at
1, 10–11.
On June 22, 2010, a DI called SHY,
and asked him why he was seeing
Respondent. Tr. 288. SHY said that he
was being treated for opiate addiction
and that he was not being treated for
chronic pain. Id. at 288–89.
At the hearing, Respondent testified
that he thought SHY was probably
abusing either Lorcet or Oxycontin. Id.
at 659. However, he then admitted that
he did not document this. Id.
Respondent then claimed that SHY
‘‘probably had a little marijuana or
something like that in a drug screen,
and that’s where we probably gave him
a substance abuse diagnosis.’’ Id. at 660.
SHY did not, however, test positive for
THC. See GX 5D, at 10–11. Respondent
also admitted that he ‘‘did not
document * * * any details of the
pain,’’ but then stated that ‘‘[a] lot of
these people with major depression
have pain from the depression, but we
still put a diagnosis of potential chronic
pain.’’ Id. at 468, see also id. at 655–56.
Respondent acknowledged that he
inappropriately prescribed other
medications than Suboxone using his X
number to SHY. Id. at 468. Respondent
believed his care of SHY was within the
standard of care. Id. 469–70.
13 Respondent also diagnosed SHY as having
major depression.
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JC2
Respondent treated JC2 for chronic
pain, substance abuse, attention deficit
disorder, and extreme anxiety. Tr. 458;
GX 5C. Respondent acknowledged that
JC2 was ‘‘a tough patient,’’ who had
been ‘‘fired’’ by other doctors and had
abused Xanax. Tr. 458–60. A note in
JC2’s chart dated ‘‘9–1–09’’ indicates
that a friend of JC2 had stated that he
was taking twelve Xanax pills at a time.
GX 5C, at 3.
Respondent noted in the chart that
JC2 was abusing Xanax and ‘‘MUST
STOP XANAX.’’ Id. at 2, 12; see also Tr.
459–60, 628. In his testimony,
Respondent stated that his treatment
plan was to gradually taper JC2 off
Xanax, which could take up to a year,
or to manage JC2’s intake. Tr. 460–62,
630. The chart also notes that in
November 2009, JC2 missed two
appointments and was jailed for
distribution. GX 5C, at 8. The chart also
again notes ‘‘Reported taking [greater
than] #12 Xanax @ a time.’’ Id.
Respondent also testified that he knew
‘‘for a fact in this young man’s history
[that] he has been jailed before’’ for
‘‘doing things [that were]
inappropriate.’’ Tr. 631.
The ALJ found that Respondent
credibly testified that he could not just
cease prescribing Xanax to JC2 because
he could have seizures. Id. at 460–61.
However, the patient file shows that
notwithstanding Respondent’s
testimony that he planned to taper JC2
off of Xanax, he actually increased the
daily doses of the prescriptions.
Compare GX 5C, at 11 (Aug. 30, 2009
RX for 30 tablets of Xanax 1.0 mg, c BID
(for daily dose of 1 mg)), with id. at 10
(Oct. 25, 2009 RX for 90 tablet of Xanax
1.0 mg., 1 TID (for daily dose of 3 mg)),
with id. at 5 (Apr. 17, 2010 RX for 60
tablets of Xanax 2.0 mg, 1q12, with 2
refills (for daily dose of 4 mg)). The
chart also demonstrates that Respondent
wrote multiple Xanax and Suboxone
prescriptions under his X number prior
to February 28, 2010. GX 5C, at 7, 9–11,
13. Respondent testified that he
conducted drug screens on JC2, but the
results of these tests were not in JC2’s
medical record. Tr. 633–34.
Respondent testified that he
prescribed Suboxone to treat JC2’s
substance abuse and that substance
abuse was JC2’s primary diagnosis. Id. at
643, 645. Moreover, a note for a visit of
April 5, 2009, states ‘‘Desires To Get
OFF Narcotics.’’ GX 5C, at 15.
Respondent also testified that JC2 was
being seen for chronic pain caused by a
football injury when he was a teenager,
but he then admitted that JC2’s chart
does not document the source or
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severity of that pain. Tr. 654–55. Nor
did Respondent document the history of
the pain, any prior treatments for it and
its effect on JC2’s functioning. See GX
5C. Respondent maintained, however,
that he knew JC2’s history and ‘‘that
he’s had a lot of problems.’’ Tr. 655.
Respondent also testified that JC2 had
been in a narcotic treatment program in
2007 or 2008 and had left against
medical advice. Id. at 631–632. Yet
Respondent did not document this in
JC2’s chart and did not obtain his
treatment records from the narcotic
treatment facility. GX 5C. Respondent
believed he treated JC2 within the
standard of care. Tr. 461.
DA
DA saw Respondent three times: in
December 2009, and in January and
February of 2010. GX 5K. According to
the progress note for the first visit,
Respondent diagnosed DA with chronic
pain and anxiety. Id. at 3. Respondent
circled ‘‘YES’’ for whether DA had pain
and noted that the location was his back
and both legs. Id. Respondent did not,
however, document the nature and
intensity of the pain, its history,
whether any treatments had been
previously tried, and the pain’s effect on
his psychological and physical function
at either this visit or his next visit. Id.
at 3. Moreover, the progress notes for
DA’s first two visits (there is no note for
a third visit on Feb. 21, 2010, even
though there is a prescription for this
date), indicate that Respondent
performed a physical examination and
found all areas normal. Id. Respondent
did not document DA’s vital signs for
either visit. Id. Respondent also noted a
diagnosis of substance abuse at DA’s
second visit but did not document the
basis for this diagnosis. Id. Respondent
issued DA prescriptions for both
Suboxone and Xanax at all three visits,
including on the second visit when he
noted that DA had ‘‘NO’’ pain; on each
occasion, Respondent issued the
prescriptions under his X number. Id. at
4–5.
On June 1, 2010, the lead DI
interviewed DA by phone. Tr. 85. DA
told the DI that he was addicted to pain
killers and that Respondent was treating
him for this condition and not for
chronic pain. Id. at 85–87. In his
testimony, Respondent admitted that he
did not get DA’s medical records for his
pain condition but maintained that he
was familiar with this patient from
treating him in the emergency
department of the Red Bay Hospital. Tr.
693; see generally GX 5K. Respondent
believed that his care was appropriate
for DA. Tr. 482.
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AH
Respondent saw AH four times
beginning on December 13, 2009, and
ending on March 28, 2010. GX 5S.
Respondent noted that AH was taking
12 Lortab 10 mg a day, which she was
getting ‘‘from doctors, friends, [and] off
the street.’’ Tr. 493. Respondent
diagnosed AH with both substance
abuse and chronic pain as a secondary
diagnosis. GX 5S, at 3. While
Respondent noted ‘‘YES’’ for whether
AH had pain, he did not document the
nature, intensity and location of the
pain; the history of the pain; what
treatments had been used; and the
pain’s effect on her physical and
psychological functioning. Id. at 3.
Respondent also noted that AH was
undergoing withdrawal, was agitated/
moody, had insomnia and a positive
MDQ. Id. AH’s physical exam was
normal and Respondent did not
document having taken her vital signs.
Id. At this visit, Respondent prescribed
Suboxone to her under his X number.
GX 5S, at 4.
At AH’s second visit (Feb. 1),
Respondent noted that she had ‘‘NO’’
pain and did not make any other
findings about her pain; he also
indicated that she did not demonstrate
withdrawal, that she was not agitated or
moody and did not have insomnia or a
positive MDQ. GX 5S, at 7. Respondent
did not note any abnormalities in the
physical exam and did not document
having taken AH’s vital signs. Id.
Respondent noted his diagnosis as
Suboxone 16 mg. and gave AH a
prescription for Suboxone which he
wrote under his X number. Id. at 8.
On Feb. 28, Respondent issued AH a
third prescription for Suboxone, again
using his X number. Id. at 8. The
progress note for this visit, however,
lists AH’s name, date of birth and a visit
date but contains no medical
information. Id. at 7.
On March 28, AH again saw
Respondent. Id. at 5. At this visit,
Respondent circled ‘‘YES’’ for whether
she had pain and noted its location as
her neck and back. Id. Once again, he
did not document the nature and
intensity of the pain, the history of the
pain, what treatments had been used,
and the pain’s effect on her physical and
psychological functioning. Id. Again,
Respondent performed a physical exam
but found no abnormalities; he also did
not document having taken AH’s vital
signs. Id. Respondent made diagnoses of
both chronic pain and substance abuse.
Id. Respondent issued AH a new
prescription for Suboxone, which was
written on a prescription form that
contained both of his numbers. Id. at 6.
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Respondent testified that AH had
some neck and back pain, but ‘‘appeared
to be functional.’’ Tr. 493. He was also
‘‘not convinced that [he] could not add
the substance abuse potential to her.’’
Id. Respondent stated that his treatment
of AH was within the standard of care.
Id. at 494.
NK
NK saw Respondent three times
during February and March 2010. GX
5U. On the intake form, NK listed his
medications as Suboxone and Xanax. Id.
at 2. On the progress note for NK’s first
visit, Respondent noted that he had
‘‘NO’’ pain and did not indicate a
location for any pain. Id. at 3.
Respondent noted that he had
performed a physical examination, but
found no abnormalities; Respondent
also did not document having taken
NK’s vital signs. Id. Respondent
nonetheless diagnosed NK as having
both chronic pain and anxiety (but not
substance abuse) and gave him
prescriptions for Suboxone and Xanax,
both of which were written under his X
number. Id. at 5.
On March 9, Respondent issued NK a
second prescription for Suboxone, and
on March 21, he issued NK
prescriptions for both Suboxone and
Xanax. Id. at 4–5. However, the progress
note dated Mar. 9 contains no medical
information and there is no note for
Mar. 21. See generally GX 5U.
On May 25, 2010, the lead DI
interviewed NK. Tr. 78. NK stated that
Respondent was treating him for opiate
addiction, and not for any other medical
problem including chronic pain. Id. at
79. NK also told the DI that he was no
longer seeing Respondent and that ‘‘he
would kick the habit himself.’’ Id. at 78.
NK’s chart also contains a prescription
for Suboxone dated April 17, 2010, even
though NK did not see Respondent on
that date. GX 5U, at 6. Respondent
explained that he had prepared the
prescription in advance of NK’s visit,
but that ‘‘no one gets that prescription
unless I hand it to them.’’ Tr. 497.
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Respondent’s Post-Suspension Conduct
On September 27, 2010, Respondent
was personally served with the Order to
Show Cause and Immediate Suspension
of Registration. At that time, the lead DI
explained to Respondent that, as of that
date, he was no longer authorized to
prescribe or handle any controlled
substances. Tr. 112–13. Respondent told
the DI that ‘‘he was not going to abide
by this order and that (the DI) didn’t
have the authority to tell him that he
couldn’t prescribe any controlled
substances.’’ Id. at 113.
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Thereafter, the lead DI discovered that
Respondent had issued controlledsubstance prescriptions which were
dated September 29, October 3 and
October 4, 2010. Tr. 114; GX 6. While
the ALJ found that there were a total of
four post-suspension prescriptions, two
of the prescription forms contained
prescriptions for two controlled
substances. ALJ at 34; but see GX 6, at
3–4.
The first prescription, which was
issued to CW and dated September 29,
2010, was for the drug Adderall, a
schedule II controlled substance. GX 6,
at 1. CW told the lead DI that
Respondent wrote the prescription after
she had been seen by Respondent’s
Physician’s Assistant, CC. CW picked
up the prescription the next day,
September 30. Tr. 115–118; GX 6, at 1.
Respondent admitted to signing this
prescription. Tr. 506–07; see also RX 29,
at 17–19 (CW’s chart for Sept. 29, 2010
visit).
The second prescription, which was
issued to JB and dated October 3, 2010,
was also for Adderall. Tr. 118–19, 200–
01; GX 6, at 2. However, the evidence
showed that Respondent had issued the
prescription on September 3, 2010. Tr.
119–20, 508, 733–34. This prescription
did not, however, include Respondent’s
registration number and listed only his
X number. GX 6, at 2.
The lead DI contacted the pharmacist
who filled the prescription, and was
told that the pharmacy would not accept
a post-dated prescription for a
scheduled drug. Tr. 123. The pharmacist
remembered this prescription and
further stated that it had actually been
presented for filling on October 3, 2010.
Tr. 123–24, 158–59. The lead DI
testified that while it would have been
permissible to write a prescription and
sign it on September 3, 2010, with the
annotation of ‘‘do not fill until October
3, 2010,’’ it was not permissible for
Respondent to sign a schedule II
prescription on September 3 but date
the prescription for October 3rd. Tr.
124.
The evidence also included two
prescriptions issued (on a single
prescription form) to MK and dated
October 4, 2010; the prescriptions were
for 60 Adderall and 90 Lortab 10 mg,
another schedule III narcotic. GX 6, at
3. The lead DI contacted MK about the
prescriptions; MK confirmed that the
prescriptions were written and received
on October 4, 2010. Tr. 124–25. While
Respondent testified that the
prescriptions had been post-dated, he
admitted to having written the
prescriptions on September 29, two
days after he was served with the
Immediate Suspension Order. Tr. 508–
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09; 740–41. Respondent maintained that
the prescription was given to MK by
mistake. Id. at 741. MK’s patient file
includes a progress note which
establishes that she saw Respondent on
September 29, 2010. RX 32, at 28.
Notwithstanding the testimony
regarding MK’s statement as to the date
the prescriptions were written, I find
that the prescriptions were written on
September 29.
The evidence also included two
prescriptions which were issued to DH
and also dated October 4, 2010. GX 6,
at 4. The prescriptions were for 90
Lortab 10 mg and 90 Xanax 1 mg. Tr.
126, 509; GX 6, at 4.
Respondent testified that he thought
that he had seen DH in September but
that he did not know ‘‘exactly which
day I saw him.’’ Tr. 509. Respondent
admitted, however, that the prescription
was in his handwriting and that he
‘‘signed it.’’ Continuing, he maintained
that he did not have an explanation for
it, that ‘‘[t]his was an accident,’’ and
that he ‘‘would never do anything to
violate an order.’’ Id. at 509.
According to DH’s patient file, DH
saw Respondent on September 29,
2010.14 RX 31, at 28. The chart for the
visit noted that DH was ‘‘Here for med
refills’’ and that he was ‘‘here for Dr.
Cochran,’’ and that his ‘‘Current Meds’’
were Lortab and Xanax. Id. In addition,
Respondent signed the chart. Id. I
therefore find that Respondent wrote the
prescriptions on September 29.
Respondent’s Testimony
Respondent maintained that some of
the patients did not know what they
were being treated for. Tr. 743–44.
However, Respondent did not document
any patient’s lack of understanding of
his diagnosis in the patient files. Tr.
745. Moreover, the ALJ did not find this
testimony credible. ALJ at 49.
As noted above, Respondent provided
evidence that he had stopped
prescribing methadone to his patients.
Moreover, Respondent established that
he had stopped using his X number to
write prescriptions for drugs other than
Suboxone and when prescribing
Suboxone to treat pain. However, on
September 3, 2010, Respondent wrote a
further controlled substance
prescription for Adderall (which was
post-dated) under his X number. GX 6,
at 2.
Respondent also testified that he
maintained the drugs screens he ordered
on his patients in a separate file which
he called the ‘‘Drug Screen Book.’’ Tr.
687. Respondent testified that when the
14 DH’s previous visit was on August 4, 2010. RX
31, at 30.
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DIs obtained the patient files, they did
not take the Drug Screen Book.’’ Id.
Respondent did not, however, submit
the Drug Screen Book for the record.
Respondent agreed that his patient
charts were incomplete. Tr. 452. In one
case Respondent testified that his record
keeping was incorrect and he had
mistakenly written the wrong primary
diagnosis for the patient. Id. at 654.
Respondent, however, offered no
evidence that he was prepared to
comply with the Alabama Board’s
Guidelines For The Use Of Controlled
Substances For The Treatment Of Pain.
See Ala. Admin Code r.540–x–4–.08.
Discussion
Section 304(a) of the Controlled
Substances Act provides that a
‘‘registration pursuant to section 823 of
this title to * * * dispense a controlled
substance * * * may be suspended or
revoked by the Attorney General upon
a finding that the registrant * * * has
committed such acts as would render
his registration under section 823 of this
title inconsistent with the public
interest as determined under such
section.’’ 21 U.S.C. 824(a)(4). In
determining the public interest,
Congress directed that the following
factors be considered:
(1) The recommendation of the
appropriate State licensing board or
professional disciplinary authority.
(2) The applicant’s experience in
dispensing * * * controlled substances.
(3) The applicant’s conviction record
under Federal or State laws relating to
the manufacture, distribution, or
dispensing of controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to
controlled substances.
(5) Such other conduct which may
threaten the public health and safety.
21 U.S.C. 823(f). In addition, pursuant
to 21 U.S.C. 824(d), ‘‘[t]he Attorney
General may, in his discretion, suspend
any registration simultaneously with the
institution of proceedings under this
section, in cases where he finds that
there is an imminent danger to public
health or safety.’’
The public interest factors are
considered in the disjunctive. Robert A.
Leslie, 68 FR 15227, 15230 (2003). I may
rely on any one or a combination of
factors and may give each factor the
weight I deem appropriate in
determining whether to revoke an
existing registration or to deny an
application for a registration. Id.
Moreover, I am ‘‘not required to make
findings as to all of the factors.’’ Hoxie
v. DEA, 419 F.3d 477, 482 (6th Cir.
2005); see also Morall v. DEA, 412 F.3d
165, 173–74 (DC Cir. 2005).
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The Government has ‘‘the burden of
proving that the requirements for * * *
revocation or suspension pursuant to
section 304(a) * * * are satisfied.’’ 21
CFR 1301.44(e); see also 21 CFR
1301.44(d) (Government has ‘‘the
burden of proving that the requirements
for [a] registration pursuant to section
303 * * * are not satisfied’’). However,
where the Government satisfies its
prima facie burden, the burden then
shifts to the registrant to demonstrate
why he can be entrusted with a new
registration. Medicine ShoppeJonesborough, 73 FR 364, 380 (2008).
Having considered all of the factors, I
conclude that the Government’s
evidence pertinent to factors two
(Respondent’s experience in dispensing
controlled substances) and four
(Respondent’s compliance with
applicable laws related to controlled
substances), establishes that Respondent
has committed acts which render his
registration ‘‘inconsistent with the
public interest.’’ 21 U.S.C. 824(a)(4). I
further conclude that Respondent has
not rebutted the Government’s prima
facie case.
Factors One and Three—The
Recommendation of the State Board
and Respondent’s Record of
Convictions Under Laws Relating to the
Manufacture, Distribution and
Dispensing of Controlled Substances
The record establishes that the State
Board has an open investigation of
Respondent. However, the Board has
not made a recommendation in this
matter, and it is undisputed that
Respondent’s medical license remains
active and unrestricted. Accordingly,
this factor does not support a finding
either for, or against, the continuation of
Respondent’s registration. See Joseph
Gaudio, 74 FR 10083, 10090 n.25
(2009); Mortimer B. Levin, 55 FR 8209,
8210 (1990).
There is also no evidence in the
record that Respondent has been
convicted of an offense related to the
manufacture, distribution or dispensing
of controlled substances. While this
factor supports the continuation of
Respondent’s registration, DEA has long
held that this factor is not dispositive.
See, e.g., Edmund Chein, 72 FR 6580,
6593 n.22 (2007).
Factors Two and Four—Respondent’s
Experience in Dispensing Controlled
Substances and Compliance With
Applicable Laws Related to Controlled
Substances
The record establishes that
Respondent violated numerous
provisions of Federal law and DEA
regulations. These include: (1) The
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17517
prescribing of methadone for substance
abuse treatment without being
registered to do so under 21 U.S.C.
823(g)(1), in violation of 21 U.S.C.
841(a)(1); (2) the prescribing of
methadone for substance abuse
treatment, in violation of 21 CFR
1306.04(c) and 1306.07; (3) prescribing
controlled substances without a
legitimate medical purpose, in violation
of 21 CFR 1306.04(a); (4) the post-dating
of prescriptions, in violation of 21 CFR
1306.05(a); and (5) prescribing
controlled substances when his
registration had been suspended, in
violation of 21 U.S.C. 843(a)(2).
The Methadone Prescriptions
Under 21 U.S.C. 823(g)(1),
‘‘practitioners who dispense narcotic
drugs to individuals for maintenance
treatment or detoxification treatment
shall obtain annually a separate
registration [from their practitioner’s
registration] for that purpose.’’15 In the
Drug Addiction Treatment Act of 2000,
Congress provided that the requirement
to obtain a separate registration is
‘‘waived in the case of the dispensing
(including the prescribing), by a
practitioner, of narcotic drugs in
schedule III, IV, or V or combinations of
such drugs if the practitioner meets the
conditions specified in [section
823(g)(2)(B)] and the narcotic drugs or
combinations of such drugs meet the
conditions specified in [section
823(g)(2)(C)].’’ Id. § 823(g)(2)(A)
(emphasis added).
Methadone is, however, a schedule II
narcotic, and thus, except for where a
patient presents with acute withdrawal
symptoms (and then for no more than a
total of three days), cannot be lawfully
dispensed for the purpose of
maintenance or detoxification treatment
absent the practitioner’s holding a
registration under section 823(g)(1). See
21 U.S.C. 812(c) (Schedule II (b)(11)); 21
CFR 1308.12(c)(15). Moreover, under
DEA’s regulations, ‘‘[a] prescription may
not be issued for ‘detoxification
treatment’ or ‘maintenance treatment,’
unless the prescription is for a Schedule
III, IV, or V narcotic drug approved by
the Food and Drug Administration
15 An applicant for registration under this
provision must meet three requirements: (1) The
applicant must be ‘‘determined by the Secretary [of
HHS] to be qualified * * * to engage in the
treatment with respect to which registration is
sought; (2) the Attorney General must ‘‘determine[]
that the applicant will comply with standards
* * * respecting (i) security of stocks of narcotic
drugs for such treatment, and (ii) the maintenance
of records * * *. on such drugs,’’ and (3) ‘‘if the
Secretary determines that the applicant will comply
with standards * * * respecting the quantities of
narcotic drugs which may be provided for
unsupervised use by individuals in such
treatment.’’ 21 U.S.C. 823(g)(1).
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specifically for use in maintenance or
detoxification treatment.’’ 21 CFR
1306.04(c).16 See also id. 1306.07(a) (‘‘A
practitioner may administer or dispense
directly (but not prescribe) a narcotic
drug listed in any schedule * * * for
the purpose of maintenance or
detoxification treatment if the
practitioner * * * is separately
registered with DEA as a narcotic
treatment program [and] is in
compliance with DEA regulations
regarding treatment qualifications,
security, records, and unsupervised use
of the drugs pursuant to the [CSA].’’)
(emphasis added); id. 1306.07(b)
(‘‘Nothing in this section shall prohibit
a physician * * * from administering
(but not prescribing) narcotic drugs to a
person for the purpose of relieving acute
withdrawal symptoms when necessary
while arrangements are being made for
referral for treatment. Not more than one
day’s medication may be administered
to the person or for the person’s use at
one time. Such emergency treatment
may be carried out for not more than
three days and may not be renewed or
extended.’’) (emphasis added).
Also relevant here is the definition of
the term ‘‘maintenance treatment.’’ 21
U.S.C. 802(29). Under the CSA, the term
‘‘means the dispensing, for a period in
excess of twenty-one days, of a narcotic
drug in the treatment of an individual
for dependence upon heroin or other
morphine-like drugs.’’ Id.17
Finally, Respondent claimed that
most of the patients whose files were
introduced into evidence (including
some of the methadone patients) were
chronic pain patients. Under a
longstanding DEA regulation, to be
effective, ‘‘[a] prescription for a
controlled substance * * * must be
issued for a legitimate medical purpose
by an individual practitioner acting in
the usual course of his professional
practice.’’ 21 CFR 1306.04(a). As the
Supreme Court has explained, ‘‘the
prescription requirement * * * ensures
patients use controlled substances
16 See also 21 CFR 1306.07(d) (‘‘A practitioner
may administer or dispense (including prescribe)
any Schedule III, IV, or V narcotic drug approved
specifically by the Food and Drug Administration
specifically for use in maintenance or detoxification
treatment to a drug dependent person if the
practitioner complies with the requirements of [21
CFR 1301.28].’’ 21 CFR 1301.28 is the provision
which implements the DATA Waiver Act.
17 The CSA also defines the term ‘‘detoxification
treatment.’’ 21 U.S.C. 802(30). The term ‘‘means the
dispensing, for a period not in excess of one
hundred and eighty days, of a narcotic drug in
decreasing doses to an individual in order to
alleviate adverse physiological or psychological
effects incident to withdrawal from the continuous
or sustained use of a narcotic drug and as a method
of bringing the individual to a narcotic drug-free
state within such period.’’ Id.
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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.
243, 274 (2006) (citing United States v.
Moore, 423 U.S. 122, 135, 143 (1975)).
Under the CSA, it is fundamental that
a practitioner must establish and
maintain a bonafide doctor-patient
relationship in order to act ‘‘in the usual
course of * * * professional practice’’
and to issue a prescription for a
‘‘legitimate medical purpose.’’ Laurence
T. McKinney, 73 FR 43260, 43265 n.22
(2008); see also Moore, 423 U.S. at 142–
43 (noting that evidence established that
physician ‘‘exceeded the bounds of
‘professional practice,’’’ when ‘‘he gave
inadequate physical examinations or
none at all,’’ ‘‘ignored the results of the
tests he did make,’’ and ‘‘took no
precautions against * * * misuse and
diversion’’). The CSA, however,
generally looks to state law to determine
whether a doctor and patient have
established a bonafide doctor-patient
relationship. See Kamir Garces-Mejias,
72 FR 54931, 54935 (2007); United
Prescription Services, Inc., 72 FR 50397,
50407 (2007).
By regulation, the Alabama Board of
Medical Examiners has adopted
Guidelines For The Use of Controlled
Substances For The Treatment of Pain.
See Ala. Admin. Code r. 540–X–4-.08.
According to the Board, the ‘‘guidelines
are not intended to define complete or
best practice, but rather to communicate
what the Board considers to be within
the boundaries of professional practice.’’
Id. (1)(g). Guideline (2)(a), which is
captioned ‘‘Evaluation of the Patient,’’
states:
A complete medical history and physical
examination must be conducted and
documented in the medical record. The
medical record should document the nature
and intensity of the pain, current and past
treatments for pain, underlying or coexisting
diseases or conditions, the effect of the pain
on physical and psychological function, and
history of substance abuse. The medical
record also should document the presence of
one or more recognized medical indications
for the use of a controlled substance.
Id. (2)(a).18
18 See also Ala. Admin. Code r. 540–X–4.08(2)(b)
(‘‘The written treatment plan should state objectives
that will be used to determine treatment success,
such as pain relief and improved physical and
psychosocial function, and should indicate if any
further diagnostic evaluations or other treatments
are planned.’’).
The Guidelines also provide that:
The physician should keep accurate and
complete records to include
1. The medical history and physical examination;
2. Diagnostic, therapeutic and laboratory results;
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The record contains substantial
evidence that Respondent prescribed
methadone to opiate addicted patients
for the purpose of providing
maintenance treatment. During his
initial interview (on Feb. 28, 2010) with
the Investigators, Respondent told them
that ‘‘he was operating a detox clinic
where he was using methadone to get
his patients onto Suboxone.’’ Tr. 43. It
was not until later that day, when the
Investigators interviewed Respondent
for the second time, that he claimed that
he prescribed methadone for pain and
that he had previously misspoken. Id. at
55.
Other evidence supports the
conclusion that Respondent was
prescribing methadone to provide
maintenance or detoxification treatment
to opiate addicted patients. On the date
of the visit, Investigators interviewed
JKB, who told them that he was being
treated by Respondent with methadone
for opiate addiction. Id. at 52. JKB
further stated that he had previously
gone to a narcotic treatment program,
which used methadone, and that he was
seeing Respondent because the latter
charged less. Id. at 52–53. JKB also
stated that Respondent was not treating
him for chronic pain. Id. at 53.
The Government introduced into
evidence seven files of patients who
received methadone prescriptions from
Respondent. GXs 5X; 5O; 5A; 5N; 5L;
5M; and 5T. The Government also
elicited the testimony of the DIs to the
effect that they had interviewed several
of the patients to determine what
condition they were being treated for.
Patient TP related that she had gone
to Respondent because she had heard
that he was using methadone to treat
addiction; TP also noted on her intake
form that she had previously gone to a
methadone clinic and was taking twelve
tablets of methadone 10 mg strength a
day. Respondent issued her
prescriptions for methadone on three
separate dates over the course of a
month, and ultimately TP returned to a
methadone clinic.
While Respondent maintained that TP
had been going to the methadone clinic
for pain, he conceded that the purpose
of a methadone clinic is to treat
addiction. Moreover, while Respondent
noted diagnoses of both chronic pain
and substance abuse on TP’s progress
3. Evaluations and consultations;
4. Treatment objectives;
5. Discussion of risks and benefits;
6. Treatments;
7. Medications (including date, type, dosage and
quantity prescribed);
8. Instructions and agreements;
9. Periodic reviews.
Id. 2(f).
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notes, he did not document having
taken a medical history, the nature and
intensity of any pain, current and past
treatments for paint, and its effect on
her physical and psychological
functioning.
I thus conclude that Respondent
prescribed methadone to TP for
maintenance or detoxification purposes
and not to treat chronic pain. In doing
so, he violated the CSA because he did
not have the registration required under
section 823(g)(1) to dispense methadone
for this purpose; he also violated DEA
regulations which prohibit the
prescribing of narcotic drugs for this
purpose except for those drugs in
schedules III through V which have
been specifically approved by the FDA
to provide maintenance or
detoxification treatment. 21 CFR
1306.04(c).
The DIs also interviewed MB, who
stated that she was being treated by
Respondent for an addiction to Lorcet
and not for chronic pain. Respondent
testified, however, that he was treating
MB both for chronic pain cause by
headaches and substance abuse.
Respondent prescribed methadone to
her on six different dates.
Notably, the Government did not
produce any evidence corroborating
MB’s statement that she was not being
treated for chronic pain. See
Consolidated Edison Co. v. NLRB, 305
U.S. 197, 230 (1938) (‘‘Mere
uncorroborated hearsay * * * does not
constitute substantial evidence.).
However, even if this evidence is not
sufficient to establish that Respondent
was treating her only for substance
abuse and crediting his testimony that
he was also treating her for chronic
pain, I conclude that the prescriptions
were unlawful.
Notably, Respondent did not
document the nature and intensity of
her pain, its effect on both her physical
and psychological function, any prior or
current treatment for it, and her history
of substance abuse. See Ala. Admin
Code r.540–X–4.08(2)(a). Accordingly,
because Respondent did not make any
of the findings required under the
Alabama guidelines, I conclude that he
did not have a basis for his diagnosis of
chronic pain. I thus conclude that
Respondent acted outside of ‘‘the usual
course of * * * professional practice’’
and lacked a ‘‘legitimate medical
purpose’’ in issuing the methadone
prescriptions to MB and violated
Federal law. 21 CFR 1306.04(a).19
19 As explained above, if Respondent was treating
MB for substance abuse, the methadone
prescriptions were illegal because methadone
cannot be prescribed for this purpose and because
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Respondent issued three methadone
prescriptions (on Feb. 9, 23, and Mar. 9)
to JC1 (GX 5N), each of which was for
210 tablets with a daily dose of 150 mg.
Respondent admitted that JC1 had come
from another methadone clinic even
though he denied that JC1 had gone to
the clinic to be treated for addiction and
maintained that he had gone there for
pain management. Moreover, while
Respondent also maintained that JC1
had come to him because ‘‘he wanted to
take a cleaner medicine for his pain,’’
when Respondent stopped writing
methadone prescriptions, JC1 decided to
go to another treatment facility.
In addition, notwithstanding
Respondent’s claim that he was treating
JC1 for pain, at his first two visits (and
at which Respondent prescribed
methadone), Respondent noted that JC1
had ‘‘NO’’ pain; and at the third visit,
where he issued a further methadone
prescription, Respondent did not even
make a progress note. Respondent also
failed to document any of the findings
set forth in Alabama’s Guideline 2(a).
Accordingly, I conclude that
Respondent prescribed methadone to
JC1 for maintenance/detoxification
purposes without the required
registration and violated DEA
regulations which prohibit the
prescribing of schedule II narcotics for
this purpose. 21 U.S.C. 823(g)(1); 21
CFR 1306.04(c).
JB also came to Respondent from a
narcotic treatment program, which he
had been kicked out of. Respondent
noted this in the chart and that JB
‘‘desire[d] to get off methadone.’’
Respondent asserted that the fact that JB
had been treated at a methadone clinic
did not mean that the clinic was treating
him for addiction, even though that is
the purpose of a methadone clinic;
moreover, he admitted that he did not
obtain JB’s records from the clinic. After
Respondent stopped prescribing
methadone to JB, the latter went to
another methadone clinic.
While Respondent documented that
JB had foot and knee pain, and the
progress notes include a few additional
statements regarding his pain such as
the location and that JB had been in an
accident, the notes do not document the
nature and intensity of pain, any prior
treatments for it, and its effect on JB’s
functioning. Moreover, Respondent
noted that he planned to put JB on his
alternative medication program. Given
JB’s prior history of substance abuse
treatment and his express ‘‘desire to get
off methadone,’’ I conclude that
Respondent’s primary purpose in
he did not hold the required registration. See 21
U.S.C. 823(g)(1); 21 CFR 1306.07(a) & (b).
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17519
prescribing methadone to him (which
he did on three occasions over a month)
was to provide maintenance/
detoxification treatment. I thus
conclude that Respondent violated the
CSA and DEA regulations in doing so.
21 U.S.C. 823(g)(1); 21 CFR 1306.04(c).
Respondent testified that NB told him
at the initial visit that she had been on
180 mg of methadone which she was
taking for pain. He also testified that she
was a ‘‘troubling patient’’ because she
was on both methadone and Xanax and
that this was a great concern, especially
if she mixed the drugs with alcohol.
Respondent diagnosed NB as having
chronic pain even though he noted on
her chart that she had ‘‘NO’’ pain, and
he did not document any further
findings to support a diagnosis of
chronic pain. Moreover,
notwithstanding his express concern
that NB was on both methadone and
Xanax, Respondent prescribed Xanax to
her and did not document that she had
anxiety, although he maintained in his
testimony that she ‘‘had some anxiety.’’
The evidence is insufficient to
support the conclusion that NB sought
treatment from Respondent for a
substance abuse problem. However, the
evidence does support the conclusion
that Respondent acted outside of the
usual course of professional practice
and lacked a legitimate medical purpose
in prescribing methadone to her. 21 CFR
1306.04(a). Having noted on NB’s chart
that she had ‘‘NO’’ pain, and having
failed to document any further findings
as required by the Guidelines to support
his chronic pain diagnosis (and to
explain the inconsistency between his
diagnosis and his notation that she had
no pain), it is clear that Respondent
lacked a legitimate medical purpose in
prescribing methadone to her.
KI noted on her intake form that she
was using three controlled substances:
methadone, Xanax and Ambien.
Respondent also acknowledged that KI
had previously been treated at a narcotic
treatment facility and that she had taken
narcotics and become addicted to them.
However, he denied that KI had told her
that she had gone to the methadone
clinic to treat her addiction—as if there
was any other reason a person would
seek treatment from a methadone clinic.
While Respondent maintained that KI
had diagnoses of both substance abuse
and chronic pain, on the progress note
for her initial visit, he noted that she
had ‘‘NO’’ pain although he wrote
‘‘Back’’ as the location. Respondent did
not document any findings that would
explain the inconsistency between his
diagnosis and his having noted that KI
had ‘‘NO’’ pain; he also did not
document the history of any pain, what
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treatment had been used, and the pain’s
effect on her physical and psychological
functioning.
Respondent issued three methadone
prescriptions to KI. I conclude that
Respondent’s purpose in doing so was
not to treat pain, but to provide
maintenance/detoxification treatment to
her. I thus conclude that Respondent
violated Federal law by prescribing
methadone to KI for maintenance/
detoxification treatment without the
required registration and violated DEA
regulations which prohibit the
prescribing of schedule II narcotics for
this purpose. 21 U.S.C. 823(g)(1); 21
CFR 1306.04(c).20
tkelley on DSK3SPTVN1PROD with NOTICES
The Suboxone Prescriptions
As found above, Respondent also
prescribed Suboxone, a schedule III
controlled substance, to numerous
patients. The Government elicited the
testimony of the DIs as to phone
interviews they conducted with sixteen
of these patients, the majority of whom
said that Respondent was treating them
for substance abuse and not chronic
pain. See Tr. at 78 (NK); id. at 80–81
(AG); id. at 82–83 (LM); id. at 83–84
(ET); id. at 85–87 (DA); id. at 87–88
(CT); id. at 89–90 (JH); id. at 92–94 (KP);
id. at 95–98 (SS); id. at 266–67 (CML);
id. at 268–69 (SJW); id. at 270 (LMJ); id.
at 271 (MR); id. at 288–89 (SHY).
As found above, Respondent testified
that many of these patients were
actually being treated for chronic pain
in addition to substance abuse, or were
just being treated for chronic pain.
Moreover, Respondent frequently noted
both diagnoses on the patient’s charts,
although in some instances he did not
note a substance abuse diagnosis until
after the first visit (and sometimes not
until after several visits). See, e.g., GX
5P (AG); GX 5V (LM); GX 5Y (CT); GX
5R (JH); GX 5B (TB); GX 5J (SW); GX 5I
(SJW); GX 5E (LMJ); GX 5D (SHY); GX
5K (DA).
However, even if it is the case that
most of the Suboxone patients were
being treated only for substance abuse,
the Government did not offer any
evidence (whether in the form of
clinical standards or expert testimony)
establishing what the appropriate course
of professional practice requires of a
physician treating patients for substance
abuse.21 In short, while in its brief, the
Government repeatedly argues that
20 Given the conflicting evidence regarding DG, I
decline to make any legal conclusions regarding
Respondent’s prescribing of methadone to him.
21 While the Government introduced the Alabama
Guidelines on using controlled substances to treat
pain, it offered no evidence establishing that these
standards apply to the treatment of substance abuse
patients.
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19:32 Mar 23, 2012
Jkt 226001
Respondent lacked a medical
justification to support his diagnosis of
substance abuse for the various patients
and his issuance of the Suboxone
prescriptions, the Government’s failure
to offer any probative evidence as to the
standards of medical practice for
diagnosing and treating a substance
abuse patient precludes a finding that
Respondent lacked a legitimate medical
purpose when he prescribed Suboxone
to these patients.
Respondent, however, testified that
many of the Suboxone patients were
actually being treated for chronic pain,
and he noted this as his primary
diagnosis in many of their charts. As
explained above, the Alabama
Guidelines require that a physician who
prescribes controlled substances to treat
pain, obtain ‘‘[a] complete medical
history’’ and document this in the
patient’s medical record. Moreover, the
Guidelines state that the record ‘‘should
document the nature and intensity of
the pain, current and past treatments for
pain, underlying or coexisting diseases
or conditions, the effect of the pain on
physical and psychological function,
and history of substance abuse.’’ Ala.
Admin. Code r. 540–X–4–.08(2)(A).
As found above, at the initial visits of
nine of the Suboxone patients,
Respondent diagnosed them as having
chronic pain but not substance abuse.
See supra Findings for Patients SS, ET,
KP, CL, CML, MR, SHY, DA, and NK.
Notwithstanding his diagnosis,
Respondent typically did not even list a
location of a patient’s purported pain
and/or did not list a location until after
the patient had made several visits. See
supra Findings for ET, KP, CL, CML,
SHY, NK. Moreover, Respondent did
not document the nature and intensity
of the patient’s pain, the pain’s effect on
the patient’s ability to function, and
rarely documented any past treatments
for the pain, and the patient’s substance
abuse history at either the initial visit or
follow-up visits.22
Tellingly, in the charts, Respondent
frequently noted that the patients had
‘‘NO’’ pain, yet nonetheless diagnosed
them as having chronic pain. See
Findings for SS, ET, KP, CL, MR, SHY,
and NK. Respondent offered no
explanation for the inconsistency
between his findings and his diagnosis
with respect to any of these patients.
Based on Respondent’s having noted
that these patients had no pain and his
failure to offer any explanation for why
he nonetheless diagnosed the patients as
22 While Respondent’s charts included a Plan
section, none of them included the ‘‘objectives that
will be used to determine treatment success.’’ Ala.
Admin. Code r.540–X–4-.08(2)(b).
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Fmt 4703
Sfmt 4703
having chronic pain, I conclude that
Respondent lacked a legitimate medical
purpose and acted outside of the usual
course of professional practice in
violation of 21 CFR 1306.04(a) when he
prescribed Suboxone to these patients
for the purpose of treating chronic pain.
The Government further argues, and
the ALJ agreed, that Respondent
violated 21 CFR 1306.07(c), because his
‘‘charts failed to show the use of any
treatment options besides the
prescribing of controlled substances.’’
ALJ at 47. The ALJ further explained
that ‘‘[s]uch lack of attempts of
alternative modalities prior to
determining that the patient suffers from
chronic pain violates’’ this regulation.
Id.
Both the Government and the ALJ
clearly misread the regulation. This
provision, which is part of the
regulation setting forth the requirements
for dispensing narcotic controlled
substances ‘‘to a narcotic dependant[sic]
person for the purpose of maintenance
or detoxification treatment’’ states:
This section is not intended to impose any
limitations on a physician or authorized
hospital staff to administer or dispense
narcotic drugs in a hospital to maintain or
detoxify a person as an incidental adjunct to
medical or surgical treatment of conditions
other than addiction, or to administer or
dispense narcotic drugs to persons with
intractable pain in which no relief or cure is
possible or none had been found after
reasonable efforts.
21 CFR 1306.07(c).
The Government’s and the ALJ’s
construction of this regulation as
imposing—by implication no less—an
affirmative obligation for a physician to
engage in alternative treatment
modalities cannot be squared with the
purpose of the CSA, which ‘‘manifests
no intent to regulate the practice of
medicine generally,’’ an authority which
remains vested in the States. Gonzales v.
Oregon, 546 U.S. 243, 270 (2006).
Rather, in any case, whether a physician
has an adequate basis for concluding
that ‘‘no relief or cure is possible’’ for
a patient’s pain, or that alternative
treatments should be tried, is a clinical
judgment which must be assessed by
reference to the standards of medical
practice as set by the state medical
boards and the profession itself. While
a practitioner’s failure to recommend
alternative treatments may provide
some evidence as to whether a
prescription complies with 21 CFR
1306.04(a), the Government produced
no expert testimony establishing with
respect to any patient, that under the
standards of medical practice,
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Respondent was required to recommend
alternative treatments.23
Other Allegations
The ALJ found that ‘‘[t]he parties do
not dispute that Respondent improperly
used his ‘X’ prescription registration to
prescribe controlled and non-controlled
substances other than Suboxone or
Subutex.’’ ALJ at 43. The problem with
the ALJ’s reasoning is that an X number
is not a registration at all, but only an
identification number.
As the statute states: ‘‘Upon receiving
a notification under subparagraph (B)
[of a practitioner’s intent to prescribe
narcotic drugs in schedules III through
V for maintenance or detoxification
treatment], the Attorney General shall
assign the practitioner involved an
identification number under this
paragraph for inclusion with the
registration issued for the practitioner
pursuant to subsection (f) of this
section.’’ 21 U.S.C. 823(g)(2)(D)(ii)
(emphasis added). See also 21 CFR
1301.28(a) (‘‘An individual practitioner
may dispense or prescribe Schedule III,
IV, or V narcotic controlled drugs * * *
which have been approved by the Food
and Drug Administration (FDA)
specifically for use in maintenance or
detoxification treatment without
obtaining the separate registration
required by § 1301.13(e). * * *’’); id.
§ 1301.28(d)(1) (‘‘If the individual
practitioner has the appropriate
registration under § 1301.13, then the
Administrator will issue the practitioner
an identification number. * * * ’’)
(emphasis added).
Moreover, under DEA’s regulations,
tkelley on DSK3SPTVN1PROD with NOTICES
[a]ll prescriptions for controlled substances
shall be dated as of, and signed on, the day
when issued and shall bear the full name and
address of the patient, the drug name,
strength, dosage form, quantity prescribed,
directions for use and the name, address and
registration number of the practitioner. In
addition, a prescription for a Schedule III, IV,
or V narcotic drug approved by FDA
specifically for ‘detoxification treatment’ or
‘maintenance treatment’ must include the
identification number issued by the
Administrator under § 1301.28(d) of this
chapter or a written notice stating that the
practitioner is acting under the good faith
exception of § 1301.28(e).
23 The ALJ noted that ‘‘Respondent testified, and
the record contains no expert evidence to the
contrary, that his treatment of his patients met the
standard of care.’’ ALJ at 48. While evidence as to
the standard of care is admissible in criminal
prosecutions under 21 U.S.C. 841(a)(1), I conclude
that the Alabama Guidelines provide substantial
evidence as to accepted boundaries of professional
practice in prescribing controlled substances for the
treatment of pain. See Ala. Admin. Code r. 540–X–
4–.08(1)(g) (guidelines are intended ‘‘to
communicate what the Boards considers to be
within the boundaries of professional practice’’).
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19:32 Mar 23, 2012
Jkt 226001
21 CFR 1306.05(a). See also 21 CFR
1301.28(d)(3) (‘‘The individual
practitioner must include the
identification number on all records
when dispensing and on all
prescriptions when prescribing narcotic
drugs under this section.’’).
As found above, Respondent issued
numerous controlled substance
prescriptions (for both Suboxone and
other drugs) on forms that listed only
his X number. The Suboxone
prescriptions issued in this manner
violated DEA’s regulation because
Respondent was required to include
both his X number and his practitioner’s
registration number on them. See 21
CFR 1306.05(a). Moreover, because he
did not include his practitioner’s
registration number, the non-Suboxone
controlled substance prescriptions
violated this provision as well.
The ALJ also concluded that
‘‘Respondent improperly prescribe
Suboxone for substance abuse using his
regular DEA registration number rather
than the required X number.’’ ALJ at 43.
Apparently, this was because
Respondent eventually started listing
both numbers on his prescription
blanks. However, as set forth above,
DEA’s regulation expressly requires that
a practitioner include both his
registration number and his X number
when issuing a prescription for
Suboxone for maintenance or
detoxification treatment under the
authority of 21 CFR 1301.28. See 21 CFR
1306.05(a).
Moreover, while a ‘‘practitioner must
include the identification number * * *
on all prescriptions when prescribing
narcotic drugs’’ for the purpose of
providing maintenance or detoxification
treatment, id. 1301.28(d), nothing in
DEA regulations prohibits a practitioner
from including both his practitioner’s
registration number and his X
identification number on his
prescription blanks. Nor does any DEA
regulation require that a practitioner
cross-out his X number when writing a
prescription for controlled substances
other than Suboxone (or Subutex) on a
prescription blank that includes both
numbers.
The evidence also shows that
Respondent violated the Immediate
Suspension Order by issuing multiple
prescriptions after he was served with
the Order. Under 21 U.S.C. 843(a)(2), it
is ‘‘unlawful for any person knowingly
or intentionally * * * to use in the
course of the distribution[] or
dispensing of a controlled substance, a
registration number which is * * *
suspended[.]’’
The evidence clearly shows that
Respondent was personally served with
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Fmt 4703
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17521
the Immediate Suspension Order on
September 27, 2010, at which time he
told the Investigator that ‘‘he was not
going to abide by this order and that [the
DI] didn’t have the authority to tell him
that he couldn’t prescribe any
controlled substances.’’ Tr. 113. True to
his word, two days later, however, he
issued prescriptions to CW for Adderall,
to MK for Adderall and Lortab, and to
DH for Lortab and Xanax. Respondent’s
explanation that these prescriptions
were just mistakes or accidents is totally
unpersuasive.
The prescriptions to MK and DH, as
well as a further Adderall prescription
which was issued to JB, were unlawful
for the further reason that they were
post-dated. As set forth above, under 21
CFR 1306.05(a), ‘‘[a]ll prescriptions for
controlled substances shall be dated as
of, and signed on, the day when
issued.’’ Respondent admitted that on
September 3, 2010, he issued CW a
prescription for Adderall, a schedule II
controlled substance which he dated
October 3, 2010. Moreover, both
Respondent’s testimony and
documentary evidence establish that
Respondent wrote the prescription to
MK and DH on September 29, while
post-dating them to October 4.
Accordingly, I also find that Respondent
violated DEA regulations in writing
these prescriptions.
I further find that Respondent lacked
a legitimate medical purpose in
prescribing Xanax to JC2. The evidence
shows that Respondent knew that JC2
was abusing Xanax and that he had been
jailed for distribution. While
Respondent testified that he could not
simply stop prescribing the drug to JC2
because JC2 could have seizures, and
that he planned to taper JC2 off the
drug, Respondent actually increased the
daily dose of JC2’s Xanax prescriptions.
Given the inconsistency between the
medical justification Respondent offered
for his continuing to prescribe Xanax to
JC2 and the actual prescriptions he
issued, I conclude that Respondent
lacked a legitimate medical purpose and
acted outside the usual course of
professional practice in prescribing
Xanax to JC2. 21 CFR 1306.04(a).
The record thus establishes that
Respondent’s experience in dispensing
controlled substances (factor two) and
his record of compliance with
applicable laws related to controlled
substances (factor four) is characterized
by his multiple violations of Federal
law. These include his prescribing of
methadone for maintenance or
detoxification purposes without being
registered to do so and in violation of
DEA regulations prohibiting the
prescribing of methadone for this
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purpose; his prescribing of controlled
substances to treat chronic pain without
a legitimate medical purpose; his
prescribing of Xanax to JC2; his issuance
of prescriptions which lacked his
practitioner’s registration number; his
issuance of post-dated prescriptions;
and his issuance of multiple
prescriptions after his registration had
been suspended. I further conclude that
the Government has made a prima facie
showing that Respondent has
committed acts which render his
registration ‘‘inconsistent with the
public interest,’’ 21 U.S.C. 824(a)(4), and
that this conduct is sufficiently
egregious to warrant the revocation of
his registration.24
tkelley on DSK3SPTVN1PROD with NOTICES
Sanction
Under Agency precedent, where, as
here, the Government has made out a
prima facie case that a registrant has
committed acts which render his
‘‘registration inconsistent with the
public interest,’’ he must ‘‘ ‘present[]
sufficient mitigating evidence to assure
the Administrator that [he] can be
entrusted with the responsibility carried
by such a registration.’ ’’ Samuel S.
Jackson, 72 FR 23848, 23853 (2007)
(quoting Leo R. Miller, 53 FR 21931,
21932 (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),
this Agency has repeatedly held that
where a registrant has committed acts
inconsistent with the public interest, the
registrant must accept responsibility for
[his] actions and demonstrate that [he]
will not engage in future misconduct.’’
Medicine Shoppe-Jonesborough, 73 FR
364 (2008). As the Sixth Circuit has
24 With respect to factor five, the ALJ found that
Respondent’s ‘‘lack of candor * * * threatens
public health and safety.’’ ALJ at 49. As support for
this conclusion, the ALJ noted that most of the
patients who were interviewed by the Investigators
had stated that Respondent was treating them for
substance abuse, yet Respondent testified that they
were being treated for chronic pain but did not
realize this. Id.
While I agree with the ALJ that Respondent
lacked candor, and appreciate that she personally
observed his testimony, I do so based on different
evidence. First, during the initial interview on Feb.
28, 2010, Respondent told the investigators that he
was operating a detox clinic and was using
methadone to transfer his patients to Suboxone. Tr.
43. Yet later that day, he claimed that he was
prescribing methadone only for pain and had
previously misspoken. Id. at 54–55. Second, when
confronted with evidence that several of his
methadone patients had come to him from
methadone clinics, he attempted to justify his
unlawful prescribing of methadone to them by
claiming that the patients had actually gone to these
clinics to treat their pain. See Tr. 695–96 (testimony
regarding JB); id. at 699 (testimony regarding JC); id.
at 716–17 (testimony regarding KI); id. at 728
(testimony regarding TP). This factor thus also
supports revocation.
VerDate Mar<15>2010
19:32 Mar 23, 2012
Jkt 226001
recognized, this Agency also ‘‘properly
consider[s]’’ a registrant’s admission of
fault and his candor during the
investigation and hearing to be
‘‘important factors’’ in the public
interest determination. See Hoxie, 419
F.3d at 483.
The ALJ found, and the record
supports the conclusion, that
Respondent eventually ceased
prescribing methadone for maintenance
and detoxification purposes. ALJ at 49–
50. The record generally supports the
conclusion that Respondent stopped
writing controlled substance
prescriptions which did not include his
registration number, as required by DEA
regulations. However, as found above,
in September 2010, Respondent issued
a further Adderall prescription to JB and
did not include his registration number.
The ALJ further noted that
Respondent expressed remorse for some
of his wrongdoing. ALJ at 50. However,
while Respondent maintained that he
had mistakenly issued the postsuspension prescriptions, and ‘‘would
never do anything to violate an order,’’
Tr. 509, his testimony is belied by the
evidence that upon being served with
the Immediate Suspension Order, he
stated his intention not to comply with
it. Indeed, his testimony is patently
disingenuous, given that he wrote the
prescriptions only two days after he was
served with the Order. In short,
Respondent’s conduct manifests a
deliberate and egregious disregard for
his obligations as a DEA registrant.
Finally, while the ALJ noted that
‘‘Respondent testified passionately
about the prevalence of narcotic abuse
in Red Bay and his want to eliminate
it,’’ she further concluded that he
‘‘likely facilitated some of that abuse.’’
Id. The ALJ’s conclusion is well
supported. Indeed, as found above, in
numerous instances, Respondent issued
controlled-substance prescriptions for
the purported purpose of treating a
patient’s pain, even though he recorded
in the patient’s chart that the patient
had ‘‘NO’’ pain and/or failed to make
the findings required under the State’s
Guidelines to properly diagnose the
patient. Moreover, during one of the
interviews by the Investigators,
Respondent admitted that he did not
follow the State’s Guidelines. Tr. 220.
Respondent, however, offered no
evidence that he now intends to comply
with the Guidelines.
Accordingly, I hold that Respondent
has not rebutted the Government’s
prima facie case. I will therefore order
that Respondent’s registration be
revoked and that any pending
application be denied. For the same
reasons that led me to order the
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Frm 00121
Fmt 4703
Sfmt 4703
Immediate Suspension of Respondent’s
registration, I conclude that the public
interest requires that this Order be
effective immediately.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) & 824(a)(4), as well
as by 28 CFR 0.100(b) & 0.104, I order
that DEA Certificate of Registration,
BC1701184, and Identification Number
XC1701184, issued to Morris W.
Cochran, M.D., be, and they hereby are,
revoked. I further order that any
application for renewal or modification
of such registration be, and it hereby is,
denied. This Order is effective
immediately.
Dated: March 16, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012–7107 Filed 3–23–12; 8:45 am]
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comments from the public and affected
agencies. Comments are encouraged and
will be accepted for ‘‘sixty days’’ until
May 25, 2012. This process is conducted
in accordance with 5 CFR 1320.10.
If you have additional comments,
especially on the estimated public
burden or associated response time,
suggestions, or need a copy of the
proposed information collection
instrument with instructions or
additional information, please contact:
Ron Malega, 202–353–0487, Bureau of
Justice Statistics, Office of Justice
Programs, Department of Justice, 810
Seventh Street NW., Washington DC
20531 or Ronald.Malega@usdoj.gov.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address one or more
of the following four points:
E:\FR\FM\26MRN1.SGM
26MRN1
Agencies
[Federal Register Volume 77, Number 58 (Monday, March 26, 2012)]
[Notices]
[Pages 17505-17522]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7107]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11-1]
Morris W. Cochran, M.D.: Revocation of Registration
On September 22, 2010, I, the then-Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Immediate
Suspension of Registration to Morris W. Cochran, M.D. (Respondent), of
Birmingham, Alabama. The Order proposed the revocation of Respondent's
DEA Certificate of Registration BC1701184, and the denial of any
pending applications to renew or modify his registration, on the ground
that his ``continued registration is inconsistent with the public
interest.'' 21 U.S.C. 824(a)(4).
More specifically, the Order alleged that while Respondent is
authorized to prescribe Suboxone and Subutex ``for maintenance or
detoxification treatment pursuant to 21 U.S.C. 823(g)(2) under DEA
identification number XC1701184,'' he had ``prescribed methadone,'' a
schedule II controlled substance, ``to patients for the purpose of drug
addiction treatment'' without the registration required under 21 U.S.C.
823(g)(1). ALJ Ex.1, at 1-2.
Next, the Order alleged that Respondent had prescribed both
methadone and Suboxone, the latter being a Schedule III controlled
substance, to numerous patients whose charts show that he ``did not
obtain a prior medical history,'' that he ``did not perform an initial
physical exam,'' that he ``established little or no basis for the
diagnoses,'' and that he ``offered no other treatment other than
prescribing controlled substances.'' Id. at 2. The Order further
alleged that ``[s]uch prescribing was not for a legitimate medical
purpose in the usual course of professional practice in violation of 21
CFR 1306.04(a), and in violation of Alabama Administrative Code 540-X-
11)(1), which requires that a physician personally obtain an
appropriate history, perform a physical exam, make a diagnosis and
formulate a therapeutic plan before prescribing drugs to a patient.''
Id. Finally, the Order alleged that Respondent had ``continue to
prescribe alprazolam, a schedule IV controlled substances depressant,
to a patient after [the] patient file explicitly noted that the patient
abused this drug.'' Id.
Based on the above, I concluded that Respondent's continued
registration during the pendency of the proceeding ``constitute[d] an
imminent danger to the public health and safety.'' Id. I therefore
invoked my authority under 21 U.S.C. 824(d) and immediately suspended
Respondent's registration.
Respondent requested a hearing on the allegations and the matter
was placed on the docket of the Agency's Administrative Law Judges
(ALJs). On November 2-4, 2010, an ALJ conducted a hearing in
Birmingham, Alabama. ALJ Decision (also ALJ), at 3.
On January 5, 2011, the ALJ issued her decision which recommended
that Respondent's registration be revoked. Id. at 51. Therein, the ALJ
found that the Alabama Medical Board had not made a recommendation in
the matter (factor one) and that Respondent has not been convicted of
an offense related to the manufacture and distribution of controlled
substances (factor three). Id. at 43, 48.
With respect to factors two (Respondent's experience in dispensing
controlled substances) and four (Respondent's compliance with
applicable laws related to controlled substances), the ALJ made
extensive findings. First, the ALJ found that Respondent violated DEA
regulations because he prescribed drugs other than Suboxone or Subutex
on prescription forms that used only his Data Waiver (or X) number. ALJ
at 43. The ALJ also found that Respondent ``improperly prescribed
Suboxone for substance abuse using his regular DEA registration number
rather than the required ``X'' number.'' Id.
Next, the ALJ found that Respondent prescribed methadone for
detoxification and maintenance treatment without holding the separate
registration required to do so under Federal law. ALJ at 43-45. The ALJ
specifically rejected Respondent's testimony that he had prescribed
methadone to nine patients to treat pain (which does not require a
separate registration), noting that Respondent had initially told a DEA
Investigator that he was prescribing methadone for detoxification
purposes, that several patients who had received methadone had told the
Investigator that they were being treated for substance abuse, and that
several of the patients had come to Respondent's clinic ``directly
after'' being treated by a methadone clinic ``where the prescription of
methadone for pain is prohibited'' and had been diagnosed by Respondent
as being substance abusers. Id. at 44-45. The ALJ also found that
Respondent had violated the limitation imposed under Federal law and
regulations which limit to 100, the number of patients who can be
treated for substance abuse with Suboxone. ALJ at 46-47 (citing 21
U.S.C. 823(g)(2)(B)(iii) and 21 CFR 1301.28(b)(1)(iii)).
Next, the ALJ found that Respondent violated both Federal and State
regulations because his medical charts ``fail[ed] to list the source
and severity of pain when chronic pain [wa]s the diagnosis. ALJ at 47
(citing Ala. Admin. Code 540-X-4.08; 21 CFR 1306.04(a) and 1306.07(c)).
The ALJ further found that Respondent's charts ``fail[ed] to record
when medical examinations were conducted and the specific results of
those examinations in support of diagnoses,'' and that ``[i]n some
instances, patients actually reported that no examination was
conducted.'' Id. The ALJ also found that the ``charts failed to show
the use of any treatment options besides the prescribing of controlled
substances,'' and that the ``lack of attempts of alternative treatment
modalities prior to determining that the patient suffers from chronic
pain violates 21 CFR 1306.07(c).'' Id.
The ALJ further found that Respondent had post-dated prescriptions
for schedule II controlled substances in violation of Federal
regulations. Id. at 47-48 (citing 21 CFR 1306.05(a) and 1306.12(b)). In
addition, the ALJ found that Respondent had admitted to having issued a
controlled substance prescription after he was served with the
Immediate Suspension Order. Id. at 48. The ALJ then found that
``Respondent testified, and the record contains no expert evidence to
the contrary, that his treatment of his patients met the standard of
care.'' Id. However, based on Respondent's improper use of his data-
waiver number on prescriptions, his unauthorized prescribing of
methadone for maintenance and detoxification purposes, his incomplete
records, his failure to recommend any treatment options for his chronic
pain patients besides the prescribing of controlled substances, and his
issuance of a controlled substance prescription after his registration
was suspended, the ALJ concluded that these factors supported the
revocation of his registration. Id.
With respect to factor five--such other conduct which may threaten
public health or safety--the ALJ found that Respondent lacked candor.
More
[[Page 17506]]
specifically, the ALJ noted that ``[p]ractically all of the patient
charts in this record had the same diagnoses: Chronic pain and
substance abuse. However, when most of the patients were asked about
their treatment by the Respondent, they stated that they were being
treated for substance abuse.'' Id. at 49. While the ALJ acknowledged
``that it may be difficult to accurately diagnose chronic pain or
substance abuse,'' she found Respondent's testimony that the patients
did not know that they were being treated for chronic pain to ``lack[]
credibility.'' Id. The ALJ thus concluded that Respondent's ``lack of
candor also threatens public health and safety.'' Id. at 49.
The ALJ then turned to Respondent's evidence as to his remedial
measures. The ALJ noted that Respondent had stopped using his X number
improperly (to prescribe drugs other than Suboxone and for purposes
other than substance abuse treatment), that he had stopped prescribing
methadone, and that at the hearing, he had ``apologized for the
issuance of prescriptions for controlled substances without a proper
DEA registration.'' Id. at 50. However, noting that upon being served
with the Immediate Suspension Order, Respondent had stated that he did
not intend to comply with it, as well as his testimony that while he
currently lacks ``authority to handle controlled substances, he
continues to `help' with the Suboxone at [another] clinic,'' the ALJ
found that Respondent's ``actions do not indicate remorse, but, rather,
are more indicative of a failure to appreciate the seriousness of the
allegations against him and the responsibility with which he was
charged.'' Id. The ALJ further found that ``Respondent, through his
actions, likely facilitated'' drug abuse. Id.
The ALJ thus concluded that Respondent had failed to rebut the
Government's prima facie case. Id. at 51. She further recommended that
Respondent's registration be revoked and that any pending applications
be denied. Id.
Neither party filed exceptions to the ALJ's decision. Thereafter,
the record was forwarded to this Office for Final Agency Action. Having
considered the record as a whole, I adopt the ALJ's findings of fact
and conclusions of law except as otherwise noted herein. I further
adopt the ALJ's recommendation that Respondent's registration be
revoked and that any pending application be denied. I make the
following findings.
Findings
Respondent is a physician licensed by the Alabama State Board of
Medical Examiners (hereinafter, State Board or Medical Board) and is
board certified in family practice. As of the date of the hearing,
Respondent's state license remains current and unrestricted. Tr. 259.
The State Board, however, has an open investigation of Respondent. Id.
at 257-58.
Respondent is also the holder of DEA Certificate of Registration
BC1701184, which prior to the issuance of the Immediate Suspension
Order, authorized him to dispense controlled substances as a
practitioner in schedules II through V, with the registered location of
Narrows Health & Wellness, 151 Narrows Parkway, Suite 110, Birmingham,
Alabama.\1\ ALJ at 4 (stipulated facts). Respondent's registration does
not expire until August 31, 2012. Id.
---------------------------------------------------------------------------
\1\ Respondent also was practicing at offices in Red Bay and
Russellville, Alabama. ALJ at 4-5 (Stipulated Facts at para. 4); Tr.
35.
---------------------------------------------------------------------------
Respondent is also authorized to dispense Suboxone and Subutex,
under the Drug Addiction Treatment Act of 2000 (DATA), for the purpose
of treating opiate addicted patients and is authorized to treat up to
100 patients; Respondent has been assigned identification number
XC1701184 for this purpose. Id.; see 21 U.S.C. 823(g)(2). Suboxone and
Subutex are schedule III controlled substances (and are the only
schedule III through V drugs) which have been approved by the Food and
Drug Administration for the treatment of opiate addiction by a DATA
Waiver physician.
Respondent is not, however, authorized to dispense methadone, a
schedule II narcotic, for the purpose of treating opiate addiction as
he does not have the registration required by 21 U.S.C. 823(g)(1). GXs
1 & 2. Respondent can, however, lawfully dispense methadone for the
purpose of treating pain.
The Investigation
Respondent first came to the attention of the authorities when
several pharmacies complained to a State Board Investigator that he was
prescribing large amounts of methadone using his X number. Tr. 35-36.
The State Investigator passed this information on to a DEA Diversion
Investigator (DI); on February 28, 2010, which was a Sunday morning,
the two Investigators went to Respondent's Red Bay Clinic and arrived
there at 6:30 a.m. Id. at 37. While the Investigators were in the
parking lot taking photographs, they were approached by TS, who said
``[h]e was waiting to get his methadone from'' Respondent. Id. at 38.
TS also stated that he paid cash for his visits, that he was seeing
Respondent for an old football injury, that he did not provide any
medical records to Respondent, and that he was not asked for
identification when he first registered as a patient. Id. at 39-40.
Respondent did not arrive at the office until shortly before 11
a.m., by which time ``close to 50 people'' were waiting to see him. Id.
The State Investigator then went inside to register in an attempt to
see Respondent. Id. However, when the State Investigator was told that
he would have to wait five to six hours to see Respondent, the
Investigators decided to identify themselves and interview him. Id. at
42. Respondent initially told the Investigators that ``he was operating
a detox clinic where he was using methadone to get his patients onto
Suboxone.'' Id. at 43. Respondent also said that he accepted cash only,
that he saw an average of 80 patients on Sundays at the Red Bay clinic,
and that he also treated chronic pain patients on whom he performed
``range of motion tests.'' Id. at 43-44.
With respect to his chronic pain patients, Respondent told the
State Investigator that he would look for surgical scars on the
patient's body and that he sent some of his patients for X-Rays and
MRIs. Id. at 218-19. Respondent admitted to the State Investigator that
``he did not'' follow the Board's guidelines for the use of controlled
substances in treating pain. Id. at 220. In the interview, Respondent
also stated that he would require his substance abuse patients to
undergo drug screens ``if he felt that they needed one.'' Id. at 219.
Respondent also maintained that he knew the requirements for using
his X number and that he was not prescribing any other drugs under this
number. Id. at 44-45. The State Investigator then showed Respondent a
methadone prescription he had written under his X number; Respondent
said that the ``prescription was a mistake.'' Id. at 45. The DI then
told Respondent that he had found ``close to 200 prescriptions * * *
written under his X number for'' drugs other than Suboxone and Subutex,
including Xanax (a schedule IV depressant) and Adderall (a schedule II
stimulant). Id.; see also id. at 221 (testimony of State Investigator).
The DI then asked Respondent how many patients he was treating
under his X number. Id. at 46. Respondent said that he had 60 patients
at his Red Bay clinic and another 50 patients at his
[[Page 17507]]
Birmingham office. Id. When told by the DI that this exceeded the 100
patient limit, Respondent claimed that ten of the patients were
actually being treated with Suboxone for pain. Id. at 46.
During the visit, the DI encountered JKB in Respondent's waiting
room and asked to speak with him. Id. at 51. The DI asked JKB what
Respondent was treating him for; JKB stated that he was treating him
for an addiction to opiates with methadone. Id. at 52. JKB also told
the DI that he had previously gone to a narcotic treatment program
which used methadone and that he was going to Respondent because it was
cheaper. Id. at 53. JKB also stated that he was not seeing Respondent
for chronic pain. Id.
Following this interview, the DI resumed his interview of
Respondent. Respondent now maintained that he was prescribing methadone
for pain. Id. When the DI told Respondent that he had just interviewed
a patient who said he was being treated for opiate addiction with
methadone, Respondent stated that the patient was mistaken. Id. at 54.
When the DI reminded Respondent that he had earlier stated that he was
using methadone to transfer patients onto Suboxone, he stated that he
had previously misspoken and ``[t]hat he was only using methadone for
pain'' and not to treat addiction. Id. at 55. When the DI asked
Respondent whether it was possible to see eighty patients in a day and
``provide the kind of treatment that was necessary for'' them,
Respondent stated that ``he was overwhelmed and . . . needed some
guidance.'' Id. at 56-57.
Upon leaving the clinic, the Investigators observed ``approximately
50 patients inside of [the] office and probably another 50 to 60 . . .
in the parking lot.'' Id. at 57. The Investigators then went to a local
CVS pharmacy and interviewed its pharmacist, who stated that since the
opening of Respondent's Red Bay clinic, he had ``seen a tremendous
spiking in the amount of prescriptions for methadone.'' Id. at 58. The
pharmacist further stated that Respondent was writing methadone
prescriptions to treat addiction and that he would not fill these
prescriptions. Id. at 59; see also GX 7.
On May 17, 2010, the Investigators (along with a Supervisory DI)
went to Respondent's Russellville office and obtained various patients'
files through either an administrative subpoena or a warrant. Tr. 48-
50, 62-63. The Investigators again interviewed Respondent who stated
that he was mainly seeing pain patients. Id. at 63. The DI then asked
Respondent if he had made any changes to his practice; Respondent
states that ``he had switched pretty much everybody from methadone to
Suboxone and that out of the 85 percent [of his] patients that he was
seeing for pain, 95 percent . . . were being treated with Suboxone.''
Id. at 64. Respondent also stated that he had stopped prescribing
methadone for pain because he was having more success using Suboxone.
Id. at 65.
During the interview, Respondent identified AK as a chronic pain
patient who he was treating with Suboxone and who was waiting to see
him. Id. at 65-66. The DI proceeded to interview AK, who had yet to see
Respondent that day; AK stated that Respondent ``was treating her for
an addiction to opiates,'' and that after the February visit by the
Investigators, he had stopped writing methadone prescriptions. Id. at
66.
The DI also interviewed another patient, SH, who was in the parking
lot. Id. at 73-74. SH stated that Respondent was treating him for
opiate addiction and not for chronic pain. Id. at 74.
The DIs seized 114 patient files which were selected on the basis
of pharmacy records showing that Respondent had prescribed either
Suboxone or methadone to the patients. Id. at 171-72, 174. The files
were taken to the DIs' office where they were reviewed. Id. at 68.
Thereafter, the DIs focused their investigation on approximately 28
patients, whose files were introduced into evidence.\2\ During the
course of the investigation, the DIs interviewed most of these patients
by telephone to determine why they were seeing Respondent. Id. at 172.
---------------------------------------------------------------------------
\2\ Twenty-six of the patient files were entered into evidence
as Government Exhibit 5; the two remaining files were entered into
evidence as Government Exhibits 22-23. Respondent also introduced
copies of the same files. See RXS 2, 4-28. I have carefully reviewed
both sets of files and conclude that there are no material
differences between the two sets.
---------------------------------------------------------------------------
The Patient Files and Interviews
Respondent's Methadone Patients
TP
On June 1, 2010, the DI spoke with TP. TP told him that Respondent
did not physically examine her, that she paid $100.00 for the visit and
that he prescribed methadone to her. Tr. 103-105; GX 5X. TP went to
Respondent because she had heard that he was using methadone to treat
addiction. Tr. 105.
TP saw Respondent on three occasions (Feb. 7 and 21, and Mar. 7,
2010). GX 5X. TP completed an intake form on which she listed her
medications as ``methadone 12 10s a day'' and wrote that her pharmacy
was the ``methadone clinic.'' Id. at 2. At her first visit, Respondent
checked ``YES'' for whether TP had pain and listed her legs and back as
the location. Id. at 3. Respondent diagnosed TP as having chronic pain,
substance abuse and anxiety. Id.
However, Respondent did not document the nature and intensity of
the pain, current and past treatments for the pain, and its effect on
TP's physical and psychological functioning. Id. at 3, 5. No vital
signs were recorded at any of her visits. Id. In addition, the chart
contains no medical history. See generally GX 5X.
Moreover, while TP indicated that she had previously gone to a
methadone clinic, Respondent did not know the name of the clinic and
did not even attempt to obtain her treatment records. See generally GX
5X; Tr. 727-28. In addition, the progress note for TP's third visit
contains no information other than her name, date of birth and the date
of the visit.
At each of TP's three visits, Respondent prescribed a daily dose of
eleven tablets of methadone 10 mg, with the first two prescriptions
being written under his X number for 154 tablets each. See GX 5X. While
TP told the DI that after DEA's February 28, 2010 visit, Respondent
told her that he was no longer prescribing methadone, Tr. 105; on March
7, Respondent again prescribed 88 tablets of methadone 10 mg to her. GX
5X, at 1. When Respondent offered TP alternative medications to
methadone, she elected to return to a methadone treatment program. Tr.
501, 728.
When asked on cross-examination if the methadone clinic which TP
had previously gone to was treating her for abusing narcotics,
Respondent testified that while the only purpose of a methadone clinic
is to treat ``substance abuse,'' she was ``going for pain.'' Id. at
728. While Respondent also diagnosed TP as having substance abuse, he
did not document the substances that she was abusing. GX 5X.
DG
DG first saw Respondent on January 3, 2010. GX 5O. On the intake
form, DG listed his medications as ``methadone.'' Respondent made a
diagnosis of chronic pain even though he checked ``NO'' for whether DG
had pain and the progress note for the visit does not document the
nature and intensity of the pain, whether any treatments had been
previously tried, and the pain's effect on his psychological and
physical function. GX 5O, at 4. While Respondent noted that he
performed a physical exam, he found each of the areas of the
examination to be normal. Id. Respondent prescribed methadone to
[[Page 17508]]
DG at this visit, as well as on January 12, 19, and February 1, 14, and
28, 2010. Id. at 5, 7, 9, 11.
On July 9, 2010, the lead DI interviewed DG. Tr. 106. DG stated
that Respondent had told him on February 28, 2010, that he would no
longer prescribe methadone, but that he would prescribe Suboxone to DG
if he was having trouble getting off of the methadone. Id. at 107-08,
386.
Respondent testified that on January 19, 2010, he diagnosed DG as
having a substance abuse problem, yet the medical chart does not
document the basis for that diagnosis. Id. at 701-02. Respondent
testified that his diagnosis was based on DG's demeanor and ``probably
. . . also a drug screen.'' Id. However, there is no drug screen in the
file. See GX 5O.
DG testified at the hearing. The ALJ found credible his testimony
that he was also seeing the Respondent for pain in his shoulder and
lower back. ALJ at 23. While DG believed this pain was a result of
masonry work he had done since he was a teenager, as well as a
snowboarding accident he had when he had lived in Utah, DG's chart does
not reflect any of this information. Tr. 367, 374; GX 5O.
According to DG, Respondent examined him and would spend about 7 to
10 minutes with him during his visits. Tr. 370. DG also denied having
told the DI that Respondent did not perform a physical exam on him and
that he was seeing Respondent for substance abuse. Tr. 371.
Respondent used his X number to prescribe methadone for DG. GX 5O,
at 5, 7, 9, 11. The methadone prescriptions were for lesser and lesser
amounts. GX 5O, at 1. In March of 2010, Respondent proposed to offer DG
an alternative medication treatment plan. Id. at 11; Tr. 386-87. The
medical chart stops at that point. GX 5O. Respondent stated that he
believed his treatment of DG was appropriate. Tr. 488.
MB
On July 20, 2010, the lead DI interviewed MB. Tr. 108; GX 5A. MB
stated that she was seeing Respondent for an addiction to Lorcet and
not for chronic pain, that she paid cash for her prescriptions, and
that Respondent did not perform any physical examinations. Tr. 109-110.
MB also commented that she thought there were too many people waiting
inside and outside the office to see Respondent. Id. at 109.
On the progress note for MB's first visit, Respondent circled
``YES'' for whether she had pain and diagnosed her as having chronic
pain due to headaches. GX 5A, at 7. At the hearing, Respondent
testified that MB was being treated for both periodic headaches and
substance abuse. Respondent did not, however, further document the
nature and intensity of the pain, how it affected MB's ability to
function, and any prior treatments for her pain. See id. Nor did he
document the history of MB's substance abuse. Tr. 533-37. Respondent
did not obtain information from MB's prior physicians. Tr. 533-34.
While Respondent indicated that the physical examination was normal, he
did not take MB's vital signs. Tr. 532-33; GX 5A, at 7.
Respondent described his treatment of MB as tapering her down on
her methadone prescriptions, and the prescriptions show that Respondent
was gradually reducing her daily dosage from 150 mg to 130 mg over the
course of the slightly more than two months in which he treated her.\3\
Tr. 463, 545, 550; GX 5A, at 5-6. At MB's last visit (Mar. 14),
Respondent offered her the option of using different medication to
control any potential withdrawal symptoms she may have from the lack of
methadone. Tr. 464-65. However, MB chose to seek treatment elsewhere.
Tr. 551.
---------------------------------------------------------------------------
\3\ Respondent issued MB a total of six methadone prescriptions
between January 5 and March 14, 2010. GX 5A, at 2. Some of the
prescriptions indicated that they were ``for pain.'' Id. at 4, 6.
---------------------------------------------------------------------------
Respondent issued MB two methadone prescriptions on his X
prescription pad. Tr. 541-42; GX 5A, at 6. MB's file has no entry for
her visits of February 28 and March 14, even though MB's drug log notes
that a methadone prescription was issued on each date for 182 and 106
dosage units of methadone respectively. GX 5A, at 2-3.
JC1
Respondent saw JC1 three times in February and March of 2010. GX
5N. On his intake form, JC1 listed his medications as methadone and
Xanax. GX 5N, at 2. On the progress note for JC1's first visit (Feb.
9), Respondent noted that he had been in an automobile accident and
wrote ``back'' on the chart. Id. at 4. However, Respondent also noted
that JC1 had ``NO'' pain and did not document the nature and intensity
of the pain, details regarding the accident such as when it occurred,
what treatments had been used, and the pain's effect on his physical
and psychological functioning. Id. The progress note indicated that
Respondent did a physical exam, during which he did not find any area
to be abnormal. Id. Respondent did not document having taken JC1's
vital signs. Id. At this visit, Respondent gave JC1 prescriptions for
210 tablets of methadone 10 mg, with a daily dose of 15 tablets, and 60
tablets of Valium, even though he noted that JC1 was not agitated or
moody and did not have insomnia. Id. at 4-5. These prescriptions were
written under his X number. Id. at 5.
At JC1's next visit (Feb. 23), Respondent again indicated that he
had ``NO'' pain and did a physical exam at which he found all areas
normal. Id. at 4. At this visit, Respondent noted diagnoses of both
chronic pain and substance abuse. Id. Respondent issued JC1 a
prescription for 210 tablets of methadone 10 mg, with a daily dose of
15 tablets ``for pain.'' Id. Respondent wrote the prescription under
his X number. Id. at 5.
On March 9, Respondent wrote JC1 two more prescriptions, one for
another 210 tablets of methadone with the same daily dose ``for pain''
as before, and one for twenty-eight tablets of Valium. Id. at 1, 7.
Respondent wrote the prescriptions under his X number. Id. at 7.
Respondent did not, however, create a progress note to document the
issuance of the prescriptions. See generally GX 5N.
Respondent testified that JC1 had been in an automobile accident
and had fractured his back, that he had developed a tolerance for pain
medicine and was taking more and more, and thus went to a methadone
clinic. Tr. 486. Respondent further testified that JC1 had come from
either the Shoal's clinic or a narcotic treatment program in Hamilton
because he ``wanted to take a cleaner medicine for his pain.'' Id. at
486, 699. Respondent denied that JC1 had gone to the narcotic treatment
program ``to be treated for addiction'' and maintained that ``he was
going there to be treated for pain from a fractured back.'' Id. at 699.
As for the basis of the substance abuse diagnosis which he made at
JC1's second visit, Respondent testified that ``we probably got our
February 9 drug screen back. And he probably had some [illicit] drug in
there.'' Id. at 700. However, Respondent acknowledged that he was
speculating about this because JC1's chart did not contain any drug
test results. Id.
Respondent prescribed methadone at a lower dosage amount than the
dosage JC1 reported he had been on. Id. at 486; GX 5N at 1, 5, 7.
However, while Respondent maintained that JC1 ``wanted to take a
cleaner medicine for his pain,'' Respondent did not taper the methadone
prescriptions for JC1, but rather prescribed the same daily dose of 150
mg in each prescription between February 9, 2010, and March 9, 2010.
Tr. 486; GX 5N, at 1, 5, 7. When in
[[Page 17509]]
March, Respondent offered him alternative medications, JC1 elected to
go to another treatment facility. Tr. 486. Respondent maintained that
his care of JC1 was appropriate. Id. at 487.
JB
Respondent treated JB in February and March of 2010.\4\ GX 5L. On
the intake form, JB listed his medications as ``methadone,'' and on the
progress note for his visit, Respondent wrote that JB had been a
patient at the Shoals Treatment Center, that he had been on 230 mg. of
methadone, but that he ``was kicked out.'' GX 5L, at 5. Respondent
further wrote that JB ``desires to get off methadone.'' Id. In
addition, Respondent noted that JB had foot pain, back pain and knee
pain which had been caused by ``a four-wheeler accident.'' Id.; Tr.
696. Respondent performed a physical examination and took JB's blood
pressure and heart rate. GX 5L, at 5. Respondent also noted that JB had
withdrawal, was agitated/moody, had insomnia, and had a positive MDQ
(Mood Disorder Questionnaire). Id. Respondent then issued JB a
prescription for a fourteen-day supply of methadone 10 mg, at a daily
dose of 18 tablets, id., and noted that his plan included placing JB on
his alternative medication (KCZZU) program. Id. Respondent issued JB a
prescription for methadone, which was written under his X number, and
wrote on it ``for pain.'' Id. at 6. Respondent also wrote JB a
prescription for Ultram, a non-controlled drug, on the same form, which
listed only his X number. Id.
---------------------------------------------------------------------------
\4\ It is unclear whether JB is the same person as JKB, who was
interviewed in the waiting room on February 28, 2010, and who told
Investigators that he had previously gone to a methadone clinic and
that Respondent was treating him for opiate addiction, as the
Government did not establish that this chart (GX 5L) was JKB's.
---------------------------------------------------------------------------
On February 28, 2010, JB again saw Respondent. Respondent circled
``YES'' for whether JB had pain and insomnia, and made a further
notation that his pain was worse, although the precise area is
illegible. Id. at 5. Respondent again noted a diagnosis of chronic pain
and issued JB another prescription for 252 methadone 10 mg, with a
daily dose of 18 tablets ``for pain.'' Id. at 6. This prescription was
also issued under his X number.
At JB's final visit (Mar. 14), Respondent noted that his ``pain
persists'' and that he was ``anxious about stopping methadone.'' Id. at
3. Respondent issued him a prescription for 156 tablets of methadone 10
mg with a daily dose of 17 tablets ``for pain.'' Id. at 4. Respondent
wrote the prescription on a form, which contained both his X number and
regular DEA number. Id.
Respondent testified that JB had been asked to leave a drug
treatment program before he saw the Respondent. Tr. 482. Respondent
testified that he had done a drug screen on JB and that he did not
``see anything that bothered [him], such as cocaine * * * or marijuana
at that time.'' Id. at 483. However, JB's file does not contain the
results of a drug screen. GX 5L.
According to Respondent, JB had been in a four-wheeler accident,
took narcotics, and went to the drug treatment program because his
other physician would not write anymore prescriptions for narcotics.
Tr. 696. Respondent did not, however obtain JB's records from the drug
treatment program and Respondent maintained that the fact that JB was
being treated at a methadone clinic did not tell him that JB was being
treated for opiate addiction. Id. at 695-96. Respondent stated that he
prescribed methadone in a tapered amount to prevent JB from going into
withdrawal. Id. at 483; GX 5L, at 1.
Respondent also testified that he had provided JB with the option
of other treatment medications, but that he elected to go to another
methadone clinic. Tr. 483. Respondent annotated in the medical chart
that he was treating JB for back and knee pain. GX 5L, at 5-6.
Respondent did not document the severity of the pain. GX 5L. Respondent
stated that his treatment of JB was appropriate. Tr. 483-84.
NB
Respondent saw NB three times in February and March of 2010. GX 5M.
At her first visit (Feb. 7), Respondent diagnosed her as having chronic
pain even though he indicated that she had ``NO'' pain. GX 5M, at 3.
Respondent did not document any further information regarding NB's
condition (such as the nature and intensity of the pain, its history,
whether any treatments had been previously tried, and the pain's effect
on her psychological and physical functioning) at any of her three
visits. Id. at 3, 5.
The progress note for NB's first visit indicates that Respondent
performed a physical exam. Id. at 3. However, Respondent noted that all
areas were normal. Id. Respondent did not document having taken NB's
vital signs. Id. At this visit, Respondent issued NB prescriptions
under his X number, for 210 tablets of methadone 10 mg (with a daily
dose of 15 tablets) and 30 Xanax. Id. at 4. Respondent did not diagnose
NB as having anxiety; indeed, he noted that she was not agitated/moody
and did not have insomnia. Id. at 3.
On Feb. 21, Respondent issued NB additional prescriptions for
methadone and Xanax under his X number. Id. at 4. The progress note for
this visit, however, contains no information regarding her medical
condition. Id. at 3. On the progress note for NB's final visit (Mar.
7), Respondent circled ``CHRONIC PAIN'' but made no other findings. Id.
at 5. At this visit, Respondent issued her prescriptions for 112
tablets of methadone 10 mg, with a daily dose of 14 tablets ``For
Pain,'' and for 20 tablets of Klonopin ``for anxiety.'' Id. at 6.
Respondent wrote the prescriptions on a form which listed both his X
number and his regular registration number. Id.
Respondent testified that NB told her at the initial visit that she
had been on 180 mg of methadone and that ``she was taking it for
pain.'' Tr. 484. He then testified that ``she also had some anxiety''
and that she was a ``troubling patient'' because she was ``on a
combination of methadone and Xanax'' which caused him great concern,
especially if ``those two drugs get mixed with alcohol.'' Id. at 485.
None of this was documented.
Respondent also testified that he gave her ``150 methadone,'' which
was ``much less methadone than she was on,'' and that he ``gave her 28
tablets of the Xanax in fear of seizure potential if we went below
that.'' Id. At her last visit, Respondent offered NB the option of
alternative medications, after which she did not return to his clinic.
Id. 485; GX 5M. Respondent believed his care of NB was appropriate. Tr.
485-86.
KI
Respondent saw KI four times in February and March of 2010. GX 5T.
On the intake form, KI noted that her medications included ``methadone,
Xanex[sic], [and] Ambien.'' Id. at 2.
According to Respondent, KI was being treated at Shoals, a narcotic
treatment facility, and she wanted out of the clinic. Tr. 494.
Respondent testified that KI had back pain; however, Respondent
indicated that she had ``NO'' pain on the progress note for her first
visit. Tr. 494, GX 5T, at 3. Although Respondent wrote ``Back'' as the
location, once again, he did not document the nature and intensity of
the pain, the history of the pain, what treatments had been used, and
the pain's effect on KI's physical and psychological functioning. GX
5T, at 3; Tr. 494, 718.
Respondent performed a physical examination but did not note any
abnormalities; he also did not document
[[Page 17510]]
having taken KI's vital signs. GX 5T, at 3. Respondent noted the
diagnoses of both chronic pain and substance abuse and prescribed a
lesser dose of methadone (130 mg per day) than what KI reported she had
been receiving at Shoals (150 mg). Tr. 494; GX 5T, at 3-4. However,
Respondent did not taper KI's methadone prescriptions; rather, he
prescribed 130 mg per day of methadone to her three times between
February 7, 2010, and March 7, 2010, with the first two prescriptions
being written under his X number. GX 5T, at 1, 4, 6.
Respondent did not obtain treatment records from the narcotic
treatment facility and did not know what substance KI was abusing; he
also did not obtain any records related to her back pain. Tr. 715-16.
Respondent testified that KI began taking narcotics to treat her pain,
became addicted to those narcotics, but then denied that she had told
him that she then entered the methadone clinic to treat her addiction.
Id. at 716-17. Respondent testified that he offered alternative
medications to KI, that on March 21, 2010, he refused to prescribe
methadone to her, and that she then ``went to another facility.'' Id.
at 494-95. Respondent maintained that his care of KI was appropriate.
Id. at 495.
Respondent's Suboxone Patients
SS
On June 1, 2010, the DI spoke with SS by phone. Tr. 96. SS said
that he was being treated for opiate addiction, that he received a
Suboxone prescription from Respondent, and that he was not being
treated for chronic pain. He also stated that he paid $100.00 cash
directly to Respondent for his prescription and that Respondent did not
conduct any examination on him. Tr. 95-98; GX 5H.
SS saw Respondent only on May 2, 2010. GX 5H, at 2-3. On the intake
form, SS listed methadone as his medication and Respondent noted on the
progress note that he was on 120 mg. Id. at 3. Respondent diagnosed SS
as having both chronic pain and methadone use; while Respondent checked
``NO'' for SS's pain, he indicated that SS had disc surgery at L5S1.
Id. at 3; Tr. 475. While Respondent recalled, and the chart reflects,
that SS had back surgery, SS's chart does not contain any copies of
records related to his back surgery and does not document the date of
the surgery. Tr. 475, 673; GX 5H. SS's chart does not document the
nature and intensity of the pain, current and past treatments for it
other than the surgery, and the pain's effect on his physical and
psychological functioning. GX 5H, at 3. No vital signs were recorded at
SS's visit. Id.
Respondent testified that SS was on methadone, which he was getting
``off the street,'' but that fact is not annotated in his chart. Tr.
672. Respondent, however, refused to prescribe methadone to SS.
Instead, he prescribed Suboxone and offered SS the choice of an
alternative medical treatment program for getting off of methadone. Id.
at 475-76, 674. Respondent believed that he gave SS appropriate care.
Id. at 476.
AG
On May 17, 2010, the DI interviewed AG. Id. at 80. AG stated that
she was seeing Respondent for treatment of her addiction to Lortab, a
schedule III narcotic containing hydrocodone. Id. at 80-81. AG further
explained that she was not being treated for chronic pain, although
such treatment was indicated in her chart. AG stated she did not know
why her chart listed this condition. Id. at 81; see also GX 5P.
According to her chart, Respondent diagnosed AG as having chronic
pain and substance abuse as a secondary condition. GX 5P, at 3; Tr.
488-89. However, the chart does not specify the basis for this
diagnosis and Respondent checked ``NO'' for whether AG had pain. Tr.
704; GX 5P, at 3. In addition, Respondent did not record any vital
signs at this or any subsequent visit.
Respondent prescribed Suboxone to AG at both the initial and
several subsequent visits. Tr. 488; GX 5P, at 1, 4, 6, 8, 9. Moreover,
at subsequent visits, Respondent continued to diagnose AG as having
both chronic pain and substances abuse while checking ``NO'' for
whether she had pain. See id. In other instances, the progress notes
indicate that AG visited on a certain date but are otherwise blank even
though Respondent issued AG a prescription. GX 5P, at 5. At AG's final
visit, Respondent circled ``YES'' for whether she had pain but provided
no further documentation as to the location of the pain, the nature and
intensity of the pain, current and past treatment for pain, and its
effect on her physical and psychological functioning. Id. at 7. In
addition, the chart contains no medical history. See generally GX 5P.
Respondent nonetheless maintained that he met the standard of care with
respect to AG. Tr. 489.
LM
On June 1, 2010, DI Michael Jones interviewed LM by telephone. Id.
at 82. LM stated that the Respondent was treating her for an addiction
to pain killers. Id. at 83. Respondent had been treating LM since
December 27, 2009, at the Red Bay clinic. LM confirmed that she was not
being treated for chronic pain. Tr. 82-83.
LM completed a form in which she listed her medications as Adderall
and Oxycontin, the latter being a schedule II narcotic. Tr. 193; GX 5V,
at 2. At LM's first visit, Respondent diagnosed LM as having chronic
pain, substance abuse, and bipolar disorder. GX 5, at 3. While
Respondent checked ``YES'' for whether LM had pain and listed her
``back'' as the location, the chart does not document the nature and
intensity of the pain, current and past treatments for pain, and its
effect on her physical and psychological functioning. Id. In addition,
the chart contains no medical history. See generally id. Respondent
prescribed Suboxone and Adderall on an X prescription pad. GX 5V, at 4,
6. Subsequently, he prescribed both controlled substances using his
regular DEA registration number. GX 5V, at 6-7.
At subsequent visits, Respondent continued to list chronic pain as
a diagnosis while checking ``NO'' for whether LM had pain.\5\ Id. at 3.
Respondent testified that he was treating LM for back pain and for
bipolar disorder. He further stated that LM was on Oxycontin and wanted
to get ``onto a better pain medicine.'' Tr. 498. However, when asked on
cross-examination as to whether his diagnosis of substance abuse was
``based on her abuse of Oxycontin,'' Respondent stated: ``I think it
had to do with--she had multiple things. She had stimulants * * * such
as Adderall,'' and ``I think she had taken periodically Xanax.'' Id. at
723.
---------------------------------------------------------------------------
\5\ At LM's second visit, Respondent listed substance abuse as a
diagnosis; however, at two subsequent visits, he no longer listed
substance abuse as a diagnosis. See GX 5V.
---------------------------------------------------------------------------
LM's progress notes do not, however, indicate what substance(s) she
was abusing. GX 5V, at 3 & 5. Moreover, notwithstanding his testimony
that her substance abuse was based in part on her use of Adderall,
Respondent prescribed this drug to LM at four of her subsequent visits.
Id. at 4, 6, 7. Respondent believed his treatment of LM was within the
standard of care. Tr. 498-99.
ET
On June 1, 2010, the DI interviewed ET by telephone. ET explained
that the Respondent was treating him for an addiction to pain killers.
Tr. 83-84. Respondent prescribed Suboxone to ET on an X pad on four
occasions between December 2009 and March 2010; in
[[Page 17511]]
April, he prescribed Suboxone to ET on a prescription pad which listed
both his X number and his practitioner's registration number. GX 5Z, at
4, 6, 8. ET told the DI that he was not being treated for chronic pain.
Tr. 83-84.
The first two progress notes (one of which is undated but which is
above the note for January 5, 2010 \6\) indicate a diagnosis of chronic
pain but not substance abuse, the latter not being listed as a
diagnosis until ET's third visit (Feb. 2, 2010). GX 5Z, at 3, 7. Here
again, Respondent noted on the chart that ET had ``NO'' pain and the
chart does not indicate the location of the pain, the nature and
intensity of the pain, current and past treatments for the pain, and
its effect on his physical and psychological functioning. Id. at 3, 5,
7. No vital signs were recorded at any of ET's visits. Id. In addition,
the chart contains no medical history. See generally GX 5Z. Respondent
maintained that his care of ET was appropriate. Tr. 503.
---------------------------------------------------------------------------
\6\ For this reason, I conclude that the undated note was for ET
visit of December 8, 2009, at which Respondent issued him a
prescription for Suboxone. See GX 5Z, at 1 & 4.
---------------------------------------------------------------------------
CT
On June 2, 2010, a DI spoke with CT. CT stated that Respondent was
treating her for opiate addiction with Suboxone. Tr. 87-88. On the
intake form, CT listed her medications as ``Suboxone, methadone, and
Zanex [sic].'' GX 5Y, at 2.
At CT's first visit, Respondent diagnosed her as having both
substance abuse and chronic pain. GX 5Y, at 3. However, Respondent did
not indicate in the chart what substance she was abusing. Id. Moreover,
Respondent indicated that she had ``NO'' pain. Id. Respondent did not
indicate a location of CT's pain until the third visit (approximately
two months later) when he noted its location as her ``back,'' but once
again checked that she had ``NO'' pain. Id. at 5. While Respondent
listed a diagnosis of chronic pain at each of CT's four visits, he
never checked ``YES'' for pain on any of the progress notes. Id. at 3,
5. Respondent did not document the nature and intensity of the pain,
current and past treatments for the pain, and its effect on CT's
physical and psychological functioning. Id. Nor did he record vital
signs at any of CT's visits. Id.
In his testimony, Respondent admitted that he did not know what
substance(s) CT was abusing, but added that ``usually they're on
multiple medicines to get whatever desired effect they want.'' Tr. 729-
30. Respondent did not obtain any prior treatment records for CT,
whether for pain or substance abuse. Id. at 731.
Respondent wrote CT prescriptions for Suboxone on a pad which
contained only his X number, as well as on a pad which contained both
his X number and his regular DEA registration number. GX 5Y, at 4, 6.
Respondent believed his treatment of CT was within the standard of
care. Tr. 502.
JH
On June 2, 2010, the lead DI spoke with JH. JH stated that
Respondent was treating him for ``a bad addiction to Oxycontin'' with
Suboxone and that he was not being treated for chronic pain. Tr. 89-90;
GX 5R. JH listed his medications as ``OXY 80 mg x4.'' GX 5R, at 9.
According to Respondent, JH was taking ``four [Oxycontin] a day for his
pain,'' which he was getting off the street because ``his doctors fired
him.'' Tr. 710.
At JH's first visit, Respondent diagnosed him as having substance
abuse, attention deficit disorder and chronic pain. GX 5R, at 10. While
in his testimony, Respondent maintained that JH had told him that he
needed OxyContin ``to get by with his pain,'' on JH's chart, Respondent
indicated that JH had ``NO'' pain and did not document a cause of the
pain. Id. Moreover, while JH saw Respondent multiple times thereafter
and diagnosed him as having chronic pain at each visit, Respondent
never checked ``YES'' in the pain entry of the progress notes and never
provided a description and location of the pain. See generally GX 5R.
Moreover, Respondent never recorded vital signs for any of JH's visits.
See generally id. Nor does JH's chart include a medical history. See
generally id.
Respondent obtained a printout of JH's prescriptions from the
State's prescription monitoring program. Id. at 2-8. While the report
showed that JH had also obtained Suboxone from another physician (Dr.
H.), Respondent neither obtained JH's records from Dr. H. nor conferred
with him. Tr. 711-12; GX 5. Respondent wrote JH prescriptions for both
Suboxone and Adderall under his X number. GX 5R, at 11, 15. However,
Respondent required JH to undergo a drug test; while this test showed
that JH was taking Suboxone (buprenorphine) and amphetamine (Adderall),
he also tested positive for marijuana use. GX 5R, at 12. Respondent
believed his care of JH was appropriate. Tr. 492.
KP
On June 2, 2010, the lead DI spoke with KP. KP stated that
Respondent was prescribing Suboxone to treat her opiate addiction and
that she was not being treated for chronic pain. Tr. 92-94. While
Respondent testified that KP was on a narcotic which she wanted off of,
KP did not list any medications she was on. GX 5W, at 2. Moreover,
Respondent did not document the name of the narcotic in KP's record.
Tr. 499.
Respondent testified that KP had ``a complaint of pain.'' Id. At
KP's first two visits (Dec. 6, 2009 and January 3, 2010), Respondent
diagnosed her as having only chronic pain. GX 5W, at 3. However, for
both visits, Respondent checked ``NO'' for whether KP had pain and did
not list a cause or location of any such pain. Id.
Respondent did not make a diagnosis of substance abuse until her
third visit (Jan. 19, 2010); however, none of the progress notes for
KP's subsequent visits list a diagnosis of substance abuse.\7\ See id.
at 5, 7, 9, 11. Moreover, while Respondent continued to diagnose KP as
having chronic pain, he did not check ``YES'' for whether she was
having pain on any of the progress notes. See id. Nor did he document
the cause, location or severity of her pain, or record her vital signs,
at any of her visits. See id.
---------------------------------------------------------------------------
\7\ Respondent also diagnosed KP as having anxiety, for which he
prescribed Xanax. GX 5W, at 5.
---------------------------------------------------------------------------
KP stated that she had to pay cash for her prescriptions as
Respondent would not file a claim with Medicare for her. Tr. 94. She
also stated that the Respondent did not perform any medical
examinations on her, although Respondent indicated on the progress
notes that he had done so and noted that the various parts of the
examinations were normal (by either checking or lining through them).
Tr. 95, see also GX 5W, at 3, 5, 9.
Respondent prescribed Suboxone and Xanax for KP on an X
prescription pad. Id. at 499; see also GX 5W, at 4, 6. Respondent
believed his treatment of KP was within the standard of care. Tr. 500.
TB
On June 10, 2010, the lead DI spoke with TB. TB stated that
Respondent was prescribing Suboxone to him for both pain and addiction.
Tr. 98-99; GX 5B. TB wrote on the intake sheet that he had used
Suboxone, but Respondent did not know who prescribed it, and he
commented that he could not tell from TB's chart if the Suboxone had
been prescribed for substance abuse. GX 5B, at 1; Tr. 580-81.
At the first visit (Dec. 20, 2009), Respondent diagnosed TB as
having chronic pain and substance abuse. Tr.
[[Page 17512]]
466. Respondent checked ``YES'' for whether TB had pain and indicated
the location as the lumbar area. GX 5B, at 6. While Respondent
testified that ``[w]e got him to tell us about his back problems,'' if
he had undergone any surgeries and how ``it affect[ed] his everyday
activity,'' Respondent did not document the nature and intensity of the
pain, whether any treatments had been previously tried, and the pain's
effect on his psychological and physical function. Id.; Tr. 578-79.
Moreover, Respondent did not know if TB's back pain was caused by an
injury or a degenerative condition. Tr. 578-79.
The chart indicates that Respondent performed an examination at
which all areas including TB's back were found to be normal. GX 5B, at
6. However, no vital signs were recorded. Id. at 6-7. Respondent
prescribed Suboxone to TB, as well as Ambien. Id. While Respondent
testified that he prescribed the Suboxone for TB's back pain, he issued
the prescription under his X number; he also issued the Ambien
prescription on the same form. Id. at 7.
Respondent also saw TB on January 19, February 16,\8\ and May 2,
2010. Id. at 4-7. At both the January and February visits, Respondent
prescribed both Suboxone and Ambien to TB using his X number. Id. at 5,
7; Tr. 466-67, 587-88. Respondent did not obtain TB's records from
other doctors even though TB listed Suboxone as one of his medications.
Tr. 578-580; GX 5B. When asked if he knew the name of the doctor who
had previously prescribed Suboxone to TB, Respondent testified ``We
might have found it out--I just didn't document it * * *. It could be a
local doctor there.'' Tr. 581. When asked why TB had previously gotten
Suboxone, Respondent could not definitively answer if it had been for
pain or substance abuse. Id. at 582. With respect to the Ambien
prescriptions, Respondent admitted that he did not document an insomnia
diagnosis. Id. at 583.
---------------------------------------------------------------------------
\8\ In the progress note for this visit, Respondent indicated
that TB had ``NO'' pain while continuing to indicate that he had
chronic pain. GX 5B, at 4. In his testimony, Respondent explained he
``marked off that [TB's] pain was controlled under the no part.''
Tr. 588. The ALJ did not, however, credit this testimony. See ALJ at
21-22. Nor do I.
---------------------------------------------------------------------------
SW
SW's chart indicates that he was being treated for chronic pain and
substance abuse. While the chart for SW's first visit indicates that he
was on Oxy 160 mg, Respondent checked ``NO'' for whether SW had pain
and did not document the cause or severity of SW's pain. GX 5J at 3, 5.
Respondent did not identify a potential source of SW's pain until his
third and final visit, when he noted that SW had a herniated disc in
his back and had undergone surgery. Id. at 3.
SW testified at the hearing and the ALJ found credible his
testimony that he had a herniated disc in his back, that he had been
taking Oxycontin for the pain, and that he had begun treatment with the
Respondent in order to get a different pain medication. Tr. 346. The
ALJ also found credible SW's testimony that he told a DI that
Respondent was treating him for chronic pain and that the Respondent
had performed a physical examination on him.\9\ However, the ALJ also
found credible SW's subsequent testimony that he had told the DI that
he was being treated for substance abuse because ``it was better being
on Suboxone than it was Oxycontin.'' Tr. 363.
---------------------------------------------------------------------------
\9\ The ALJ noted that the testimony of the lead DI and SW
conflicted on this point. ALJ at 22 n.3. The DI testified that SW
told him that Respondent was not treating him for chronic pain and
had not performed a physical examination on him; SW testified to the
contrary. Compare Tr. 102-03, with id. at 348-49. The ALJ found,
however, that the DI had difficulty recalling the conversation that
he had with SW and his memory had to be refreshed by the use of his
notes, id. at 101-102, but that SW's memory required no similar
refreshment. Id. at 345-65. I therefore adopt the ALJ credibility
finding that SW's testimony is a more reliable account of the
conversation that took place between SW and the DI.
---------------------------------------------------------------------------
Respondent did not know who had prescribed Oxycontin to SW, and
SW's chart does not contain any prior medical records. Tr. 684-85; GX
5J. SW testified that he was addicted to his pain medications. Tr. 355.
Respondent spent 15 to 20 minutes with SW and prescribed Suboxone to
him. Id. at 351-52; GX 5J. SW testified that he had an MRI in 2005 or
2006, and a bone scan in 2001 or 2002, but these test results were not
part of his patient chart in evidence. Tr. 346, 349, 353, 357; GX 5J.
SW saw Respondent three times. See GX 5J.\10\ At the time of the
hearing, SW was still taking Suboxone, but he was not getting it from
Respondent. Tr. at 364-65. Respondent refused to file an insurance
claim for SW., and required that he pay $100 cash for the visits. Id.
at 102-103.
---------------------------------------------------------------------------
\10\ SW testified that he saw Respondent four or five times. Tr.
364. However, SW's patient file documents only three visits.
---------------------------------------------------------------------------
CL
CL first saw Respondent on December 20, 2009. See GX 22, at 6.
Respondent made a diagnosis of both chronic pain and bipolar disorder;
however, Respondent did not document the nature and intensity of the
pain (he did not check either ``YES'' or ``NO'' for whether CL had
pain), the history of the pain, whether any treatments had been
previously tried, and the pain's effect on her psychological and
physical function. Id. While Respondent noted that he had performed a
physical exam and found all areas normal, he did not record any vital
signs. Id. Respondent did not make a substance abuse diagnosis at this
visit and yet prescribed Suboxone to CL under his X number. Id. at 7.
Respondent saw CL again on January 17, 2010. Id. at 6. At this
visit, Respondent again diagnosed CL as having pain even though he
noted that she had ``NO'' pain and made none of the findings as
explained above. Id. He also diagnosed her as having substance abuse
and required that CL undergo a drug screen, the results of which are
not in her chart. Tr. 127-28, 153-54; GX 22. Respondent did not,
however, document CL's history of substance abuse. GX 22, at 6.
Respondent again provided CL with a prescription for Suboxone. Id. at
7.
Respondent provided CL with prescriptions for Suboxone on February
14, March 14, April 10, and May 9, 2010. Id. at 2-3, 5. However, the
progress notes for both February 14 and March 14 contain no information
besides CL's name, date of birth and the date of the visit. Id. at 4.
The progress note for April 10 indicates that CL had chronic pain even
though Respondent checked ``NO'' for her pain and no longer listed
substance abuse as a diagnosis. Id. at 1. Finally, the progress note
for CL's last visit (May 9) again lists chronic pain as one of three
diagnoses even though Respondent checked that she had ``NO'' pain. Id.
While the notes for both the April 10 and May 9 visits indicate that
CL's physical exam was normal, Respondent did not document having taken
any vital signs as either visit. Id.
CP
The earliest progress note for CP is dated December 20, 2009, which
also corresponds with the earliest date listed on the record of CP's
Suboxone prescriptions. GX 23, at 5, 10. The progress note indicates a
diagnosis of chronic pain, even though Respondent checked that CP had
``NO'' pain and contains no other documentation (such as the nature and
intensity of the pain, its history, and its effect on CP's functioning)
to support this diagnosis. Id. at 5. Respondent also diagnosed CP as
having substance abuse (with no supporting findings) and anxiety. Id.
While Respondent performed a physical exam and found all areas normal,
he did not document having taken CP's vital
[[Page 17513]]
signs. Id. Respondent prescribed Suboxone and Xanax at this visit using
his X number.
At the next visit, Respondent again noted that CP had chronic pain
while indicating that he had ``NO'' pain. Id. Respondent, however, made
an entry in the blank for ``EXT'' and for the ``Location,'' both of
which are illegible. Id. Respondent did not, however, note a diagnosis
of substance abuse at this or any subsequent visit. See generally id.
at 1,3,5.
At CP's next visit (Feb. 16), Respondent again diagnosed him as
having chronic pain while noting that he had ``NO'' pain. Id. at 3.
Subsequently, at CP's April 10 visit, Respondent again checked that CP
had ``NO'' pain while writing ``knee pain'' in the ``Review of
Systems'' section; he also made a note next to the ``EXT'' section of
the Examination which is illegible but was not asked about this during
his testimony. Id. Finally, at CP's final visit, Respondent again
diagnosed him as having chronic pain but noted that he had ``NO'' pain
and did not otherwise document any other findings regarding CP's pain.
Id. at 1. Moreover, the Government did not offer any testimony as to
whether it had interviewed CP.
Respondent issued CP prescriptions for Suboxone on Dec. 20, 2009,
Jan. 17, Feb. 16, Mar. 16, April 10, and May 9, 2010; he also wrote CP
prescriptions for Xanax on each of these dates except for April 10. GX
23. Respondent wrote both the Suboxone and Xanax prescriptions on Dec.
20, 2009, as well as the Jan. 17, Feb. 16, and March 16, under his X
number. Id. He also wrote the April 10 Suboxone prescription under his
X number even though he did not list a diagnosis of substance abuse on
any of CP's visits after the first visit. Id; Tr. 130-31.
CML
On June 23, 2010, another DI interviewed CML and asked whether she
was ``being treated for pain or addiction.'' Tr. 266-67. CML stated
that she was being treated for addiction to controlled substances and
that the Respondent was prescribing Suboxone to her. Id. at 267-68. She
paid $100.00 cash for her visits. Id. at 268.
On the progress note for CML's first visit (Dec. 8, 2009),
Respondent checked that she had both pain and chronic pain, as well as
insomnia. GX 5F, at 7. While Respondent noted that her physical exam
was normal in all areas, he did not record any vital signs and did not
document the nature and intensity of the pain, the history of the pain,
whether any treatments had been previously tried, and the pain's effect
on her psychological and physical function at any of her subsequent
visits. See GX 5F. Respondent did not document that CML had back pain
until her sixth and final visit (April 27, 2010), while on the same
note checking that she had ``NO'' pain. Id. at 3.
Indeed, several of the progress notes for CML's visits contain no
medical information whatsoever. With respect to this, Respondent
testified, ``In fact, there's some entries I didn't even put in on
February and March of 2010 and I don't know why that's the case.'' Tr.
472.
At CML's second visit, Respondent noted a diagnosis of substance
abuse. GX 5F, at 7. However, Respondent did not note this diagnosis at
any of CML's subsequent visits. See GX 5F. Moreover, the chart contains
no information about what substances CML was abusing and her history of
substance abuse. GX 5F, at 7; Tr. 666.
Respondent admitted that the chart fails to adequately document
CML's pain. Tr. 472. Respondent also testified that he was tapering
CML's dosages of Suboxone to find the appropriate levels to treat her
chronic pain. Id. at 473. Respondent maintained that his care of CML
was within the standard of care. Id. Respondent prescribed Suboxone
(and Ambien at the first visit) to CML under his X number at several of
the visits even though he did not document that he was treating her for
substance abuse at those visits. See GX 5F.
SJW
On December 29, 2009, SJW made her initial visit to Respondent.\11\
GX 5I, at 7. At the visit, Respondent diagnosed SJW as having both
chronic pain and substance abuse, although he noted that she had ``NO''
pain and did not document the nature and intensity of the pain, the
history of the pain, whether any treatments had been previously tried,
and the pain's effect on her psychological and physical function at
this or any of her subsequent visits. Id. While Respondent indicated
that all areas of her physical examination were normal, he did not
record any vital signs at this visit. Id. Nor did Respondent make any
notes regarding SJW's history of substance abuse. There is, however, no
evidence that Respondent prescribed to SJW at this visit.
---------------------------------------------------------------------------
\11\ SJW's file includes an intake form in which she listed her
medications as ``Suboxin.'' GX 5I, at 1.
---------------------------------------------------------------------------
Respondent did, however, prescribe Suboxone (and Xanax) to SJW at
her second visit, which occurred one week later. Id. at 7-8. On the
progress note for this visit, Respondent listed the diagnoses as
chronic pain (while indicating that she had ``NO'' pain and failing to
document any other information regarding her condition) and substance
abuse, again without any documentation. Id. at 7. Moreover, he again
documented that SJW's physical exam was normal but did not record any
vital signs. Id. Nor did Respondent document that SJW had anxiety, the
condition for which Xanax is typically prescribed, and, in fact,
Respondent indicated ``NO'' for whether she was agitated/moody. Id.
While SJW's chart shows that she received prescriptions for
Suboxone (and Xanax) in February and March, the progress notes for this
period contain no information regarding her medical condition(s). Id.
at 2,--5-6. Regarding these incidents, Respondent stated: ``I don't
have an explanation for it unless I had to zip over and take care of
another patient and I just took care of her and then took off. I don't
know the situation.'' Tr. 681.
On May 9, 2010, SJW made her final visit to Respondent. GX 5I, at
3. At this visit, Respondent again diagnosed her as having chronic pain
while indicating that she had ``NO'' pain and that her physical
examination was normal in all areas. Id. at 3. Respondent also
diagnosed her as having anxiety, even though he indicated ``NO'' for
whether she was agitated or moody. Id. Respondent issued her
prescriptions for both Suboxone and Xanax. Id. at 4.
On June 23, 2010, a DI phoned SJW and interviewed her. SJW told the
DI that Respondent was treating her for her addiction to controlled
substances and that she paid $100 cash for each visit. Tr. 268-69. On
two occasions (Jan. 5 and Feb. 2), Respondent prescribed both Suboxone
and Xanax to SJW under his X number. Tr. 269; GX 5I, at 6, 8.
Respondent testified that he was treating SJW for pain and anxiety. Tr.
477, 679.
As for how he made his diagnosis of substance abuse, Respondent
testified that ``[i]t could be in her history with me; it could be a
drug screen.'' Id. at 679. There is, however, no evidence in SJW's
chart establishing that Respondent took a history or that he required
her to undergo a drug screen. See generally GX 5I. Moreover, when asked
``do we see an indication that [SJW] complained of pain?,'' Respondent
answered: ``No. I did not fill that out.'' TR. at 679-80. As for
Respondent's failure to note why he prescribed Xanax, Respondent
testified: ``No, I did not put an anxiety there. And there was a good
chance that she was on Xanax already. Did not give it to her in the
December because she probably
[[Page 17514]]
already had an active prescription for it. And we probably got that
from the drug monitoring system.'' Id. at 680. Respondent believed his
treatment of SJW was appropriate, but that his documentation was
``terrible.'' Tr. 478.
LMJ
On her intake form, LMJ listed her medications as ``Loricets''
[sic]. GX 5E. At her first visit (Feb. 16, 2010), Respondent made
diagnoses of both chronic pain and substance abuse. Id. at 4. However,
Respondent noted that LMJ had ``NO'' pain, that her physical
examination was normal and did not document the nature and intensity of
the pain, the history of the pain, whether any treatments had been
previously tried, and the pain's effect on her psychological and
physical function at this visit or her next two visits. Id. at 2 & 4.
Respondent did not note a location of any pain LMJ had until her final
visit; even then, however, he did not document any information other
than that the pain was in her ``back & arms.'' Id. at 2. Respondent did
not document having taken LMJ's vital signs at any of her visits. Id.
at 2, 4. Moreover, while at LMJ's first three visits, Respondent listed
a diagnosis of substance abuse, the chart contains no information as to
her history of substance abuse. Id. at 2, 4. At each of LMJ's visits,
Respondent prescribed Suboxone to her. Id. at 3, 5.
On June 24, 2010, a DI interviewed LMJ by phone. Tr. 270. The DI
asked LMJ whether she was seeing Respondent for pain or for addiction
to controlled substances; LMJ said that she was seeing Respondent for
addiction for which he was prescribing Suboxone. Id. LMJ also stated
that she paid $100.00 cash for each visit. Id.
The ALJ found that Respondent credibly testified that he did not
``have a good grasp on her history and physical as to, is this chronic
pain or substance abuse, so we put the differential as both of these
right now.'' Id. at 470. She also found credible Respondent's testimony
that LMJ was a patient ``who wanted to get off Lorcet because she was
building such a tolerance having to take more and more of this for her
pain, but I could not totally rule out that she had a substance abuse
problem.'' Id. at 471. While Respondent testified that he could
sometimes rule out a substance abuse diagnosis ``later on as [I] get a
grasp on these patients, and periodic random drug screens help me with
this also,'' there is no evidence that Respondent required LMJ to
undergo a drug test. Id. Respondent thought his treatment of LMJ was
within the standard of care. Id.
MR
MR first saw Respondent on December 15, 2009. GX 5G, at 7.
Respondent diagnosed MR as having chronic pain even though he noted
that MR had ``NO'' pain. Id. Respondent documented the pain's location
as MR's ``Teeth'' and prescribed Suboxone to him. Id. at 7-8.
Respondent testified that MR's pain was in his mouth and jaw, but the
chart does not contain any other information regarding this condition.
Tr. 474, 668; GX 5G. Moreover, Respondent continued to list a diagnosis
of chronic pain at MR's visits of Jan. 17, Feb. 14, and Mar. 30, even
though on the respective progress notes, he checked ``NO'' for whether
MR had pain, did not list a location of the pain, noted that the
physical exam was normal in all areas, and did not document having
taken any vital signs Id. at 5, 7. Nor is there any evidence that
Respondent referred MR to a dentist.
On both the January 17 and March 30 progress notes, Respondent also
listed a diagnosis of substance abuse. Id. at 5, 7. However, Respondent
did not document the basis for his diagnosis. Id. At MR's final visit,
Respondent no longer listed a diagnosis of substance abuse. However, he
now documented that MR had right shoulder pain as the result of a motor
vehicle accident. Id. at 3; Tr. 671. Respondent testified that MR had
gone to the emergency room, but that he had not obtained those records.
Tr. 671.
When asked whether MR's tooth pain ``was no longer an issue in the
subsequent visits''; Respondent maintained that ``I just didn't enter
it.'' Id. at 672. As for the diagnosis of substance abuse, Respondent
did not note in MR's chart the substances he abused, and Respondent
could not remember during his testimony.\12\ Id. at 668-69; GX 5G.
---------------------------------------------------------------------------
\12\ The ALJ found credible Respondent's testimony that he had
also diagnosed MR with bipolar disorder, but that he had failed to
annotate that in the patient's chart as well. Tr. 474.
---------------------------------------------------------------------------
On June 24, 2010, a DI phoned MR and interviewed him. Id. at 271.
The DI asked MR whether he was seeing Respondent for chronic pain or
for addiction; MR stated that ``he was addicted.'' Id. at 271-72. MR
also said that he paid $100.00 cash for each visit. Id. at 272. MR was
treated with Suboxone, which was written on an X prescription pad. Tr.
474; GX 5G, at 6, 8. Respondent believed his treatment of MR was
appropriate. Tr. 475.
SHY
SHY first saw Respondent on December 13, 2009. GX 5D, at 8. On the
intake form, SHY listed his medications as Suboxone and Zyprexa. Id. at
1. Respondent diagnosed SHY as having chronic pain even though he
circled ``NO'' for whether SHY had pain, did not note the location of
the pain, and did a physical examination during which he found all
areas normal. Id. at 8. Moreover, Respondent did not document a history
of the pain, whether any treatments had been previously tried, and the
pain's effect on his psychological and physical function at this visit.
Id. Respondent also did not document having taken SHY's vital
signs.\13\ Id.
---------------------------------------------------------------------------
\13\ Respondent also diagnosed SHY as having major depression.
---------------------------------------------------------------------------
At SHY's subsequent visits, Respondent continued to document that
SHY had chronic pain even though he repeatedly noted that he had ``NO''
pain, never found anything that was not normal during the physical
exams, and never listed a location of any pain. Id. at 4, 6. Respondent
also noted a diagnosis of substance abuse on two separate occasions,
but did not document SHY's history of substance abuse and what
substances he was abusing. Id. He did, however, require SHY to undergo
a drug screen at the first visit, the results of which were negative
with the exception of the test for synthetic opioids, which was
consistent with SHY having indicated that his medications included
Suboxone. Id. at 1, 10-11.
On June 22, 2010, a DI called SHY, and asked him why he was seeing
Respondent. Tr. 288. SHY said that he was being treated for opiate
addiction and that he was not being treated for chronic pain. Id. at
288-89.
At the hearing, Respondent testified that he thought SHY was
probably abusing either Lorcet or Oxycontin. Id. at 659. However, he
then admitted that he did not document this. Id. Respondent then
claimed that SHY ``probably had a little marijuana or something like
that in a drug screen, and that's where we probably gave him a
substance abuse diagnosis.'' Id. at 660. SHY did not, however, test
positive for THC. See GX 5D, at 10-11. Respondent also admitted that he
``did not document * * * any details of the pain,'' but then stated
that ``[a] lot of these people with major depression have pain from the
depression, but we still put a diagnosis of potential chronic pain.''
Id. at 468, see also id. at 655-56. Respondent acknowledged that he
inappropriately prescribed other medications than Suboxone using his X
number to SHY. Id. at 468. Respondent believed his care of SHY was
within the standard of care. Id. 469-70.
[[Page 17515]]
JC2
Respondent treated JC2 for chronic pain, substance abuse, attention
deficit disorder, and extreme anxiety. Tr. 458; GX 5C. Respondent
acknowledged that JC2 was ``a tough patient,'' who had been ``fired''
by other doctors and had abused Xanax. Tr. 458-60. A note in JC2's
chart dated ``9-1-09'' indicates that a friend of JC2 had stated that
he was taking twelve Xanax pills at a time. GX 5C, at 3.
Respondent noted in the chart that JC2 was abusing Xanax and ``MUST
STOP XANAX.'' Id. at 2, 12; see also Tr. 459-60, 628. In his testimony,
Respondent stated that his treatment plan was to gradually taper JC2
off Xanax, which could take up to a year, or to manage JC2's intake.
Tr. 460-62, 630. The chart also notes that in November 2009, JC2 missed
two appointments and was jailed for distribution. GX 5C, at 8. The
chart also again notes ``Reported taking [greater than] 12
Xanax @ a time.'' Id. Respondent also testified that he knew ``for a
fact in this young man's history [that] he has been jailed before'' for
``doing things [that were] inappropriate.'' Tr. 631.
The ALJ found that Respondent credibly testified that he could not
just cease prescribing Xanax to JC2 because he could have seizures. Id.
at 460-61. However, the patient file shows that notwithstanding
Respondent's testimony that he planned to taper JC2 off of Xanax, he
actually increased the daily doses of the prescriptions. Compare GX 5C,
at 11 (Aug. 30, 2009 RX for 30 tablets of Xanax 1.0 mg, [frac12] BID
(for daily dose of 1 mg)), with id. at 10 (Oct. 25, 2009 RX for 90
tablet of Xanax 1.0 mg., 1 TID (for daily dose of 3 mg)), with id. at 5
(Apr. 17, 2010 RX for 60 tablets of Xanax 2.0 mg, 1q12, with 2 refills
(for daily dose of 4 mg)). The chart also demonstrates that Respondent
wrote multiple Xanax and Suboxone prescriptions under his X number
prior to February 28, 2010. GX 5C, at 7, 9-11, 13. Respondent testified
that he conducted drug screens on JC2, but the results of these tests
were not in JC2's medical record. Tr. 633-34.
Respondent testified that he prescribed Suboxone to treat JC2's
substance abuse and that substance abuse was JC2's primary diagnosis.
Id. at 643, 645. Moreover, a note for a visit of April 5, 2009, states
``Desires To Get OFF Narcotics.'' GX 5C, at 15. Respondent also
testified that JC2 was being seen for chronic pain caused by a football
injury when he was a teenager, but he then admitted that JC2's chart
does not document the source or severity of that pain. Tr. 654-55. Nor
did Respondent document the history of the pain, any prior treatments
for it and its effect on JC2's functioning. See GX 5C. Respondent
maintained, however, that he knew JC2's history and ``that he's had a
lot of problems.'' Tr. 655.
Respondent also testified that JC2 had been in a narcotic treatment
program in 2007 or 2008 and had left against medical advice. Id. at
631-632. Yet Respondent did not document this in JC2's chart and did
not obtain his treatment records from the narcotic treatment facility.
GX 5C. Respondent believed he treated JC2 within the standard of care.
Tr. 461.
DA
DA saw Respondent three times: in December 2009, and in January and
February of 2010. GX 5K. According to the progress note for the first
visit, Respondent diagnosed DA with chronic pain and anxiety. Id. at 3.
Respondent circled ``YES'' for whether DA had pain and noted that the
location was his back and both legs. Id. Respondent did not, however,
document the nature and intensity of the pain, its history, whether any
treatments had been previously tried, and the pain's effect on his
psychological and physical function at either this visit or his next
visit. Id. at 3. Moreover, the progress notes for DA's first two visits
(there is no note for a third visit on Feb. 21, 2010, even though there
is a prescription for this date), indicate that Respondent performed a
physical examination and found all areas normal. Id. Respondent did not
document DA's vital signs for either visit. Id. Respondent also noted a
diagnosis of substance abuse at DA's second visit but did not document
the basis for this diagnosis. Id. Respondent issued DA prescriptions
for both Suboxone and Xanax at all three visits, including on the
second visit when he noted that DA had ``NO'' pain; on each occasion,
Respondent issued the prescriptions under his X number. Id. at 4-5.
On June 1, 2010, the lead DI interviewed DA by phone. Tr. 85. DA
told the DI that he was addicted to pain killers and that Respondent
was treating him for this condition and not for chronic pain. Id. at
85-87. In his testimony, Respondent admitted that he did not get DA's
medical records for his pain condition but maintained that he was
familiar with this patient from treating him in the emergency
department of the Red Bay Hospital. Tr. 693; see generally GX 5K.
Respondent believed that his care was appropriate for DA. Tr. 482.
AH
Respondent saw AH four times beginning on December 13, 2009, and
ending on March 28, 2010. GX 5S. Respondent noted that AH was taking 12
Lortab 10 mg a day, which she was getting ``from doctors, friends,
[and] off the street.'' Tr. 493. Respondent diagnosed AH with both
substance abuse and chronic pain as a secondary diagnosis. GX 5S, at 3.
While Respondent noted ``YES'' for whether AH had pain, he did not
document the nature, intensity and location of the pain; the history of
the pain; what treatments had been used; and the pain's effect on her
physical and psychological functioning. Id. at 3. Respondent also noted
that AH was undergoing withdrawal, was agitated/moody, had insomnia and
a positive MDQ. Id. AH's physical exam was normal and Respondent did
not document having taken her vital signs. Id. At this visit,
Respondent prescribed Suboxone to her under his X number. GX 5S, at 4.
At AH's second visit (Feb. 1), Respondent noted that she had ``NO''
pain and did not make any other findings about her pain; he also
indicated that she did not demonstrate withdrawal, that she was not
agitated or moody and did not have insomnia or a positive MDQ. GX 5S,
at 7. Respondent did not note any abnormalities in the physical exam
and did not document having taken AH's vital signs. Id. Respondent
noted his diagnosis as Suboxone 16 mg. and gave AH a prescription for
Suboxone which he wrote under his X number. Id. at 8.
On Feb. 28, Respondent issued AH a third prescription for Suboxone,
again using his X number. Id. at 8. The progress note for this visit,
however, lists AH's name, date of birth and a visit date but contains
no medical information. Id. at 7.
On March 28, AH again saw Respondent. Id. at 5. At this visit,
Respondent circled ``YES'' for whether she had pain and noted its
location as her neck and back. Id. Once again, he did not document the
nature and intensity of the pain, the history of the pain, what
treatments had been used, and the pain's effect on her physical and
psychological functioning. Id. Again, Respondent performed a physical
exam but found no abnormalities; he also did not document having taken
AH's vital signs. Id. Respondent made diagnoses of both chronic pain
and substance abuse. Id. Respondent issued AH a new prescription for
Suboxone, which was written on a prescription form that contained both
of his numbers. Id. at 6.
[[Page 17516]]
Respondent testified that AH had some neck and back pain, but
``appeared to be functional.'' Tr. 493. He was also ``not convinced
that [he] could not add the substance abuse potential to her.'' Id.
Respondent stated that his treatment of AH was within the standard of
care. Id. at 494.
NK
NK saw Respondent three times during February and March 2010. GX
5U. On the intake form, NK listed his medications as Suboxone and
Xanax. Id. at 2. On the progress note for NK's first visit, Respondent
noted that he had ``NO'' pain and did not indicate a location for any
pain. Id. at 3. Respondent noted that he had performed a physical
examination, but found no abnormalities; Respondent also did not
document having taken NK's vital signs. Id. Respondent nonetheless
diagnosed NK as having both chronic pain and anxiety (but not substance
abuse) and gave him prescriptions for Suboxone and Xanax, both of which
were written under his X number. Id. at 5.
On March 9, Respondent issued NK a second prescription for
Suboxone, and on March 21, he issued NK prescriptions for both Suboxone
and Xanax. Id. at 4-5. However, the progress note dated Mar. 9 contains
no medical information and there is no note for Mar. 21. See generally
GX 5U.
On May 25, 2010, the lead DI interviewed NK. Tr. 78. NK stated that
Respondent was treating him for opiate addiction, and not for any other
medical problem including chronic pain. Id. at 79. NK also told the DI
that he was no longer seeing Respondent and that ``he would kick the
habit himself.'' Id. at 78. NK's chart also contains a prescription for
Suboxone dated April 17, 2010, even though NK did not see Respondent on
that date. GX 5U, at 6. Respondent explained that he had prepared the
prescription in advance of NK's visit, but that ``no one gets that
prescription unless I hand it to them.'' Tr. 497.
Respondent's Post-Suspension Conduct
On September 27, 2010, Respondent was personally served with the
Order to Show Cause and Immediate Suspension of Registration. At that
time, the lead DI explained to Respondent that, as of that date, he was
no longer authorized to prescribe or handle any controlled substances.
Tr. 112-13. Respondent told the DI that ``he was not going to abide by
this order and that (the DI) didn't have the authority to tell him that
he couldn't prescribe any controlled substances.'' Id. at 113.
Thereafter, the lead DI discovered that Respondent had issued
controlled-substance prescriptions which were dated September 29,
October 3 and October 4, 2010. Tr. 114; GX 6. While the ALJ found that
there were a total of four post-suspension prescriptions, two of the
prescription forms contained prescriptions for two controlled
substances. ALJ at 34; but see GX 6, at 3-4.
The first prescription, which was issued to CW and dated September
29, 2010, was for the drug Adderall, a schedule II controlled
substance. GX 6, at 1. CW told the lead DI that Respondent wrote the
prescription after she had been seen by Respondent's Physician's
Assistant, CC. CW picked up the prescription the next day, September
30. Tr. 115-118; GX 6, at 1. Respondent admitted to signing this
prescription. Tr. 506-07; see also RX 29, at 17-19 (CW's chart for
Sept. 29, 2010 visit).
The second prescription, which was issued to JB and dated October
3, 2010, was also for Adderall. Tr. 118-19, 200-01; GX 6, at 2.
However, the evidence showed that Respondent had issued the
prescription on September 3, 2010. Tr. 119-20, 508, 733-34. This
prescription did not, however, include Respondent's registration number
and listed only his X number. GX 6, at 2.
The lead DI contacted the pharmacist who filled the prescription,
and was told that the pharmacy would not accept a post-dated
prescription for a scheduled drug. Tr. 123. The pharmacist remembered
this prescription and further stated that it had actually been
presented for filling on October 3, 2010. Tr. 123-24, 158-59. The lead
DI testified that while it would have been permissible to write a
prescription and sign it on September 3, 2010, with the annotation of
``do not fill until October 3, 2010,'' it was not permissible for
Respondent to sign a schedule II prescription on September 3 but date
the prescription for October 3rd. Tr. 124.
The evidence also included two prescriptions issued (on a single
prescription form) to MK and dated October 4, 2010; the prescriptions
were for 60 Adderall and 90 Lortab 10 mg, another schedule III
narcotic. GX 6, at 3. The lead DI contacted MK about the prescriptions;
MK confirmed that the prescriptions were written and received on
October 4, 2010. Tr. 124-25. While Respondent testified that the
prescriptions had been post-dated, he admitted to having written the
prescriptions on September 29, two days after he was served with the
Immediate Suspension Order. Tr. 508-09; 740-41. Respondent maintained
that the prescription was given to MK by mistake. Id. at 741. MK's
patient file includes a progress note which establishes that she saw
Respondent on September 29, 2010. RX 32, at 28. Notwithstanding the
testimony regarding MK's statement as to the date the prescriptions
were written, I find that the prescriptions were written on September
29.
The evidence also included two prescriptions which were issued to
DH and also dated October 4, 2010. GX 6, at 4. The prescriptions were
for 90 Lortab 10 mg and 90 Xanax 1 mg. Tr. 126, 509; GX 6, at 4.
Respondent testified that he thought that he had seen DH in
September but that he did not know ``exactly which day I saw him.'' Tr.
509. Respondent admitted, however, that the prescription was in his
handwriting and that he ``signed it.'' Continuing, he maintained that
he did not have an explanation for it, that ``[t]his was an accident,''
and that he ``would never do anything to violate an order.'' Id. at
509.
According to DH's patient file, DH saw Respondent on September 29,
2010.\14\ RX 31, at 28. The chart for the visit noted that DH was
``Here for med refills'' and that he was ``here for Dr. Cochran,'' and
that his ``Current Meds'' were Lortab and Xanax. Id. In addition,
Respondent signed the chart. Id. I therefore find that Respondent wrote
the prescriptions on September 29.
---------------------------------------------------------------------------
\14\ DH's previous visit was on August 4, 2010. RX 31, at 30.
---------------------------------------------------------------------------
Respondent's Testimony
Respondent maintained that some of the patients did not know what
they were being treated for. Tr. 743-44. However, Respondent did not
document any patient's lack of understanding of his diagnosis in the
patient files. Tr. 745. Moreover, the ALJ did not find this testimony
credible. ALJ at 49.
As noted above, Respondent provided evidence that he had stopped
prescribing methadone to his patients. Moreover, Respondent established
that he had stopped using his X number to write prescriptions for drugs
other than Suboxone and when prescribing Suboxone to treat pain.
However, on September 3, 2010, Respondent wrote a further controlled
substance prescription for Adderall (which was post-dated) under his X
number. GX 6, at 2.
Respondent also testified that he maintained the drugs screens he
ordered on his patients in a separate file which he called the ``Drug
Screen Book.'' Tr. 687. Respondent testified that when the
[[Page 17517]]
DIs obtained the patient files, they did not take the Drug Screen
Book.'' Id. Respondent did not, however, submit the Drug Screen Book
for the record.
Respondent agreed that his patient charts were incomplete. Tr. 452.
In one case Respondent testified that his record keeping was incorrect
and he had mistakenly written the wrong primary diagnosis for the
patient. Id. at 654. Respondent, however, offered no evidence that he
was prepared to comply with the Alabama Board's Guidelines For The Use
Of Controlled Substances For The Treatment Of Pain. See Ala. Admin Code
r.540-x-4-.08.
Discussion
Section 304(a) of the Controlled Substances Act provides that a
``registration pursuant to section 823 of this title to * * * dispense
a controlled substance * * * may be suspended or revoked by the
Attorney General upon a finding that the registrant * * * has committed
such acts as would render his registration under section 823 of this
title inconsistent with the public interest as determined under such
section.'' 21 U.S.C. 824(a)(4). In determining the public interest,
Congress directed that the following factors be considered:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f). In addition, pursuant to 21 U.S.C. 824(d),
``[t]he Attorney General may, in his discretion, suspend any
registration simultaneously with the institution of proceedings under
this section, in cases where he finds that there is an imminent danger
to public health or safety.''
The public interest factors are considered in the disjunctive.
Robert A. Leslie, 68 FR 15227, 15230 (2003). I may rely on any one or a
combination of factors and may give each factor the weight I deem
appropriate in determining whether to revoke an existing registration
or to deny an application for a registration. Id. Moreover, I am ``not
required to make findings as to all of the factors.'' Hoxie v. DEA, 419
F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165,
173-74 (DC Cir. 2005).
The Government has ``the burden of proving that the requirements
for * * * revocation or suspension pursuant to section 304(a) * * * are
satisfied.'' 21 CFR 1301.44(e); see also 21 CFR 1301.44(d) (Government
has ``the burden of proving that the requirements for [a] registration
pursuant to section 303 * * * are not satisfied''). However, where the
Government satisfies its prima facie burden, the burden then shifts to
the registrant to demonstrate why he can be entrusted with a new
registration. Medicine Shoppe-Jonesborough, 73 FR 364, 380 (2008).
Having considered all of the factors, I conclude that the
Government's evidence pertinent to factors two (Respondent's experience
in dispensing controlled substances) and four (Respondent's compliance
with applicable laws related to controlled substances), establishes
that Respondent has committed acts which render his registration
``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). I
further conclude that Respondent has not rebutted the Government's
prima facie case.
Factors One and Three--The Recommendation of the State Board and
Respondent's Record of Convictions Under Laws Relating to the
Manufacture, Distribution and Dispensing of Controlled Substances
The record establishes that the State Board has an open
investigation of Respondent. However, the Board has not made a
recommendation in this matter, and it is undisputed that Respondent's
medical license remains active and unrestricted. Accordingly, this
factor does not support a finding either for, or against, the
continuation of Respondent's registration. See Joseph Gaudio, 74 FR
10083, 10090 n.25 (2009); Mortimer B. Levin, 55 FR 8209, 8210 (1990).
There is also no evidence in the record that Respondent has been
convicted of an offense related to the manufacture, distribution or
dispensing of controlled substances. While this factor supports the
continuation of Respondent's registration, DEA has long held that this
factor is not dispositive. See, e.g., Edmund Chein, 72 FR 6580, 6593
n.22 (2007).
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Related to Controlled
Substances
The record establishes that Respondent violated numerous provisions
of Federal law and DEA regulations. These include: (1) The prescribing
of methadone for substance abuse treatment without being registered to
do so under 21 U.S.C. 823(g)(1), in violation of 21 U.S.C. 841(a)(1);
(2) the prescribing of methadone for substance abuse treatment, in
violation of 21 CFR 1306.04(c) and 1306.07; (3) prescribing controlled
substances without a legitimate medical purpose, in violation of 21 CFR
1306.04(a); (4) the post-dating of prescriptions, in violation of 21
CFR 1306.05(a); and (5) prescribing controlled substances when his
registration had been suspended, in violation of 21 U.S.C. 843(a)(2).
The Methadone Prescriptions
Under 21 U.S.C. 823(g)(1), ``practitioners who dispense narcotic
drugs to individuals for maintenance treatment or detoxification
treatment shall obtain annually a separate registration [from their
practitioner's registration] for that purpose.''\15\ In the Drug
Addiction Treatment Act of 2000, Congress provided that the requirement
to obtain a separate registration is ``waived in the case of the
dispensing (including the prescribing), by a practitioner, of narcotic
drugs in schedule III, IV, or V or combinations of such drugs if the
practitioner meets the conditions specified in [section 823(g)(2)(B)]
and the narcotic drugs or combinations of such drugs meet the
conditions specified in [section 823(g)(2)(C)].'' Id. Sec.
823(g)(2)(A) (emphasis added).
---------------------------------------------------------------------------
\15\ An applicant for registration under this provision must
meet three requirements: (1) The applicant must be ``determined by
the Secretary [of HHS] to be qualified * * * to engage in the
treatment with respect to which registration is sought; (2) the
Attorney General must ``determine[] that the applicant will comply
with standards * * * respecting (i) security of stocks of narcotic
drugs for such treatment, and (ii) the maintenance of records * * *.
on such drugs,'' and (3) ``if the Secretary determines that the
applicant will comply with standards * * * respecting the quantities
of narcotic drugs which may be provided for unsupervised use by
individuals in such treatment.'' 21 U.S.C. 823(g)(1).
---------------------------------------------------------------------------
Methadone is, however, a schedule II narcotic, and thus, except for
where a patient presents with acute withdrawal symptoms (and then for
no more than a total of three days), cannot be lawfully dispensed for
the purpose of maintenance or detoxification treatment absent the
practitioner's holding a registration under section 823(g)(1). See 21
U.S.C. 812(c) (Schedule II (b)(11)); 21 CFR 1308.12(c)(15). Moreover,
under DEA's regulations, ``[a] prescription may not be issued for
`detoxification treatment' or `maintenance treatment,' unless the
prescription is for a Schedule III, IV, or V narcotic drug approved by
the Food and Drug Administration
[[Page 17518]]
specifically for use in maintenance or detoxification treatment.'' 21
CFR 1306.04(c).\16\ See also id. 1306.07(a) (``A practitioner may
administer or dispense directly (but not prescribe) a narcotic drug
listed in any schedule * * * for the purpose of maintenance or
detoxification treatment if the practitioner * * * is separately
registered with DEA as a narcotic treatment program [and] is in
compliance with DEA regulations regarding treatment qualifications,
security, records, and unsupervised use of the drugs pursuant to the
[CSA].'') (emphasis added); id. 1306.07(b) (``Nothing in this section
shall prohibit a physician * * * from administering (but not
prescribing) narcotic drugs to a person for the purpose of relieving
acute withdrawal symptoms when necessary while arrangements are being
made for referral for treatment. Not more than one day's medication may
be administered to the person or for the person's use at one time. Such
emergency treatment may be carried out for not more than three days and
may not be renewed or extended.'') (emphasis added).
---------------------------------------------------------------------------
\16\ See also 21 CFR 1306.07(d) (``A practitioner may administer
or dispense (including prescribe) any Schedule III, IV, or V
narcotic drug approved specifically by the Food and Drug
Administration specifically for use in maintenance or detoxification
treatment to a drug dependent person if the practitioner complies
with the requirements of [21 CFR 1301.28].'' 21 CFR 1301.28 is the
provision which implements the DATA Waiver Act.
---------------------------------------------------------------------------
Also relevant here is the definition of the term ``maintenance
treatment.'' 21 U.S.C. 802(29). Under the CSA, the term ``means the
dispensing, for a period in excess of twenty-one days, of a narcotic
drug in the treatment of an individual for dependence upon heroin or
other morphine-like drugs.'' Id.\17\
---------------------------------------------------------------------------
\17\ The CSA also defines the term ``detoxification treatment.''
21 U.S.C. 802(30). The term ``means the dispensing, for a period not
in excess of one hundred and eighty days, of a narcotic drug in
decreasing doses to an individual in order to alleviate adverse
physiological or psychological effects incident to withdrawal from
the continuous or sustained use of a narcotic drug and as a method
of bringing the individual to a narcotic drug-free state within such
period.'' Id.
---------------------------------------------------------------------------
Finally, Respondent claimed that most of the patients whose files
were introduced into evidence (including some of the methadone
patients) were chronic pain patients. Under a longstanding DEA
regulation, to be effective, ``[a] prescription for a controlled
substance * * * must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice.'' 21 CFR 1306.04(a). As the Supreme Court has explained,
``the prescription requirement * * * ensures 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. 243, 274 (2006) (citing United States v.
Moore, 423 U.S. 122, 135, 143 (1975)).
Under the CSA, it is fundamental that a practitioner must establish
and maintain a bonafide doctor-patient relationship in order to act
``in the usual course of * * * professional practice'' and to issue a
prescription for a ``legitimate medical purpose.'' Laurence T.
McKinney, 73 FR 43260, 43265 n.22 (2008); see also Moore, 423 U.S. at
142-43 (noting that evidence established that physician ``exceeded the
bounds of `professional practice,''' when ``he gave inadequate physical
examinations or none at all,'' ``ignored the results of the tests he
did make,'' and ``took no precautions against * * * misuse and
diversion''). The CSA, however, generally looks to state law to
determine whether a doctor and patient have established a bonafide
doctor-patient relationship. See Kamir Garces-Mejias, 72 FR 54931,
54935 (2007); United Prescription Services, Inc., 72 FR 50397, 50407
(2007).
By regulation, the Alabama Board of Medical Examiners has adopted
Guidelines For The Use of Controlled Substances For The Treatment of
Pain. See Ala. Admin. Code r. 540-X-4-.08. According to the Board, the
``guidelines are not intended to define complete or best practice, but
rather to communicate what the Board considers to be within the
boundaries of professional practice.'' Id. (1)(g). Guideline (2)(a),
which is captioned ``Evaluation of the Patient,'' states:
A complete medical history and physical examination must be
conducted and documented in the medical record. The medical record
should document the nature and intensity of the pain, current and
past treatments for pain, underlying or coexisting diseases or
conditions, the effect of the pain on physical and psychological
function, and history of substance abuse. The medical record also
should document the presence of one or more recognized medical
indications for the use of a controlled substance.
Id. (2)(a).\18\
---------------------------------------------------------------------------
\18\ See also Ala. Admin. Code r. 540-X-4.08(2)(b) (``The
written treatment plan should state objectives that will be used to
determine treatment success, such as pain relief and improved
physical and psychosocial function, and should indicate if any
further diagnostic evaluations or other treatments are planned.'').
The Guidelines also provide that:
The physician should keep accurate and complete records to
include
1. The medical history and physical examination;
2. Diagnostic, therapeutic and laboratory results;
3. Evaluations and consultations;
4. Treatment objectives;
5. Discussion of risks and benefits;
6. Treatments;
7. Medications (including date, type, dosage and quantity
prescribed);
8. Instructions and agreements;
9. Periodic reviews.
Id. 2(f).
---------------------------------------------------------------------------
The record contains substantial evidence that Respondent prescribed
methadone to opiate addicted patients for the purpose of providing
maintenance treatment. During his initial interview (on Feb. 28, 2010)
with the Investigators, Respondent told them that ``he was operating a
detox clinic where he was using methadone to get his patients onto
Suboxone.'' Tr. 43. It was not until later that day, when the
Investigators interviewed Respondent for the second time, that he
claimed that he prescribed methadone for pain and that he had
previously misspoken. Id. at 55.
Other evidence supports the conclusion that Respondent was
prescribing methadone to provide maintenance or detoxification
treatment to opiate addicted patients. On the date of the visit,
Investigators interviewed JKB, who told them that he was being treated
by Respondent with methadone for opiate addiction. Id. at 52. JKB
further stated that he had previously gone to a narcotic treatment
program, which used methadone, and that he was seeing Respondent
because the latter charged less. Id. at 52-53. JKB also stated that
Respondent was not treating him for chronic pain. Id. at 53.
The Government introduced into evidence seven files of patients who
received methadone prescriptions from Respondent. GXs 5X; 5O; 5A; 5N;
5L; 5M; and 5T. The Government also elicited the testimony of the DIs
to the effect that they had interviewed several of the patients to
determine what condition they were being treated for.
Patient TP related that she had gone to Respondent because she had
heard that he was using methadone to treat addiction; TP also noted on
her intake form that she had previously gone to a methadone clinic and
was taking twelve tablets of methadone 10 mg strength a day. Respondent
issued her prescriptions for methadone on three separate dates over the
course of a month, and ultimately TP returned to a methadone clinic.
While Respondent maintained that TP had been going to the methadone
clinic for pain, he conceded that the purpose of a methadone clinic is
to treat addiction. Moreover, while Respondent noted diagnoses of both
chronic pain and substance abuse on TP's progress
[[Page 17519]]
notes, he did not document having taken a medical history, the nature
and intensity of any pain, current and past treatments for paint, and
its effect on her physical and psychological functioning.
I thus conclude that Respondent prescribed methadone to TP for
maintenance or detoxification purposes and not to treat chronic pain.
In doing so, he violated the CSA because he did not have the
registration required under section 823(g)(1) to dispense methadone for
this purpose; he also violated DEA regulations which prohibit the
prescribing of narcotic drugs for this purpose except for those drugs
in schedules III through V which have been specifically approved by the
FDA to provide maintenance or detoxification treatment. 21 CFR
1306.04(c).
The DIs also interviewed MB, who stated that she was being treated
by Respondent for an addiction to Lorcet and not for chronic pain.
Respondent testified, however, that he was treating MB both for chronic
pain cause by headaches and substance abuse. Respondent prescribed
methadone to her on six different dates.
Notably, the Government did not produce any evidence corroborating
MB's statement that she was not being treated for chronic pain. See
Consolidated Edison Co. v. NLRB, 305 U.S. 197, 230 (1938) (``Mere
uncorroborated hearsay * * * does not constitute substantial
evidence.). However, even if this evidence is not sufficient to
establish that Respondent was treating her only for substance abuse and
crediting his testimony that he was also treating her for chronic pain,
I conclude that the prescriptions were unlawful.
Notably, Respondent did not document the nature and intensity of
her pain, its effect on both her physical and psychological function,
any prior or current treatment for it, and her history of substance
abuse. See Ala. Admin Code r.540-X-4.08(2)(a). Accordingly, because
Respondent did not make any of the findings required under the Alabama
guidelines, I conclude that he did not have a basis for his diagnosis
of chronic pain. I thus conclude that Respondent acted outside of ``the
usual course of * * * professional practice'' and lacked a ``legitimate
medical purpose'' in issuing the methadone prescriptions to MB and
violated Federal law. 21 CFR 1306.04(a).\19\
---------------------------------------------------------------------------
\19\ As explained above, if Respondent was treating MB for
substance abuse, the methadone prescriptions were illegal because
methadone cannot be prescribed for this purpose and because he did
not hold the required registration. See 21 U.S.C. 823(g)(1); 21 CFR
1306.07(a) & (b).
---------------------------------------------------------------------------
Respondent issued three methadone prescriptions (on Feb. 9, 23, and
Mar. 9) to JC1 (GX 5N), each of which was for 210 tablets with a daily
dose of 150 mg. Respondent admitted that JC1 had come from another
methadone clinic even though he denied that JC1 had gone to the clinic
to be treated for addiction and maintained that he had gone there for
pain management. Moreover, while Respondent also maintained that JC1
had come to him because ``he wanted to take a cleaner medicine for his
pain,'' when Respondent stopped writing methadone prescriptions, JC1
decided to go to another treatment facility.
In addition, notwithstanding Respondent's claim that he was
treating JC1 for pain, at his first two visits (and at which Respondent
prescribed methadone), Respondent noted that JC1 had ``NO'' pain; and
at the third visit, where he issued a further methadone prescription,
Respondent did not even make a progress note. Respondent also failed to
document any of the findings set forth in Alabama's Guideline 2(a).
Accordingly, I conclude that Respondent prescribed methadone to JC1 for
maintenance/detoxification purposes without the required registration
and violated DEA regulations which prohibit the prescribing of schedule
II narcotics for this purpose. 21 U.S.C. 823(g)(1); 21 CFR 1306.04(c).
JB also came to Respondent from a narcotic treatment program, which
he had been kicked out of. Respondent noted this in the chart and that
JB ``desire[d] to get off methadone.'' Respondent asserted that the
fact that JB had been treated at a methadone clinic did not mean that
the clinic was treating him for addiction, even though that is the
purpose of a methadone clinic; moreover, he admitted that he did not
obtain JB's records from the clinic. After Respondent stopped
prescribing methadone to JB, the latter went to another methadone
clinic.
While Respondent documented that JB had foot and knee pain, and the
progress notes include a few additional statements regarding his pain
such as the location and that JB had been in an accident, the notes do
not document the nature and intensity of pain, any prior treatments for
it, and its effect on JB's functioning. Moreover, Respondent noted that
he planned to put JB on his alternative medication program. Given JB's
prior history of substance abuse treatment and his express ``desire to
get off methadone,'' I conclude that Respondent's primary purpose in
prescribing methadone to him (which he did on three occasions over a
month) was to provide maintenance/detoxification treatment. I thus
conclude that Respondent violated the CSA and DEA regulations in doing
so. 21 U.S.C. 823(g)(1); 21 CFR 1306.04(c).
Respondent testified that NB told him at the initial visit that she
had been on 180 mg of methadone which she was taking for pain. He also
testified that she was a ``troubling patient'' because she was on both
methadone and Xanax and that this was a great concern, especially if
she mixed the drugs with alcohol. Respondent diagnosed NB as having
chronic pain even though he noted on her chart that she had ``NO''
pain, and he did not document any further findings to support a
diagnosis of chronic pain. Moreover, notwithstanding his express
concern that NB was on both methadone and Xanax, Respondent prescribed
Xanax to her and did not document that she had anxiety, although he
maintained in his testimony that she ``had some anxiety.''
The evidence is insufficient to support the conclusion that NB
sought treatment from Respondent for a substance abuse problem.
However, the evidence does support the conclusion that Respondent acted
outside of the usual course of professional practice and lacked a
legitimate medical purpose in prescribing methadone to her. 21 CFR
1306.04(a). Having noted on NB's chart that she had ``NO'' pain, and
having failed to document any further findings as required by the
Guidelines to support his chronic pain diagnosis (and to explain the
inconsistency between his diagnosis and his notation that she had no
pain), it is clear that Respondent lacked a legitimate medical purpose
in prescribing methadone to her.
KI noted on her intake form that she was using three controlled
substances: methadone, Xanax and Ambien. Respondent also acknowledged
that KI had previously been treated at a narcotic treatment facility
and that she had taken narcotics and become addicted to them. However,
he denied that KI had told her that she had gone to the methadone
clinic to treat her addiction--as if there was any other reason a
person would seek treatment from a methadone clinic. While Respondent
maintained that KI had diagnoses of both substance abuse and chronic
pain, on the progress note for her initial visit, he noted that she had
``NO'' pain although he wrote ``Back'' as the location. Respondent did
not document any findings that would explain the inconsistency between
his diagnosis and his having noted that KI had ``NO'' pain; he also did
not document the history of any pain, what
[[Page 17520]]
treatment had been used, and the pain's effect on her physical and
psychological functioning.
Respondent issued three methadone prescriptions to KI. I conclude
that Respondent's purpose in doing so was not to treat pain, but to
provide maintenance/detoxification treatment to her. I thus conclude
that Respondent violated Federal law by prescribing methadone to KI for
maintenance/detoxification treatment without the required registration
and violated DEA regulations which prohibit the prescribing of schedule
II narcotics for this purpose. 21 U.S.C. 823(g)(1); 21 CFR
1306.04(c).\20\
---------------------------------------------------------------------------
\20\ Given the conflicting evidence regarding DG, I decline to
make any legal conclusions regarding Respondent's prescribing of
methadone to him.
---------------------------------------------------------------------------
The Suboxone Prescriptions
As found above, Respondent also prescribed Suboxone, a schedule III
controlled substance, to numerous patients. The Government elicited the
testimony of the DIs as to phone interviews they conducted with sixteen
of these patients, the majority of whom said that Respondent was
treating them for substance abuse and not chronic pain. See Tr. at 78
(NK); id. at 80-81 (AG); id. at 82-83 (LM); id. at 83-84 (ET); id. at
85-87 (DA); id. at 87-88 (CT); id. at 89-90 (JH); id. at 92-94 (KP);
id. at 95-98 (SS); id. at 266-67 (CML); id. at 268-69 (SJW); id. at 270
(LMJ); id. at 271 (MR); id. at 288-89 (SHY).
As found above, Respondent testified that many of these patients
were actually being treated for chronic pain in addition to substance
abuse, or were just being treated for chronic pain. Moreover,
Respondent frequently noted both diagnoses on the patient's charts,
although in some instances he did not note a substance abuse diagnosis
until after the first visit (and sometimes not until after several
visits). See, e.g., GX 5P (AG); GX 5V (LM); GX 5Y (CT); GX 5R (JH); GX
5B (TB); GX 5J (SW); GX 5I (SJW); GX 5E (LMJ); GX 5D (SHY); GX 5K (DA).
However, even if it is the case that most of the Suboxone patients
were being treated only for substance abuse, the Government did not
offer any evidence (whether in the form of clinical standards or expert
testimony) establishing what the appropriate course of professional
practice requires of a physician treating patients for substance
abuse.\21\ In short, while in its brief, the Government repeatedly
argues that Respondent lacked a medical justification to support his
diagnosis of substance abuse for the various patients and his issuance
of the Suboxone prescriptions, the Government's failure to offer any
probative evidence as to the standards of medical practice for
diagnosing and treating a substance abuse patient precludes a finding
that Respondent lacked a legitimate medical purpose when he prescribed
Suboxone to these patients.
---------------------------------------------------------------------------
\21\ While the Government introduced the Alabama Guidelines on
using controlled substances to treat pain, it offered no evidence
establishing that these standards apply to the treatment of
substance abuse patients.
---------------------------------------------------------------------------
Respondent, however, testified that many of the Suboxone patients
were actually being treated for chronic pain, and he noted this as his
primary diagnosis in many of their charts. As explained above, the
Alabama Guidelines require that a physician who prescribes controlled
substances to treat pain, obtain ``[a] complete medical history'' and
document this in the patient's medical record. Moreover, the Guidelines
state that the record ``should document the nature and intensity of the
pain, current and past treatments for pain, underlying or coexisting
diseases or conditions, the effect of the pain on physical and
psychological function, and history of substance abuse.'' Ala. Admin.
Code r. 540-X-4-.08(2)(A).
As found above, at the initial visits of nine of the Suboxone
patients, Respondent diagnosed them as having chronic pain but not
substance abuse. See supra Findings for Patients SS, ET, KP, CL, CML,
MR, SHY, DA, and NK. Notwithstanding his diagnosis, Respondent
typically did not even list a location of a patient's purported pain
and/or did not list a location until after the patient had made several
visits. See supra Findings for ET, KP, CL, CML, SHY, NK. Moreover,
Respondent did not document the nature and intensity of the patient's
pain, the pain's effect on the patient's ability to function, and
rarely documented any past treatments for the pain, and the patient's
substance abuse history at either the initial visit or follow-up
visits.\22\
---------------------------------------------------------------------------
\22\ While Respondent's charts included a Plan section, none of
them included the ``objectives that will be used to determine
treatment success.'' Ala. Admin. Code r.540-X-4-.08(2)(b).
---------------------------------------------------------------------------
Tellingly, in the charts, Respondent frequently noted that the
patients had ``NO'' pain, yet nonetheless diagnosed them as having
chronic pain. See Findings for SS, ET, KP, CL, MR, SHY, and NK.
Respondent offered no explanation for the inconsistency between his
findings and his diagnosis with respect to any of these patients. Based
on Respondent's having noted that these patients had no pain and his
failure to offer any explanation for why he nonetheless diagnosed the
patients as having chronic pain, I conclude that Respondent lacked a
legitimate medical purpose and acted outside of the usual course of
professional practice in violation of 21 CFR 1306.04(a) when he
prescribed Suboxone to these patients for the purpose of treating
chronic pain.
The Government further argues, and the ALJ agreed, that Respondent
violated 21 CFR 1306.07(c), because his ``charts failed to show the use
of any treatment options besides the prescribing of controlled
substances.'' ALJ at 47. The ALJ further explained that ``[s]uch lack
of attempts of alternative modalities prior to determining that the
patient suffers from chronic pain violates'' this regulation. Id.
Both the Government and the ALJ clearly misread the regulation.
This provision, which is part of the regulation setting forth the
requirements for dispensing narcotic controlled substances ``to a
narcotic dependant[sic] person for the purpose of maintenance or
detoxification treatment'' states:
This section is not intended to impose any limitations on a
physician or authorized hospital staff to administer or dispense
narcotic drugs in a hospital to maintain or detoxify a person as an
incidental adjunct to medical or surgical treatment of conditions
other than addiction, or to administer or dispense narcotic drugs to
persons with intractable pain in which no relief or cure is possible
or none had been found after reasonable efforts.
21 CFR 1306.07(c).
The Government's and the ALJ's construction of this regulation as
imposing--by implication no less--an affirmative obligation for a
physician to engage in alternative treatment modalities cannot be
squared with the purpose of the CSA, which ``manifests no intent to
regulate the practice of medicine generally,'' an authority which
remains vested in the States. Gonzales v. Oregon, 546 U.S. 243, 270
(2006). Rather, in any case, whether a physician has an adequate basis
for concluding that ``no relief or cure is possible'' for a patient's
pain, or that alternative treatments should be tried, is a clinical
judgment which must be assessed by reference to the standards of
medical practice as set by the state medical boards and the profession
itself. While a practitioner's failure to recommend alternative
treatments may provide some evidence as to whether a prescription
complies with 21 CFR 1306.04(a), the Government produced no expert
testimony establishing with respect to any patient, that under the
standards of medical practice,
[[Page 17521]]
Respondent was required to recommend alternative treatments.\23\
---------------------------------------------------------------------------
\23\ The ALJ noted that ``Respondent testified, and the record
contains no expert evidence to the contrary, that his treatment of
his patients met the standard of care.'' ALJ at 48. While evidence
as to the standard of care is admissible in criminal prosecutions
under 21 U.S.C. 841(a)(1), I conclude that the Alabama Guidelines
provide substantial evidence as to accepted boundaries of
professional practice in prescribing controlled substances for the
treatment of pain. See Ala. Admin. Code r. 540-X-4-.08(1)(g)
(guidelines are intended ``to communicate what the Boards considers
to be within the boundaries of professional practice'').
---------------------------------------------------------------------------
Other Allegations
The ALJ found that ``[t]he parties do not dispute that Respondent
improperly used his `X' prescription registration to prescribe
controlled and non-controlled substances other than Suboxone or
Subutex.'' ALJ at 43. The problem with the ALJ's reasoning is that an X
number is not a registration at all, but only an identification number.
As the statute states: ``Upon receiving a notification under
subparagraph (B) [of a practitioner's intent to prescribe narcotic
drugs in schedules III through V for maintenance or detoxification
treatment], the Attorney General shall assign the practitioner involved
an identification number under this paragraph for inclusion with the
registration issued for the practitioner pursuant to subsection (f) of
this section.'' 21 U.S.C. 823(g)(2)(D)(ii) (emphasis added). See also
21 CFR 1301.28(a) (``An individual practitioner may dispense or
prescribe Schedule III, IV, or V narcotic controlled drugs * * * which
have been approved by the Food and Drug Administration (FDA)
specifically for use in maintenance or detoxification treatment without
obtaining the separate registration required by Sec. 1301.13(e). * *
*''); id. Sec. 1301.28(d)(1) (``If the individual practitioner has the
appropriate registration under Sec. 1301.13, then the Administrator
will issue the practitioner an identification number. * * * '')
(emphasis added).
Moreover, under DEA's regulations,
[a]ll prescriptions for controlled substances shall be dated as
of, and signed on, the day when issued and shall bear the full name
and address of the patient, the drug name, strength, dosage form,
quantity prescribed, directions for use and the name, address and
registration number of the practitioner. In addition, a prescription
for a Schedule III, IV, or V narcotic drug approved by FDA
specifically for `detoxification treatment' or `maintenance
treatment' must include the identification number issued by the
Administrator under Sec. 1301.28(d) of this chapter or a written
notice stating that the practitioner is acting under the good faith
exception of Sec. 1301.28(e).
21 CFR 1306.05(a). See also 21 CFR 1301.28(d)(3) (``The individual
practitioner must include the identification number on all records when
dispensing and on all prescriptions when prescribing narcotic drugs
under this section.'').
As found above, Respondent issued numerous controlled substance
prescriptions (for both Suboxone and other drugs) on forms that listed
only his X number. The Suboxone prescriptions issued in this manner
violated DEA's regulation because Respondent was required to include
both his X number and his practitioner's registration number on them.
See 21 CFR 1306.05(a). Moreover, because he did not include his
practitioner's registration number, the non-Suboxone controlled
substance prescriptions violated this provision as well.
The ALJ also concluded that ``Respondent improperly prescribe
Suboxone for substance abuse using his regular DEA registration number
rather than the required X number.'' ALJ at 43. Apparently, this was
because Respondent eventually started listing both numbers on his
prescription blanks. However, as set forth above, DEA's regulation
expressly requires that a practitioner include both his registration
number and his X number when issuing a prescription for Suboxone for
maintenance or detoxification treatment under the authority of 21 CFR
1301.28. See 21 CFR 1306.05(a).
Moreover, while a ``practitioner must include the identification
number * * * on all prescriptions when prescribing narcotic drugs'' for
the purpose of providing maintenance or detoxification treatment, id.
1301.28(d), nothing in DEA regulations prohibits a practitioner from
including both his practitioner's registration number and his X
identification number on his prescription blanks. Nor does any DEA
regulation require that a practitioner cross-out his X number when
writing a prescription for controlled substances other than Suboxone
(or Subutex) on a prescription blank that includes both numbers.
The evidence also shows that Respondent violated the Immediate
Suspension Order by issuing multiple prescriptions after he was served
with the Order. Under 21 U.S.C. 843(a)(2), it is ``unlawful for any
person knowingly or intentionally * * * to use in the course of the
distribution[] or dispensing of a controlled substance, a registration
number which is * * * suspended[.]''
The evidence clearly shows that Respondent was personally served
with the Immediate Suspension Order on September 27, 2010, at which
time he told the Investigator that ``he was not going to abide by this
order and that [the DI] didn't have the authority to tell him that he
couldn't prescribe any controlled substances.'' Tr. 113. True to his
word, two days later, however, he issued prescriptions to CW for
Adderall, to MK for Adderall and Lortab, and to DH for Lortab and
Xanax. Respondent's explanation that these prescriptions were just
mistakes or accidents is totally unpersuasive.
The prescriptions to MK and DH, as well as a further Adderall
prescription which was issued to JB, were unlawful for the further
reason that they were post-dated. As set forth above, under 21 CFR
1306.05(a), ``[a]ll prescriptions for controlled substances shall be
dated as of, and signed on, the day when issued.'' Respondent admitted
that on September 3, 2010, he issued CW a prescription for Adderall, a
schedule II controlled substance which he dated October 3, 2010.
Moreover, both Respondent's testimony and documentary evidence
establish that Respondent wrote the prescription to MK and DH on
September 29, while post-dating them to October 4. Accordingly, I also
find that Respondent violated DEA regulations in writing these
prescriptions.
I further find that Respondent lacked a legitimate medical purpose
in prescribing Xanax to JC2. The evidence shows that Respondent knew
that JC2 was abusing Xanax and that he had been jailed for
distribution. While Respondent testified that he could not simply stop
prescribing the drug to JC2 because JC2 could have seizures, and that
he planned to taper JC2 off the drug, Respondent actually increased the
daily dose of JC2's Xanax prescriptions. Given the inconsistency
between the medical justification Respondent offered for his continuing
to prescribe Xanax to JC2 and the actual prescriptions he issued, I
conclude that Respondent lacked a legitimate medical purpose and acted
outside the usual course of professional practice in prescribing Xanax
to JC2. 21 CFR 1306.04(a).
The record thus establishes that Respondent's experience in
dispensing controlled substances (factor two) and his record of
compliance with applicable laws related to controlled substances
(factor four) is characterized by his multiple violations of Federal
law. These include his prescribing of methadone for maintenance or
detoxification purposes without being registered to do so and in
violation of DEA regulations prohibiting the prescribing of methadone
for this
[[Page 17522]]
purpose; his prescribing of controlled substances to treat chronic pain
without a legitimate medical purpose; his prescribing of Xanax to JC2;
his issuance of prescriptions which lacked his practitioner's
registration number; his issuance of post-dated prescriptions; and his
issuance of multiple prescriptions after his registration had been
suspended. I further conclude that the Government has made a prima
facie showing that Respondent has committed acts which render his
registration ``inconsistent with the public interest,'' 21 U.S.C.
824(a)(4), and that this conduct is sufficiently egregious to warrant
the revocation of his registration.\24\
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\24\ With respect to factor five, the ALJ found that
Respondent's ``lack of candor * * * threatens public health and
safety.'' ALJ at 49. As support for this conclusion, the ALJ noted
that most of the patients who were interviewed by the Investigators
had stated that Respondent was treating them for substance abuse,
yet Respondent testified that they were being treated for chronic
pain but did not realize this. Id.
While I agree with the ALJ that Respondent lacked candor, and
appreciate that she personally observed his testimony, I do so based
on different evidence. First, during the initial interview on Feb.
28, 2010, Respondent told the investigators that he was operating a
detox clinic and was using methadone to transfer his patients to
Suboxone. Tr. 43. Yet later that day, he claimed that he was
prescribing methadone only for pain and had previously misspoken.
Id. at 54-55. Second, when confronted with evidence that several of
his methadone patients had come to him from methadone clinics, he
attempted to justify his unlawful prescribing of methadone to them
by claiming that the patients had actually gone to these clinics to
treat their pain. See Tr. 695-96 (testimony regarding JB); id. at
699 (testimony regarding JC); id. at 716-17 (testimony regarding
KI); id. at 728 (testimony regarding TP). This factor thus also
supports revocation.
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Sanction
Under Agency precedent, where, as here, the Government has made out
a prima facie case that a registrant has committed acts which render
his ``registration inconsistent with the public interest,'' he must ``
`present[] sufficient mitigating evidence to assure the Administrator
that [he] can be entrusted with the responsibility carried by such a
registration.' '' Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting
Leo R. Miller, 53 FR 21931, 21932 (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), this Agency has
repeatedly held that where a registrant has committed acts inconsistent
with the public interest, the registrant must accept responsibility for
[his] actions and demonstrate that [he] will not engage in future
misconduct.'' Medicine Shoppe-Jonesborough, 73 FR 364 (2008). As the
Sixth Circuit has recognized, this Agency also ``properly consider[s]''
a registrant's admission of fault and his candor during the
investigation and hearing to be ``important factors'' in the public
interest determination. See Hoxie, 419 F.3d at 483.
The ALJ found, and the record supports the conclusion, that
Respondent eventually ceased prescribing methadone for maintenance and
detoxification purposes. ALJ at 49-50. The record generally supports
the conclusion that Respondent stopped writing controlled substance
prescriptions which did not include his registration number, as
required by DEA regulations. However, as found above, in September
2010, Respondent issued a further Adderall prescription to JB and did
not include his registration number.
The ALJ further noted that Respondent expressed remorse for some of
his wrongdoing. ALJ at 50. However, while Respondent maintained that he
had mistakenly issued the post-suspension prescriptions, and ``would
never do anything to violate an order,'' Tr. 509, his testimony is
belied by the evidence that upon being served with the Immediate
Suspension Order, he stated his intention not to comply with it.
Indeed, his testimony is patently disingenuous, given that he wrote the
prescriptions only two days after he was served with the Order. In
short, Respondent's conduct manifests a deliberate and egregious
disregard for his obligations as a DEA registrant.
Finally, while the ALJ noted that ``Respondent testified
passionately about the prevalence of narcotic abuse in Red Bay and his
want to eliminate it,'' she further concluded that he ``likely
facilitated some of that abuse.'' Id. The ALJ's conclusion is well
supported. Indeed, as found above, in numerous instances, Respondent
issued controlled-substance prescriptions for the purported purpose of
treating a patient's pain, even though he recorded in the patient's
chart that the patient had ``NO'' pain and/or failed to make the
findings required under the State's Guidelines to properly diagnose the
patient. Moreover, during one of the interviews by the Investigators,
Respondent admitted that he did not follow the State's Guidelines. Tr.
220. Respondent, however, offered no evidence that he now intends to
comply with the Guidelines.
Accordingly, I hold that Respondent has not rebutted the
Government's prima facie case. I will therefore order that Respondent's
registration be revoked and that any pending application be denied. For
the same reasons that led me to order the Immediate Suspension of
Respondent's registration, I conclude that the public interest requires
that this Order be effective immediately.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a)(4), as well as by 28 CFR 0.100(b) & 0.104, I order that DEA
Certificate of Registration, BC1701184, and Identification Number
XC1701184, issued to Morris W. Cochran, M.D., be, and they hereby are,
revoked. I further order that any application for renewal or
modification of such registration be, and it hereby is, denied. This
Order is effective immediately.
Dated: March 16, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-7107 Filed 3-23-12; 8:45 am]
BILLING CODE 4410-09-P