Bienvenido Tan, M.D.; Denial of Application, 17673-17694 [2011-7394]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 76, Number 61 (Wednesday, March 30, 2011)]
[Notices]
[Pages 17673-17694]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7394]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 09-12]


Bienvenido Tan, M.D.; Denial of Application

    On October 31, 2008, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Bienvenido Tan, M.D. (Respondent), of Newhall, 
California. The Show Cause Order proposed the denial of Respondent's 
application for a DEA Certificate of Registration as a practitioner, on 
the ground that ``his registration is inconsistent with the public 
interest.'' ALJ Ex. 1, at 1.
    More specifically, the Show Cause Order alleged that on April 12, 
2007, Respondent ``voluntarily surrendered [his] controlled substances 
privileges'' when he was under investigation for illegally distributing 
controlled substances, and that in February 2008, he had applied for a 
new registration. Id. The Order alleged that ``[l]aw enforcement 
personnel conducted at least eleven (11) undercover visits'' to 
Respondent's office between October 2006 and March 2007 and that on 
several occasions, he had prescribed Lorcet and Vicodin, schedule III 
controlled substances which contain hydrocodone, as well as alprazolam, 
a schedule IV controlled substance, to them ``with cursory or no 
medical examinations, and without a legitimate medical purpose.'' Id. 
(citing 21 CFR 1306.04).
    The Show Cause Order further alleged that a medical expert had 
reviewed Respondent's files and ``found `strong

[[Page 17674]]

evidence for inappropriate prescribing of controlled [substances]'' and 
that his ``prescribing was `an extreme departure from the standard of 
care expected of a licensed practicing physician.' '' Id. at 2. The 
Order also alleged that Respondent had admitted to investigators that 
he ``authorized an employee to dispense controlled substances to [his] 
patients in violation of state law.'' Id. at 1 (citing Cal. Bus. & 
Prof. Code Sec.  4170).
    By letter of November 4, 2008, Respondent timely requested a 
hearing and the matter was placed on the docket of the Agency's 
Administrative Law Judges (ALJs). Following pre-hearing procedures, an 
ALJ conducted a hearing from March 24 through March 26, 2009 in Los 
Angeles, California. At the hearing, both parties called witnesses to 
testify and submitted documentary evidence. Thereafter, both parties 
filed post-hearing briefs.
    On January 8, 2010, the ALJ issued her recommended decision (also 
ALJ). Therein, the ALJ considered the evidence relevant to the five 
public interest factors. See 21 U.S.C. 823(f).
    As to factor one--the recommendation of the appropriate State 
licensing board--the ALJ found that the Medical Board of California 
(``the Board'') had not made a recommendation in this matter. ALJ at 
34. The ALJ then noted that the Board had brought a proceeding against 
Respondent based on its review of three patient files (which are not at 
issue in this proceeding), but had found that ``cause did not exist to 
discipline the Respondent's medical license `for prescribing without a 
good faith examination and medical indication, as to all three 
patients.' '' Id. The ALJ noted, however, that the Board found that 
``cause did exist to discipline Respondent's medical license `for 
maintaining inadequate records' for one of the three patients'' and 
that the Board ``publicly reprimanded the Respondent `for his 
departures from the standard of care regarding his medical record 
keeping' of that specific patient.'' Id. at 34. The ALJ did not make a 
finding as to whether this factor weighed for or against a finding that 
Respondent's registration was inconsistent with the public interest. 
See id.
    The ALJ then considered factors two and four--the applicant's 
experience in dispensing controlled substances and his compliance with 
applicable Federal, State, or local laws related to controlled 
substances--together. Under these factors, the ALJ considered evidence 
pertaining to various undercover visits by a Special Agent (SA) and 
Confidential Informant (CI), Respondent's dispensing practices, his 
office procedures, and his recordkeeping. Id. at 35-39.
    With respect to the undercover visits, the ALJ did not make 
findings as to whether the prescriptions Respondent issued to the SA or 
CI violated the CSA's prescription requirement. Id. at 36-37. Instead, 
the ALJ observed that ``[t]he primary concern regarding the Respondent 
is his dispensing practices.'' Id. Noting that the evidence showed that 
``Respondent is dispensing multiple times more dosage units than the 
patient should consume, if taking the medication as prescribed,'' the 
ALJ explained that ``either the patient is at risk of taking an 
overdose of the controlled substances, or the patient is diverting the 
controlled substances to the illicit market.'' Id. at 37. ``Based on 
this factor alone,'' the ALJ concluded that ``the Government has 
established a prima facie basis for denying * * * Respondent's 
application for a DEA registration.'' Id. at 38.
    The ALJ further found that Respondent ``is allowing unlicensed 
office staff to fill and dispense controlled substances.'' Id. She also 
found that Respondent did not require his pain patients to undergo 
urine or blood screens to determine whether they were actually using 
the drugs he prescribed and to determine whether they were taking drugs 
obtained either from other doctors or on the street. Id. The ALJ 
concluded that this ``allows diversion of such medications without 
detection by * * * Respondent.'' Id.
    The ALJ also found relevant Respondent's continuing to prescribe 
controlled substances without obtaining his patient's medical records. 
Id. She further noted that Respondent increased dosages without 
performing physical examinations, and that in some cases, he continued 
to prescribe controlled substances to patients for ``almost a year'' 
without seeing them. Id. at 38-39. Finally, she noted that while in 
some cases, he had indicated ``his desire to decrease the dosage units 
of controlled substances,'' he would ``oftentimes without even seeing 
the patient * * * return to the higher dosage without recording his 
treatment plan or otherwise explaining the higher dosage in the 
patient's records.'' Id. at 39. The ALJ, therefore, concluded that 
these factors support a finding that Respondent's registration is 
inconsistent with the public interest.\1\
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    \1\ With respect to factor three--Respondent's record of 
convictions for offenses related to the dispensing or distribution 
of controlled substances--the ALJ noted that there is no evidence 
that he has been convicted of an offense within this factor. ALJ at 
39.
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    Turning to factor five--such other conduct which may threaten the 
public health and safety--the ALJ reviewed the reports of each party's 
experts (who had examined various patient records) regarding the 
standard of care for prescribing controlled substances. Id. at 39-43. 
The ALJ noted that she had ``a problem with the conclusions of both 
expert witnesses.'' Id. According to the ALJ, this was so because the 
Government's expert had opined that Respondent's care was ``markedly 
below the accepted standards of licensed physicians in the United 
States today,'' thus suggesting that he had not applied the standard 
applicable under California law, id. at 40-41, and Respondent's expert 
had opined that he should be compared against ``physicians of similar 
age, training, and background,'' which ``is not the standard followed 
in California.'' Id. at 41.
    The ALJ noted, however, that in preparing his report, the 
Government's Expert had relied on the Medical Board of California's 
``Guidelines for Prescribing Controlled Substances for Pain.'' Id. at 
42. Because the Government's Expert's conclusions were ``more 
consistent with the California requirements for determining the 
standard of care,'' she found persuasive his findings that Respondent's 
charting practices were ``extremely deficient,'' that there were 
``inadequate records of consultation requests for further medical 
evaluations,'' and that ``it would not be safe [for a patient] to 
ingest the quantity of controlled substances received in that short of 
a period of time'' as occurred between the dates on which Respondent 
dispensed controlled substances to the various patients. Id. at 40, 43. 
The ALJ thus found that this ``factor * * * weighs in favor of denying 
the Respondent's application,'' and that ``[i]n total * * * the 
Government has met its burden of proof in presenting a prima facie case 
for denying the Respondent's application for a DEA registration.'' Id. 
at 43.
    The ALJ then discussed various facts she deemed favorable to 
Respondent. These included that he ``was not dispensing controlled 
substances for monetary gain,'' that he ``refused to prescribe 
Oxycontin because of its addictive properties,'' that he ``refused to 
prescribe controlled substances for recreational purposes,'' and that 
because he had a major increase in patients, he did not see them as 
often as necessary and did not keep careful track of his refills. Id. 
at 43-44. The ALJ further noted that ``Respondent credibly testified 
that, if given a DEA registration, he would use the CURES

[[Page 17675]]

database \2\ and he would limit his prescribing of controlled 
substances to the PDR \3\-defined limits.'' Id. at 44. The ALJ 
nonetheless concluded that ``this does not go far enough'' because 
Respondent had failed ``to address his use of unlicensed individuals to 
dispense controlled substances,'' as well as what ``procedures he would 
put in place to monitor his patients to ensure they were consuming the 
controlled substances as prescribed.'' Id. at 44-45. Thus, the ALJ 
recommended that ``Respondent's application for a DEA registration * * 
* be denied at this time.'' Id. at 45.
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    \2\ CURES is a database maintained by the State of California, 
Bureau of Narcotics Enforcement, from which doctors may obtain 
Patient Activity Reports (PARs) showing a patient's controlled 
substance prescriptions and who prescribed them. GX 39; Tr. 104. 
Dispensers of controlled substances, including pharmacies and 
physicians who dispense, must report to CURES. Id. Thus, the PARs 
allow a physician to determine whether a patient is receiving 
controlled substances from other doctors and is thus engaged in 
doctor shopping. Id. at 103.
    \3\ The PDR, or Physician's Desk Reference, contains 
manufacturers' recommendations as to the dosing of drug products. RX 
D, at 3.
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    On January 28, 2010, Respondent filed Exceptions to the ALJ's 
Decision; these Exceptions have been considered and are discussed 
throughout this decision. Respondent also requested that the ALJ reopen 
the record and admit his Exhibit A, which is a sworn statement signed 
by him and dated January 27, 2010, addressing the ALJ's findings that 
he had failed to address several critical deficiencies identified in 
the proceedings. Resp. Exceptions at 10.
    On February 16, 2010, the ALJ denied Respondent's request, noting 
that Respondent should have been aware of ``the Agency's longstanding 
rule'' that where ```the Government has made out a prima facie case 
that a practitioner has committed acts which render his registration 
inconsistent with the public interest, the relevant inquiry is whether 
a practitioner has put forward `sufficient mitigating evidence to 
assure the Administrator that he can be entrusted with the 
responsibility carried by such a registration.' '' Order Denying 
Respondent's Request to Reopen the Record and Include ``Exhibit A,'' at 
2 (citations omitted). The ALJ further explained that ``this inquiry 
looks to whether the registrant has accepted responsibility for his 
misconduct and undertaken corrective measures to prevent the re-
occurrence of similar acts.'' Id. While noting that ``[t]he evidence 
might have proven material when considering whether or not Respondent's 
continued registration would be a threat to the public interest,'' the 
ALJ noted that the evidence was available at the time of the hearing 
and that Respondent had the ``burden of persuasion'' on the issue. Id. 
at 4. She therefore denied Respondent's request to reopen the record. 
Id. Finding no error, I adopt the ALJ's ruling denying Respondent's 
request to reopen the record.
    Thereafter, on February 18, 2010, the ALJ forwarded the record to 
me for final agency action. Having reviewed the record in its entirety 
and considered Respondent's Exceptions, I adopt the ALJ's findings 
except as expressly noted herein. I also adopt her recommendation that 
I deny Respondent's application. As the ultimate finder of fact, I make 
the following findings.

Findings

    Respondent has been a licensed physician and surgeon in the State 
of California since 1959; he was 83 years old at the time of the 
hearing. ALJ Ex. 3, at 1; Tr. 553. Respondent previously held a DEA 
Certificate of Registration, which authorized him to dispense 
controlled substances in schedules II through V. GX 2. However, on 
April 12, 2007, Respondent voluntarily surrendered his registration. 
Id. On February 29, 2008, Respondent applied for a new registration; 
this application is at issue in this proceeding. ALJ Ex. 3, at 2; GX 1.
    Until 1998, Respondent primarily practiced as a surgeon. During 
this period, he also had a family practice with four offices and 
operated a dispensary on the premises of his practice for thirty to 
forty years. Tr. 562, 570, 598. From 1968 through 1998, he owned and 
operated Newhall Community Hospital, where he was the Medical Director 
and also a staff surgeon. Id. at 599, 602. During the course of his 
surgical career, Respondent had occasion to prescribe pain medications; 
while running the hospital he often had discussions with colleagues on 
pain medicine issues. Id. at 597, 602.\4\
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    \4\ Respondent excepted to the ALJ's Decision arguing that it 
``neglect[ed] to recognize Respondent's medical training as a 
surgeon and his years of experience with pain management as a 
surgeon and as the chair of the Newhall Community Hospital and as a 
participant in hospital peer review proceedings dealing with pain 
management.'' Resp. Exc., at 4.
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    In 1998, Respondent opened his current family practice. Tr. 563. 
While he is not formally trained in pain management, in 2003 he 
attended a 5-day course on pain management. Id. at 564, 638. At that 
course, he learned about Pain Management Agreements and Patient Comfort 
Assessment Guide tools, which he began to utilize in his practice. Id. 
at 307-09.

The State Board Proceeding

    On June 20, 2006, the Medical Board of California (the Board) filed 
a seventeen-count accusation against Respondent's medical license based 
on his treatment of patients P.P., D.F., and K.Z. RX A, at 2; RX V. The 
allegations included, inter alia, that Respondent had prescribed 
various drugs without performing adequate physical examinations and 
taking adequate histories, that he had committed negligent and 
incompetent acts, and that he had failed to maintain adequate records. 
RX V.
    On April 2, 2007, a State ALJ rejected all of the allegations 
except for that which alleged that Respondent's recordkeeping with 
respect to K.Z. was inadequate. RX A, at 18. The State ALJ thus 
recommended that Respondent be ``publicly reprimanded * * * for his 
departures from the standard of care regarding his medical record 
keeping of patient K.Z.'' Id. at 22. On May 4, 2007, the Board adopted 
the State ALJ's decision. Id. at 1. Of note, in this proceeding, the 
Government does not rely on Respondent's treatment of any of these 
three patients.\5\
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    \5\ In his decision, the State ALJ found that Respondent had 
told patient K.Z. that he could take Vicodin at the rate of up to 
twelve tablets per day. RX A, at 6. The ALJ also found that one of 
the Board's experts had observed that at one point, K.Z. would have 
been consuming ``approximately nine grams of Acetaminophen'' per day 
and that the expert ``considered any quantity over four grams of 
Acetaminophen [per day] troubling.'' Id. at 10. While the State ALJ 
found that the Physician's Desk Reference (``PDR'') states that 
```[t]he total 24 hour dose [of Vicodin] should not exceed five 
tablets,' '' id. at 13, he did not make any further finding as to 
whether there is an appropriate maximum dose of drugs containing 
acetaminophen such as Vicodin and simply concluded that the Board 
had failed to show that Respondent's ``off-label dosage instructions 
departed from the standard of care.'' Id. at 20. This is not the 
same as saying--as Respondent testified--that the Board found that 
the maximum safe dosage of Vicodin ES is twelve tablets per day, and 
of Lorcet, eighteen tablets per day. Tr. 299-300. Indeed, according 
to one of the findings of the State ALJ's decision, 
``[a]cetaminophen is potentially toxic if between 7.5 to 10 grams 
are consumed daily for one to two days.'' RX A, at 14 (citation 
omitted).
     However, for the purpose of resolving this proceeding, I accept 
the premise that Respondent had a good faith belief that a patient 
can safely consume up to 9 to 10 grams per day of acetaminophen. 
However, even accepting this, there was ample other evidence 
including an expert's report establishing the need to perform 
regular blood tests to determine how ingesting this much of the drug 
is affecting a patient's liver function.
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The DEA Investigation

    In either August or September 2006, DEA's Los Angeles Field 
Division received information from a confidential source that 
Respondent was

[[Page 17676]]

unnecessarily prescribing hydrocodone to the ``younger, mid-twenties 
population.'' Tr. 24. Thereafter, a DEA Diversion Investigator (DI) 
obtained reports from the Controlled Substance Utilization Review and 
Evaluation System (CURES), the State's prescription monitoring program 
showing prescriptions issued for schedule II through IV controlled 
substances, as well as ARCOS, a DEA database which monitors the sale of 
Schedule III and IV controlled substances from manufacturers and 
distributors. Id. at 25-27; GX 39. While the CURES report showed 
``minimal activit[y],'' Tr. 26, the ARCOS report showed that between 
2004 and 2006, Respondent's purchases of hydrocodone had increased from 
63,600 tablets to 388,000, and that between January 1 and April 11, 
2007, Respondent purchased 221,000 such tablets. Id. at 26-27; GX 4.\6\ 
According to the DI, such large hydrocodone purchases were not 
consistent with a family practice or even with the operation of a 
typical family pharmacy, which he estimated might purchase 100,000 
hydrocodone tablets per year. Tr. 44. Among physician purchasers of 
hydrocodone in the Los Angeles area, Respondent ranked second; the 
ARCOS database could not be queried, however, as to a ranking for 
physicians who also operate their own dispensaries. Id. at 28-30, 34, 
43-44.
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    \6\ Respondent testified that during these years, his practice 
was growing. Tr. 282. In 2004, he had 1,740 patients; in 2005, he 
had 1,970 patients; in 2006, he had 2,320 patients; and in 2007, he 
had 2,353 patients. Id. He indicated that the reason for this 
increase was that prior to his heart surgery in 2003, he had 
retained a physician's assistant at his practice. Id. at 283. 
However, on losing patients after the heart surgery, he had 
dismissed the physician's assistant. Id. He attributed the 
subsequent growth of his practice to the fact that the patients were 
able to see him instead of just a physician's assistant. Id. at 284. 
Respondent further testified that with the increase in patients, he 
also experienced an increase in pain patients and therefore 
increased his purchases of Vicodin and other opioids. Id. The ALJ 
``generally f[ou]nd the Respondent's testimony credible.'' ALJ at 10 
n.4.
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    During the investigation, the DEA sent an undercover special agent 
(SA) using the name of ``Kim Jackson'' to Respondent in an attempt to 
obtain controlled substances. Tr. 51. The SA wore a wire and was 
monitored by a DI. Id. at 52.
    At the SA's first undercover visit with Respondent on October 3, 
2006, she told Respondent that she had just moved from Montana and had 
been getting Vicodin, a Schedule III controlled substance which 
contains hydrocodone and acetaminophen, from a physician there. Tr. 
187, 192 (playing of GX 47 in hearing); GX 47; RX AA, at 1 (transcript 
of visit); see 21 CFR 1308.13(e). When Respondent asked her why she was 
taking the Vicodin, she responded, ``It just made me feel better.'' Tr. 
193; GX 47; RX AA, at 1. Respondent then said, ``No, you know, I don't 
prescribe Vicodin for recreational purposes or to feel better * * * 
because Vicodin is a controlled drug and it is specifically for 
specific pains, you know?'' Tr. 193-94; GX 47; RX AA, at 1. The SA then 
inquired whether ``if [her] back hurt'' would ``be a way to get'' the 
drug. Tr. 194; GX 47; RX AA, at 1. Respondent replied: ``Yeah, what 
happened to your back?'' Tr. 194; GX 47; RX AA, at 1. The SA answered: 
``I don't really specifically remember anything happening to it. But if 
it hurt, would Vicodin help it?'' Tr. 194; GX 47; RX AA, at 1. 
Respondent answered in the affirmative.
    Respondent then inquired about the doctor in Montana who had 
prescribed the Vicodin and whether that physician had obtained 
additional studies given her report of back pain. Tr. 194-95; GX 47; RX 
AA, at 1-2. The SA indicated that the doctor in Montana performed a 
physical examination but did not take x-rays or order any other tests. 
Tr. 195; GX 47; RX AA, at 2. Respondent then noted that it was 
``unusual'' for someone as ``young'' as the SA to be having back pain, 
and asked: ``where in your back are you having the pains?'' Tr. 195; GX 
47; RX AA, at 2. The SA answered: ``I don't specifically have it, I was 
just asking you if that would be a reason someone would have it?'' Tr. 
195; GX 47; RX AA, at 2. Respondent next stated, ``well you know, if it 
is for that reason for now * * * I can give you a prescription * * * 
which Vicodin are you using? Extra strength?'' Tr. 196; GX 47; RX AA, 
at 2. The SA told Respondent that she was getting 10 mg. strength. Tr. 
196.
    Shortly thereafter, Respondent then asked, ``Which part of your 
back are you hurting * * * show me where?'' Tr. 196; GX 47; RX AA, at 
2. The SA responded, ``Here.'' Tr. 196; GX 47; RX AA, at 2. She then 
elaborated, ``it's not really sensitive.'' Tr. 196; GX 47; RX AA, at 2. 
When Respondent asked her how long she had been having the pain, the SA 
replied, ``A couple years I guess.'' Tr. 196; GX 47; RX AA, at 2. 
Respondent indicated that he would write for thirty tablets of 10 mg. 
Vicodin (Vicodin ES) but that ``we have to have more documentation as 
to * * * why this [sic] controlled drugs * * * are being prescribed for 
you, you know?'' Tr. 196; GX 47; RX AA, at 2.
    Regarding her having pointed to her lower back and her statement 
that she had had pain for a ``couple years I guess,'' the SA testified 
that she had told Respondent several times that she ``was not in pain'' 
and that she wanted Vicodin ``because it made me feel good.'' Tr. 216. 
The SA further testified that Respondent was trying to provide her 
``with a story--oh, okay, yes, that works--back pain.'' Id. The SA also 
testified that Respondent did not appear to be hard of hearing as she 
was never asked to repeat herself. Id. While the SA acknowledged that 
Respondent may have been skeptical of whether she had pain, she 
testified that ``right after that, he agreed to give me the Vicodin 
without further examination or questions.'' Id. at 217.
    Respondent then indicated that he could either give her a 
prescription or that she could buy the medication from his dispensary. 
Tr. 197; GX 47; RX AA, at 3. The SA opted to buy her Vicodin from the 
dispensary. Tr. 197; GX 47; RX AA, at 3. Respondent instructed her to 
take the Vicodin as one tablet every eight hours. Tr. 198; GX 47; RX 
AA, at 3. The SA's visit with Respondent lasted approximately six 
minutes. Tr. 192, 199.
    The SA received a paper bag containing Vicodin from the 
receptionist. Tr. 201. According to the SA, she did not receive 
anything in writing from Respondent notifying her that she had the 
option of obtaining the medication either with a prescription from a 
pharmacy or from his dispensary. Id. at 201. When the DIs later counted 
the pills, there were thirty-five tablets, not thirty. Id. at 202.
    According to the patient record, Respondent observed a ``muscle 
spasm.'' GX 14, at 4. In her testimony, the SA stated that Respondent 
examined her back ``for maybe five seconds, at which time he touched me 
two to three times, lightly.'' Tr. 200. She also testified that 
Respondent never mentioned back spasms to her and that she never 
mentioned that she had back spasms to him. Id. The SA further testified 
that in examining her, Respondent never saw her skin as he did not lift 
the garment covering her back. Id. at 213.
    In his testimony, Respondent asserted that when he touched the SA's 
back, he noticed muscle spasms, which confirmed his ``impression that 
she did [have] back pain.'' Tr. 404. Respondent also testified that 
usually when he detects muscle spasms in a pain patient, he does not 
mention it to the patient but only notes it in the patient record as 
the observation is a ``confirmation for [his] own information.'' Id. at 
319. According to Respondent, a physical examination of the back 
largely ``is by palpation of the back muscles.'' Id. at 486. He further 
maintained that, in checking for muscle spasms, it is preferable to 
touch through light clothing rather than to touch skin directly so as 
to avoid cold hands triggering a muscle spasm. Id. at 320.

[[Page 17677]]

    Regarding the SA's visit, Respondent testified that in almost fifty 
years of practicing medicine he had never had a patient claim to not 
have pain yet request pain medication; nor had a patient who initially 
claimed to not have pain later claim to have pain. Id. at 404-05. 
According to Respondent, ``I don't believe, nor do I remember, that she 
told me that she did not have any back pain.'' Id. at 405.
    The ALJ found that ``Respondent credibly testified that he believed 
she was suffering from back pain for the past two years. He believed he 
saw muscle spasms, which would be consistent with back pain.'' ALJ at 
7. The ALJ did not explain how Respondent would have seen muscle spasms 
given the SA's testimony that he did not lift the garment that was 
covering her back. Nor did she reconcile her credibility findings with 
the actual conversation which was recorded during the visit which shows 
that Respondent had agreed to provide the Vicodin before the Agent had 
made any representation that she had back pain.
    If taken as instructed, the thirty pills that the SA should have 
received would have lasted a minimum of ten days. On October 19, the SA 
phoned Respondent's office and requested a refill of Vicodin and asked 
for sixty pills instead of the thirty of her initial prescription. Tr. 
202. The receptionist told her to call back after 3:00 to confirm 
whether the refill was approved. Id. When the SA called back, she was 
told that the refill had been approved; the SA picked up the 
prescription the following day. Id. at 203.
    If taken as prescribed, the refill should have lasted a minimum of 
twenty days. Eighteen days later, on November 7, the SA called for 
another refill and asked for 120 Vicodin because she was going out of 
town. Id. This time, the SA was not told to call back to verify whether 
the refill had been approved. Id. Two days later, the SA obtained the 
drugs. Id.
    At an appointment on December 1, 2006, the SA told Respondent that 
Vicodin made her nauseous and requested OxyContin. Tr. 203-04; RX Z, at 
2. Respondent stated that OxyContin had worse side effects and that he 
would give her Lorcet (another hydrocodone drug) instead. Tr. 204; RX 
Z, at 3. He also recommended that she get massaged with warm olive oil 
and use a heating pad on her back. RX Z, at 3-4. The SA received 120 
Lorcet from Respondent's staff on that day. Tr. 204. The SA also 
testified that although she had been asked to bring her medical records 
during the phone call in which she made her initial appointment, she 
never did and was never again asked to bring them. Id. at 205. On 
cross-examination, the SA testified that she did not receive early 
refills. Id. at 226.
    R.E., who had reported Respondent to the DI, also agreed to wear a 
wire and visit Respondent; a portion of the recording of his initial 
visit was played at the hearing. Tr. 55; GX 47. On October 13, 2006, 
R.E. visited Respondent. GX 12, at 3. R.E. complained of stiffness in 
his neck which he had had for ``a couple of years'' duration and said 
that he had been taking Norco, a drug which contains 10 mg. hydrocodone 
and 325 mg. acetaminophen. Tr. 60-61, 68; GX 12, at 3, GX 47. R.E. also 
indicated that he had tried acupuncture and ``[a] little yoga.'' Tr. 
63. He also complained that it was hard for him to fall asleep. Id. at 
64.
    During the visit, Respondent touched R.E. lightly on the neck a 
couple of times. While Respondent noted the presence of muscle spasms 
in R.E.'s patient record, the recording of the visit contains no 
comment by Respondent which indicates that he had found that R.E. had a 
muscle spasm. GX 12, at 3; Tr. 60-67. The DI also testified that when 
he interviewed R.E. after the visit, R.E. never mentioned that 
Respondent had said that he had muscle spasms. Tr. 122. Respondent 
advised R.E. to use a heating pad and to get someone to massage the 
muscles for him. Id. at 63. Respondent also told R.E. he could either 
provide, or write a prescription for, 60 Vicodin ES, as well as 60 
Xanax (alprazolam) to help him sleep. Id. at 64. R.E. opted to buy the 
drugs from Respondent's dispensary and Respondent instructed him to 
take one Vicodin ES every eight hours and one Xanax at night for sleep 
and another during the day ``if you need it.'' Id. at 65, 174; GX 12, 
at 3.
    If taken as directed, the Vicodin ES thus should have lasted twenty 
days; the Xanax should have lasted thirty days. On October 20, one week 
later, R.E. obtained a refill of 120 Vicodin ES. GX 12, at 5. According 
to R.E.'s patient record, on November 9, R.E. did a follow-up 
appointment with Respondent at which time Respondent switched him to 
Lorcet and dispensed to him 120 tablets, with the instruction to take 
one tablet every six hours. GX 12, at 5.
    While this quantity would have provided a thirty-day supply if 
taken as directed, on December 1 (twenty-two days later), R.E. obtained 
a refill of 150 Lorcet, 30 tablets more than the previous refill. While 
if taken as directed, this refill would have lasted thirty-seven days, 
only six days later on December 7, Respondent approved refills for 
another 150 Lorcet with the same dosing instructions, as well as for 60 
Xanax. Id. at 6.
    On February 27, 2007, R.E. received refills for 150 Lorcet (again a 
thirty seven-day supply) and 60 Xanax, with the same dosing 
instructions. Id. On March 13, R.E. obtained another refill for 150 
Lorcet and Respondent changed the dosing instruction to one tablet 
every four hours. Id. However, there are no notes indicating that 
Respondent had talked with R.E. and learned of any change in his 
condition that would support an increase in the dosing. Beside 
Respondent's initials on the phone message requesting the refill is the 
message: ``Need visit & agreement.'' Id. at 9. A note saying ``No 
Refill'' three times in a row followed by ``NEEDS TO BE SEEN,'' dated 
March 19, 2007 appears in R.E.'s patient record. Id. at 7.
    A CURES Patient Activity Report (PAR) indicates that R.E. received 
hydrocodone/apap 7.5 mg./300 mg. from another doctor on November 8, 
2006; Vicodin ES the following day from another doctor; and Suboxone 
\7\ from another doctor on November 22. GX 44, at 2. On December 6, 
2006, R.E. received more hydrocodone/apap 7.5 mg./300 mg., as well as 
diazepam, from yet another doctor; on February 13 and March 5, 2007, he 
received Suboxone from the same physician who had issued the 
prescription filled on November 22. Id.
---------------------------------------------------------------------------

    \7\ Suboxone is a drug which is used to detoxify addicts from 
narcotics. Tr. 111.
---------------------------------------------------------------------------

    R.E. had disclosed to DEA Investigators his consumption of 
Suboxone. Tr. 126. The DI testified that during the time that R.E. 
worked as a confidential informant, he had no reason to believe that 
R.E. was improperly consuming controlled substances.\8\ Id. at 179.
---------------------------------------------------------------------------

    \8\ The record does not indicate at what point DEA became aware 
that R.E. was obtaining controlled substance prescriptions from 
other doctors or what course of action investigators took as a 
result. Because my findings regarding Respondent's prescribing to 
R.E. are based on the recording of his visit (which was played into 
the record) and his patient file, R.E.'s credibility is not in 
issue.
---------------------------------------------------------------------------

    The investigators subsequently obtained warrants to search 
Respondent's office and residence. Id. at 70. On April 12, 2007, the 
warrants were executed and the authorities seized approximately one 
hundred patient records which were selected based on these persons 
having received large quantities of hydrocodone, Xanax, and Valium; the 
DIs also seized the patient files for the SA and CI. Id. at 90-91. 
During the search of Respondent's residence, the DIs interviewed him. 
Id. at 71.

[[Page 17678]]

    In the interview, Respondent indicated that he had approximately 
two thousand patients, including approximately fifty pain patients for 
whom he either wrote prescriptions or dispensed medication. Id. at 72. 
Respondent related that he took primarily cash patients and some 
MediCal patients but he did not take patients with private insurance. 
Id. at 90.
    Respondent further stated that an employee, H.C., filled the 
prescriptions at his dispensary. Id. at 73. According to the DI, H.C. 
was not licensed in California to dispense drugs. Id. Respondent told 
the DIs that those patients who wanted refills would call his office, 
that he reviewed the requests, and that where appropriate, he approved 
a refill. Id. He further stated that he would authorize a refill 
approximately once a month. Id. The DI testified that Respondent's 
statement as to the frequency of his authorizing of refills was not 
consistent with what he observed in the patient files. Id. at 73-74.
    As discussed below, the various patient records include slips 
memorializing the refill requests his patients phoned in. Respondent 
testified that upon reviewing these slips, he would instruct his staff 
to note on the slip when the patient had last received a refill 
(indicated by ``LR'') and/or the date when he/she had last been seen 
(indicated by ``LS''). Id. at 337-38. He further testified that he used 
follow-up visits to obtain ``information as to how that patient is 
doing at the particular moment'' which he would use ``either to keep 
the medications the same, lower it, or increase it.'' Id. at 337.
    Respondent further testified that H.C. repackages pain medications 
into smaller bottles and labels them with pre-labeled dosing 
instructions. Id. at 306, 328. H.C. then brings the pain medication to 
``the girl in front who in turn gives them to the patient who pays [for 
the drug] up front.'' Id. at 328.\9\
---------------------------------------------------------------------------

    \9\ Respondent later identified this individual as the 
receptionist, who first takes a patient's payment. Tr. 592.
---------------------------------------------------------------------------

    Respondent admitted, however, that he did not personally supervise 
the receptionist as she delivered the controlled substances to his 
patients. Id. at 593. He also testified that his pharmacy, including 
his manner of dispensing medication to patients, was inspected by the 
Medical Board on two separate occasions and that he was not cited for 
any infractions. Id. at 328-29. Respondent was not present during one 
of the inspections. Id. at 329.
    The DI also obtained additional PARs from CURES. These reports 
showed that four additional patients whose prescriptions were at issue 
in the proceeding obtained controlled substances from other physicians 
during the same period in which they obtained controlled substances 
from Respondent. Id. at 108-11; GXs 41, 42, 44, 45. California 
authorizes a licensed physician to obtain PARs ``so that well-informed 
practitioners can and will use their professional expertise to evaluate 
their patients' care and assist patients who may be abusing controlled 
substances.'' GX 39, at 2.
    Respondent testified that he was unaware of the availability of 
PARs until he saw the documents the Government was presenting in this 
proceeding. Tr. 343. He testified that, should his registration be 
restored, he would use the database when a patient is requesting 
refills too quickly, when a patient reports at his initial visit that 
he has already been on controlled substances, as well as thirty days 
after having prescribed controlled substances to a patient. Id. at 344, 
557-58.

The Expert Reports on the Standard of Care and Usual Course of 
Professional Practice

    At the hearing, neither party offered the testimony of an expert 
witness. However, each party submitted into evidence a report from a 
physician who had reviewed at least some of the patient files in 
question. GX 6; RX D. While neither party's witness was formally 
qualified as an expert (as would likely be the case if they had been 
called to testify), both parties referred to the physicians as experts 
and the ALJ treated them as such, as do I.
    The Government's Expert was Rick Chavez, M.D. Dr. Chavez, who holds 
a B.A. from Stanford University and obtained his M.D. from the U.C.L.A. 
School of Medicine, is the founder and Medical Director of The P.A.I.N. 
Institute and is an Assistant Clinical Professor of family medicine at 
the U.C.L.A. School of Medicine. GX 6, at 33; GX 5. Dr. Chavez holds 
board certifications in family practice, pain management, and addiction 
medicine. GX 5, at 1. He is a member of the American Academy of Pain 
Management, the Society for Pain Management, the American Society of 
Interventional Pain Physicians, the American Pain Society, and the 
American Academy of Addiction Psychiatry. Id. at 8.
    In addition to his medical practice, since 2001 Dr. Chavez has 
served as a Consultant/Physician Reviewer for the California Board of 
Medical Quality Assurance. Id. In this capacity, he reviews cases 
involving pain management, family medicine, addiction medicine, and 
general medical quality.\10\ Id.
---------------------------------------------------------------------------

    \10\ Dr. Chavez also has extensive experience in conducting 
utilization review and case management, which involves monitoring 
the activities of primary care physicians for excessive or 
unwarranted use of services in pain management, neurosurgery, 
plastic surgery, orthopedics, podiatry, and general surgery. GX 5, 
at 3-4. He has also ``developed guidelines for surgical, orthopedic, 
plastic surgery and pain management procedures to ensure appropriate 
utilization and quality of care.'' Id. at 4.
---------------------------------------------------------------------------

    Respondent's Expert was William A. Norcross, M.D. Dr. Norcross 
received a B.S. from Ursinus College and his M.D. from the Duke 
University School of Medicine and holds board certification in family 
practice and geriatric medicine. RX D, at 5. At the time of the 
hearing, he was the Director of the University of California--San 
Diego's Physician Assessment and Clinical Education (PACE) Program and 
a Professor of Clinical Family Medicine at the University's School of 
Medicine. Id. at 6. However, Dr. Norcross is not board-certified in 
pain management.
    In their respective reports, Dr. Chavez reviewed fifteen patient 
files; \11\ Dr. Norcross reviewed four patient files. See GX 6; RX D. 
In their reports, both Dr. Chavez and Dr. Norcross opined as to whether 
Respondent had met the standard of care. However, Dr. Chavez provided 
an extensive discussion of what steps Respondent was required to take 
in order to meet the standard of care and discussed the Medical Board 
of California's Guidelines for Prescribing Controlled Substances for 
Pain (Guidelines), which were first adopted in 1994.\12\ GX 6, at 16. 
By contrast, Dr.

[[Page 17679]]

Norcross's report discussed only whether he believed Respondent's 
``charting and clinical decision making,'' as well as his prescribing 
of drugs beyond the maximum recommended daily dosage listed in the 
Physician Desk Reference, met the standard of care. RX D.
---------------------------------------------------------------------------

    \11\ Dr. Chavez reviewed the patient records of W.C., J.D., 
R.A., M.T., B.W., S.M., M.H., D.M., ``Kim Jackson,'' R.E., E.A., 
J.N., M.D., J.W., and S.R. GX 6, at 2. Dr. Norcross reviewed the 
patient files of W.C., J.D., R.A., and M.T.; these files include 
three of the patients who, according to the PARs obtained by the 
Government, had obtained controlled substances from other physicians 
during the period in which Respondent prescribed to them. RX D, at 
1; GX 41-43.
    \12\ In his discussion of the standard of care, Dr. Chavez noted 
that the Board has promulgated Guidelines for Prescribing Controlled 
Substances for Pain, a copy of which was attached to the 
Government's Post-Hearing Brief. Gov't Post. Hrng. Br., App. E. 
These were adopted by the Board in 1994, GX 6, at 16, and were 
subsequently revised in 2003. Id. at 16; App. E, at 1. I take 
official notice of the fact that the Board adopted the revised 
Guidelines on August 1, 2003. The Guidelines are intended ``to 
improve effective pain management in California, by avoiding under 
treatment, over treatment, or other inappropriate treatment of a 
patient's pain and by clarifying the principles of professional 
practice that are endorsed by the Medical Board so that physicians 
have a higher level of comfort in using controlled substances, 
including opioids, in the treatment of pain.'' Id. at 1 (emphasis 
added).
     The Guidelines state that ``[t]he Medical Board expects 
physicians and surgeons to follow the standard of care in managing 
patients.'' Id. Under the heading ``History/Physical Examination,'' 
it provides that ``[a] medical history and physical examination must 
be accomplished. This includes an assessment of the pain, physical 
and psychological function; a substance abuse history; history of 
prior pain treatment; an assessment of underlying or coexisting 
diseases or conditions; and the documentation of the presence of a 
recognized medical indication for the use of a controlled 
substance.'' Id. at 2 (emphasis added).
---------------------------------------------------------------------------

    According to Dr. Chavez, ``[a]ccepted standards of medical practice 
require that physicians obtain a sufficient history and perform a 
focused physical exam when evaluating patients in chronic pain.'' GX 6, 
at 17. Furthermore, ``[b]efore prescribing narcotic analgesic 
medications[,] the physician should have an understanding as to the 
probable diagnosis and a picture of the overall general health of the 
patient.'' Id.
    Dr. Chavez explained that a physician must obtain a history of the 
condition, which includes determining the onset of the pain, the 
``[e]xact location and character of pain'' and use either ``a visual 
analogue'' or a ``1-10 scale'' to measure the pain level. Id. The 
physician must assess the degree of the patient's functional and 
physical impairment, which includes the patient's physical and 
psychological function, documentation of the presence of recognized 
medical indications for the use of controlled substances, and a 
substance abuse history with the latter being ``a basic requirement.'' 
Id. at 17-18. In addition, the physician should do a review of prior 
pain treatment and medications and determine the patient's ``response 
to previous treatment,'' as well as review the patient's medical 
records and test results from prior treatment. Id. Moreover, the 
physician must determine whether the patient has any coexisting or 
underlying conditions. Id. at 18.
    Dr. Chavez further explained that ``[b]ased on the patient's 
complaints, the physician must determine the most likely reasons for 
the patient's pain complaint'' and that ``[d]etermining the exact Pain 
Generator or source of pain requires a thorough focused exam which 
correlates with historical data.'' Id. Continuing, Dr. Chavez observed 
that ``[h]alf of all patients in chronic pain suffer from 1 or more 
other medical conditions and thus, may have multiple different 
diagnoses. Therefore, assessment of cardiac, renal, hepatic, GI, 
pulmonary, and psychiatric status are imperative before prescribing 
opiate analgesics and other medication which may not be indicated in 
particular medical conditions, or which may affect end-organ 
function.'' Id. Moreover, ``[i]t is of utmost importance that the 
physician keep an accurate and complete medical record with thorough 
documentation at every visit for each chronic pain patient.'' Id. Dr. 
Chavez also explained that a patient may require further testing to 
verify a presumed diagnosis and to assess major organ systems because 
prescribing certain drugs, including those containing Tylenol 
(acetaminophen), ``in a patient who may develop end organ damage may be 
contraindicated.'' Id. at 19.
    In this regard, Dr. Chavez further observed that ``[p]atients on 
large doses of medications which might cause serious side effects must 
have regular blood chemistries drawn in order to assess end-organ 
function and a baseline measurement of function. It is crucial for the 
treating physician to recognize early on whether any evidence of 
medication induced organ dysfunction is present.'' Id. at 29.
    According to Dr. Chavez, once the physician makes a diagnosis, a 
treatment plan should be created which lists, inter alia, the 
objectives of treatment, how the success of the treatment plan will be 
evaluated, and whether any further tests or consultations with 
specialists are required. Id. at 20-21. In addition, ``the prescribing 
physician should have discussed the risks and benefits of the use of 
controlled substances with the patient and have [obtained] a signed 
medication agreement with the patient, within the first [three] visits, 
which spells out the requirement for continued opioid therapy.'' Id. at 
20-21. Dr. Chavez further noted that ``[c]hronic pain treatment 
requires more than the use of opiate analgesic medications.'' Id. at 
30.
    Dr. Chavez observed that ``[i]t is not considered good medical 
practice to allow refills on addictive medications in pain patients 
unless they have been under the care of the physician for [a] long-term 
and/or are well-known to the prescribing physician.'' Id. at 20. 
Continuing, he explained that ``[f]requent visits and re-evaluation of 
the situation are necessary'' and that ``[i]t is prudent to see the 
opiate treated chronic pain patient once every 1 to 3 months.'' Id. He 
also explained that a ``[p]eriod of titration of medication and 
physician follow-up is necessary to determine [the] effectiveness of 
therapy or [to] re-evaluate whether the presumed diagnosis is 
correct.'' Id. at 22.
    In his review of the patient files, Dr. Chavez found that ``for 
each patient receiving opiate analgesic(s), anti-anxiety, muscle 
relaxant(s), or sleep agents for chronic pain therapy,'' Respondent's 
``charts did not exhibit [the] clear presence of'' ``[a] thorough 
history,'' ``[a] thorough focused physical exam,'' and ``[a] thorough 
past historical review.'' Id. at 30. Moreover, not one of the charts 
had evidence that Respondent had ``[b]egun a diagnostic work-up or 
thoughtful discussion to verify the presumed diagnosis and probable 
pain generator(s),'' \13\ or that the patients had ``been placed on a 
multi-modality pain treatment and management program with appropriate 
use of other non-addictive medications'' and consideration of other 
treatment modalities. Id.
---------------------------------------------------------------------------

    \13\ Dr. Chavez stated that while it is not expected that a 
physician can conduct all the ``recommended evaluations on the first 
visit,'' ``by the 2nd, 3rd, or 4th visit patient charts should have 
many of the basic standards of care during the course of 
treatment.'' GX 6, at 30.
---------------------------------------------------------------------------

    According to Dr. Chavez, ``[c]hronic pain treatment requires more 
than use of opiate analgesic medication and, therefore, on chart 
review, one should see evidence of discussion of other therapies and 
offer recommendations regarding behavioral therapy, psychological 
therapy and support, physical therapy, exercise, weight loss, and other 
modalities.'' Id. There should also ``be plans for appropriate 
specialty consultation, diagnostic studies * * * and drug screens to 
rule out illicit drug use or diversion,'' as well as ``medication 
contracts or agreements.'' Id.
    Dr. Chavez observed that ``the patient medication agreement that 
[Respondent] did have in the chart did not seem to be followed like it 
should have been.'' Id. at 30. More specifically, the terms of 
Respondent's pain management agreement included that the patient ``will 
submit to a blood or urine test if requested by my doctor to determine 
my compliance with my program of pain control medicine,'' and that the 
patient ``will use [his] medicine at a rate no greater than the 
prescribed rate and that use of * * * medicine at a greater rate will 
result in * * * being without medication for a period of time.'' GX 7 
at 10.
    Dr. Chavez noted, however, ``that there is no consistent refill 
rate'' in the charts, and that ``[s]ome refills occurred within two 
days of the last refill which would mean that large quantities of 
opiates had * * * been ingested during that time.'' GX 6, at 30. He 
also observed that ``not one of the patients had a urine

[[Page 17680]]

drug screen done to verify that they were indeed ingesting the 
medication as opposed to diverting it.'' Id. at 30-31. He also further 
found that Respondent ``did not do any significant medical workup on 
any of the patients.'' Id. at 31.
    Dr. Chavez also noted that while under the California guidelines 
``there is no maximum or minimum of medication limitations as long as 
[the] amounts provided match a safe dosing schedule,'' he further 
opined that ``if the maximum exceeds the manufacturer's (pharmaceutical 
company; PDR) recommendations, then, generally, one may conclude that 
misuse or diversion of opiates or other addictive drugs may be 
occurring.'' Id. at 31-32. Dr. Chavez then explained that ``the normal 
maximum dosage of Norco would be two tablets every four hours or a 
maximum of 12 tablets per day, and for Vicodin ES 7.7/750[,] a maximum 
of 4-6 per day because of the amount of Tylenol [acetaminophen] 
involved,'' which ``generally should not exceed 4000 milligrams per 
day.'' Id. at 32.
    According to Dr. Chavez, while ``most of the quantities 
[Respondent] prescribed'' would be ``reasonable and appropriate'' if 
``given on a monthly interval,'' he noted that ``[m]any of the refills 
occurred within 2 to 7 days of the last refill'' and that ``[i]n many 
cases, it would have been impossible * * * to use this quantity of 
controlled medications within that short of period of time.'' Id. at 
32. In Dr. Chavez's opinion, ``[t]his should have been a red flag for 
possible drug diversion and/or abuse.'' Id.
    Dr. Chavez opined that ``[b]ased on the types and quantities of 
medications prescribed, the younger age range of many of [Respondent's] 
patients,\14\ the frequency of prescriptions, the excessive quantities 
of medications, and irregular refill dates, there is substantial 
evidence to indicate the probability of abuse or diversion of opiate 
medications in the majority of the patient charts reviewed.'' Id. at 
31. He also opined that ``[t]he fact that [Respondent] so freely 
prescribed these drugs without a thorough evaluation of these patients 
is not an acceptable approach to pain management.'' Id.
---------------------------------------------------------------------------

    \14\ According to Dr. Chavez, ``[p]atients between the ages of 
21 and 39 who suffer with chronic pain and who are on chronic opiate 
therapy are not that prevalent, even in a busy `Pain Practice.' '' 
GX 6, at 32. Moreover, the majority of patients ``in this age group 
can be treated with non-opiate and non-addictive medications for the 
most part.'' Id.
---------------------------------------------------------------------------

    Continuing, Dr. Chavez noted that ``[n]ot one chart had evidence of 
the physician undertaking a workup in evaluation of the underlying 
medical problem'' and ``[t]he 15 charts reviewed lacked any objective 
evidence or chart notes justifying the use of opiate therapy to the 
level exhibited on the charts evaluated.'' Id. at 32. Dr. Chavez also 
observed that the charts demonstrated no ``effort to try nonaddictive 
medications or offer alternative modalities of treatment.'' Id. Dr. 
Chavez then opined that ``[t]he medical care and treatment provided by 
[Respondent] are markedly below the accepted standards of treatment for 
licensed physicians in the United States today. The represents an 
EXTREME DEPARTURE from the standard of care expected of a licensed 
practicing physician in the U.S. today.'' Id. at 33 (caps in original).
    In addition to the four patient records indicated above, Dr. 
Norcross reviewed Dr. Chavez's report on Respondent and the Board's 
decision referenced above. RX D, at 1. Dr. Norcross indicated he had 
formed certain opinions based on these materials and also on his 
``personal knowledge'' of Respondent in that he had known Respondent 
``for almost 4 years in [Dr. Norcross's] capacity as a teacher, helping 
[Respondent] to improve the quality of his prescribing and record-
keeping.'' Id. Further, Dr. Norcross had ``also served as a witness in 
[Respondent's] Medical Board of California matter.'' Id.
    Dr. Norcross concurred with Dr. Chavez that Respondent's ``medical 
record-keeping still has room for improvement'' and that his ``charting 
of the patient history and physical examination would not be `thorough' 
by the standards Dr. Chavez cite[d].'' Id. at 2. However, he then 
asserted that Respondent should be ``judge[d] * * * against the 
standard of care defined by `the community of licensees,' and within 
that group, against physicians of similar age, culture, experience, 
training background, and clinical environment.'' Id. at 2. Continuing, 
Dr. Norcross opined that ``if compared to other older generation 
general practitioners who were not the beneficiaries of a full 3-year 
residency training program and were providing care to an underserved 
patient population, I believe [Respondent's] charting and clinical 
decision making are well within the middle of that Bell Curve.'' Id.
    Dr. Norcross further opined that as to the four patients whose 
medical records he reviewed, ``there was a plausible source of pain, 
and [Respondent] provided enough history and enough examination, that 
the diagnosis was clear in all cases.'' Id. With respect to Dr. 
Chavez's criticism as to the lack of ``laboratory tests and imaging 
studies'' as well as consultations with specialists, Dr. Norcross 
explained that he understood the costs of these were a ``deterrent[] * 
* * for a significant portion of [Respondent's] patient population'' 
because they do not have insurance. Id.
    Respondent, however, produced no credible evidence that any of the 
specific patients whose files were reviewed by Dr. Chavez lacked the 
financial resources to pay for these tests and/or consultations.\15\ 
Moreover, given that some of these patients had the ability to purchase 
more drugs (and sometimes multiple drugs) on numerous occasions within 
a month, it seems likely that they had the ability to pay for some 
tests and/or consultations.
---------------------------------------------------------------------------

    \15\ On this issue, Respondent's testimony was generally vague. 
With respect to patient M.T. (GX 19), who complained of lower back 
pain, Respondent stated that he did not do any additional diagnostic 
studies because ``actually in talking to him it sounds like he's a 
patient of very limited means and to get the x-rays and all of the 
other studies would cost him a lot of money which he cannot 
afford.'' Tr. 384. Yet M.T.'s record contains no indication that 
Respondent discussed this issue with him. See generally GX 19. With 
respect to M.H. (GX 13), who complained of migraines, Respondent 
acknowledged that ``there could have been a lot more studies'' but 
the patient ``would have to incur considerable expense.'' Tr. 397. 
Here again, there is no evidence in M.H.'s record that Respondent 
discussed the issue with him.
---------------------------------------------------------------------------

    Dr. Norcross did, however, agree with Dr. Chavez's ``point that 
physicians should, as a general rule, limit their prescribing habits, 
for all drugs, not just opiates, to the manufacturer's prescribing 
limits, even though responsible physicians can, and do, prescribe 
medications, including pain medications, `off label' in appropriate 
cases.'' Id. at 3. Dr. Norcross further noted that he had advised 
Respondent that ``it was [his] strong recommendation [to] limit his 
prescribing to the * * * recommended daily maximum dosage, even though 
other reasonable physicians do engage in `off label' prescribing in 
appropriate cases'' and that ``there are epidemiological studies 
regarding liver toxicity supporting the PDR dosage recommendations.'' 
Id. According to Dr. Norcross' report, he had ``reviewed this'' with 
Respondent, who had ``committed himself to doing this henceforth, 
notwithstanding the `off label,' dosage levels discussed in the 
[Board's] decision.'' Id.
    While the ALJ ``ha[d] a problem with the conclusions of both of the 
expert[s],'' she held that Dr. Chavez's findings were entitled to more 
weight because ``they are more consistent with the California 
requirements for determining the standard of care to be levied against 
the Respondent's practices.'' ALJ at 43. I agree with the ALJ's 
conclusion although I disagree with her reasoning to the extent it 
suggests that Dr. Chavez erroneously ``seemed to infer that there

[[Page 17681]]

is a national standard of care.'' Id. at 40; see also id. (noting that 
``[i]n California * * * a doctor is held to the standard of skill or 
care prevailing in the medical profession in the locality in which he 
practices'') (citing Inouye v. Black, 238 Cal.App.2d 31, 33 (Cal. Ct. 
App. 1965)).
    In his Exceptions, Respondent contends that the ALJ ``completely 
ignore[d] the standard of care set by the California Supreme Court and 
ratified by the California Medical Board'' that ```a physician is 
required to possess and exercise, in both diagnosis and treatment, that 
reasonable degree of knowledge and skill which is ordinarily possessed 
and exercised by other members of his profession in similar 
circumstances.' '' Resp. Exceptions at 7 (quoting Landeros v. Flood, 17 
Cal. 3d 399, 408 (1976)). According to Respondent, the standard applied 
by the ALJ ``has long been repudiated * * * in favor of the `similar 
circumstances' standard articulated by'' his expert. Id. at 7-8.
    Both the ALJ's reasoning and Respondent's contention ignore, 
however, that the standard applicable under Federal law is whether the 
prescriptions were ``issued for a legitimate medical purpose by an 
individual practitioner acting in the usual course of his professional 
practice.'' 21 CFR 1306.04(a). In United States v. Moore, 423 U.S. 122, 
138-39 (1975), the Supreme Court upheld the conviction of a physician 
for unlawful distribution of methadone based on a jury instruction that 
allowed the jury to find him guilty if he dispensed the drug ``other 
than in good faith for detoxification in the usual course of a 
professional practice and in accordance with a standard of medical 
practice generally recognized and accepted in the United States.'' 
(emphasis added).
    Moreover, even after Gonzalez v. Oregon, 546 U.S. 243 (2006), 
several courts of appeals ``have applied a general-practice standard 
when determining whether the practitioner acted in the `usual course of 
professional practice.' '' See United States v. Smith, 573 F.3d 639, 
647-48 (8th Cir. 2009); see also id. at 648 (discussing Moore; ``Thus 
informed by the Supreme Court and other controlling and persuasive 
precedent, we believe that it was not improper to measure the `usual 
course of professional practice' under Sec.  841(a)(1) and [21 CFR] 
1306.04 with reference to generally recognized and accepted medical 
practices. * * * ''); see also United States v. Merrill, 513 F.3d 1293, 
1306 (11th Cir. 2008) (quoting Moore, 423 U.S. at 139) (``The 
appropriate focus is not on the subjective intent of the doctor, but 
rather it rests upon whether the physician prescribes medicine `in 
accordance with a standard of medical practice generally recognized and 
accepted in the United States.' '').
    Of further significance, post-Gonzales, the Ninth Circuit has 
expressly recognized that ``both the Supreme Court and this Circuit 
have previously approved jury instructions that refer to a national 
standard of care.'' United States v. Feingold, 454 F.3d 1001, 1009 (9th 
Cir. 2006).-- As these cases make clear, the opinion of the 
Government's Expert that Respondent's treatment of the patients whose 
files he reviewed was ``markedly below the accepted standards of 
treatment for licensed physicians in the United States today'' and 
``represents an EXTREME DEPARTURE from the standard of care expected of 
a licensed practicing physician in the U.S. today'' is clearly 
admissible and probative of whether Respondent's prescriptions were 
``issued for a legitimate medical purpose'' and whether he acted 
``within the usual course of professional practice.'' 21 CFR 
1306.04(a).\16\
---------------------------------------------------------------------------

    \16\ State Board regulations and/or guidelines are, of course, 
relevant in determining what practices are necessary for a physician 
to act in the usual course of professional practice. See Volkman v. 
DEA, 567 F.3d 215 (6th Cir. 2009). This, however, is not a case 
where a State rule or guideline expressly allows a physician to act 
in a manner which is in conflict with the accepted standards of 
medical practice throughout the country. Nor is it a case in which 
the Attorney General seeks to declare illegal conduct which is 
clearly permitted under State law. See Gonzalez, 546 U.S. at 258.
---------------------------------------------------------------------------

    In any event, the record establishes that Dr. Chavez serves as a 
consultant/physician reviewer to the California Board on pain 
management and is thus clearly familiar with the standards of medical 
practice related to prescribing controlled substances to treat chronic 
pain patients in California. Moreover, in his report, Dr. Chavez made 
clear that he had