[Federal Register Volume 74, Number 71 (Wednesday, April 15, 2009)]
[Notices]
[Pages 17529-17544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-8624]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 08-52]
George C. Aycock, M.D.; Revocation of Registration
On June 25, 2008, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to George C. Aycock, M.D. (Respondent), of Sumter, South
Carolina. The Show Cause Order proposed the revocation of Respondent's
DEA Certificate of Registration, AA1071947, which authorizes him to
dispense controlled substances as a practitioner, and the denial of any
pending application to renew or modify the registration, on the grounds
that: (1) Respondent's state controlled substance registrations had
been suspended, and thus he no longer has authority to handle
controlled substances under South Carolina law; and (2) Respondent had
committed acts inconsistent with the public interest. ALJ Ex. 1, at 1
(citing 21 U.S.C. 823(f) & 824(a)(4)).
With respect to the second ground for the proceeding, the Show
Cause Order alleged that Respondent had ``repeatedly failed to
establish a proper physician-patient relationship, as required by state
and federal law, and ha[d] authorized controlled substance[]
prescriptions without a legitimate medical purpose and outside the
usual course of professional practice, in violation of 21 CFR
1306.04(a), 21 U.S.C. 841(a)(1), and S.C. Code Regs. 81-28.'' Id. More
specifically, the Order alleged that Respondent issued controlled-
substance prescriptions to persons he knew were exhibiting drug-seeking
behavior, abusing controlled substances, or selling their drugs to
others. Id. The Order further alleged that Respondent failed to obtain
appropriate medical histories, perform appropriate physical
examinations, discuss treatments options and create a therapeutic plan
as required by state law.\1\ Id. at 2.
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\1\ On July 10, 2008, the Government served the Show Cause Order
on Respondent. ALJ Ex. 3.
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Thereafter, the Government sought the Immediate Suspension of
Respondent's registration based on information that on July 3, 2008,
the State of South Carolina had reinstated Respondent's controlled-
substance registration, and that on the same day, Respondent had issued
to a person, who had traveled 250 miles to see him, prescriptions for
sixty tablets of Oxycontin (80 mg.), 90 tablets of Lortab (10 mg.), and
90 tablets of Xanax (1 mg.). ALJ Ex. 2, at 1-2. The Order further
alleged that this person had been receiving prescriptions from
Respondent since July 2007, and that medical records which the
Government had seized during the execution of a search warrant
indicated that Respondent had not ``perform[ed] an appropriate physical
examination, ma[de] appropriate diagnoses or
[[Page 17530]]
formulate[d] a therapeutic plan before prescribing high doses of
opioids to this individual.'' Id. at 2.
Based on the above, I found that Respondent had authorized, and was
``continu[ing] to authorize, controlled substance[] prescriptions''
which lacked a ``legitimate medical purpose,'' and were issued
``outside the usual course of professional practice,'' and that there
was a ``substantial likelihood that [he] will continue to allow the
diversion of controlled substances.'' Id. I further concluded that
Respondent's ``continued registration during the pendency of the[]
proceedings would constitute an imminent danger to the public health or
safety.'' Id. Accordingly, on July 22, 2008, I immediately suspended
Respondent's registration.
On or about July 10, 2008, Respondent was served with the Show
Cause Order, and on July 25, 2008, Respondent was served with the
Immediate Suspension Order. ALJ Ex. 3. On July 25, 2008, Respondent
requested a hearing on the allegations, and the matter was placed on
the docket of the Agency's Administrative Law Judges (ALJ). ALJ Ex. 4.
On December 10, 2008, a hearing was held in Arlington, Virginia. At
the hearing, the Government called witnesses to testify and introduced
various documents into evidence; Respondent introduced various
documents and testified on his own behalf. Thereafter, the Government
submitted a post-hearing brief. While Respondent sought and was granted
an extension of the filing deadline, he failed to file a post-hearing
brief.
On January 21, 2009, the ALJ issued her recommended decision (ALJ).
Therein, the ALJ generally ``found the Government's witnesses more
credible than Respondent,'' that the former ``appeared to be
straightforward and candid, but Respondent appeared to tailor his
testimony to suit his version of [the] events.'' ALJ at 50.
The ALJ also found that the various patient files were consistent
with hearsay evidence as to what the patients had told Investigators
regarding Respondent's prescribing practices. Id. at 51. Moreover, the
ALJ found credible the testimony of the Government's expert as to the
appropriate treatment of pain patients and the use of methadone to
treat pain. Id.
With respect to the public interest factors, the ALJ found that
Respondent was authorized to handle controlled substances under South
Carolina law and had not been convicted of any offense under either
Federal or State law related to controlled substances. ALJ at 51 & 53.
As for Respondent's experience in dispensing controlled substance, the
ALJ specifically found that:
Respondent saw patients in groups; that he did not conduct
complete physical examinations of them or document complete medical
histories; that he did not document the bases for his diagnoses,
especially his diagnoses of anxiety; and that he did not document
any treatment plans other than to list the medications he prescribed
and note the date of the next visit. Respondent also failed to order
any tests or refer patients to specialists for their underlying
conditions.
Id. at 52.
The ALJ also found that Respondent inappropriately prescribed
methadone to treat pain, and that ``he ignored indications that at
least some of the persons to whom he issued controlled substance
prescriptions were abusing those medications.'' Id. More specifically,
the ALJ noted that ``some of Respondent's patients had obvious track
marks * * * but Respondent's only response to this testimony was that
he took blood pressure and listened to patient's lungs through their
shirts, and thus did not see their arms.'' Id. Relatedly, the ALJ found
that Respondent ``ignored obvious signs of drug-seeking behavior,'' and
that he ``increased the strength and/or quantities of the drugs he
prescribed without explaining the increases in the patient charts and,
in some instances, [did so] while simultaneously recording that the
patients were doing well.'' Id. at 52-53. Finally, the ALJ adopted the
conclusion of the Government's expert ``that Respondent issued
prescriptions for other than legitimate medical reasons.'' Id. at 53.
The ALJ thus concluded that this factor supported ``a finding that
Respondent's continued registration would be inconsistent with the
public interest.'' Id.
Relatedly, the ALJ found that Respondent had failed to comply with
the laws and regulations of South Carolina which require that a
physician establish a valid doctor-patient relationship (and set forth
various steps a physician must take) prior to prescribing a drug. Id.
The ALJ thus concluded that Respondent violated both South Carolina law
and the Controlled Substances Act's prescription requirement, 21 CFR
1306.04, and that this factor also supported ``a finding that the
Respondent's continued registration would be inconsistent with the
public interest.'' Id.
As for the fifth factor, the ALJ noted that while Respondent had
introduced into evidence letters ``attesting to his good character and
professional competence,'' the letters did not ``controvert the
[Government's] evidence.'' Id. at 54. Finally, the ALJ found that
Respondent had ``refus[ed] to acknowledge his wrongdoing,'' and that
his refusal to do so ``offers little hope * * * that he will act more
responsibly in the future.'' Id.
The ALJ thus apparently concluded that Respondent's continued
registration ``would not be consistent with the public interest,'' and
recommended that I revoke his registration and deny any pending
application to renew or modify his registration. Id. Neither party
filed exceptions to the ALJ's recommendation. Thereafter, the recorded
was forwarded to me for final agency action.
Having considered the entire record in this matter, I adopt the
ALJ's decision in its entirety with the exception of the first
paragraph of footnote 82.\2\ More specifically, I conclude that
Respondent's experience in dispensing controlled substances and record
of compliance with applicable laws amply demonstrate that he committed
acts which render his registration ``inconsistent with the public
interest.'' 21 U.S.C. Sec. 824(a)(4). I further conclude that
Respondent failed to rebut the Government's prima facie showing that
his continued registration would be inconsistent with the public
interest. Accordingly, I will order the revocation of Respondent's
registration and the denial of any pending application to renew or
modify the registration. I make the following findings.
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\2\ Therein, the ALJ noted that Respondent had violated 21
U.S.C. 844(a) ``by asking someone else to pick up a controlled
substance from [his] home.'' ALJ at 53 n.82. This provision,
however, renders it ``unlawful for any person knowingly or
intentionally to possess a controlled substance unless such
substance was obtained directly, or pursuant to a valid prescription
or order, from a practitioner, while acting in the course of his
professional practice, or except as otherwise authorized by this
subchapter or subchapter II of this chapter.'' 21 U.S.C. 844(a). It
is not clear how Respondent violated the statute when the Government
produced no evidence that he lacked a lawful prescription for the
drug. Nor did the Government cite to any authority holding that the
act it relies on constitutes a violation of the statute where a
person has a lawful prescription.
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Findings
Respondent is a Medical Doctor who is currently licensed in the
State of South Carolina to both practice medicine and handle controlled
substances. ALJ Ex. 4, at 1. Respondent is also the holder of DEA
Certificate of Registration, AA1071947, which prior to my issuance of
the immediate suspension order, authorized him to dispense controlled
substances in schedules II through V as a practitioner.
[[Page 17531]]
GX 1, at 1. Respondent's registration does not expire until June 30,
2009.\3\ Id.
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\3\ Respondent registration was issued to him at the address of
295 Lakewood Drive, Sumter, South Carolina. GX 1, at 2.
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Respondent, who is board-certified in family practice, previously
practiced medicine in Greeneville, Tennessee, in a practice which
apparently was owned by another physician. Tr. 276. In his testimony,
Respondent claimed that while he lived in Greeneville, he ``ticked
off'' a prominent person in the town and thereafter, became the target
of ``the vindictiveness of the town.'' Id. at 278-79. As an example,
Respondent testified that one day he was stopped for speeding. Id. at
279-80. Respondent did not, however, have his license on him and was
arrested for driving without a license. Id. at 280. Following the
incident, Respondent was also charged with resisting arrest; Respondent
claimed, however, that he had done nothing to warrant the charge. Id. A
jury apparently felt differently and convicted him of all three
charges. Id. at 134.
In November 2005, Respondent, who apparently was also having
marital difficulties, was arrested a second time by the Greeneville
police and charged with domestic assault on his then-wife and
stepdaughter; Respondent was also charged with resisting arrest on this
occasion. Id. at 133. At some point, Respondent, who was arrested a
third time for missing a court appearance, pled guilty to the charges.
Id. at 134.
According to Respondent, at some point following his trial and
conviction on the first set of charges, ``rumors * * * were being
started around town'' that he was ``selling drugs out of [his]
office.'' Id. at 282. Moreover, the doctor who owned the office where
Respondent practiced died suddenly and the former's son-in-law told
Respondent to leave. Id. at 283. Respondent then moved to Sumter, South
Carolina. Id. at 285.
On November 21, 2006, Respondent was arrested in South Carolina and
jailed in Sumter. Id. Respondent was eventually extradited back to
Tennessee, and jailed in the Greene County Jail in Greeneville. Id. at
285-86. On or about February 13, 2007, Respondent was released from the
jail. Id.
While in jail, Respondent met several individuals who eventually
became his ``patients'' including W.G. and B.J.P.; both A.C. and B.C.,
who also became Respondent's patients, were incarcerated in the jail
during some portion of the period of his residence therein. Id. at 156,
174, 243. In his testimony, Respondent admitted that while he was in
jail, he had met ``three or four of'' his patients. Id. at 294.
While in jail, Respondent discussed with B.J.P. (who was his ``pod
mate''), the latter's ``pain problems,'' and on one occasion,
Respondent looked at B.J.P.'s back. Id. at 157-58. Respondent agreed to
write controlled-substance prescriptions for B.J.P. after they were
released from jail. Id. at 156. The day after he was released,
Respondent wrote a controlled substance prescription for B.J.P., and
called in another prescription a month later. Id. at 156-57; 184-85.
During an interview with investigators, Respondent initially denied
writing prescriptions for B.J.P. Tr. 184. The Investigators then
confronted Respondent with the prescription that he wrote for B.J.P.
the day after his release from the jail. Id. Respondent then admitted
he should not have written the prescription. Id.
Following his release from jail, Respondent returned to South
Carolina. Id. at 157. While Respondent lived approximately four-and-a-
half to five hours away (by driving) from Greeneville, Tennessee,
B.J.P. began traveling to Respondent's home to obtain controlled-
substance prescriptions from him. Id. According to the testimony of a
DEA Investigator who interviewed B.J.P., B.J.P. would travel with a
friend (M.H.), who also obtained controlled-substance prescriptions
from Respondent. Id. at 158.
B.J.P. also related to the Investigator that during the visits, he
and his friend would talk with Respondent but did not undergo a
physical examination. Id. at 157-58. B.J.P. also told the Investigator
that Lortab, a schedule III controlled substance which combines
hydrocodone with acetaminophen, ``was his drug of choice'' and ``what
he received from'' Respondent, id. at 159, but that Respondent had also
given him prescriptions for Oxycontin, a schedule II controlled
substance which contains oxycodone. Id. at 160. While Oxycontin was not
B.J.P.'s ``drug of choice,'' he was able to sell it and pay for his
trips to Respondent. Id. at 160.
An Investigator also interviewed M.H., who had accompanied B.J.P.
on the latter's visits. Id. at 170-71. M.H. confirmed B.J.P.'s
statement that when the two of them visited Respondent, they would talk
with him in the latter's living room, and that Respondent did not take
their blood pressure, require them to disrobe, or conduct any type of
physical examination ``like [M.H.] had ever seen in a regular doctor's
office.'' Id. at 171. After some discussion, Respondent would go
upstairs and print out whatever prescriptions he was going to issue to
them. Id. M.H. did not ``know what his diagnosis was,'' what his
treatment plan was, and never ``receive[d] a referral for other
treatment'' or tests. Id. at 172. M.H. told investigators that he
initially received prescriptions for schedule III drugs containing 10
mg. of hydrocodone, ``after a short period,'' Respondent issued him
prescriptions for Percocet or Oxycontin, both of which contain
oxycodone. Id. at 171-72.
B.J.P. and M.H. were not, however, the only ``patients'' who
jointly saw Respondent. H.R. and A.R., who were married to each other,
told investigators that Respondent had been recommended to them by two
other persons who were seeing him, M.C. and P.G. Id. at 234. These four
individuals traveled together to see Respondent at his residence. Id.
Giving new meaning to the term ``group practice,'' the four persons
jointly met with Respondent in his living room. Id. H.R. related to the
investigators that he became ``rather embarrassed'' when during the
meeting, Respondent ``asked him to unbutton his trousers so that
[Respondent] could examine his back in front of the other three
individuals in the same room.'' Id. at 234-35. Thereafter, Respondent
``went upstairs.'' Id. at 235. When Respondent returned he gave
controlled-substance prescriptions to H.R. Id. Respondent charged H.R.
$150 at the initial visit and $100 at subsequent visits. Id.
According to H.R.'s patient file, which was seized pursuant to a
warrant, on July 24, 2007, Respondent diagnosed H.R. as having chronic
lower back pain and anxiety, and issued him prescriptions for sixty
tablets of Oxycontin (20 mg.), ninety tablets of Lortab (10 mg.),
ninety tablets of Xanax (1 mg.), and ninety tablets of Soma
(carisoprodol).\4\ GX 51, at 5. At H.R.'s next visit (August 21, 2007),
Respondent increased the strength of the Oxycontin to forty milligrams,
and issued additional prescriptions for Lortab, Xanax, and Soma; \5\
Respondent issued additional prescriptions for these four drugs on
September 20 and October 19, 2007. See id. at 2 & 4.
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\4\ Soma (carisoprodol) is not a controlled substance under
federal law. It is, however, a highly abused drug which metabolizes
into meprobamate, a schedule IV depressant. See Paul Volkman, 73 FR
30630, 30636 n.21 (2008). The drug is frequently taken by drug
abusers as part of a cocktail which also includes an opiate and
benzodiazepine. See id. at 30638.
\5\ Respondent slightly reduced the number of tablets of the
various drugs to reflect the fact that H.R. had returned after
twenty-eight rather than thirty days. GX 51, at 4.
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The patient files of M.C. (GX 46) and A.R. (GX 59) reflect that
both
[[Page 17532]]
individuals obtained controlled-substance prescriptions from Respondent
on both July 24 and August 21, 2007.\6\ See GX 46, at 7; GX 59, at 2,
5-6. More specifically, at the July 24 visit, Respondent issued to
A.R., prescriptions for sixty tablets of Oxycontin (20 mg.), ninety
tablets of Lortab (10 mg.), ninety tablets of Xanax (1 mg.), and ninety
tablets of Soma. GX 59, at 5. On the same date, Respondent issued to
M.C. a refill of the prescriptions he had previously issued to him (on
June 26) for Oxycontin (80 mg.), Lortab (10 mg.), Xanax (1 mg.) and
Soma.\7\ GX 46, at 7-8.
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\6\ The patient file for P.G. was not admitted into the record.
\7\ The patient file for M.C. does not indicate the number of
tablets he prescribed for the various drugs on June 26 and July 24,
2007; the file does, however, include the abbreviations for the
dosing instructions on the progress note which is dated June 26. GX
46, at 7-8. The note indicates that M.C. was to take the Oxycontin
b.i.d., or twice a day (thus suggesting that the prescription was
for sixty tablets); the other drugs were to be taken t.i.d., or
three times per day (thus suggesting that prescriptions were for
ninety tablets).
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According to the note dated August 21, 2007, M.C. was ``working
[and] unable to come.'' Id. at 7. The note nonetheless related that
M.C. ``is doing well [and] pain is stable,'' and that Respondent issued
him prescriptions for fifty-six tablets Oxycontin (80 mg.), eighty-four
tablets of Lortab (10 mg.), eighty-four tablets of Xanax (1 mg.), and
eighty-four tablets of Soma.\8\ Id. M.C. received prescriptions for the
same drugs from Respondent on September 15, October 8, November 5, and
December 3, 2007. Id. at 2, 4-6.
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\8\ The record does not establish whether the prescriptions were
mailed to M.C. or were provided to M.C.'s acquaintances.
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As for A.R., at the August 21 visit, Respondent prescribed fifty-
six tablets of a stronger version of Oxycontin (40 mg.), as well as
eighty-four tablets of Lortab (10 mg.), Xanax (1 mg.), and Soma. GX 59,
at 5. On September 20 and October 19, 2007, Respondent issued to A.R.
prescriptions for the same four drugs. Id. at 2 & 4.
On or about October 1, 2007, Respondent opened an office in Sumter
and started seeing patients there. Tr. 185. Prior to opening his
office, Respondent sought to develop his patient base by placing ads in
newspapers that were published in both Sumter and Greeneville,
Tennessee. Id. at 229. Apparently, the ad placed in the Greeneville
paper was far more successful than the one placed in the local paper as
the overwhelming majority of the fifty-seven patients he had (as of the
date the warrant was executed) were from Tennessee, and only three of
them were from South Carolina. See Tr. 244-45 (testimony that
Respondent told his nurse that ``the patients were his previous
patients from Tennessee, who came when [he] ran the ad in the
newspaper''); id. at 229, 180-81. Investigators were only able to
identify two persons (J.C., and an unnamed woman), who he had
previously treated when he practiced in Tennessee. Id. at 180-81.
K.C., M.B., and S.M. were also among the patients interviewed by
DEA Investigators who drove from the Greeneville, Tennessee area, to
obtain prescriptions from Respondent. M.B., an admitted drug dealer,
told Investigators that H.R. and A.R. had told him that if he saw
Respondent, he could ``get whatever you want from'' him.\9\ Id. at 164.
M.B. accordingly visited Respondent and obtained controlled-substance
prescriptions from him. Id. During one of the visits, M.B. told
Respondent that he had ``just tried a friend's [Oxycontin] and liked
it.'' Id. M.B. asked for an Oxycontin prescription and Respondent
obliged. Id. M.B. further told investigators that when he saw
Respondent ``he didn't have a normal exam,'' and ``wasn't asked to
disrobe.'' Id. at 166. ``Basically,'' M.B. ``just talked to''
Respondent. Id.
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\9\ According to Lieutenant Crum of the Greeneville, Tennessee
Police Department, during the execution of a search warrant at
M.B.'s residence, the authorities found both ``several pounds of
marijuana and several pill bottles from Respondent.'' Tr. 138.
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Various prescription records show that Respondent issued to M.B.
the following prescriptions for Oxycontin (20 mg.): sixty tablets on
October 1, fifty tablets on October 26, and ninety tablets on November
27, 2007. See GX 64, at 26, 56 & 130. Respondent also issued to M.B.
the following prescriptions for Percocet (10/325): sixty tablets on
both November 27 and December 28, 2007. See id. at 24 & 149. Finally,
on January 28, 2008, Respondent issued M.B. a prescription for 90
Klonopin (clonazepam 2 mg.). See id. at 268.
S.M., who admitted to investigators that he was a lifelong drug
abuser, had also purchased drugs from M.B., which the latter had
obtained from Respondent. Tr. 138-39. According to both a DI and Lt.
Crum, S.M. had visible track marks on his arms, which indicated that he
was taking drugs intravenously (IV). Id. at 138 & 167. S.M. also told
the DIs ``that he would use any drugs that he could get his hands on,''
and that he would shoot up every day but for the expense. Id. at 167.
Moreover, S.M. had chronic obstructive pulmonary disorder and was being
treated for this condition by a physician (Dr. R.L.) in Greene County.
Id. at 190; GX 52, at 15. In April 2008, two DIs interviewed Dr. R.L.
regarding S.M. Id.
Dr. R.L. told the DIs that S.M. had admitted to him that he was an
IV drug abuser, and in any event, S.M.'s track marks and gaunt
appearance made it obvious that he was a drug abuser, and that one did
not have to be a physician to recognize as much. Id.; see also id. at
167 (Investigator testifying that S.M.'s track marks were ``very
obvious,'' that his vein area was ``discolored,'' and there were ``open
sores on his arms where he shot up''). Dr. R.L. stated that because of
S.M.'s history of drug abuse, he would not prescribe controlled
substances to him. Id. at 191. Moreover, Dr. R.L. had never been
contacted by Respondent regarding S.M., and ``had no idea'' that S.M.
was seeing Respondent. Id.
S.M.'s patient file contains several documents which indicated that
he was being treated by Dr. R.L. See GX 52, at 15-16. Moreover, a
report of a physical examination which was done on May 4, 2007 when
S.M. sought disability, noted that he ``has used marijuana and IV
drug[s], specifically cocaine.'' Id. at 8. While the report also
indicated that S.M.'s ``last use of [illicit drugs] was about [three]
years ago,'' id., the report also noted that he had been in jail ``for
the last 17 months and * * * has been out about 2 or 3 months.'' Id. at
7.
Respondent first saw S.M. on, or about October 1, 2007.\10\ While
S.M.'s file includes the report of a recent MRI of his right knee which
indicated that he had tears of the lateral and medial menisci,
chondromalacia, a ``probable tear of the anterior cruciate ligament,''
and a Baker's cyst, S.M. had not been treated with controlled
substances. Id. at 5, 12-13. Respondent issued S.M. a prescription for
sixty tablets of Oxycontin (20 mg.), with instructions to take one
tablet twice a day, as well as for Motrin, a non-controlled drug. Id.
at 6. Respondent's treatment plan was limited to prescribing these two
drugs and a follow-up in thirty days. Id.
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\10\ While the notes pertaining to the initial visit are cut off
where the date is indicated, the note for the October 26, 2007
visit, indicates that Respondent had ``first seen [ S.M.] 25 days
ago.'' GX 52, at 4.
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On October 26, S.M. again saw Respondent. Id. at 4. The progress
note indicates that S.M. had only one tablet of the Oxycontin left,
even though only twenty-five days had passed since the earlier visit.
Id. Moreover, S.M. told Respondent ``[h]e also took someone else's
Roxicodone 30 mg, & says it really helped his pain.'' Id. S.M. also
complained of ``nerves'' and that he was ``not sleeping well.'' Id. On
the note,
[[Page 17533]]
Respondent indicated that S.M. had the following conditions: 1) Chronic
knee pain--menisci tears, 2) osteoarthritis, 3) chronic anxiety, 4)
COPD, and 5) Hepatitis C. Id. Respondent then issued S.M. prescriptions
for fifty tablets of Oxycontin (20 mg.), sixty tablets of Roxicodone
(15 mg.), and sixty tablets of Klonopin, and indicated that there would
be a follow-up in ``30 days.'' Id.\11\
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\11\ In this note, Respondent also indicated that S.M. had been
in a motor vehicle accident when he fell asleep while driving. Id.
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S.M. returned to Respondent on November 27. S.M. complained of knee
pain and lower back pain/hip pain, which radiated down his leg. Id. at
2. He also complained that the ``pain meds aren't lasting long
enough.'' Id. At the visit, Respondent prescribed sixty tablets of
Oxycontin (20 mg.), sixty tablets of Klonopin, increased the Roxicodone
(15 mg.) prescription to ninety tablets ``temporarily due to'' the
earlier car accident, and added a prescription for Soma. Id. Respondent
also noted that there would be a follow-up in thirty days and if S.M.'s
back was not better, he ``will get MRI.'' Id.\12\
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\12\ According to prescriptions records, Respondent issued to
S.M. additional prescriptions for ninety tablets of Roxicodone (15
mg.) on December 28, 2007, and January 28, 2008; on the latter date,
he also issued to S.M. prescriptions for sixty Oxycontin (20 mg.)
and sixty Klonopin. See GX 64, at 151 & 228.
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On one occasion, S.M. had traveled to Respondent accompanied by
M.B. and K.C. On the way to South Carolina, S.M. was having trouble
breathing, and according to K.C. was exhibiting ``extreme respiratory
distress.'' Tr. 162; see also id. at 165 (M.B. told DI that S.M. ``was
having extreme difficulty breathing''). Respondent nonetheless gave
S.M. a prescription for Oxycontin, and apparently after S.M. filled the
prescription at a pharmacy in South Carolina, he proceeded to inject
the Oxycontin intravenously.\13\ Id. According to both K.C. and M.B.,
S.M. injected himself with Oxycontin three times on the trip back to
Tennessee. Id. at 162-63, 165. After returning to Greeneville, S.M.,
who had a collapsed lung, was admitted to the intensive care unit of a
local hospital. Id. at 165 & 168.
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\13\ K.C. testified that on her first trip to see Respondent she
obtained a prescription for Percocet. Tr. 163. Various records show
that on January 28, 2008, S.M., K.C., and M.B. all filled
prescriptions issued by Respondent at the same pharmacy which was
located in Columbia, South Carolina. See GX 64, at 228-29 (Rx to
S.M. for Oxycontin 20 mg.), 266-67 (Rx to S.M. for Klonopin), 246-47
(Rx to K.C. for Percocet 10/325 mg.), 268-69 (Rx to M.B. for
Klonopin). According to the records, these four prescriptions were
dispensed between 4:11 p.m. and 4:58 p.m. See id. Approximately one
hour later, S.M. filled a prescription for Roxicodone at a CVS
Pharmacy, which was also located in Columbia. See GX 64, at 308-09.
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Regarding his visit with Respondent on the day of this incident,
S.M. acknowledged that he ``was having great difficulty breathing.''
Id. at 168. Respondent did not, however, mention S.M.'s condition or
question him about it. Id. Respondent did not recommend that S.M. seek
treatment for the condition, and after S.M. paid him in cash, issued
him controlled-substance prescriptions. Tr. 168.
DEA Investigators interviewed several other persons who had
obtained prescriptions from Respondent and related similar information
regarding his prescribing practices. W.G., who as found above, had met
Respondent in the Greene County Jail, saw Respondent at his home on
multiple occasions. Tr. 174; GX 7. W.G., who at the time of the
interview had been re-incarcerated, told Investigators that Respondent
did not perform a physical examination on him, and he could not recall
what conditions he was diagnosed with. Tr. 174. W.G. also told the
Investigators that Respondent did not refer him to any specialist, and
that his treatment was limited to taking medication. Id.
W.G.'s patient file indicates that he first saw Respondent on May
21, 2007. GX 7, at 3. According to the file, W.G. had a history of
lower back pain, and an MRI indicated that he had disc problems. Id.
W.G.'s file did not, however, contain an MRI report.\14\ See GX 7.
Moreover, under the portion for the physical exam, the notation for
``Back'' is blank. Id. at 3. Respondent nonetheless diagnosed W.G. as
having the following conditions: (1) Lumbar Disc Disease, (2)
Hypertension, (3) Hyperlipidemia, and (4) Chronic Anxiety. Id. At this
visit, Respondent prescribed to W.G. ninety tablets of Lortab
(hydrocodone) (10 mg.), sixty tablets of Avinza (morphine sulfate) \15\
(90 mg.), ninety tablets of Valium (1 mg.) and ninety tablets of Soma.
Id. At W.G.'s second visit, which occurred on June 26, 2007, Respondent
re-issued prescriptions for each of these four drugs in the same
quantities and strengths. Id.
---------------------------------------------------------------------------
\14\ W.G.'s file also indicated that he had a history of HTN
(hypertension) and lipid problems. GX 7, at 3.
\15\ Avinza (morphine sulfate), a schedule II controlled
substance. See 21 CFR 1308.12(b)(1).
---------------------------------------------------------------------------
On July 24, 2007, W.G. again saw Respondent. Id. at 2. Respondent
noted that W.G. ``still has [Lower back pain]. Meds are helping but he
took one of daughters [sic] Oxycontin & it helped better than Avinza.''
Id. Respondent also noted that he observed ``mild tenderness @ lower
paravertebral area of lumbar spine,'' and that ``muscle spasm [is]
present.'' Id. Instead of renewing the Avinza prescription, Respondent
prescribed sixty tablets of Oxycontin (80 mg.). Id.; see also GX 64, at
3. Respondent also issued refills of the Lortab, Valium and Soma
prescriptions. Id.
W.G.'s fourth visit with Respondent occurred on August 21, 2007.
Id. Respondent indicated that W.G. is ``doing well'', but that he had a
``muscle spasm lower back & mild tenderness @ paravertebral area.'' Id.
Respondent re-issued prescriptions for Oxycontin (80 mg.), Lortab (10
mg.), Valium (1 mg.), and Soma, although he decreased the quantities
because W.G. had showed up two days early.\16\ Id.
---------------------------------------------------------------------------
\16\ It also appears that W.G. saw Respondent on January 11,
2008, after he was released from jail, at which time he obtained
additional prescriptions for Lortab and Valium. See GX 64, at 248-
49, 250-51.
---------------------------------------------------------------------------
R.B. received at least five prescriptions for controlled substances
from Respondent including three for Opana ER (oxymorphone
hydrochloride), a schedule II controlled substance (21 CFR
1308.12(b)(1)), hydrocodone/acetaminophen (10/500 mg.), and clonazepam
(1 mg.). See GX 64, at 110; GX 65, at 1-3. Moreover, at his visit of
October 20, 2007, Respondent issued R.B. prescriptions for Opana ER,
hydrocodone, clonazepam, and carisoprodol. See GX 65, at 1-3. While
R.B. told Investigators that he had ``some pain problems,'' he also
stated that Respondent did not examine him, did not refer him to any
specialists, and that he did not know ``how long he was going to be on
the medications.'' Tr. 173. Rather, R.B.'s understanding was ``that if
he paid, he got this many [drugs] for this month,'' and that he was to
``come back next month.'' Id.
The Expert Testimony
Y. Eugene Mironer, M.D., testified for the Government as an expert
witness in pain management. Dr. Mironer is a 1980 graduate of the
Moscow State Medical School, did a four-year residency in general
surgery at Moscow Medical School Hospital, and practiced for five years
as a general surgeon at the Municipal Hospital, Moscow, in the former
Soviet Union. GX 5, at 1. Thereafter, Dr. Mironer emigrated to the
United States, and has completed an internship in Internal Medicine at
SUNY-St. John's Hospital, Queens, NY; a three-year residency in
Anesthesiology at the University of Massachusetts, Worcester, MA; and a
fellowship in Pain
[[Page 17534]]
Management at the Medical College of Virginia, Richmond,VA\17\ Id.
---------------------------------------------------------------------------
\17\ Dr. Mironer has also served as an Instructor in Anesthesia
at the University of Massachusetts, and practiced as an
anesthesiologist. GX 5, at 1.
---------------------------------------------------------------------------
Dr. Mironer is board certified in both Anesthesiology and Pain
Management, and is the Managing Partner and Medical Director of the
Carolinas Center for Advanced Management of Pain, which has numerous
offices in South Carolina and North Carolina, where he has practiced
since 1996.\18\ Tr. 10, GX 5, at 1. Dr. Mironer is also a member of
various medical organizations including the American Pain Society, the
Southern Pain Society, the International Spinal Injection Society, the
American Medical Association, and the North Carolina and South Carolina
Medical Associations. Id. at 2. Dr. Mironer has published numerous
articles, and written several chapters of a textbook, on pain
management; he has also presented at several conferences. Id. at 2-5;
Tr. 12-13. Moreover, Dr. Mironer has continued to keep himself informed
as to developments in the practice of pain management. Tr. at 13.
---------------------------------------------------------------------------
\18\ According to Dr. Mironer, the Carolinas Center has fifteen
to twenty thousand patients. Tr. 10.
---------------------------------------------------------------------------
Dr. Mironer was qualified as an expert and testified at length
regarding the course of medical practice used to assess, diagnose and
treat pain patients. Dr. Mironer testified that ninety-nine percent of
his practice's patients have been referred by either their primary care
physician or a specialist, and that the patients either have their
records sent prior to their appointment or hand carry them. Id. at 14.
Before seeing a doctor, new patients are required to register and
complete various forms and disclose what drugs they are currently
taking and what pharmacies they are using. Id.
Upon meeting the patient, the physician obtains a thorough medical
history which includes questions about the pain's location, origin,
frequency, intensity, length of time it has been present, what
aggravates it or eases it, and whether there are any other sensations
that are related to it. Id. at 15-16. The physician also asks the
patient about tests that have been done; what treatments including
medications have been previously, or are currently being, used; if the
patient has allergies; and the patient's surgeries. Id. at 16. The
final part of the patient's history including reviewing other medical
problems that the patient may have including mental health conditions
and treatments, past drug and alcohol abuse, and sleep disorders.\19\
Id. at 16-17.
---------------------------------------------------------------------------
\19\ Dr. Mironer also testified that it is not the ``usual or
typical way of conducting [medical] practice'' to see multiple
patients simultaneously, whether in one's living room or an
examination room. Tr. 90.
---------------------------------------------------------------------------
Next, the physician does ``a full physical examination.'' Id. at
17. In the case of a complaint of back pain (which was a common
complaint among Respondent's patients), this involves observing the
patient's gait, assessing his ability to walk on both his toes and
heels, and checking the patient's range of motion in his back both
forwards/backwards and from side to side. Id. at 17-18. The patient's
back is then visually examined for abnormalities such as scoliosis and
scars from surgery; this is followed by palpation of the back for
tender spots or trigger points. Id. at 18.
The physician next examines the strength, sensory condition, and
reflexes of the patient's lower extremities. Id. Finally, the physician
tests for Wadell's non-organic signs; these tests are used to determine
whether the patient's pain has a psychological component. Id. at 18-19.
Based on the above, the physician arrives at his findings,
formulates a treatment plan, and discusses both the findings and
treatment plan with the patient. Id. at 20. As part of this process,
the physician provides a detailed explanation as to why he/she is
prescribing a particular drug (or no longer prescribing a drug the
patient was previously taking), what procedures or treatments may help,
and whether consultations with other specialists would be beneficial.
Id. According Dr. Mironer, at least three out of four patients have not
undergone enough diagnostic testing to determine the exact ``source of
the[ir] pain and how to treat it.'' Id. at 21.
Dr. Mironer also stated that if a patient appeared at the initial
visit without his/her records, he would prescribe a controlled
substance--and do so only in a limited amount and in a low dose--only
if the physical ``examination reveal[ed] some significant
abnormalities.'' Id. at 23. The patient would be told, however, to come
back in a couple days with all of his records. Id.
While Dr. Mironer testified that he accepts a patient's word that
he is ``in pain,'' he further stated that ``not every pain is the same,
and not every pain requires prescribing controlled substances,'' some
pain may not be so bad as to require ``any serious intervention,'' and
that some pain may be of ``a psychological origin'' and ``should not be
treated with medication.'' Id. at 23-24. Dr. Mironer further noted that
there are a variety of treatment modalities available for treating pain
including physical therapy, psychological counseling, various types of
injections, nerve blocks, and referrals to a spinal surgeon if short-
term treatments do not improve the patient's pain level. Id. at 27-28.
Dr. Mironer also explained that he does not rely on a patient's
recollection as to what drugs they are using because the patient may
give mistaken information or mix up medications. Id. at 24. Moreover,
in prescribing controlled substances, the amount of drug taken by the
patient should be titrated. Id. at 34. Specifically, if treatment with
a controlled substance is warranted and the patient is not currently
taking a controlled substance, the patient is started on a lower
strength drug such as hydrocodone of either 5 or 7.5 mg. strength, to
be taken two to three times a day. Id. at 36. However, if the condition
is severe, the dosing may be increased to ``every four to six hours.''
Id. at 37. Moreover, some patients may be started on oxycodone. Id. at
36 & 38.
Dr. Mironer further testified that he had reviewed the files
Respondent maintained on fifty-seven of his patients, which were
provided to him by Investigators with the DEA Columbia, S.C. Office.
Id. at 40-41. The Government also introduced thirteen of the files into
evidence and specifically questioned Dr. Mironer regarding what the
records showed with respect to Respondent's prescribing practices.\20\
---------------------------------------------------------------------------
\20\ The contents of some of the files have been set forth
above.
---------------------------------------------------------------------------
With respect to his review of all of the patient files, Dr. Mironer
noted that ``practically all [of the] patients were self-referred and
not from the local area,'' Tr. 44, and that fifty-four of the fifty-
seven patients ``were coming from Tennessee,'' that this ``is usually
not the case unless they are coming for some unique procedure,'' id. at
45, and that Respondent was not providing any unique procedures. Id. at
46. With respect to the out-of-state patients, Dr. Mironer observed
that ``it is difficult to provide pain management for patients that
live far away, because your ability to control what they take and what
they receive and how they do it [is] significantly diminished with the
distance'' they live from the practice. Id.
Dr. Mironer explained that when patients live out of state, ``there
is much less communication [with] the pharmacist,'' a patient may be
``receiv[ing] the same medication from you and their family doctor,''
or even going to another pain clinic. Id. at 47. Dr. Mironer also noted
that in his practice, at least ninety-nine percent of
[[Page 17535]]
the patients are referred to it by another physician, whether a
specialist or a family doctor. Id. at 47-48. According to Dr. Mironer,
in dealing with self-referred patients, it is ``much more difficult to
get the information from them and verify what kind of treatment they
[have] received and are receiving currently.'' Id.; see also id. at 64
(discussing importance of communicating with a patient's other
physicians to ensure that he/she is not receiving similar drugs from
other physicians).
Relatedly, Dr. Mironer subsequently explained that he did not find
``any'' evidence that Respondent was attempting to control his
patients' use of controlled substances through such standard practices
as ``random urine toxicology screening to make sure that the patient is
taking the medications that [are] prescribed, and not taking other
controlled substances or street drugs,'' and/or calling the patients to
come to the office for pill counts. Id. at 63-64. Dr. Mironer also
noted that pill counts were not possible, because most of the patients
lived out of state.\21\ Id. at 64-65.
---------------------------------------------------------------------------
\21\ Dr. Mironer also observed that while patients who engage in
drug-seeking behavior may indeed have legitimate medical conditions
that cause pain and require treatment, these patients must be more
closely monitored through pill counts, urine tests, and pharmacy
checks. Id. at 87.
---------------------------------------------------------------------------
Dr. Mironer further opined that ``practically all of the patients
[were] receiving an inadequate physical examination, as far as the
areas of their pain is concerned,'' that ``practically all, if not all,
receive[d] a prescription of controlled substances, but no specific
treatment plan ha[d] been made.'' Id. at 48. Moreover, ``practically
all the patients received opioids without any specific discernible
plan,'' and a ``very significant number of the patients were receiving
very high doses of opioids.'' \22\ Id. at 49.
---------------------------------------------------------------------------
\22\ Dr. Mironer explained that giving high doses of opioids can
cause constipation, depression, hormonal release and in the event of
an overdose, respiratory depression and even death. Tr. 52-53.
Moreover, because patients develop tolerance, ``one would try to
increase the [dosing] from small amounts * * * very slowly, because
after you reach a certain amount of medicine you are not getting
much more benefit at all.'' Id. at 53.
---------------------------------------------------------------------------
Furthermore, the files contained ``no indications that there were
any attempts to control or verify or check the use of controlled
substances, such as urine toxicology screening or pharmacy check[s,] or
check[ing] with the other treating physicians to see what kind of
medication [the patients] have been prescribed, which is one of the
typical steps that pain clinics * * * tak[e] to'' monitor their
patients. Id. Dr. Mironer also explained that he found that ``very
significant numbers [of patients] were diagnosed with anxiety without
indication of how that diagnosis was made, and they were treated with
the same medications for anxiety.'' Id. at 48-49.
Dr. Mironer further noted that in the ``vast majority of the
cases'' in which Respondent prescribed controlled substances for lower
back pain, the physical examination was limited to determining whether
the patient had tenderness. Tr. 54. Moreover, ``most of the time''
Respondent's patient files lacked ``enough diagnostic or physical
examination to confirm the severity of [the] disease,'' and ``[n]o
additional tests were done or planned that [would] help[] with the
determination.'' Id. at 122-23. Dr. Mironer also rejected the notion
that additional tests should not be performed simply because a patient
lacks insurance, noting that certain tests such as x-ray and CT scan
are considerably cheaper than an MRI, and in any case, while a CT scan
``is still expensive,'' its cost is ``on par'' with the cost of filling
multiple prescriptions. Id. at 126-27.
Accordingly to Dr. Mironer, Respondent's exam involved ``just
basically press[ing] on the area, and if the patient says ouch, that is
tenderness.'' Id. at 54. Dr. Mironer reiterated that to properly
examine a patient's back, ``[t]here should be a range of motion
examination of [the] musculoskeletal, nervous system, including the
reflexes, strength of the muscles, sensitivity to touch, the
possibility of abnormality in the sympathetic system which you check by
examining the look of the skin, the possibility of what is called
allodenia, or extremely painful response to a non-painful stimulus, and
so on.'' Id.
With respect to Respondent's diagnosis of anxiety in various
patients and prescribing of benzodiazepines, Dr. Mironer explained that
``there was nothing in the notes indicating as to why this diagnosis
appears.'' Id. at 55. According to Dr. Mironer, there should be
``something in [the] description of [the] encounter with the patient
[which] should tell us something. For example, the patient looks
anxious and jittery, constantly shaking, sweating, complaining of
constant feeling of anxiety running all the time, or panic attacks or
what not. There was nothing like that described in any of the patients
most of the time. * * * '' Id.
Dr. Mironer also stated that ``it is a common practice in pain
clinics to do psychological testing * * * for a majority of the
patients, because it is well known that a significant number of
patients with chronic pain are suffering from psychological
conditions,'' and the ``prevalence of psychological conditions among
pain patients is higher than in general populations.'' Id. at 56.
Moreover, among chronic pain patients, depression ``is more prevalent''
than anxiety. Id.
Dr. Mironer further observed that ``benzodiazepines were the
medications that were prescribed in most of the cases I reviewed.'' Id.
at 57. According to Dr. Mironer, they are ``usually not the first line
of defense for anxiety,'' and are ``not the best medication to
prescribe for patients who are on opioids as well.'' Id. Dr. Mironer
explained that prescribing benzodiazepines with opioids increases the
risk ``of opioid overdose or significant side effect[s] such as
drowsiness.'' Id. at 58. Dr. Mironer also noted that most of his
patients that are being treated for chronic anxiety ``are being treated
without benzodiazepines or other controlled substances.'' Id. at 61.
Next, Dr. Mironer noted that in most of the files, after Respondent
issued prescriptions, ``the only plan of care was to come back in one
month.'' Id. at 62. Dr. Mironer opined ``[t]hat this is fairly
unusual,'' because for ``the majority of the patients, prescribing
medication'' is ``just a starting point to get them into other
modalities of treatment, either testing or consulting and so on.'' Id.
Dr. Mironer further explained that practically none of the files
included ``a plan of treatment saying I will start the patient on
hydrocodone and muscle relaxants, obtain nerve conduction studies,
obtain new MRIs, consider doing this injection or sending him to
physical therapy or neurosurgical consult. * * * [T]here were no plans
for treatment other than a follow up report.'' Id.
Dr. Mironer also noted that there were ``quite a few patients''
whose ``dose of opioids was increased after the patient asked for an
increase.'' Id. at 63. Dr. Mironer found that this was ``very
significant'' because there was no ``specific plan of treatment,'' and
the patients ``were just on this free flow regimen where they received
controlled substances, and whenever they wanted an increase they were
getting an increase most of the time.'' Id. According to Dr. Mironer,
this is ``not the regular way of practicing pain medicine.'' Id. Dr.
Mironer also noted that there were instances in which patients had told
Respondent that they had obtained a controlled substances from others
or patients had taken their drug ``more often'' than was prescribed.
Id.
[[Page 17536]]
Patient Specific Evidence
Next, Dr. Mironer testified regarding Respondent's prescribing to
specific patients. With respect to W.G. (GX 7), who met with Respondent
while they were both in jail, and to whom Respondent prescribed three
controlled substances including morphine, hydrocodone, Valium, as well
as carisoprodol at the first visit (as well as at three subsequent
visits), Dr. Mironer opined that Respondent prescribed inappropriate
amounts of opioids and that ``[t]here were no reasons obvious from the
chart for prescribing benzodiazepines.'' \23\ Tr. 67. Dr. Mironer
further noted that the ``physical examination was incomplete,'' and
that Respondent's diagnoses, which included both lumbar disc disease
and chronic anxiety (see GX 7, at 2) ``had no support with tests or as
a result of'' the physical examination. Id. at 67-68. Moreover,
Respondent did not create a treatment plan. Id. at 68. Based on all of
these findings, Dr. Mironer concluded that the prescriptions Respondent
issued to W.G. ``were not issued for medical purposes.'' Id.
---------------------------------------------------------------------------
\23\ W.G.'s patient file is discussed above.
---------------------------------------------------------------------------
Respondent diagnosed D.F. (GX 13) with mild degenerative disc
disease in the lumbar region, facet joint arthropathy, chronic muscle
tension headaches, and chronic anxiety, and issued her prescriptions
for sixty tablets of Oxycontin (80 mg), as well as ninety tablet
prescriptions for Lortab (10 mg.), Xanax (1 mg.) and Soma. According to
Dr. Mironer, a radiologist who reviewed a CT scan of D.F.'s lumbar
spine had found that she had ``very mild degenerative changes'' of her
lumbar spine, but that ``significant discomfort or radiculopathy would
not be expected from these findings.'' Tr. 73, GX 13, at 9. Moreover,
while D.F.'s file contained multiple radiology reports, it did not
contain any records of prior treatments she had received. See GX 13;
Tr. 73.
Dr. Mironer noted that ``there was again an inadequate examination
of the back, and the patient was diagnosed with chronic anxiety without
any'' findings to support the diagnosis. Tr. 73, see also GX 13, at 7-
8.\24\ Dr. Mironer also found that D.F. had ``received an extremely
high dose of opioids together with Xanax and a muscle relaxant [Soma],
and no treatment plan, and the same prescribing continue[d] for
durations [sic] that was in the chart.'' Tr. 73. Dr. Mironer thus
concluded that the prescriptions were ``not issued for legitimate
medical purposes.'' Id.
---------------------------------------------------------------------------
\24\ Dr. Mironer also found that Respondent had mistakenly
diagnosed D.F. as having tension headaches, when her headaches were
related to a brain cyst. Tr. 73. While this finding might be
evidence of medical malpractice, it is not relevant to the issues in
this proceeding.
Under the heading of ``Meds,'' a progress note dated June 26,
2007 contained in D.F.'s file indicates that she was taking Lortab
(10 mg.), Xanax (1 mg.), Oxycontin (80 mg.) and Soma. GX 13, at 8.
Yet, as Dr. Mironer testified, the patient file does not contain any
records related to D.F.'s being prescribed these drugs by other
physicians. Tr. 73.
---------------------------------------------------------------------------
On March 19, 2007, Respondent diagnosed D.M. as having five
conditions: (1) Degenerative Lumbar Disc Disease with Radiculopathy,
(2) Bilateral Lumbar Facet Joint Arthropathy, (3) S 1 Nerve Root
Compression, (4) L Sciatica, and (5) Chronic Anxiety. GX 25, at 8.
D.M.'s file contained the reports of two MRIs, which were done on May
12, 2001, and May 29, 2003. Id. at 9-10. At this visit, Respondent
issued D.M. prescriptions for Avinza 90 mg (morphine sulfate), Lortab
(10 mg), Xanax (1 mg.), and Soma. Id. at 8. Respondent issued to D.M.
new prescriptions for these drugs on April 16, May 29, June 29; at the
July 28 visit, Respondent noted that D.M. ``would like to [change]
Avinza to Oxycontin due to expense,'' and issued her prescriptions for
Oxycontin (40 mg.), as well as Lortab (10 mg.), Xanax (1 mg.), and
Soma. Id. at 6-7. On August 25, September 20, October 18, and November
15, Respondent issued D. M. new prescriptions for the latter four
drugs. Id. at 2, 4, 5, & 6.
According to Dr. Mironer, the findings of D.M.'s most recent MRI,
which was then four years old, were not ``very significant.'' Tr. 74.
Dr. Mironer opined that Respondent's ``examination of the back was
again inadequate.'' Id. Relatedly, Dr. Mironer noted that Respondent
had recorded the result of D.M.'s straight leg raise as negative, which
suggested that ``a lack of radiculopathy, or nerve pinching of [the]
sciatica,'' yet he had diagnosed D.M. with radiculopathy. Id. Moreover,
Respondent had diagnosed D.M. as having chronic anxiety without noting
any findings to support the diagnosis. Id.
Dr. Mironer observed that Respondent had prescribed a ``high dose
of opioid, with benzodiazepine and no treatment plan.'' Id. Moreover,
on the ``very next visit,'' Respondent increased ``the amount of
opioids,'' and at a later visit, Respondent had ``changed from one
medication to the other at [D.M's] request.'' Id. Finally, Respondent
continued to prescribe ``for another five months without any treatment,
testing or additional plans.'' Id. at 74-75. Dr. Mironer thus concluded
that ``the prescription[s] of controlled substances were not issued for
legitimate medical purpose in this case as well.'' Id. at 75.
With respect to F.M. (GX 26), Dr. Mironer noted that while he
complained ``of low back pain,'' his patient file included records
which indicated that he had been treated at a pain clinic and had been
``discharged just about ten days prior to'' his initial visit with
Respondent. Tr. 75; see also GX 26, at 6-17. More specifically, F.M.'s
file included a letter which indicated that during a September 6, 2007
office visit at the pain clinic, he had undergone a random urinalysis.
GX 26, at 6. While F.M. had been prescribed Dilaudid (hydromorphone), a
schedule II controlled substance, he tested negative for the drug when
he ``should have been positive.'' Id. According to the letter, this was
a breech of F.M.'s pain contract with the clinic; the clinic also
recommended that F.M. go to a chemical dependency treatment center. Id.
At the initial visit (on October 18, 2007), Respondent noted that
F.M. had been discharged based on the negative drug screen for
Dilaudid; Respondent also diagnosed him as having approximately nine
conditions including degenerative disk disease of the lumbar region,
right SI joint pain, muscle spasm in his back, and chronic anxiety. GX
26, at 4-5. The progress note indicates, however, that Respondent
performed a physical examination which included taking vitals signs, a
neurological examination and various other findings. Id. at 4-5.
Respondent issued him prescriptions for ninety tablets of Roxicodone 30
mg., sixty tablets of MS Contin 30 mg. (another schedule II drug),
ninety tablets of Xanax (.5 mg), and sixty tablets of Soma. Id.
Respondent also noted that he had discussed a narcotic contract with
F.M. and told him that ``any breech will [result in] immediate
dismissal,'' and that F.M. should consider injections of both his lower
back and SI joint area. Id.
F.M. also saw Respondent on November 15, 2007. Id. at 2. At this
visit, F.M. complained that he was ``still having pain'' and that ``the
MS Contin causes some nausea.'' Id. F.M. reported, however, that ``the
Roxicodone helps his pain the best.'' Id. Respondent noted he needed to
make changes in F.M.'s medications; while Respondent renewed F.M.'s
prescriptions for Roxicodone (30 mg.) and Xanax (.5 mg.), he also
increased the strength of the MS Contin to 60 mg.\25\
---------------------------------------------------------------------------
\25\ Respondent also changed F.M.'s muscle relaxant from Soma to
Zanaflex. GX 26, at 2.
---------------------------------------------------------------------------
Regarding Respondent's prescribing to F.M., Dr. Mironer observed
that notwithstanding that ``a discharge letter * * * recommended
treatment with
[[Page 17537]]
[an] addictionologist,'' F.M. ``was given a high dose prescription of
benzodiazepine and a muscle relaxant with no plans for treatment or no
plans for further strict control of his use of control substances, such
as mediation check, pharmacy check, or urine toxicology screening.''
Tr. 75-76. Dr. Mironer further noted that while F.M. had complained
that the MS Contin caused nausea, Respondent had issued him a new
prescription which doubled the strength of the MS Contin. Tr. 76.
Finally, Dr. Mironer noted that Respondent had not made a ``new plan.''
Id. Dr. Mironer thus concluded that the prescriptions were ``not issued
for legitimate medical purposes.'' Id.
J.M.'s first visit with Respondent was April 16, 2007. GX 27, at
14. At the visit, J.M. complained of lower back pain, hip pain, and
neck pain. Id. In the progress note, Respondent also indicated that
J.M. had undergone an MRI on November 11, 2003, which showed that she
had two herniated discs (L4-5 & L5-S1), and either an X-ray or an MRI
(two years ago) of her cervical spine which showed that she had two
ruptured discs (C1-2 & C2-3). Id. Moreover, Respondent noted that J.M.
had seen another physician until October 2006. Id. J.M.'s file does
not, however, contain reports for either radiological exam or any
records from the physician who previously treated her. See generally GX
27.
Respondent's physical exam noted that J.M.'s lungs were clear and
included a notation for a finding with respect to her cardiovascular
system.\26\ With respect to J.M.'s back, Respondent indicated
``nontender x over [right] buttocks,'' and with respect to her neck,
Respondent indicated ``tender [with] spasm over [right] trapezius [and]
periscapular area.'' Id. Respondent diagnosed J.M. with cervical disc
disease, lumbar disc disease, and chronic anxiety, although there were
no findings to support the latter. Id. Respondent's treatment plan for
J.M. was to issue her prescriptions for sixty tablets of each of the
following: Avinza (morphine sulfate 120 mg.), Roxicodone (30 mg.), and
Xanax, as well as ninety tablets of Soma, with a follow-up in thirty
days. Id. At J.M.'s next visit, Respondent issued her new prescriptions
for each of the above drugs (although he reduced the number of pills by
one day's worth). Id. at 13.
---------------------------------------------------------------------------
\26\ The record does not establish what the notation signified.
---------------------------------------------------------------------------
At J.M.'s third visit (June 6, 2007), Respondent noted that J.M.
``wants to [change] Avinza to MS Contin due to cost.'' Respondent
obliged and issued J.M. a prescription for ninety tablets of MS Contin
(60 mg.); Respondent also issued J.M. new prescriptions for sixty
tablets of both Roxicodone (30 mg.) and Xanax (1 mg.), as well as
ninety Soma. Id.
On the next visit (July 1, 2007), Respondent noted that the MS
Contin was not helping her as well as the Avinza. Id. at 12. He also
noted that J.M.'s hip pain was ``much worse internally [with] very
limited movement'' and that she was ``still tender over [left]
trapezius.'' Id. Respondent then issued new prescriptions for the same
three controlled substances (as well as the Soma) and increased the
quantity of MS Contin to 120 tablets. Id. Respondent re-issued the same
four prescriptions on August 3, September 1 and 29, October 24, and
November 20. Id. at 7, 9-11. Throughout the entire course of his
treating J.M., her plan of care was limited to prescribing medication
and follow-up visits. See generally GX 27.
Based on his review of J.M.'s record, Dr. Mironer concluded that
Respondent's physical examination was ``inadequate,'' that she had
``received exceedingly high doses of opioids,'' as well as a
``benzodiazepine for anxiety'' with no findings to support the
diagnosis. Tr. 76. Dr. Mironer further noted that ``no treatment plan
was given,'' and that the ``prescribing was continued for more than
half a year with no additional treatments, testing, or additional plans
for the future.'' Id. Dr. Mironer thus opined that ``the prescriptions
of controlled substances in [J.M's] case were * * * not issued for
legitimate medical purposes.'' Id. at 77.
L.C.'s initially visited Respondent on March 19, 2007, and
complained of lower back pain. GX 41, at 8. L.C.'s file includes a copy
of a report for an MRI which had been done on November 29, 2006; the
Radiologist's report indicates that the MRI had found ``only minimal
disk disease'' of her lumbar spine, and that her disks ``are actually
still within normal limits.'' Id. at 12. While the report also noted
that there were ``degenerative changes * * * within the facet joints,''
it indicated that ``these should not be the cause of a radiculopathy.''
Id.
The note for L.C.'s first visit listed three doctors she had
previously seen, yet her patient file did not contain any records from
these doctors. Id. at 8. According to the history section, L.C. also
had radiculopathy in her left leg to the back of her knee, and that her
pain level was ``8.'' Id. According to the physical examination
section, Respondent found tender the paravertebral area of L.C.'s lower
back. Id. Respondent also apparently did a straight leg raise test on
L.C; while findings appear to have been noted, the significance of the
findings is not clear on the record.\27\
---------------------------------------------------------------------------
\27\ Respondent also apparently checked L.C.'s lungs and
cardiovascular system. GX 41, at 8.
---------------------------------------------------------------------------
Respondent diagnosed L.C. as having four conditions: 1) Facet joint
arthropathy, 2) mild lumbar disc disease, 3) chronic anxiety, and 4)
chronic lower back pain with left radiculopathy. Id. Respondent then
issued her prescriptions for Avinza (90 mg.), Lortab (10 mg.), Xanax (1
mg.), and Soma, with a follow-up in thirty days. Id. Respondent re-
issued the prescriptions for the same drugs on April 16 (although he
increased the dosing of the Avinza from twice to three times a day),
and on May 29; on the latter date, Respondent did so without even
requiring L.C. to appear. Id. at 7.
On June 29, L.C. returned to Respondent and requested that he
prescribe Oxycontin instead of Avinza due to the latter's cost. Id.
Respondent agreed and issued her a prescription for ninety tablets of
Oxycontin (40 mg); Respondent also issued L.C. prescriptions for sixty
tablets of Lortab (10 mg.), as well as ninety tablets of both Xanax and
Soma. Id. Respondent issued new prescriptions for these drugs on or
about July 28, August 25 (based on a telephone call), September 27,
October 29, and November 30, 2007. Id. at 2, 4-6.
While L.C.'s patient file spans eight months of visits, it contains
no indication that she was ever subjected to a urine drug screen or
pill count. See generally id. at 2-8. Moreover, Respondent's plan of
treatment for L.C. was invariably to prescribe controlled substances
(and Soma); Respondent did not recommend any other treatment modalities
to L.C. Id.
With respect to L.C., Dr. Mironer observed that ``[t]he only
available record was an MRI, which was appropriate for [her] age,'' and
that at the first visit, she had ``received a very high amount of
opioids on this visit, with [a] benzodiazepine for anxiety that was
again not documented.'' Tr. 77. Dr. Mironer further noted that at
L.C.'s ``next visit,'' Respondent had increased her medications by
``[thirty] percent,'' that he ``later changed to a different pain
medication,'' and that the prescribing ``continued for * * * seven,
eight months with no control of intake of the medication and no plans
for a future treatment.'' Id. Dr. Mironer thus concluded that the
prescriptions Respondent issued to L.C. were ``not
[[Page 17538]]
issued for legitimate medical purposes.'' Id. at 77-78.
M.C., a patient who participated in Respondent's ``group
practice,'' received prescriptions for Oxycontin (80 mg.), Lortab (10
mg.), Xanax (1 mg.) and Soma on June 26, July 24, August 21, September
15, October 8, November 5, and December 3, 2007. See generally GX 46.
According to the progress note for his initial visit, M.C. reported
that he was currently taking all four of the above drugs yet the file
contains no records from other physicians. Id.
Respondent performed a physical examination of his lungs,
cardiovascular, and back. Id. at 8. With respect to M.C.'s back,
Respondent noted that it was tender at both the ``lower & upper
paravertebral areas of [the] lumbar region,'' as well as ``at [the]
lower [right] scapula area.'' Id. Respondent diagnosed M.C. as having
degenerative disc disease in the lumbar region, facet joint
arthropathy, and anxiety. Id. There is, however, no indication of any
finding that would support a diagnosis of anxiety. Id.
Dr. Mironer noted with respect to M.C. that ``[n]o records [were]
available at the time of the visit,'' and that Respondent's examination
of his back ``was not adequate.'' Tr. 78. Dr. Mironer further observed
that Respondent had prescribed ``an extremely high dose opioids * * *
with benzodiazepines for anxiety that was not documented, and muscle
relaxants,'' and that ``the pain prescribing continued for * * * half a
year with again no'' plans for other treatment modalities. Id. Dr.
Mironer thus concluded that Respondent's prescribing of controlled
substances to M.C. ``was not for [a] legitimate medical purpose.'' Id.
at 79.
H.R., another of Respondent's group practice patients, first saw
Respondent on July 24, 2007, complaining of lower back pain, but ``no
radiation.'' GX 51, at 5. H.R.'s file included two radiology reports,
one for an MRI of his hips (dated June 19, 2006), and another for an
apparent X-ray examination of his lumbar spine (dated March 28, 2006).
Id. at 6-7. With respect to the latter exam, the Radiologist found that
``degenerative disc disease is present at the lumbar spine with mild
degenerative levoscoliosis.'' Id. at 7.
In the physical exam section of the progress note, Respondent
indicated that H.R.'s back was ``tender [bilateral] paravertebral areas
of lumbar spine,'' and that he was ``able to bend to 90'' degrees. Id.
at 5. Respondent further noted that H.R.'s straight leg raise was
negative. Id.
According to the progress note, Respondent diagnosed H.R. as having
chronic lower back pain caused by degenerative disc disease, and
chronic anxiety. Id. Here again, the progress note contains no findings
that support a diagnosis for anxiety. Id. As found above, Respondent
issued H.R. prescriptions for sixty tablets of Oxycontin (20 mg.),
ninety tablets of both Lortab (10 mg.) and Xanax (1 mg.), and ninety
tablets of Soma. Id.
At the next visit (Aug. 21, 2007), H.R. reported that he was still
having lower back pain. Id. at 4. Respondent doubled the strength of
the Oxycontin he prescribed to 40 mg. and issued new prescriptions for
Lortab, Xanax and Soma. Id. Respondent re-issued the same four
prescriptions on two additional occasions. Id. at 2 & 4. Moreover,
there is no indication in H.R.'s file that Respondent ever recommended
alternative treatment modalities.
H.R.'s file also contained a Tennessee Board of Pharmacy Patient Rx
History Report (dated November 26, 2007), which showed that H.R. had
been receiving prescriptions for alprazolam (Xanax) and hydrocodone
from multiple doctors and had obtained several of the prescriptions
during the same period in which he was obtaining prescriptions from
Respondent. Id. at 8-9. There is, however, no evidence that Respondent
prescribed to H.R. after he received the report.
Dr. Mironer observed that ``the only available record at the time
of [H.R.'s] visit was [an] age-appropriate X-ray of the spine with some
mild to moderate degenerative changes, and [a] normal X-ray of the
hip.'' Tr. 79. Dr. Mironer also noted that Respondent's initial
prescribing was for ``a fairly high dose of opioid,'' and that the
benzodiazepine prescriptions ``for anxiety * * * was undocumented.''
Id. Dr. Mironer further noted that ``[d]uring [the] next visit the
amount of opioids that was fairly high already was increased more than
fifty percent, and that [the] prescribing continued for a couple more
months.'' Id. Here again, Dr. Mironer concluded that Respondent's
prescribing of controlled substance lacked a ``legitimate medical
purpose.'' Id. at 79-80.
A.R., who was H.R's wife, also visited Respondent on July 24, 2004,
and complained of lower back pain and pain radiating down her left leg
to her ankle. GX 59. A.R.'s file included the reports of two
radiological examinations (one of her cervical spine and one of her
lumbar spine), which were then more than three and a half years old.
Id. at 7-9. While the report on A.R.'s cervical spine noted the
presence of a paravertebral muscle spasm, it was otherwise
``unremarkable''; similarly, while the report on A.R.'s lumbar spine
found ``disc desiccation at the level of L5/S1, with mild posterior and
left paracentral disc bulging * * * the remaining portions of the exam
are unremarkable.'' Id. at 7 & 9.
According to the progress note, Respondent examined A.R. and found
tenderness at the bilateral paravertebral region of her lower back and
a muscle spasm. Id. at 6. Respondent also found tenderness over A.R.'s
left buttocks in the region of the sciatic nerve, that A.R. was able to
bend over to ninety degrees, and that the straight leg raise was
negative bilateral. Id. Respondent thus diagnosed A.R. as having
chronic lower back pain caused by degenerative disc disease, chronic
anxiety, and chronic left sciatica, and issued her prescriptions for
sixty Oxycontin (20 mg.), ninety Lortab (10 mg.), ninety Xanax (1mg.),
ninety Soma, with a follow-up in thirty days. Id. at 5-6.
At the next visit (August 21), A.R complained that she still had
lower back pain despite her taking Oxycontin (20 mg.). Id. at 5.
Respondent thus doubled the strength of the Oxycontin to 40 mg. and
also re-issued the prescriptions for Lortab (10 mg), Xanax, and Soma.
Id. Respondent also issued prescriptions for the same four drugs on
September 20 and October 19. Id. at 2 & 4. At no point in his treatment
of A.R. did Respondent recommend alternative treatment modalities.
At each of her four visits, Respondent issued the exact same
prescriptions to A.R.--including drug, drug strength, and dosing--as he
did for her husband, H.R. Moreover, at their August 21 visit,
Respondent doubled the strength of the Oxycontin he prescribed to both
H.R. and A.R. Compare id. at 5, with GX 51, at 4.
As Dr. Mironer observed, ``the treatment of both Mr. and Mrs. [R]
was exactly the same as far as medication and increases and the
dates.'' Tr. 80. Dr. Mironer further noted that while an MRI indicated
that A.R. had a bulging disk, it ``may be a very benign condition.''
Id. Moreover, A.R. had ``received a fairly high amount of opioids on
her first visit with [a] benzodiazepine for anxiety that was not
documented.'' Id. Dr. Mironer also observed that Respondent had
increased the amount of opiates at the second visit, and that A.R.
continued to receive the medication for two more months thereafter. Id.
Dr. Mironer thus concluded that the prescriptions Respondent issued to
A.R. lacked a legitimate medical purpose. Id.
C.H. first saw Respondent on November 8, 2007, and apparently
complained of back and shoulder pain.
[[Page 17539]]
GX 19, at 3. According to the progress note, C.H. had been undergoing
treatment by a clinic for opiate dependence for the last ten months and
was taking a ``maintenance dose of methadone hcl 80 mg daily.'' Id. at
3. C.H. further reported to Respondent that methadone ``controls his
pain better than hydrocodone,'' which he had become addicted to. Id.
C.H. patient's file included numerous records from the methadone
clinic including a printout of C.H.'s ``Patient Drug Screen Results,''
which indicated that it was printed out on the morning of his first
visit with Respondent. Id. at 16. This document showed that C.H. had
been given a urine drug screen the day before; the document also
contained a handwritten notation stating that ``[C.H.] is currently
medicating @ 80 mg. daily.'' \28\ Id. There is no indication in C.H.'s
file that Respondent contacted the clinic to determine whether C.H. was
still being treated by it.
---------------------------------------------------------------------------
\28\ While the notation gives a date of ``1/8/07,'' the date
appears to be cut off and obviously could not have been written ten
months before the document was printed out and a month before C.H.
commenced treatment with the clinic. See GX 19, at 10. I thus find
that the notation was made on November 8, 2007, the date the
document was printed out.
---------------------------------------------------------------------------
Dr. Mironer did not take issue with the physical exam that
Respondent performed on C.H. or his diagnosis of pain. Tr. 81-82. He
noted, however, that Respondent had prescribed to C.H. an eighty
milligram dose of methadone to be taken once a day. Id. at 81. More
specifically, Dr. Mironer explained that ``methadone is prescribed once
a day for treatment of addiction because of the length of methadone
being in the body makes it different'' as the drug remains in the body
``exceed[ing] two days.'' Id. 50. In contrast, the analgesic effect of
methadone ``is only six to eight hours,'' and thus the ``prescribing
[of] methadone for pain should be in the form of [a] low dose for
three, four, five times a day, rather than a high dose once a day.''
Id.
According to Dr. Mironer, ``[w]hen you prescribe a high dose once a
day, you are not providing pain relief, but you are providing a certain
amount of opioid in the body for a long duration that is usually what
is needed for [the] treatment of addiction.'' Id. Moreover, if
methadone is used to treat pain, the dosing ``should be started at 5 to
10 milligrams three or four times a day,'' and titrated to a total
dosage of sixty milligrams a day. Id. Finally, because methadone is
``so long acting,'' a patient ``may eventually accumulate [a]
significant amount of the drug,'' thus risking ``respiratory depression
and the possibility of death.'' Id. at 52. Dr. Mironer therefore
concluded that Respondent's prescribing of methadone to C.H. was not
issued for ``appropriate medical purposes.'' \29\ Id. at 81.
---------------------------------------------------------------------------
\29\ Dr. Mironer further noted that ``[i]f a patient finishes
his treatment at a methadone clinic, we require usually a
psychiatric or psychological evaluation * * * to make sure * * *
that the patient * * * is a good candidate to try to treat * * *
with chronic opioids. We will try to avoid it as much as we can.
However, if we will prescribe for this patient medication, it
probably won't be methadone, and it for sure won't be a high dose of
methadone once a day.'' Id. at 81-82. Dr. Mironer also explained
that ``it is a well documented knowledge, and even the PDR
[Physicians' Desk Reference] refers to the duration of pain action
and advises to not prescribe methadone for pain.'' Id. at 83. See
also id. at 111 (``If the patient is treated for addiction and
cured, then he shouldn't be on methadone any more. If he still
required daily doses of methadone, it means that he is still in
treatment for addiction'' and the prescribing should ``be done only
by the methadone clinic'').
The Government also introduced the patient file of K.M., who
complained of chronic lower back pain. GX 24, at 2. K.M.'s chart
contains but a single progress note, which appears to be incomplete
as indicated by the notation ``OVER'' at the bottom of the page, but
the continuation page is not in the record. Id. Nor does the note
appear to document the full scope of the physical examination as it
makes no mention of Respondent's findings with respect to K.M.'s
back, even though with respect to every other patient, Respondent
made some finding with respect to a patient's back even if his exams
were inadequate. Id. Moreover, the file is missing Respondent's
assessment and does not clearly indicate what drugs he may have
prescribed and the plan of treatment; while the file contains a
document which lists various medications, the record does not
establish the significance of this document. Nor did the Government
submit other records which show the prescriptions Respondent issued
to K.M.
---------------------------------------------------------------------------
Finally, with respect to S.M. (GX 52), whose history of medical
problems and substance abuse, as well as his road trip (accompanied by
K.C. and M.B.) to visit Respondent was discussed above, Dr. Mironer
acknowledged that the records ``showed significant disease of the knee
joint.'' Tr. 83. Dr. Mironer further noted, however, that the available
records showed that S.M had a ``history of street drug use'' including
marijuana and IV cocaine use, and ``long term incarceration.'' Id.
Dr. Mironer noted that Respondent issued S.M. a prescription for
Oxycontin (20 mg.) at the initial visit, that he did not create any
treatment plan other than to prescribe drugs, and that he did not
attempt control S.M.'s use of his medication. Id. at 83-84. Dr. Mironer
also noted that S.M. had run ``out of his medication early,'' and had
``received additional controlled substance [Roxicodone 30 mg.] from a
third person.'' Id. at 84. Dr. Mironer then observed that ``[d]espite
all that, [S.M.] received [a] renewal of his prescription for
Oxycontin, and actually received an additional prescription for the
same medicine [Roxicodone] that he received from the third person.''
Id. Finally, Dr. Mironer again explained that while Respondent had
increased the amount of controlled substances he prescribed, no plan
was made for alternative treatments or to control S.M.'s ``intake of
medication.'' Id. Dr. Mironer thus concluded that Respondent's
prescribing of controlled substances lacked a legitimate medical
purpose. Id.
Respondent's Cross-Examination of Dr. Mironer
On cross-examination, Respondent did not challenge Dr. Mironer's
testimony with respect to a specific patient. Respondent did, however,
inquire into the basis for Dr. Mironer's more general observations
about both Respondent's patient pool and the practice of pain
management.
For example, with regard to the ``large number'' of patients who
were traveling from Greeneville, Tennessee to see Respondent, Dr.
Mironer testified that while patients may go out of state ``to obtain a
consult or to have a procedure done,'' it is ``fairly unusual'' for
patients ``to go a long distance on a monthly basis just to see a
family doctor or * * * a pain doctor who is prescribing their
medication.'' Id. at 96. Moreover, when asked by Respondent whether he
would still require studies and MRIs for a chronic pain patient who has
been treated with medications for a five to ten-year period, Dr.
Mironer testified that he ``would absolutely do'' the test ``unless [he
had] a clear understanding of what is the pathology and * * * that
there is nothing [that] can be done to improve the condition, which is
extremely rare.'' Id. at 98. Dr. Mironer further stated that the
``majority'' of chronic pain patients can be helped with alternative
treatments such as injections, nerve destruction or surgery, even if
they ``cannot be cured completely,'' and that in his experience, the
majority of chronic pain patients have ``never received proper medical
treatment.'' Id. at 99-100.
Moreover, while acknowledging that ``[p]ain is subjective,'' Dr.
Mironer explained that the cause of chronic pain can only be assessed
through ``objective findings.'' Id. at 100. If the patient's findings
through physical examination and diagnostic tests are normal, and the
``patient has severe pain,'' the pain is ``probably psychological in
origin,'' and should be treated accordingly. Id.
Respondent's Evidence
Respondent testified on his own behalf. Respondent generally did
not address Dr. Mironer's testimony regarding the specific patients and
his opinion testimony regarding the legality
[[Page 17540]]
of the prescribings. Rather, Respondent testified as to the
circumstances surrounding his starting his South Carolina practice, the
results of the patient interviews conducted by the Investigators, his
reasons for not requiring his patients to undergo diagnostic testing
and alternative treatments, his prescribing for anxiety, and his
prescribing to a person with track marks.
The ALJ found that ``Respondent appeared to tailor his testimony to
suit his version of the events.'' ALJ at 50. This was for good reason
as beyond her personal observation of Respondent's demeanor, as much of
his testimony was patently self-serving, and frequently, absurd.
According to Respondent, he opened up his pain management practice
notwithstanding his lack of board certification in pain management and
that he had not attended any conferences on pain management, based on
what he had learned in his seven years as a family practitioner in
Tennessee and while being treated by a board-certified pain specialist.
Id. at 322 & 324. Respondent maintained that he opened a pain
management practice rather than a family practice, because it ``would
be simple,'' ``[i]t wouldn't require a lot of employees'' or ``a lot of
the things that family practice requires,'' and he ``wouldn't have to
mess with insurance companies taking [forty to sixty] percent of the
money.'' Id. at 290. Respondent subsequently testified that he ``needed
money for retirement'' and to pay bills for his old office in Tennessee
because his office manager had ``stolen between forty and two hundred
thousand dollars.'' Id. at 304. Respondent maintained, however, that
his need for money was not the only reason he resumed practicing as he
missed caring for patients. Id.
Respondent also maintained ``that it made sense that probably
patients would come down'' from Greeneville, Tennessee to see him,
because ``the pain clinics'' near Greenville ``were mostly full,'' and
the patients are ``not going to go to a pain clinic that they don't
know something about the doctor.'' Id. at 291. Respondent did not,
however, establish that he had surveyed any pain clinics to determine
whether they were still accepting patients. According to Respondent,
patients would not simply go to a pain management center of a
university-hospital (such as Duke or the University of Tennessee, which
might also be a shorter drive) to be treated because they want a doctor
that ``they know something about.'' Id. at 324-25.
With respect to the evidence pertaining to his prescribing
practices, Respondent admitted that ``I could have done blood pressures
and all at the house, but it is a little more cumbersome to do blood
pressures.'' Id. at 292. Respondent further acknowledged that ``[i]f
there were families there or whatever, they're on the couch and we're
talking and I'm getting a history from them and all.'' Id. Respondent
maintained, however, that ``I did examine patients that were there,''
that ``I don't [sic] people's pants down in front of other people,''
that ``I didn't discuss anything that was * * * confidential'' without
taking the person to another room. Id. at 292-93.
Moreover, Respondent asserted that he was ``just floor[ed]'' by the
evidence that the patients had told investigators that ``they weren't
examined.'' Id. at 293. Relatedly, Respondent stated that ``[i]t's
nothing to listen to somebody's heart[ ], lungs, check their back and
neck,'' and that he could ``do a complete physical on somebody in three
or four minutes.'' Id. Respondent, however, then implicitly
acknowledged that he had not performed physical examinations on at
least some of the persons, testifying that ``[B.J.P.] and a number of
these patients say that they were not examined at my house, but they
were at the office.'' Id.
Respondent also testified that ``this is probably some of the worse
documentation I've probably ever done.'' Id. at 301. Respondent further
asserted that those patients who told investigators that they didn't
know ``what their diagnosis is or what the [treatment] plans are for
them [were] lying, plain and simple * * * because I go over the same
routine with every patient.'' Id. Respondent also maintained that he
was ``eminently qualified to treat anxiety and depression,'' and that
he would ``always ask the basic questions'' that are needed to diagnose
``anxiety and depression.'' Id. at 303. I conclude, however, that the
records speak for themselves and because they do not set forth the
findings required to support the numerous diagnoses Respondent made for
both pain and chronic anxiety, or that he created plans that
recommended treatments (other than taking drugs), I reject Respondent's
testimony.
Relatedly, Respondent testified that ``he was probably at fault''
for not seeing track marks on several of his patients' arms was
``because it was easier [to] listen to somebody's heart and lungs, just
underneath their shirt, [to] lift up their shirt, because they would
wear long-sleeved shirts * * * and I didn't remove their shirts
usually.'' Id. at 294. On cross-examination, Respondent acknowledged
that if a patient's medical records indicated that he had a history of
IV drug use (as in the case of S.M., GX 52, at 8), it would ``[t]o some
degree'' raise a red flag to examine his arms for current use. Tr. 329.
Respondent insisted, however, that ``I * * * make my own decisions
about patients I treat.'' \30\ Id.
---------------------------------------------------------------------------
\30\ Respondent further maintained that S.M., who was
hospitalized with a collapsed lung after obtaining prescriptions for
Oxycontin which he proceeded to inject intravenously, was not in
respiratory distress on ``that day.'' Id. at 299. While Respondent
acknowledged that ``respiratory depression will come from the
narcotics,'' he maintained that narcotics would not cause a lung to
collapse. Id. at 300.
Regardless of whether narcotics would cause a collapsed lung,
respiratory depression is a known side effect of taking opiates, and
it seems unusual to prescribe narcotics to a patient who has been
diagnosed with C.O.P.D. The Government did not, however, ask its
expert regarding the propriety of Respondent's prescribing of
Oxycontin and Roxicodone to S.M. in light of this condition. I thus
do not rely on this conduct in determining whether the prescriptions
were for a legitimate medical purpose.
---------------------------------------------------------------------------
Respondent also maintained that that he was willing to accept that
a patient has not ``had an MRI in four or five years * * * for a
while,'' but ``there was going to be a time within a year, year and a
half, that [he] was going to come up with something'' because he was
``not going to jeopardize a patient.'' Id. at 296.
Relatedly, Respondent maintained that he did not ``immediately''
ask his patients to get MRIs because of the costs involved. Id.
Finally, Respondent maintained that if his patients continued to put
off obtaining trigger point injections, ``the medication was going to
stop.'' Id. at 297. Respondent admitted, however, that he had never
actually stopped prescribing to a patient even though he acknowledged
that there were a few patients who he had been prescribing to for that
long a period (a year and a half). Id. at 319. Finally, when asked
whether he was aware of what was required under South Carolina law to
establish a doctor-patient relationship, Respondent testified that he
did not ``know the details of it,'' but that ``you make contact and do
basic things.'' Id. at 335.
Respondent also introduced into evidence various statements which
were prepared by family members, professional acquaintances, and
friends. See RXs 1-10. Of these statements, most are not remotely
probative of the issues in this case. Among the statements, however, is
one from a physician who ``assisted him at his clinic during the summer
of 2008,'' RX 1, as well as one from a nurse who worked for him ``from
approximately May 2002-May 2006,'' when he was practicing in
Greeneville, Tennessee. RX 3.
[[Page 17541]]
Notably, neither of these persons worked with Respondent during the
period when he issued the prescriptions which are at issue here.
Moreover, the unsworn statement of Dr. Koon (RX 1), reflects his
observations of Respondent at a time when the latter was aware that he
was under investigation and had ample reason to portray himself as
responsible and law abiding. See GXs 2 & 3 (Respondent's letters to DEA
Investigators regarding pending investigation).
Nor does the statement from his former nurse support him. According
to the nurse, Respondent ``was very strict when it came to pain
medicine and always attempted to control a patient's pain first with a
non-controlled substance and/or alternative medicine[,]'' and
``required all his patients to have supporting MRI/x-rays etc. * * *
before ever giving any narcotic pain medication.'' RX 3. Respondent's
former nurse also stated that he ``always did thorough examines on his
patients with each office visit,'' that he requires his patents ``to
bring in their narcotic prescription bottles with each monthly visit,''
and would do pill counts, and that he would request that his patients
``come in for a drug screen'' and give them 24 hours to come to the
office and provide the specimen. Id. Indeed, the statement is
remarkably consistent with Dr. Mironer's testimony as to the
appropriate and usual course of professional practice in prescribing
controlled substances to patients and monitoring them to ensure that
they are neither abusing the drugs nor diverting them, and buttresses
Dr. Mironer's opinion testimony that Respondent issued numerous
prescriptions which lacked a legitimate medical purpose.
Discussion
Section 304(a) of the Controlled Substances Act (CSA) provides that
a registration 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. Sec.
824(a)(4). With respect to a practitioner, the Act requires the
consideration of the following factors in making the public interest
determination:
(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.
Id. Sec. 823(f).
``[T]hese factors are * * * considered in the disjunctive.'' Robert
A. Leslie, M.D., 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 a registration should be
revoked.'' 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 (D.C. Cir. 2005).
In this matter, it is undisputed that Respondent holds a valid
medical license and a controlled substance registration from the State
of South Carolina (factor one). It is also undisputed that Respondent
had not been convicted of an offense related to controlled substances
under either federal or state law (factor three).\31\ This proceeding
focused, however, on Respondent's experience in dispensing controlled
substances (factor two) and his record of compliance with applicable
federal and state laws (factor four). Having considered the record as a
whole, I conclude that the Government has proved by a preponderance of
the evidence that Respondent issued numerous controlled substance
prescriptions which were unlawful under federal law and that he has
therefore committed acts which render his continued registration
``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). As the
ALJ did, I also conclude that Respondent has failed to accept
responsibility for his misconduct and therefore cannot be entrusted
with a registration.
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\31\ Under Agency precedent, neither of these findings is
dispositive. See Edmund Chein, 72 FR 6580, 6590 n.22 (2007);
Mortimer B. Levin, 55 FR 8209, 8210 (1990).
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Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Controlled
Substance Laws
The principal issue in this case is whether the controlled-
substance prescriptions Respondent issued complied with federal law.
Under a longstanding DEA regulation, a prescription for a controlled
substance is not ``effective'' unless it is ``issued for a legitimate
medical purpose by an individual practitioner acting in the usual
course of his professional practice.'' 21 CFR 1306.04(a). This
regulation further provides that ``an order purporting to be a
prescription issued not in the usual course of professional treatment *
* * is not a prescription within the meaning and intent of [21 U.S.C.
Sec. 829] and * * * the person issuing it, shall be subject to the
penalties provided for violations of the provisions of law related to
controlled substances.'' Id. See also 21 U.S.C. Sec. 802(10) (defining
the term ``dispense'' as meaning ``to deliver a controlled substance to
an ultimate user by, or pursuant to the lawful order of, a
practitioner, including the prescribing and administering of a
controlled substance'') (emphasis added).
As the Supreme Court recently 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).
Under South Carolina law, ``[i]t is unprofessional conduct for a
licensee initially to prescribe drugs to an individual without first
establishing a proper physician-patient relationship.'' S.C. Code Ann.
Sec. 40-47-113(A). The statute further provides that:
[a] proper relationship, at a minimum, required that the
licensee make an informed medical judgment based on the
circumstances of the situation and on the licensee's training and
experience and that the licensee:
[[Page 17542]]
(1) personally perform and document an appropriate history and
physical examination, make a diagnosis, and formulate a therapeutic
plan;
(2) discuss with the patient the diagnosis and the evidence for
it, and the risks and benefits of various treatment options;
(3) ensure the availability of the licensee or coverage for the
patient for appropriate follow-up care.
Id.
Relatedly, the South Carolina Board of Medical Examiners had
adopted Pain Management Guidelines, which represent ``what the Board
considers to be within the boundaries of professional practice.'' GX
67, at 2. The Guidelines advise that the prescribing of ``controlled
substances for pain [will be considered] to be for a legitimate medical
purpose if based on accepted scientific knowledge of the treatment of
pain or if based on sound clinical grounds.'' Id.
However, ``[a]ll such prescribing must be based on clear
documentation of unrelieved pain and in compliance with applicable
state or federal law.'' Id. Moreover, ``[a] complete medical history
and physical examination must be conducted and documented in the
medical record.'' Id. at 2. The Guidelines further state that ``[t]he
medical records should document the nature and intensity of the pain,
current and past treatments for pain, underlying or coexisting diseases
or condition, the effect of the pain on physical and psychological
function, and history of substance abuse,'' as well as ``the presence
of one or more recognized medical indications for use of a controlled
substance.'' Id.
Moreover, ``[t]he 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.'' Id. at 3. Continuing, the Guidelines advise that ``[o]ther
treatment modalities or a rehabilitation program may be necessary
depending on the etiology of the pain and the extent to which the pain
is associated with physical and psychosocial impairment.'' Id. The
Guidelines also advise that the physician should periodically review
the patient's progress toward treatment goals, ``monitor patient
compliance in medication usage,'' and ``refer the patient as necessary
for additional evaluation and treatment in order to achieve treatment
objectives.'' Id.
The Guidelines further state that ``special attention should be
given to those pain patients who are at risk for misusing their
medications and those whose living arrangements pose a risk for
medication misuse or diversion.'' Id. Finally, the Guidelines advise
that ``[t]he management of pain in patients with a history of substance
abuse or with a comorbid psychiatric disorder may require extra care,
monitoring, documentation, and consultation with or referral to an
expert in the management of such patients.'' Id.
The record clearly establishes that Respondent repeatedly exceeded
the bounds of professional practice and issued controlled-substance
prescriptions which lacked a legitimate medical purpose as required by
Federal law. 21 CFR 1306.04. Even putting aside the scandalous evidence
obtained by the Investigators in their interviews with the patients,
Dr. Mironer, who reviewed the patient files, testified that Respondent
invariably prescribed narcotic controlled substances for pain based on
inadequate physical examinations, as well as benzodiazepines for
anxiety without any findings to support his diagnosis. Moreover,
Respondent's treatment plans were typically limited to prescribing
multiple controlled substances; he rarely recommended that a patient
undergo further testing, obtain a consultation from specialists, or try
alternative treatment modalities, and failed to do so even when the
prescribing went on and on.
For these reasons, Dr. Mironer specifically testified that
Respondent lacked a legitimate medical purpose in issuing controlled
substance prescriptions to W.G., D.F., D.M., J.M., L.C., M.C., H.R. and
A.R. (the latter two being married to each other and who received the
same exact prescriptions on the same dates). See Tr. 68, 73, 75, 77,
77-78, 79, 79-80. I agree and adopt Dr. Mironer's conclusion that these
prescriptions lacked a legitimate medical purpose and were therefore
unlawful under federal law. 21 CFR 1306.04(a).
With respect to F.M., who was discharged by his previous physician
only a short while before his first visit with Respondent when a drug
screen was negative for a drug (Dilaudid) which had been prescribed to
him, Dr. Mironer did not find that Respondent's physical exam was
inadequate. Tr. 75-76. Dr. Mironer did, however, note that
notwithstanding F.M.'s having been discharged for noncompliance,
Respondent issued controlled-substance prescriptions without any plan
to monitor his use of the drugs through pill counts, pharmacy checks or
urine testing; Dr. Mironer also noted that Respondent did not recommend
any alternative treatments or consultations. Id. Notably, Respondent
issued F.M. prescriptions for two schedule II opiates (MS Contin and
Roxicodone), as well as benzodiazepines.
Based on Respondent's failure to properly monitor F.M.'s use of
medications, his doubling of the strength of the MS Contin even though
F.M. complained that the drug made him nauseous, and failure to create
a treatment plan, Dr. Mironer concluded that the prescriptions were not
issued for a legitimate medical purpose. Tr. 76. As the Supreme Court
has explained, one of the purposes of the prescription requirement is
to ensure that ``patients use controlled substances under the
supervision of a doctor so as to prevent addiction and recreational
abuse.'' 546 U.S. at 274. As Dr. Mironer's testimony establishes,
Respondent did not properly supervise F.M.'s use of controlled
substances, notwithstanding the evidence which suggests that he was
either diverting or taking excessive amounts of Dilaudid. I thus adopt
Dr. Mironer's conclusion that the prescriptions Respondent issued
lacked a legitimate medical purpose as required by federal law. 21 CFR
1306.04(a).
Similarly, while S.M.'s medical history indicated that he had
significant knee problems, it also established that he had abused
street drugs including marijuana and cocaine, which he took
intravenously. Moreover, at the second visit (which occurred twenty-
five days after his initial visit), S.M. had only one tablet left of
Oxycontin (out of the originally sixty tablets--a thirty day supply--
which had been prescribed to him), and told Respondent that he had used
Roxicodone (another schedule II drug) which he had obtained from a
third person. Respondent nonetheless issued him a new prescription for
Oxycontin and added a prescription for Roxicodone. As Dr. Mironer
observed, notwithstanding the information Respondent had obtained as to
S.M.'s history of drug abuse, he recommended no alternative treatment
modalities and made no plan to control S.M.'s use of medications. Tr.
84. Dr. Mironer again concluded that Respondent's prescribing to S.M.
lacked a legitimate medical purpose. Id. So do I.
Finally, with respect to C.H., Dr. Mironer did not take issue with
Respondent's physical examination or his diagnosis of pain. Dr. Mironer
did, however, note that Respondent had prescribed methadone to C.H.,
and used the same dosing regime (a large dose once a day) which the
drug treatment clinic had used and which is used to treat addiction.
Id. at 81, 50. Dr. Mironer's testimony established that
[[Page 17543]]
Respondent's prescribing to C.H. was fundamentally dangerous because
the analgesic effect of methadone is only six to eight hours, the
proper dosing for pain involves much smaller amounts of the drug such
as five or ten milligrams which are taken three to four times a day,
and a patient may accumulate significant amounts of the drug and risk
respiratory depression and possibly death. Id. at 52.
Moreover, Dr. Mironer explained that when a patient has finished
treatment for addiction, a psychiatric or psychological evaluation is
required to ensure that the patient ``is a good candidate'' to treat
with chronic opioids, that if the patient has been successfully treated
for addiction he should no longer be on methadone, and if the patient
still requires methadone, he is still addicted and should be treated by
a methadone clinic. Id. at 81-82, 111.\32\ Dr. Mironer also observed
that the Physicians' Desk Reference advises against prescribing
methadone for pain. Id. at 83.
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\32\ Under federal law, a practitioner must meet extensive
requirements and be separately registered to lawfully dispense
narcotic drugs for maintenance or detoxification treatment. 21
U.S.C. 823(g).
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Furthermore, given that C.H. had been subjected to a drug screen
the day before his first visit with Respondent, and that the printout
of C.H.'s drug screen results stated that he ``is currently
medicating'' with 80 mg. of methadone, Respondent had ample reason to
question why it was necessary to prescribe to C.H. C.H.'s patient file
contains, however, no indication that Respondent contacted the
methadone clinic to determine whether C.H. was still being treated by,
and receiving methadone from, it. I therefore agree with Dr. Mironer
that Respondent's prescribing of methadone to C.H. lacked a legitimate
medical purpose.
As the forgoing demonstrates, Respondent repeatedly issued
controlled substance prescriptions without a legitimate medical purpose
and therefore violated the CSA's prescription requirement. See 21 CFR
1306.04(a). Moreover, substantial evidence supports the conclusion that
Respondent was knowingly diverting controlled substances.
For example, Respondent initially denied writing prescriptions for
B.J.P., his ``pod mate'' in the Greene County Jail, but then
acknowledged that he had done so when confronted with the prescription
he issued the day after his release from the jail. Moreover, the
statements of various persons to Investigators regarding their road
trips to see Respondent and the group sessions that occurred in his
living room were to some degree corroborated by progress notes and
prescription records indicating that the patients had seen Respondent
on the same date. Relatedly, in his testimony Respondent did not deny
that the group sessions occurred, but rather insisted that the patients
were ``on the couch and we're talking and I'm getting a history from
them and all.'' Tr. 292.
Furthermore, there was extensive evidence that nearly all of
Respondent's patients were driving from the Greeneville, Tennessee area
(a nine to ten-hour round trip), when they could have obtained
treatment much closer to home. It is absurd to suggest--as Respondent
does--that his patients were legitimate but could not obtain treatment
much closer to home. Finally, not only did H.R. and A.R., who were
married to each other, jointly visit Respondent; at each visit, they
received the exact same controlled substance prescriptions and did so
even when Respondent doubled the strength of the Oxycontin he was
prescribing.
In sum, Respondent's experience in dispensing controlled substances
and record of compliance with applicable laws is characterized by his
knowing diversion of controlled substances. I thus conclude that the
Government has made out its prima facie case that Respondent has
committed acts which render his registration ``inconsistent with the
public interest.'' 21 U.S.C. 824(a)(4).
Sanction
Under Agency precedent, where, as here, ``the Government has proved
that a registrant has committed acts inconsistent with the public
interest, a registrant must `present[] sufficient mitigating evidence
to assure the Administrator that [he] can be entrusted with the
responsibility carried by such a registration.''' Medicine Shoppe-
Jonesborough, 73 FR 363, 387 (2008) (quoting 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),
[DEA] has repeatedly held that where a registrant has committed acts
inconsistent with the public interest, the registrant must accept
responsibility for [his]s actions and demonstrate that [he] will not
engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also
Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006);
Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v.
DEA, 419 F.3d at 483 (``admitting fault'' is ``properly consider[ed]''
by DEA to be an ``important factor[]'' in the public interest
determination).
In her discussion of factor five, the ALJ specifically found that
Respondent had ``refus[ed] to acknowledge his wrongdoing,'' and that
there was ``little hope'' that ``he will act more responsibly in the
future.'' ALJ at 54. The ALJ thus ``conclude[d] that Respondent is
unwilling * * * to accept the responsibilities inherent in a DEA
registration,'' and recommended that his registration be revoked and
any pending applications be denied. Id. I agree.
On balance, Respondent's testimony does not establish that he has
accepted responsibility for his misconduct. For example, while it was
an ancillary issue in the proceeding, Respondent insisted that he had
done nothing to warrant the charge of resisting arrest even though he
was convicted by a jury of the charge. Moreover, he insisted that his
patients had lied when they told Investigators that he had not
performed physical exams on them or told them what their treatment plan
was. Indeed, with respect to the latter, he maintained that his
patients had lied notwithstanding that his records rarely listed any
plan other than to prescribe drugs and return in thirty days.
Furthermore, Respondent maintained that he could do a complete
physical examination ``in three or four minutes,'' and insisted that
``he always ask[ed] the basic questions'' needed to diagnose anxiety
and depression even though the progress notes repeatedly lacked the
findings necessary to support such a diagnosis. And while Respondent
initially acknowledged that he was ``probably at fault'' for not
examining his patients' arms for track marks indicative of current
intravenous drug abuse, when asked whether he should have done so when
a patient's medical records established a history of drug abuse, he
insisted that he ``makes [his] own decisions about patients that [he]
treat[s].'' Tr. 329.
As forgoing demonstrates, Respondent has not accepted
responsibility for his misconduct. Moreover, while Respondent produced
a letter from a physician, who had worked with him ``[f]or a short
period of time'' during the summer of 2008, which suggests that
Respondent has reformed his practices, it is significant that at the
time, Respondent was well aware that he was under investigation and had
ample incentive to behave. Finally, Respondent's misconduct was
egregious
[[Page 17544]]
and caused extraordinary harm to public health and safety.\33\
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\33\ According to the National Center on Addiction and Drug
Abuse, ``[t]he number of people who admit abusing controlled
prescription drugs increased from 7.8 million in 1992 to 15.1
million in 2003.'' National Center on Addiction and Substance Abuse,
Under the Counter: The Diversion and Abuse of Controlled
Prescription Drugs in the U.S. 3 (2005). The above figure is ``23
percent more than the combined number abusing cocaine (5.9 million),
hallucinogens (4.0 million), inhalants (2.1 million) and heroin
(328,000).'' Id. Moreover, ``between 1992 and 2003, there has been a
* * * 140.5 percent increase in the self-reported abuse of
prescription opioids,'' and during this period, the ``abuse of
controlled prescription drugs has been growing at a rate twice that
of marijuana abuse, five times greater than cocaine abuse and 60
times greater than heroin abuse.'' Id. at 4.
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I thus conclude that the revocation of Respondent's registration is
necessary to protect the public interest. For the same reasons that led
me to order the immediate suspension of his registration, I conclude
that 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), as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA
Certificate of Registration, AA1071947, issued to George C. Aycock,
M.D., be, and it hereby is, revoked. I further order that any pending
application to renew or modify the registration be, and it hereby is,
denied. This Order is effective immediately.
Dated: April 3, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-8624 Filed 4-14-09; 8:45 am]
BILLING CODE 4410-09-P