[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Pages 14028-14043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06617]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Bernard Wilberforce Shelton, M.D.; Decision and Order

    On February 16, 2017, the Assistant Administrator, Diversion 
Control Division, Drug Enforcement Administration, issued an Order to 
Show Cause to Bernard Wilberforce Shelton, M.D. (hereinafter, 
Registrant), which proposed the revocation of his DEA Certificates of 
Registration Nos. BS9770961 and FS6457407, as well as the denial of any 
pending application to renew these registrations or for any other 
registration. GX 2, at 1. As grounds for the proposed actions, the 
Government alleged that Registrant's continued registration is 
``inconsistent with the public interest'' and that he is without state 
authority to handle controlled substances in the State of Michigan, the 
State in which he holds his registrations. Id. at 1-2 (citing 21 U.S.C. 
824(a)(3) and (4), 823(f)).
    With respect to the Agency's jurisdiction, the Show Cause Order 
alleged that Registrant holds two

[[Page 14029]]

registrations, pursuant to which he is authorized to dispense 
controlled substances in schedules II-V as a practitioner in the State 
of Michigan: No. BS9770961, at the registered address of 30140 Harper 
Avenue, Suite #300, Saint Clair Shores, which was due to expire on 
February 28, 2018, and No. FS6457407, at the registered address of 
21700 Greenfield Road, Suite 130, Oak Park, which expires on February 
29, 2020. Id. at 1.
    As to the substantive grounds for the proceeding, the Show Cause 
Order alleged that the Michigan Department of Licensing and Regulatory 
Affairs (hereinafter, DLRA) summarily suspended Registrant's Michigan 
Medical License on January 12, 2017, and that pursuant to Mich. Comp. 
Laws Sec.  333.7311(6), ``a controlled substance license is 
automatically void if a licensee's license to practice is suspended or 
revoked under Article 15 of the Code.'' Id. at 2. The Order alleged 
that as a result of the DLRA's action, Registrant ``is without 
authority to handle controlled substances in the State of Michigan,'' 
and ``[c]onsequently, DEA must revoke [his] DEA registration.'' Id. 
(citing 21 U.S.C. 824(a)(3)).
    Next, the Show Cause Order alleged that Registrant violated Federal 
law on numerous occasions when he issued controlled substance 
prescriptions to four patients outside the usual course of professional 
practice and for other than a legitimate medical purpose, and that 
these ``multiple instances of unlawful prescribing in violation of 
federal law weigh[] in favor of the revocation of [his registration].'' 
Id. at 2 (citing 21 U.S.C. 841(a)(1), 823(f)(2) and 823(f)(4) and 21 
CFR 1306.04). The Order also alleged that Registrant's prescribing to 
the four patients violated Michigan law, id. (citing Mich. Comp. Laws 
Sec. Sec.  333.7401(1), 333.7333, 333.7405(1)(a)), and the Michigan 
Guidelines for the Use of Controlled Substances for the Treatment of 
Pain (hereinafter, Michigan Guidelines). Id. at 2-3.
    The Show Cause Order then alleged that between October 2013 and 
February 2016, Registrant failed to comply with Federal and State law 
and the Michigan minimal standards when he issued controlled substance 
prescriptions to an undercover investigator (hereinafter, UC) and three 
other patients, D.S., A.L. and R.H. Id. at 3-10.
    Specifically, the Show Cause Order alleged that on April 1, May 1 
and June 15, 2015, Registrant issued prescriptions to the UC for 
hydrocodone-acetaminophen, a schedule II controlled substance, and 
alprazolam, a schedule IV controlled substance, which were not for a 
legitimate medical purpose and outside the scope of professional 
practice. Id. at 3-6 (citing 21 CFR 1306.04(a) and Mich. Comp. Laws 
Sec. Sec.  333.7311(1)(e), 333.733, 333.7401(1) and 333.7405(1)(a)). 
The Order alleged that Registrant issued the controlled substance 
prescriptions to the UC ``without undertaking actions typical of 
medical professionals or in accordance with the Michigan Guidelines, 
such as conducting and documenting a complete medical history, 
conducting a physical examination, or properly assessing the needs of 
[the UC] for controlled substances.'' Id. at 3. The Order further 
alleged that Registrant did not make any attempt to address or resolve 
numerous ``red flags that [the UC] was abusing and/or diverting 
controlled substances'' before issuing the controlled substance 
prescriptions to him. Id. at 3-6. Further, it alleged that Registrant's 
medical records for the three visits ``contain multiple false or 
misleading statements which [are] inconsistent with the Michigan 
Guidelines standard that medical records are to be ``accurate and 
complete'''' and gave numerous specific examples. Id. at 4-6.
    Next, the Show Cause Order alleged that Registrant issued a total 
of 73 prescriptions to patients D.S., A.L., and R.H., ``despite failing 
in most instances to conduct an appropriate medical examination and 
meeting the minimal medical standards required under Michigan law in 
prescribing controlled substances (or documenting such in the patient's 
file),'' in violation of Federal and Michigan law. Id. at 6-9 (citing 
21 CFR 1306.04(a) and Mich. Comp. Laws Sec. Sec.  333.7311(1)(e), 
333.733, 333.7401(1) and 333.7405(1)(a)).
    Specifically, the Show Cause Order alleged that ``[f]rom on or 
about January 12, 2015, through on or about February 29, 2016,'' 
Registrant issued to D.S. 14 prescriptions for oxycodone 30 mg, a 
schedule II controlled substance; two prescriptions for phendimetrazine 
tartrate 105 mg, a schedule III controlled substance; four 
prescriptions for phentermine 37.5 mg and five prescriptions for Ultram 
(tramadol) 50 mg, both schedule IV controlled substances. Id. at 7. The 
Order also alleged that Registrant ``issued these orders despite the 
presence of . . . red flags that D.S. was abusing and/or diverting 
controlled substances, '' including a Michigan Automated Prescriptions 
Report (MAPS) which showed ``that D.S. had been prescribed combinations 
of opioids, benzoids and stimulants'' between February and June 2011, 
by up to three different medical providers; that his ``medical records 
indicate that D.S. was likely suffering from drug dependence''; and 
that ``D.S.'s urine drug tests showed signs of dangerous drug use or 
dependency,'' including positive results for methadone, cocaine and 
amphetamines when none of these drugs had been prescribed in the 
previous month. Id. at 7. The Order further alleged ``there is no 
documentation in D.S.'s medical records demonstrating that [Registrant] 
conducted any appropriate medical examination or review to address or 
resolve these indicators of possible abuse and/or diversion.'' Id. at 
8.
    With respect to A.L., the Show Cause Order alleged that between 
October 17, 2013 and May 6, 2014, Registrant issued to her three 
prescriptions for Norco (hydrocodone/acetaminophen), then a schedule 
III controlled substance; three prescriptions for Adipex (phentermine) 
37.5 mg, two prescriptions for Xanax (alprazolam) 2 mg, and three 
prescriptions for Soma (carisoprodol) 350 mg, and authorized two 
refills for each prescription. Id. at 8. The Order alleged that the 
combination of hydrocodone, alprazolam and carisoprodol is a drug 
``cocktail'' known as the ``Holy Trinity'' and ``is widely known to be 
abused and/or diverted.'' Id. The Order also alleged that on three 
occasions in 2011, Registrant prescribed to A.L. ``another variation of 
the Holy Trinity cocktail,'' substituting Roxicodone (oxycodone) for 
hydrocodone and that ``[t]here is no documentation in A.L's medical 
records demonstrating any legitimate medical need for prescribing her 
that cocktail.'' Id.
    The Show Cause Order further alleged A.L.'s medical records show 
that she presented various red flags and that ``there is no 
documentation in [her] medical records demonstrating that [Registrant] 
conducted any appropriate medical examination or review to address or 
resolve these indicators of possible abuse and/or diversion.'' Id. at 
8-9. The Order alleged that these included a MAPS report dated January 
24, 2011 showing that A.L. ``had been prescribed combinations of 
opioids, benzoids, and stimulants by up to eight different medical 
providers'' between January 2010 and January 2011, and that this 
combination of stimulants with opioids or benzoids or both is known to 
drug users as ``speed-balling.'' Id. at 8-9.
    The Order also alleged that on a ``Health History Questionnaire'' 
which A.L. completed when she first became Registrant's patient, she 
listed the drugs she was currently taking as including Roxicodone, 
Xanax and Soma, and that

[[Page 14030]]

this combination ``also constitutes the `Holy Trinity' drug cocktail.'' 
Id. at 9. The Order further alleged that a Feb. 25, 2013 chart entry 
showed that A.L. was possibly engaged in diversion as it states: ``She 
says she cannot get her pain medications and has to be buying it off 
the streets to satisfy her pain. The last time she was given pain 
medication from this office was in September of last year.'' Id.
    With respect to patient R.H., the Show Cause Order alleged that 
from June 2015 through February 24, 2016, Registrant issued to him 10 
prescriptions for Norco (hydrocodone-acetaminophen \1\) 10/325 mg, 10 
prescriptions for morphine sulfate 30 mg tablets, and 10 prescriptions 
for morphine sulfate 100 mg tablets, each of these being a schedule II 
controlled substance; five prescriptions for alprazolam 1 mg; and two 
prescriptions for Soma (carisoprodol) 350 mg tablets. Id. The Order 
again alleged that ``there [was] no documentation in R.H.'s medical 
records demonstrating any legitimate medical need for prescribing him 
the [combination of Hydrocodone, Alprazolam and Carisoprodol drugs 
known as the] Holy Trinity cocktail,'' ``which is widely known to be 
abused and/or diverted.'' Id.
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    \1\ Effective October 6, 2014, combination hydrocodone drugs 
were moved from schedule III to schedule II. See DEA, Schedules of 
Controlled Substances: Rescheduling of Hydrocodone Combinations 
Products from Schedule III to Schedule II, 79 FR 49661 (2014).
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    The Show Cause Order also alleged that on six other occasions in 
2011, Registrant prescribed other variations of this cocktail to R.H. 
despite the presence of red flags in his medical records. Id. at 10. 
Specifically, the Order alleged that Registrant's ``medical records 
indicated that R.H. was possibly suffering from drug dependency'' 
because the ``medical chart dated December 21, 2011 states `he [sic] is 
taking the valium three times ad [sic] although he is given it twice 
daily so he runs out early [sic].''' Id.
    The Show Cause Order further alleged that R.H.'s urine drug test 
results showed signs of dangerous drug use or drug dependency. The 
Order alleged that on seven occasions during 2015 through 2016, R.H. 
tested positive for amphetamines and that on three occasions during 
2015, he tested positive for benzodiazepines and that Registrant ``had 
not prescribed'' either class of drugs to him in the months preceding 
the positive results. Id. Finally, the Order alleged that ``[t]here is 
no documentation in R.H.'s medical records demonstrating that 
[Registrant] conducted any appropriate medical examination or review to 
address or resolve these indicators of possible abuse and/or 
diversion.'' Id.
    The Show Cause Order then asserted that Registrant ``fail[ed] in 
most instances to conduct an appropriate medical examination'' and 
failed to meet ``the minimal medical standards required under Michigan 
law in prescribing controlled substances (or documenting such in the 
patient's file).'' Id. at 9 (citing 21 CFR 1306.04(a) and Mich. Comp. 
Laws Sec. Sec.  333.7311(1)(e), 333.733, 333.7401(1) and 
333.7405(1)(a)). The Order further asserted that Registrant's conduct 
``completely betrayed any semblance of legitimate medical treatment'' 
in that he ``failed to take reasonable steps, like conduct medical 
examinations, to guard against diversion of controlled substances.'' 
Id. at 10 (citing Jack A. Danton 76 FR 60,900 (2011); Hatem M. Ataya 81 
FR 8221 (2016) (other citations omitted)).
    The Show Cause Order notified Registrant of his right to request a 
hearing on the allegations or to submit a written statement in lieu of 
a hearing, the procedure for electing either option, and the 
consequence for failing to elect either option. Id. at 11 (citing 21 
CFR 1301.43). The Show Cause Order also notified Registrant of his 
opportunity to submit a Corrective Action Plan in accordance with 21 
U.S.C. 824(c)(2)(C). Id. at 11-12.
    On February 23, 2017, a DEA Special Agent and a Diversion 
Investigator (DI) personally served Registrant with the Order to Show 
Cause at his office located at 30140 Harper Avenue, Suite #300, Saint 
Clair Shores, Michigan. GX 31 (Declaration of Special Agent), at 4. 
According to the Agent, Registrant signed a DEA Receipt for the Show 
Cause Order. Id., see also GX 29.
    On May 8, 2017, the Government filed its Request for Final Agency 
Action (RFAA) with my Office and forwarded the evidentiary record, 
stating that more than 30 days have passed since Registrant was 
personally served, and DEA has not received a request for a hearing or 
any other reply from Registrant. RFAA, at 1.
    Based on the Government's representations that more than 30 days 
have now passed since the date of service of the Show Cause Order and 
that Registrant has not submitted a request for a hearing or any other 
reply including a Corrective Action Plan, I find that Registrant has 
waived his right to a hearing or to submit a written statement in lieu 
of a hearing. 21 CFR 1301.43(d). I therefore issue this Decision and 
Final Order based on relevant evidence contained in the record 
submitted by the Government. 21 CFR 1301.43(d) & (e). I make the 
following findings of fact.

Findings of Fact

    Registrant is the holder of DEA Certificate of Registration No. 
FS6457407, pursuant to which he is authorized to dispense controlled 
substances in schedules II--V, at the registered location of 21700 
Greenfield Road, Oak Park, Michigan. GX 1 (Copy of Registrations). This 
registration does not expire until February 29, 2020. Id. Registrant 
also held DEA Certification of Registration No. BS9770961, pursuant to 
which he was authorized to dispensed controlled substances at the 
registered location of 30140 Harper Avenue, Suite #300, in Saint Clair 
Shores. Id. He was also authorized, under DATA-Waiver Identification 
Number XO9770961, to dispense Suboxone and Subutex to up to 100 opiate-
addicted patients pursuant to the Drug Addiction Treatment Act of 2000 
(DATA). Id.; see 21 U.S.C. 823(g)(2). However, Registration No. 
BS9770961 and DATA-Waiver Identification No. XO9770961 expired on 
February 28, 2018, when Registrant failed to renew this registration.
    Registrant holds a license to practice medicine in the State of 
Michigan, as well as several controlled substance and drug control 
licenses issued by the Michigan Board of Pharmacy. GX 30, at 1-2. 
However, on January 12, 2017, the Director of the Bureau of 
Professional Licensing, Michigan Department of Licensing and Regulatory 
Affairs (DLRA), ordered the summary suspension of Registrant's medical 
license based on the Department's ``find[ing] that the public health, 
safety, and welfare requires emergency action.'' See GX 30, at 1. The 
Order also stated that ``[Public Health] Code Sec.  7311(6) provides 
that a controlled substance license is automatically void if a 
licensee's license to practice is suspended or revoked.''\2\
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    \2\ According to the website of the Michigan Department of 
Licensing and Regulatory Affairs, Registrant held: a Pharmacy CS-3 
license 5315079480, which was issued on November 23, 2016 but is 
currently in a ``lapsed'' status; a Pharmacy Drug Treatment Program 
Prescriber license 5304001334, which was issued November 3, 2016 but 
is currently in ``lapsed'' status; and a Pharmacy Drug Control 
Location license 5315079209, which was issued November 14, 2016 but 
is also currently in ``lapsed'' status. See https://w2.lara.state.mi.us.
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    According to the online records of the DLRA, of which I take 
official notice, see 5 U.S.C. 556(e),\3\ on July 12, 2017,

[[Page 14031]]

Registrant entered into a consent order with the Board of Medicine 
pursuant to which the summary suspension was dissolved but his medical 
license was suspended for 15 months to include the period ``during 
which the order of summary suspension was in effect.'' See In re 
Bernard Wilberforce Shelton, M.D., No. 43-16-140510, Consent Order at 2 
(Mich. Bd. of Med., July 12, 2017). The Consent Order further ordered 
that ``[r]einstatement of [Registrant's] license shall not be 
automatic'' and he must petition for reinstatement. Id. Under the 
consent order, to obtain reinstatement, ``Respondent must demonstrate . 
. . by clear and convincing evidence: (1) Good moral character; (2) the 
ability to practice the profession with reasonable skill and safety; 
(3) satisfaction of the guidelines on reinstatement adopted by the 
Department; and (4) that it is in the public interest for the license 
to be reinstated.'' Consent Order, at 2.
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    \3\ In the RFAA, the Government noted that it had been notified 
by the DLRA that a settlement had been reached with Registrant 
subject to Board approval; however, the Consent Order had not been 
issued at the time the RFAA was submitted to my office. RFAA, at 2 
n.1. Under the Administrative Procedure Act (APA), an agency ``may 
take official notice of facts at any stage in a proceeding--even in 
the final decision.'' U.S. Dept. of Justice, Attorney General's 
Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & 
Sons, Inc., Reprint 1979). While under DEA's regulations, ``any 
party, on timely request, shall be afforded [an] opportunity to 
controvert such fact,'' 21 CFR 1316.59(e), Registrant waived his 
right to a hearing or to submit a written statement and is therefore 
not entitled to refute my findings with respect to the Consent 
Order.
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    The DLRA also required that Registrant pay a $10,000 fine. Id. I 
also take official notice that Respondent's medical license remains 
suspended as of the date of this Decision and Order. See also https://w2.state.mi.us.

The Investigation

    In January 2015, DEA began its investigation of Registrant after 
receiving information from the St. Clair Shores Police Department and 
Michigan Blue Cross/Blue Shield (MBCBS) about the investigation they 
were conducting of Registrant. GX 31, at 1 (Declaration of Special 
Agent). DEA then initiated this investigation, which included 
supervising three undercover visits by an MBC/BS investigator 
(hereinafter, also referred to as UC) to Registrant at his office in 
St. Clair Shores. Id. at 1-2; see also GX 8. As part of the 
investigation, on September 29, 2015, a Special Agent (SA) and a 
Diversion Investigator (DI) interviewed Registrant. GX 31, at 2-3.
    During the interview, Registrant informed the SA and DI about ``his 
[patient] protocols . . . including how his office conducts drug 
screens and his new patient procedures, how he conducts physical exams 
on his patients, and how he determines what controlled substances to 
prescribe over time.'' Id. at 2. According to the SA, in the interview 
he ``also discussed with [Registrant] his patient `James Howard' (the 
MBC/BS investigator), specifically discuss[ing] the three visits and 
how Mr. Howard's diagnoses were determined, . . . reviewed the 
associated patient records, discussed his urine drug screen results and 
how those were evaluated, and . . . discussed the controlled substances 
[Registrant] had prescribed to'' the investigator. Id.
    The same day, the St. Clair Shores Police Department executed a 
state search warrant at Registrant's office and a second warrant at his 
residence. Id. at 2-3. During the execution of the warrant, the SA and 
another SA conducted a second interview with Registrant, who ``stated 
that he conducts physical exams on his patients and that he can do an 
exam by looking at the patient.'' Id. at 3.
    On approximately February 22, 2016, the SA subpoenaed various 
patient records, and Registrant provided copies of the electronic 
patient records that were requested. Id. The SA also subpoenaed 
Registrant's records for specific patients, including those of D.S., 
A.L., and R.H., from Network Technology Inc., d/b/a RXNT, a firm which 
develops and implements products related to electronic health records 
and electronic prescribing. Id. at 2-3. On June 22, 2016, after 
reviewing MAPS and RxNT's records to identify specific prescriptions, 
the SA also subpoenaed from various pharmacies copies of the 
prescriptions issued by Registrant to various patients, including D.S., 
A.L., and R.H. Id. Subsequently, the SA also subpoenaed and obtained 
from Registrant the patient records of the MBC/BS Investigator. Id.

The Undercover Visits

    On April 1, 2015, the MBC/BS Investigator (UC) conducted the first 
of three undercover visits to Registrant at his St. Claire Shores 
Medical office. GX 12, at 5. During each visit, he posed as patient 
D.H., whose occupation was driving. Id. The investigative record 
includes video recordings of each of his visits, transcripts of the 
recorded visits, his medical file, and photographs of the vials 
containing the filled controlled substance prescriptions issued by 
Registrant. GXs 3-12.
    At the visit, the UC filled out new patient paperwork which 
included a registration form, a health history questionnaire, a pain 
questionnaire, and signed a narcotics contract. GX 12, at 5, 6-9, 11-
12, 13-14. On the Health History Questionnaire, the UC wrote the name 
of a referring doctor and stated that his last exam had been in the 
``summer 2014,'' and that ``Nerves'' and ``Back'' were ``medical 
problems that other doctors have diagnosed.'' Id. at 6. Under 
``prescribed drugs,'' he wrote ``Zanax [sic] Strength 1 Frequency Taken 
2.'' Id. at 7. He left the ``Health Habits and Personal Safety'' 
section mostly blank, including questions about his alcohol intake and 
recreational or street drug use. Id. at 7-8. In the Mental Health 
section, he circled ``no'' as his answer to the questions: ``Is stress 
a major problem for you?''; ``Do you feel depressed?''; ``Do you feel 
panic when stressed?''; and ``Have you ever been to a counselor?'' Id. 
at 9. He circled ``yes'' to the question ``Do you have trouble 
sleeping?'' Id.
    The UC also filled out a Pain Questionnaire. Id. at 11. This 
consisted of a body diagram where he circled the lower back portion, 
and a section where he was to circle words describing his pain, such as 
``Aching, Stabbing, Gnawing, Sharp, Burning, Exhausting, Tiring, 
Nagging, Numb, Miserable or Unbearable.'' UC did not, however, circle 
any of these descriptors, and instead, wrote ``Stiff.'' Id. He 
indicated that his pain was ``worst'' in the morning, but left blank 
four questions which asked him to rate his pain level at its worst, 
least, average for the month, as well as ``right now,'' on a scale of 
one to ten. Id. He wrote that ``Meds'' made his pain better, and left 
blank what made it worse. Id. at 12. He circled ``None'' in answer to 
``what treatment or medication are you receiving for your pain?'' Id. 
He also left blank a series of questions asking him to rate the level 
of interference of pain on his general activity, mood, normal work, 
sleep, enjoyment of life, ability to concentrate, and relationships 
with other people. Id. He signed and dated this form ``7-9-70.'' Id. A 
section at the bottom of the form for Notes, Action Plan details and 
the Clinician's Signature are blank. Id.
    UC also signed a narcotic contract, stating that he would use a 
Walgreens pharmacy. Id. at 13-14.
    The video recording and transcript of the visit show that after he 
filled out the paperwork, he saw a nurse in an exam room, who asked a 
series of questions from a form while taking notes, including: ``Have 
anxiety? I noticed that you take uh . . . .'' GX 4, at 3. UC stated ``I 
don't know what you call it. . . uh . . . you know my nerves get jacked 
up and what not. I don't know what you call it.'' Id. UC added that he 
took Xanax and Norco, and that he had previously seen a physician in 
Flint, but it was ``too far and I travel a lot.'' Id.; GX 3, Video 
Recording (VR) 2, at 15:45:20-15:46:41.

[[Page 14032]]

    The nurse asked: ``As far as your medical history goes you want me 
just . . . to put anxiety down?'' GX4, at 3. UC stated: ``Whatever you 
call that, I don't know what the word,'' which prompted the nurse to 
ask: ``What brings you here?'' Id. UC answered: ``Just to get Xanax 
refills.'' Id. The nurse then asked UC if he ``had pain anywhere?'' and 
UC answered: ``Ah . . . like my back is stiff. But I don't know . . . 
Pretty much a stiff back. I drive a lot and what not, know what I'm 
saying.'' Id. at 3-4; GX 3, VR 2, at 15:46:41-15:47:11.
    Following a discussion of Registrant's background, the Nurse then 
told UC that Registrant ``drug test[s] everybody.'' GX 4, at 4. As the 
Nurse proceeded with obtaining his weight, UC said that he was 
``cool,'' that he did not ``want to cause any problems for anybody'' 
including Registrant, and that he was ``[m]ore or less healthy. You 
know what I'm saying?'' Id. at 4-5; GX 3, VR 2, at 15:47:11-15:48:48.
    After determining UC's marital status, the nurse said: ``So, 
basically, you don't even--you don't have any problems besides the 
little bit of anxiety and your back gets stiff because of driving.'' GX 
4, at 5. UC replied: ``Yeah, yeah. You got it.'' Id.; see also GX 3, VR 
2, at 15:48:48-15:49:22.
    The nurse continued to take UC's vitals as the two discussed his 
work as a driver, after which UC mentioned a patient in the lobby who, 
in UC's words, was ``yip-yapping and jaw-jacking.'' GX 4, at 6-7. The 
nurse denied that patients could easily get their prescriptions and 
stated that patients were tested and ``if they have other stuff in 
their system they cannot get their script . . . because they could drop 
dead if they mix.'' Id. at 7-8. Continuing, the nurse stated that 
Registrant is ``really strict about that'' and UC said: ``The worst 
thing I do is drink moonshine here and there. Little liquor on the 
weekends you know. But when I take that Xanax, I'm pretty chilled, so I 
don't really need to drink too much. You know it keeps me from getting 
stupid.'' Id. at 8; GX 3, VR 2, at 15:49:22-15:53:59.
    As the nurse continued to review UC's medical history and discussed 
various subjects with him, UC noted that a sign on the wall ``says our 
office is no longer writing prescriptions for . . . ah . . . oxycodone 
or [R]oxicodone. Is that what that says?'' GX 4, at 11. The nurse 
replied: ``I don't think it says that. He writes that.'' Id. UC pointed 
out where he read the statement, and the nurse replied that ``it's for 
people that come in here just one time . . . [T]hey can't come in here 
(unintelligible).\4\ Id. at 11-12; see also GX 3, VR 2 at 15:53:59-
16:01:44.
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    \4\ The sign is not, however, visible on the video. GX 3, VR 2, 
at 16:00:52-16:01:44.
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    Registrant eventually entered the exam room, greeted UC while 
donning a headphone set connected to the computer, resolved an issue 
with another patient, and appeared to dictate and record into the 
computer while he spoke to UC. GX 4, at 14. The nurse informed 
Registrant that UC was a new patient, and Registrant read aloud UC's 
height, weight, age and occupation from the computer screen. Id. at 16; 
see also GX3, VR3, at 16:16:23-16:19:39.
    Registrant confirmed with UC that he drove for a living, and asked: 
``And you have pain or what?'' ``What is your problem mostly?'' GX 4, 
at 17. UC stated: ``My back gets stiff because I drive a lot so sitting 
down too much. My back, you know, so it's stiff pretty much.'' Id. 
Registrant determined that UC did not have a CDL (commercial driver's 
license) and asked, ``You don't use methadone?'' UC responded: 
``Absolutely not. I use moonshine. You know what that is?'' Id. 
Registrant asked: ``Too much?'' UC answered: ``No'' and ``You know if I 
take that Xanax it keeps me from drinking too much so it works out 
good.'' Id. at 17-18; GX 3, VR 3, at 16:19:40-16:21:22.
    Registrant then asked: ``So what can I give you today to help you 
out?'' Id. UC answered: ``Usually Xanax helps me out. And Norco helps 
my back. That's all I really need. I don't have any--I'm pretty 
healthy.'' GX 4, at 18; GX 3, VR 3, 16:21:27-16:21:41.
    Thereafter, Registrant resolved a problem with accessing the 
dictation software on his computer and began dictating into it, stating 
that UC ``is here for his first visit. . . . He is suffering also from 
anxiety and back spasms due to his long sitting. He currently does not 
have a CDL.'' GX 4, at 18. After UC told Registrant that he drove eight 
to 12 hours a day, Registrant stated: ``He denies drinking or using any 
stimulants such as methadone.'' Id. Registrant then asked whether UC 
was diabetic, and after UC said that he was not, Registrant dictated: 
``He only uses Xanax occasionally for his anxiety. . . . Today, he is 
complaining mostly of some level of anxiety.'' Id. Registrant then 
asked UC if had ever seen a psychiatrist and UC answered: ``No, if I 
did, it was a long, long time ago.'' Id.; GX 3, VR 3, at 16:21:41-
16:24:16.
    Registrant then asked UC if he ``suffered from any childhood mental 
disorder'' such as ``attention deficit'' disorder. GX 4, at 18. UC 
said: ``Well . . . yeah. I don't know what they called it, but I didn't 
do very good in school.'' Id. Registrant asked: ``But not diagnosed? 
Not medicated?'' Id. UC replied: ``I use to take ADD--Ritalin.'' Id. 
Registrant asked: ``Ritalin as a child?'' Id. at 19. UC replied: 
``Yeah. You know sometimes I do lose focus so I mean it might help me 
focus.'' Id. Registrant then resumed dictating and stated: ``After 
questioning the patient, admits to having had some childhood diagnosis 
of attention deficit disorder and was on Ritalin occasionally as a 
child. Sometime he complains of losing some focus but other than that 
he is doing well.'' Id. After dictating several additional comments, 
Registrant told UC to ``[l]ook at me'' and said ``ok.'' Id.; GX 3, VR 
3, at 16:24:16-16:25:18.
    UC told Registrant that he was ``[p]retty much a healthy guy'' and 
``I try to take care of myself.'' GX 4, at 19. Continuing, UC said: 
``Drink a little too much on the weekends sometimes, but you know.'' 
Id.; GX 3, VR 3, at 16:25:18-16:25:29.
    Registrant then told UC: ``You know in this business of what I do, 
I don't know who is who. I have to be very careful when patients come 
in here.'' GX 4, at 19. UC replied: ``Oh you don't want trouble makers 
coming in here'' and Registrant said:

    Not the trouble makers. You know people come in here in all 
different shapes and forms. Sometimes they are investigators. 
Sometimes they are undercover cops.
    Sometimes they're anything and when I miss something it's just 
the right time for them to jump on me for something. So don't be 
worried that I'm paying attention to almost everything, you know. 
Did they give you a urine screen and test?

    Id. UC said ``[n]o.'' Id. Registrant again asked UC if he gave a 
urine; UC again said ``no.'' Id.; GX 3, VR 3, at 16:25:30-16:26:20.
    Again looking at his computer screen, Registrant stated: ``Your 
last physician recorded here was Dr. Vora Kandarp. He gave you Norco. 
He also gave you Xanax 0.5mg. He also gave you Naproxen. You saw a Dr. 
Miky in September.'' GX 4, at 19. UC said, ``I did,'' after which 
Registrant named three other doctors who he believed UC had seen in 
July and May of the previous year, noted that one of doctors had 
prescribed Adderall, and named the drug store which had filled this 
prescription. Id. Registrant then asked UC if he had high blood 
pressure because ``somebody gave you blood pressure medication.'' Id. 
UC denied having high blood pressure, stating that it was ``low 
actually'' and ``I never took that.'' Id. at 19-20; GX 3, VR 3, at 
16:26:20-16:27:15.
    UC then asked Registrant: ``How do you see that on there? You guys 
on the

[[Page 14033]]

same computer system?'' GX 4, at 20. Registrant replied: ``Everything. 
Everything shows up.'' UC then noted that the nurse had said that 
Registrant had ``a lot of problems with idiots coming in here trying to 
get drugs'' but ``that's not me.'' Id. Registrant discussed with UC his 
use of amphetamines, with UC noting that he ``didn't take it all the 
time'' and it ``[t]ook [him] a while to use it.'' Id. Registrant stated 
that he ``shouldn't take it all the time'' and did not prescribe the 
drug. Id.; GX 3, VR 3, at 16:27:15-16:27:46; see also GXs 5 & 12.
    Registrant then moved on to UC's use of Xanax, noting that ``it 
seems like you started with .25 Xanax. You're up to .5 now, double it, 
to 60, that's in December. Is that sufficient for you?'' GX 4, at 20. 
UC said ``Yeah . . . Probably,'' and Registrant said: ``Okay. I will do 
that for you, sir.'' Id.; GX 3, VR 3, at 16:27:45-16:28:11.
    Registrant further noted, ``And . . . you did get a few pain 
medication'' and asked: ``You want that too?'' GX 4, at 20. UC said 
``[y]es'' and Registrant said ``[a]lright.'' Id.; GX 3, VR 3, at 
16:28:11-16:28:18.
    Registrant then stated: ``It's just the good thing is nothing is 
hidden anymore, you know. You can't come and hide anything.'' GX 4, at 
20. Continuing, Registrant said: ``And these medications are good 
medications.'' Registrant then discussed the dosing of two non-
controlled medications he was prescribing (Baclofen and Naproxen). Id. 
at 20-22; GX 3, VR 3, at 16:28:18-16:28:48.
    Registrant proceeded to dictate dosing instructions for the 
prescriptions and asked UC which pharmacy he used. GX 4, at 22. UC 
asked if there was ``a good pharmacy around here'' or if he could 
``take them on paper and go wherever I want?'' Id. Registrant suggested 
a pharmacy that was ``right up the street.'' Id. UC asked: ``They won't 
give me a hard time?'' and Registrant said ``no.'' Id. at 23. 
Registrant then wrote electronic prescriptions which he sent to the 
pharmacy that he and UC had agreed upon. Id.; GX 3, VR 3, at 16:28:48-
16:31:56.
    As the visit was about to end, Registrant noted that ``we need to 
get a urine from him'' and added: ``All the new patients--did they draw 
blood from you? You'll give a urine on the way out.'' GX 4, at 23. UC 
said he wasn't ``too good with needles'' and avoided the blood test but 
provided a urine sample. Id. at 26. See also GX 3, VR 3, at 16:31:56-
16:44:32.
    In the subjective section of the visit note, Registrant documented 
UC's chief complaint as: ``I drive for a living my back gets very stiff 
anxiety as well.'' GX 12, at 16. Under ``History of Present Illness,'' 
Registrant wrote that UC:

is here for his first visit . . . he is suffering also from anxiety 
and back spasms due to his long sitting . . . he denies drinking or 
using any stimulants such as methadone or is a diabetic nor . . . on 
insulin. On the only use is Xanax occasionally for his anxiety. 
Today he is complaining mostly of [] some level of anxiety. . . . 
[P]atient admits to having had . . . a diagnosis of attention 
deficit disorder. . . . Sometimes he complains of losing some focus 
but other than that he's doing well.

    Id.
    The visit note's Review of Systems section contained fourteen 
different areas. Id. at 16-17. With the exception of ``BJE/
Muscoskeltal,'' next to which Registrant noted ``Back Pain'' but 
``Negative for Arhitis [sic], Joint Pain, Joint Swelling, Muscle 
Cramps, Muscle Weakness, Stiffness and Leg Cramps,'' all the areas 
contained negative findings, including the entry for Psychiatric, next 
to which Registrant documented: ``Negative for Anxiety, Depression, 
Hallucinations, Memory Loss, Mental Disturbance, Paranoia, Suicidal 
Ideation, Panic Attacks.'' Id.
    In the ``Physical Examination'' section, Registrant noted UC's 
``General Appearance'' as: ``Patient appears to be appropriate for age 
dressed appropriate for work responded to questions and no acute 
distress at this time.'' Id. at 17. Registrant noted that there were 
``[n]o abnormal findings'' with respect to the ``exam'' of UC's 
``[m]uscoskeletal'' and ``[n]eurologic'' systems. Id. at 18.
    Yet Registrant then noted diagnoses of ``Spasm of Muscle,'' 
``Anxiety State not Otherwise Specified,'' as well as ``Attention or 
Concentration Deficit.'' \5\ Id. For each diagnosis, he documented that 
``7/22/2015,'' a date more than three months into the future, was both 
the date of onset and the date of diagnosis; he also noted that each 
diagnosis was active. Id. at 18.
---------------------------------------------------------------------------

    \5\ He also documented a diagnosis of ``Body Mass Index Between 
29.0-29.9 Adult.'' GX 12, at 18.
---------------------------------------------------------------------------

    As for Registrant's treatment plan, he listed only medications, 
which included ``naproxen 500 mg,'' ``hydrocodone 7.5 mg-acetaminophen 
325 mg,'' \6\ and ``alprazolam 0.5 mg,'' and a follow-up visit ``after 
[one] month.'' Id. at 19. Consistent with other evidence, the record 
includes two photographs of a pharmacy bottle with the label for 90 
tablets of hydrocodone APAP'' 7.5/325 mg prescribed to D.H. (UC's 
alias) by Registrant, to be taken three times daily as needed for back 
pain and stiffness, which was filled by a pharmacy in Mt. Clemens, 
Michigan on April 1, 2015. GX 5, at 1-2. Two other photos show the 
label attached to a vial which indicates that it was a prescription for 
60 Alprazolam 0.5 mg, to be taken twice daily for anxiety, which was 
also prescribed by Registrant to UC and was filled at the same 
pharmacy. Id. at 5-6.
---------------------------------------------------------------------------

    \6\ Hereinafter, referred to as hydrocodone/apap.
---------------------------------------------------------------------------

    UC's medical file includes the report of the urine drug screen 
obtained at his April 1 visit, as well as a report run on the same date 
from the Michigan Automated Prescription System (MAPS). GX 12, at 20 
(UDS report); id. at 3 (MAPS report). As for the drug screen results, 
which were reported back to Registrant on April 9, 2015, the results 
were negative for all controlled substances listed, including 
alprazolam, hydrocodone, and hydromorphone, the latter being a 
metabolite of hydrocodone. Id. at 20. As found above, UC had 
represented to Registrant (and his nurse) that he took both hydrocodone 
and Xanax, and the visit note listed hydrocodone as a current 
medication. GX 4, at 18 (transcript of visit); GX 12, at 7 
(questionnaire), 17 (visit note), and 20 (UDS report noting UC was 
prescribed hydrocodone and Xanax).
    As for the MAPS report, it showed that on December 15, 2014, UC had 
last filled prescriptions which were issued by Dr. Vora of Gladwin, 
Michigan for 90 tablets of hydrocodone/apap 7.5/325 mg and 60 tablets 
of alprazolam .5 mg. Id. at 3. The report also showed that the UC had 
obtained four prescriptions for various quantities and dosages of 
alprazolam from four different providers, two of whom were located in 
Flint, the others in Marquette and Detroit. Id.
    The Government also submitted a declaration by the UC. GX 32. With 
respect to the April 1 visit, UC stated that Registrant reviewed his 
alias's purported medical history and saw that he had seen at least 
three other doctors in the months prior to his first visit, but did not 
conduct any further inquiry or follow up with him on that issue. Id. at 
2. UC also stated that during the April 1 visit, Registrant conducted 
virtually no physical examination, and that the portion of his visit 
with Registrant lasted only a few minutes and consisted mainly of 
answering questions. Id. He also stated that during the visit, 
Registrant was repeatedly distracted by issues he was having with the 
dictation software for his electronic patient records. Id. My review of 
the video evidence corroborates each of these statements. GX 3, VR 3, 
16:15:22-16:33:22.
    UC further stated that he reviewed Registrant's patient records for 
him and determined that portions of it either

[[Page 14034]]

misstate his statements during the visit or falsely indicate the extent 
to which he received or did not receive a medical examination. GX 32, 
at 2. UC explained:

    For instance, the patient record lists ``spasm of muscle'' as 
one diagnosis, even though I did not complain of spasms during the 
visit. And the record states that I ``den[ied] drinking'' even 
though I indicated that I do drink. The record also documents 
findings from a physical exam in categories such as ``Eyes,'' 
``ENT,'' ``Cardiovascular,'' ``Muscoskeletal'' and ``Neurologic'' 
even though other than the taking of my vitals no physical exam was 
performed during the visit.

    Id.

Second Undercover Visit

    On May 1, 2015, UC again saw Registrant at the St. Claire Shores 
clinic. GX 12, at 22; GX 6 (video recording of visit). After UC 
provided a urine sample, a medical assistant (MA) took his vitals and 
UC asked if he could get paper prescriptions. GX 7, at 12 (transcript 
of recording). The MA asked what medications he was taking, UC said 
``Norco and Xanax'' and that he had gotten them last month. Id. As the 
MA continued to take his vitals, she asked UC if he had a ``pharmacy 
problem'' and UC said: ``They take forever.'' Id.; GX 6, VR 5, at 
11:19:58-11:22:31.
    The MA then asked: ``[W]hat's bothering you actually?'' GX 7, at 
12. UC replied: ``Just refills. I'm just here for refills. I'm just 
here for my back pills and my nerves.'' Id. The MA asked, ``Your lower 
back?'' and UC replied ``Yeah.'' Id.; GX 6, VR 5, at 11:22:31-11:23:03.
    After she confirmed that ``just your back is [the] problem,'' the 
MA asked UC if he ``had a back injury before?'' GX 7, at 13. UC said 
that he didn't know and didn't ``know what it was.'' Id. The MA went 
through a list of symptoms including headaches and anxiety and asked if 
he had none of them; UC answered: ``I get headaches when I drink too 
much liquor'' and ``I do it big sometimes.'' Id. After a discussion of 
her shoes, MA asked UC: ``just back right?'' Id. UC said ``Uh-Huh,'' 
after which MA asked if he ``sometimes'' took medicine for headaches; 
UC answered: ``No, I just take the Xanax and Norco.'' Id.; see also GX 
6, VR5, at 11:23:03-11:24:23.
    The MA then asked if he had an ``anxiety problem?'' GX 7, at 13. 
Id. UC replied: ``Yeah. No--I don't know what you call it. But my 
nerves,'' prompting the MA to interject ``Anxiety'' and UC said ``I 
call it nerves.'' Id. The MA then asked UC if he took Xanax, and after 
UC confirmed this and that he took the one milligram dosage form, UC 
added: ``7.5 Norcos. That's all I need. I'm easy. What do you need?'' 
after which the MA asked UC to fill out a questionnaire. Id.; GX 6, VR 
5, at 11:24:20-11:25:44.
    UC filled out the questionnaire, and after the MA asked him if he 
had undergone various tests and had his blood drawn, UC was escorted to 
Registrant's office where the visit took place. Notably, the video 
shows that Registrant sat behind his desk for the duration of the 
visit, which lasted approximately three and a half minutes. See GX 6, 
VR 5, at 11:46:33-11:49:46; VR 6, at 11:49:47-11:50:01.
    Registrant greeted the UC, confirmed his name, checked his computer 
screen, and discussed his lunch order with an unidentified employee, 
after which he asked UC about his insurance, and finally inquired if 
``the medication [he] had last time went well?'' GX 7, at 16-17; UC 
replied ``Yep.'' After commenting about UC's blood pressure and height, 
Registrant asked: ``So you're okay with what we have?'' Id. at 18. UC 
said ``Yes'' and asked: ``Can I get it on paper this time?'' Id. 
Registrant asked ``why'' and if he went to a particular pharmacy, to 
which UC replied that ``it took forever,'' that he ``waited in line 
behind eight people,'' and he was ``going the other way this time too . 
. . to Detroit.'' Id. Registrant then agreed to give UC a paper 
prescription. Id.; GX 6, VR 5, at 11:46:3-11:48:05.
    Registrant and UC proceeded to discuss the latter's job as a driver 
for a car transporter and cars in general, and were interrupted by the 
MA. GX 7, at 18-20. While Registrant discussed another patient with the 
MA, she handed several paper prescriptions to Registrant. Registrant 
signed the prescriptions and handed them to UC, saying, ``Here, sir'' 
and ``Alright, Take care.'' Id. at 19-20. UC thanked Registrant and 
said he would see Registrant ``in a month,'' and the visit ended. Id. 
20; GX 6, VR 5, at 11:49:23-11:49:46; VR 6, at 11:49:50-11:50:01.
    The evidence includes a visit note dated May 1, 2015, which lists 
UC's Chief Complaint as: ``I am having lower back pain with anxiety 
problem[.]'' GX 12, at 22. In the note's Review of Systems section, 
Registrant documented: ``BJE/Musculoskeletal: ``Back Pain:--.Negative 
for Arhitis [sic], Joint Pain, Joint Swelling, Muscle Cramps, Muscle 
Weakness, Stiffness, Leg Cramps.'' Id. Registrant noted UC's 
psychiatric condition as ``Anxiety:--.Negative for, Depression, 
Hallucinations, Memory Loss, Mental Disturbance, Paranoia, Suicidal 
ideation, Panic Attacks.'' Id. With respect to all other systems, 
including ``neurological,'' Registrant noted: ``No symptoms at this 
time.'' Id.
    In the Physical Examination section, Registrant noted under 
``General Appearance,'' that ``patient doesn't seems [sic] to be in any 
distress, appropriate to respond to questions alert,'' and under 
``Muscoskeletal,'' he noted ``Limited Motion:--Arthritis.'' Id. at 23. 
Registrant again listed his diagnoses as ``Attention or Concentration 
Deficit,'' ``Spasm of Muscle,'' and ``Anxiety State Not Otherwise 
Specified.'' Id. at 23-24. For each diagnosis, he again listed ``7/22/
2015'' as both the date of diagnosis and the date of onset and noted 
that the diagnosis was ``[a]ctive.'' Id.
    In the Plan section of the note, Registrant did not list any 
prescriptions. See id. The evidence, however, includes copies of the 
prescriptions he issued at this visit; these include a prescription for 
90 hydrocodone/apap 7.5/325 mg, 60 alprazolam 0.5 mg, as well as 
naproxen and baclofen. GX 8, at 1-4. As part of his plan Registrant 
ordered a ``urine drug screen'' and noted a follow-up visit ``after one 
month.'' GX 12, at 24.
    A result sheet for the urine drug screen which was done on this 
date and apparently tested by Registrant's clinic \7\ states that UC's 
test results were ``normal'' for amphetamines, benzodiazepines, opiates 
and oxycodone, as well as other controlled substances. Id. at 25. A 
second report shows the results of a test which was done by a lab 
(which were reported on May 6, 2015). Id. at 26. Notably, the lab 
reported ``Not Detected'' for both alprazolam and hydrocodone as well 
as each drug's metabolites \8\ even though Registrant had prescribed 
the drugs at UC's previous visit. Id.
---------------------------------------------------------------------------

    \7\ The result sheet indicates that these results were obtained 
within 20 minutes of the time of the test.
    \8\ These include hydroxyalprazolam, a metabolite of alprazolam, 
and norhydrocodone and hydromorphone, which are metabolites of 
hydrocodone. GX 12, at 26.
---------------------------------------------------------------------------

    In his declaration, UC stated that Registrant ``did not conduct any 
physical examination'' and ``sat behind his [office] desk the entire 
time we talked'' which ``lasted only a few minutes.'' GX 32, at 3. He 
also stated that he had reviewed Registrant's patient records for the 
May 1, 2015 visit and determined that ``portions of them either 
misstate my statements during the visit or falsely indicate the extent 
to which I received (or did not receive) a medical examination.'' Id. 
These included the diagnosis of ``spasm of muscle'' even though ``I did 
not complain of and was not found to have muscle spasms during the 
visit,'' as well as that the medical ``record quotes me as saying `I am 
having lower back pain'

[[Page 14035]]

even though I made no such statement.'' Id.

Third Undercover Visit

    On June 15, 2015, UC again saw Registrant. GX 9 (Video Record), GX 
10 (transcript), GX 32 (UC's Declaration); see also GX 12, at 28 (Pt. 
file). According to the visit transcript, UC paid a co-pay and provided 
a urine sample. GX 10, at 1-3. Next, UC met with a nurse, who took his 
blood pressure and heart rate and asked him his weight and height. Id. 
at 4; GX 9, VR 3, at 13:32:58-13:35:43.
    After UC noted that the last visit had taken place in Registrant's 
office and that he had ``sat across from the doctor who wrote me up,'' 
the nurse asked: ``you just needed your refills?'' GX 10, at 5. UC 
said: ``Yeah. That's all I need. I'm easy. Easy for sure.'' Id.; GX 9, 
VR 3, at 13:35:43-13:36:08.
    The nurse accessed UC's electronic medical record and asked: ``So 
you're here for meds?'' Id. at 6. UC said: ``That's it. I'm pretty 
healthy.'' Id. The nurse then asked: ``Any new pain or anything? Pain 
is about the same?''; UC said: ``It's the same. Everything is the 
same.'' Id. The nurse replied: ``Unfortunately we still have to do all 
this charting, you know . . . [f]or DEA . . . It's just really crazy . 
. . those controlled things are really . . . it's like impossible to 
find meds . . . . It's being purposely done. People don't realize that, 
but DEA is behind it . . . .'' Id. UC remarked ``[c]lamping down?'' to 
which she replied ``Yep.'' Id.; GX 9, VR 3, at 13:36:08-13:37:59.
    The nurse had UC fill out some paperwork, after which she proceeded 
to question UC as to whether he had experienced various symptoms 
including appetite problems, chills, fatigue, fevers, night sweats, 
weight gain or loss, ringing ears (which prompted UC to say that ``[m]y 
ears only ring after I drink a jug of moonshine''), blurry or double 
vision, coughing, difficulty breathing, wheezing, snoring, chest pain, 
or heart skippings; UC answered ``no'' to each of these. GX 10, at 9-
10; GX 9, VR 3, at 13:39:26-13:43:52.
    Continuing, the nurse asked UC if he had ``[a]ny muscular skeletal 
problems? Pain? Back pain, joint pain, and arthritis? No? No back 
pain?'' GX 10, at 10. UC stated: ``I got like, you know, the normal,'' 
to which the nurse said, ``No, I don't'' and asked again: ``You got 
back pain?'' Id. UC responded ``I got stiffness.'' Tr. at 10. UC then 
denied having joint pain. Id.; GX 9, VR 3, at 13:43:52-13:44:54.
    The nurse then asked: ``Any anxiety, depression?'' GX 10, at 10. UC 
replied: ``No. Just my nerves get jacked up a little bit, but,'' 
prompting the nurse to ask: ``Panic attacks?'' Id. UC replied: ``I 
don't know what you would call it. Like I drink a couple cocktails on 
the weekend and I'm cool or that Xanax pretty much chills me down, so . 
. . Basically I take that Xanax, I don't need to drink too much. 
Everything is smooth. Makes sense?'' Id.; GX 9, VR 3, at 13:44:54-
13:45:16.
    The nurse stated: ``Makes perfect sense'' and asked if UC had 
``[a]ny memory loss?'' Id. UC denied memory loss. GX 10, at 10. The 
nurse asked UC ``[w]hen was the last time'' he had visited; UC stated 
``a month and a half ago'' and added that the ``last time they just let 
me go in his office.'' Id. at 11; GX 9, VR 3, at 13:45:15-13:46:16.
    The nurse then asked what medications UC was taking; he answered 
``Norco, Xanax, Baclofen'' and ``sometimes'' Naproxen. GX 10, at 11. 
The Nurse asked UC about his daily dosing for each drug, before asking 
if he had ``been out of some of these meds?'' Id. at 12. UC admitted 
that he had been out, and after the Nurse noted that his visit had been 
on May 1, asked: ``So what have you been doing?'' Id. UC replied: ``I 
have to get them from my neighbor. Well, I tried to get in here. They 
cancelled my appointment. The doctor was sick one day.'' Id.; GX 9, VR 
3, at 13:46:40-13:48:48.
    The nurse and UC discussed what pharmacy he used, stating that 
Registrant wanted to have one in case UC needed to have something 
called in, and that it was easier for e-scripting. GX 10, at 12. The 
nurse then encountered some difficulty with the electronic records and 
stated she was ``just putting no symptoms, because I'm not going 
through all that again. We already went through it.'' Id. at 14; GX 9, 
VR 3, at 13:48:50-13:52:00.
    After a discussion of the use of suboxone, the nurse asked: ``Did 
you say you have joint pain, back pain?'' GX 10, at 15. UC replied: 
``My back's stiff, but when I take that Norco, I'm cool'' and asked if 
``[t]that make[s] sense?'' Id. The nurse replied: ``that's a reason to 
have it . . . for insurance purposes. You know what I mean?'' and UC 
said: ``As long as I take that, I'm smooth.'' Id.; GX 9, VR 3, at 
13:54:36-13:54:47.
    UC and the nurse then went to Registrant's office, where the latter 
was seated behind his desk and an MA was seated facing him. During this 
period, the nurse and MA remained in the office, and Registrant asked 
UC if he was a new patient. GX 9, at 16. After UC said ``No,'' 
Registrant asked: ``You a regular? How many times?'' Id. UC said: 
``It's the third time I've been here . . . you cancelled me last 
time.'' Id.; GX 9, VR 3, at 13:55:02-13:55:40.
    After several minutes of discussing whether Registrant remembered 
UC, the nurse told Registrant, ``he just needs these four,'' and that 
``he needs them printed.'' GX 10, at 17. Apparently referring to the 
pharmacy UC wanted to use, Registrant asked UC if he didn't know which 
pharmacy he normally went to and whether he went ``to different 
people?'' Id. UC said he ``was going to Walgreens,'' but ``last time 
they didn't have some of my stuff. I had to come back two days later. 
So I'll just take them on paper if I can.'' Id. Registrant said ``ok.'' 
Id.; GX 9, VR 3, at 13:55:40-13:57:37.
    Registrant and UC then discussed where the latter worked as well as 
Registrant's car and its gas mileage, after which Registrant 
demonstrated the versatility of a Bluetooth speaker system in his 
office, followed by the MA, Registrant and UC discussing their musical 
tastes and sharing stories about Registrant's daughter. GX 10, at 17-
20. As the video shows, during the course of this conversation, 
Registrant checked his computer screen, signed the prescriptions which 
he handed to the nurse, who in turn handed them to the UC saying 
``[y]ou're all set,'' UC asked ``Am I good, ok?'' and Nurse said 
``yep.'' Id. at 22. Registrant told the UC to ``take care''; UC thanked 
Registrant and left his office. Id.; GX 9, VR 3, at 13:57:37-14:03:06.
    The visit note lists UC's chief complaint as ``I am having lower 
back pains and anxiety.'' GX 12, at 28. In the Review of Systems 
section, Registrant again noted ``Stiffness'' under BJE/Muscoskeletal; 
however, he also noted ``negative'' for each of the symptoms that were 
listed including ``back pain'' and ``muscle cramps.'' Id. Under 
Psychiatric, he noted ``Anxiety'' and ``Panic Attacks.'' Id.
    In the Physical Exam section, Registrant noted under ``General 
Appearance'' that ``patient states hes [sic] very anxious appears to be 
in mild pain alert to question and appropriate with his response.'' Id. 
at 29. As for his purported ``Muscoskeletal'' findings, Registrant 
noted: ``Limited Motion:--Muscle Spasm:--Tenderness:--Arthritis.'' And 
as for his purported ``Neurologic'' findings, Registrant noted: 
``Abnormal reflexes:--Abnormal Gait:--Weakness Atrophy.'' Id.
    As for his diagnoses, Registrant again listed ``Attention or 
Concentration Deficit,'' ``Spasm of Muscle'' and ``Anxiety State Not 
Otherwise Specified,'' and noted ``7/22/2015'' as the date of both 
diagnosis and onset for

[[Page 14036]]

each diagnosis. He further noted that each diagnosis was ``Active.'' 
Id.
    As for his plan, Registrant listed hydrocodone/apap 7.5/325 mg, 
Xanax 0.5 mg, as well as Baclofen 10 mg and Naproxen 500 mg. Id. at 30. 
He also noted a follow-up in one month. Id. The Government's evidence 
includes copies of the prescriptions issued by Registrant to UC at this 
visit; the prescriptions include 60 tablets of alprazolam .5 mg and 90 
tablets hydrocodone 7.5/325 mg, as well as baclofen and naproxen. GX 
11.
    UC's patient file includes a report for a urine drug sample 
collected from him at the June 15, 2015 visit which was tested at 
Registrant's clinic the same day. The report noted that neither 
benzodiazepines or opiates were detected and listed the results as 
``normal.'' Id. at 31. While these results were available the same day, 
UC's visit occurred approximately two weeks after the medication from 
his previous visit would have run out.\9\
---------------------------------------------------------------------------

    \9\ UC file's also includes the results of the UDS which was 
tested by an outside laboratory on June 18, 2015. GX 12, at 32. The 
report noted that the results were inconsistent with the drugs 
prescribed in that neither alprazolam nor hydrocodone were detected. 
Id.
---------------------------------------------------------------------------

    In his declaration, UC stated that he told Registrant's staff that 
when he ran out of medication, he obtained controlled substances from a 
neighbor to fill the gap between visits and that neither Registrant nor 
his staff conducted any further inquiry on this issue. GX 32, at 3. UC 
also stated that Registrant did not conduct any physical examination 
and that the portion of his visit with Registrant occurred in 
Registrant's office, where Registrant ``sat behind his desk the entire 
time.'' Id. UC further stated that his patient record quotes him ``as 
saying `I am having lower back pains' even though I explicitly stated 
that I had `stiffness.' '' Id. at 4 (Compare GX 12, at 28 with GX 10, 
at 10 (Nurse asks ``You got back pain?'' and UC responds: ``I got 
stiffness.''). Finally, UC stated that the visit note lists the results 
of a muscoskeletal exam, but other than the taking of his vital signs, 
no physical exam was performed during this visit and none of the 
conditions listed were discussed or found. GX 32, at 4.

The Government's Expert

    The Government retained Dr. R. Andrew Chambers, M.D., to review the 
videos, transcripts and prescriptions related to the undercover visits 
made by the UC investigator, as well as the medical files for three 
patients, D.S., A.L. and R.H., which were obtained during the 
investigation. Dr. Chambers is an addiction psychiatrist in Indiana. GX 
33 (Expert's Declaration). He is also an Associate Professor of 
Psychiatry at the Indiana University (IU) School of Medicine in the IU 
Neuroscience Center where he trains psychiatrists and physicians on the 
diagnosis and treatment of mental illness and drug addiction. Id. at 1. 
He also runs a university-affiliated mental health center and addiction 
treatment clinic where he treats patients. Id. He has been board 
certified in addiction medicine since 2008 and addiction psychiatry 
since 2012, and has published over 40 peer-reviewed journal articles 
and approximately nine textbook sections. Id. In addition, Dr. Chambers 
has provided expert testimony which was found credible in a previous 
DEA proceeding. See Lon F. Alexander, 82 FR 49704, 49714, 49725-26 
(2017).
    Dr. Chambers stated that he reviewed various materials to 
familiarize himself with the standard of care for the prescribing of 
controlled substances in Michigan, including the Michigan Board of 
Medicine's Guidelines for the Use of Controlled Substances for the 
Treatment of Pain, (hereinafter, ``Michigan Guidelines''), as well as 
various state laws, a document of the Michigan Board of Pharmacy 
entitled ``Pharmacy--Controlled Substances,'' and information posted by 
the Michigan Advisory Committee on Pain and Symptom Management. Id. at 
2.
    Dr. Chambers stated that ``as a professor and practicing 
psychiatrist, I have an understanding of how to prescribe controlled 
substances and the risks associated with doing so. I am also familiar 
with how doctors and practitioners should conduct themselves when 
prescribing controlled substances for a legitimate medical purpose in 
the usual c[o]urse of their profession.'' Id. Based on his 
``professional experience and review'' of the Michigan Guidelines and 
state law, he opined that ``the standard of care for prescribing 
controlled substances in Michigan is similar to and consistent with 
that in Indiana . . . and that the standards in Michigan are similar to 
and consistent with the national norms in the medical profession for 
prescribing controlled substances.'' Id. He then discussed the 
standards for prescribing controlled substances in Michigan:

    First, in accordance with Michigan state law, any controlled 
substance must be prescribed for a legitimate or professionally 
recognized therapeutic purpose. To determine that, the practitioner 
must take a complete medical history of the patient and conduct an 
adequate physical examination to determine if there is a legitimate 
medical basis for so prescribing. Second, as explained in the 
Michigan Guidelines, ``when evaluating the use of controlled 
substances for pain control, . . . [a] complete medical history and 
physical examination must be conducted and documented in the medical 
record. The medical record should document the nature and intensity 
of the pain, current and past treatments for pain, underlying or 
coexisting diseases or conditions, the effect of the pain on 
physical and psychological function, and history of substance 
abuse.'' The guidelines also instruct on providing a written 
treatment plan, obtaining informed consent and agreement for 
treatment, conducting a periodic review at ``reasonable intervals 
based on the individual circumstances of the pain,'' and ``referring 
the patient as necessary for additional evaluation and treatment in 
order to achieve treatment objectives.'' Third, practitioners must 
keep accurate and complete records of the forgoing and other aspects 
of medical care. Although that requirement is explicitly stated in 
the Michigan Guidelines, I can also [] attest based on my knowledge 
and experience that keeping accurate and complete patient records is 
required to meet the standard of care for the prescribing of any 
controlled substance, not just that which relate to pain control.

    Id. at 3.
    Dr. Chambers also stated that he was ``aware of red flags, or 
possible indicators of potential abuse, addiction or diversion, and the 
need for red flags to be addressed and resolved by a practitioner.'' 
Id. According to Dr. Chambers, these include ``patients seeking to have 
medications refilled early, patients asking for specific medications, 
and indications that the patient is addicted to or is diverting 
medications.'' Id. He further stated that ``under the standard of care, 
practitioners' records should identify any potential red flags and 
steps taken to resolve them.'' Id.
    I find that Dr. Chambers is qualified to provide an expert opinion 
on the standards of professional practice for prescribing controlled 
substances under the Michigan Board's Guidelines and Michigan law, as 
well as the standard of care generally with respect to the treatment of 
both pain and anxiety. I also find that Dr. Chambers is qualified to 
provide expert testimony as to the risks associated with prescribing 
controlled substances.
    Dr. Chambers provided a written report regarding Registrant's 
prescribing of controlled substances to UC and three other patients 
(D.S., R.H., and A.L.). With respect to UC, Dr. Chambers stated that he 
``reviewed the undercover videos, transcripts, and prescriptions,'' as 
well as the medical records related to each of the three visits.
    Dr. Chambers opined that Registrant prescribed both hydrocodone, an 
opioid, and alprazolam, a

[[Page 14037]]

benzodiazepine, and that this combination of drugs raises a serious 
overdose risk. Id. He further opined that ``[t]here are three clinical 
contexts in which the risks associated with opioid and benzodiazepine 
combination therapies are considered acceptable, these being for 
hospice care, for ``critical-care or closely monitored inpatient 
settings,'' and ``for short-term, closely monitored detoxification 
protocols for patients with addictions,'' none of which are relevant in 
assessing Registrant's prescribing to UC. Id. at 3-4.
    Dr. Chambers opined that at UC's first visit, Registrant failed to 
do a ``proper evaluation of current substance use symptoms or substance 
disorder history.'' GX 33, Attachment B, at 19. As Dr. Chambers 
explained, UC had admitted to significant alcohol use at this visit yet 
Registrant did not further question UC about his alcohol use. Id. While 
UC had represented that he was taking Xanax and Registrant reviewed his 
MAPS report which showed that he had obtained the drug from multiple 
providers, some of whom were hundreds of miles apart, Registrant did 
not do a ``proper evaluation of current psychiatric symptoms or 
psychiatric history of present illness.'' Id. Dr. Chambers also noted 
that while a nurse obtained UC's vital signs and weight, ``a physical 
exam was never performed'' and yet the medical records include ``normal 
physical examination findings.'' Id. at 20. Moreover, the patient 
record ``falsely states that the patient denies drinking.'' Id.
    With respect to Registrant's diagnoses, Dr. Chambers opined that 
none of them was properly supported. As for the diagnosis of muscle 
spasm, Dr. Chambers noted that ``there was no physical exam . . . to 
confirm muscle spasm or any other somatic source of pain or muscular-
skeletal disorder.'' Id. at 21. He further observed that Registrant 
prescribed opioids but there was no diagnosis of pain and ``opioids are 
not indicated for muscle spasm.'' Id.
    As for the diagnosis of anxiety, Dr. Chamber reiterated that 
Registrant did not perform an ``adequate psychiatric evaluation.'' Id. 
Dr. Chambers also observed that the diagnosis of an attention or 
concentration deficit ``was not evaluated[,] or measured in any current 
way.'' Id at 20.
    Dr. Chambers observed that while Registrant went over the dosing 
instructions, he did not caution UC about the risks of combining 
opioids and benzodiazepines, which ``may produce serious hazards for 
driving''' even though UC said he was professional driver. Id. at 19.
    Addressing UC's second visit, Dr. Chambers noted that ``there [was] 
no physical examination.'' Id. at 19. Dr. Chambers further observed 
that ``[t]he actual clinical encounter and evaluation with [Registrant] 
last[ed] three minutes'' and that ``[t]he most substantial evaluative 
questions'' which Registrant asked the UC were: ``Doing OK?'' and ``Med 
went well?'' Id.
    With respect to UC's third visit, Dr. Chambers noted that UC had 
``again ma[de] comments that he engage[d] in significant drinking.'' 
Id. Dr. Chambers then observed that ``[t]his information was ignored 
and/or falsified in the Medical Record by'' Registrant. Id. at 22.
    Dr. Chambers also noted that UC stated that because his third 
appointment was two weeks late, he had run out of medications and had 
obtained controlled substances from his neighbor. Id. at 20. Dr. 
Chambers observed that ``this activity was never addressed by'' 
Registrant. Id.
    As for UC's interaction with Registrant, Dr. Chambers noted that 
this occurred in Registrant's office, that the entire encounter lasted 
eight minutes, during which ``there [was] essentially no clinical 
evaluation of the patient to assess symptoms, illness course or 
treatment response,'' and ``the only questions'' asked by Registrant 
were ``where the patient work[ed] and what pharmacy he use[d].'' Id. 
Dr. Chambers also observed that most of the encounter was spent 
discussing matters that had nothing to do with the UC's medical 
condition and a physical exam was not performed. Id.
    In addition, Dr. Chambers noted that Registrant falsified the visit 
note in various respects. These include: (1) The statement that UC 
``appears to be in mild pain,'' which Dr. Chambers opined was 
inconsistent with the UC's ``voice, affect and thought content,'' 
notwithstanding that the video does not show how UC appeared; (2) the 
statement that ``patient states he is very anxious,'' which UC ``never 
stated''; and (3) the exam findings of ``limited motion, spasm, 
tenderness,'' as well as ``abnormal reflexes'' and ``weakness/
atrophy,'' as Registrant ``never performed a physical exam or touched 
the patient.'' Id. at 21.
    Dr. Chambers thus concluded that ``the controlled substances 
prescriptions that [Registrant] issued to the investigator during the 
undercover visits were not issued for any legitimate medical basis and 
were issued outside of the standard of care in . . . Michigan.'' GX 33, 
at 4.

The Expert's Chart Review of Registrant's Patients D.S., A.L. and 
R.H.D.S.

    Dr. Chambers reviewed the patient file for D.S., whose ``typical 
chief complaints were back and neck pain, and sometimes knee pain'' 
during the five years she was treated by Registrant. GX 33, at 4. 
According to the patient file, D.S.'s initial appointment with 
Registrant was on August 31, 2011. GX 14, at 5.
    Dr. Chambers found that documented prescription records from 
Registrant's electronic patient file showed a prescribing pattern which 
rapidly escalated from D.S.'s initial visit. GX 33, Attachment B, at 7. 
Dr. Chambers specifically expert found that on August 31, 2011, 
Registrant prescribed 90 mg/day morphine, yet only two weeks later 
(September 14, 2011), Registrant doubled the dosage to 180 mg/day. Id. 
Only one month later (October 14, 2011), Registrant increased D.S.'s 
dosing to 320 mg/day morphine and added 700 mg/day carisoprodol. Id. at 
8.
    Dr. Chambers also found that in two years of appointments between 
January 2014 and February 2016, Registrant's records show diagnoses of 
pain and depression. Id. The Expert found, however, that over this 
period, D.S.'s patient file contained no evidence that Registrant did 
physical exams other than to take vital signs; he also found that 
Registrant's treatment plans were essentially non-existent. Id. Yet 
during this period, Registrant prescribed to D.S. such narcotics as 
hydrocodone 10/325 mg. and oxycodone 30 mg. which included repeated 
prescriptions for 120 dosage units of the latter drug; he also 
repeatedly prescribed carisoprodol, a schedule IV muscle relaxant 
during this period. GX 13, at 1-48. Dr. Chambers noted, however, that 
the D.S.'s ``records do not typically document evidence of improvement 
in pain symptoms.'' GX 33, at 6.
    Registrant also repeatedly prescribed other controlled substances 
including stimulants such as Adipex-P (phentermine) and Bontril 
(phendimetrazine), which are schedule III and IV controlled substances. 
GX 13, at 6. Dr. Chambers further found that Registrant's introduction 
of these stimulants into D.S.'s medication regimen was ``not 
accompanied by a diagnosis or clinical indication in the charting.'' GX 
33, Attachment B, at 8.\10\
---------------------------------------------------------------------------

    \10\ He also found that Registrant made a diagnosis of 
depression on January 15, 2014, but there was no attempt to treat 
it. Id., see also GX 15, at 1-3. In fact, the record shows that 
under Review of Systems, Registrant noted ``no [psychiatric] 
symptoms at this time: Negative for anxiety, depression . . . mental 
disturbance . . . panic attacks.'' Id. at 1. There were also ``no 
[psychiatric] symptoms at this time'' noted at D.S.'s following 
visit. Id. at 4.

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

[[Page 14038]]

    Dr. Chambers identified multiple instances in which D.S.'s medical 
records indicated that she was suffering from addiction. These include 
notes on April 11 and May 9, 2012 documenting ``dependence,'' a note on 
June 8, 2012 that ``she constantly needs more [pain medications],'' a 
note on September 28, 2012 of ``medication dependence,'' a note on 
October 26, 2012 of ``[m]edication dependence illness,'' and a note on 
November 20, 2012 of ``patient continues to display dependence.'' GX 
33, at 6.
    Dr. Chambers also identified multiple instances in which D.S. 
provided aberrant urine drug screens. These included tests which showed 
the presence of methadone on February 14, 2014 and buprenorphine on 
November 10, 2014, neither of which were prescribed to D.S.; the 
presence of cocaine on March 14, 2014; the presence of psychostimulants 
(amphetamines) on March 14, April 14, and May 12, 2014 which were not 
prescribed by Registrant; instances in which the tests were negative 
for drugs prescribed by Registrant (Nov. 10, 2014 negative test for 
oxycodone and morphine and June 22, 2015 negative test for oxycodone); 
and four tests which found levels of oxycodone which were above the 
recommended therapeutic range of those drugs.\11\ GX 33, Attachment B, 
at 8-9.
---------------------------------------------------------------------------

    \11\ Two tests also found amphetamines at levels above the 
recommended therapeutic range. GX 33, Attachment B, at 9.
---------------------------------------------------------------------------

    Dr. Chambers explained that the drug test results show ``a number 
of different problems that represent serious warning signs of dangerous 
drug use and or addiction.'' Id. at 8. He further observed that 
Registrant's records contain no acknowledgment of D.S.'s aberrational 
drug tests results and reflect that he did not change the treatment 
plan or any clinical actions to address the results. Id. at 9.
    Dr. Chambers concluded that ``D.S. was very likely suffering from 
drug addiction that was not adequately diagnosed or treated, and 
[Registrant] failed to act on an overall lack of treatment response to 
the controlled substance combinations he was prescribing.'' GX 33, at 
6. He further opined that Registrant ``was prescribing dangerous 
combinations of controlled substances without documenting a medical 
need for so doing, and he failed to adequately document ongoing 
examinations and treatment planning . . . and/or he failed to perform 
these professional functions altogether.'' Id. Dr. Chambers thus 
concluded that Registrant issued numerous prescriptions without ``any 
legitimate medical basis'' and acted ``outside of the standard of care 
in the state of Michigan.'' Id.
A.L.
    Registrant treated patient A.L. from January 17, 2011 through April 
30, 2014. Id. at 14-16. See also GX 18 (patient medical file), GX 19 
and 20 (electronic patient files). Regarding Registrant's patient 
records for A.L., Dr. Chambers reported that they contain notes for 
various medical issues including anxiety, depression, and pain, the 
latter including knee, lower back, ankle and neck pain. GX 33, at 6-7.
    Dr. Chambers reviewed 11 controlled substance prescriptions 
Registrant issued to A.L. between October 17, 2013 and May 6, 2014. Id. 
at 7. The prescriptions included three prescriptions for 120 du of 
hydrocodone/apap 10/325 mg with two refills, three prescriptions for 30 
du of phentermine 37.5 mg with two refills, three prescriptions for 150 
du of carisoprodol 350 mg with two refills, and three prescriptions for 
120 du of alprazolam 2 mg. GX 17, at 2-23 (copies of prescriptions 
obtained from filling pharmacy, and pharmacy patient profile report).
    Dr. Chambers observed that ``[f]or the most part there are no 
physical examinations documented in the medical records.'' GX 33, at 7. 
Dr. Chambers also noted that ``the combination of Hydrocodone, 
Alprazolam and Carisoprodol drugs . . . is a prescription `cocktail' 
known among users and law enforcement as the `Trinity,''' and that it 
``is widely known to be used non-therapeutically as part of a substance 
disorder and/or diverted.'' Id. He further noted that on four occasions 
in 2011, Registrant had also prescribed another variation of this 
cocktail, which substituted Roxicodone (oxycodone) for hydrocodone. Id. 
He then opined that ``there is no documentation in A.L.'s medical 
records demonstrating a legitimate medical justification or clinical 
context for prescribing this dangerous combination of controlled 
substances.'' Id.
    Dr. Chambers also found that ``[t]here are numerous signs of 
addiction'' in A.L.'s patient file, beginning with her initial visit 
with Registrant on January 17, 2011. Id. Dr. Chambers noted that the 
MAPS report showed that A.L. ``had seen up to eight prior prescribers 
over the prior year for various controlled substances, including 
combinations of opioids, benzodiazepines, and stimulants,'' resulting 
in 50 dispensings of drugs which included hydrocodone, oxymorphone, 
oxycodone, morphine, diazepam, alprazolam and amphetamine. GX, 33 at 7-
8; see also GX 18, at 32-40. He also observed that on her ``Health 
History Questionnaire,'' which was completed in January 2011, she 
reported taking Roxicodone, Xanax, and Soma, which as Dr. Chambers 
previously explained, comprises the highly abused ```Trinity' drug 
cocktail.'' Id. at 8; see also GX 18, at 14.\12\
---------------------------------------------------------------------------

    \12\ The same Health History Questionnaire also lists Opana, 
Vickodin [sic], and MS Contin as ``prescribed drugs.'' GX 18, at 14.
---------------------------------------------------------------------------

    Dr. Chambers further noted that A.L.'s medical records documented 
that she ``was possibly engag[ed] in diversion.'' Id. at 8. As support 
for this observation, Dr. Chambers pointed to a chart entry of February 
25, 2013 which states: ``She says she cannot get her pain medications 
and has to be buying it off the streets to satisfy her pain. The last 
time she was given pain medication from this office was in September of 
last year.'' Id. at 8; see also GX 19, at 8. Dr. Chambers found that 
there was no evidence in the patient record that Registrant ``addressed 
or resolved these red flags.'' GX 33, at 8. Moreover, Dr. Chambers 
found that Registrant's ``charting is devoid of UDS data collection or 
tracking.'' GX 33, Attachment B, at 18.
    Based on his review of A.L.'s record and the prescriptions, Dr. 
Chambers concluded that that she ``was suffering from a drug addiction 
that was not adequately diagnosed or treated; [that Registrant] was 
prescribing extremely dangerous combinations of controlled substances 
without documenting an appropriate medical context or justification for 
so doing, and [that he] failed to adequately document ongoing 
examinations and treatment planning . . . and/or he failed to perform 
these professional functions altogether.'' GX 33, at 8. Dr. Chambers 
thus opined that ``the prescriptions [Registrant] issued to A.L. were 
not issued for any legitimate medical basis and were issued outside of 
the standard of care in the state of Michigan.'' Id.

R.H.

    Dr. Chambers also reviewed the controlled substances Registrant 
issued to R.H. from June 2, 2015 through February 24, 2016. According 
to Dr. Chambers, during this time period, R.H. presented a variety of 
chief complaints which ``included complaints of lower back and hand 
joint pain, anxiety,

[[Page 14039]]

numbness, a rash on face/head, fractured left toes, sciatica, and arms 
and shoulder pain.'' Id.
    During this period, Registrant issued to R.H. 10 prescriptions for 
90 du of hydrocodone/apap 10/325 mg; 10 prescriptions for 60 du of 
morphine sulfate 100 mg; 10 prescriptions for 120 du of morphine 
sulfate 30 mg; five prescriptions for 60 du of alprazolam 1 mg, 
including one which provided for two refills; and two prescriptions for 
60 du of carisoprodol 350 mg, each of which provided for two refills. 
Id. at 8-10. Dr. Chambers again noted that the combination of 
hydrocodone, alprazolam, and carisoprodol comprise the Trinity 
cocktail. Id. at 10. He also found that on six occasions between March 
11, 2011 and September 26, 2011, Registrant prescribed hydrocodone, 
carisoprodol and Valium (diazepam), another version of the Trinity 
cocktail. Id.
    Dr. Chambers found that ``[f]or the most part there are no physical 
exams documented in the medical records.'' Id. He also found that 
``[t]here is no documentation in R.H.'s medical records demonstrating a 
legitimate medical justification or clinical context for prescribing 
this dangerous combination of controlled substances.'' Id.
    Dr. Chambers noted that R.H.'s records contain ``numerous signs of 
possible addiction or abuse.'' Id. at 11. These include a note (Dec. 
21, 2011) in which Registrant documented that ``R.H. is taking the 
valium three times a [day] although he is given it twice daily so he 
runs out eary'' [sic]. Id. Dr. Chambers also found that ``R.H.'s urine 
drug screens also show[] a number of different problems that represent 
serious warnings signs of dangerous drug use and or addiction, 
including the presence of amphetamines and benzodiazepine[s] that 
[were] not prescribed by'' Registrant. Id. Dr. Chambers further found 
that ``[t]here are no indications in the patient records that 
[Registrant] addressed or resolved these red flags.'' Id.
    Based upon his review of R.H.'s patient file and prescriptions, Dr. 
Chambers concluded that he ``was suffering from drug addiction that was 
not adequately diagnosed or treated.'' Id. Dr. Chambers further 
concluded that Registrant ``was prescribing extremely dangerous 
combinations of controlled substances without documenting a medical 
need for so doing, and [that Registrant] failed to adequately document 
ongoing examinations and treatment planning . . . and/or he failed to 
perform these professional functions altogether.'' Id. Dr. Chambers 
thus opined that the prescriptions Registrant issued to R.H. ``were not 
issued for any legitimate medical basis and were issued outside of the 
standard of care in . . . Michigan.'' Id.

Summary of the Expert's Findings

    With respect to the UC and the three other patients, Dr. Chambers 
opined that:

    The evidence reveals that [Registrant] has been engaged in 
prescribing dangerous levels and combinations of opioid and benzoid 
drugs to multiple patients in chronic patterns that have no 
legitimate medical purpose, and are not supported by the evidence 
base. Moreover, it is precisely these types of controlled substance 
patterns that are shown by a wealth of biomedical, clinical and 
epidemiological evidence to produce diversion and to contribute to 
addiction, worsening mental illness, and premature death. The case 
evidence suggests to various degrees that all of these outcomes have 
happened as a result of [Registrant's] prescribing and clinical 
practices.
    This prescribing was also occurring in the absence of minimally 
adequate practice standards of care by [Registrant], including 
failures to appropriately evaluate, diagnose and monitor disease 
processes, and treatment outcomes or treatment side effects. All 4 
cases presented strong evidence that patients were suffering with 
mental illness and addiction of some kind when initially presenting 
for treatment. In 3 cases, these conditions did not change and/or 
worsened over time even as they were not appropriately treated, or 
referred elsewhere for treatment, and even as these conditions were 
adversely contributed to by the benzoid-opioid combination of drugs 
[Registrant] was prescribing.
Id. at Attachment B, at 5.
    Dr. Chambers further opined that Registrant was not practicing in 
``good faith'' as defined by Michigan Code Sec.  333.7333(1). Id. This 
provision defines ``good faith'' as:

    The prescribing or dispensing of a controlled substance by a 
practitioner licensed under section 7303 in the regular course of 
professional treatment to or for an individual who is under 
treatment by the practitioner for a pathology or condition other 
than that individual's physical or psychological dependence upon or 
addiction to a controlled substance, except as provided in this 
article.

    Mich. Code Sec.  333.7333(1). Dr. Chambers thus concluded that 
``rather than providing legitimate medical care, [Registrant] was 
actually using the guise of medical practice . . . to deal addictive 
drugs to patients with untreated addictions and mental illness.'' GX 
33, Attachment B, at 5.
    Dr. Chambers also evaluated the evidence in light of the Michigan 
Guidelines for the Use of Controlled Substances for the Treatment of 
Pain. Dr. Chambers explained that the Guidelines ``set forth six key 
components of legitimate medical practice that should be observed in 
the use of controlled substance for the treatment of pain,'' to 
``include appropriate:

    (1) Evaluation (history taking and physical examination, 
psychiatric screening);
    (2) Treatment Planning;
    (3) Informed consent (discussion of risks and benefits of 
medications . . .);
    (4) Periodic Review (evaluate and monitoring of treatment 
progress);
    (5) Consultation; and
    (6) Medical record keeping.''
Id. at 5-6.
    Dr. Chambers opined that ``there are 2 other key aspects of the 
evidence that highlight the particularly malignant nature of 
[Registrant's] practices and prescribing pattern.'' Id. at 6. First, 
Dr. Chambers concluded that the ``evidence suggest[s] that Registrant 
deliberately acted to obscure, in the medical record, the dangerousness 
of his practice, to cover-up the degree to which it was a drug dealing 
operation, instead of a legitimate medical practice.'' Id. As he 
further explained, the evidence ``show[s] that [Registrant] is padding 
the medical record with initial PDMP evaluations and UDS testing that 
he never acts on regardless of what these data show, as if the point is 
to create the appearances of maintaining standards and adequate 
monitoring in the medical record without actually doing so.'' Id. 
Second, Dr. Chambers explained that the evidence shows that ``[h]e not 
only engages in little history taking and no physical examination of 
the patient, but he falsely documents examination findings that do not 
exist, in an examination that was never performed, in order to justify 
the continuing prescription of controlled drugs.'' Id.
    Dr. Chambers thus concluded that ``this evidence shows that 
[Registrant] is performing well below the standard of care, and is a 
danger to []his patients and the public at large with respect to his 
prescribing of controlled substances. The evidence is highly suggestive 
that he is providing prescriptions for addictive substances, not in 
`good faith' consistent with medical norms, but as a distribution 
business, i.e. as a drug dealing operation under the guise of 
legitimate health care.'' Id. I agree.

Discussion

    In its Request for Final Agency Action, the Government seeks 
revocation on two independent grounds. First, it argues that revocation 
is warranted because Registrant lacks authority under state law to 
dispense controlled substances. RFAA, at 6 (citing 21 U.S.C. 
824(a)(3)). Second, it

[[Page 14040]]

argues that Registrant has committed acts which render his registration 
inconsistent with the public interest because he unlawfully distributed 
controlled substances in violation of 21 U.S.C. 841(a)(1) and 21 CFR 
1306.04(a). Id. at 9. I agree that the Government is entitled to an 
order of revocation on both grounds.

Lack of State Authority

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized 
to suspend or revoke a registration issued under section 823, ``upon a 
finding that the registrant . . . has had his State license . . . 
suspended [or] revoked . . . by competent State authority and is no 
longer authorized by State law to engage in the . . . dispensing of 
controlled substances.'' Moreover, DEA has held repeatedly that the 
possession of authority to dispense controlled substances under the 
laws of the State in which a practitioner engages in professional 
practice is a fundamental condition for obtaining and maintaining a 
practitioner's registration. See, e.g., James L. Hooper, 76 FR 71371 
(2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); 
Frederick Marsh Blanton, 43 FR 27616 (1978).
    This rule derives from the text of two provisions of the CSA. 
First, Congress defined ``the term `practitioner' [to] mean[] a . . . 
physician . . . or other person licensed, registered or otherwise 
permitted, by . . . the jurisdiction in which he practices . . . to 
distribute, dispense, [or] administer . . . a controlled substance in 
the course of professional practice.'' 21 U.S.C. 802(21). Second, in 
setting the requirements for obtaining a practitioner's registration, 
Congress directed that ``[t]he Attorney General shall register 
practitioners . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated 
that a practitioner possess state authority in order to be deemed a 
practitioner under the Act, DEA has held repeatedly that revocation of 
a practitioner's registration is the appropriate sanction whenever he 
is no longer authorized to dispense controlled substances under the 
laws of the State in which he practices medicine. See, e.g., Calvin 
Ramsey, 76 FR 20034, 20036 (2011); Sheran Arden Yeates, M.D., 71 FR 
39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); 
Bobby Watts, 53 FR 11919, 11920 (1988). See also Frederick Marsh 
Blanton, 43 FR 27616 (1978).
    Here, while the Michigan Board's Consent Order suspended 
Registrant's medical license for 15 months, the Board's Order further 
provides that ``reinstatement shall not be automatic,'' and that 
Registrant must petition for reinstatement by demonstrating, ``by clear 
and convincing evidence,'' that he: (1) Is of ``good moral character''; 
(2) has ``the ability to practice the profession with reasonable skill 
and safety''; (3) has satisfied ``the guidelines on reinstatement 
adopted by the Department''; and (4) ``that it is in the public 
interest for the license to be reinstated.'' Consent Order, at 2. Thus, 
it is far from certain that Registrant will be able to satisfy these 
conditions and be reinstated to the practice of medicine.
    More importantly, this Agency has held that even where a State has 
imposed a suspension of finite duration of a practitioner's medical 
license, revocation is nonetheless warranted because the controlling 
question is not whether a practitioner's license to practice medicine 
in the State is suspended or revoked; rather, it is whether the 
Registrant is currently authorized to handle controlled substances in 
the State. Hooper, 76 FR at 71371 (citing Anne Lazar Thorn, 62 FR 
12847, 12848 (1997)). Because one cannot obtain a practitioner's 
registration unless one holds authority under state law to dispense 
controlled substances, and because where a registered practitioner's 
state authority has been revoked or suspended, the practitioner no 
longer meets the statutory definition of a practitioner, DEA has held 
repeatedly that the possession of authority to dispense controlled 
substances under the laws of the State in which a practitioner engages 
in professional practice is a fundamental condition for both obtaining 
and maintaining a practitioner's registration. See Blanton, 43 FR 27616 
(1978) (revoking registration based on one-year suspension of medical 
license); Hooper, 76 FR at 71371 (same).
    Thus, because Registrant is no longer currently authorized to 
dispense controlled substances in Michigan, the State in which he is 
registered with the Agency, I find that he is not entitled to maintain 
a DEA registration in the State. Accordingly, I will order the 
revocation of his existing registration on this ground. See 21 U.S.C. 
824(a)(3) .
The Public Interest Analysis
    Section 304(a) of the Controlled Substances Act (CSA) provides that 
a registration to ``dispense a controlled substance * * * may be 
suspended or revoked by the Attorney General upon a finding that the 
registrant * * * has committed such acts as would render his 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). With respect to a practitioner, the Act requires the 
consideration of the following factors in making the public interest 
determination:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing * * * controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.
Id. Sec.  823(f)
    ``These factors are * * * considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or 
a combination of factors, and may give each factor the weight [I] deem[ 
] appropriate in determining whether a registration should be 
revoked.'' Id.; see also Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 
2009). While I must consider each factor, I am ``not required to make 
findings as to all of the factors.'' Volkman, 567 F.3d at 222; see also 
Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. 
DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).
    In short, this is not a contest in which score is kept; the Agency 
is not required to mechanically count up the factors and determine how 
many favor the Government and how many favor the registrant. Rather, it 
is an inquiry which focuses on protecting the public interest; what 
matters is the seriousness of the registrant's misconduct. Jayam 
Krishna--Iyer, M.D., 74 FR 459, 462 (2009). Accordingly, as the Tenth 
Circuit has recognized, findings under a single factor can support the 
revocation of a registration. MacKay v. DEA, 664 F.3d. 808, 821 (10th 
Cir. 2011).
    Even in a non-contested proceeding, the Government has the burden 
of producing substantial evidence to support the allegations and its 
proposed sanction. See Gabriel Sanchez, 78 FR 59060, 59063 (2013); 21 
CFR 1301.44(e). In this case, I find that the Government's evidence 
with respect to Factors Two and Four \13\ establishes that Registrant

[[Page 14041]]

``has committed such acts as would render his registration . . . 
inconsistent with the public interest.'' 21 U.S.C. 824(a)(4).
---------------------------------------------------------------------------

    \13\ In its Request for Final Agency Action, the Government 
states that Factors I, III and V do not weigh in favor of or against 
revoking Registrant's registration. RFAA at 8, fn. 4 (citing 21 
U.S.C Sec. Sec.  823(f)(1), (3) and (5)). As explained above, with 
respect to Factor One--the Recommendation of the State Board--the 
Board made no recommendation to the Agency in this matter. More 
importantly, as discussed above, the Board has suspended his medical 
license thus rendering him ineligible to maintain his registration.
    With respect to Factor Three, I acknowledge that there is no 
evidence that Respondent has been convicted of an offense under 
either Federal or Michigan law ``relating to the manufacture, 
distribution or dispensing of controlled substances.'' 21 U.S.C. 
823(f)(3). However, there are a number of reasons why even a person 
who has engaged in criminal misconduct may never have been convicted 
of an offense under this factor, let alone prosecuted for one. Dewey 
C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied, MacKay 
v. DEA, 664 F.3d at 822. The Agency has therefore held that ``the 
absence of such a conviction is of considerably less consequence in 
the public interest inquiry'' and is therefore not dispositive. Id.
    The Government makes no argument that Factor Five is implicated 
in this matter.
---------------------------------------------------------------------------

Factors Two and Four--Registrant's Experience in Dispensing Controlled 
Substances and Compliance With Applicable Laws Related to Controlled 
Substances

    Under a longstanding DEA regulation, a prescription for a 
controlled substance is not ``effective'' unless it is ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a). See 
also Mich. Comp. Laws Sec.  333.7333(1) (``As used in this section, 
`good faith' means the prescribing of a controlled substance by a 
practitioner licensed under section 7303 in the regular course of 
professional treatment to or for an individual who is under treatment 
by the practitioner for a pathology or condition other than that 
individual's physical or psychological dependence upon or addiction to 
a controlled substance, except as provided in this article.''); id. 
Sec.  333.7401 (``A practitioner licensed by the administrator under 
this article shall not dispense, prescribe, or administer a controlled 
substance for other than a legitimate and professionally recognized 
therapeutic or scientific purposes or outside the scope of practice of 
the practitioner . . . .'').
    Under the CSA, it is fundamental that a practitioner must establish 
a bonafide doctor-patient relationship in order to act ``in the usual 
course of . . . professional practice'' and to issue a prescription for 
a ``legitimate medical purpose.'' See United States v. Moore, 423 U.S. 
122, 142-43 (1975); United States v. Lovern, 590 F.3d 1095, 1100-01 
(10th Cir. 2009); United States v. Smith, 573 F.3d 639, 657 (8th Cir. 
2009); see also 21 CFR 1306.04(a) (``An order purporting to be a 
prescription issued not in the usual course of professional treatment . 
. . is not a prescription within the meaning and intent of [21 U.S.C. 
829] and . . . the person issuing it, shall be subject to the penalties 
provided for violations of the provisions of law relating to controlled 
substances.'').
    As the Supreme Court has explained, ``the prescription requirement 
. . . ensures patients use controlled substances under the supervision 
of a doctor so as to prevent addiction and recreational abuse. As a 
corollary, [it] also bars doctors from peddling to patients who crave 
the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S. 
243, 274 (2006) (citing Moore, 423 U.S. 122, 135, 143 (1975)).
    Both this Agency and the federal courts have held that establishing 
a violation of the prescription requirement ``requires proof that the 
practitioner's conduct went `beyond the bounds of any legitimate 
medical practice, including that which would constitute civil 
negligence.' '' Laurence T. McKinney, 73 FR 43260, 43266 (2008) 
(quoting United States v. McIver, 470 F.3d 550, 559 (4th Cir. 2006)). 
However, as the Sixth Circuit (and other federal circuits have noted), 
`` `[t]here are no specific guidelines concerning what is required to 
support a conclusion that an accused acted outside the usual course of 
professional practice. Rather, the courts must engage in a case-by-case 
analysis of the evidence to determine whether a reasonable inference of 
guilt may be drawn from specific facts.' '' United States v. August, 
984 F.2d 705, 713 (6th Cir. 1992) (citations omitted) (quoted in United 
States v. Singh, 54 F.3d 1182, 1187 (4th Cir. 1995)).
    Thus, in Moore, the Supreme Court held the evidence in a criminal 
trial was sufficient to find that a physician's ``conduct exceeded the 
bounds of `professional practice,' '' where the physician ``gave 
inadequate physical examinations or none at all,'' ``ignored the 
results of the tests he did make,'' ``took no precautions against . . . 
misuse and diversion,'' ``did not regulate the dosage at all'' and 
``graduated his fee according to the number of tablets desired.'' 423 
U.S. at 142-43.
    However, as the Sixth Circuit has explained, ``[o]ne or more of the 
foregoing factors, or a combination of them, but usually not all of 
them, may be found in reported decisions of prosecutions of physicians 
for issuing prescriptions for controlled substances exceeding the usual 
course of professional practice.'' United States v. Kirk, 584 F.2d 773, 
785 (6th Cir. 1978). See also United States v. Hooker, 541 F.2d 300, 
305 (1st Cir. 1976) (affirming conviction under section 841 where 
physician ``carried out little more than cursory physical examinations, 
if any, frequently neglected to inquire as to past medical history and 
made little to no exploration of the type of problem a patient 
allegedly'' had, and that ``[i]n light of the conversations with the 
agents, the jury could reasonably infer that the minimal `professional' 
procedures followed were designed only to give an appearance of 
propriety to [the] unlawful distributions''); United States v. Tran 
Trong Cuong, 18 F.3d 1132, 1139 (4th Cir. 1994) (holding evidence 
sufficient to find physician prescribed outside of professional 
practice, in that ``in most cases the patients complained of such 
nebulous things as headaches, neckaches, backaches and nervousness, 
conditions that normally do not require . . . controlled substances,'' 
physician was ``aware that some of the[] patients were obtaining the 
same drugs from other doctors,'' ``[m]ost of the patients were given 
very superficial physical examinations,'' and patients were not 
``referred to specialists''); United States v. Bek, 493 F.3d 790, 799 
(7th Cir. 2007) (upholding convictions; noting that the evidence 
included ``uniform, superficial, and careless examinations,'' 
``exceedingly poor record-keeping,'' ``a disregard of blatant signs of 
drug abuse,'' ``prescrib[ing] multiple medications having the same 
effects . . . and drugs that are dangerous when taken in 
combination''); United States v. Feingold, 454 F.3d 1001, 1010 (9th 
Cir. 2006) (``[T]he Moore Court based its decision not merely on the 
fact that the doctor had committed malpractice, or even intentional 
malpractice, but rather on the fact that his actions completely 
betrayed any semblance of legitimate medical treatment.''); United 
States v. Joseph, 709 F.3d 1082, 1104 (11th Cir. 2013) (upholding 
conviction of physician where ``record establishe[d] that [physician] 
prescribed an inordinate amount of certain controlled substances, that 
he did so after conducting no physical examinations or only a cursory 
physical examination, that [physician] knew or should have known that 
his patients were misusing their prescriptions, and that many of the 
combinations of prescriptions drugs were not medically 
necessary'').\14\
---------------------------------------------------------------------------

    \14\ However, as the Agency has held in multiple cases, ``the 
Agency's authority to deny an application [and] to revoke an 
existing registration . . . is not limited to those instances in 
which a practitioner intentionally diverts a controlled substance.'' 
Bienvenido Tan, 76 FR 17673, 17689 (2011) (citing Paul J. Caragine, 
Jr., 63 FR 51592, 51601 (1998)); see also Dewey C. MacKay, 75 FR at 
49974. As Caragine explained: ``[j]ust because misconduct is 
unintentional, innocent, or devoid of improper motive, [it] does not 
preclude revocation or denial. Careless or negligent handling of 
controlled substances creates the opportunity for diversion and 
[can] justify'' the revocation of an existing registration or the 
denial of an application for a registration. 63 FR at 51601.
    ``Accordingly, under the public interest standard, DEA has 
authority to consider those prescribing practices of a physician, 
which, while not rising to the level of intentional or knowing 
misconduct, nonetheless create a substantial risk of diversion.'' 
MacKay, 75 FR at 49974; see also Patrick K. Chau, 77 FR 36003, 36007 
(2012).

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

[[Page 14042]]

    The evidence shows that Registrant unlawfully distributed 
controlled substances by issuing prescriptions to the UC on multiple 
occasions outside the usual course of professional practice and for 
other than a legitimate medical purpose, in violation of 21 U.S.C. 
841(a)(1) and 21 CFR 1306.04(a). See also Mich. Comp. Laws Sec.  
333.7401(1) (``A practitioner . . . shall not . . . prescribe . . . a 
controlled substance for other than legitimate and professionally 
recognized therapeutic or scientific purposes or outside the scope of 
practice of the practitioner.''); id. Sec.  333.7405(1)(a) (a licensed 
practitioner shall not ``distribute, prescribe, or dispense a 
controlled substance in violation of section 7333'').
    The Michigan Guidelines set forth the applicable standards of 
professional practice for the prescribing of controlled substances in 
the State. GX 28. The Guidelines provide that:

when evaluating the use of controlled substances for pain control . 
. . [a] complete medical history and physical examination must be 
conducted and documented in the medical record. The medical record 
should document the nature and intensity of the pain, current and 
past treatments for pain, underlying or coexisting diseases or 
conditions, the effect of the pain on physical and psychological 
function, and history of substance abuse.

    GX 28. The Guidelines also state that the physician is to keep 
``accurate and complete records'' of the forgoing and other aspects of 
medical care. Id.
    The Government's evidence shows that Registrant dispensed 
controlled substances to the UC on multiple occasions, notwithstanding 
his failure to conduct an adequate evaluation, including any physical 
examination to support a finding that the prescribing of both 
hydrocodone and the Xanax was medical necessary to treat the UC. GX 3-
4, 6-7, 9-10. Dr. Chambers explained that Registrant failed to do a 
proper evaluation of the UC's substance use even though he admitted to 
significant alcohol use, did not properly evaluate his psychiatric 
symptoms even though he said he was using Xanax and the PMP report 
showed that he had obtained this drug from multiple providers, failed 
to perform a physical examination of the [UC] at any point, and failed 
to perform adequate treatment planning. Dr. Chambers further explained 
that Registrant falsified the medical record by fraudulently 
documenting in it that the UC denied drinking, as well as by making 
physical exam findings such as ``[l]imited motion, spasm, tenderness, 
weakness, atrophy, abnormal reflexes,'' when he did not perform the 
tests necessary to make these findings. GX 33, Attachment B, at 22.
    Moreover, on the pain questionnaire, the UC did not circle any of 
the descriptors, did not rate his pain, nor indicate whether his pain 
interfered with various life activities listed on the form. Yet 
Registrant made no inquiry as to why the UC left most of the form 
blank.
    Most significantly, during his visit with Registrant, the UC never 
complained of anything more than back stiffness, made no complaint that 
he suffered from anxiety and stated that he took Xanax because it kept 
him from drinking too much on the weekends. Here again, Registrant 
falsified the medical record by documenting: ``Today [the UC] is 
complaining mostly of [ ] some level of anxiety.'' Dr. Chambers further 
concluded that there was no basis for the various diagnoses which 
Registrant documented in the UC's record, including anxiety and muscle 
spasms; he also noted that Registrant made no diagnosis of pain and 
that opioids are not indicated for muscle spasms.
    The UC's second visit with Registrant lasted all of three and a 
half minutes. As Dr. Chambers explained, the most substantial questions 
Registrant asked the UC for evaluating his need for the (hydrocodone 
and alprazolam, were: ``Doing OK?'' and ``Med went well?'' Moreover, 
Registrant did not perform a physical exam during the visit and yet, he 
again falsified the medical record by noting various exam findings.
    As for the third visit, Dr. Chambers noted that Registrant did not 
address the UC's statements regarding his drinking and statements that 
he had run out of medication and obtained controlled substances from 
his neighbor. Dr. Chambers further opined that there was essentially no 
clinical evaluation of the UC's symptoms, illness course or treatment 
response. Registrant again falsified the visit note by indicating that 
the UC ``appears to be in mild pain'' and ``states he is very 
anxious,'' as well as by making physical exam findings of ``limited 
motion, spasm, tenderness,'' ``abnormal reflexes'' and ``weakness/
atrophy,'' when he did not perform the tests necessary to make these 
findings.
    I thus conclude that Registrant acted outside of the usual course 
of professional practice and lacked a legitimate medical purpose when 
he issued the prescriptions for hydrocodone and alprazolam at each of 
the UC's visits. 21 CFR 1306.04(a); 21 U.S.C. 841(a)(1); see also Mich. 
Comp. Laws Sec.  333.7401(1). With respect to the UC, I conclude, based 
on Dr. Chambers' testimony, that Registrant failed to comply with the 
Michigan Guidelines in that he failed to take a complete medical 
history, conduct a physical examination, and document in the medical 
record ``the nature and intensity of the pain, current and past 
treatments for pain, underlying or coexisting diseases or conditions, 
the effect of the pain on physical and psychological function, and 
history of substance abuse.'' Michigan Guidelines, Section II.1. Based 
on Dr. Chambers' testimony, I also conclude that Registrant 
``essentially'' failed to comply with each of the standards of the 
Michigan Guidelines, including developing a treatment plan which sets 
forth objectives for determining treatment success and considering 
other treatment modalities, obtaining informed consent, conducting 
periodic reviews, and maintaining accurate and complete records. GX 33, 
Attachment B, at 5-6. (Expert Declaration), at 6. I further conclude 
that Registrant violated Michigan Law and the CSA in that he acted 
outside of the usual course of professional practice and lacked a 
legitimate medical purpose when he prescribed controlled substances to 
the UC. 21 CFR 1306.04(a); see also Mich. Comp. Laws Sec. Sec.  
333.7401(1).
    I also find that Registrant failed to comply with the Michigan 
Guidelines, and violated both Michigan Law and the CSA in that he acted 
outside of the usual course of professional practice and lacked a 
legitimate medical purpose when he prescribed controlled substances to 
patients D.S., A.L. and R.H. 21 CFR 1306.04(a); see also Mich. Comp. 
Laws Sec.  333.7401(1). As discussed above, Dr. Chambers found that 
there was evidence that all three patients were suffering from drug 
addiction which Registrant did not adequately diagnose or treat, and 
that Registrant's prescribing practices contributed to their addiction. 
With respect to each of the chart review patients, Dr. Chambers also 
found that Registrant ``was prescribing extremely dangerous 
combinations of controlled substances without documenting an 
appropriate medical context or justification for so

[[Page 14043]]

doing, and [that he] failed to adequately document ongoing examinations 
and treatment planning . . . and/or he failed to perform these 
professional functions altogether.'' GX 33, at 6 (D.S.), 8 (A.L.), 11 
(R.H.).
    With respect to D.S., Dr. Chambers found that over the two-year 
period between January 2014 and February 2016, there was no evidence in 
the patient file that Registrant performed physical exams other than to 
take vital signs and that his treatment plan was essentially non-
existent. He also found that D.S.'s chart contained multiples notations 
that she was suffering from addiction but no evidence that Registrant 
addressed this with her. Most significantly, as Dr. Chambers observed, 
D.S. provided multiple aberrational drug tests which included: (1) The 
presence of controlled substances which he did not prescribe on six 
occasions, including methadone, buprenorphine, cocaine, and 
amphetamines; (2) the non-presence of controlled substances (oxycodone 
and morphine) which he had prescribed on two occasions; and (3) the 
presence of oxycodone above the recommended therapeutic range on four 
occasions. Yet there is no evidence that Registrant addressed any of 
these aberrational test results with D.S.
    As for A.L., Dr. Chambers found that ``for the most part,'' 
Registrant did not document the performance of a physical exam and 
there is no documentation in the patient file to support Registrant's 
prescribing of the combinations of narcotics, benzodiazepines, and 
carisoprodol that he did. GX 33, at 7. Moreover, A.L.'s MAPS report 
showed that she had seen eight other providers in the year prior to her 
first visit with Registrant and that she had obtained controlled 
substances on 50 occasions \15\ which included hydrocodone, 
oxymorphone, oxycodone, morphine, diazepam, alprazolam and amphetamine 
based on prescriptions issued by these providers. Moreover, at her 
first visit with Registrant, A.L. reported that she was taking the 
Trinity of oxycodone, Xanax, and Soma, and while at one point, 
Registrant even documented that A.L. stated that she was buying drugs 
off the street, Registrant did not address this aberrant behavior. 
Moreover, as Dr. Chambers observed, her chart is devoid of evidence 
that she was monitored through the use of urine drug screens. See GXs 
18-20.
---------------------------------------------------------------------------

    \15\ In some instances, she obtained the controlled substances 
through a refill of a previously issued prescription. See, e.g., GX 
18, at 32 (alprazolam refill); id. at 33-34 (refills of 
hydrocodone).
---------------------------------------------------------------------------

    With respect to R.H., Dr. Chambers found that ``[f]or the most part 
there are no physical exams documented in the medical records'' and 
``[t]here is no documentation in R.H.'s medical records demonstrating a 
legitimate medical justification . . . for [Registrant's] prescribing'' 
the ``dangerous combination[s]'' of narcotics, benzodiazepines, and 
carisoprodol to R.H. GX 33, at 10. Dr. Chambers also found that R.H.'s 
urine drug screens showed the presence of controlled substances 
including amphetamines and benzodiazepines that Registrant did not 
prescribe to him and that Registrant had also documented that R.H. was 
overmedicating with respect to Valium. However, R.H.'s medical record 
contains no indication that Registrant resolved these red flags.
    Accordingly, I agree with Dr. Chambers that Registrant lacked a 
legitimate medical purpose and acted outside of the usual course of 
professional practice when he issued the various controlled substance 
prescriptions identified above to D.S., A.L., and R.H. 21 CFR 
1306.04(a); 21 U.S.C. 841(a)(1). I also agree with Dr. Chambers that 
Registrant's prescribing to D.S., A.L. and R.H. violated Mich. Comp. 
Laws Sec.  333.7401(1) and did not comply with the Michigan Guidelines.
    I thus conclude that Registrant's multiple violations of 21 CFR 
1306.04 (a), 21 U.S.C. 841(a)(1), and Mich. Comp. Laws Sec.  
333.7401(1) are egregious and support the conclusion that he ``has 
committed such acts as would render his registration . . . inconsistent 
with the public interest.'' 21 U.S.C. 824(a)(4).\16\ I therefore 
conclude that the Government's evidence with respect to Factors Two and 
Four makes out a prima facie case for revoking his existing 
registration and denying any applications for a new registration. As 
Registrant has waived his right to a hearing or to submit a written 
statement of position, there is no evidence to refute the conclusion 
that his registration is inconsistent with the public interest. I will 
therefore order that Registrant's remaining registration be revoked and 
that any pending application be denied.
---------------------------------------------------------------------------

    \16\ This provides a separate and independent ground from the 
finding that he does not currently possess state authority for 
revoking his registration and denying his application.
---------------------------------------------------------------------------

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration No. FS6457407 issued to Bernard Wilberforce Shelton, M.D., 
be, and it hereby is, revoked. I further order that any pending 
application of Bernard Wilberforce Shelton to renew or modify the above 
registration, as well as any other pending application for registration 
be, and it hereby is, denied. This Order is effective immediately.\17\
---------------------------------------------------------------------------

    \17\ Based on the egregious nature of Respondent's prescribing 
violations, I conclude that the public interest necessitates that 
this Order be effective immediately. 21 CFR 1316.67.

    Dated: March 24, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-06617 Filed 3-30-18; 8:45 am]
 BILLING CODE 4410-09-P