George C. Aycock, M.D.; Revocation of Registration, 17529-17544 [E9-8624]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 74, Number 71 (Wednesday, April 15, 2009)]
[Notices]
[Pages 17529-17544]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8624]


-----------------------------------------------------------------------

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

    \1\ On July 10, 2008, the Government served the Show Cause Order 
on Respondent. ALJ Ex. 3.
---------------------------------------------------------------------------

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

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

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

    \3\ Respondent registration was issued to him at the address of 
295 Lakewood Drive, Sumter, South Carolina. GX 1, at 2.
---------------------------------------------------------------------------

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

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

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

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

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

    \8\ The record does not establish whether the prescriptions were 
mailed to M.C. or were provided to M.C.'s acquaintances.
---------------------------------------------------------------------------

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

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

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

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

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

    \11\ In this note, Respondent also indicated that S.M. had been 
in a motor vehicle accident when he fell asleep while driving. Id.
---------------------------------------------------------------------------

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

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

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

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

    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