[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Notices]
[Pages 57749-57762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23503]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17-21]
Lesly Pompy, M.D.; Decision and Order
On March 2, 2017, a former Acting Administrator of the Drug
Enforcement Administration (hereinafter, DEA or Government), issued an
Order to Show Cause and Immediate Suspension of Registrations to Lesly
Pompy, M.D. (hereinafter, Respondent), of Monroe, Michigan.
Administrative Law Judge Exhibit (hereinafter, ALJX) 1 (Order to Show
Cause and Immediate Suspension of Registrations (hereinafter
collectively, OSC)), at 1. The OSC informed Respondent of the immediate
suspension of his DEA Certificates of Registration BP2527058 and
FP2665478 pursuant to 21 U.S.C. 824(d) ``because . . . [his] continued
registration constitute[d] an imminent danger to the public health and
safety.'' Id.
The substantive ground for the proceeding, as alleged in the OSC,
is that Respondent ``committed such acts as would render . . . [his]
registrations under 21 U.S.C. 823(f) inconsistent with the public
interest. See 21 U.S.C. 824(a)(4).'' Id. at 2. Specifically, the OSC
alleges that Respondent issued numerous prescriptions, including to an
undercover investigator, outside the usual course of the professional
practice of medicine in violation of 21 CFR 1306.04(a) and in violation
of the minimal standards of medical practice in Michigan. Id. at 2-3.
The OSC also alleges that, at one of his registered locations and at
his (unregistered) residence, Respondent unlawfully possessed numerous
controlled substances including, but not limited to, varying quantities
of Schedule II controlled substances that had been dispensed to
patients. Id. at 4 (citing 21 CFR 1301.12, 1317.30, and 1317.40; Mich.
Comp. Laws Sec. 333.7403). Finally, the OSC alleges that Respondent
was unable to provide any of the records that DEA requested concerning
his two registrations--an inventory at both registered locations and
records for each controlled substance received, sold, and delivered.
OSC, at 4 (citing 21 CFR 1304.11 and 1304.21).
On March 2, 2017, based on his preliminary findings that Respondent
prescribed controlled substances outside the usual course of the
professional practice, unlawfully possessed controlled substances at
both his home and his office, and committed numerous recordkeeping
violations, the former Acting Administrator concluded that Respondent's
``continued registration . . . [was] inconsistent with the public
interest.'' OSC, at 5. Citing 21 U.S.C. 824(d), he also made the
preliminary finding that Respondent's continued registration during the
pendency of proceedings ``would constitute an imminent danger to the
public health or safety because of the substantial likelihood that . .
. [Respondent] will continue to prescribe controlled substances in a
manner that . . . creates a substantial likelihood of an immediate
threat that death, serious bodily harm, or abuse of a controlled
substance will occur.'' Id. Pursuant to 21 U.S.C. 824(f) and 21 CFR
1301.36(f), the former Acting Administrator authorized the DEA Special
Agents and Diversion Investigators serving the OSC on Respondent to
place under seal or to remove for safekeeping all controlled substances
Respondent possessed pursuant to the immediately suspended
registrations. Id. The former Acting Administrator also directed those
DEA employees to take possession of Respondent's Certificates of
Registration BP2527058 and FP2665478 and any unused prescription forms.
Id.
The OSC notified Respondent of his right to request a hearing on
the allegations or to submit a written statement while waiving his
right to a hearing, the procedures for electing each option, and the
consequences for failing to elect either option. Id. at 5-6 (citing 21
CFR 1301.43). According to the Government's Notice of Service, a member
of the DEA Detroit Field Division personally served the OSC on
Respondent on March 3, 2017. ALJX 2 (Government's Notice of Service of
OSC/ISO), at 1.
By letter dated March 16, 2017, Respondent timely requested a
hearing. ALJX 3, at 1. The matter was placed on the docket of the
Office of Administrative Law Judges and assigned to Chief
Administrative Law Judge John J. Mulrooney, II (hereinafter, Chief
ALJ). On March 16, 2017, he established a schedule for the filing of
prehearing statements. ALJX 4 (Order for Prehearing Statements), at 1.
On April 20, 2017, the Chief ALJ issued a Prehearing Ruling that, among
other things, set out the six Stipulations already agreed upon and
established schedules for the filing of additional joint stipulations
and supplemental prehearing statements. ALJX 11 (Prehearing Ruling) at
1-2.\1\
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\1\ The parties agreed to an additional 26 stipulations. ALJX 26
and ALJX 30. The first 31 stipulations are set out on pages 3 to 5
of the Chief ALJ's recommendations. The last stipulation is: ``On
August 4, 2017, Dr. Pompy was served with a copy of an Order of
Summary Suspension by the State of Michigan Department of Licensing
and Regulatory Affairs. This order became effective upon service and
summarily suspended Dr. Pompy's medical license.'' ALJX 30.
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The Government filed its Prehearing Statement on March 29, 2017,
and its Supplemental Prehearing Statement on June 8, 2017. ALJX 9 and
17, respectively. Respondent filed his Prehearing Statement on April
19, 2017, and his Supplemental Prehearing Statement on June 7, 2017.
ALJX 10 and 20, respectively.
The hearing in this matter spanned seven days and took place at
multiple locations.\2\ On August 4, 2017, after the sixth day of
hearings, the Government filed a Notice of Respondent's Lack of State
Authority. ALJX 29 (hereinafter,
[[Page 57750]]
Notice). According to the Notice, the Government learned hours before
filing the Notice that the Michigan Department of Licensing and
Regulatory Affairs had served Respondent with a summary suspension of
his medical license. Id. at 1. Although lack of State authority was not
charged in the OSC, the Notice states that this allegation may be
raised at any stage of a proceeding, even sua sponte by the
Administrator. Id. (citing Hatem M. Ataya, M.D., 81 FR 8,221, 8,224
(2016)). The Notice states the Government's intention to continue
litigating the OSC to its final conclusion. Notice, at 2.
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\2\ Hearings were held in Detroit, Michigan on July 11, 12, 13,
and 14, 2017 and in Arlington, Virginia on July 31, August 1, and
August 21, 2017.
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The Recommended Rulings, Findings of Fact, Conclusions of Law and
Decision of the Administrative Law Judge (hereafter, R.D.) is dated
December 20, 2017. Neither party filed exceptions to the R.D.
Transmittal Letter, at 1.
Having considered the record in its entirety, I agree with the R.D.
that the record establishes, by substantial evidence, two independent
grounds for the revocation of Respondent's registrations: (1)
Respondent committed acts rendering his continued registration
inconsistent with the public interest and (2) Respondent lacks
authority in Michigan to practice medicine and to handle controlled
substances.\3\ R.D., at 124-126. I further agree with the R.D. that
Respondent's acceptance of responsibility is insufficient and that,
even if it were sufficient, Respondent did not offer adequate remedial
measures. Id. at 126-127.
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\3\ My conclusion that Respondent committed acts rendering his
continued registration inconsistent with the public interest would
not change if Respondent regains authority to practice medicine in
Michigan.
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Accordingly, I conclude that the appropriate sanctions are (1) For
both of Respondent's DEA Certificates of Registration to be revoked;
(2) for any pending application by Respondent to renew or modify these
registrations to be denied; (3) for any other pending application by
Respondent for registration in Michigan to be denied; (4) for the Order
of Immediate Suspension of Registrations issued to Respondent to be
affirmed; (5) for all controlled substances seized pursuant to the
Order of Immediate Suspension of Registrations to be forfeited to the
United States according to statutory provisions; and, (6) for all
right, title, and interest in those controlled substances to be vested
in the United States according to statutory provisions. See id. at 127-
129. I make the following findings.
Findings of Fact
Respondent's DEA Registrations
Respondent is registered with the DEA as a practitioner in
schedules II through V under DEA Certificate of Registration No.
FP2665478, at Interventional Pain Management, 307 Stewart Road, Monroe,
Michigan 48162-2934. Government Exhibit (hereinafter, GX) 1
(Respondent's CORs), at 1; see also GX 2 (Registration History for
Respondent's CORs), at 1, ALJX 11, at 2 (Stipulation No. 3). This
registration expires on March 31, 2020. GX 1, at 1; see also GX 2, at
1, ALJX 11, at 2 (Stipulation No. 3). Respondent is also registered
with the DEA as a practitioner DW/100 in schedules II through V under
DEA Certificate of Registration No. BP2527058 at 730 North Macomb
Street, Suite #222, Monroe, Michigan 48162. GX 1, at 2; see also GX 2,
at 3, ALJX 11, at 1 (Stipulation No. 1). On February 27, 2017, DEA
received a renewal and change of address for this registration and put
this registration in a ``renewal pending'' status. GX 2, at 1, 3; see
also ALJX 11, at 1-2 (Stipulation No. 2). Both of these registrations
were suspended pursuant to the Immediate Suspension Order dated March
2, 2017, ``after which date no controlled substances could be legally
obtained, stored, administered, prescribed, or dispensed.'' GX 2, at 1,
3.
The Investigation of Respondent
The Monroe Area Narcotics Team and Investigative Service in
Michigan (hereinafter, MANTIS) investigated Respondent and his medical
practice, Interventional Pain Management. The investigation concerned
whether Respondent issued controlled substance prescriptions without a
medical need and included information from search warrants and
undercover visits to Respondent's medical practice.
According to MANTIS, Blue Cross Blue Shield of Michigan
(hereinafter, BCBS) documents report that Respondent ``prescribed the
most overall prescription medication of the . . . [2,304] providers in
his same specialty during the date range of 01/2014 to 12/2014.'' \4\
GX 11 (Michigan Department of State Police ``MTS Supplemental Incident
Report 0002'' dated Sept. 21, 2016), at 1. MANTIS also cited BCBS
documents as stating that, based on claims submitted to BCBS,
Respondent prescribed the ``most controlled prescription medication''
and the ``most days [sic] supply of controlled prescription
medication'' of the same 2,304 providers during the same time period.
Id. at 1-2. The MANTIS report states that BCBS documents also report
that Respondent ranked first in 2015 for the ``total day supply of
controlled medication (52,026) . . . and total quantity dispensed of
controlled prescription medication (136,267).'' Id. at 2.
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\4\ BCBS was also involved in the MANTIS investigation, at least
initially. Transcript page (hereinafter, Tr.) 140.
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The Allegations of Dispensing and Non-Dispensing Violations
The OSC alleges three bases for the revocation of Respondent's
registrations pursuant to 21 U.S.C. 824(a)(4) and for the denial of any
pending applications pursuant to 21 U.S.C. 823(f). In addition, as
already discussed, the Government filed Notice of the Respondent's lack
of State authority during the hearing. Notice, at 1 (citing 21 U.S.C.
824(a)(3)).
There is factual agreement among the witnesses on a number of
matters. When there is factual disagreement, I apply the R.D.'s
credibility recommendations, all of which I adopt. See R.D., at 5-106.
The Government's Case
The Government's documentary evidence consists primarily of medical
records for six patients, including records concerning an undercover
investigator. The Government called five witnesses: A DEA Diversion
Investigator (hereinafter, DI); a Detective assigned to MANTIS
(hereinafter, MANTIS Det); a BCBS investigator who made undercover
visits to Respondent's medical practice (hereinafter U/C); a Detective
assigned to the Monroe County Sheriff's Office (hereinafter, Monroe
Det); and its expert, Dr. Carl Christensen.
DI testified about his investigation-related actions, including his
roles in executing search warrants at Respondent's property and in
interviewing Respondent and Respondent's employees. Tr. 34-114, 1811-
23; see also R.D., at 5-9. Having read and analyzed all of the record
evidence, I agree with the R.D. that DI ``presented as an objective,
rational, careful regulator who was not prone to exaggeration or
hyperbole.'' R.D., at 9. I also agree that DI's testimony is
``sufficiently detailed, plausible, and internally consistent'' to be
given full credibility. Id.
MANTIS Det testified about the investigative work that MANTIS did
regarding Respondent, including search warrants and U/C visits. Tr.
117-29, 134-60; see also R.D., at 9-11. He testified as the drafter of
the search warrant for one of Respondent's offices
[[Page 57751]]
and the supervisor of the execution of that search warrant. He also
testified that he drafted and served a search warrant on a bank
regarding Respondent's financial records. Having read and analyzed all
of the record evidence, I agree with the R.D. that MANTIS Det
``presented as an objective, rational, careful law enforcement
officer'' and that his testimony deserves ``full credibility.'' R.D.,
at 11.
U/C testified about his role in the investigation of Respondent and
his role-related training and experience. Tr. 164-246, 247-311, 884-90;
see also R.D., at 11-25. U/C's interactions with Respondent and
Respondent's medical practice are recorded in videos and transcriptions
of those videos. GX 9 (Transcript of U/C Visits from January 5, 2016
through May 17, 2016 (hereinafter, U/C Visits Transcript)); see also GX
8 (U/C patient file).
Monroe Det testified about the scope of the search warrant executed
at Respondent's office and home, iPatientCare, and his role in the
investigation.\5\ Tr. 895-914; see also R.D., at 25-26. Having read and
analyzed all of the record evidence, I agree with the R.D. that Monroe
Det ``presented as an impartial law enforcement officer and provided
testimony that was sufficiently plausible, detailed, and internally
consistent to be afforded full credibility.'' R.D., at 26.
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\5\ Respondent uses iPatientCare for his office's electronic
medical records.
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The Government's expert, Dr. Carl Christensen, is a physician
licensed and practicing in Michigan. GX 18 (Curriculum Vitae of Dr.
Carl Christensen, M.D., Ph.D.). He is Board certified in Addiction
Medicine, holds doctorates in Medicine and Biochemistry, and is
registered with the DEA and the State of Michigan to handle controlled
substances.\6\ Id.; Tr. 314-15. The Chief ALJ accepted Dr. Christensen
as an expert in the treatment of pain and in the standard of care for
controlled substance prescribing in the State of Michigan. Tr. 325-26.
The matters about which Dr. Christensen testified included his review
and standard-of-care analysis of medical records belonging to six of
Respondent's patients, including U/C. E.g., id. at 326-44, 363-464,
466-533, 536-90, 594-95, 603-38, 645-809, 816-69, 871-80, 1789-1810;
see also R.D., at 26-54. Having read and analyzed all of the record
evidence, I agree with the R.D. that Dr. Christensen, ``[o]verall, . .
. presented persuasive testimony regarding the standard of care
applicable to controlled substance prescribers in Michigan.'' R.D., at
53. I also agree that Dr. Christensen is a ``well-credentialed,
thoughtful, candid expert witness who presented the most persuasive
expert testimony received at the hearing.'' \7\ Id. at 54.
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\6\ Dr. Christensen is the Medical Director at the Substance
Abuse Treatment Center at Wayne State School of Medicine (Detroit,
Michigan), the Medical Director of Dawn Farm Treatment Center (Ann
Arbor, Michigan), the Medical Director at the Michigan Health
Professional Recovery Program, and a Clinical Associate Professor in
Psychiatry and OB/GYN at Wayne State School of Medicine. Tr. 315.
\7\ The R.D. states that the ``utility'' of Dr. Christensen's
testimony, as opposed to its credibility, is diminished for a few
reasons. R.D., at 53. First, the ``principal issue of hesitation
regarding Dr. Christensen's testimony . . . [is] teasing out those
portions of his opinions motivated, not by state practice standards,
but rather by his own views related to best practices.'' Id. at 54.
Given the expert testimony in the record, all of the evidence that
the parties put in the record concerning the standard of care in
Michigan, and the care that counsel took to focus their questioning
and argument on Michigan's standard of care, I am confident that
this proceeding's record is sufficient for me to make a decision on
the OSC's standard of care-related allegations, including OSC
paragraph 4(b)(3) and 4(d)(3).
Second, Dr. Christensen is a BCBS consultant and BCBS, as the
R.D. notes, is ``motivated, at least in part, by cost concerns
related to healthcare fraud'' and is ``motivated, in no small
measure, by interests of cost containment.'' Id. at 53-54. Yet,
regarding this utility concern, Dr. Christensen testified that he
``initially reviewed files on . . . [U/C for BCBS], and then
sometime during that time period, the DEA assumed the case, and
after that . . . [his] dealings were all with the DEA.'' Tr. 324.
Thus, I do not share this ``utility'' concern.
Third, ``some of Dr. Christensen's testimony addressed
treatment matters outside the . . . [Controlled Substances Act's]
goal of preventing abuse and diversion.'' Id. at 54. This third
concern goes to Subsys treatment matters that the R.D. suggests are
outside the scope of the statute. I agree to the extent that the
record evidence and analysis concerning Subsys and Food and Drug
Administration requirements are insufficient to answer legal issues
raised by some of the Government's Subsys-related allegations. See,
e.g., Gonzales v. Oregon, 546 U.S. 243, 268 (2006) (``Were this
argument accepted, he could decide whether any particular drug may
be used for any particular purpose, or indeed whether a physician
who administers any controversial treatment could be
deregistered.''). Thus, those Subsys-related allegations are given
no weight and play no role in my public interest assessment or my
decisions about the Government's requested relief.
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Respondent's Case
Respondent testified and called five witnesses: A medical assistant
(hereinafter, MA), who worked for him; a lab technician (hereinafter,
LT), who worked at Respondent's practice; a Licensed Practical Nurse
(hereinafter, LPN), who worked for Respondent and has known him since
1992; the Office Manager (hereinafter, OM) for Respondent's practice
since about 2010 who, prior to working for him, was one of his
patients; and his expert, Dr. Lynn Webster, an anesthesiologist board
certified in Anesthesia, Pain Medicine, and Addiction Medicine.
Respondent testified over the course of several days.\8\ The topics
addressed in his direct testimony included: His background, education,
and accomplishments (e.g., Tr. 924-37, 941, 942-43); the administration
and staffing of his medical practice (e.g., id. at 942-50, 1292-95,
1392-1418, 1472, 1477-86); policies, procedures, and practices
concerning new and existing patients (e.g., id. at 936-41, 1393, 1414-
69); diversion-related issues (e.g., id. at 1398-1400, 1433-36); his
practice's medical records (e.g., id. at 1404-13, 1494); search warrant
execution (e.g., id. at 1472-76, 1498-99); the unlawful possession of
controlled substances allegation (e.g., id. at 1486-94); the
recordkeeping allegations (e.g., id. at 1494-99); the TIRF REMS \9\
Program, including Subsys prescriptions and presentations (e.g., id. at
1499-1522); and his treatment of specific patients (e.g., id. at 1529-
48 (RB), 1556-87 (DA), 1587-1610 (RF), 1611-28 (ES), 1628-44 (JH),
1644-94 (U/C).\10\ See also R.D., at 84-106.
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\8\ In addition to Respondent's hearing testimony, the record
includes transcriptions of parts of two interviews of Respondent
that law enforcement conducted. GX 24 and GX 26. GX 24 was offered
and admitted without objection. Tr. 37-38. GX 26 was admitted over
Respondent's ``context'' objection. Id. at 1812-15. I agree with all
of the Chief ALJ's pre-hearing and hearing evidentiary rulings and
orders.
\9\ Transmucosal Immediate Release Fentanyl Risk and Evaluation
Mitigation Strategy.
\10\ Some testimony fits in more than one category. Respondent
also testified on re-direct and the Government's cross-examination.
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Having read and analyzed all of the record evidence, I agree with
the R.D. that Respondent is the witness with the most at stake in these
proceedings and that his testimony and interview statements are marked
by numerous implausibilities and internal inconsistencies. Id. at 104-
06. Before issuance of the OSC, for example, Respondent told law
enforcement officers that all documents, including Michigan Automated
Prescription System (hereinafter, MAPS) reports, are ``definitely''
scanned into iPatientCare. GX 24, at 10. During the hearing though,
Respondent variously testified that (1) his policy is to put the first
visit's MAPS report into the medical record, ``but I don't always put
them in after that;'' (2) there is no rhyme or reason for why he would
or would not put MAPS reports into the medical record; and, (3) if he
sees something ``abnormal'' on a MAPS report, he would put it into the
medical record as ``standard practice . . . the vast majority of the
time.'' Tr. 1442. The differences between Respondent's
[[Page 57752]]
statements before the OSC was issued and his testimony at the hearing
are troubling. For example, the marked change from Respondent's pre-OSC
statement (all documents including MAPS reports are ``definitely''
scanned into iPatientCare) to his testimony during the hearing (not all
MAPS reports are put in the patient's medical record) does not indicate
candor or forthrightness, particularly given Respondent's position that
MAPS reports would have helped his case.\11\ See also R.D., at 104-06.
For all of these reasons, I agree with the R.D. that Respondent's
testimony must be considered with much caution when his testimony
conflicts with credible record evidence. Id. at 106.
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\11\ At the hearing, the Government moved GX 27 for
identification into evidence. I agree with the Chief ALJ's exclusion
of the document due to an inadequate foundation. Tr. 1816-23.
Further, in connection with the colloquy during this portion of the
hearing, I note my disagreement with Respondent's suggestion that
law enforcement, during search warrant execution, mishandled
Respondent's records thereby impeding Respondent's defense, or that
the Government is the reason Respondent does not have access to MAPS
reports that ``would've been very helpful in this case to me.'' Tr.
544 (Dr. Christensen's testimony that the history of present illness
or the interval history should include information about relevant
past treatments or treatment failures or medications); id. at 551
(Dr. Christensen's testimony that one medical decision-making area
lists all of the patient's diagnoses); id. at 157 (MANTIS Det's
testimony that Respondent need not use his personal computer to
access his patients' medical records on iPatientCare because those
records are on the internet, not his personal computer); id. at 895,
899-900, 914 (Monroe Det's testimony that he learned from
Respondent's staff that patient records are kept in the cloud and
that iPatientCare searched for and provided law enforcement with
responsive records).
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MA's testimony summarizes the work she did for Respondent. Tr.
1212-64. She corroborated Respondent's testimony that Respondent
schedules new patient visits for one hour, patients' second visits for
30 minutes, and ``[a]nything other than that, if they're just coming in
for, say, just a refill or they say they're just to refill, it's a
five-minute appointment slot.'' \12\ Id. at 1260. Regarding MAPS, MA
stated that ``there should be a MAPS report on every new patient.'' Id.
at 1242. Having read and analyzed all of the record evidence, I agree
with the R.D. that, ``while there was no foundation laid upon her
testimony regarding patient volume . . . which could be sufficiently
based on actual knowledge to be credited, she did present testimony in
other areas that was sufficiently detailed, plausible, and internally
consistent to be deemed credible.'' R.D., at 58.
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\12\ Accord Tr. 948-49 (Respondent's testimony); 1301-02 (LPN's
testimony regarding new patient visits and second visits); cf. id.
at 1366 (OM's testimony that new patients' first visits with
Respondent last ``a long time, an hour, hour and a half''); but see
id. at 1302 (LPN's testimony that the normal allocation of time for
visits by patients who are stable is ten to 15 minutes).
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LT testified about the work he did for Respondent's practice. He
stated that the method he employed to confirm drug screens was liquid
chromatography, mass spectrometry. Tr. 1267. He testified that,
according to his manager, every patient sample would be confirmed
starting in approximately August 2016. Id. at 1273. Based on his
experiences visiting an office where Respondent saw patients, LT found
an ``unusually high number of patients or people there waiting to see .
. . [Respondent].'' Id. at 1274. He did not, however, see any illegal
activity. Id. Having read and analyzed all of the record evidence, I
agree with the R.D. that, ``overall, the testimony . . . [LT] presented
was sufficiently detailed, plausible, and internally consistent to
merit credibility here.'' R.D., at 59.
The topics about which LPN testified included: Appointment
scheduling (e.g., Tr. 1301-02, 1330-34, 1336-40); the process of
becoming a new patient (e.g., id. at 1310-14); tests that Respondent
might order for a new patient (e.g., id. at 1302-03, 1320-22); a new
patient's initial visit with Respondent (e.g., id. at 1315-20, 1322-
23); and diversion-related issues (e.g., id. at 1304-10, 1325-29,
1330). Having read and analyzed all of the record evidence, I agree
with the R.D. that LPN and Respondent ``shared a professional
relationship spanning two and a half decades, and the testimony . . .
[LPN] provided regarding the practices prevalent at . . . [Respondent's
office] inextricably reflect on her own level of professionalism, and
must be viewed through that prism.'' R.D., at 62. In addition, the
meaning of some of LPN's testimony is unclear. I find that lack of
clarity, whether due to common semantic vagueness, imprecision by the
questioner and the witness, or something else, diminishes the value of
LPN's testimony. Nevertheless, areas of LPN's testimony are
``sufficiently detailed, plausible, and internally consistent to be
deemed generally credible.'' Id.
The subject areas of OM's testimony included: Her work as
Respondent's office manager (e.g., Tr. 1342-43, 1344-46, 1382, 1385-
86); the genesis of the lab in Respondent's office (e.g., id. at 1346-
50, 1363-64); office configuration and use for patient visits (id. at
1350-51); office policies and employee training (e.g., id. at 1352-53,
1359-62, 1367-70); controlled substances in Respondent's office,
including a controlled substances inventory (e.g., id. at 1355-59,
1379-83, 1386-87); the process of becoming a new patient (e.g., id. at
1360-61, 1364-65, 1370-71); diversion-related issues (e.g., id. at
1362-63, 1376-79); and a new patient's initial visit with Respondent
(e.g., id. at 1365-67, 1370, 1387). Having read and analyzed all of the
record evidence, I agree with the R.D. that, ``[a]s an employee of the
Respondent's and the . . . office manager, . . . [OM] has a significant
stake in the outcome of the proceedings.'' R.D., at 65. I also agree
that ``inasmuch as the manner in which . . . [Respondent's] office is
managed and run perforce reflects on her own level of professionalism,
. . . [OM] can hardly be viewed in the same light as an independent
evaluator of office procedures.'' Id. In addition, portions of OM's
testimony are internally inconsistent. Compare Tr. 1359 (OM's testimony
on direct examination that she has not seen the controlled substances
inventory since the execution of the search warrant and that she does
not ``know what happened to it''), with id. at 1386-87 (OM's testimony
on cross-examination that she saw the inventory after execution of the
search warrant). Otherwise, I agree with the R.D. that OM's hearing
testimony, overall, is ``sufficiently detailed, plausible, and
internally consistent to be deemed generally credible.'' R.D., at 65.
Dr. Webster was offered and accepted as Respondent's expert ``in
the . . . [subject] of pain medicine and addiction medicine, . . . the
prescribing of controlled substances in the State of Michigan, . . .
[including] transmucosal Fentanyl, . . . [and] overall for the
prescribing of pain medicine in Michigan.'' Tr. 986. Dr. Webster is an
anesthesiologist, who is Board certified in anesthesia, pain medicine,
and addiction medicine. Id. at 966. When he practiced medicine, he was
not located in Michigan; he is not and never has been licensed to
practice medicine in Michigan. Id. at 986-87. Dr. Webster reviewed
Respondent Exhibit (hereinafter, RE-) C to form his opinion of the
standard of care in Michigan.\13\ Id. at 987-90. He also reviewed ``a
summary of records of the six subjects . . . but not the videotapes''
of the U/C visits.\14\ Id. at 1121.
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\13\ RE-C is the Michigan Guidelines for the Use of Controlled
Substances for the Treatment of Pain (hereinafter, Michigan
Guidelines).
\14\ See R.D., at 83 (``The (presumably tactical) decision to
avoid reviewing the video footage of . . . [the U/C visits], when
viewed in context with the balance of his testimony[,] strikes as a
technique to avoid explaining events and dynamics that may not lend
themselves to defensible explanations.''). I agree.
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[[Page 57753]]
Dr. Webster repeatedly answered questions about the applicable
standard of care by referencing what doctors actually do instead of
referencing the actual provisions of the standard of care. For example,
when asked about the standard of care in Michigan regarding a pain
patient's first visit and ordering a MAPS report, Dr. Webster stated
that ``there is no standard . . . [b]ecause, actually, today there's
recent publications that show that only now, after a lot of education
and recommendations, about 50 percent of physicians order them because
they're afraid.'' \15\ Id. at 1006. By way of an additional example,
when asked whether prescribing a benzodiazepine, such as Xanax, along
with an opioid is a ``departure from the standard of care,'' Dr.
Webster answered that it is not, again referencing what doctors
actually do, while opining that the practice is unsafe and should be
avoided: ``Unfortunately, it's common. . . . There's still about 30
percent of the people who are taking opioids have a Benzodiazepine
onboard, but it's unsafe . . . [because] the dose at which an opioid
can cause respiratory depression is much lower if a Benzodiazepine is
onboard.'' Id. at 1080-81. By way of a further example, when asked if
the standard of care requires a doctor to have a discussion with a
patient whose drug screen tests negative for a prescribed controlled
substance, Dr. Webster answered, ``[N]o. . . . It's what's done most
often.'' Id. at 1111. On cross examination, Dr. Webster admitted his
view is that ``what is good medicine is a higher standard than what is
the standard of care.'' Id. at 1163.
---------------------------------------------------------------------------
\15\ Dr. Webster explained that ``doctors are afraid of having
data in their chart that could be used against them.'' Tr. 1007.
---------------------------------------------------------------------------
According to Dr. Webster, a physician is ``always looking at
aberrant behavior.'' Id. at 1150. He explained that this is different
from ``checking'' for aberrant behavior. Id. He stated, ``[I]t's
passive. That's passive because it's not an active thing you do. It's
passive. It happens.'' Id. When asked whether there is a point when
such aberrant behavior imposes a duty on a physician to do something,
Dr. Webster responded, ``Oh, yes. I think if you know that a patient
has diverted, you know a patient has been injecting intravenously,
manipulating their medicines, I think you have to intervene.'' \16\ Id.
at 1151 [emphasis added].
---------------------------------------------------------------------------
\16\ When asked, ``And when you say you know the patient's been
injecting, what do you--can you describe how that happens in
patients,'' Dr. Webster responded, ``Yeah. They take their Percocet
and grind it up, put it in a solution and inject it in their vein.''
Tr. 1151-52.
---------------------------------------------------------------------------
Having read and analyzed all of the record evidence, I agree with
the R.D. that Dr. Webster's testimony is ``punctuated with the variety
of vagueness and equivocation that presented the unmistakable
appearance of an expert unwilling to draw any standard, for fear of
conflicting with anything the Respondent may have done or not done in
his prescribing.'' R.D., at 83. I also agree with the R.D. that, ``to
the extent that . . . [Dr. Webster] actually believed that a
prescriber-registrant had even the slightest duty to minimize
diversion, that conviction could not be discerned from even the closest
reading of his testimony.'' Id. When Dr. Webster's testimony conflicts
with other persuasive expert testimony, I do not credit Dr. Webster's
testimony. Id. at 84; see also id. at 65-84.
Michigan Physicians' Standard of Care
According to the Controlled Substances Act (hereinafter, CSA),
``Except as authorized by this subchapter, it shall be unlawful for any
person knowingly or intentionally . . . to . . . distribute, . . .
dispense, or possess with intent to . . . distribute[ ] or dispense, a
controlled substance.'' 21 U.S.C. 841(a)(1). The CSA's implementing
regulations state that a lawful controlled substance order or
prescription is one that 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).
The OSC is addressed to Respondent at his registered locations and
medical practice in Michigan. Therefore, I also evaluate Respondent's
actions according to Michigan's laws and standard of care.\17\ The
State of Michigan, similar to the CSA, requires that a ``practitioner .
. . shall not dispense, prescribe, or administer a controlled substance
for other than legitimate and professionally recognized therapeutic or
scientific purposes or outside the scope of practice of the
practitioner.'' Mich. Comp. Laws Sec. 333.7401(1) (Westlaw, current
through P.A. 2019, No. 18 of the 2019 Regular Session, 100th
Legislature). Respondent offered into evidence the Michigan Guidelines,
RE-C, and the Model Policy on the Use of Opioid Analgesics in the
Treatment of Chronic Pain that was adopted as policy by the House of
Delegates of the Federation of State Medical Boards in July 2013
(hereinafter, FSMB Model Policy), RE-D. Both documents were admitted
into evidence without objection. Respondent used these documents to
present his case, including during examination and cross-examination of
his and the Government's expert witness. I find that the provisions of
the Michigan Guidelines and the FSMB Model Policy are consistent with
each other.
---------------------------------------------------------------------------
\17\ See Gonzales v. Oregon, supra, 546 U.S. at 269-71.
---------------------------------------------------------------------------
The intent of the Michigan Guidelines is to ``communicate what the
Boards [of Medicine and Osteopathic Medicine & Surgery (hereinafter,
Boards)] consider to be within the boundaries of professional
practice.'' Michigan Guidelines, at 2. According to Section I of the
Michigan Guidelines, the Preamble, the ``medical management of pain
should be based on current knowledge and research and include the use
of both pharmacologic and non-pharmacologic modalities.'' Id. at 1. The
Preamble also states, ``Pain should be assessed and treated promptly,
and the quantity and frequency of doses should be adjusted according to
the intensity and duration of the pain.'' Id. It further states,
``Physicians should be diligent in preventing the diversion of drugs
for illegitimate purposes.'' Id.
The Preamble specifically addresses prescribing and dispensing
standards, indicating that the Boards will consider prescribing and
dispensing to be ``for a legitimate medical purpose if based on
accepted scientific knowledge of the treatment of pain or if based on
sound clinical grounds.'' Id. at 2. According to the Preamble, ``All
such prescribing must be based on clear documentation of unrelieved
pain and in compliance with applicable state or federal law.'' Id. The
Preamble advises that the Boards will evaluate prescribing for pain
``on an individual basis'' and ``will not take disciplinary action
against a physician for failing to adhere strictly to the provisions of
these guidelines, if good cause is shown for such deviation.'' Id.
Instead, according to the Preamble, the physician's conduct ``will be
evaluated to a great extent by the treatment outcome, taking into
account whether the drug used is medically and/or pharmacologically
recognized to be appropriate for the diagnosis, the patient's
individual needs--including any improvement in functioning--and
recognizing that some types of pain cannot be completely relieved.''
Id. The stated goal is to ``control the patient's pain for its duration
while effectively addressing other aspects of the patient's
functioning, including physical, psychological, social and work-related
factors'' and, thus, the Boards ``will judge the validity of
prescribing based on the physician's treatment of the patient and on
available documentation,
[[Page 57754]]
rather than on the quantity and chronicity of prescribing.'' Id.
Section II of the Michigan Guidelines, the ``Guidelines,'' is used
to ``evaluat[e] the use of controlled substances for pain control.''
Id. at 3. First, the Guidelines state that a ``complete medical history
and physical examination must be conducted and documented in the
medical record.'' Id. The Guidelines specifically address the Boards'
expectations regarding documentation.
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 medical record also should document the presence of one or more
recognized medical indications for the use of a controlled
substance.
Id.
Second, the Guidelines address the content of the written treatment
plan, stating that it ``should state objectives that will be used to
determine treatment success, such as pain relief and improved physical
and psychosocial function, and should indicate if any further
diagnostic evaluations or other treatments are planned.'' Id. This
section states that ``[a]fter treatment begins, the physician should
adjust drug therapy to the individual medical needs of each patient.''
Id.
Third, the next section of the Guidelines addresses informed
consent and agreement for treatment. It states, ``The physician should
discuss the risks and benefits of the use of controlled substances with
the patient. . . . The patient should receive prescriptions from one
physician and one pharmacy where possible.'' Id. This section suggests
that the physician may use a written agreement between the physician
and the patient ``[i]f the patient is determined to be at high risk for
medication abuse or have a history of substance abuse.'' Id. According
to the Guidelines, the written agreement's patient responsibilities
include ``urine/serum medication levels screening when requested;
number and frequency of all prescription refills; and, reasons for
which drug therapy may be discontinued (i.e., violation of
agreement).'' Id.
Fourth, the Guidelines state that the physician, ``[a]t reasonable
intervals based on the individual circumstances of the patient, . . .
should review the course of treatment and any new information about the
etiology of the pain.'' Id. at 4. This ``Periodic Review'' section of
the Guidelines states that ``[c]ontinuation or modification of therapy
should depend on the physician's evaluation of progress toward stated
treatment objectives, such as improvement in patient's pain intensity
and improved physical and/or psychosocial function, i.e., ability to
work, . . . activities of daily living and quality of social life.''
Id. It also states that ``the physician should reevaluate the
appropriateness of continued treatment . . . [i]f treatment goals are
not being achieved . . . despite medication adjustments.'' Id. The
``Periodic Review'' section also states, ``The physician should monitor
patient compliance in medication usage and related treatment plans.''
Id.
Fifth, the Guidelines state, ``The physician should be willing to
refer the patient as necessary for additional evaluation and treatment
in order to achieve treatment objectives.'' Id. This ``Consultation''
section also states, ``Special attention should be given to those pain
patients who are at risk for misusing their medications and those whose
living arrangement pose[s] a risk for medication misuse or diversion.''
Id. Here, the Guidelines specifically warn, ``The management of pain in
patients with a history of substance abuse . . . may require extra
care, monitoring, documentation and consultation with or referral to an
expert in the management of such patients.'' \18\ Id.
---------------------------------------------------------------------------
\18\ ``Substance abuse,'' according to the Michigan Guidelines,
is ``the use of any substance(s) for non-therapeutic purposes or use
of medication for purposes other than those for which it is
prescribed.'' Michigan Guidelines, at 6.
---------------------------------------------------------------------------
Sixth, the next section of the Guidelines concerns medical records
and states, ``The physician should keep accurate and complete records
to include the medical history and physical examination; diagnostic,
therapeutic and laboratory results; evaluations and consultations;
treatment objectives; discussion of risks and benefits; treatments;
medications (including date, type, dosage and quantity prescribed);
instructions and agreements; and, periodic reviews.'' Id. This section
also states that these medical records ``should remain current and be
maintained in an accessible manner and readily available for review.''
Id.
Seventh, the last section of the Guidelines reminds physicians that
they must be licensed in Michigan to prescribe or dispense controlled
substances, and that they must comply with applicable Federal and State
regulations. Id. at 5. This section refers physicians to the
``Physicians Manual of the U.S. Drug Enforcement Administration and . .
. any relevant documents issued by the state medical board . . . for
specific rules governing controlled substances as well as applicable
state regulations.'' Id.
The stated goal of the FSMB Model Policy is to ``provide state
medical boards with an updated guideline for assessing physicians'
management of pain, so as to determine whether opioid analgesics are
used in a manner that is both medically appropriate and in compliance
with applicable state and federal laws and regulations.'' FSMB Model
Policy, at 3. It ``emphasizes the professional and ethical
responsibility of physicians to appropriately assess and manage
patients' pain, assess the relative level of risk for misuse and
addiction, monitor for aberrant behaviors and intervene as
appropriate.'' Id. at 1. It states that ``adverse outcomes associated
with the misuse, abuse and diversion of prescription opioids have
increased dramatically'' and that ``[p]hysicians and other health care
professionals have contributed--often inadvertently--to these
increases.'' Id. at 2 (reference omitted). Regarding ``the criminal
patient, whose primary purpose is to obtain drugs for resale,'' the
FSMB Model Policy advises that, ``[p]hysicians' attention to patient
assessment and the routine use of state prescription drug monitoring
programs (PDMPs), where available, have been cited as effective ways to
identify individuals who engage in such criminal activities.'' Id. at 3
(references omitted). The FSMB Model Policy ``highly'' recommends
``consulting the state's PDMP before prescribing opioids for pain and
during ongoing use.'' Id. at 10.
The FSMB Model Policy ``makes it clear'' that ``inappropriate
management of pain . . . [is] a departure from accepted best clinical
practices.'' Id. at 3. It discusses six ways that pain is not managed
appropriately. First, there is inadequate attention to an initial
assessment to determine if opioids are clinically indicated and to
determine the risks associated with their use in a particular patient.
Id. Second, monitoring during the use of potentially abusable
medications is inadequate. Id. Third, education for the patient about
the risks of opioid therapy and the patient's informed consent to
opioid therapy are inadequate. Id. at 4. Fourth, unjustified dose
escalation without adequate attention to risks, such as concurrent
alcohol use, or to alternative treatment is a departure from accepted
best clinical practices. Id. Fifth, relying excessively on opioids,
particularly high dose opioids for chronic pain management, and
continuing opioid therapy that does not meet clear and objective
outcomes are departures from
[[Page 57755]]
accepted best clinical practices. Id. Sixth, not using available risk
mitigation tools, such as the state PDMP, in advance of prescribing
opioids and during ongoing monitoring is a departure from accepted best
clinical practices. Id.
The Preamble of the FSMB Model Policy defines ``inappropriate
treatment of pain'' to include non-treatment, inadequate treatment,
overtreatment, and continued use of ineffective treatments. Id. at 5.
The use of opioids for pain management is considered to be for a
legitimate medical purpose when the use is based on sound clinical
judgment and current best clinical practices, is appropriately
documented, and demonstrably benefits the patient. Id. The use of
opioid therapy for pain management is within the usual course of
professional practice when a legitimate physician-patient relationship
exists, the use is appropriate for the identified diagnosis, there is
careful follow-up monitoring of the patient's response to treatment and
the patient's safe use of the medication, the opioid therapy is
adjusted when needed, and appropriate referrals are documented. Id.
Physicians are expected to incorporate safeguards into their practices
to minimize the risk of misuse and diversion of controlled substances.
Id. at 6.
The goal of a physician treating a patient in pain is to manage the
pain while effectively addressing the patient's functioning and
mitigating the risk of misuse, abuse, diversion, and overdose. Id. The
validity of the physician's treatment is judged on the basis of
available documentation, not solely on the quantity and duration of
medication administered. Id.
The FSMB Model Policy Guidelines include criteria for evaluating a
physician's management of a patient's pain. The physician ``must
understand the relevant pharmacologic and clinical issues in the use of
. . . [opioid] analgesics, and carefully structure a treatment plan
that reflects the particular benefits and risks of opioid use'' for the
patient.\19\ Id. The patient's medical record ``should document the
presence of one or more recognized medical indications for prescribing
an opioid analgesic and reflect an appropriately detailed patient
evaluation.'' Id. (references omitted). The assessment of the patient's
pain typically includes ``the nature and intensity of the pain, past
and current treatments for the pain, any underlying or co-occurring
disorders and conditions, and the effect of the pain on the patient's
physical and psychological functioning.'' Id. at 7 (reference omitted).
For every patient, ``the initial work-up should include a systems
review and relevant physical examination, as well as laboratory
investigations as indicated.'' Id. (references omitted).
---------------------------------------------------------------------------
\19\ ``The treatment plan should contain information supporting
the selection of therapies, both pharmacologic (including
medications other than opioids) and nonpharmacologic. It also should
specify the objectives that will be used to evaluate treatment
progress, such as relief of pain and improved physical and
psychosocial function.'' FSMB Model Policy, at 8 (references
omitted).
---------------------------------------------------------------------------
According to the FSMB Model Policy, ``Assessment of the patient's
personal and family history of alcohol or drug abuse and relative risk
for medication misuse or abuse also should be part of the initial
evaluation, and ideally should be completed prior to a decision as to
whether to prescribe opioid analgesics.'' \20\ Id. (references
omitted). The reasons for these criteria include that ``[p]atients who
have a history of substance use disorder (including alcohol) are at
elevated risk for failure of opioid analgesic therapy to achieve the
goals of improved comfort and function, and also are at high risk for
experiencing harm from this therapy.'' Id. (references omitted).
Further, patients with an ``active substance use disorder should not
receive opioid therapy until they are established in a treatment/
recovery program or alternatives are established such as co-management
with an addiction professional.'' Id. (reference omitted). Here, again,
the FSMB Model Policy states that the state PDMP ``should be consulted
to determine whether the patient is receiving prescriptions from any
other physicians'' and that the PDMP results ``should be documented in
the patient record.'' Id. at 7-8 (reference omitted).
---------------------------------------------------------------------------
\20\ ``This can be done through a careful clinical interview . .
. . Information provided by the patient is a necessary but
insufficient part of the evaluation process. Reports of previous
evaluations and treatments should be confirmed by obtaining records
from other providers, if possible. Patients have occasionally
provided fraudulent records, so if there is any reason to question
the truthfulness of a patient's report, it is best to request
records directly from the other providers. '' FSMB Model Policy, at
7 (references omitted).
---------------------------------------------------------------------------
The FSMB Model Policy states that opioid therapy ``should be
presented to the patient as a therapeutic trial or test for a defined
period,'' during which ``progress will be carefully monitored for both
benefit and harm.'' Id. at 9 (reference omitted). Monitoring ``should''
continue at each visit ``by assessing what have been called the `5As'
of chronic pain management.'' \21\ Id. (references omitted). The
continuation, modification, or termination of opioid therapy ``should
be contingent on the physician's evaluation of (1) evidence of the
patient's progress toward treatment objectives and (2) the absence of
substantial risks or adverse events, such as overdose or diversion.''
Id. at 9-10 (references omitted).
---------------------------------------------------------------------------
\21\ ``[T]hese involve a determination of whether the patient is
experiencing a reduction in pain (Analgesia), has demonstrated an
improvement in level of function (Activity), whether there are
significant Adverse effects, whether there is evidence of Aberrant
substance-related behaviors, and mood of the individual (Affect).''
FSMB Model Policy, at 9 (references omitted).
---------------------------------------------------------------------------
The FSMB Model Policy suggests that ``[p]eriodic drug testing may
be useful in monitoring adherence to the treatment plan, as well as in
detecting the use of non-prescribed drugs.'' Id. at 10 (references
omitted). According to the FSMB Model Policy, ``[t]est results that
suggest opioid misuse should be discussed with the patient . . . [and
b]oth the test results and subsequent discussion with the patient
should be documented in the medical record.'' \22\ Id. (reference
omitted). When drug tests show the presence of illicit or unprescribed
drugs, prescriber action is required. Id. at 11. If the patient does
not receive a benefit, including demonstrated functional improvement,
from opioid therapy, the treatment ``should not continue.'' Id. at 12.
---------------------------------------------------------------------------
\22\ According to the FSMB Model Policy, ``Periodic pill
counting is also a useful strategy to confirm medication adherence
and to minimize diversion.'' FSMB Model Policy, at 10.
---------------------------------------------------------------------------
The FSMB Model Policy emphasizes that ``the current state of
medical knowledge and medical therapies, including opioid analgesics,
does not provide for complete elimination of chronic pain in most
cases.'' Id. at 2 (references omitted). Yet, ``[i]nappropriate
treatment . . . can result from a mistaken belief on the part of
patients and their physicians that complete eradication of pain is an
attainable goal, and one that can be achieved without disabling adverse
effects.'' Id. at 3.
The FSMB Model Policy states, ``Every physician who treats patients
for chronic pain must maintain accurate and complete medical records.''
Id. at 12. It provides a list of ``[i]nformation that should appear in
the medical record.'' \23\ Id. (references omitted). Most
[[Page 57756]]
notably, the list includes ``[a]ny other information used to support
the initiation, continuation, revision, or termination of treatment and
the steps taken in response to any aberrant medication use behaviors.''
Id. (references omitted). According to the FSMB Model Policy,
``[r]ecords should be up-to-date and maintained in an accessible manner
so as to be readily available for review.'' Id. (reference omitted).
The FSMB Model Policy states that, ``Good records demonstrate that a
service was provided . . . [and] establish that the service provided
was medically necessary. . . . [T]horough records protect the physician
as well as the patient.'' Id. (references omitted).
---------------------------------------------------------------------------
\23\ The FSMB Model Policy list of information that should
appear in the medical record includes: (1) Copies of the signed
informed consent and treatment agreement; (2) the patient's medical
history; (3) results of the physical examination and all laboratory
tests; (4) results of the risk assessment, including results of any
screening instruments used; (5) a description of the treatments
provided; (6) instructions to the patient, including discussions of
risks and benefits; (7) results of ongoing monitoring of patient
progress (or lack of progress) in terms of pain management and
functional improvement; and, (8) notes on evaluations by, and
consultations with, specialists. Id. at 12.
---------------------------------------------------------------------------
Having read and analyzed all of the record evidence, I find that
Dr. Christensen's testimony concerning a Michigan physician's standard
of care when prescribing controlled substances accurately applies the
Michigan Guidelines.\24\ As already discussed, the credit I afford the
testimony of Dr. Webster and Respondent is limited. As such, I afford
Dr. Christensen's Michigan standard of care-related testimony
controlling weight in this proceeding.
---------------------------------------------------------------------------
\24\ Further, I find that Dr. Christensen's testimony is also
consistent with the provisions of the FSMB Model Policy.
---------------------------------------------------------------------------
Allegation That Respondent Lacks the Requisite State Authority To Hold
a DEA Certificate of Registration
On August 3, 2017, the Michigan Department of Licensing and
Regulatory Affairs, Bureau of Professional Licensing (hereinafter,
MBPL) summarily suspended Respondent's Michigan license to practice
medicine based on a finding that the public health, safety, or welfare
required emergency action.\25\ Notice (Attachment A, Michigan
Department of Licensing and Regulatory Affairs Bureau of Professional
Licensing Board of Medicine Disciplinary Subcommittee Order of Summary
Suspension), at 1. The MBPL further determined that, pursuant to
Michigan law, Respondent's Michigan controlled substance license is
``automatically void'' because his license to practice medicine is
suspended. Id. (citing Mich. Comp. Laws Sec. 333.7311(6) (Westlaw,
current through P.A. 2019, No. 18 of the 2019 Regular Session, 100th
Legislature)). Respondent entered into a Joint Stipulation with the
Government in which he stipulated to the summary suspension of his
medical license effective August 4, 2017. ALJX 30, at 1.
---------------------------------------------------------------------------
\25\ The MBPL emergency summary suspension was effective the
next day, August 4, 2017, upon service of the Summary Suspension
Order on Respondent. Notice, at 1; ALJX 30, at 1.
---------------------------------------------------------------------------
According to the MBPL Administrative Complaint issued the same day
as the summary suspension, Respondent ``ranked among Michigan's
highest-volume prescribers of commonly abused and diverted controlled
substances in 2015 and during the first three quarters of 2016.''
Notice (Attachment A, Administrative Complaint), at 3 (citing MAPS
data). The Administrative Complaint alleges that, based on MAPS data
for the same time period, Respondent prescribed about 26% of all
hydrocodone combination products, about 19% of all oxycodone
combination products, and about 65% of all strengths of hydrocodone
combination products, oxycodone combination products, buprenorphine/
naloxone, and methadone. Id. On average, according to the
Administrative Complaint, Respondent authorized more than 89 controlled
substance prescriptions for every workday between January 1, 2015 and
September 30, 2016. Id.
The Administrative Complaint further alleges that the investigation
of Respondent, including the analysis of the medical records of ten of
Respondent's patients, ``discovered . . . deficiencies consistently
across files.'' Id. at 4. The identified deficiencies included:
``Unnecessarily voluminous'' patient files due to ``cut-and-pasted
segments repeated from note to note;'' ``poorly organized and
frequently unintelligible'' patient notes; descriptions of the
patient's pain problem that were not ``adequate to permit informed
prescription decision-making;'' the use of the word ``guarded'' for
each patient's prognosis, ``which suggests Respondent made no actual
consideration of individual patient prognosis;'' negative symptoms
usually noted for the musculoskeletal element of the review of systems,
despite the fact that each patient was apparently seen for a chronic
pain diagnosis; ``failure to document consideration of alternative
treatments to opioid prescribing, except for pain blocks Respondent
himself performed and for which he billed;'' no ``treatment records
from previous physicians . . . [or] documentation of any contact with
other health care providers (except for imaging study reports);'' no
patient narcotic agreements; multiple dates of service with ``no
clinical information at all;'' no ``document[ed] responses to evidence
of abuse or diversion of controlled substances;'' the prescribing of
high addiction-potential controlled substances without documenting that
Respondent ``ask[ed] patients if they exhausted their previously
prescribed supply;'' and, the routine prescribing of ``high opioid
dosages, consistently exceeding 50 MMEs, and in some cases exceeding
100 MMEs, without adequate explanation for the high level of narcotic
dosage.'' \26\ Id. at 4-5. The MBPL expert also noted that Respondent's
patient files, while ``occasionally stating that MAPS records were
reviewed, . . . often do not contain any MAPS reports.'' Id. at 5. The
Administrative Complaint also includes more than three pages listing
the deficiencies the expert discovered in the individual medical files
Respondent produced. Id. at 5-9.
---------------------------------------------------------------------------
\26\ MME means morphine milligram equivalent.
---------------------------------------------------------------------------
Further, according to Michigan's online records, of which I take
official notice, Respondent's medical license is currently ``Lapsed--
Suspended.'' \27\ Michigan Department of Licensing and Regulatory
Affairs, Bureau of Professional Licensing, Bureau of Community and
Health Systems website, https://www.michigan.gov/lara (last visited
September 25, 2019). As such, I find that Respondent is still not
authorized to practice medicine in Michigan.
---------------------------------------------------------------------------
\27\ Under the Administrative Procedure Act, an agency ``may
take official notice of facts at any stage in a proceeding--even in
the final decision.'' United States Department of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e),
``[w]hen an agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a party is
entitled, on timely request, to an opportunity to show the
contrary.'' Accordingly, Respondent may dispute my finding by filing
a properly supported motion for reconsideration within 15 calendar
days of the date of this Order. Any such motion shall be filed with
the Office of the Administrator and a copy shall be served on the
Government. In the event Respondent files a motion, the Government
shall have 15 calendar days to file a response.
---------------------------------------------------------------------------
Accordingly, I find that Respondent currently is without authority
to engage in the practice of medicine or to handle controlled
substances in Michigan, the State in which he is registered.
Allegation That Respondent Issued Prescriptions for Controlled
Substances Outside the Usual Course of the Professional Practice
Having read and analyzed all of the record evidence, I agree with
the R.D.'s conclusion and find that the record contains substantial
evidence that Respondent prescribed controlled substances outside of
the usual course
[[Page 57757]]
of the professional practice in Michigan. R.D., at 124. Respondent did
not follow up on MAPS reports indicating an abnormality. See, e.g., Tr.
417-18, 535-38; Michigan Guidelines, at 1; FSMB Model Policy, at 1, 3,
6, 10. Despite his noting a diagnosis of ``opiate dependence
continuous,'' Respondent failed to document in the patient's medical
records either a referral or an evaluation for an addictive disorder,
as the standard of care mandates. See, e.g., Tr. 418-21, 424-25;
Michigan Guidelines, at 4; FSMB Model Policy, at 7. When Respondent
switched a patient's diagnosis from ``opiate dependence continuous'' to
``long-term use'' of medications, and when he changed a controlled
substance prescription he issued to a patient, Respondent did not
document his decision making or any of the reasons for the change, as
called for by the applicable standard of care. See, e.g., Tr. 427-28,
443-44, 478-79; Michigan Guidelines, at 2, 4; FSMB Model Policy, at 6.
After receiving the results of abnormal urine drug tests, Respondent
did not document any discussion of those results with the patient, as
the applicable standard of care mandates. See, e.g., Tr. 429, 452-53,
458-61, 480-81, 482-83, 488-89, 498-99, 515-16; Michigan Guidelines, at
1-4; FSMB Model Policy, at 1, 6, 9-12. Despite abnormal urine drug
tests, Respondent re-issued controlled substance prescriptions without
sufficiently documenting that he had appropriately addressed the
abnormalities. See, e.g., Tr. 444, 447-50, 459, 469-72, 477, 488-89,
490-92, 515-16, 582-84; Michigan Guidelines, at 1, 3, 4; FSMB Model
Policy, at 1, 6, 9-11.
Further, despite the appearance in a patient's urine drug test of
controlled substances that Respondent had not prescribed, or illegal
substances, Respondent continued to issue controlled substance
prescriptions and did not put adequate documentation of his decision
making in the medical records. See, e.g., Tr. 463-64, 467, 561-70;
Michigan Guidelines, at 1-2, 4; FSMB Model Policy, at 1, 6-7, 9-11; see
also Tr. 494-95, 572-76, 590. Respondent prescribed an ultra-rapid
schedule II controlled substance to a patient for whom he had not
prescribed sufficient long-acting medication to control the patient's
baseline pain. See, e.g., Tr. 430-33, 443, 445; Michigan Guidelines, at
1-4; FSMB Model Policy, at 4-6. Respondent issued a prescription for
double the strength of an ultra-rapid schedule II medication without
documenting the change or decision making. See, e.g., Tr. 446; Michigan
Guidelines, at 2-4; FSMB Model Policy, at 5-6. Respondent's prescribing
violated the standard of care relating to patient safety. See, e.g.,
Tr. 446, 521-31, 578-80, 587; Michigan Guidelines, at 1, 3-4; FSMB
Model Policy, at 5, 9-12. Respondent re-prescribed the same controlled
substance prescriptions to a patient even though the controlled
substances lacked efficacy as evidenced by the patient's complaint of
uncontrolled pain. See, e.g., Tr. 438, 439, 443, 445; Michigan
Guidelines, at 1, 3-4; FSMB Model Policy, at 5-6, 9-12; see also Tr.
366-67.
While the record includes statements from Respondent and his staff
about the protocols Respondent purportedly follows to ensure that the
issuance of a controlled substance prescription is warranted, the
record evidence, most vividly the video-related evidence, shows
Respondent acting contrary to the so-called protocols and authorizing
unwarranted controlled substance prescriptions. For example, U/C
repeatedly states he feels ``stiff'' or has ``stiffness'' when
Respondent and his staff ask him about being in ``pain.'' U/C Visits
Transcript, at 19-22, 23-25. Regardless, Respondent issues controlled
substance prescriptions to U/C that are not justified by test results
or by U/C's symptoms.\28\ Id. at 25 (``You know you gotta get your
testing done and all that. Your urine drug screen.''); see also id. at
48-49; Tr. 370.
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\28\ According to Dr. Christensen's testimony about the standard
of care for prescribing controlled substances:
Stiffness is not the same complaint as pain. Stiffness can be
either due to muscle contractions, to a joint disorder, to
deconditioning, to an underlying immune disorder. But it is not a
complaint of pain. It is not an indication for opioids. . . . [A]
non-pharmacologic treatment would initially be physical therapy,
hydrotherapy, exercise programs, psychological programs, mindfulness
programs. And pharmacologic treatment typically includes Tylenol,
which is acetaminophen, non-steroidals. And if there is a flare, if
somebody is having an usually [sic] difficult time, you can add for
a short period of time what we call a muscle relaxer, which is a
centrally acting, sedating medication that typically works for about
a week.
Tr. 367, 370.
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The U/C visits also document that Respondent authorized the
issuance of controlled substance prescriptions to U/C without
appropriately addressing abnormal drug screens. U/C Visits Transcript,
at 64-65 (authorizing prescriptions for Norco (schedule II) and Lyrica
(schedule V) without addressing the abnormal drug screen from the prior
visit). At a subsequent visit, Respondent authorized the same two
controlled substance prescriptions for U/C after verbally noting an
abnormal drug screen but not implementing the follow-up mandated by the
applicable standard of care. Id. at 77-80 (``Hold on one second. Um, no
hydrocodone. That's a problem. Ok. We're gonna have to see him . . . in
one week.''). According to Dr. Christensen's testimony about meeting
the standard of care in Michigan, ``an abnormal urine drug screen
should be addressed immediately, either with referral or evaluation,
and definitely starting off with an interview.'' Tr. 402. Dr.
Christensen's opinion is that Respondent's above-quoted statements do
not meet the interview requirement of the Michigan standard of care.
Id.
Since there are alternate explanations for an abnormal drug
screen the initial evaluation should include asking the patient . .
. how are you taking it, are you taking it, are you taking too
little, too much, and then going from that point on. . . . I would
include either referral or evaluation, depending on who the
prescriber was. And this appears almost certainly to be a drug
screen. So if you have a negative result for a prescribed drug, you
should also send out for confirmation. I wasn't able to find any
confirmation for that date. And then the patient should be asked to
return at an early date for another visit, which was done.
Id. at 402-03.
Further, Respondent authorized controlled substance prescriptions
for U/C without addressing any of U/C's statements about his use of
alcohol. U/C Visits Transcript, at 12, 18, 22, 43, 63, 93. Dr.
Christensen, addressing the standard of care for prescribing controlled
substances, explained that alcohol use indicates a possible addictive
or substance-use disorder and, when mixed with an opioid, could result
in death.
[Alcohol use is] one of the indications of possible addictive
disorder or substance use disorder. And if you're evaluating a
patient for pain, you need to take that into account if you're
attempting to make a legitimate diagnosis or write a legitimate
prescription. And if you decide that it's a legitimate prescription,
it is extremely dangerous to mix alcohol and opioids. . . . Because
both of them act upon the brain's respiratory center, and when they
are combined together, they are worse than either one alone. It's
called a super-additive effect, and the patient is more likely to
have respiratory arrests, overdose, and death.
Tr. 369.
While it is clear that Respondent noticed U/C's drug-seeking
behavior, it is also clear that Respondent failed to address that
behavior as the applicable standard of care requires. Id. at 385-
87.\29\ Instead, Respondent reacted by
[[Page 57758]]
telling U/C, ``You look like an undercover agent to me right now'' and
asking him, ``Are you trying to trap me? All right now, we've been
through this with the cops.'' U/C Visits Transcript, at 25.\30\ The
facts encapsulate the breadth of Respondent's departure from the
applicable standard of care: Respondent undoubtedly identified U/C's
drug-seeking behavior; responded immediately and solely out of his
self-interest to protect himself from law enforcement detection;
ignored the standard of care ramifications of the drug-seeking
behavior; and, ultimately issued controlled substance prescriptions to
U/C.
---------------------------------------------------------------------------
\29\ According to Dr. Christensen:
Requesting opiates without a confirmed diagnosis is concerning,
and requesting opiates by name is also concerning . . . [because it
is] consistent with drug-seeking behavior, and it's a red flag. . .
. A red flag is a sign or a piece of information that is indicative
of possible abuse or addiction, which would require additional
evaluation or referral if you're not an addiction specialist in
order to prescribe controlled substances [under the applicable
Michigan standard of care]. . . . I did not see [the required
evaluation of U/C ever done].''
Tr. 385-87.
\30\ Members of Respondent's staff later explained that ``the
feds are always on him,'' ``they have to watch him very . . .
closely,'' ``the other two doctor's [sic] here in Monroe . . . got
busted,'' ``[t]he FDA, the state, the government is on him hot and
heavy . . . breathing down his neck,'' and ``[h]e's had undercover
agents in here before.'' U/C Visits Transcript, at 26-27.
---------------------------------------------------------------------------
In sum, based on all of the evidence in the record, I find
substantial evidence that Respondent prescribed controlled substances
outside of the usual course of the professional practice in Michigan.
Allegation That Respondent Unlawfully Possessed Controlled Substances
Respondent admits that he stored controlled substances previously
prescribed to patients and controlled substance samples in his office
at North Macomb Street and his residence. Tr. 1486-87, 1490-91, 1719-
28. There is no evidence in the record that Respondent is registered as
a reverse distributor or is authorized in any way to possess these
controlled substances. Thus, I agree with the R.D. and find that the
record contains uncontradicted evidence that Respondent possessed large
quantities of controlled substances in his office at North Macomb
Street and his residence without the authority to do so. R.D., at 117.
Recordkeeping Allegations
According to Respondent's testimony, he maintained at his Stewart
Road office, and still possesses, an inventory of controlled substances
that he ``can introduce . . . any time that you wish.'' Tr. 1732; see
also Tr. 1729-32. I do not credit Respondent's testimony due to the
fact that he did not offer any inventory into evidence at any time
during the proceeding. See also R.D., at 105 (``In view of the level of
professional exposure attendant upon the potential loss of his DEA
registration, the Respondent's account that exculpatory inventories and
logs laid motionless in his office while proceedings were initiated and
conducted is simply not believable.''). Also according to Respondent's
own testimony, he transferred controlled substances between his two
offices and did not document the transfers. Tr. 1733. Thus, I agree
with the R.D. and find that there is substantial evidence in the record
that Respondent did not maintain the required inventory of controlled
substances and did not record his transfer of controlled substances.
R.D., at 117-18.
Discussion
Allegation That Respondent Lacks the Requisite State Authority To Hold
a DEA Certificate of Registration
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under section 823 of the CSA
``upon a finding that the registrant . . . has had his State license or
registration suspended . . . [or] revoked . . . by competent State
authority and is no longer authorized by State law to engage in the . .
. dispensing of controlled substances.'' With respect to a
practitioner, the DEA has also long held 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, M.D., 76 FR 71,371 (2011),
pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); Frederick
Marsh Blanton, M.D., 43 FR 27,616, 27,617 (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 CSA, the 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. See, e.g., Hooper, supra, 76
FR at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131
(2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby
Watts, M.D., 53 FR 11,919, 11,920 (1988); Blanton, supra, 43 FR at
27,617.
According to the Michigan statute concerning controlled substances,
``A license under section 7306 to manufacture, distribute, prescribe,
or dispense a controlled substance is automatically void if the
licensee's license to practice is suspended or revoked under article
15.'' \31\ Mich. Comp. Laws Sec. 333.7311(6) (Westlaw, current through
P.A. 2019, No. 18 of the 2019 Regular Session, 100th Legislature).
---------------------------------------------------------------------------
\31\ ``Section 7306'' is Mich. Comp. Laws Sec. 333.7306.
``Article 15'' includes Mich. Comp. Laws. Sec. 333.16233
(Investigations; order to cease and desist; hearing; violation of
order; summary suspension of license or registration), the statute
MBPL cites for taking emergency action in its Order of Summary
Suspension of Respondent's medical license.
---------------------------------------------------------------------------
The evidence in the record before me is not in dispute. The
Additional Stipulation consists of Respondent's admission that his
medical license was summarily suspended on August 4, 2017 and, as
already discussed, that summary suspension is still in effect. ALJX 30,
at 1. Respondent's controlled substance registration is void under
Michigan law since his medical license is suspended. Mich. Comp. Laws
Sec. 333.7311(6) (Westlaw, current through P.A. 2019, No. 18 of the
2019 Regular Session, 100th Legislature). As such, Respondent currently
lacks authority in Michigan to practice medicine and to handle
controlled substances. He is not, therefore, eligible for a DEA
registration. For this reason, I will order that Respondent's DEA
registrations be revoked. At the Government's request, however, I am
also ruling on the allegations in the OSC.
Allegation That Respondent's Registrations Are Inconsistent With the
Public Interest
Under Section 304 of the CSA, ``[a] registration . . . to . . .
distribute[ ] or dispense a controlled substance . . . may be suspended
or revoked by the Attorney General upon a finding that the registrant .
. . has committed such acts as would render his registration under
section 823 of this title
[[Page 57759]]
inconsistent with the public interest as determined by such section.''
21 U.S.C. 824(a)(4). In the case of a ``practitioner,'' which is
defined in 21 U.S.C. 802(21) to include a ``physician,'' Congress
directed the Attorney General to consider 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 . . . 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.
21 U.S.C. 823(f). These factors are considered in the disjunctive.
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003).
According to Agency decisions, I ``may rely on any one or a
combination of factors and may give each factor the weight [I] deem[ ]
appropriate in determining whether'' to revoke a registration. Id.; see
also Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881
F.3d 823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't
Admin., 841 F.3d 707, 711 (6th Cir. 2016); MacKay v. Drug Enf't Admin.,
664 F.3d 808, 816 (10th Cir. 2011); Volkman v. U. S. Drug Enf't Admin.,
567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin., 419 F.3d
477, 482 (6th Cir. 2005). Moreover, while I am required to consider
each of the factors, I ``need not make explicit findings as to each
one.'' MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see
also Hoxie, 419 F.3d at 482. ``In short, . . . 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, 664 F.3d at 821.
Under DEA's regulation, ``[a]t any hearing for the revocation . . .
of a registration, the . . . [Government] shall have the burden of
proving that the requirements for such revocation . . . pursuant to . .
. 21 U.S.C. [Sec. ] 824(a) . . . are satisfied.'' 21 CFR 1301.44(e).
In this matter, while I have considered all of the factors, the
Government's evidence in support of its prima facie case is confined to
Factors One, Two and Four.\32\ I find that the Government's evidence
with respect to Factors One, Two, and Four satisfies its prima facie
burden of showing that Respondent's continued registration would be
``inconsistent with the public interest.'' 21 U.S.C. 823(f). I further
find that Respondent failed to produce sufficient evidence to rebut the
Government's prima facie case.
---------------------------------------------------------------------------
\32\ I already discussed the unrefuted evidence in the record
and found that the MBPL summarily suspended Respondent's Michigan
medical license after considering matters similar to those alleged
in the OSC. I incorporate that discussion into this section
regarding Factor One.
As to Factor Three, there is no evidence in the record that
Respondent has a ``conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of
controlled substances.'' 21 U.S.C. 823(f)(3). However, as Agency
cases have noted, there are a number of reasons why 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, M.D., 75 FR 49,956, 49,973 (2010), pet. for rev. denied,
MacKay v. Drug Enf't Admin., 664 F.3d 808 (10th Cir. 2011). Agency
cases have 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.
---------------------------------------------------------------------------
Factors Two and/or Four--The Respondent's Experience in Dispensing
Controlled Substances and Compliance With Applicable Laws Related to
Controlled Substances Allegation That Respondent Issued Prescriptions
for Controlled Substances Outside the Usual Course of the Professional
Practice
According to the CSA's implementing regulations, a lawful
prescription for controlled substances is one that 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). The
Supreme Court has stated, in the context of the CSA's requirement that
schedule II controlled substances may be dispensed only by written
prescription, that ``the prescription requirement . . . ensures
patients use controlled substances under the supervision of a doctor so
as to prevent addiction and recreational abuse . . . [and] also bars
doctors from peddling to patients who crave the drugs for those
prohibited uses.'' Gonzales v. Oregon, supra, 546 U.S. at 274.
The Agency recently revoked the registrations of two Michigan
practitioners based on charges and fact patterns that are similar to,
and alleged to have taken place during the same time period as, the
charges and fact patterns in this matter. Garrett Howard Smith, M.D.,
83 FR 18,882 (2018); Bernard Wilberforce Shelton, M.D., 83 FR 14,028
(2018).
Respondent engaged a skillful team and defended himself against all
of the OSC's allegations. I read and analyzed every aspect of
Respondent's defense including all of the evidence he put in the
record. Regarding the unlawful prescribing charge, Respondent's
evidence and argument are not persuasive.\33\
---------------------------------------------------------------------------
\33\ As already discussed, the record evidence and analysis
concerning Subsys and Food and Drug Administration requirements are
insufficient to answer the legal issues raised by some of the
Subsys-related allegations. Thus, those Subsys-related allegations
are given no weight and play no role in my public interest
assessment or my decisions about the Government's requested relief.
---------------------------------------------------------------------------
I disagree with Respondent's characterization of the Government's
evidence. For example, Respondent attacks Dr. Christensen's testimony
by stating that ``he [Dr. Christensen] himself has prescribed a
controlled substance to a patient without seeing that patient'' and
that ``it is not a violation of the standard of care to rely on past
physical examinations of a patient when making medical decisions.''
Respondent's Closing Argument, Proposed Findings of Fact, and
Conclusions of Law dated Oct. 19, 2017 (hereinafter, Resp Brief), at
12. The context of this portion of Dr. Christensen's testimony is
missing from Respondent's argument, even though it is essential to
understand the expert's testimony. That context is ``a patient who is
on stable medication, who has shown no aberrant behavior, and who has a
normal prescription search on the day of the prescription, and between
60-day visits.'' Tr. 603.
By way of further example, Respondent asserts that, ``Dr.
Christensen provided an evasive answer as to whether a whole record or
a partial record would be needed to form an opinion as to a physician's
standard of care.'' Resp Brief, at 15; see also id. at 21-23. Dr.
Christensen's testimony, however, clearly debunks the notion of a whole
or partial patient record because ``interval history and history of
present illness, if done, would reflect what . . . relevant information
or relevant events had occurred before.'' Tr. 681. In other words, Dr.
Christensen's expert opinion and explanation of the Michigan standard
of care support the common sense conclusion that Respondent may not
defeat a charge of violating the applicable standard of care by
maintaining inadequate patient records.
Respondent's characterization of some of the Government's evidence
is also
[[Page 57760]]
unpersuasive when, for example, he argues that ``if a patient was
denied Subsys by the insurance company, it is reasonable to assume the
patient did not receive the medication.'' Resp Brief, at 33. The
insurance company's refusal to pay for a prescription and the
supposedly ``reasonable'' assumption that the patient, therefore, did
not receive that medication follow the actions that are legally
relevant--Respondent's issuance of controlled substance prescriptions--
and the Government's resulting allegation--that Respondent issued
controlled substance prescriptions outside the usual course of the
professional practice. In other words, the issuance of controlled
substance prescriptions outside the usual course of the professional
practice of medicine violates the law whether or not the patient fills
a prescription or ingests one of the prescribed pills.\34\
---------------------------------------------------------------------------
\34\ This important principle applies to all controlled
substance prescribing.
---------------------------------------------------------------------------
Respondent invites me to apply alternative analyses to the OSC's
allegations. For example, according to Respondent's expert, it is
``rare'' and ``less likely'' for an older patient, such as RF (80 years
old) and ES (79 years old), to abuse or divert a controlled substance
or medication. Id. at 33, 35. I decline to decide this case based on
Dr. Webster's estimated probabilities instead of the applicable
standard of care. See also FSMB Model Policy, at 3 (``Some patients
share their drugs with others without intending harm (a pattern of
misuse that is seen quite often among older adults).''). By way of
further example, Respondent argues that his patient's views of the
``quality of care they received'' were not obtained. Resp Brief, at 5.
Respondent fails, however, to provide a sound legal basis for the
relevancy of those views in this proceeding. In addition, Respondent
asserts that ``Dr. Christensen testified that there were no `negative
outcomes' that he was aware of with any of the patients he reviewed,
other than a possible `confusion' incident from a patient going through
chemotherapy.'' Id. at 14. Nowhere, however, does Respondent cite legal
authority for his argument that the issuance of controlled substance
prescriptions outside the usual course of the professional practice
only violates the law when there is a certain ``negative outcome.'' I
reject Respondent's argument as meritless.\35\
---------------------------------------------------------------------------
\35\ See, e.g., FSMB Model Policy, at 12 (``Good records
demonstrate that a service was provided to the patient and establish
that the service provided was medically necessary. Even if the
outcome is less than optimal, thorough records protect the physician
as well as the patient.'').
---------------------------------------------------------------------------
Respondent suggests that his practice of medicine complies with the
standard of care. If Respondent's expert were to be believed that good
medicine is a higher standard than the standard of care, Respondent's
suggestion could be true. Tr. 1163. As already discussed, however, I
credit Dr. Christensen's articulation of the Michigan standard of care
and his testimony measuring Respondent's actions against that standard
of care. I reject the testimony of Respondent's expert to the extent
that it conflicts with Dr. Christensen's testimony or posits an
untenable ``standard of care.'' In addition, I note that even the
testimony of Respondent's own expert indicates that the expert's
practice of medicine differs in some respects from how the evidence
shows Respondent practices medicine. See, e.g., id. at 1067
(Respondent's expert testifying that he ``would expect more'' medical
decision making and ``talk about treatment and why certain treatments
are implemented''); id. at 1073 (Respondent's expert testifying that
``it's just good practice to explain what you've discussed with the
patient and their response'').
Respondent offered into evidence both the Michigan Guidelines and
the FSMB Model Policy. He argues, unconvincingly, that he complied with
both documents' applicable standards of care and did not commit
``malpractice.'' Resp Brief, at 49. In response to the testimony of the
Government's expert that the medical records the Respondent created do
not establish that Respondent complied with the applicable standard of
care, Respondent blames law enforcement's execution of the search
warrant for his incomplete patient records. As already discussed, I
reject this argument. Respondent also suggests that the standard of
care does not mandate a specific level of detail for recordkeeping.
See, e.g., id. at 49, 51. Respondent's argument is without merit; I
reject it. As the above-cited portions of the Michigan Guidelines and
FSMB Model Policy show, the requisite recordkeeping is recordkeeping
that complies with the requirements articulated in the standard of care
and that supports subsequent reviews of Respondent's actions for
compliance with the standard of care. In other words, a physician may
not expect to vindicate himself through oral representations at the
hearing about his compliance with the standard of care that were not
documented in appropriately maintained patient records.
Thus, I agree with the R.D. that the record in this case
establishes by substantial evidence that Respondent violated 21 CFR
1306.04(a). R.D., at 124. As such, I find that the record in this case
likewise calls for the revocation of Respondent's registrations and the
denial of all pending applications by Respondent for registration in
Michigan. R.D., at 121-29.
Allegation That Respondent Unlawfully Possessed Controlled Substances
The CSA requires a ``separate registration . . . at each principal
place of business or professional practice where the applicant . . .
distributes . . . or dispenses controlled substances.'' 21 U.S.C.
822(e)(1); see also 21 CFR 1301.12(a), Clarification of Registration
Requirements for Individual Practitioners, 71 FR 69,478 (2006); Joe W.
Morgan, D.O., 78 FR 61,961 (2013). The CSA's definition of ``dispense''
explicitly includes the delivery of a controlled substance to an
ultimate user and the prescribing of a controlled substance. 21 U.S.C.
802(10). There is no evidence in the record that Respondent is
authorized to collect controlled substances from ultimate users and
other non-registrants for destruction. 21 CFR 1317.30 and 1317.40.
Michigan law prohibits a person from knowingly or intentionally
possessing a controlled substance ``unless the controlled substance . .
. was obtained directly from, or pursuant to, a valid prescription or
order of a practitioner while acting in the course of the
practitioner's professional practice.'' Mich. Comp. Laws Sec. 333.7403
(Westlaw, current through P.A. 2019, No. 18 of the 2019 Regular
Session, 100th Legislature).
As already discussed, Respondent admits that he stored controlled
substances previously prescribed to patients and controlled substance
samples at his North Macomb Street office and his residence, which is
not a registered location. Thus, I agree with the R.D. that Respondent
violated both Federal and Michigan law by possessing controlled
substances previously prescribed to patients and controlled substance
samples at his North Macomb Street office and his residence. R.D., at
117.
Recordkeeping Allegations
The OSC contains two recordkeeping-related charges. First, citing
21 CFR 1304.11, paragraph 10 of the OSC charges Respondent with failing
to maintain an inventory at both of his registered locations. OSC, at
4. The CSA and its implementing regulations require registrants to make
a complete and accurate record of all controlled substances on hand
according to
[[Page 57761]]
specified time schedules and to keep those records available for
inspection by authorized individuals. See, e.g., 21 U.S.C. 827, 21 CFR
1304.11. Respondent admits that he kept controlled substances at both
of his registered locations but that he did not maintain an inventory
at his North Macomb Street office. Tr. 1729-30. Thus, Respondent admits
to violating the inventory requirement as to his Macomb office.
In addition, as already discussed, although Respondent's testimony
is that he maintains and still possesses an inventory of controlled
substances for the Stewart Road office that he ``can introduce . . .
any time that you wish,'' he did not produce that alleged inventory at
any time, including during the hearing. Id. at 1732; see also id. at
1729-32. As such, in addition to the violation to which Respondent
admits concerning his North Macomb Street office, I find another
violation of 21 CFR 1304.11 by Respondent concerning his Stewart Road
office, where he admitted to having controlled substances. Id. at 1490.
Second, paragraph 11 of the OSC charges Respondent with failing to
maintain required records for controlled substances, including records
for controlled substances that were transferred from one registered
location to another. OSC, at 4 (citing 21 CFR 1304.21). As a DEA
registrant, Respondent is required to keep records that are complete
and accurate. 21 CFR 1304.21. Respondent admits that he transferred
controlled substances between his registered locations but that he did
not complete the records required to memorialize those transfers. Tr.
1733. As such, I find that Respondent admits to violating 21 CFR
1304.21.
Summary of Factors Two and Four and Imminent Danger
As found above, the Government's case establishes by substantial
evidence that Respondent issued controlled substance prescriptions
outside the usual course of the professional practice. There is also
substantial evidence that Respondent unlawfully possessed controlled
substances and violated the recordkeeping requirements incumbent upon a
registrant. I, therefore, conclude that Respondent engaged in egregious
misconduct which supports the revocation of his registrations. See
Wesley Pope, 82 FR 14,944, 14,985 (2017).
For purposes of the imminent danger inquiry, my findings also lead
to the conclusion that Respondent has ``fail[ed] . . . to maintain
effective controls against diversion or otherwise comply with the
obligations of a registrant'' under the CSA. 21 U.S.C. 824(d)(2). The
substantial evidence that Respondent issued controlled substance
prescriptions outside the usual course of the professional practice
establishes that there was ``a substantial likelihood of an immediate
threat that death, serious bodily harm, or abuse of a controlled
substance . . . [would] occur in the absence of the immediate
suspension'' of Respondent's registrations. Id.; see, e.g., Tr. 369
(the opinion of the Government's expert, Dr. Christensen, that mixing
alcohol and opioids could result in death); Tr. 1080-81 (the opinion of
Respondent's expert, Dr. Webster, that mixing opioids and a
benzodiazepine is unsafe).
Sanction
Where, as here, the Government has met its prima facie burden of
showing that Respondent's continued registration is inconsistent with
the public interest due to his numerous violations pertaining to
controlled substance prescribing, possession, and recordkeeping as well
as due to his non-compliance with State law, the burden shifts to the
Respondent to show why he can be entrusted with a new registration.
Garrett Howard Smith, M.D., supra, 83 FR at 18,910 (collecting cases).
Moreover, as past performance is the best predictor of future
performance, DEA Administrators have held that a registrant who has
committed acts inconsistent with the public interest must accept
responsibility for those acts and demonstrate that he will not engage
in future misconduct. Id. A registrant's acceptance of responsibility
must be unequivocal. Id. In addition, a registrant's candor during the
investigation and hearing has been an important factor in determining
acceptance of responsibility and the appropriate sanction. Id.
(collecting cases). In addition, DEA Administrators have found that the
egregiousness and extent of the misconduct are significant factors in
determining the appropriate sanction. Id. DEA Administrators have also
considered the need to deter similar acts by the respondent and by the
community of registrants. Id.
Regarding all of these matters, I agree with the analyses and
conclusions contained in the R.D.'s Recommendations on Disposition.
R.D., at 125-29. I agree with the R.D. that the record is ``devoid of
any inclination on the part of the Respondent to accept any level of
responsibility'' for his controlled substance prescribing in the face
of multiple indications of abuse, danger, or diversion. See id. at 126.
Concerning his recordkeeping, Respondent steadfastly maintained that he
kept the required inventories and that he could produce them. Yet, he
never produced those inventories and, instead, blamed the law
enforcement officers who executed the search warrant for the fact that
his inventories were not among the records they seized. I agree with
the analysis in the R.D.
Even beyond the dubious credibility attached to the notion that
he would deliberately sit on inventories requested by DEA at the
potential cost of a . . . [registration], and the impenetrable logic
involved [in] blaming the agents who executed the search warrant,
neither tack embodies an acceptance of responsibility under any
reasonable definition.
Id. at 126-27.
Respondent stated during his testimony that he accepted
responsibility for unlawfully possessing controlled substances at one
of his offices and his residence. As already discussed, this limited
acceptance of responsibility is unavailing. Further, even if Respondent
had unequivocally accepted responsibility for all his unlawfulness such
that I would reach the matter of remedial measures, I note that the
remedial measures Respondent presented concerning his unlawful
possession of controlled substances are not adequate. When asked what
he would do if, in the future, a patient wanted to give him unused
controlled substances, Respondent said that ``he `would have the
patient either dispose of it or have them call''' DI. Id. at 127
(citation omitted). The Chief ALJ, who observed Respondent's demeanor,
concluded that Respondent's ``wry addition of . . . [DI] into the
solution was an ill-timed attempt at humor.'' Id. I agree with the R.D.
that, ``[e]ven if the Respondent's acceptance of responsibility on this
issue were deemed sincere, his offer of potential remedial measures . .
. [was] unpersuasive'' because he had not identified a reverse
distributor and could only testify about ``some unspecified'' way of
disposing of the medicine ``with coffee grounds.'' Id.
In sum, I find that the record supports the imposition of a
sanction because the Respondent did not unequivocally accept
responsibility.
The interests of specific and general deterrence ``militate in
favor of revocation.'' Id. at 128. Respondent has evidenced no
understanding that his controlled substance prescribing and
recordkeeping fell short of legal requirements. As such, it is not
reasonable to believe that Respondent's future prescribing and
recordkeeping will comply with legal requirements.
[[Page 57762]]
Further, given the nature and number of Respondent's violations, a
sanction less than revocation would send a message to the regulated
community that compliance with the law is not a condition precedent to
maintaining a registration. Id. at 128-29.
Accordingly, I shall order the sanctions the Government requested,
as contained in the Order below.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(f) and 824(a), I hereby revoke DEA Certificates of
Registration BP2527058 and FP2665478 issued to Lesly Pompy, M.D. I
further hereby deny any pending application of Lesly Pompy, M.D., to
renew or modify these registrations, as well as any other pending
application of Lesly Pompy, M.D. for registration in Michigan. Pursuant
to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a)
and (d), I hereby affirm the Order of Immediate Suspension of
Registrations issued to Lesly Pompy, M.D. Pursuant to 28 CFR 0.100(b)
and the authority vested in me by 21 U.S.C. 824(f), I hereby order the
forfeiture to the United States, upon this revocation order becoming
final, of all controlled substances seized pursuant to the Order of
Immediate Suspension of Registrations. Pursuant to 28 CFR 0.100(b) and
the authority vested in me by 21 U.S.C. 824(f), I hereby declare that
all right, title, and interest in all controlled substances seized
pursuant to the Order of Immediate Suspension of Registrations are
vested in the United States upon this revocation order becoming final.
This Order is effective November 27, 2019.
Dated: September 25, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-23503 Filed 10-25-19; 8:45 am]
BILLING CODE 4410-09-P