Bernard Wilberforce Shelton, M.D.; Decision and Order, 14028-14043 [2018-06617]
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pursuant to section 201.12 of the
Commission’s rules, shall not be
accepted unless good cause is shown for
accepting such submissions, or unless
the submission is pursuant to a specific
request by a Commissioner or
Commission staff.
In accordance with sections 201.16(c)
and 207.3 of the Commission’s rules,
each document filed by a party to the
investigations must be served on all
other parties to the investigations (as
identified by either the public or BPI
service list), and a certificate of service
must be timely filed. The Secretary will
not accept a document for filing without
a certificate of service.
Authority: These investigations are being
conducted under authority of title VII of the
Tariff Act of 1930; this notice is published
pursuant to section 207.21 of the
Commission’s rules.
By order of the Commission.
Issued: March 27, 2018.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2018–06565 Filed 3–30–18; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Bureau of Alcohol, Tobacco, Firearms
and Explosives
[OMB Number 1140–0031]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Extension
without Change of a Currently
Approved Collection; Records of
Acquisition and Disposition,
Registered Importers of Arms,
Ammunition & Implements of War on
the U.S. Munitions Import List
Bureau of Alcohol, Tobacco,
Firearms and Explosives, Department of
Justice.
ACTION: 60-Day notice.
AGENCY:
The Department of Justice
(DOJ), Bureau of Alcohol, Tobacco,
Firearms and Explosives (ATF), will
submit the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
DATES: Comments are encouraged and
will be accepted for 60 days until June
1, 2018.
FOR FURTHER INFORMATION CONTACT: If
you have additional comments,
particularly with respect to the
estimated public burden or associated
response time, have suggestions, need a
copy of the proposed information
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SUMMARY:
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collection instrument with instructions,
or desire any additional information,
please contact Desiree Dickinson either
by mail at Firearms and Explosives
Imports Branch, 244 Needy Road
Martinsburg, WV 25405, by email at
desiree.dickinson@atf.gov, or by
telephone at (304) 616–4584.
SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the
public and affected agencies concerning
the proposed collection of information
are encouraged. Your comments should
address one or more of the following
four points:
—Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
—Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
—Evaluate whether and if so how the
quality, utility, and clarity of the
information to be collected can be
enhanced; and
—Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of This Information
Collection
1. Type of Information Collection
(check justification or form 83):
Extension, without change, of a
currently approved collection.
2. The Title of the Form/Collection:
Records of Acquisition and Disposition,
Registered Importers of Arms,
Ammunition & Implements of War on
the U.S. Munitions Import List.
3. The agency form number, if any,
and the applicable component of the
Department sponsoring the collection:
Form number (if applicable): None.
Component: Bureau of Alcohol,
Tobacco, Firearms and Explosives, U.S.
Department of Justice.
4. Affected public who will be asked
or required to respond, as well as a brief
abstract:
Primary: Business or other for profit.
Other (if applicable): None.
Abstract: This information collection
involves records of imported items that
are on the United States Munitions
Import List. The importers must register
with ATF, file an intent to import
specific items, as well as certify to the
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Bureau, that the list of imported items
were received. The records are
maintained at the registrant’s business
premises where they are available for
inspection by ATF officers during
compliance inspections or criminal
investigations.
5. An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: An estimated 50 respondents
will utilize this information collection,
and it will take each respondent
approximately 5 hours to provide a
response.
6. An estimate of the total public
burden (in hours) associated with the
collection: The estimated annual public
burden associated with this collection is
250 hours, which is equal to 50 (total #
of responses) *5 (# of hours to provide
each response).
If additional information is required
contact: Melody Braswell, Department
Clearance Officer, United States
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE, 3E.405A,
Washington, DC 20530.
Dated: March 28, 2018.
Melody Braswell,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2018–06593 Filed 3–30–18; 8:45 am]
BILLING CODE 4410–FY–P
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
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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
§ 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
§§ 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 hydrocodoneacetaminophen, a schedule II controlled
substance, and alprazolam, a schedule
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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
§§ 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
§§ 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
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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
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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.
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
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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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 §§ 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
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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 § 7311(6)
provides that a controlled substance
license is automatically void if a
licensee’s license to practice is
suspended or revoked.’’2
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,
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.
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
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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.
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.
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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
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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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
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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.
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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
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(unintelligible).4 Id. at 11–12; see also
GX 3, VR 2 at 15:53:59–16:01:44.
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
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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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
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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
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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.
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 He also documented a diagnosis of ‘‘Body Mass
Index Between 29.0–29.9 Adult.’’ GX 12, at 18.
6 Hereinafter, referred to as hydrocodone/apap.
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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.
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
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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
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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
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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.
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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.
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’
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.
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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
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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 . . .
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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
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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
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
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.
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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
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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
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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.
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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.
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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]
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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.
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
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.
11 Two tests also found amphetamines at levels
above the recommended therapeutic range. GX 33,
Attachment B, at 9.
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. . . 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
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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
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,
12 The same Health History Questionnaire also
lists Opana, Vickodin [sic], and MS Contin as
‘‘prescribed drugs.’’ GX 18, at 14.
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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
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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
§ 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 § 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
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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
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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
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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
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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. § 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
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
§§ 823(f)(1), (3) and (5)). As explained above, with
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‘‘has committed such acts as would
render his registration . . . inconsistent
with the public interest.’’ 21 U.S.C.
824(a)(4).
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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 § 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. § 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
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.
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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).
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Sfmt 4703
14041
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
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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 § 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.
§ 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.
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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
(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).
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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,’’
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Fmt 4703
Sfmt 4703
‘‘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 § 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 §§ 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 § 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
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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 nonpresence 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.
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 § 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 § 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.
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).
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.
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Jkt 244001
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
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Fmt 4703
Sfmt 4703
14043
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
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
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Angela L. Lorenzo, P.A.: Decision and
Order
On December 18, 2017, the Acting
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration (DEA), issued an Order
to Show Cause to Angela L. Lorenzo,
P.A. (Registrant), of Las Vegas, Nevada.
The Show Cause Order proposed the
revocation of Registrant’s Certificate of
Registration No. ML0901985 on the
ground that she lacks ‘‘authority to
handle controlled substances in the
State of Nevada, the State in which [she
is] registered with the DEA.’’ Order to
Show Cause, Government Exhibit (GX)
A–3, at 1 (citing 21 U.S.C. 824(a)(3)).1
For the same reason, the Order also
proposed the denial of any of
Registrant’s ‘‘pending applications for a
new registration or for renewal.’’ Id.
With respect to the Agency’s
jurisdiction, the Show Cause Order
alleged that Registrant is registered as a
practitioner in schedules II through V,
pursuant to DEA Certificate of
Registration No. ML0901985, at the
address of 811 N Buffalo Road, Suite
113, Las Vegas, Nevada. Id. at 1–2. The
Order also alleged that this registration
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.
1 The Show Cause Order also proposed that
Registrant’s DEA registration should be revoked
because she ‘‘committed acts which render [her]
registration inconsistent with the public interest.’’
GX 3, at 1 (citing 21 U.S.C. 823(f), 824(a)(4)).
However, the Government did not include evidence
to support this allegation with its Request for Final
Agency Action (RFFA). Instead, the Government
requested ‘‘leave to supplement its [R]equest to
include the grounds for revocation under 21 U.S.C.
823(f), 824(a)(4)’’ should Registrant ‘‘regain her
Nevada state license during the pendency of this
Request for Final Agency Action.’’ RFFA at 1 n.1.
The Government has not filed a request to
supplement its RFFA, apparently because
Registrant has not regained her Nevada state
medical license. Accordingly, I do not consider the
Government’s public interest allegation.
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02APN1
Agencies
[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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\4\ The sign is not, however, visible on the video. GX 3, VR 2,
at 16:00:52-16:01:44.
---------------------------------------------------------------------------
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,