[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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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