[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