[Federal Register Volume 77, Number 58 (Monday, March 26, 2012)]
[Notices]
[Pages 17505-17522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7107]
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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.
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\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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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.
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\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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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.
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\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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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.
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\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 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]
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