Carlos Gonzalez, M.D., Decision and Order, 63118-63147 [2011-26070]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Notices]
[Pages 63118-63147]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26070]



[[Page 63117]]

Vol. 76

Tuesday,

No. 196

October 11, 2011

Part VII





Department of Justice





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Drug Enforcement Administration





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Carlos Gonzalez, M.D., Decision and Order; Notice

Federal Register / Vol. 76 , No. 196 / Tuesday, October 11, 2011 / 
Notices

[[Page 63118]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 11-33]


Carlos Gonzalez, M.D., Decision and Order

    On July 18, 2011, Chief Administrative Law Judge (ALJ) John J. 
Mulrooney, Jr., issued the attached recommended decision (also ALJ). 
Thereafter, the Government filed Exceptions to the ALJ's decision.\1\
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    \1\ All citations to the ALJ's decision are to the slip opinion 
as originally issued on July 18, 2011.
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    Having reviewed the entire record and the Government's Exceptions, 
I have decided to adopt the ALJ's recommended rulings, findings of 
fact, conclusions of law, and recommended order except as discussed 
below.\2\ I will therefore order that Respondent's registration be 
revoked and that any pending application to renew his registration be 
denied.
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    \2\ Because it is dictum, I do not adopt the first sentence of 
the last paragraph which begins on page 56 of the slip opinion and 
continues on to the following page.
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The Government's Exceptions

    The Government's Exceptions fall within two categories. First, the 
Government takes exception to the ALJ's finding that it had not proved 
that Respondent violated Federal law (the Ryan Haight provisions) by 
issuing controlled substance prescriptions through the Internet without 
having conducted ``at least one in-person medical evaluation'' of the 
patients. Exceptions at 3; see also ALJ at 69-71. Second, the 
Government takes exception to the ALJ's declination to give weight to 
testimony it elicited regarding several hearsay statements which it 
offered to prove various material facts (including the alleged 
violations of the Ryan Haight provisions).

The Ryan Haight Violations

    With respect to its first contention, the Government points to 
various controlled substance prescriptions (typically for steroids) 
found during an inspection of a Florida pharmacy which list Respondent 
as the prescriber and the patients as residents of some fourteen States 
outside of Florida; the prescriptions are on forms bearing the 
letterhead of three separate entities, which were internet sites 
through which a person could obtain a prescription for a controlled 
substance which the pharmacy filled. Exceptions at 2; GX 37. The 
Government contends that the prescriptions by themselves constitute 
substantial evidence to support a finding that Respondent violated the 
CSA, which following the passage of the Ryan Haight Act, prohibits the 
distribution or dispensing of ``a controlled substance by means of the 
Internet without a valid prescription,'' and requires that such a 
prescription be ``issued for a legitimate medical purpose in the usual 
course of professional practice by * * * a practitioner who has 
conducted at least one in-person medical evaluation of the patient.'' 
21 U.S.C. 829(e).
    This is so, the Government argues, because none of the patients who 
received the prescriptions in GX 37 reside in Florida, and ``it is 
unlikely that [Respondent] traveled all over the country to conduct 
physical examinations with these patients'' and ``it is also highly 
unlikely that these patients traveled from all over the country to see 
[Respondent] in Florida.'' Exceptions at 3. Based on the respective 
geographic locations of Respondent and the patients, the Government 
argues that ``it is clear that these controlled substance prescriptions 
were issued outside of the usual course of professional practice and 
lacked a legitimate medical purpose because these patients were not 
examined by'' him. Id. at 4.
    Contrary to the Government's position, the prescriptions alone are 
insufficient to establish that Respondent failed to perform an in-
person medical evaluation of the patients. Notably, the Government 
provided only thirty-seven prescriptions, which were issued to twenty-
eight patients, over a period of nearly six months. Thus, this case 
bears none of the hallmarks of the assembly-line prescribing methods 
which DEA has frequently encountered in other internet prescribing 
schemes and the small number of prescriptions does not foreclose the 
possibility that the patients traveled to Florida to be evaluated by 
him.\3\ See Sun & Lake Pharmacy, Inc., 76 FR 24523 (2011); William R. 
Lockridge, 71 FR 77791 (2006). Moreover, in contrast to other internet 
cases, the Government did not introduce any evidence showing how the 
websites functioned (such as an undercover buy) and whether persons 
were able to obtain controlled substances without undergoing an in-
person examination. Nor did the Government produce any other evidence 
which might have been probative of the issue and met the Administrative 
Procedure Act's standard of reliability, see 5 U.S.C. Sec.  556(d), 
such as evidence regarding how the websites promoted their service, the 
lack of documentation of an in-person examination in patient records, 
or the lack thereof of any patient records. Thus, the prescription 
evidence alone does not create a permissible inference that Respondent 
did not physically examine the patients.
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    \3\ While there was evidence that it exceeds the bounds of 
professional practice to prescribe narcotics to a pain patient who 
had not been seen in six months without doing a new history and 
physical exam, no evidence was presented as to what constitutes a 
legitimate medical purpose for prescribing steroids and the 
standards of medical practice for prescribing them. Moreover, that 
most of the pharmacy's steroid prescriptions were mailed to the 
patients does not foreclose the possibility that the patients had 
previously been examined by Respondent.
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    The Government further argues that the ALJ erred in holding ``that 
additional evidence was needed * * * to prove that'' Respondent did not 
physically examine the internet patients because the evidence stands 
unrefuted. Exceptions at 4. In support of this contention, the 
Government also noted that Respondent was subpoenaed and invoked his 
Fifth Amendment privilege and refused to testify. Id. at 4. Unclear is 
whether the Government believes that Respondent's invocation of his 
Fifth Amendment privilege entitles it to the adverse inference that he 
did not physically examine the patients.
    As for its contention that Respondent's failure to refute its 
evidence (in any manner whatsoever) entitles it to a finding that he 
did not physically examine the patients, the argument ignores that the 
Government has the burden of proof on the issue. Because its evidence 
does not create even a permissible inference that Respondent did not 
physically examine the patients, Respondent had no obligation to refute 
it.
    As for whether Respondent's refusal to testify entitles the 
Government to an adverse inference that he failed to physically examine 
the patients identified in GX 37, it is noted that the Government 
subpoenaed him to testify and obviously Respondent has knowledge of 
whether he did so. However, in neither its original nor its 
supplemental pre-hearing statement did the Government state that it 
intended to elicit testimony from him on this issue. See ALJ Exs. 5 & 
6. Moreover, at the hearing, when Respondent's counsel informed the 
tribunal that Respondent intended to assert his Fifth Amendment 
privilege, the Government did not make an offer of proof. Thus, there 
is no basis to conclude that the Government would have questioned him 
about the internet prescriptions, and thus, an adverse inference cannot 
be drawn on the issue of whether he physically examined the patients.

[[Page 63119]]

    The Government further argues that its evidence supports the 
conclusion that Respondent did not physically examine the patients 
because it also elicited the testimony of a Diversion Investigator (DI) 
that the prescriptions ``were `absolutely' the result of the Internet 
drug-based process used by'' the pharmacy. Exceptions at 4 (citing its 
Post-Hearing Br. at 29). In its Exceptions, the Government acknowledges 
that this testimony was hearsay as it was based on the unsworn 
statements made by two employees of the pharmacy which filled the 
Internet prescriptions. Exceptions at 5.
    Under DEA regulations, a party's exceptions ``shall include a 
statement of supporting reasons for such exceptions, together with 
evidence of record (including specific and complete citations of the 
pages of the transcript and exhibits) * * * relied upon.'' 21 CFR 
1316.66(a) (emphasis added). The Government's citation to its post-
hearing brief does not comply with this requirement, which DEA has 
previously applied in rejecting the exceptions filed by a respondent. 
See Paul H. Volkman, 73 FR 30630, 30640 (2008), pet. for rev. denied 
567 F.3d 215 (6th Cir. 2009). Because the Government did not identify 
which specific hearsay statements it believes should be given weight, 
this alone provides reason to reject the exception.\4\
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    \4\ In his decision, the ALJ noted that ``[i]t would not be 
unreasonable for the Agency to interpret the [Ryan-Haight Act] in 
such a way that a clear and convincing demonstration on the part of 
the Government that a practitioner has caused controlled substances 
prescribed and/or dispensed under his or her [registration] to be 
shipped to a remote, out-of-state location from the * * * registered 
address would result in a burden of production on the part of the 
registrant to demonstrate that an in-person physical examination had 
been conducted.'' ALJ at 71 n.109. I conclude, however, that such a 
rule is not justified given that the Government has ample means 
available to it to prove that a registrant failed to perform a 
physical examination, including by introducing the physician's 
patient records which it has the power to obtain through either 
subpoena or an administrative warrant; where such process is issued 
and no records are provided or a warrant is issued and no records 
are found, the Government would be entitled to the inference that 
the registrant failed to perform a physical exam. In addition, the 
Government can call the registrant as a witness and elicit testimony 
on the issue, and as explained above, where the registrant invokes 
his Fifth Amendment privilege, the Government would be entitled to 
an adverse inference. Finally, the Government can either call 
patients as witnesses (as it has done in several cases) or obtain 
sworn statements from them. In the event a potential witness resides 
more than 500 miles from the place of the hearing, and either the 
Government seeks to call the witness to provide live testimony or a 
respondent seeks to cross-examine the witness, the ALJ has authority 
to move the hearing so that a subpoena can be issued to compel the 
attendance of the witness and the ALJ can take such testimony 
through telephone or videoconferencing.
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The ALJ's Declination to Give Weight to Various Other Hearsay 
Statements

    In addition to the hearsay testimony related above, the Government 
also takes exception to the ALJ's failure to give weight to hearsay 
statements made by several other persons. More specifically, these 
statements included: (1) Those made by four patients of the pain clinic 
where Respondent practiced, which were related by a Task Force Officer 
(TFO) who interviewed them; (2) the statements made to the TFO by the 
co-owners of the clinic; and (3) the statements made by a former 
employee who had been fired by the pain clinic which were related by 
the DI.
    As for the first category of statements, the Government cites more 
than 100 pages of transcript and argues that the patients' statements, 
which were unsworn, were supported by the patient files; however, the 
Government does not identify the specific statements it believes should 
have been ``given substantial weight.'' Exceptions at 6. Here again, 
the Government has not complied with the Agency's regulation and 
properly presented the exception for review. Beyond that, the 
Government's contention that the Agency should give weight to these 
unsworn statements because ``there would be nothing to gain through 
cross-examination of these * * * clinic patients because [Respondent], 
in his absence left the clinic operation and the issuing of controlled 
substances prescriptions to the [clinic] staff and therefore [has] no 
idea as to what occurred with these patients,'' Exceptions at 6-7, 
ignores that one of the fundamental purposes of cross-examination is to 
show that witnesses lack credibility or an accurate recollection of the 
event. See McCormick on Evidence Sec.  19, at 47 (3d ed. 1984) (``For 
two centuries, common law judges and lawyers have regarded the 
opportunity of cross-examination as an essential safeguard of the 
accuracy and completeness of testimony.''). The APA specifically 
protects this critical right in 5 U.S.C. 556(d), which states in 
relevant part that ``[a] party is entitled * * * to conduct such cross-
examination as may be required for a full and true disclosure of the 
facts.''
    As for the hearsay statements of the clinic's owners and the former 
employee, the ALJ cited extensive judicial authority discussing when 
hearsay statements constitute substantial evidence, including two cases 
which are binding precedent in the Eleventh Circuit. See ALJ at 37 
(citing Basco v. Machin, 514 F.3d 1177, 1182 (11th Cir. 2008) and 
J.A.M. Builders v. Herman, 233 F.3d 1350, 1354 (11th Cir. 2000)).\5\ As 
the ALJ explained, while hearsay evidence is admissible in 
administrative proceedings, the weight that can be given such evidence 
and whether it constitutes substantial evidence ``is an entirely 
different matter'' and is dependent upon ``the underlying reliability 
and probative value of the evidence.'' Basco, 514 F.3d at 1182 (quoting 
U.S. Pipe and Foundry Co. v. Webb, 595 F.2d 264, 270 (5th Cir. 1979)). 
As set forth in the ALJ's decision, the Eleventh Circuit has held that 
four factors should be considered in assessing whether hearsay 
statements are sufficiently reliable. These are: (1) Whether the 
declarant was unbiased and had no interest in the outcome of the case; 
(2) whether the opposing party could have obtained the hearsay 
information prior to the hearing and subpoenaed the declarant for 
cross-examination; (3) whether the information was inconsistent on its 
face; and (4) whether the information has been recognized by the courts 
as inherently reliable. ALJ at 37 (discussing J.A.M. Builders, 233 F.3d 
at 1354).
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    \5\ To make clear, the ALJ also relied on the principles set 
forth in these two cases in declining to give weight to the some of 
other hearsay evidence such as the statements of the four patients 
to the TFO.
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    In its Exceptions, the Government does not even acknowledge either 
J.A.M. Builders or Basco, let alone offer any argument that the ALJ 
misapplied the relevant factors. Indeed, the Government does not cite a 
single judicial authority that supports its position that unsworn 
hearsay statements can constitute substantial evidence. However, even 
if it had, DEA is bound by the precedential authority of a United 
States Court of Appeals which would have jurisdiction over a subsequent 
petition for review of the Agency's final decision under 21 U.S.C. 877.
    The Government nonetheless argues that other evidence, which is 
also hearsay, corroborates the testimony at the hearing. More 
specifically, with respect to the TFO's testimony as to the statements 
made by the clinic owners in two interviews, the Government argues that 
audio recordings and supporting transcripts corroborate the TFO's 
testimony. Exceptions at 7.
    This misses the point entirely because the ALJ did not decline to 
give weight to the TFO's testimony regarding the interviews of the 
clinic owners because he found the TFO to lack credibility. To the 
contrary, the ALJ found the TFO to be credible. ALJ at 41. However, the 
ALJ

[[Page 63120]]

declined to give weight to this portion of the TFO's testimony because 
he found the statements of the clinic owners to be inherently 
unreliable based on the high likelihood that they were motivated by the 
owners' instinct for ``self-preservation'' and interest in shielding 
themselves from criminal liability; moreover, because the statements 
were not sworn, they are not the type which the courts have recognized 
``as inherently reliable.'' ALJ at 39. Thus, that the transcripts and 
audio recording corroborate the TFO's testimony does not cure the 
fundamental flaws with the underlying hearsay statements to which he 
testified.\6\
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    \6\ Here again, the Government did not identify which of the 
numerous statements made by the clinic owners it believes the ALJ 
should have given weight to. Exceptions at 7.
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    It is acknowledged that the TFO testified that the owners had 
stated ``that the physician assistants were in charge of seeing 
patients and prescribing medications, although it was possible that 
they to some degree communicated with the Respondent through computer 
equipment at times * * * for him to approve prescriptions,'' id., and 
that this is corroborated by the testimony at the hearing of the two 
UCs as to how they obtained their prescriptions. Nonetheless, this does 
not support reliance on the statement because the third J.A.M. Builders 
factor does not ask whether the hearsay statement is inconsistent with 
other evidence in the case, but only whether the hearsay statement is 
inconsistent on its face. Moreover, even if the owners' statements are 
internally consistent, and the owners could have been subpoenaed, the 
other factors still counsel against the Agency's reliance on the 
statements. Thus, the ALJ properly concluded that the statements of the 
clinic owners could not be relied upon. Id.
    For similar reasons, the ALJ properly declined to give any weight 
to a DI's testimony regarding an interview she conducted with a former 
clinic employee who had been fired. Here again, while there is no 
evidence that the employee's statement was inconsistent on its face and 
the employee likely could have been subpoenaed (although the Government 
offered no evidence as to her whereabouts, notwithstanding that it was 
the proponent of the evidence), the other factors strongly support the 
ALJ's declination to give weight to this evidence. Having been 
terminated, the employee could well have been biased (again, while the 
Government was the proponent of statement, it did not produce any 
evidence that she was unbiased), and in any event, her unsworn 
interview with the DI is not the type of hearsay statement which the 
courts have recognized is inherently reliable. See ALJ at 42.
    Accordingly, I reject the Government's various Exceptions to the 
ALJ's Recommended Decision. However, I agree with the ALJ's findings 
and legal conclusions that: (1) ``Respondent's prescribing practice 
fell well below the applicable standard in Florida regarding the 
controlled substances prescribed and dispensed to the undercover 
agents, as well as to the patients whose charts'' were reviewed by the 
Government's Expert, ALJ at 69; (2) ``Respondent employed his 
[registration] and/or allowed/enabled others to do so in a manner where 
controlled substances were prescribed and dispensed for other than a 
legitimate medical purpose or outside the usual course of professional 
practice,'' id., and thus allowed controlled substances to be 
``provided to individuals he never met,'' id. at 72;-- and (3) 
Respondent's charts include ``out-and-out falsehoods'' and ``failed to 
provide even the most basic documentation to support his prescribing 
and dispensing.'' Id.
    I therefore conclude that Respondent has committed acts which 
render his continued registration ``inconsistent with the public 
interest.'' 21 U.S.C. 824(a)(4). Because Respondent has offered no 
evidence to rebut this conclusion, I adopt the ALJ's recommended Order 
and revoke his registration and deny any pending applications.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration BG8251845, issued to Carlos Gonzalez, M.D., be, and it 
hereby is, revoked. I further order that any pending application of 
Carlos Gonzalez, M.D., to renew or modify his registration, be, and it 
hereby is denied. This Order is effective immediately.\7\
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    \7\ For the same reasons which led me to order the Immediate 
Suspension of Respondent's Registration, I conclude that the public 
safety requires that this Order be effective immediately. 21 CFR 
1316.67.

    Dated: September 29, 2011.
Michele M. Leonhart,
Administrator.
    Theresa Krause, Esq., for the Government
    Michael Metz, Esq., for the Respondent

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

    John J. Mulrooney, II, Chief Administrative Law Judge. On February 
18, 2011, the Administrator of the Drug Enforcement Administration (DEA 
or Government), issued \1\ an Order to Show Cause and Immediate 
Suspension of Registration (OSC/ISO) immediately suspending the DEA 
Certificates of Registration (COR), Numbers BG8251845, FG1242471, and 
FG2021804, of Carlos Gonzalez, M.D. (Respondent), as a practitioner, 
pursuant to 21 U.S.C. Sec.  824(d) (2006), based on the Administrator's 
assessment of an imminent danger to the public health and safety. The 
OSC/ISO also seeks revocation of the Respondent's registrations, 
pursuant to 21 U.S.C. Sec.  823(a)(4) (2006 & Supp. III 2010), and 
denial of any pending applications for renewal or modification of 
registration, pursuant to 21 U.S.C. Sec.  823(f), alleging that the 
Respondent's continued enjoyment of the privileges vested in those 
registrations is inconsistent with the public interest, as that term is 
used in 21 U.S.C. Sec.  823(f). On March 16, 2011, the Respondent, 
through counsel, timely requested a hearing, which was conducted in 
Miami, Florida on May 17-19, 2011. The immediate suspension of the 
Respondent's COR has remained in effect throughout these proceedings.
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    \1\ The Government served the OSC/ISO upon the Respondent on 
February 23, 2011.
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    The issue ultimately to be adjudicated by the Administrator, with 
the assistance of this recommended decision, is whether the record as a 
whole establishes by substantial evidence that Respondent's 
registration with the DEA should be revoked as inconsistent with the 
public interest as that term is used in 21 U.S.C. Sec. Sec.  823(f) and 
824(a)(4). The Respondent is the holder of DEA practitioner 
registration, No. BG8251845, which expires by its terms on September 
30, 2011. The Respondent surrendered two other registrations, Nos. 
FG1242471 and FG2021804, prior to requesting a hearing.
    After carefully considering the testimony elicited at the hearing, 
the admitted exhibits, the arguments of counsel,\2\ and the record as a 
whole, I

[[Page 63121]]

have set forth my recommended findings of fact and conclusions of law 
below.
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    \2\ The parties were afforded the opportunity to file post-
hearing briefs in this matter. The Government's brief was timely 
filed on June 14, 2011, but no brief was filed on behalf of the 
Respondent. The decision to forgo filing a brief has resulted in a 
record that contains no position from the Respondent on the weight 
that should be accorded the evidence admitted during the 
proceedings, beyond the arguments made at the hearing in connection 
with objections. Neither party filed any exceptions or proposed 
corrections to the transcript, notwithstanding being afforded the 
opportunity to do so.
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The Allegations

    The OSC/ISO issued by the Government alleges that during the 
approximate time period of October 2009 through September 2010, the 
Respondent ``distributed * * * oxycodone, a Schedule II controlled 
substance, and alprazolam, a Schedule IV controlled substance by 
issuing prescriptions to several undercover law enforcement officers 
for other than a legitimate medical purpose or outside the usual course 
of professional practice.'' ALJ Ex. 1 at 2 (internal quotation marks 
and parentheses omitted). Furthermore, the OSC/ISO alleges that 
patients at the Respondent's practice were able to procure similarly 
illegitimate prescriptions in a similarly illegitimate manner as the 
undercover officers. Id.
    Interactions with two undercover officers are alleged in the OSC/
ISO. The first undercover officer (UC1),\3\ allegedly obtained 
prescriptions for various controlled pain medications issued from the 
Respondent's registration despite the Respondent's absence from the 
office and notwithstanding the fact that he never personally examined 
him. Id. The OSC/ISO also alleges that ``a nurse practitioner who was 
represented as being a doctor'' examined UC1 cursorily in the 
Respondent's stead, despite UC1's admission to the nurse practitioner 
that he had illicitly acquired controlled substances from a friend. Id.
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    \3\ Evidence received at the hearing establishes that UC1, as 
referred to in the OSC/ISO, refers to Task Force Officer (TFO) 
William Schwartz. TFO Schwartz employed the fictitious name ``Bill 
Rix'' during his undercover office visits.
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    The OSC/ISO also alleges that upon a subsequent visit, UC1 obtained 
prescriptions for, and distributions of, controlled pain medications 
without the Respondent conducting a physical examination, reaching a 
diagnosis, or providing a justification for the increase in dosage 
units and in the face of the UC's admission that he illegally obtained 
controlled substances from another person prior to the visit. 
Furthermore, the OSC/ISO charges that on two or more subsequent 
occasions, controlled substance pain prescriptions emanated from the 
Respondent's COR to UC1, even though UC1 was not personally examined by 
anyone and during a time wherein the Respondent was purportedly absent 
from the office. Id.
    Regarding the second undercover officer (UC2),\4\ the OSC/ISO 
alleges that while the Respondent was out of the office, UC2, after a 
cursory examination performed by a physician's assistant, was 
prescribed controlled pain medications through the Respondent's COR. 
Id. According to the Government, UC2 was issued the prescriptions even 
in the face of his admission to the physician's assistant that he had 
illegally obtained controlled substances from his girlfriend. Id.
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    \4\ Evidence received at the hearing establishes that UC2, as 
referred to in the OSC/ISO, refers to Special Agent (SA) Jack 
Lunsford. SA Lunsford assumed the fictitious name ``David Hays'' 
during his undercover visits.
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    The OSC/ISO also alleges that from February 2009 through December 
2009, the Respondent allegedly procured 238,000 dosage units of 
oxycodone, and from January 2010 through June 2010, he allegedly 
obtained through purchase 259,000 dosage units of oxycodone at his 
registered location in Lake Park, Florida.\5\ Id. at 3.
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    \5\ COR No. FG1242471 is the corresponding registration with 
this address.
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    Subsequent prehearing and supplemental prehearing statements 
alleged additional facts, including (but not limited to) recordkeeping 
deficiencies and the illegal prescribing of controlled substances over 
the Internet in violation of the Ryan Haight Act.\6\ ALJ Ex. 6 at 6.
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    \6\ On October 15, 2008, the President signed into law the Ryan 
Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight 
Act), Pub. L. No. 110-425, 122 Stat. 4820 (2008), which became 
effective on April 13, 2009 and is codified at 21 U.S.C. Sec.  
829(e).
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The Stipulations of Fact

    The parties, through their respective counsel, have entered into 
stipulations regarding the following matters:
    Stipulation A: The Respondent is registered with the DEA as a 
practitioner in Schedules II through V under DEA registration number 
BG8251845 at 7108 Fairway Drive, Suite 120, Palm Beach 
Gardens, Florida 33418. Respondent's DEA registration number BG8251845 
expires by its terms on September 30, 2011.
    Stipulation B: On February 23, 2011 the Respondent was personally 
served with an Order to Show Cause and Immediate Suspension of 
Registration and was simultaneously arrested on state drug-related 
felony charges. The state criminal trial is pending.
    Stipulation C: Oxycodone is a Schedule II controlled substance 
pursuant to 21 C.F.R. Sec.  1308.12(b)(1)(xiii) (2010).
    Stipulation D: OxyContin is a brand of oxycodone, a Schedule II 
narcotic controlled substance pursuant to 21 C.F.R. Sec.  
1308.12(b)(1)(xiii) (2010).
    Stipulation E: Roxicodone is a brand of oxycodone, a Schedule II 
narcotic controlled substance pursuant to 21 C.F.R. Sec.  
1308.12(b)(1)(xiii) (2010).
    Stipulation F: Alprazolam is a Schedule IV controlled substance 
pursuant to 21 C.F.R. Sec.  1308.14(c)(1) (2010).
    Stipulation G: Xanax is a brand of alprazolam, a Schedule IV 
controlled substance pursuant to 21 C.F.R. 1308.14(c)(1) (2010).
    Stipulation H: Vicodin is a brand of hydrocodone combination 
product, a Schedule III narcotic controlled substance pursuant to 21 
C.F.R. Sec.  1308.13(e)(1)(iv) (2010).
    Stipulation I: Soma is a brand of carisoprodol which is a non-
controlled muscle relaxant.

The Evidence

    At the hearing, the Government presented the testimony of several 
witnesses on the issue of the Respondent's medical practice, 
recordkeeping, and controlled substance prescribing practices. The 
testimony received during the Government's case-in-chief revealed that 
three undercover (UC) law enforcement officers infiltrated the North 
Palm Pain Management Clinic (NPPM) where the Respondent was employed 
and were able to obtain controlled substances issued under his COR. The 
Government also presented the testimony of an expert witness who 
reviewed the files maintained by NPPM on two of the UC officers as well 
as four charts maintained on other patients of the clinic who 
voluntarily consented to speak with law enforcement and to have their 
files examined.

UC Patient Rix

    Task Force Officer (TFO) William Schwartz, a sixteen-year veteran 
of the Sheriff's Office in Broward County, Florida, testified that he 
has served as a detective for thirteen years,\7\ been a designated DEA 
TFO since 2009, and has participated in thousands of drug diversion 
investigations.\8\ Tr. 592-93, 752. Schwartz made multiple undercover 
visits to the North Palm Pain Management Clinic (NPPM) under the 
assumed name Bill Rix (UC Patient Rix). Schwartz wore a wire, the UC

[[Page 63122]]

visits were recorded, and the recordings and transcripts were received 
into evidence.
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    \7\ Tr. 656.
    \8\ TFO Schwartz also testified that he completed the DEA 
Diversion Investigators Course in 2002 and the Federal Bureau of 
Investigation (FBI) School in 2007. Tr. 751-52.
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    TFO Schwartz testified that he made his first UC visit to NPPM as 
UC Patient Rix on October 21, 2009 (October 21st visit).\9\ Upon 
arrival, Rix encountered an armed security guard and Donna Palemire, 
one of two non-physician owners of NPPM. Tr. 598-99. In response to an 
inquiry from UC Patient Rix, Palemire assured him that a one-and-a-
half-year-old MRI report would be sufficient to be admitted to the 
practice for treatment,\10\ asked him to make efforts to locate past 
pharmacy profile documentation, and referred him to her husband, non-
physician NPPM co-owner Anthony Laterza, to discuss ``rejuvenation'' 
therapy. Tr. 599-600.
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    \9\ An audio recording and a corresponding transcript were 
received into evidence. Gov't Ex. 13; Tr. 596.
    \10\ According to Schwartz, Palemire told UC Patient Rix that 
she could refer him to an MRI facility if his efforts to locate his 
18-month-old MRI proved fruitless. Tr. 600; See Gov't Ex. 40 at 1 
(MRI referral).
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    The wire transcript and audio recording received in evidence 
regarding the October 21st visit are consistent with Schwartz's 
recollection. See Gov't Ex. 13. Like Schwartz's testimony, the 
transcript reflects that in seeking admittance to the clinic as a new 
pain management patient, UC Patient Rix encountered Palemire, and that 
she instructed Rix that he needed to furnish an MRI report as a 
condition precedent to begin treatment. Id. at 4. Although UC Patient 
Rix asserted that he already had a year-and-a-half-old MRI somewhere in 
his possession, Ms. Palemire advised that the dated MRI would be fine 
``for now'' but that he would need to procure a recent one. Id. 
Palemire referred UC Patient Rix to an imagining place for another MRI, 
and told him to ask for ``Rose.'' Id. at 6; see Gov't Ex. 40 at 1 (MRI 
referral). Additionally, Palemire recommended that UC Patient Rix bring 
in a pharmacy profile and copies of prescriptions that he had received 
in the past. Gov't Ex. 13 at 7. When UC Patient Rix told Palemire that 
he did not want the doctor to be put off by his history of having taken 
80 mg oxycodone, Palemire reassured UC Patient Rix that the doctor 
would not be alarmed on that account. Id. Palemire explained, ``He * * 
* I mean she [sic] doesn't have a problem with [o]xycodone, but with 
[m]ethadone she does. But, if you come on [m]ethadone, she'll probably 
give it to you, but then kind of wean you off.'' Id. UC Patient Rix 
stated that he was seeking the 30 mg dose, which inspired Palemire to 
issue a warning that while the Respondent is ``cool'' and ``awesome,'' 
that Rix should not get himself caught in a lie because the doctor 
``doesn't like it.'' \11\ Id. at 7-8. The referral to Laterza for 
rejuvenation therapy in the form of human growth hormone (HGH) \12\ and 
testosterone is also confirmed by the transcript. See id. at 5, 10-11.
---------------------------------------------------------------------------

    \11\ Confusingly, this transcript reflects that Palemire used 
the terms ``he'' and ``she'' interchangeably.
    \12\ HGH is not a controlled substance, and under current Agency 
precedent, a consideration of its handling by the Respondent is 
irrelevant to the public interest determination that must be made in 
these proceedings. See Tony T. Bui, M.D., 75 Fed. Reg. 49979, 49988 
(2010) (``Because it is not a controlled substance, Respondent's 
prescribings of [HGH] could not have violated the CSA's prescription 
requirement.''). Testosterone, by contrast, is an anabolic steroid 
and a Schedule III controlled substance. 21 C.F.R. Sec.  
1308.13(f)(1); see 21 U.S.C. Sec.  802 (41)(A); 21 C.F.R. Sec.  
1300.01.
---------------------------------------------------------------------------

    TFO Schwartz testified that he again presented to NPPM as Rix two 
days later on October 23, 2009 (October 23rd visit).\13\ Tr. 603. 
According to Schwartz, Ms. Palemire explained some NPPM paperwork 
procedures, accepted the fictitious lumbar/thoracic MRI and pharmacy 
profile he offered as UC Patient Rix, and instructed him to wait for 
the Respondent's assistant. Tr. 605. According to Schwartz, while 
waiting to be seen by the assistant, Laterza coached him through the 
preparation of some paperwork, and advised him to indicate as many 
health issues as he could. Tr. 605-08. Specifically, the wire 
transcript indicates that Laterza advised Rix ``to have as many 
complaints as possible.'' Gov't Ex. 14 at 18.
---------------------------------------------------------------------------

    \13\ A transcript of the wire recording of the visit was 
received into evidence. Gov't Ex. 14; Tr. 604.
---------------------------------------------------------------------------

    It was at this point that UC Patient Rix encountered a female 
identified by Laterza as ``Dr. Betsy.'' Tr. 608. Schwartz later 
ascertained that ``Dr. Betsy'' \14\ is not really a doctor at all, but 
a nurse practitioner named Betsy Sanchez. See Tr. 777. Sanchez asked 
Rix if he had ``[a]ny medical history,'' Gov't Ex. 14 at 62, checked 
his heart rate and respiration, and applied pressure with her fingers 
below his navel, Tr. 609-10; Gov't Ex. 14 at 62-63. Nurse Sanchez told 
Rix that it would not be necessary for him to remove his shirt for the 
examination. Gov't Ex. 14 at 62. Laterza then left Rix alone with Nurse 
Sanchez, explaining that his rejuvenation portion of the visit was 
complete, and that Sanchez was going to ``triage [him] for [his] 
pain.'' Id. at 63.
---------------------------------------------------------------------------

    \14\ An examination of the wire transcript reveals that Laterza 
and Palemire go to considerable lengths to refer to Nurse Sanchez as 
``Dr. Betsy,'' see Gov't Ex. 14, and Nurse Sanchez never corrects 
anyone in UC Patient Rix's presence or intimates to Rix that she is 
not a physician, Tr. 823. There is no indication in the record, 
however, that this was done at the direction of the Respondent. 
Further, during Sanchez's interaction with UC Patient Rix, she tells 
him that she is ``gonna review this with the doctor.'' Gov't Ex. 14 
at 70; Tr. 796.
---------------------------------------------------------------------------

    Sanchez asked UC Patient Rix some questions about his reasons for 
seeking pain management. Intentionally omitting any reference to 
``pain,'' Tr. 790, Rix told her that he was a stunt man, that he 
experienced some ``stiffness,'' and that as he's getting older he does 
not ``recover'' as quickly from workouts as he did when he was young, 
Gov't Ex. 14 at 65; Tr. 618. Rix also told Sanchez that his previous 
pain clinic had closed up suddenly, rendering his prior charts 
unavailable.\15\ Gov't Ex. 14 at 65, 68. In response to questioning 
from Sanchez, Rix indicated that his pain was zero out of ten with pain 
medications, and four or five without. Id. at 67; Tr. 784. In this 
interview with Sanchez, as in the paperwork he filled out, Rix asserted 
that his discomfort was focused on his neck. Tr. 613; Gov't Ex. 14 at 
69. Thus, inasmuch as the fictitious MRI \16\ he provided related only 
to the lumbar/thoracic regions of his back, no objective evidence 
related to any neck malady was ever presented by this patient. The 
forms Rix completed also represented his pain levels between zero and a 
maximum of three and restricted the complaints to his neck.\17\ Tr. 
613; Gov't Ex. 4 at 5-6. Notwithstanding Rix's written and oral 
complaints centered on his neck, and his lumbar/thoracic MRI, neither 
his neck nor his back were examined by Sanchez, Laterza, or anyone else 
during the visit. Tr. 620-22.
---------------------------------------------------------------------------

    \15\ Rix, as part of his undercover ruse, described his prior 
pain clinic to Sanchez as ``the kind of place where you had fifty 
(50) people in the waiting room, five (5) doctors, and whoever the 
doctor was available [sic] was who you went to see.'' Gov't Ex. 14 
at 71. In fact, Rix told Sanchez that he was ``kinda glad they're 
closed.'' Id. By his description, UC Patient Rix unsubtly painted a 
picture of a pill mill. This description yielded no additional 
inquiry or corresponding chart note from Nurse Sanchez.
    \16\ Gov't Ex. 4 at 30.
    \17\ A copy of the NPPM patient chart prepared and maintained on 
UC Patient Rix was obtained by a signed release form and was 
received into evidence. Gov't Ex. 4; Tr. 613-15.
---------------------------------------------------------------------------

    In another, intentionally-engineered anomaly,\18\ UC Patient Rix 
provided Sanchez with a physician name that conflicted with the 
information he provided on the fictitious pharmacy printout to see if 
it would generate a reaction from her. Tr. 619, 788-89; Gov't Ex. 14 at 
70. It did not. Id. Sanchez told Rix that she would review his case 
``with the doctor,'' and would ``find out[] when he's coming.'' Gov't 
Ex. 14 at 70, 72. In the waiting room, Palemire told Rix that the 
Respondent was in surgery and that Sanchez would ``call [the 
Respondent], review the chart over

[[Page 63123]]

the phone and then * * * [Rix would be] good to go.'' Id. at 72. During 
his post-exam wait, Laterza counseled him that when he meets the 
Respondent (an event that ultimately did not occur during this UC 
visit), that he should ``[l]ook, talk, walk like you're in pain [and 
that] I want to see absolute suffering in you.'' Id. at 74.
---------------------------------------------------------------------------

    \18\ See Tr. 762-63.
---------------------------------------------------------------------------

    Approximately an hour and a half later, Sanchez informed UC Patient 
Rix that the Respondent had approved prescriptions for controlled 
substances, but in lesser amounts than Rix's (fictitious) pharmacy 
report had indicated he had been receiving in past. Id. at 100; Tr. 
622-23. Schwartz testified that he watched as Sanchez printed out 
controlled substance prescription scripts (as well as a script for 
physical therapy with no recommended or identified source for that 
modality) \19\ that bore the Respondent's printed name. Tr. 624-25. 
Schwartz also testified that he saw Sanchez write something on or near 
the prescription scripts, but was unable to tell if she was signing 
them. Id. at 625. Schwartz testified that shortly after receiving the 
signed scripts (a remarkable development in light of the Respondent's 
absence from the room where the documents were printed and handed to 
Rix), he handed them to Palemire, who stepped into a dispensing area, 
filled the prescriptions, and handed the controlled substances over. 
Tr. 626-27, 715-16, 723-24; \20\ see Gov't Ex. 38 at 1(a), 2(a); Gov't 
Ex. 39 at 4, 6-7. Schwartz left NPPM that day with the dispensed 
controlled substances and never encountered the Respondent, who he was 
told, was performing surgery. Gov't Ex. 14 at 71, 99. TFO Schwartz 
testified that during those visits to NPPM where he did not encounter 
the Respondent, the layout of the clinic and the open doors (except for 
the restroom door) gave him confidence that if the Respondent had been 
on premises, Schwartz would have seen him. Tr. 775-77.
---------------------------------------------------------------------------

    \19\ Tr. 627.
    \20\ While later in his testimony TFO Schwartz misidentified 
pictures depicting a bottle of 2 mg alprazolam tablets as dispensed 
to him on December 21, 2009, the photographs clearly show a dispense 
date of October 23, 2009. Compare Tr. 724, with Gov't Ex. 38 at 
2(a).
---------------------------------------------------------------------------

    Schwartz returned to NPPM as UC Patient Rix to pick up a lab 
requisition form on November 2, 2009.\21\ There was also a visit where 
Schwartz introduced another undercover officer to Laterza as part of 
the operation, and some telephone exchanges related to the logistics of 
picking up medications. Tr. 638-43; Gov't Ex. 18.
---------------------------------------------------------------------------

    \21\ An audio recording and corresponding transcript were 
received in evidence. Gov't Ex. 15; Tr. 631.
---------------------------------------------------------------------------

    UC Patient Rix finally got to meet the Respondent during the course 
of his fifth UC visit to NPPM, which occurred on November 21, 2009 
(November 21st visit).\22\ The November 21st visit started with Laterza 
opening and explaining the hormone therapy medications and enthanate (a 
Schedule III controlled substance testosterone medication) that were 
shipped to Rix in care of NPPM. Tr. 644-46. Laterza agreed to keep the 
delivered medications refrigerated while Rix was seen by the 
Respondent. Tr. 644-45.
---------------------------------------------------------------------------

    \22\ An audio recording and corresponding transcript were 
received in evidence. Gov't Ex. 19; Tr. 644.
---------------------------------------------------------------------------

    After a short wait, the Respondent called UC Patient Rix into an 
examination room. Tr. 646-47. Schwartz testified that the Respondent 
had the Rix patient chart as the two men entered the examination room. 
Id. at 647. UC Patient Rix explained to the Respondent that he had been 
seen by ``Dr. Betsy'' and Laterza during his prior visit to NPPM, and 
that he received controlled pain medications from the former and 
controlled testosterone from the latter. Id. at 647-48. Furthermore, 
Rix informed the Respondent that ``Dr. Betsy'' had provided him with 
pain medication at a reduced level from what he had been prescribed by 
his former pain clinic. Id. Rix asked the Respondent about obtaining 
additional medication for breakthrough pain, acknowledged that he had 
run out of the pain medication that had been previously issued to him 
by ``Dr. Betsy'' at his last visit to NPPM, and confessed that he had 
procured more pain medicine ``from some people.'' Id. at 647; Gov't Ex. 
19 at 19. Rix also mentioned to the Respondent that his last pain 
clinic was frequented by ``shady people'' and closed after a Molotov 
cocktail was thrown through a clinic window. Gov't Ex. 19 at 19. 
Additionally, UC Patient Rix inquired as to whether the Respondent (his 
pain management physician) thought that two years was enough for him to 
train to compete in a triathlon. Tr. 648; Gov't Ex. 19 at 22.
    The Respondent, who had the Rix patient chart in hand, absorbed 
Rix's representation that he had received controlled substances from 
Laterza and ``Dr. Betsy'' without comment or discernible reaction. Tr. 
647-48. Likewise, he did not question Rix about which ``people'' 
supplemented his controlled substance pain medications when he ran out, 
why he had previously frequented an unsavory pain clinic, or even why 
he needed pain medication at all if he felt fit enough to commence a 
truncated triathlete training regimen. Tr. 647-49. To the contrary, the 
Respondent's reaction to the input he received from Rix was to issue a 
script (that was filled by NPPM) increasing his Roxicodone dosage by 
one additional pill a day from the level set the previous month by 
Nurse Sanchez, with the reassurance that he generally commences 
prescribing medication for breakthrough pain at the third visit. Tr. 
649, 718, 725; Gov't Ex. 19 at 20; Gov't Ex. 4 at 24; Gov't Ex. 38 at 
4(a); compare Gov't Ex. 4 at 24 (script for 150 Roxicodone 30 
mg issued November 21, 2009), with Gov't Ex. 4 at 27 (script for 
120 Roxicodone 30 mg issued October 23, 2009). During this 
November 21st visit, UC Patient Rix was not asked to fill out any 
additional questionnaires or other paperwork,\23\ he was not examined 
(or even touched) by the Respondent or anyone else at NPPM, no vital 
signs were taken, and he was never asked about side effects or pain 
issues. Tr. 649-50. There was no discussion about Rix's fictitious MRI 
and its facial inconsistencies with his paperwork (neck versus back), 
and no treatment plan, goals for treatment, risks and benefits, or 
alternative treatments found their way into the discussion. Tr. 651. In 
fact, according to Schwartz, during the entire brief encounter, the 
Respondent was writing in the Rix patient chart or typing on the 
computer, and only even made eye contact with Rix ``for a few seconds 
at most.'' Tr. 649. The November 21st UC visit clearly established that 
the Respondent knew, or should have known (in the unlikely event that 
he did not already know), that UC Patient Rix was receiving controlled 
substances at NPPM issued on scripts over his printed name.
---------------------------------------------------------------------------

    \23\ Schwartz testified that as UC Patient Rix, he was never 
asked to fill out another form after the October 23rd visit. Tr. 
649.
---------------------------------------------------------------------------

    Schwartz returned to NPPM on December 18, 2009 (December 18th UC 
visit) \24\ and was seen by Nurse Sanchez. Tr. 661. UC Patient Rix told 
Sanchez that he had been hospitalized with the flu, lost weight, was 
working out, and only had three out of ten pain, but would like some 
breakthrough medication based on the Respondent's previous 
encouragement that breakthrough pain medication prescribing could 
commence at the third visit. Tr. 661; Gov't Ex. 24 at 8-11. When 
questioned on the issue of pain level, UC Patient Rix told Sanchez that 
``[i]t's not that it gets so bad, it's just that

[[Page 63124]]

I run out.'' Gov't Ex. 24 at 10. Rix even asked if the three of ten 
number pain assessment he provided was appropriate. Id.; Tr. 662. 
Sanchez demurred on Rix's request for breakthrough pain medication, 
emphasizing to Rix that the Respondent had just increased his dosage. 
Tr. 661-62, 800; Gov't Ex. 24 at 11. Again, this UC visit, like the 
visit before it, did not include any type of physical exam, treatment 
plan, objectives and goals discussion, medication risks and benefits 
discussion, alternative pain treatment modalities, or follow up on the 
previous script that recommended a physical therapy consult. Tr. 663-
64. At Sanchez's command, the examination room printer yielded the same 
compliment of prescription scripts for controlled substances that had 
been produced by the Respondent on the previous visit. Tr. 665; see Tr. 
719-20, 724, 727-28, 800-01; Gov't Ex. 38 at 2(a), 11(a), 12(a), 13(a); 
Gov't Ex. 39 at 22, 26. Sanchez wrote something on the prescription 
scripts, and the visit ended with controlled substance prescriptions 
being authorized and dispensed, and without the Respondent making an 
appearance.\25\ Tr. 665.
---------------------------------------------------------------------------

    \24\ An audio recording and corresponding transcript were 
received in evidence. Gov't Ex. 24; Tr. 660.
    \25\ Schwartz testified that he did not know if any of the 
scripts issued to him during any of his visits to NPPM were pre-
signed. Tr. 812.
---------------------------------------------------------------------------

    The next NPPM visit by UC Patient Rix occurred on January 11, 
2010.\26\ Tr. 666. Upon UC Patient Rix's arrival at NPPM, Palemire told 
him that the Respondent was not in the office because his wife was in 
the hospital giving birth, but that because Rix was ``an established 
patient,'' he would not need to see the Respondent to get his 
controlled substance prescriptions. Tr. 671; Gov't Ex. 26 at 6. At 
Palemire's direction, Rix left the clinic and telephoned back on two 
occasions to query when he could return. Tr. 668; Gov't Ex. 25. On the 
second call, Palemire told Rix that he could come in. Gov't Ex. 25 at 
3; Tr. 668. Palemire handed Rix two controlled substance prescription 
scripts and dispensed the medications. Tr. 671-72, 728-29; Gov't Ex. 26 
at 15; see Gov't Ex. 4 at 18; Gov't Ex. 38 at 13(a), 14(a).
---------------------------------------------------------------------------

    \26\ An audio recording and corresponding transcript were 
received in evidence. Gov't Ex. 26; Tr. 670. An audio recording and 
transcript of a phone call to NPPM by UC Patient Rix wherein he 
attempted to negotiate an earlier refill visit date was also 
introduced into evidence. Gov't Ex. 28; Tr. 676. Rix convinced 
Palemire to advance the visit from January 16th to the 11th. Id.
---------------------------------------------------------------------------

    Schwartz did not return to NPPM for six months. On July 22, 2010, 
UC Patient Rix visited NPPM and told Palemire he has been away in 
California starring in films.\27\ Tr. 679. After a brief conversation, 
Palemire handed UC Patient Rix three controlled substance 
prescriptions. Tr. 680. Although Rix conversed with an individual named 
``Ted'' regarding rejuvenation therapy, he never met with any medical 
professional during this UC visit. Tr. 681. He was not asked anything 
further about his extended absence from the practice or what treatments 
and/or medications he received during the hiatus. No one asked if he 
had been taking medication during that time, or if not, how well (or 
poorly) he was able to manage his activities of daily living without 
the benefit of controlled substance medications.
---------------------------------------------------------------------------

    \27\ An audio recording and corresponding transcript were 
received in evidence. Gov't Ex. 31; Tr. 678.
---------------------------------------------------------------------------

    The testimony presented by TFO Schwartz was sufficiently detailed, 
consistent, and plausible to be found fully credible. Schwartz's 
demeanor appeared forthright and candid, and although his recollection 
of the relevant events was excellent, he demonstrated a consistent 
readiness to not acknowledge elements of the case where he was in any 
way unsure (e.g., whether Nurse Sanchez was affixing a signature to 
prescription scripts in his presence).
    A patient chart maintained by the Respondent's practice on UC 
Patient Rix was received into evidence. Gov't Ex. 4. The chart 
contained what the evidence established to be a compliment of forms and 
documents that are generally common to other patient charts from the 
Respondent's practice that were also admitted into evidence. These 
forms are collected, completed, and/or executed by the patient during 
initial intake procedures. See Tr. 617. These intake documents include: 
(1) A patient sign-in sheet; (2) a patient information form (Patient 
Intake Form); (3) a consent to treat and guarantee of payment form; (4) 
a Brief Pain Inventory (Pain Inventory); (5) a Patient Medication 
Management Agreement (Pain Med Contract); (6) a Contract for Long-Term 
Use of Opioid Analgesic (Opioid Contract); (7) an advisal to patients 
regarding possible criminal consequences under state law associated 
with acts of drug-diversion-related activity and consent for the 
Respondent's practice to cooperate in law enforcement efforts 
associated with diversion; (8) an advisal to patients regarding 
possible consequences of lost medication; (9) a HIPAA \28\ notice to 
patients; and (10) a driver's license photocopy. Gov't Ex. 4 at 2-14, 
34, 36; Tr. 615-17. Additionally, the chart contained forms that were 
completed by the Respondent and/or personnel at the practice, such as a 
Patient Reassessment Opioid Analgesic 4-A's+ Chart Note (Chart Note), 
as well as progress note pages (Progress Note Form), imaging reports, 
and copies of prescription scripts. Gov't Ex. 4 at 15-33, 35; see Tr. 
17-18, 21.
---------------------------------------------------------------------------

    \28\ Health Insurance Portability and Accountability Act of 
1996.
---------------------------------------------------------------------------

    In the Patient Intake Form, UC Patient Rix listed his occupation as 
an actor, described the purpose of the visit simply as ``pain,'' and he 
wrote that he heard of the Respondent's practice through a ``friend/
word of mouth.'' Id. at 3. Rix responded on the form that he was not 
involved in an auto accident. Id. Under a section labeled ``MEDICAL 
HISTORY: (CHECK ALL THAT APPLY),'' concerning a legion of listed 
medical ailments, conditions, diseases, and symptoms, Rix declined to 
identify a single malady, and responded that he had no allergies. Id.
    The Pain Inventory consists largely of questions prompting the 
Respondent to rate his pain and how it interferes with daily activities 
and quality of life on a ten-scale (with zero representing no pain and 
ten amounting to ``pain as bad as you can imagine''). Id. at 5-6. UC 
Patient Rix affirmatively indicated therein that he experienced pain on 
the same day different from ``everyday'' pain, and signaled that he 
experienced neck pain by circling the corresponding anatomical 
representation on a diagram. Id. Underneath the diagram, Rix expressed 
that his pain in the last twenty-four hours had been constant, to wit: 
he rated his pain at its least, worst, average, and at present all as a 
three. Id. Also within the last twenty-four hours, Rix marked that he 
had experienced no pain relief (zero percent) from pain treatments or 
medications, despite reporting in an adjacent area that he was 
receiving oxycodone 30 mg, oxycodone 15 mg, and Xanax for his 
discomfort. Id. The next array of seven questions inquired into the 
level of interference that the patient's pain caused with routine 
functions. Id. The scale employed also ranges from zero (does not 
interfere) to ten (completely interferes). Id. To these metrics, UC 
Patient Rix variably fixed his pain between one and three on a ten 
scale, and in another portion of the form, characterized his pain as 
``aching'' that has lasted more than a month. Id. at 6. Regarding the 
kinds of things that improve his pain or make it worse, Rix wrote in 
respectively ``medication'' and ``no medication.'' Id. At another part 
of the form, Rix declined to circle any of a large number of symptoms. 
Id.
    The fictitious reports supplied to NPPM by Schwartz are in the Rix 
chart.

[[Page 63125]]

The fictitious MRI report reflects some multilevel mild thoracic and 
lumbar spondylosis, that there is no evidence of cord injury, and that 
there was no evidence of fracture history. Id. at 31. The fictitious 
pharmacy history indicates five prescriptions for controlled substances 
filled on two occasions during non-consecutive months and prescribed by 
two different doctors.\29\ Gov't Ex. 4 at 33. A handwritten note across 
the bottom of the report reads ``South FL Pain,'' ``Moved to Pain 
Manager,'' ``Broward Co.'' Id.
---------------------------------------------------------------------------

    \29\ This is yet another none-too-subtle reference to possible 
doctor shopping and a potential red flag of possible diversion that 
received no discernible heightened scrutiny during the visit or in 
the patient chart.
---------------------------------------------------------------------------

    During the October 23rd examination, Nurse Sanchez prepared a Chart 
Note. Gov't Ex. 4 at 28-29. Under a section denoted ``Current Analgesic 
Regimen,'' Sanchez wrote oxycodone 30 mg 210, oxycodone 15 mg 
90, and Xanax 2 mg 30, with a note in the left margin 
signifying that they were all last filled in September 2009 (the month 
before this visit). Id. Under a section styled ``Analgesia (average/
best/worst pain intensity; % pain relief),'' is found ``best 0/10'' and 
``worst 4/10.'' An ``Activities of Daily Living (functional status/
relationships/mood)'' section does not list any activities of daily 
living, but does contain the phrase ``stunt man.'' Id. Zeros are 
entered in sections entitled ``Adverse Events (type/severity),'' and 
``Aberrant Drug-Related Behaviors (type/severity).'' Id. ``MRI 5/08 -> 
mild spondylosis'' are inscribed under ``Monitoring Tests/Reports 
(urine screen/pill counts/other).'' Id. at 29. UC Patient Rix's 
physical and psychological assessment does not contain any diagnoses, 
but does state that Rix is ``pleasant.'' Id. Sanchez's notes related to 
the physical examination are not entirely legible, but do include a 
notation that UC Patient Rix is 38 years old, is in no apparent 
distress, and has clear lungs. Id. Below the physical examination 
findings is a front and back body sketch, with X's drawn upon the neck 
and lower back of the posterior depiction. Id. Further below the 
sketches is a section entitled ``Action Plan (continue/adjust/
discontinue therapy),'' wherein the controlled substances that were 
ultimately prescribed to Rix that day (``Roxi 30 mg 120'' and 
``Xanax 2 mg 30'') are indicated. Id. In a space designed for 
the medical professional to enter additional comments, Sanchez wrote 
the word ``obtain.'' Id.
    The Government presented testimony and a written report from Mark 
A. Rubenstein, M.D., FAAPMR, FAAEM. Tr. 24-25; Gov't Ex. 11. Dr. 
Rubenstein, a Florida-licensed physician and academic, whose 
qualifications include a board certification in Physical Medicine and 
Rehabilitation with a subspecialty certificate in Pain Medicine, as 
well as extensive experience serving as a medical expert to multiple 
entities in varied litigation forums,\30\ was offered and accepted as 
an expert in the area of pain management. Tr. 21, 129; see Gov't Ex. 
10. Rubenstein testified that he was compensated at a rate of $750.00 
per hour for his testimony, $500.00 per hour for his preparation time, 
and that there was no cap fixed on the compensation arrangement. Tr. 
118.
---------------------------------------------------------------------------

    \30\ Tr. 129.
---------------------------------------------------------------------------

    Dr. Rubenstein's report and testimony set forth his professional 
evaluation of six patient charts seized from the Respondent's practice, 
including the chart maintained on UC Patient Rix. Tr. 27. As a 
preliminary matter, it is worthy of note that the format of Dr. 
Rubenstein's report was confusing and singularly unhelpful. While a 
critical objective of securing expert assistance is to aid the trier of 
fact in analyzing and processing material that can benefit from 
expertise beyond the ken of the ordinary citizen, Dr. Rubenstein's 
report is disorganized, unfocused, and written in a manner that 
bespeaks a free association narration of documents and other items 
provided to him by the Government in no particular order. A principal 
reason for the difficulty in utilizing the report undoubtedly comes 
from the manner of its genesis. Rubenstein testified that over time he 
has developed a relationship with the Florida State Attorney's Office 
wherein he would review files and provide whatever opinions he felt the 
documents warranted, with scarce guidance regarding a specific mandate. 
Tr. 28-29. Moreover, Rubenstein was asked to review a mass of paper 
wherein patient charts that were eventually properly admitted into 
evidence are interspersed with DEA investigative reports and other 
documents that were not. Tr. 35; Gov't Ex. 12. The exhibit that 
contained the documents reviewed by Dr. Rubenstein was admitted into 
evidence in these proceedings as a single exhibit (Expert Review 
Package), Tr. 28-29, for the singular purpose to enable a review ove