Zvi H. Perper, M.D., Decision and Order, 64131-64142 [2012-25618]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 77, Number 202 (Thursday, October 18, 2012)]
[Notices]
[Pages 64131-64142]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25618]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 11-34]


Zvi H. Perper, M.D., Decision and Order

    On July 19, 2011, Administrative Law Judge (ALJ) Gail A. Randall 
issued the attached recommended decision. The Respondent did not file 
exceptions to the decision.
    Having reviewed the entire record, I have decided to adopt the 
ALJ's recommended rulings, findings of fact, conclusions of law, and 
recommended Order except for her legal conclusions as to the initial 
visits of the two undercover officers (UCs) and her discussion in the 
first full paragraph at page 34 of her slip opinion.\1\ However, I need 
not decide whether the prescriptions Respondent issued at the initial 
visits of the two UCs violated 21 CFR 1306.04(a), because there is 
substantial evidence to support the ALJ's legal conclusions that he 
acted outside of the usual course of professional practice and lacked a 
legitimate medical purpose in issuing prescriptions at the UCs' 
subsequent visits.
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    \1\ The ALJ noted that Respondent and his PA ``were given direct 
evidence of diversion and failed to act.'' Slip Op. at 34. More 
specifically, the ALJ noted that UC1 had told the PA that his 
girlfriend had used some of his controlled substances and that the 
PA did nothing in response and that UC2 had told both Respondent and 
his PA that he had bought controlled substances off the street and 
that neither Respondent nor his PA took any action. Id. The ALJ thus 
reasoned that ``[a] practitioner who takes no `precautions against * 
* * misuse and diversion' exceeds the bound of professional practice 
when he prescribes controlled substances[,]'' and that ``[s]uch 
action violates the standard of diligence expected of a DEA 
registrant.'' Id. (quoting United States v. Moore, 423 U.S. 122, 
142-43 (1975)).
     While purchasing drugs off the street may well be evidence that 
a patient is a substance abuser, the record contains no evidence 
establishing the appropriate course of professional practice when a 
practitioner is confronted with such information. Likewise, while 
UC1's statement to the PA that his girlfriend had gotten into his 
medication supports a finding that diversion is occurring, here 
again, the record contains no evidence establishing what precautions 
were required to be taken under the standard of professional 
practice. Thus, while I find this conduct extremely disturbing, I do 
not rely on it.
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    More specifically, one week after the initial visit of David Hays 
(UC1), at which he was prescribed 150 Percocet, a drug which combines 
10 mg of oxycodone with 325 mg of acetaminophen, Hays returned to 
Respondent complaining that the drug was causing digestive problems. 
Respondent then prescribed 150 Roxicodone (oxycodone) 30 mg, without 
any inquiry into Hays' pain level. Tr. 54, GX 3a, at 13. Respondent 
noted in the chart, however, that Hays ``had no relief [from] pain.'' 
GX 12, at 14.
    With respect to this prescription, the Government's Expert 
testified that the ``[m]edication would not have been indicated given 
the complaints of the patient, [and] certainly not that particular 
agent and certainly not that dose or frequency.'' Tr. 54. Notably, this

[[Page 64132]]

testimony was unrefuted. I thus conclude that Respondent acted outside 
of the usual course of professional practice and lacked a legitimate 
purpose in issuing the prescription and thus violated federal law. 21 
CFR 1306.04(a).
    Hays returned three weeks later (May 19, 2010) and saw Respondent's 
Physician Assistant (PA). While during the visit, the PA initially 
confused Hays with a patient whose name was spelled Hayes, upon 
recognizing his error he nonetheless noted that Hays was ``too early.'' 
GX 4, at 14. During the visit, Hays asked the PA if he could increase 
the Roxicodone 30 mg prescription because he was probably going to be 
gone for three or four months working on a tugboat. Id. at 23. The PA 
instead offered to give Hays ``the fifteen milligrams * * * strength.'' 
Id. at 25. Hays asked the PA if he ``[c]ould * * * increase the 
thirties * * * just to whatever is reasonable and add some fifteens,'' 
to which the PA answered: ``I have to ask.'' Id. The PA then told Hays 
To ``have a seat in the waiting room'' and ``[l]et me find out for 
you.'' Id. Notably, during this visit, Hays did not tell the PA that he 
was experiencing breakthrough pain.
    Approximately fifteen minutes later, the PA spoke with Hays and 
told him that Respondent ``was very generous'' but that the ``the 
deal'' was that Hays could not see the PA again until after the fourth 
of July. Id. at 31. The PA then told Hays that Respondent had given him 
210 Roxicodone 30 mg and 90 Roxicodone 15 mg. Id. at 32; GX 12, at 23 
(copies of prescriptions). On the prescription for the Roxicodone 15 
mg, Respondent noted that it was for ``breakthrough'' pain, even though 
Hays never complained of having breakthrough pain.\2\
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    \2\ Under Federal law, a practitioner may issue a patient 
``multiple prescriptions authorizing the patient to receive a total 
of up to a 90-day supply of a schedule II controlled substance'' 
provided, inter alia, that the prescriptions otherwise comply with 
21 CFR 1306.04(a) (as well as other provisions of the CSA and state 
law), the prescriptions include the earliest date on which they can 
be filled, and that they ``do not create an undue risk of diversion 
or abuse.'' 21 CFR 1306.12(b)(1).
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    While the progress note for this visit stated ``Earliest pt. can be 
seen until 7/5/10,'' id. at 20; on June 16, Hays returned and saw 
Respondent. GX 5, at 16. While Hays was nearly three weeks early, 
Respondent did not raise this as an issue, see id. at 16-19, even 
though according to the Government's Expert, this is a ``red flag'' 
indicative of ``[d]rug-seeking behavior'' and either abuse or 
diversion. Tr. 65, 67. Moreover, Hays told Respondent that he still had 
not been on the tugboat assignment--the purported reason for why he 
needed an increase in his prescriptions--and once again asked for an 
increase. GX 5, at 16-19.
    Respondent then noted that Hays' ``pain level is only a two over 
ten'' and that this was ``pretty good.'' Id. at 17. Respondent then 
asked Hays if he was ``having some breakthrough pain mostly at work.'' 
Id. Hays answered: ``Every now and then something feels * * * a little 
bit hey-wire back there,'' that it was ``mostly in the mornings,'' and 
that he would ``get all sore and stiff back there.'' Id. Respondent 
noted that at the last visit, Hays had been ``given a prescription for 
breakthrough pain'' and Hays was ``going kind of rapidly with [his] 
medicine.'' Id. Notwithstanding that Hays had reported his pain level 
as only a two and was nearly three weeks early, Respondent gave him a 
prescription for 210 tablets of Roxicodone 30 mg, a prescription for 90 
Roxicodone 15 mg for breakthrough pain, and a prescription for a liver 
function test, which Hays never obtained. GX 12, at 26.
    Hays returned on July 20 and saw the PA. Hays told the PA that he 
was doing ``pretty good'' and that his back had improved. GX 6, at 3-4. 
During the visit, Hays told the PA that his girlfriend had gotten into 
his medicine (which according to the Government's Expert was indicative 
of ``misuse and diversion,'' Tr. 65) and wanted to come to the clinic. 
GX 6, at 5. The PA told Hays that ``we could only see her with a valid 
reason * * * like an MRI report'' and ``not just because [the drugs] 
made her feel good.'' Id. at 6. The PA, however, then commented that 
``she got that subtle euphoria and of course she liked it. But if she 
doesn't have a true pain area * * * it's not appropriate.'' Id. The PA 
then explained that the laws had changed and that the clinic would 
never fill prescriptions again and that Hays would have to go to a 
pharmacy to fill the prescriptions and that the clinic was going to 
discuss with local pharmacies where they could ``at least direct 
patients to.'' Id. at 7.
    The PA then discussed giving Hays ``this new medicine called 
Dilaudid, which is a morphine derivative'' for his breakthrough pain. 
After discussing how Dilaudid (hydromorphone) was different from 
oxycodone, the PA and Hays resumed discussing where the latter could 
fill his prescriptions with the PA stating that because of the number 
of pills (210 Roxicodone), it was ``extremely hard to believe that 
[Hays would] be able to get'' the Oxycodone 30s from big chain drug 
stores such as CVS or Publix. Id. at 11. Hays then asked the PA to 
recommend a pharmacy which would fill the prescriptions; the PA told 
him he would give him a list and that the pills would cost four dollars 
each. Id. at 12. In response, Hays stated that he could not afford to 
fill 210 pills and asked if the PA could split his prescription; the PA 
agreed. Id. at 12-13. The PA stated that a lot of the small pharmacies 
were going to ``require a non-narcotic, non-controlled medicine to go 
with'' the narcotic prescriptions and that ``[t]hey wouldn't just take 
* * * the Roxicodone, Dilaudid script from'' him because there is ``a 
perception problem.'' Id. at 14-15. The PA then explained that he would 
give Hays a prescription for thirty Motrin to put in his ``back 
pocket'' which he could produce if the pharmacist questioned the 
prescriptions. Id. at 15. However, the PA told Hays to ``shred'' the 
script if the pharmacist did not question the prescriptions. Id.
    Later, the PA asked Hays if he was ``satisfactory in the sleep 
department and in the anxiety department?'' Id. at 18. Hays answered: 
``You know, I never have anxiety, really. And I sleep pretty good.'' 
Id. Following a discussion of a new state law prohibiting pain 
management clinics from dispensing and a proposal to establish a state 
prescription database, the PA left to have Respondent review and sign 
the prescriptions. Id. at 23. Respondent issued Hays two prescriptions 
totaling 210 tablets of Roxicodone 30 mg, as well as prescriptions for 
60 Dilaudid 4 mg and 30 Motrin.
    Hays returned on August 18 and again saw the PA. Notably, on the 
Patient Comfort Assessment form, Hays indicated that the worst his pain 
had been in the last month was a ``3'' on a ``0'' to ``10'' scale, that 
his pain had averaged a ``2'' during the last month, and that it was 
currently a ``1.'' GX 12, at 33. Hays also wrote that his pain ``was in 
my lower back but feels better now'' and circled that pain was 
``occasional'' and not ``continuous.''
    Hays told the PA that the Dilaudid made him ``kind of dizzy and 
nauseous'' and that he thought the oxycodone were ``good for'' him and 
asked if Respondent ever prescribed the 80s. GX 7, at 22-23. The PA 
stated that Respondent would ``start out a little slower[,] like the 
40's * * * but yes, we do, do the 80s.'' Id. at 23. Hays told the PA 
that he did not have any problems getting the thirties and that his 
``girlfriend knew [a] a place that has them * * * readily available.'' 
Id. The PA then asked Hays whether he had ``hand[ed] two split scripts 
in in one time''; Hays said ``No.'' Id. at 24. The PA then told 
Respondent that he had to get his liver function tested and told him 
where to get it and that it would cost $45. Id. at 24-25.

[[Page 64133]]

    Next, the PA asked Hays if his ``lower back [was] okay this 
month?'' Id. at 25. Hays answered: ``You know, I think it really feels 
pretty good.'' Id. The PA then asked: ``Do you even need a breakthrough 
* * * I mean * * * [y]ou're taking seven * * * a day, why don't you 
just stick with them?'' Id. Hays answered: ``well, there might be that 
occasion when I did need it but * * * I don't know.'' Id. at 26. The PA 
replied: ``I'll throw you a few Percocets then just to get on the safe 
side but the 15s are very hard to come by and they're very expensive.'' 
Id.
    Hays asked if the stuff Michael Jackson had taken would work; the 
PA stated that that drug was only indicated to ``put people out with 
and perform surgery.'' Id. at 27. Hays then asked ``if there is some 
other creative way that you could deal with me?'' Id. at 28. In 
response, the PA asked: ``Are you having trouble sleeping? Is [that] 
what you're getting at?'' Id. Hays answered ``I wonder * * * I do have 
trouble sleeping. I don't sleep much.'' Id. The PA then asked Hays if 
he had ``ever tried Valium?'' Id. After Hays answered that he had not, 
the PA asked if he would like to. Id. Hays replied ``You know I might, 
because there are times when I * * * and it could be because * * * I've 
got too much on my mind, with work and everything, and I wake up at 
night and then I just stay awake.'' Id. The PA then told Hays to ``try 
it one hour before you want it to work,'' but not to drive on it and 
not to take it every night.\3\ Id. at 29.
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    \3\ Under DEA precedent, a registrant is strictly liable for the 
misconduct of those employees that he has authorized to act on his 
behalf with respect to the registrant's handling of controlled 
substances. See Anthony L. Capelli, 59 FR 42288 (1994) (holding 
registrant strictly liable for unauthorized prescriptions issued 
under his registrant by unlicensed persons). See also Scott C. 
Bickman, 76 FR 17694, 17703 (2011); Harrell Robinson, 74 FR 61370, 
61377-78 2009, Paul Volkman, 73 FR 30630, 30644 n.42 (2008). While 
in this case the PA did not have authority to issue controlled 
substance prescriptions under Florida law, it is clear that 
Respondent authorized the PA to act on his behalf in evaluating his 
patients and relied on the PA's evaluation to issue controlled 
substances prescriptions. Accordingly, Respondent is strictly liable 
for issuing the prescriptions.
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    Hays and the PA returned to discussing his use of Dilaudid, with 
the PA stating that he was going to discontinue it. Id. at 30. The PA 
then asked Hays to move each leg up to his hand, and whether doing so 
bothered his back; Hays indicated that it did not. Id. at 31; see also 
GX 20 (audio recording of visit). The PA asked Hays if he needed the 
prescriptions split again; Hays answered that he did not. GX 7, at 31. 
The PA then said he was going to give Hays ``a couple [of] Percocet for 
the day'' for ``breakthrough'' pain and advised him to ``eat with 
them.'' Id. at 31-32. The PA added that ``hopefully the seven thirties 
a day will be enough pain relief for you and you don't need anything 
else'' and advised Hays to fill the Percocet prescription only if he 
needed it. Id. Following a discussion of doctor shopping, the PA went 
to Respondent to obtain his approval for the prescriptions. Id. at 39. 
Thereafter, Hays was provided with prescriptions for 210 Roxicodone 30 
mg, 60 Percocet 10/325mg, 30 Valium 10mg, and Motrin. GX 12, at 35.
    With respect to the Dilaudid prescription Respondent issued to 
Hays, the Government's Expert testified that there was no evidence that 
Hays was experiencing break-through pain ``of any significant degree.'' 
Tr. 60. The Expert further explained that ``[t]here was no history 
consistent with severe break-through pain and it appeared that [Hays'] 
pain was adequately--more than adequately managed, even based on the 
subjective history.'' Id. The Expert thus concluded that Dilaudid 
prescription was ``not justified.'' Id. This testimony stands 
unrefuted.
    I therefore conclude that substantial evidence supports the 
conclusion that Respondent acted outside of the usual course of 
professional practice and lacked a legitimate medical purpose in 
issuing the Dilaudid prescription to Hays. 21 CFR 1306.04(a). Moreover, 
for the same reasons that the Expert concluded that the Dilaudid 
prescription was not medically justified, I also conclude that 
Respondent acted outside of the usual course of professional practice 
and lacked a legitimate medical purpose in issuing the May 15 and June 
16 prescriptions for Roxicodone 15mg, as well as the August 18 
prescription for Percocet 10, all of which were purportedly issued for 
breakthrough pain.
    As for the Valium prescription, the Government's Expert observed 
that the progress note ``indicated that the patient had insomnia for 
the past month'' but that Respondent did not explain ``in his note why 
Valium [was] being added, although the prescription is to be taken one 
at bedtime only.'' Id. at 61. Continuing, the Expert testified that 
while he could ``hypothesize why [Valium] may have been chosen * * * 
there was nothing that would justify that dose * * * for this 
individual.'' Id.
    The Government's Expert further explained that before prescribing 
Valium for insomnia, ``[t]he first reasonably standard thing to do 
would be to ensure that the patient wasn't doing anything that may be 
promoting insomnia'' such as having ``caffeine at night or excessive 
meals right before bedtime.'' Id. at 62. Once this was addressed, the 
Expert stated that if ``medications were indicated there are [other] 
agents that are appropriate for insomnia, rather than a benzodiazepine 
like Valium, [which is available in 2, 5 and 10 mg tablets], at its 
highest dose.'' Id. at 63. Finally, the Expert noted that Valium's 
``primary purpose is not [to treat] insomnia.'' Id.
    Here too, the testimony of the Government's Expert was unrefuted. I 
therefore conclude that substantial evidence supports the conclusion 
that Respondent acted outside of the usual course of professional 
practice and lacked a legitimate medical purpose in issuing the Valium 
prescription to Hays. 21 CFR 1306.04(a).\4\
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    \4\ Noting that Hays had asked the PA ``if there is some other 
creative way that you could deal with me?'' and the PA's response 
that: ``Are you having trouble sleeping? Is [that] what you're 
getting at?,'' the ALJ reasoned that the circumstances surrounding 
the prescription ``nearly equate[] to outright drug dealing.'' ALJ 
at 31. I go one step further and conclude that it was an outright 
drug deal, noting not only unusual nature of Hays' statement, but 
also that Hays had denied a sleep problem just one month earlier, as 
well as the Expert's testimony that: (1) the PA's evaluation of 
Hays' sleep problem was inadequate, Tr. 62; (2) that there are other 
drugs which are indicated for insomnia and that Valium's ``primary 
purpose is not [to treat] insomnia''; and (3) that the prescribed 
dose was ``very high.'' Id. at 63.
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    As for the prescriptions issued to Eddie Martinez, the evidence 
showed that Respondent increased his prescription from 120 Percocet 10/
325 at the initial visit (for a total daily dose of 40 mg of oxycodone) 
to 90 Oxycodone 30 mg (for a total daily dose of 90 mg of oxycodone) at 
the second visit. GX 13, at 16, 20. The Government's Expert opined that 
Martinez's complained-of pain level did not justify a prescription for 
Roxicodone 30, which was more than double the dosing of the previous 
prescription, as ``[t]here wasn't any physical examination abnormality 
or focal neurological deficit * * * consistent with his MRI finding or 
even his complaints that * * * would have warranted those medications 
at that dose[].'' Tr. 85. This testimony was unrefuted.
    At the third visit, Martinez told Respondent that he had run out a 
week early and bought drugs on the street even though in Respondent's 
words ``[y]ou changed from Percocet to Oxycodone, that's a much 
stronger medicine than what you were using'' and ``there's a 
significant increase in the total amount of medicine you're getting 
daily.'' GX 11, at 20; see also id. at 22. At the visit, Respondent 
wrote Martinez

[[Page 64134]]

prescriptions for 90 Roxicodone 30 mg, as well as 60 Percocet 10 mg, 
the latter being for ``breakthrough pain.'' GX 13, at 24. Notably, on 
the Patient Comfort Assessment Guide for this visit, Martinez noted 
that at its worst, his pain was a ``5'' on a scale of 0 to 10, a 
decrease from the level of 7-8 which he reported the previous month. GX 
13, at 17, 21. Moreover, at no point did Martinez complain of having 
breakthrough pain. See GX 11, at 20-24.
    According to the Government's Expert, that Martinez said he had run 
out early and complained of unrelieved pain was not a legitimate 
medical justification for increasing the dosing of oxycodone because it 
was ``[n]ot based on the history, physical, and objective information 
available in this patient's file.'' Tr. 87. The Expert further opined 
that while it would be within the course of professional practice to 
prescribe analgesic medications ``if the clinical justification 
existed,'' Martinez's ``history and physical'' did not meet the 
criteria for prescribing. Id. at 90.
    Here again, this testimony was unrefuted. Accordingly, I hold that 
substantial evidence supports the conclusion that Respondent acted 
outside of the usual course of professional practice and lacked a 
legitimate medical purpose in issuing oxycodone prescriptions to 
Martinez at both his second and third visits. 21 CFR 1306.04(a). I thus 
conclude that Respondent violated Federal law in issuing numerous 
controlled substance prescriptions to both UCs.
    This finding provides reason alone to conclude that Respondent has 
committed acts which render his registration inconsistent with the 
public interest. See 21 U.S.C. 824(a)(4). However, this conclusion is 
buttressed by the ALJ's additional findings and legal conclusions, 
including those regarding the shortages of controlled substances 
ordered under Respondent's registration (nearly 24,000 dosage units of 
oxycodone 30 and 2,565 dosage of Endocet 10/325), his failure to take 
initial inventories after moving his practice, 21 CFR 1304.11, and his 
failure ``to provide any explanation for his conduct or any assurances 
regarding his future conduct.'' ALJ at 37. See also Medicine Shoppe-
Jonesborough, 73 FR 364, 387 (2008).\5\
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    \5\ As explained in Medicine Shoppe-Jonesborough, 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.''' 73 FR at 387 (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] 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).
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    Accordingly, I adopt the ALJ's recommended order that Respondent's 
registrations be revoked and any pending applications be denied. For 
the same reasons which led me to order the Immediate Suspension of 
Respondent's registrations, I conclude that the public interest 
requires that this Order be made effective immediately. See 21 CFR 
1316.67.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificates of 
Registration Nos. FP1312406, BP8477639, and BP3429835, issued to Zvi H. 
Perper, M.D., be, and they hereby are revoked. I further order that any 
pending applications of Zvi H. Perper, M.D., to renew or modify any of 
his registrations, be, and they hereby are denied. This Order is 
effective immediately.

    Dated: October 8, 2012.
Michele M. Leonhart,
Administrator.
Frank Mann, Esq., for the Government
Richard G. Lubin, Esq. & Anthony Vitale, Esq., for the Respondent

RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION 
OF THE ADMINISTRATIVE LAW JUDGE

I. PROCEDURAL BACKGROUND

    Gail A. Randall, Administrative Law Judge. The Administrator, 
Drug Enforcement Administration (``DEA'' or ``Government''), issued 
an Order to Show Cause and Immediate Suspension of Registration 
(``Order I'') dated February 18, 2011, proposing to revoke the DEA 
Certificate of Registration, Number FP1312406, of Zvi H. Perper, 
M.D., (``Respondent'' or ``Dr. Perper''), as a practitioner, 
pursuant to 21 U.S.C. Sec.  824(a)(4) (2006), and deny any pending 
applications for renewal or modification of such registration 
pursuant to 21 U.S.C. Sec.  823(f), because the continued 
registration of the Respondent would be inconsistent with the public 
interest, as that term is used in 21 U.S.C. Sec. Sec.  823(f) and 
824(a)(4). Order I also immediately suspended the registration 
pursuant to 21 U.S.C. Sec.  824(d), because the Respondent's 
continued registration constituted an imminent danger to the public 
health or safety. [Administrative Law Judge Exhibit (``ALJ Exh.'') 
1].
    The Administrator, Drug Enforcement Administration, issued a 
second Order to Show Cause and Immediate Suspension of Registration 
(``Order II'') dated March 4, 2011, proposing to revoke the DEA 
Certificates of Registration, Numbers BP7732349,\6\ BP7622764,\7\ 
BP7622752,\8\ BP3429835, and BP8477639, of Dr. Perper, as a 
practitioner, pursuant to 21 U.S.C. Sec.  824(a)(4) (2006), and deny 
any pending applications for renewal or modification of such 
registrations pursuant to 21 U.S.C. Sec.  823(f), because the 
continued registration of the Respondent would be inconsistent with 
the public interest, as that term is used in 21 U.S.C. Sec. Sec.  
823(f) and 824(a)(4). Order II also immediately suspended these 
registrations pursuant to 21 U.S.C. Sec.  824(d), because the 
Respondent's continued registration constituted an imminent danger 
to the public health or safety. [ALJ Exh. 3].
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    \6\ This registration expired by its own terms on March 31, 
2011, and the Respondent did not file an application to renew it. 
[Tr.293-94, 323; Govt. Exh. 1].
    \7\ This registration expired by its own terms on March 31, 
2011, and the Respondent did not file an application to renew it. 
[Tr. 297, 323-324; Govt. Exh. 1].
    \8\ This registration expired by its own terms on March 31, 
2011, and the Respondent did not file an application to renew it. 
[Tr. 297, 324; Govt. Exh. 1].
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    The Respondent was served with the Order II on March 7, 2011. 
[ALJ Exh. 2].
    The Orders asserted that the Respondent dispensed controlled 
substances to undercover law enforcement officers for other than a 
legitimate medical purpose and/or outside the usual course of 
professional practice. [ALJ Exh. 1]. Further, the Orders also 
alleged that Respondent's Physician's Assistant coached an 
undercover law enforcement person on how to procure large amounts of 
narcotics from pharmacies without ``arousing suspicions that the 
prescriptions were being issued for other than legitimate medical 
purposes.'' [ALJ Exh. 1 at 2].
    By letter dated March 15, 2011, the Respondent, through counsel, 
timely filed a request for a hearing in the above-captioned matter. 
[ALJ Exh. 4].
    At the Respondent's request, the hearing was held in St. Lucie, 
Florida, on May 18-19, 2011. [ALJ Exh. 6; Transcript (``Tr.'') 
Volume I-II]. At the hearing, Counsel for the DEA called witnesses 
to testify and introduced documentary evidence. The Respondent, 
through Counsel, elected not to present any evidence. [Tr. 346]. 
After the hearing, both Counsel submitted Proposed Findings of Fact, 
Conclusions of Law and Argument.

II. ISSUE

    The issue in this proceeding is whether or not the record as a 
whole establishes by a preponderance of the evidence that the Drug 
Enforcement Administration should revoke the DEA Certificate of 
Registrations, Numbers FP1312406, BP7732349, BP7622764, BP7622752, 
BP3429835, BP8477639, of Zvi H. Perper, M.D., (``Respondent''), as a 
practitioner, pursuant to 21 U.S.C. Sec.  824(a),

[[Page 64135]]

and deny any pending applications for renewal or modification of 
such registrations, pursuant to 21 U.S.C. Sec.  823(f), because his 
continued registrations would be inconsistent with the public 
interest, as that term is defined in 21 U.S.C. Sec.  823(f). [Tr. 8; 
ALJ Exh. 5].

III. FINDINGS OF FACT

    I find, by a preponderance of the evidence, the following facts:

A. Stipulated Facts

    The parties have jointly agreed to the following stipulated 
facts:
    1. Respondent is registered with DEA as a practitioner in 
Schedules II-V under DEA registration numbers FP1312406, BP7732349, 
BP7622764, BP7622752, BP3429835, and BP8477639 at the following 
locations, respectively: (1) Delray Pain Management, 102 N. Swinton 
Avenue, Delray Beach, Florida 33444; (2) Women's Center of Hyde 
Park, LLC, 502 S. Magnolia Avenue, Tampa, Florida 33606-2257; (3) 
1103 Lucerne Terrace, Orlando, Florida 32806; (4) 609 Virginia 
Drive, Orlando, Florida 32803; (5) 3025 Andrews Place, Boca Raton, 
Florida 33234; and (6) Ocala Womens Center, 108 NW Pine Avenue, 
Ocala, Florida 34475. [ALJ Exh. 5].
    2. DEA registration Nos. BP7732349, BP7622764, and BP7622752 
expire by their terms on March 31, 2011; DEA registration Nos. 
FP1312406 and BP8477639 expire by their terms on March 31, 2012; and 
DEA registration No. BP3429835 expires by its terms on March 31, 
2013. [Id.{.
    3. Respondent is currently licensed in the State of Florida as a 
Medical Doctor (Dispensing Practitioner), Lic. No. ME 65525, 
expiration date: 1/31/2013. [Id.].

B. Background Facts

    4. The Respondent works at Delray Pain Management (``clinic''). 
The clinic disqualified some patients because of the distance they 
had to travel to get to the clinic. [Tr.183].
    5. In 2009, the Respondent ordered 321,600 dosage units of 
oxycodone. [Tr. 318; Government Exhibit (``Govt. Exh.'') 14 at 3]. 
From January 1 to June 30 of 2010, the Respondent ordered 387,248 
dosage units of oxycodone. [Tr. 318-19; Govt. Exh. 14 at 4]. Based 
on these purchases, the Respondent ranked 22nd in the nation 
regarding practitioners purchasing oxycodone. [Tr. 319].
    6. The Respondent accepted cash for office visits and 
prescriptions. [Tr. 320-323; Govt. Exh. 34].
    7. The record does not contain any legal documents indicating 
the ownership of Delray Pain Management. Mr. Kent Murray appears to 
have been the owner of the pain clinic for some time, but the 
Respondent acted as either the general manager or also the owner of 
the clinic. [Tr. 326-329].
    8. The clinic requires a valid Florida identification for the 
patients seen there. [Tr. 332].
    9. The clinic also requires each patient to provide an MRI. [Tr. 
332-33]. The MRIs of Mr. Hays and Mr. Martinez were verified by an 
individual named Lynette or Lynn. [Tr. 334-35; Govt. Exh. 12 at 16; 
Govt. Exh. 13 at 12].
    10. Both undercover agents were required to take a urinalysis 
examination on their first visit. [Tr. 335].
    11. Each new patient at the clinic was required to give a 
medical history with an emphasis on their pain complaint. [Tr. 336]. 
The undercover agents, on their first visits, had a face-to-face 
meeting with the Respondent. [Tr. 336].

C. Dr. Rubenstein's Testimony

    12. Dr. Rubenstein, a medical doctor, is board certified in 
Physical Medicine in Rehabilitation, in Pain Medicine, and in 
Electrodiagnostic Medicine. [Tr. 20; Govt. Exh. 25 at 1]. Dr. 
Rubenstein has a private practice focused on his specialties, and he 
is licensed to practice medicine in Florida and Virginia. [Tr. 23]. 
Approximately 90 percent of his patients have some type of pain 
complaint. [Tr. 24].
    13. He also has two certificates, one as a Diplomate of the 
American Academy of Pain Management, and Board Certification through 
the American Board of Medical Specialties, with a sub-specialty in 
Pain Medicine. [Tr. 21]. He has been practicing pain medicine since 
1993. [Id.].
    14. Dr. Rubenstein holds four academic appointments and teaches 
pain medicine at each one. [Tr. 22].
    15. Dr. Rubenstein was qualified as an expert in pain management 
and pain medicine. [Tr. 24].
    16. Prior to rendering his opinion concerning the Respondent's 
prescribing of controlled substances, Dr. Rubenstein reviewed the 
medical records reporting the treatment of two individuals, David 
Hays \9\ and Eddie Martinez.\10\ Dr. Rubenstein also reviewed the 
transcripts of their visits with the Respondent. [Tr. 29-30, 34; 
Govt. Exhs. 12 and 13, 2-11].
---------------------------------------------------------------------------

    \9\ David Hays is the undercover name used by Special Agent Jack 
Lunsford. For consistency with the documentary exhibits, I will 
refer to this individual as Mr. Hayes. Since this investigation, SA 
Lunsford has retired from the DEA. [Tr. 118, 179, 308].
    \10\ Eddie Martinez is the undercover name used by Special Agent 
Eddie Brigantty. [Tr. 308].
---------------------------------------------------------------------------

D. Treatment of David Hays

    17. David Hays first visited the Respondent on April 21, 2010. 
[Govt. Exh. 12 at 5; Govt. Exh. 15]. On that date, Mr. Hays' chart 
\11\ notes a drug screen was taken with negative results for all 
tested substances, to include opiates. [Tr. 123-24; Govt. Exh. 12 at 
8]. At none of the other visits, after controlled substances were 
prescribed, did the Respondent require a urinalysis screen. [Govt. 
Exhs. 3-7, 9-11].
---------------------------------------------------------------------------

    \11\ The Respondent maintained a medical record for Mr. Hays. 
[Govt. Exh. 12].
---------------------------------------------------------------------------

    18. In his medical history forms, Mr. Hays reported taking over-
the-counter anti-inflammatories such as Advil or Motrin. [Govt. Exh. 
12 at 9-10]. From the medical history, Dr. Rubenstein concluded that 
he had not taken opiates in the past. [Tr. 40-41]. The urinalysis 
results corroborated this conclusion as to the immediate past. [Tr. 
96].
    19. The medical history form also indicated that Mr. Hays did 
not have a primary physician, and that his last physical examination 
was in August 1980. [Govt. Exh. 12 at 4].
    Mr. Hays also wrote that he had never taken opiates before. 
[Govt. Exh. 12 at 11].
    20. Mr. Hays also signed an agreement regarding his 
responsibilities in taking medications that may be prescribed 
(``Agreement''). The Agreement informed Mr. Hays of his agreement to 
random drug testing, to only receiving pain medications from the 
Respondent, to understanding that lost medications will not be 
refilled, and to keeping referral appointments should the Respondent 
make such a referral. The Agreement also defines actions Mr. Hays 
may take that would result in his being discharged from the 
practice. Such actions include selling or distributing prescribed 
medications, obtaining pain medication from a source other than ``my 
doctor,'' forging or altering a prescription, or failing to receive 
any therapeutic benefit from the pain medication. Mr. Hays and the 
Respondent signed this Agreement on April 21, 2010. [Tr. 41-42; 
Govt. Exh. 12 at 12].
    21. At the initial visit there was no evidence that Mr. Hays was 
doctor shopping. [Tr. 97].
    22. Mr. Hays' medical history also disclosed, in response to 
questions asked on the form, that his pain was sharp and had been 
with him for three years, and that his pain interfered with work, 
sleep, and daily activities. [Tr. 190-93; Govt. Exh. 12 at 10]. 
However, the form did not provide space for Mr. Hays to discuss the 
basis for his answers to these questions, and nowhere else in the 
medical record are these concerns addressed. [Tr. 42-43; Govt. Exh. 
12 at 10-11].
    23. When asked on the intake form if Mr. Hays had provided 
honest and valid medical records to the clinic, he answered ``Yes.'' 
[Tr. 193]. As for his treatment goals, Mr. Hays wrote that he wanted 
to ``work better''. [Tr. 193]. Mr. Hays also wrote and told the 
Respondent that the pain interfered with his self-esteem, his 
overall energy, and his ability to perform physical activities. [Tr. 
193-94, 198; Govt. Exh. 12 at 11]. Mr. Hays also told the Respondent 
that his back ``hurt.'' [Tr. 200]. However, none of these 
complaints, other than pain, was discussed with Mr. Hays. [Govt. 
Exh. 2].
    24. Mr. Hays' magnetic resonance imaging (``MRI'') report noted 
that there was ``L4/5 and L5/S1, small protrusions with annular 
bulge and no nerve effacement.'' [Tr. 44; Govt. Exh. 12 at 16]. Per 
Dr. Rubenstein, the MRI report, alone, does not justify prescribing 
of narcotics on April 21, 2010. [Tr. 46]. This MRI, ``in and of 
itself, (doesn't) define necessarily a pain generator, maybe a 
potential pain generator, that needs to be related to the patient's 
history and physical examination.'' [Tr. 46].
    25. Mr. Hays' basic complaint was low back stiffness, having 
never said pain during the physical examination. [Tr. 129, 189]. Low 
back pain is a diagnosis, however. [Tr. 47]. Mr. Hays explained that 
he restored BMW motorcycles, and his back was ``stiff and jammed up 
and all.'' [Govt. Exh. 2 at 22]. He agreed, however, that his pain 
had worsened over the last three years. [Govt. Exh. 2 at 23]. He 
managed his pain with over-the-counter

[[Page 64136]]

medications like Aleve. He denied currently taking any medications 
or having taken medications in the past year. [Govt. Exh. 2 at 23, 
27]. The Respondent then instructed Mr. Hays that he only gives 
prescriptions for one month and that Mr. Hays must only be seen by 
him. [Id. at 25].
    26. Next, the Respondent physically examined the patient. [See 
id. at 27]. The Respondent noted that Mr. Hays experienced ``no pain 
with straight leg raising bilaterally and normal motor and 
sensory.'' [Govt. Exh. 12 at 14]. Dr. Rubenstein opined that this 
would represent a limited neurologic exam for this patient. [Tr. 
47]. But the results were ``normal,'' and Dr. Rubenstein opined that 
he did not see ``what the justification is, then, to even treat 
(him) if the exam is normal.'' [Tr. 98].
    27. As part of the physical examination, the Respondent noted 
that there was a ``positive, moderate tenderness at L5/S1.'' [Tr. 
48]. In response to the question of whether his pain was in his 
lower back, Mr. Hays responded ``yes.'' [Tr. 203]. However, Dr. 
Rubenstein noted that Mr. Hays did not complain of pain or 
tenderness during the physical examination, and such a complaint 
would need to be made for the Respondent to make such a legitimate 
observation. [Tr. 49].
    28. The Respondent diagnosed Mr. Hays with ``chronic lumbar pain 
with bulge L4-5 and L5/S1 with protrusions. No radiculopathy.'' [Tr. 
48; Govt. Exh. 12 at 14]. During the visit, the Respondent discussed 
a back brace that Mr. Hays could use, and he even showed Mr. Hays 
how to wear the belt. [Tr. 204; Govt. Exh. 2 at 32-40].
    29. Mr. Hays paid $250.00 cash for an examination fee at this 
first visit. He was a ``walk-in patient'' without an appointment. 
[Tr. 121, 178].
    30. On April 21, 2010, the Respondent prescribed Percocet 10/325 
in a quantity of 150, to be taken every four to six hours. [Govt. 
Exh. 12 at 17]. Dr. Rubenstein opined that the ``doses and frequency 
of the medication were excessive. . . Percocet 10 milligrams would 
be excessive for an opioid na[iuml]ve patient . . . and that 
quantity of medication would be excessive given the patient's pain 
complaints and lack of any objective pathology on physical 
examination.'' [Tr. 52]. Although muscle spasm may be expected given 
this diagnosis, opiates are not often given as a result of this 
observation. [Tr. 55-56].
    31. Mr. Hays purchased 150 Percocet tablets and paid $195.00 
cash for them. [Tr. 130, 178].
    32. Mr. Hays next visited the Respondent, unscheduled, on April 
28, 2010. On that date the Respondent wrote in Mr. Hays' medical 
records that the patient had complained of severe stomach upset and 
that the Percocet did not relieve his pain. The Respondent then 
prescribed Roxycodone, 30 milligrams, 150 dosage units to be taken 
as needed for pain. [Tr. 52, 150; Govt. Exh. 12 at 14, 18].
    33. Yet Mr. Hays told the Respondent that the prior medication 
``doesn't seem to be having the total effect I expected. And another 
side thing it does is it, it's giving me some kinda like-digestive-
anxiety or something. I'm always feeling kinda unsettled.'' Later in 
the conversation, Mr. Hays stated that the medication ``[k]inda 
makes me not want to eat.'' [Govt. Exh. 3A at 11-12; see also Tr. 
312; Govt. Exh. 16 ]. When asked about the Flexeril, Mr. Hays 
responded that ``I don't know that it does anything at all.'' [Govt. 
Exh. 3A at 13]. He was not asked if the Percocet relieved his pain, 
and he did not comment about the Percocet and pain. [Tr. 145; Govt. 
Exh. 3A]. Yet Mr. Hays medical chart contained the statement that 
the prior prescription had provided ``no relief (from) pain.'' 
[Govt. Exh. 12 at 14. Mr. Hays denied making such a statement, and 
no such statement appears on the recording or in the transcript. 
[Tr. 145; see also Govt. Exh. 3A and 16A]. Dr. Perper did not ask 
Mr. Hays whether he still had pills from the earlier script for 
Percocet, nor did he instruct him what to do with those remaining 
pills, if they existed. [Govt. Exh. 3A at 12, 16].
    34. Dr. Rubenstein disagreed with this prescription, noting that 
the medication ``would have not been indicated given the complaints 
of the patient, certainly not that particular agent and certainly 
not that dose or frequency.'' [Tr. 54].
    35. Mr. Hays did not pay anything for this visit. [Tr. 178].
    36. On May 19, 2010, Mr. Hays visited with Mitchell Cohen, a 
physician's assistant at the Respondent's clinic. [Tr. 151, 312; 
Govt. Exh. 17 and 17A]. Mr. Hays reported that his pain was between 
zero to five on a ten point scale, and it was completely alleviated 
by taking the prescribed medication of six Roxycodone 30 milligram 
tablets per day. [Tr. 56; Govt. Exh. 12 at 21-22]. Mr. Hays rated 
his average pain as a ``2'' for the prior month, and rated his 
current pain level as ``no pain''. [Tr. 152; Govt. Exh. 12 at 22]. 
He also wrote ``was in lower back; gone now.'' [Id.]. Mr. Hays told 
Mr. Cohen that his lower back was ``no problem at all'' and denied 
having any side effects from the medication. [Govt. Exhs. 4 at 18, 
17A]. He did state, however, that his symptoms ``might come back if 
(he) didn't have medication.'' [Govt. Exh. 4 at 19; Govt. Exh. 17A].
    37. Mr. Cohen performed a cursory physical examination, asking 
him to raise and lower his legs, declaring that Mr. Hays' back felt 
``a little tight'' but not ``horribly bad.'' [Govt. Exh. 4 at 21; 
Govt. Exh. 17A]. During this examination, Mr. Hays expressed no pain 
or discomfort. He also denied any anxiety or sleep problems. [Govt. 
Exh. 17A]. Here, Mr. Cohen asked about Mr. Hays'earlier prescription 
for Percocet, which Mr. Hays stated he still had. Mr. Cohen then 
instructed him to flush those pills and not to give them to anyone. 
[Govt. Exh. 4 at 22].
    38. Mr. Hays requested a larger amount of pain medication, 
because he was joining a tugboat crew and would be gone for three 
months. [Tr. 156; Govt. Exh. 17A]. Mr. Cohen refused to approve this 
request and advised Mr. Hays to ``stretch out'' his medication by 
breaking it in half and ``tak(ing) some Advil in between.'' [Govt. 
Exhs. 4 at 24, 17A]. Mr. Cohen then offered to give Mr. Hays some 15 
mg. strength oxycodone tablets instead of increasing the number of 
30 mg. strength tablets prescribed to Mr. Hays. Mr. Hays again 
requested a greater quantity of Roxicodone (30 mg pills) as well as 
the 15 mg. oxycodone pills. [Govt. Exh. 4 at 24; Govt. Exh. 17A]. 
Mr. Cohen agreed to speak to the Respondent, whom Mr. Cohen later 
stated had been ``very generous'' in his prescribing to Mr. Hays. 
[Govt. Exh. 4 at 31-32; Govt. Exh. 12 at 23; Govt. Exh. 17A]. 
Ultimately, the Respondent added a prescription for 15 mg. strength 
oxycodone to Mr. Hays' 30 mg. prescription. [Govt. Exh. 12 at 20].
    39. On this date, Mr. Hays received two prescriptions signed by 
the Respondent; one for Roxycodone 30 mg, 210 tablets, and one for 
Roxycodone 15 mg., 90 tablets. [Tr. 164; Govt. Exh. 12 at 23]. Mr. 
Cohen told Mr. Hays not to return to the clinic until after July 4. 
[Tr. 157; Govt. Exh. 4 at 31].
    40. Mr. Hays paid $175.00 for this visit and $510.00 for the 
medication. [Tr. 178].
    41. On June 16, 2010, Mr. Hays reported, and the Respondent 
acknowledged that Mr. Hays' lower back pain ranged from zero to four 
out of ten, with an average pain level of two, and a current pain 
level of one. [Tr. 58; Govt. Exh. 12 at 24, Govt. Exh. 5]. Mr. Hays 
circled on his intake form that his pain was ``gnawing'' and 
``nagging.'' [Tr. 209; Govt. Exh. 12 at 24].
    42. There was no discussion about Mr. Hays returning to the 
clinic before July 4. [Tr. 165].
    43. During this visit, the Respondent again remarked that he was 
due to set out on a three month tug boat excursion, and asked for 
additional pills to tide him over. The Respondent noted that Mr. 
Hays was going through his medication rather quickly. [Govt. Exh. 5 
at 17]. The Respondent asked Mr. Hays whether his break-through pain 
was mostly with work. Mr. Hays had not complained of break-through 
pain, however. [Tr. 166; Govt. Exh. 5 at 17]. Yet, at this visit he 
received a prescription for 210 Roxycodone 30 mg and 90 Roxycodone 
15 mg., with ``break through pain'' written on the bottom. [Govt. 
Exh. 12 at 26].
    44. Mr. Hays was prescribed a liver function test. [Tr. 210; 
Govt. Exh. 12 at 26]. However, Mr. Hays did not get such a test. 
[Tr. 210].
    45. Mr. Hays paid $175.00 for this visit and $638.00 for his 
medication. [Tr. 178].
    46. On July 20, 2010, Mr. Hays returned to the clinic. [Tr. 169; 
Govt. Exh. 6]. He met with Mitchell Cohen on that date. [Tr. 170]. 
Mr. Hays reported that his lower back pain ranged from zero to three 
out of ten, with complete relief after taking seven oxycodone \12\ 
30 milligram tablets and three oxycodone 15 milligram tablets per 
day. [Tr. 57; Govt. Exh. 12 at 29-30]. When asked if his lower back 
had improved with the medicine, Mr. Hays said that he thought it had 
improved. [Govt. Exh. 6 at 4].
---------------------------------------------------------------------------

    \12\ Roxycodone is a medication containing oxycodone. [Tr. 83].
---------------------------------------------------------------------------

    47. On this date, the Respondent \13\ prescribed Dilaudid four 
milligrams, 60 tablets to be taken one, twice daily, as needed for 
breakthrough pain. [Tr. 59; Govt. Exh. 12

[[Page 64137]]

at 31]. He also signed two prescriptions \14\ for Roxycodone 30 mg., 
one for 120 tablets and one for 90 tablets. [Govt. Exh. 12 at 31]. 
However, after reviewing the medical records for this date, there 
was no evidence that Mr. Hays was experiencing any breakthrough 
pain. [Tr. 60].
---------------------------------------------------------------------------

    \13\ Although Mr. Cohen saw Mr. Hays, the prescriptions bore the 
Respondent's signature. [Govt. Exh. 12 at 3].
    \14\ Instead of writing one prescription for 210 Roxicodone 
tablets, the prescriptions were divided into two separate 
prescriptions, one for 120 tablets and one for 90 tablets. Mr. Cohen 
advised Mr. Hays to hand in one of the prescriptions, then ``wait a 
couple of days or a week and go hand in the other one.'' [Govt. Exh. 
6 at 13; Govt. Exh. 19 and 19A]. In this way Mr. Cohen advised Mr. 
Hays in how to avoid arousing suspicion when presenting his 
prescriptions to a pharmacy. Further, Mr. Cohen gave Mr. Hays a 
prescription for ibuprofen, saying that by providing a prescription 
for a non-controlled substance, he could waylay such suspicion, if 
needed. If the ibuprofen prescription was not needed in this way, 
Mr. Hays was to shred the prescription. [Govt. Exh. 6 at 15].
---------------------------------------------------------------------------

    48. This shift of medication to Dilaudid was not justified 
according to Dr. Rubenstein. [Tr. 60]. Further, Dr. Rubenstein noted 
that no neurological musculoskeletal exam had been performed, and 
that Mr. Hays had violated his pain contract by allowing his 
girlfriend to share his medications. [Tr. 39-41; Govt. Exh. 12 at 
12]. Dr. Rubenstein agreed that sharing medication with a girlfriend 
would be a violation of the Agreement. [Tr. 42]. In reviewing Mr. 
Hays' medical chart, Dr. Rubenstein found that ``drug-seeking 
behavior is suspected.'' [Tr. 95].
    49. On this date, Mr. Hays told Mr. Cohen that his girlfriend 
``got into [his] medication'' and ``liked it.'' [Tr. 170-71; Govt. 
Exh. 6 at 5; Govt. Exh. 19 and 19A]. Next, Mr. Hays said that his 
girlfriend wanted to come to the Respondent's clinic, but he was 
unsure whether she had a ``valid reason'' for requesting medication. 
[Govt. Exh. 6 at 5-6]. Mr. Hays also admitted that his own 
medication made him euphoric. [Govt. Exh. 6 at 6]. Mr. Cohen took no 
action in response to these comments except to tell Mr. Hays that 
the Respondent would not see his girlfriend unless she had a ``valid 
reason.'' [Govt. Exh. 6 at 6]. Mr. Cohen further stated that if Mr. 
Hays' girlfriend ``has a legitimate area of pain'' that is ``proven 
with an objective test . . . like an MRI, then no problem.'' [Govt. 
Exh. 6 at 6-7]. Mr. Cohen made no response to the news that Mr. 
Hays' girlfriend had gotten into his medication or that Mr. Hays 
experienced euphoria from his controlled substances. [Id.]. During 
this visit, Mr. Cohen also had a long conversation with Mr. Hays 
about the price of medication and where to have his prescriptions 
filled. Mr. Cohen advised Mr. Hays that ``at this level,'' he should 
not go to large chain pharmacies and that the clinic would provide 
him with a list of places to go. [Govt. Exh. 6 at 7-14]. Mr. Cohen 
then indicated that he would give him a script for Motrin, even 
though he already had two refills, because otherwise the script for 
controlled substances would not be filled by the pharmacy. [Govt. 
Exh. 6 at 14-15]. Then Mr. Cohen asked Mr. Hays how he would like 
his ``pills split.'' [Govt. Exh. 6 at 16].
    50. Mr. Hays spent $200.00 cash for this visit. [Tr. 178].
    51. On August 18, 2010, Mr. Hays returned to the clinic and met 
with Mitchell Cohen. [Tr. 174-75; Govt. Exh. 7; see also Tr. 314; 
Govt. Exh. 20]. Mr. Hays spent $200.00 for this visit. [Tr. 178].
    52. Mr. Hays reported that his back pain ``feels better now,'' 
with a pain level from zero to three out of ten, averaging two, and 
a present rating of one. [Tr. 59; Govt. Exh. 12 at 33-34]. Further, 
during a physical exam where Mr. Cohen told Mr. Hays to move his 
legs up against Mr. Cohen's hand, Mr. Hays indicated that neither 
action caused him any discomfort or pain. [Govt. Exh. 7 at 30-31; 
Govt. Exh. 20]. He told Mr. Cohen that his girlfriend knew of a 
place for him to get prescriptions filled.
    53. On this date, Mr. Hays asked Mr. Cohen whether there was 
some other ``creative way that he could deal with him.'' [Govt. Exh. 
7 at 28]. To this Mr. Cohen responded, ``Are you having trouble 
sleeping? Is that what you're getting at?'' [Id.]. Mr. Hays replied, 
``ummm[hellip].you know. I wonder . . . I do have trouble sleeping. 
I don't sleep much . . .'' [Id.]. Mr Cohen then asked if Mr. Hays 
had ever tried Valium and if he'd like to this month. [Id.]. The 
Respondent prescribed Roxycodone 30 mg, 210 tablets, Percocet 10 
mg., 60 tablets for break-through pain, and Valium 10 mg., 30 
tablets. [Tr. 177; Govt. Exh. 12 at 35]. Although the treatment note 
documented Mr. Hays' insomnia and noted that he was to take one 
Valium at bedtime only, Dr. Rubenstein opined that ``there was 
nothing that would justify that dose . . . for this individual.'' 
[Tr. 61-62; see also Govt. Exh. 7 at 28]. Rather, Dr. Rubenstein 
stated that the ``first reasonably standard thing to do would be to 
ensure that the patient wasn't doing anything or taking anything 
that may be promoting insomnia . . .'' [Tr. 62]. Dr. Rubenstein 
objected to the fact that the Respondent prescribed Valium at the 
highest available dose, which would be a very high dose, and ``its 
primary purpose is not for insomnia.'' [Tr. 63].
    54. The Respondent had told Mr. Hays to obtain a liver function 
test, yet the medical records fail to indicate that such a test was 
taken. [Tr. 68]. Mr. Cohen also emphasized at this visit that the 
Respondent should get the test, and he told the Respondent where he 
could go and the cost of the test. [ Govt. Exh. 7 at 24-25]. Dr. 
Rubenstein opined that he would be concerned about Mr. Hays' lack of 
compliance with the test recommendation, as well as being concerned 
about the possible liver toxicity that results from the medications 
being prescribed to Mr. Hays. [Tr. 68, 102-03].
    55. Mr. Hays also told Mr. Cohen that he was not experiencing 
any side effects from the medication and that he felt ``real good'' 
now and was able to work better. [Tr. 212].
    56. Dr. Rubenstein ultimately opined that, after reviewing the 
transcripts of the visits, the medical records, and the recording of 
the first visit, he did not believe the prescribing of controlled 
substances was within the acceptable standard of care, given the 
quantities and frequency of such prescriptions. [Tr. 68-69]. There 
was also a problem with patient safety because of the large dose of 
controlled substances prescribed at the initial visit. [Tr. 52, 69]. 
He also opined that the prescribing of controlled substances to Mr. 
Hays was not based on sound clinical grounds. [Tr. 69]. Dr. 
Rubenstein would not consider the prescribing appropriate, given 
``the history and physical examination and objective information.'' 
[Tr. 69-70]. Thus, this prescribing of these controlled substances 
was outside the usual course of professional practice and without a 
legitimate medical purpose. [Tr. 70].
    57. Further, Dr. Rubenstein did not find any evidence that the 
Respondent discussed the risk and benefits of the use of controlled 
substances with Mr. Hays. [Tr. 70].
    58. Lastly, Dr. Rubenstein identified numerous ``red flags'' 
indicating potential diversion and/or abuse of controlled 
substances. [Tr. 65]. The Respondent seemed to ignore these red 
flags, for there was no reaction to Mr. Hays' constant requests for 
more narcotic medication or his sharing of medication with a 
girlfriend. [Tr. 65; see also Govt. Exhs. 3A at 7]. Also, no mention 
was made of Mr. Hays' visit before July 5, 2010. [Tr. 68].

E. Treatment of Eddie Martinez \15\
---------------------------------------------------------------------------

    \15\ Eddie Martinez is the undercover name of Special Agent Ed 
Brigantty. [Tr. 218, 221 308].
---------------------------------------------------------------------------

    59. Mr. Martinez was first treated by the Respondent on June 10, 
2010. He did not have an appointment. [Tr. 73, 226; Govt. Exh. 13; 
see also Tr. 314; Govt. Exh. 21 and 21A]. Digital audio and video 
recordings were made of the visit. [Govt. Exh. 21 and 21A]. A 
transcript of the audio recording was also made. [Govt. Exh. 8].
    60. On the intake documentation,\16\ Mr. Martinez answered 
``yes'' to several of the questions asked in reference to his pain 
information. [Govt. Exh. 13 at 4]. However, the form did not provide 
space for Mr. Martinez to discuss his ``yes'' answers, and nothing 
in the medical record indicates that the Respondent discussed these 
questions with Mr. Martinez. [Tr. 73; Govt. Exh. 13]. The Respondent 
did not discuss the lack of information in Mr. Martinez 
documentation, for he did not list an emergency contact or a 
previous doctor. [Govt. Exh. 13 at 1]. When asked to note how long 
he had been on opiates, Mr. Martinez left that question blank. He 
also left blank the questions asking if he had taken a list of 
controlled substances. [Govt. Exh. 13 at 4]. He never described the 
duration of his pain or whether it was constant. [Govt. Exh. 13 at 
2]. On the intake documents, Mr. Martinez denied taking Motrin, 
Advil, Aleve, or Naproxyn [Govt. Exh. 13 at 4], but then told the 
Respondent that he had tried taking at least some of those drugs. 
[Govt. Exh. 8 at 13-14]. Mr. Martinez even admitted that over-the-
counter medications provided ``temporary'' relief. [Tr. 228; Govt. 
Exh. 13 at 14].
---------------------------------------------------------------------------

    \16\ The Respondent maintained a medical record for Mr. 
Martinez. [Govt. Exh. 13].
---------------------------------------------------------------------------

    61. Yet the Respondent did enter into a physician-patient 
relationship with Mr. Martinez. [Tr. 92]. He had a face-to-face 
meeting with Mr. Martinez, and he kept medical records and evidence 
of the prescriptions he wrote to Mr. Martinez. [Tr. 92; Govt. Exh. 
13].

[[Page 64138]]

    62. Mr. Martinez told the Respondent that he had pain in his leg 
and his back, and that the pain is worse in the morning. [Tr. 259]. 
On the pain assessment form, Mr. Martinez had circled his neck and 
upper spine as the locations for his pain. [Tr. 229-30, 259; Govt. 
Exh. 13 at 4]. Mr. Martinez told the Respondent that when he would 
lay down flat on a hard surface, that helped his pain. [Tr. 259].
    63. Mr. Martinez signed a pain management agreement. [Govt. Exh. 
13 at 5]. Mr. Martinez agreed not to obtain pain medications from 
any other sources other than the Respondent. [Tr. 74]. Dr. 
Rubenstein agreed that, if a patient stated that he had purchased 
illegally pain medications on the street, the patient would have 
violated this provision of the pain agreement. [Id.].
    64. Mr. Martinez's urinalysis report was negative for all 
substances tested, to include opiates. [Tr. 96; Govt. Exh. 13 at 6]. 
After controlled substances were prescribed, at follow-up visits, 
the Respondent did not require any other urinalysis tests. [Tr. 112, 
231, 249].
    65. Mr. Martinez told the Respondent that his pain started ten 
years ago and ``slowly and surely got worse.'' [Govt. Exh. 8 at 11]. 
The Respondent asked him about his work, his other medications, and 
symptoms, and whether he saw any other physicians. [Id. at 12-14]. 
The Respondent conducted a physical examination of Mr. Martinez, 
which consisted of his raising his arm and leg and the Respondent 
asking if it hurt in various places on his body. [Tr. 227]. At no 
time did Mr. Martinez indicate he was experiencing any significant 
pain. [Govt. Exh. 8 at 16-17; see also Govt. Exhs. 21 and 21A]. Yet, 
compared to his MRI, Mr. Martinez's statements were contradictory. 
Though he circled areas on a diagram that corresponded to his center 
back and neck, he told the Respondent he was feeling pain ``[m]ore 
on my left.'' [Govt. Exh. 8 at 15; Govt. Exh. 13 at 4]. In the 
written documentation, Mr. Martinez had denied any ``lower back 
problems.'' [Govt. Exh. 13 at 2]. The Respondent did not address 
these inconsistencies.
    66. The radiologist, interpreting an MRI of Mr. Martinez dated 
May 27, 2010, found a disc bulge at L3-4 which approached the canal 
where the nerve leaves at that level, but there was no evidence that 
the spinal cord was encroached. [Tr. 75; Govt. Exh. 13 at 12]. The 
radiologist also noted that at L4-5, there was a disc bulge that 
touched the front of the region where the spinal cord sat. The disc 
bulge ``was narrowing the canals where the nerves would leave on 
either side between the fourth and fifth vertebrae of the lumbar 
spine.'' [Tr. 75-76]. Also, at L5/S1 there were similar findings of 
enchroachment on both sides. [Tr. 76]. Dr. Rubenstein credibly 
opined that an MRI, alone, does not justify the prescribing of 
controlled substances. [Tr. 76]. However, these MRI results could 
lead a doctor to believe that ``there were some significant changes 
in the lower back that could be a pain generator.'' [Tr. 104]. Dr. 
Rubenstein also found a significant disconnect between Mr. 
Martinez's complaints and the actual diagnosis. Dr. Rubenstein found 
that Mr. Martinez's complaints of pain in his middle back and neck 
were not consistent with the MRI. [Tr. 77].
    67. The Respondent made a diagnosis of Mr. Martinez, finding 
``chronic lumbar pain with stenosis, and in parentheses, spasm, 
multiple bulges with spondylosis with neural foraminal 
enchroachment, which is the NFE, canal stenosis and lumbosacral 
stenosis, which is the LSS. No radicular pain.'' [Tr. 77; Govt. Exh. 
13 at 15]. Yet Dr. Rubenstein opined that this is a radiologic 
diagnosis based on the MRI, not on the complaint of Mr. Martinez, 
for he complained of pain in his cervical and thoracic region, not 
the lumbar region. [Tr. 77-78, 106; Govt. Exh. 13 at 4]. Such an 
inconsistency raised a ``pink'' flag for Dr. Rubenstein. [Tr. 79]. 
Neither the medical record nor the transcript of the patient visit 
contain evidence that the Respondent explored this inconsistency 
with Mr. Martinez. [Tr. 79; Govt. Exhs. 13, 8]. Dr. Rubenstein 
pointed out that the Respondent seemed only to treat the pathology 
included in the MRI, while ignoring the fact that Mr. Martinez had 
identified pain in his middle back and neck. [Tr. 106-07; Govt. Exh. 
13 at 4].
    68. Mr. Martinez had indicated on his intake forms that he had 
only taken over-the-counter medications and that they provided 
temporary relief. [Tr. 79, 228; Govt. Exhs. 8 at 13-14, 13 at 4]. He 
also told the Respondent that he had taken some ``blues'' \17\ and 
that he had purchased them from someone that he knew had them. [Tr. 
228; Govt. Exh. 8 at 12-13; Govt. Exh. 21 and 21A].
---------------------------------------------------------------------------

    \17\ ``Blues'' are street slang for Roxicodone which contains 
oxycodone. [See Tr. 75].
---------------------------------------------------------------------------

    69. However, the Respondent prescribed controlled substances to 
Mr. Martinez on his first visit, Percocet 10mg, 120 tablets, 
totaling 1200 mg of oxycodone. [Tr. 81; Govt. Exh. 13 at 15-16]. Dr. 
Rubenstein thought such prescribing would not be appropriate. [Tr. 
80]. Specifically, he credibly testified that ``I think the 
prescription was excessive and not warranted based on the history 
and physical examination presented.'' [Tr. 81].
    70. Mr. Martinez paid $250.00 in cash for this visit and $156.00 
for his medication. [Tr. 226, 232-33]. There was no explanation of 
his diagnosis and no discussion about physical therapy or any other 
modalities. [Govt. Exh. 8].
    71. Next, Mr. Martinez saw Mr. Cohen on June 17, 2010. [Tr. 314; 
Govt. Exhs. 9, 22, 22A]. Mr. Martinez told Mr. Cohen that the 
medication did not agree with him and that he wanted a different 
prescription. [Tr. 233-34]. Mr. Cohen refused to prescribe another 
medication. He offered to give Mr. Martinez a shot of pain 
medication, but he refused the offer. [Tr. 234-35]. In answer to a 
question concerning how he had managed his pain prior to coming to 
the clinic, Mr. Martinez told Mr. Cohen that he bought ``stuff'' off 
the street. [Tr. 235-36]. Mr. Cohen advised Mr. Martinez that he 
would have to ``go back to'' purchasing controlled substances on the 
street. [Tr. 236; Govt. Exh. 9 at 4-5]. He insisted that Dr. Perper 
would not change a prescsription for a patient who came back a week 
later. [Govt. Exh. 9 at 3].\18\
---------------------------------------------------------------------------

    \18\ Although this is inconsistent with Dr. Perper's treatment 
of David Hays. [See FOF 30-33].
---------------------------------------------------------------------------

    72. Next, the Respondent treated Mr. Martinez on July 28, 2010. 
[Tr. 82, 238, 314; Govt. Exh. 13 at 19, Govt. Exhs. 10, 23]. Again, 
Mr. Martinez told the Respondent that he had gotten meds off of the 
street. [Govt. Exh. 10 at 13]. The Respondent prescribed Roxicodone 
30 mg, 90 tablets, a total of 2700 mg of oxycodone. [Tr. 82; Govt. 
Exh. 13 at 19-20]. This prescription was an increase in the dosage 
strength of the oxycodone prescribed at the initial visit. [Tr. 83-
84]. Again, Dr. Rubenstein found that such prescribing was not 
warranted, given the lack of any physical examination noting an 
abnormality ``or focal neurologic deficit to be consistent with his 
MRI finding or even his complaints.'' [Tr. 85]. Dr. Rubenstein would 
have expected the Respondent to `re-examine strengths, sensation and 
reflexes; or at a minimum strength and reflexes at subsequent visits 
with those types of complaints. And gait would be something I would 
expect him to assess, too, at least to a degree.'' [Tr. 114]. Yet 
the medical record fails to indicate that any of these tests were 
performed at subsequent visits. [Govt. Exh. 13].
    73. Lastly, the Respondent saw Mr. Martinez on August 25, 2010. 
[Tr. 85, 314; Govt. Exhs. 13 at 23-24, Govt. Exhs. 11, 24, 24A]. 
Again, the Respondent increased the amount of oxycodone given to Mr. 
Martinez by prescribing Percocet 10mg, 60 tablets for break-through 
pain, Roxycodone, also an oxycodone containing medication, 30mg, 90 
tablets, with a total of 3300 mg of oxycodone. [Tr. 85-86; Govt. 
Exh. 13 at 24]. The only justification given for increasing the 
dosage was that Mr. Martinez ran out of his medication early, had 
purchased controlled substances illegally,\19\ and was still 
complaining of unrelieved pain. [Tr. 86; Govt. Exh. 11 at 20-21; 
Govt. Exh. 13 at 23]. The Respondent was clearly suspicious of Mr. 
Martinez, for when Mr. Martinez attempted to argue that the 
Respondent had decreased his medications, the Respondent urged him 
to ``do the math.'' [Govt. Exh. 11 at 21]. Yet, in response to Mr. 
Martinez's statement that he had to get more, the Respondent issued 
him another prescription for Percocet, the same medication that Mr. 
Martinez had told Mr. Cohen had made him ill. [Govt. Exh. 11 at 22; 
Govt. Exhs. 24 and 24A; Govt. Exh. 9 at 3-4].
---------------------------------------------------------------------------

    \19\ The Respondent made no comment regarding this break of the 
pain management agreement. [Tr. 245-46].
---------------------------------------------------------------------------

    74. Dr. Rubenstein opined that ``[j]ust simply his complaint of 
pain without a physical exam that would correlate with the need for 
same, wouldn't be a reason to titrate the medications.'' [Tr. 86]. 
Dr. Rubenstein concluded that, based on the history, physical, and 
objective information available in Mr. Martinez's file, the increase 
in medication was not a legitimate medical justification. [Tr. 86-
87].
    75. Dr. Rubenstein did not believe that the Respondent's 
prescribing of controlled substances to Mr. Martinez was within the 
acceptable standard of care. [Tr. 87]. The

[[Page 64139]]

Respondent's prescribing demonstrated a lack of reasonable safety 
given Mr. Martinez's complaints. [Tr. 87-88].
    76. Further, Mr. Martinez had also told the Respondent that he 
had purchased controlled substances on the street. [Tr. 88-89, 245-
46; Govt. Exh. 11 at 20]. Per Dr. Rubenstein, the Respondent's 
prescribing of controlled substances did not evidence the diligence 
needed to prevent the risk of diversion or to monitor for such risk. 
[Tr. 88-89].
    77. The Respondent told Mr. Martinez to get a liver function 
test, but Mr. Martinez did not do that. [Tr. 249-50]. Dr. Rubenstein 
was concerned that the Respondent failed to consider any treatment 
options other than prescribing controlled substances. For instance, 
Mr. Martinez had stated that over-the-counter medications provided 
``temporary'' relief, yet no such approach was attempted. [Tr. 79-
80].
    78. In total, Dr. Rubenstein concluded that ``I don't believe 
that this patient's history and physical met that criteria for those 
prescriptions.'' [Tr. 90].

F. The Respondent

    79. The Government called the Respondent as a witness, and he 
asserted his Fifth Amendment rights against self-incrimination and 
refused to answer any questions beyond stating his name and business 
address. [Tr. 116-117].

G. Audit

    80. Diversion Investigator Janice Barnes (``DI Barnes'') 
conducted an accountability audit based on the Respondent's records. 
[Tr. 280-81]. Specifically, she reviewed the Respondent's inventory 
records of controlled substances on hand, receiving records to 
include DEA Form 222 for Schedule II controlled substances, and 
dispensing records, to include prescriptions. [Tr. 281-82].
    81. The audit covered the timeframe of March 2, 2010, to 
February 23, 2011. The beginning inventory came from the 
Respondent's computerized inventory. The beginning inventory and the 
amount of controlled substances received during the audit period are 
added together to reflect the total number of controlled substances 
for which the Respondent would be accountable. [Tr. 283]. For 
oxycodone 30 mg. that total number accountable was 199,752. [Tr. 
283; Govt. Exh. 32]. On the date of the closing inventory, February 
23, 2011, the Respondent had no controlled substances on hand. [Tr. 
284; Govt. Exh. 32]. The Respondent was able to account for, using 
his prescriptions, 180,559 tablets of oxycodone 30 mg. [Tr. 284; 
Govt. Exh. 32]. Thus, he did not have records showing the dispensing 
of 19,193 tablets of oxycodone 30 mg. [Tr. 284; Govt. Exh. 32]. 
However, after verifying the receiving documents with the 
Respondent's suppliers, in fact the Respondent should have received 
an additional 4800 tablets of oxycodone 30 mg. [Tr. 285; Govt. Exh. 
32 at 2]. Thus, the Respondent was actually responsible for 202,980, 
and the total accountable is now 204,552 tablets. The Respondent's 
records still only showed his dispensing of 180,559 tablets, 
resulting in his being unable to account for 23,993 tablets of 
oxycodone 30 mg. [Tr. 286-87; Govt. Exh. 32 at 2].
    82. Using the same computation method and the Respondent's 
records, the DEA's audit disclosed that the Respondent had an 
overage, and therefore, was unable to account for 4808 tablets of 
oxycodone 15 mg. [Tr. 288; Govt. Exh. 32 at 1]. However, using the 
suppliers' records, the Respondent was only unable to account for 8 
tablets of oxycodone 15 mg. [Tr. 288; Govt. Exh. 32 at 2].
    83. Using the same computation method and the Respondent's 
records, the DEA's audit disclosed that the Respondent was unable to 
account for 38 tablets of oxycodone 40 mg., 71 tablets of oxycodone 
80 mg., 2,565 Endocet 10/325 mg. and 365 tablets of Endocet 10/650 
mg. [Tr. 289-293; Govt. Exh. 32 at 1]. Although DEA personnel 
searched for records disclosing controlled substances returned from 
customers, returns to suppliers, thefts, or surrenders of controlled 
substances, no such records were found. [Tr. 291; Govt. Exh. 32 at 
1].
    84. Lastly, the DEA personnel were unable to find an initial 
inventory which should have been taken on the date the Respondent 
moved to the North Swinton Avenue address. [Tr. 294]. Even if the 
Respondent had no controlled substances on hand, he needed to take 
an initial, written inventory reflecting this zero balance. [Tr. 
294].

IV. STATEMENT OF LAW AND DISCUSSION

A. Position of the Parties

1. Position of the Government

    The Government asserts that the Respondent's DEA Certificates of 
Registration should be revoked. As a basis for that assertion, the 
Government argues that the Respondent prescribed controlled 
substances to patients without a legitimate medical purpose and 
outside the course of professional practice, in violation of DEA 
regulations and precedent. Further, the Respondent violated Florida 
law when he prescribed controlled substances after an inadequate 
physical examination and history which failed to justify such 
prescribing. [Government's Proposed Findings of Fact, Conclusions of 
Law and Argument (``Government's Brief'') at 26-28]. The medical 
records actually contained inaccuracies and possibly false 
statements, the Government argues. [Id.]. Further, the Respondent 
failed to discuss the risks and benefits of using controlled 
substances, and he failed to refer Mr. Hays and Mr. Martinez for 
``additional evaluation and treatment.'' [Government's Brief at 26-
27].
    Next the Government asserts that the Respondent issued 
controlled substance prescriptions knowing that his patients could 
be drug abusers or diverters. [Government's Brief at 27]. 
Prescribing under such circumstances ``constitutes prescribing 
outside the usual course of professional practice'' and is contrary 
to DEA regulations. [Government's Brief at 27]. Further, the 
Respondent increased the amount of controlled substances without a 
legitimate medical reason. The Respondent also prescribed additional 
types of controlled substances without medical justification. The 
Respondent ``demonstrated no skill when issuing prescriptions to the 
obviously opiate na[iuml]ve DEA officers and issued those 
prescriptions without regard for their safety.'' [Government's Brief 
at 27-28].
    The Government further asserts that the Respondent failed to 
follow the steps outlined in the Florida Administrative Code prior 
to prescribing pain medication. [Government's Brief at 28].
    The Government also asserts that the Respondent violated DEA 
regulations when he failed to guard against diversion of controlled 
substances. The Respondent overlooked numerous instances of drug 
seeking behavior and prescribed controlled substances to such 
patients anyway. [Government's Brief at 28]. The Respondent's 
decision to keep providing those patients with controlled substance 
prescriptions increased the risk of illegal diversion. [Government's 
Brief at 29].
    As for the actions taken by the physician assistant, Mr. Cohen, 
under both Florida law and DEA precedent, the Respondent is liable 
for Mr. Cohen's conduct. Mr. Cohen issued prescriptions for 
controlled substances signed by the Respondent, instructed Mr. Hays 
in ways to ensure pharmacists would fill controlled substances 
prescriptions, and he advised Mr. Martinez to go back to purchasing 
controlled substances on the street. The fact that Mr. Cohen 
performed these actions does not absolve the Respondent from his 
responsibilities in supervising Mr. Cohen. [Government's Brief at 
29].
    The Government argues that the Respondent's failure to maintain 
accurate medical records threatens the public health and safety. 
``Moreover, Respondent's employment of a physician assistant who 
provides advice to patients to assist them in obtaining drugs for 
abuse and/or diversion is both troubling and inconsistent with the 
public interest.'' [Government's Brief at 30].
    Lastly, the Respondent's failure to admit fault or to accept 
responsibility for his misconduct also weighs heavily in the public 
interest determination under DEA precedent. The fact that the 
Respondent neither testified nor presented any evidence to rebut the 
Government's prima facie case weighs in favor of revocation. The 
Government argues that an adverse inference should be taken from the 
Respondent's refusal to testify, and the record clearly lacks any 
evidence of mitigating circumstances to consider on the Respondent's 
behalf. In conclusion, the Government requests revocation of the 
Respondent's DEA Certificates of Registration. [Government's Brief 
at 30-32].

2. Position of the Respondent

    The Respondent requests that his DEA Certificate of Registration 
be reinstated. He argues that the Government has failed to meet its 
burden of proof regarding his prescribing of pain medication; for he 
prescribed controlled substances for a legitimate medical purpose 
and in compliance with the standards set forth by the Florida 
Medical Board Guidelines. [Respondent Zvi H. Perper, M.D.'s Post-
Hearing Brief (Resp. Brief) at 2,4,6]. Further, the Government has 
not met its burden of proof that the Respondent's registration is 
inconsistent with the public interest. [Resp. Brief at 6].

[[Page 64140]]

    The Respondent next argues that the Court lacked subject matter 
jurisdiction of Certificate of Registration numbers BP7732349, 
BP7622752, BP7622764, BP3429835, and BP8477639 because the Order to 
Show Cause only addressed Certificate of Registration number 
FP1312406. He asserts that the DEA did not issue an Order to Show 
Cause for the remaining DEA registration numbers. [Resp. Brief at 2-
3, 5].\20\
---------------------------------------------------------------------------

    \20\ But see ALJ Exhibit 2 which shows that Order II had been 
served on the Respondent.
---------------------------------------------------------------------------

B. Statement of Law

    Pursuant to 21 U.S.C. Sec.  824(a)(4), the Deputy Administrator 
\21\ may revoke a DEA Certificate of Registration if she determines 
that the continuance of such registration would be ``inconsistent 
with the public interest'' as determined pursuant to 21 U.S.C. Sec.  
823(f). Section 823(f) requires that the following factors be 
considered:
---------------------------------------------------------------------------

    \21\ The Deputy Administrator has the authority to make such 
determinations pursuant to 28 C.F.R. Sec. Sec.  0.100(b) and 0.104 
(2011).
---------------------------------------------------------------------------

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to 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.
    These factors may be considered in the disjunctive: The Deputy 
Administrator may properly rely on any one or a combination of these 
factors, and may give each factor the weight she deems appropriate, 
in determining whether a registration should be revoked or an 
application for registration denied. Marvin L. Gibbs, Jr., M.D., 69 
Fed. Reg. 18299, 18302 (DEA 2004) (citing Henry J. Schwarz, Jr., 
M.D., 54 Fed. Reg. 16,422 (DEA 1989)).
    Also, in an action to revoke a registrant's certificate, the DEA 
has the burden of proving that the requirements for revocation are 
satisfied. [21 C.F.R. Sec.  1301.44(e)]. The burden of proof shifts 
to the Respondent once the Government has made its prima facie case. 
[Medicine Shoppe, 73 Fed. Reg. 364, 387 (DEA 2008); Thomas Johnston, 
45 Fed. Reg. 72,311 (DEA 1980)].
    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))]. When an 
administrative tribunal elects to disregard the uncontradicted 
opinion of an expert, it runs the risk of improperly declaring 
itself as an interpreter of medical knowledge. [Ross v. Gardner, 365 
F.2d 554 (6th Cir. 1966)].
    DEA precedent has also held that ``past performance is the best 
predictor of future performance.'' [ALRA Labs, Inc. v. DEA, 54 F.3d 
450, 452 (7th Cir. 1995)]. Further, DEA has repeatedly held that 
``where a registrant has committed acts inconsistent with the public 
interest, the registrant must accept responsibility for his actions 
and demonstrate that he will not engage in future misconduct.'' 
[Medicine Shoppe, 73 Fed. Reg. at 387; see also Samuel S. Jackson, 
72 Fed. Reg. 23,848, 23,853 (DEA 2007)].
    In this matter, factors two, four and five are relevant in 
determining the appropriate resolution.

C. Discussion

1. Factors 2 and 4: The applicant's experience in dispensing, or 
conducting research with respect to controlled substances; Compliance 
with applicable State, Federal, or local laws relating to controlled 
substances

a. Patient Care

    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 C.F.R. Sec.  
1306.04(a); George C. Aycock, M.D., 74 Fed. Reg. 17529, 17541 (DEA 
2009)]. 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'')].
    Likewise, under Florida law, grounds for disciplinary action or 
denial of state licensure include ``prescribing . . . any controlled 
substance, other than in the course of the physician's professional 
practice,'' and prescribing such substances ``inappropriately or in 
excessive or inappropriate quantities is not in the best interest of 
the patient and is not in the course of the physician's professional 
practice, without regard to his or her intent.'' [Fla. Stat. Sec.  
458.331(q)(2009)].
    Rulemaking authority regarding the practice of medicine within 
the state of Florida has been delegated to the Florida Board of 
Medicine (Florida Board). [Fla. Stat. Sec.  458.326 (2009)]. Florida 
has promulgated a regulation, ``Standards for the Use of Controlled 
Substances for Treatment of Pain,'' Fla. Admin. Code r 64B8-9.013 
(2009) (``Florida Standards''), which recognize that ``inappropriate 
prescribing of controlled substances . . . may lead to drug 
diversion and abuse by individuals who seek them for other than 
legitimate medical use.'' [Id. at Sec.  9.013(d)]. The language 
employed by the regulation under the preamble section entitled 
``Pain Management Principles'' makes clear that the standards ``are 
not intended to define complete or best practice, but rather to 
communicate what the [Florida Board] considers to be within the 
boundaries of professional practice.'' Id. at 9.013(1)(g). Thus, the 
plain text supports an inference that the standards provide the 
minimum requirements for establishing conduct that meets the 
professional practice of controlled substance-based pain management 
within the state. Likewise, the range of acceptable practice that is 
built into the regulation underscores the importance of seeking an 
expert opinion in reaching a correct adjudication of whether a 
registrant has met the applicable Florida standard.
    Here, Dr. Rubenstein found that the Respondent issued 
prescriptions that were not for a legitimate medical purpose or in 
the course of usual medical practice. Specifically, he found that 
the prescriptions issued to Mr. Hays were not within the acceptable 
standard of care, given the quantities and frequency of such 
prescriptions. [FOF 56]. Also, given the medical history, the 
physical examination, and other objective information, Dr. 
Rubenstein opined that the prescriptions were not based on sound 
clinical grounds. Thus, he concluded that the prescriptions issued 
to Mr. Hays were issued outside the usual course of professional 
practice and were not issued for a legitimate medical purpose. [FOF 
56].
    Likewise, Dr. Rubenstein found that the Respondent issued 
prescriptions to Mr. Martinez outside the acceptable standard of 
care. [FOF 74-75]. Specifically, he found that the Respondent 
demonstrated a lack of reasonable safety in his prescribing, given 
Mr. Martinez's complaints. As he credibly concluded, ``I don't 
believe that this patient's history and physical met the criteria 
for those prescriptions.'' [FOF 78].
    For both Mr. Hays and Mr. Martinez, the Respondent shifted 
medications, either increasing the dosages or adding Dilaudid and 
Valium without medical justification. [FOF 48, 53, 72, 73, 74]. In 
addition, the circumstances surrounding the Respondent's 
prescription of Valium nearly equates to outright drug dealing. [See 
FOF 53 (suggesting patient had trouble sleeping in response to his 
request that Mr. Cohen find a ``creative way to deal with him.'')].
    Dr. Rubenstein found that the Respondent's physical examinations 
failed to provide an adequate basis for his prescribing of 
controlled substances. [See FOF 26, 27, 52]. Likewise, relying upon 
the MRI interpretation as a sole basis for prescribing controlled 
substances is not appropriate. [FOF 24]. However, it appears that 
the Respondent did so rely. For example, while Mr. Hays experienced 
no pain during the neurological examination, the Respondent 
prescribed controlled substances for him. [FOF 24, 26, 28, 52]. In 
addition, when treating Mr. Martinez, the Respondent, per Dr. 
Rubenstein, seemed only to treat the pathology included in the MRI, 
while ignoring the fact that Mr. Martinez had identified pain in his 
middle back and neck. [FOF 67]. [See Laurence T. McKinney, 73 Fed. 
Reg. 43260, 43265 n. 22 (DEA 2008)]. Further, the Respondent 
prescribed controlled substances to Mr. Hays too often, and in one 
instance prescribed controlled

[[Page 64141]]

substances prior to the date he had told Mr. Hays to return without 
even discussing the early dispensing of controlled substances. [FOF 
39, 41, 42]. This occurred despite the Respondent's assertion that 
he only gives out pills for one month, and Mr. Cohen's statement 
that Dr. Perper would not change a prescription for a patient that 
came back a week later. [FOF 25, 71]. Thus, based on the foregoing, 
it is clear that the Respondent issued prescriptions for excessive 
amounts without an adequate basis. Therefore, his prescriptions were 
for an illegitimate medical purpose in violation of both Federal and 
Florida law.
    Subsequent to the initiation of treatment, ``the physician 
should adjust drug therapy to the individual medical needs of each 
patient. Other 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.'' Fla. Admin. Code r 64B8-9.013(3)(b). Here, the 
Respondent failed to meet this standard. The Respondent failed to 
discuss other treatment modalities or physical therapy with Mr. 
Martinez, despite an indication in his case, that non-controlled 
substances had been utilized to control his pain in the past. [FOF 
70, 77]. Although he ordered liver function tests, the Respondent 
failed to take action when the patients refused to comply other than 
to discuss their non-compliance. Both this failure to comply and 
decision not to discuss other treatment options concerned Dr. 
Rubenstein. [FOF 44, 54, 58, 77].
    Further, the Respondent failed to adjust his drug therapy to the 
individual medical needs of each patient. Dr. Rubenstein found that 
the doses and frequency of prescribing to Mr. Hays were excessive 
given the medical indications. [FOF 30, 34, 53]. Subsequently, the 
Respondent \22\ prescribed controlled substances at the patient's 
request, without medical justification for the increase in 
controlled substances. [FOF 38, 39].
---------------------------------------------------------------------------

    \22\ The Respondent remains liable for Mr. Cohen's actions. 
Florida law states that ``[e]ach physician . . . supervising a 
licensed physician assistant must be qualified in the medical areas 
in which the physician assistant is to perform and shall be 
individually . . . responsible and liable for the performance and 
the acts and omissions of [the] physician assistant.'' Fla. Stat. 
Ann. Sec.  458.347(3) (2009).
---------------------------------------------------------------------------

    Likewise, Dr. Rubenstein found that the Respondent's prescribing 
to Mr. Martinez on the first visit ``was excessive and not warranted 
based on the history and physical examination presented.'' [FOF 69].
    Another standard adopted by the Medical Board, under the 
subheading ``Informed Consent and Agreement for Treatment,'' is the 
directive that ``[t]he physician should discuss the risks and 
benefits of the use of controlled substances with the patient, 
persons designated by the patient, or with the patient's surrogate 
or guardian if the patient is incompetent.'' [Fla. Admin. Code r 
64B8-9.003(3)(c)]. Here the Respondent failed to discuss the risks 
associated with the use of controlled substances. [FOF 57].
    The Florida Standards also state that, ``if the patient is 
determined to be at high risk for medication abuse or have a history 
of substance abuse, the physician should employ the use of a written 
agreement between the physician and patient outlining patient 
responsibilities, including, but not limited to: ``1. Urine/serum 
medication levels screening when requested; 2. Number and frequency 
of all prescription refills; and 3. Reasons for which drug therapy 
may be discontinued (i.e. violation of agreement.)'' Yet the 
Respondent was provided with information from the patients that 
clearly showed a violation of the agreement, and the Respondent 
failed to take any action in response. [FOF 48, 73]. [Fla. Admin. 
Code r 64B8-9.003(3)(c)]. In addition, despite these red flags of 
diversion, the Respondent failed to follow up with urine screens 
beyond the first visit, to ensure the prescribed controlled 
substances were being consumed by the patient and not diverted. [FOF 
64]. Yet, the Respondent utilized pain management agreements. [FOF 
20, 63].
    The Florida Standards direct that ``[p]hysicians should be 
diligent in preventing the diversion of drugs for illegitimate 
purposes.'' [Id. at 9.013(1)(d). Here, the Respondent and Mr. Cohen 
were given direct evidence of diversion and failed to act. Mr. 
Martinez clearly told the Respondent and Mr. Cohen that he had 
purchased controlled substances off the street. [FOF 68, 71, 76]. 
Yet neither one took any action in response to this information. Mr. 
Hays told Mr. Cohen that he had shared his controlled substances 
with his girlfriend, and again, Mr. Cohen failed to take any action. 
[FOF 49]. A practitioner who takes no ``precautions against . . . 
misuse and diversion'' exceeds the bounds of professional practice 
when he prescribes controlled substances. [United States v. Moore, 
423 U.S. 122, 142-43 (1975)]. Such inaction violates the standard of 
diligence expected of a DEA registrant.
    Florida law further provides that grounds for such disciplinary 
action also include:

Failing to keep legible, as defined by department rule in 
consultation with the board, medical records that identify the 
licensed physician . . . and that justify the course of treatment of 
the patient, including, but not limited to, patient histories; 
examination results; test results; records of drugs prescribed, 
dispensed, or administered; and reports of consultations and 
hospitalizations.

[Id. Sec.  458.331(m)].
    Inherent in this law is the requirement that the medical records 
accurately report the required data. [See Fla. Admin. Code r. 64B8-
9.013(3)]. Here, Mr. Martinez failed to complete his intake 
documentation, leaving critical portions, such as his level of pain, 
blank. [FOF 60]. The Respondent did not discuss the missing data 
with Mr. Martinez and made no effort to complete the medical 
history. [Id.].
    Further, the Respondent charted inaccurately. For example, 
despite no discussion about the relief of pain Mr. Hays experienced 
from the Percocet, the Respondent wrote that Mr. Hays had 
experienced ``no relief (from) pain.'' [FOF 33]. Likewise, the 
Respondent charted ``break-through pain'' and utilized this 
information to justify increasing the amount of controlled 
substances dispensed to Mr. Hays. Yet Mr. Hays had not complained of 
break-through pain. [FOF 43, 47].

b. Inventory and Audit

    Under Florida law, a dispensing physician is required to abide 
by the statutory and regulatory recordkeeping provisions identical 
to those levied against a pharmacy. [Fla. Stat. Ann. Sec.  
465.0276(2)(b) (2009)]. That includes compliance with 21 C.F.R. 
Sec.  1304.04, which requires dispensed prescriptions to be 
maintained in a readily retrievable manner for two years after 
dispensing. [ See Fla. Admin. Code r. 64B16-28.140 (2009) (stating a 
pharmacy must comply with Sec.  1304.04)].
    In addition, under federal law, a dispensing physician is 
required to keep certain records similar to those kept by retail 
pharmacies. For example, 21 C.F.R Sec.  1304.03(d) requires a 
registered practitioner who regularly dispenses to keep records of 
Schedule II-V controlled substances that he dispenses. Specifically, 
the registrant is required to keep inventories of schedules I and II 
controlled substances. In addition, the registrant is required to 
keep inventories of schedules III through V controlled substances 
either separate from all other records of the registrant or in a 
manner that is readily retrievable. [Sec.  1304.04 (f)(1) and (2); 
See also Sec.  1304.04(g) (imposing this requirement on registered 
practitioners required to maintain records)]. Federal regulations 
also set out in detail the requirements of those inventories. [See 
Sec.  1304.11(e)(3) (specifying that a dispensing practitioner's 
inventory of Schedules I and II must be conducted by hand count but 
that Schedules III through V can be estimated provided the container 
holds less than 1000 tablets and requiring the practitioner to 
maintain records identical to those maintained by manufacturers 
under Sec.  1304.11(e)(1)(iii) and (iv))].
    Here, the Respondent failed to meet such requirements. 
Specifically, the Respondent failed to conduct the required initial 
inventory after moving to a new practice location. [FOF 84]. Next, 
when conducting an accountability audit, the DEA found that the 
Respondent was unable to account for, among other discrepancies, 
23,993 dosage units of oxycodone 30 mg tablets, [FOF 81], and 2,565 
dosage units of Endocet 10/325, [FOF 83].
    Factor Five: Such other conduct which may threaten the public 
health and safety.
    Although factor five is quite broad, the Deputy Administrator 
has qualified its breadth by limiting the considerations made under 
that factor to those where there is ``a substantial relationship 
between the conduct and the CSA's purpose of preventing drug abuse 
and diversion.'' [Tony T. Bui, 75 Fed. Reg. 49,979, 49,988 (DEA 
2010)].
    Here, I find that Mr. Cohen advised Mr. Hays on ways to present 
prescriptions so that the pharmacy would not be ``suspicious.'' 
Specifically, Mr. Hays was to hand in one of the controlled 
substances prescriptions and then wait to hand in the other one. 
[FOF 49]. Further, Mr. Cohen gave Mr. Hays a prescription for 
ibuprofen, to be used to waylay the pharmacist's suspicion. If the 
pharmacist was not suspicious, Mr. Hays was to destroy the ibuprofen 
prescription. [FOF 49]. Such deception in handling

[[Page 64142]]

prescriptions for controlled substances threatens the public health 
and safety, for it circumvents the checks and balances available in 
the pharmacist's corresponding liability for the dispensing of 
controlled substances. [See 21 C.F.R. 1306.04].
    Next Mr. Cohen advised Mr. Martinez to go back to buying 
controlled substances on the street if he needed more drugs than the 
ones already prescribed. [FOF 71]. Advising Mr. Martinez to engage 
in illegal activity in purchasing controlled substances in this 
manner promotes diversion and therefore, directly threatens the 
public health and safety.
    Lastly, Dr. Rubenstein found that the Respondent lacked concern 
for patient safety. He prescribed large amounts of controlled 
substances to opioid na[iuml]ve patients. [FOF 30, 53, 56]. He also 
increased the amounts of controlled substances he prescribed, and 
such increases were unjustified and reflect a lack of concern for 
patient safety. [FOF 69, 72-74]. Dr. Rubenstein concluded that the 
increase in medication was not medically justified. [FOF 74].
    The Respondent did not testify in this proceeding.\23\ 
Therefore, he neither took responsibility for his misconduct nor 
provided any assurances that he has implemented remedial measures to 
ensure such conduct is not repeated. Such silence weighs against the 
Respondent's continued registration. [Medicine Shoppe, 73 Fed. Reg. 
at 387; see also Samuel S. Jackson, 72 Fed. Reg. 23,848, 23,853 (DEA 
2007)].
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    \23\ The Government asks me to take an adverse inference from 
the Respondent's failure to testify. However, the Government does 
not assert what adverse inference it believes such silence 
establishes. Although I agree that the Government is entitled to 
such an inference as established by the cited case law, without a 
requested inference, I am at a loss in granting the Government's 
request.
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V. CONCLUSION AND RECOMMENDATION

    Consistent with the analysis in this matter, I conclude that the 
Government has met its burden and established its prima facie case 
for revocation. The Respondent has failed to provide any explanation 
for his conduct or any assurances regarding his future conduct. 
Therefore, I recommend that the Respondent's viable DEA 
registrations FP1312406, BP3429835, and BP8477639, be revoked and 
any pending applications for renewal or modification of such 
registrations be denied.

    Dated: July 19, 2011
Gail A. Randall, Administrative Law Judge

[FR Doc. 2012-25618 Filed 10-17-12; 8:45 am]
BILLING CODE 4410-09-P