[Federal Register Volume 87, Number 29 (Friday, February 11, 2022)]
[Notices]
[Pages 8039-8058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02973]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 20-03]
John X. Qian, M.D.; Decision and Order
On November 18, 2019, a former Acting Administrator, Drug
Enforcement Administration (hereinafter, DEA or Government), issued an
Order to Show Cause and Immediate Suspension of Registration
(hereinafter, OSC/ISO) to John X. Qian, M.D. (hereinafter, Respondent).
Administrative Law Judge Exhibit (hereinafter, ALJX) 1 (Order to Show
Cause), at 1. The OSC proposed the revocation of Respondent's
Certificates of Registration Nos. FQ7186174, FQ7906968, and BQ7364970,
and denial of the pending application for a new DEA Certificate of
Registration (hereinafter, COR or registration), Application No.
W18124091C, pursuant to 21 U.S.C. 824(a)(4) ``because [his] continued
registration is inconsistent with the public interest. . . .'' Id.
(citing 21 U.S.C. 823(f)).
I. Procedural History
The OSC alleged that ``from at least early 2017, through at least
April 29, 2019,\1\ [Respondent] unlawfully issued or approved the
issuance of prescriptions for controlled substances'' to three patients
``that were not for a legitimate medical purpose, were beneath the
standard of care for the practice of medicine in the State of
California, and were not issued in the usual course of professional
medical practice.'' Id. at 5. The OSC alleged violations of 21 U.S.C.
841(a) and 842(a); 21 CFR 1306.04(a); Cal. Health & Safety Sec. Sec.
11153(a), 11154(a); and Cal. Bus. Sec. Prof. Sec. Sec. 725(a), 22334,
and 2242(a). Id.
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\1\ In the Prehearing Statement, the Government clarified the
relevant time period to be between early 2017 and ``late 2019.''
ALJX 4, at 15.
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Pursuant to 21 U.S.C. 824(d) and 21 CFR 1301.36(e), the former
Acting Administrator immediately suspended Respondent's Certificate of
Registration, found ``that [Respondent's] continued registration [was]
inconsistent with the public interest'' and that ``continued
registration while [the] proceedings are pending constitutes an
imminent danger to the public health or safety.'' Id. at 13. Pursuant
to 21 U.S.C. 824(f) and 21 CFR 1301.36(f), the former Acting
Administrator authorized DEA Special Agents (hereinafter, SA) and
Diversion Investigators (hereinafter, DI) serving the OSC on Respondent
to place under seal or to remove for safekeeping all controlled
substances that Respondent possessed pursuant to the suspended
registrations and to take the registrations themselves. Id.
The OSC notified Respondent of the right to either request a
hearing on the allegations or submit a written statement in lieu of
exercising the right to a hearing, the procedures for electing each
option, and the consequences for failing to elect either option. Id. at
13 (citing 21 CFR 1301.43).
By letter dated November 21, 2019, Respondent timely requested a
hearing.\2\ ALJX 2 (Request for Hearing), at 1. The matter was placed
on the docket of the Office of Administrative Law Judges and was
assigned to Mark M. Dowd (hereinafter, ALJ). In addition to the
traditional procedural history, the parties filed robust Joint
Stipulations of Facts, ALJX 10 (Joint Stipulations of Facts), and the
Government filed several Motions in Limine, which I will briefly
summarize here. The first, a Motion in Limine to Exclude Second Expert
Witness, ALJX 11, sought to exclude the testimony of a second expert
witness identified a week before the hearing in this matter was
scheduled to begin. Id. at 1. The ALJ found good cause for the
Respondent's delay and agreed to permit both of Respondent's experts to
testify so long as the testimony was not cumulative or repetitive. ALJX
12 (Order Granting in Part Government's Motion in Limine and to Exclude
Evidence). Respondent ended up calling only the later-added expert
witness to testify. The second was a Motion in Limine to Exclude
Character Witnesses, ALJX 13, which alleged that the dozen character
witnesses that Respondent proposed could only offer testimony that was
either irrelevant or duplicative. ALJX 13. The ALJ did not grant the
Government's motion, but he did limit the number of witnesses who could
discuss Respondent's character and dispensing experience to three
patients and four medical professionals and limited the scope of the
testimony to what was relevant to the hearing. Transcript of
Proceedings in the Matter of John X. Qian, M.D. (hereinafter, Tr.), 7-
10. In the end, Respondent did not call any witnesses for these
purposes but instead presented documentary evidence. During the
hearing, the Government filed a Motion in Limine to Strike Testimony
and Evidence, ALJX 18, related to Respondent's treatment of E.N. that
predated the medical records provided to the Government in response to
a subpoena (which began in July 2012). ALJX 18, at 1. The ALJ
[[Page 8040]]
determined that the issue was simply a miscommunication between the
parties and denied the Government's motion. ALJX 21 (Order Denying
Motion to Strike).
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\2\ I find that the Government's service of the OSC was
adequate.
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The hearing in this matter took place both in-person in San Diego,
California, and virtually, and spanned eight days in February and May
of 2020. Recommended Decision (hereinafter, RD), at 1. On July 27,
2020, the ALJ issued his Recommended Rulings, Findings of Fact,
Conclusions of Law and Decision. The Respondent filed Exceptions to the
Recommended Decision on August 14, 2020.\3\ (hereinafter ``Respondent's
Exceptions'') ALJX 30. The Government was granted leave to file a
response to the Respondent's Exceptions, and it filed them on September
11, 2020. See ALJX 31-33. I have reviewed and agree with the procedural
rulings of the ALJ during the administration of the hearing.
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\3\ This decision, as compared to the ALJ's decision with which
Respondent took exception, has been simplified and narrowly focuses
on the issues that are relevant to my determination as to whether or
not the relevant prescriptions were issued within the usual course
of professional practice and standard of care in California and in
compliance with the relevant state laws, as it was established in
this case. Several of Respondent's Exceptions relate to findings in
the ALJ's decision that I have not determined to be relevant to my
decision and, accordingly, I have not addressed those Exceptions in
detail. Throughout this decision, I have addressed in detail
Respondent's exceptions to findings that my decision relies upon.
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Having considered the record in its entirety, I find that
Respondent issued one-hundred and fifteen prescriptions beneath the
applicable standard of care and outside of the usual course of the
professional practice in California in violation of federal law, and I
find that Respondent committed violations of state law. I agree with
the ALJ that revocation is the appropriate sanction. RD, at 242. I make
the following findings of fact.
II. Findings of Fact
A. DEA Registration
The parties stipulated that Respondent is registered with DEA as an
individual practitioner authorized to handle controlled substances in
schedules II through V under DEA Certificate of Registrations
FQ7186174, at 5360 Jackson Drive, Suite 100, La Mesa, CA 91942,
scheduled to expire on April 30, 2020; \4\ FQ7906968, at 7024 Seville
Ave., Suite D, Huntington Park, CA 90255, scheduled to expire on April
30, 2021; and BQ7364970 (and XBQ7364970), at 5395 Ruffin Rd., Suite
204, San Diego, CA 92123, scheduled to expire on April 30, 2022. ALJX
10, at 1; GX 1a-c (Respondent's Certificates of Registration), 2a-c
(Respondent's Certificate of Registration Histories); RD, at 159. The
parties further stipulated that Respondent submitted an application for
a DEA COR as an individual practitioner authorized to handle controlled
substances in scheduled II through V under Application No. W18124091C,
at 344 F St., Suite 203, Chula Vista, CA 90910. ALJX 10, at 1; RD, at
160.
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\4\ The fact that a registrant allows his registration to expire
during the pendency of an OSC does not impact my jurisdiction or
prerogative under the Controlled Substances Act (hereinafter, CSA)
to adjudicate the OSC to finality. Jeffrey D. Olsen, M.D., 84 FR
68,474 (2019). Accordingly, even though one of the registrations at
issue in this case has expired, it is still included as part of my
revocation order. Infra ``Order.''
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B. Government's Case
The Government's documentary evidence \5\ consisted of voluminous
patient records for three individuals to whom Respondent issued the
controlled substances prescriptions that are at issue in this case. See
e.g., GX 4, 5, 8, 9, 12, and 13. The Government's evidence also
contained prescription records and California Controlled Substance
Utilization Review and Evaluation System (hereinafter, CURES) reports
for those three individuals, the Curriculum Vitae for its expert
witness, some DEA records, and an Accusation filed against Respondent
by the Medical Board of California (hereinafter, MBC). See GX 1-3, 6,
7, 10, 11, 14-16, 23. Finally, the Government produced a number of
guidelines and publications that it presented as evidence in support of
establishing the standard of care in California. GX 17-22.
Additionally, the Government called three witnesses: DI, the
Government's expert Dr. Timothy Munzing, and a systems analyst for an
electronic medical record program, Mr. Parag Deshpande.
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\5\ I have reviewed and considered all of the documentary
evidence presented by both the Government and Respondent, and hereby
incorporate the entire record; I have not cited to every record in
this decision.
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DI testified regarding her professional background and education.
Tr. 66-69. She also testified about her investigation-related actions
since early-2019 in this matter including, but not limited to, her
involvement in obtaining and reviewing CURES reports, pharmacy records,
and records from Respondent pursuant to the May 7, 2019 administrative
subpoena, including records for patients D.B., B.G., and E.N. Id. at
71-168. DI testified that her review of the records indicated that
various red flags were present and she retained Dr. Munzing as an
expert to review the records at issue. Id. at 167, 169, 183-222. Having
read and analyzed all of the record evidence, I agree with the ALJ that
DI's testimony was ``credible and should be afforded considerable
weight.'' RD, at 165.
Dr. Munzing testified regarding his professional and educational
background. Tr. 249-256; GX 16 (Curriculum Vitae of Dr. Munzing); RD,
at 27-30. He graduated medical school from the University of
California, Los Angeles, in 1982 and has been Board-certified in family
medicine since 1985. Id. at 250-51. He has been employed with Kaiser
Permanente for thirty-five years and has experience treating pain
patients. Id. at 250-254, 971-72, 980-83. Also, he has authored several
peer-reviewed publications on pain management and prescribing for
chronic pain.\6\ Id. at 253-55, 952-53. Dr. Munzing has testified as an
expert witness approximately thirty times and has been qualified as an
expert witness in cases where the respondent was a pain specialist. Id.
at 257-60. Dr. Munzing was accepted in this matter as ``an expert in
the standard of care [for] prescribing controlled substances in the
State of California, including for management of pain.'' \7\ Tr. 260,
265.
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\6\ Dr. Munzing describes chronic pain as ``pain that last[s]
three months'' or more and that is ``less likely to suddenly get
completely better.'' Tr. 276. In contrast, Dr. Munzing explains that
acute pain is shorter term such as when you are injured and your
body heals with or without surgery. Id.
\7\ At the hearing, Respondent objected to Dr. Munzing's
qualification as an expert based on his ``lack of specialty in the
area of pain management.'' Tr. 262. Throughout the hearing stage,
Respondent repeatedly argued that Dr. Munzing's experience in pain
management is lacking, that his lack of experience is evident in his
testimony, and that his opinions can be afforded no weight. ALJX 28
(Respondent's Posthearing), at 4-7, 11-2, 21-22, 25-28; ALJX 30
(Respondent's Exceptions), at 2-10, 14-21. Respondent also took
exception to the ALJ's determination that Dr. Munzing was qualified
as an expert in this matter. ALJX 30, at 2-7. I have fully
considered these arguments. Many of the areas where Respondent
focused on Dr. Munzing's lack of experience, such as in determining
what morphine milligram equivalent (MME) is too high for a
particular patient, developing a titration schedule for patients, or
managing a patient's pain pump, did not end up being relevant to my
decision in this case. This is because the record established
through the testimony of both experts that the standard of care does
not set a cap on MMEs, it does not dictate a titration schedule, and
it does not have firm rules for managing pain pumps. Infra II.D.3.a.
Moreover, Respondent's general medical decision making is not the
basis for the allegations in the OSC; the OSC allegations are
focused on whether or not the identified prescriptions were issued
in accordance with the applicable standard of care and in the usual
course of professional practice and in accordance with state law.
See generally, OSC. The expert testimony in this case is necessary,
in conjunction with California law and guidelines, to understand the
applicable standard of care. Dr. Munzing clearly demonstrated his
expertise in how the standard of care applied to the facts in this
case and furthermore, his testimony regarding his expertise was
credible. Tr. 1112-16, 1199-1201, 1206-07. Moreover, as is
demonstrated below, infra II.D., in those places where Dr. Munzing's
and Dr. Polston's testimony differed regarding the standard of care,
California law and guidelines aligned more closely with Dr.
Munzing's testimony. Accordingly, I affirm the ALJ's decision to
qualify Dr. Munzing as an expert in this case.
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[[Page 8041]]
The ALJ conducted a thorough analysis of Dr. Munzing's credibility,
see RD, at 165-169 and I agree with much of it. I agree that Dr.
Munzing's prior experience as a government witness and his compensation
therefore does not create an actual credibility concern. RD, at 165. I
agree that Dr. Munzing's professional experience with regard to pain
management, while sufficient to be qualified as an expert witness and
to offer credible opinions, was not as robust as Dr. Polston's. RD, at
167. Dr. Munzing was a family practitioner, he was not Board-certified
as a pain management specialist, Tr. 251, 973, 976; however, Dr.
Munzing explained that in the Kaiser Permanente system (where he
worked), the family practitioner managed pain conditions and prescribed
the necessary medication even when consulting with a pain management
specialist. Tr. 971-72, 980-83. The nature of Dr. Munzing's practice,
along with his peer-reviewed publications in pain management, Tr. at
253-55, 952-53, suggest that he had more experience in prescribing
controlled substances for pain management than a typical family
practitioner. Dr. Polston, however, was a Board-certified pain
management specialist and had more clinical experience treating complex
pain in patients with chronic conditions including more experience
titrating patients down from extraordinarily high levels of opioids and
managing patients with pain pumps.\8\ Infra II.C.; RD, at 167.
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\8\ Although Dr. Polston's testimony regarding the
appropriateness of Respondent's titration with respect to the
standard of care was at times more detailed and credible than Dr.
Munzing's, as described in infra II.D.3.a. and RD, at 183-87, Dr.
Munzing's testimony was more far more credible than Dr. Polston's
regarding the requirement to document a titration treatment and plan
appropriately. Ultimately, I find that, as demonstrated by
Respondent's recordkeeping, Respondent failed to provide
documentation that justified the titration schedule used and the
gaps between downward adjustments, and that failure to document
supported a finding that Respondent issued prescriptions outside the
usual course of professional practice and beneath the applicable
standard of care. Infra II.D.3.a.
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The ALJ found that ``Dr. Munzing's testimony critiquing
[Respondent's] actual treatment of the three subject patient[s]
carrie[d] limited weight,'' because it did not ``address[] the patient-
specific strategies used and described by [Respondent].'' RD, at 168-
69. I disagree. I find that, overall, Dr. Munzing's testimony was more
detailed and reflected a much more thorough review of the Respondent's
records than Dr. Polston's. Dr. Polston opined regarding the medical
records in their entirety, which allowed Dr. Polston to apply
subsequent prescribing rationale retroactively to justify earlier
prescriptions, even though there was no documented justification at the
time that the prescription was issued. Tr. 616. However, Dr. Munzing
approached each prescription individually while also looking at the
records as a whole. Tr. 1196-97. His testimony focused on whether the
medical records justified each prescription at the time the
prescription was issued consistent with 21 CFR 1306.04. Tr. 1233; infra
III.A.2.a.
With regard to recordkeeping, the ALJ found that ``Dr. Munzing's
testimony . . . was internally consistent, did not depend [on]
specialized expertise relating to the evaluation of pain management
specialists, was consistent with the relevant statute and Guidelines,
and thus was wholly credible.'' RD, at 169. I agree that Dr. Munzing's
testimony regarding recordkeeping was wholly credible.
The ALJ found, and I agree, that ``[t]he basic tenets of the
standard of care for prescribing opioids, as described by Dr. Munzing,
was fully credible and not controverted by the Respondent.'' RD, at
168. Ultimately, as addressed with more specificity in the Standard of
Care section below, where the two experts differed regarding
application of the standard of care, I find that Dr. Munzing's
testimony was more detailed and more closely aligned with the law and
guidelines governing the standard of care in California. Infra. II.D. I
therefore find Dr. Munzing's testimony to be fully credible.
As a rebuttal witness, the Government called Mr. Deshpande who was
a systems analyst with BizMatics, the company who developed the
electronic medical record (hereinafter, EMR) program used by Respondent
and his practice. Tr. 1874-75, 1878-79. Mr. Deshpande explained the
operation of Respondent's EMR system, Tr. 1892-1901, and explained that
physicians have the ability to ``copy over'' specific sections of
information from a previously completed visit report to the current
visit for the same patient. Tr. 1901. The system can also be set up so
that it automatically copies information from the most recent previous
visit into the current visit record. Tr. 1902-03. Finally, Mr.
Deshpande explained his assessment of the number of times entries and
findings from precious encounters were automatically copied into the
record for a current encounter related specifically to the three
individuals for whom the controlled substance prescriptions at issue in
this case were written. Tr. 1910-49. The ALJ found, and I agree, that
Mr. Deshpande had ``a high level of expertise in each of the areas in
which he offered testimony.'' RD, at 170. The ALJ also found, and I
agree, that ``[h]is testimony was internally consistent and generally
consistent with the testimony of [Respondent] regarding the basic
functioning of the program.'' Id. Therefore, the ALJ ``found his
testimony fully credible and deserving considerable weight.'' Id. I
agree.
C. Respondent's Case
The Respondent's documentary evidence was largely duplicative of
the Government's documentary evidence.\9\ See RX E-J, N-P. The
Respondent presented the Curriculum Vitae of his expert, Dr. Gregory
Polston, along with his expert report. RX HHH, TTT. The Respondent also
presented a number of publications including the MBC's 2007 Prescribing
Guidelines, RX A, a clarification memorandum from the authors of the
CDC Guidelines, RX D, an AMA article criticizing the CDC Guidelines'
impact on pain treatment, RX DD, an MBC Update to Prescribers, RX SS,
and an Aberrant Drug Taking Behaviors Information Sheet, RX TT.\10\
Respondent introduced several curricula vitae and declarations of
support from other medical professionals. See RX T-AA, RR, HHH, PPP.
The record also contained declarations that patients of Respondent
offered in support of Respondent's case. RX JJ-LL. Respondent produced
records regarding training programs he had attended, RX PP-QQ, his
Curriculum Vitae, RX RR, his Board Certifications, RX XX-YY, and
miscellaneous records related to his practice generally, e.g. RX LLL-
MMM, QQQ. Finally, there were some records offered in support of
Respondent's treatment of the specific individuals at issue in this
case. RX, JJJ-KKK, RRR-SSS, UUU-VVV. Additionally, Respondent called
two witnesses: His expert, Dr. Gregory Polston, and himself.
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\9\ Duplicative documentary evidence that was offered, but not
admitted, included the CDC Guidelines; the MBC Guidelines for
Prescribing; pain agreements, urine drug screens, CURES reports
summaries, and patient records for the individuals at issue in this
case. I agree with the ALJ's decision to not admit these duplicates.
\10\ Respondent also attempted to introduce what the ALJ
characterized as a ``newspaper article,'' which the ALJ did not
admit because it was not ``necessarily reliable'' and was not
``authenticate[d].'' Tr. 1847. I agree that absent evidence
establishing the reliability therein, newspaper articles should not
be admitted into evidence. See Jones Total Health Care Pharmacy,
L.L.C., 71 FR 79188, 79222 n. 11 (2016).
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[[Page 8042]]
Respondent testified regarding his medical education and
background--he came to the United States as a visiting scholar to
conduct research related to cancer cells in 1990. Tr. 1316-19. He then
decided to change his focus to Physical Medicine and Rehabilitation
(hereinafter, PMR), which complimented his specialized training in
anesthesiology. Tr. 1319-22. Respondent became Board-certified in PMR
in 2003, and Board-certified in pain medicine in 2005 (which he allowed
to lapse in 2015). Tr. 1328-30. Respondent opened his own practice at
the end of 2005, and described himself as the ``go-to-guy'' in the San
Diego area for pain management and stated that his multiple practice
locations see approximately 100 patients a day. Tr. 1336-43.
Respondent offered some testimony regarding his office policies,
his recordkeeping practices, and how his EMR system worked.\11\ See
e.g. Tr. 1564-68. Respondent testified that he was the attending or
supervising physician for each of the three individuals at issue in
this case, B.G., D.B., and E.N., that he was personally responsible for
the treatment each individual received from Respondent and Respondent's
staff, and that he was personally responsible for the controlled
substance prescriptions issued to each individual by Respondent and
Respondent's staff. Tr. 1564-68; ALJX 10, at 3; see also Tr. 399.
Respondent also offered testimony regarding his understanding of the
standard of care in California, which I have credited where it aligns
with the testimony of the two experts in this case. Tr. 1561-86.
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\11\ I do not find a violation with regard to the Government's
allegation related to a note related to alcohol use and, therefore,
I will not address this allegation further. The Government alleged
that Respondent's recordkeeping was deficient because the records
repeatedly included an internally inconsistent note that stated,
``[p]atient states that [she or he] drinks alcohol [she or he] never
drinks alcohol.'' OSC, at 4; RD, at 205-06. Respondent explained
that this note appeared as a result of a computer glitch; an error
within the computer program that produced the inconsistent statement
in printed records despite the proper selection of one option
(drinks alcohol) or the other (never drinks alcohol) in the system's
drop down menu. Tr. 1412-24, 1831-32. As the computer error was
corroborated by Mr. Deshpande's testimony, Tr. 2000-04, I agree with
the ALJ and find that the Government did not sustain their burden as
to this allegation. RD, at 206. In his decision, the ALJ found for
Respondent but noted there was ``some level of negligence
attributable to him for his failure to confirm the EMR was operating
properly.'' RD, at 206. The Respondent took exception to this note.
ALJX 30, at 14. I do not see anything in the record that suggests
that Respondent's failure to catch the computer glitch meant that
the relevant prescriptions were issued outside the standard of care.
Accordingly, the ALJ's note is not relevant to and is not being
considered as part of my decision in this matter.
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The ALJ found Respondent's testimony to be credible at times.\12\
See e.g. RD, at 199, 208, 212, and 216. But at other times, the ALJ
found Respondent to be so not credible that it ``suggest[ed]
[Respondent] deliberately misled [the] tribunal during the hearing.''
RD, at 225.
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\12\ The ALJ evaluated Respondent's credibility, ``within the
relevant factual findings.'' RD, at 171. Many of the specific
factual findings where the Respondent was found credible were on
issues that I have found were not material to the case. For example,
the ALJ credited Respondent's testimony that Retrospective Drug
Utilization Review letters were so routine in the practice of pain
management that they did not represent red flags under the
circumstances of this case. RD, at 212. However, I found that the
government did not explain why the 2016 Drug Utilization Review
letter at issue in this case was relevant to the 2017-2019
prescribing so the issue is not material to my decision. See infra
n. 55. The ALJ credited Respondent's testimony that he was aware of
and investigating E.N.'s 2015 increase in pain, RD, at 216; but
again, the Government did not explain how this 2015 issue was
relevant to the relevant prescribing in 2017-2019. Infra n. 52. The
ALJ credited Respondent's testimony that an inconsistent drug screen
was not aberrant because medication infused through a pain pump
would not be expected to show up in urine. Tr. 208. This issue was
abandoned by the Government and is not material to my decision in
this case. Infra. n. 49.
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I find that, at times, Respondent's testimony was self-serving to
the point it denied belief. On cross examination, Respondent was asked
if a particular individual had ``obtained [Soma] from her daughter's
prescription, then she's obtained Soma in an unlawful manner,
correct?'' Tr. 1688. Respondent testified, ``[l]et's put it this way.
If it's a Soma, if you [are] so close to each other, it could be from a
liquid contamination to make her urine positive too.'' Id. When pressed
by the ALJ to explain how Soma could show up in your system ``[u]nless
you took the Soma tablet,'' Respondent said ``you could get
contaminat[ion] with the food or drop it somewhere.'' Tr. 1689. Dr.
Munzing's testimony completely discredited Respondent's suggestion of
``liquid contamination.'' Tr. 2066, 2118; Infra II.E.2.
Another area of Respondent's testimony that lacked credibility, as
the ALJ thoroughly assessed, was Respondent's testimony regarding his
recordkeeping, particularly how the patient records that were verbatim
for every visit were created. RD, at 216-224 (citing Tr. 1786-1804).
Specifically, the ALJ ``found that Respondent lacked candor in [the]
proceeding by his fallacious explanation for the verbatim repetition of
examination results throughout the medical records.'' RD, at 240.
Respondent testified that the records regarding the physical
examination remained the same for lengthy periods because Respondent
was doing the exact same examination of the patient from the prior
month. Tr. 1775-79, 1799-1801. Because the selections were the same,
according to Respondent, the records produced the same narrative. Id.
However, Respondent's version of events conflicts with Mr. Deshpande's
evidence showing that the examination results were copied forward and
further conflicts with Dr. Munzing's and Dr. Polston's testimony that
you would expect some visit to visit variability in the examination
even for patients with chronic pain. I agree with the ALJ and discredit
Respondent's testimony in this area.
Overall, I find credible those portions of Respondent's testimony
that were supported by the medical records, the expert testimony, and
the record as a whole. Where his testimony was inconsistent with the
record, I do not credit Respondent's testimony.
Dr. Polston testified regarding his professional and educational
background. Tr. 509-38; RX HHH (Curriculum Vitae of Dr. Polston); RD,
at 91-94. He graduated medical school from the University of Wisconsin
in 1989 and has been Board-certified in anesthesiology since 1999. Tr.
509-10, 519; RX HHH, at 2. He completed a fellowship in pain management
in 2001 and his practice has been limited to pain management since that
time. Tr. 513. His experience includes work as a private practice pain
physician with the Advanced Medical Centers of Alaska, a Clinical
Professor at the University of California San Diego, a Clinical
Director with the Center for Pain Medicine University of California San
Diego Medical Center, and a Clinical Director and a Clinical Professor
with the VA San Diego Medical Center. Id. Also, he has authored journal
articles and book chapters regarding pain management, has served on
numerous committees, and has received awards for his work as is set
forth in his Curriculum Vitae and in the RD. RX HHH, at 2-8; RD, 92-94.
Dr. Polston has been retained as an expert witness on behalf of
physicians approximately ten times, Tr. 535, and has assisted the MBC
in evaluating pain physicians since approximately 2010, Tr. 528. Dr.
Polston was accepted in this matter as ``an expert in the area of pain
management.'' Tr. 538.
The ALJ conducted a thorough analysis of Dr. Polston's credibility,
see RD, at 170-171, much of which I agree with. I agree that Dr.
Polston ``sometimes argued the position of his
[[Page 8043]]
sponsor in lieu of a direct response.'' \13\ RD, at 170. I agree that
Dr. Polston's professional experience with regard to pain management
was robust and that he appeared to have more hands-on professional
experience in the areas of downward titration and pain pump management
than Dr. Munzing.\14\ RD, at 167, 171. I disagree with the ALJ that Dr.
Polston ``offered credible detailed testimony relating to the specifics
of [Respondent's] treatment, prescribing and titration strategies.''
RD, at 170. Instead, I find that Dr. Polston's testimony lacked detail
and often took the specific facts of the case, excused gaps or filled
them with speculation, and then conclusively determined that the
standard of care was met without adequately explaining why.\15\ See Tr.
714-16, 756, 773. I find that Dr. Polston's testimony, while generally
credible, was not as thorough or as specific as Dr. Munzing's.
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\13\ For example, Dr. Polston testified that in the prior seven
years, he, himself, had not prescribed controlled substances to a
chronic pain patient on a regular basis above 800 MME. Tr. 703.
Right after this acknowledgment, the ALJ asked Dr. Polston, ``other
than palliative care, cancer patients, have you ever taken a patient
to 2,400 MME?'' Id. at 704. Dr. Polston evasively replied, ``That's
where I--that's where some of the caution that--that some of those
patients who have come in--they have come into my practice. And I
don't think that that is--at the--at those higher doses that I
would--would say that coming from before these documents came in,
and at the time when they came in, suddenly there was a lot of
physicians who stopped prescribing, and that they . . . taken them
off, and then we were faced with a lot of these kind of patients.''
Tr. 704. I found this testimony to be evasive and it caused me to
question Dr. Polston's objectivity.
Another example of evasiveness and inconsistency occurred
during Dr. Polston's testimony regarding whether it is outside of
the standard of care to repeatedly copy physical examination notes
from a prior office visit into physical exam notes for a current
office visit without performing a physical examination during the
current visit. See Tr. 717-23. Documentation of a physical
examination that did not occur seems to be patently false, yet Dr.
Polston evaded acknowledging this.
\14\ Ultimately, as explained herein, I did not find that
Respondent's titration schedule or use of pain pumps was in itself
outside the standard of care. Supra n. 7-8; infra n. 28, 49.
\15\ By way of one example, when asked if there was a physical
examination performed on patient B.G. regarding his MS during a
specific office visit, Dr. Polston answered ``[there is] a lot of
inference there. One that . . . there's no significant changes in
the physical exam since the last follow-up visit. The fact that he's
got good hygiene is telling me . . . that he's being cared for and
getting himself dressed.'' Tr. 773. Dr. Polston seems to be stating
that the note ``good hygiene'' was sufficient to satisfy the
physical examination requirement of the standard of care. Not only
is his opinion based on an ``inference,'' but Dr. Polston's
testimony reflects an extreme departure from Dr. Munzing's credible
testimony on what a physical examination requires. See infra.
II.D.2, II.E.1.
Additionally, when Dr. Polston testified about whether the
physical examination notes are simply ``cop[ied] forward'' from past
office visits, he stated, ``when I see a `just copy forward,' and I
see other changes, then I would say that I would think that most
physicians are doing . . . hopefully are doing the right things.''
Tr. 716. Again, Dr. Polston evaded the question and filled the gap
with an assumption.
---------------------------------------------------------------------------
The two experts were generally in agreement about the basic
elements of the standard of care in California. However, Dr. Polston
seemed to advocate for leniency in the standard of care when applied to
pain physicians, testifying that guidelines for prescribing opioids for
pain have been and are continuing to evolve, and that because of this,
``pain physicians, maybe, should be judged differently . . . [because]
across the country, [there is] a wide variance of how . . . opioids
are'' prescribed. Tr. 566-68.\16\ Dr. Polston rarely expanded upon the
text of the law and guidelines governing the standard of care in
California. In one place where Dr. Polston did expand--namely regarding
what constitutes a sufficient physical examination to satisfy the
standard of care in California, his testimony appeared to be in
conflict with the relevant guidelines. See infra II.D.2. and II.E.2.
With regard to recordkeeping, the ALJ found that ``Dr. Polston's
opinions had diminished reliability,'' because the ``testimony was
inconsistent with the relevant Guideline, was sometimes illogical, and
frankly, sometimes defied common sense.'' RD, at 171.
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\16\ The standard of care guidelines that are being relied upon
in this case explicitly state that they are the ``standard of care
in managing pain patients,'' and that physicians and surgeons are
expected to follow them. GX 17, at 59. I cannot see any
justification for carving out pain specialists who are managing pain
patients from its requirements. Notably, the MBC Guide to the Laws
states ``[i]n continuing care situations for chronic pain
management, the physician and surgeon should have a more extensive
evaluation of the history, past treatment, diagnostic tests, and
physical exam.'' GX 17, at 59. This suggests that Dr. Polston's
position of leniency is inconsistent with the standard of care. The
standard of care applied here is that standard of care that was in
place in the State of California at the time of Respondent's actions
as determined by the exert testimony and supporting literature. Any
differences in the standard of care that existed prior to or after
Respondent's actions are not relevant to this matter, nor is the
standard of care in other geographic locations.
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Ultimately, as addressed with more specificity in the Standard of
Care section below, I find that Dr. Munzing's testimony regarding the
standard of care was more detailed and more closely aligned with the
law and guidelines governing the standard of care in California.
Accordingly, I differ with the ALJ, and find generally overall, not
just on recordkeeping, that Dr. Munzing's testimony is more credible
than Dr. Polston's where the two experts offered different opinions.
D. The Standard of Care in the State of California
The parties seem to be largely in agreement as to the general
components of the standard of care in this case, that the standard of
care is primarily informed by California law and guidance, and that it
is primarily captured by a 2014 publication from the MBC entitled,
``The Guide to the Laws Governing the Practice of Medicine by
Physicians and Surgeons,'' (hereinafter, MBC Guide to the Laws). Tr.
266-67, 554-55, 567, 698; RD, at 168, 172-73; GX 17 (MBC Guide to the
Laws). Based on this publication and the entire record, I find that the
standard of care for managing pain patients in California requires: (1)
History and physical examination; (2) treatment plan objectives; (3)
informed consent; (4) periodic review; (5) consultation; and (6)
complete and accurate records. Tr. 270-87, 694-95; RD, at 31-32, 172-
73. Additionally, according to Dr. Munzing, there is a 2014 publication
from the MBC titled, ``Guidelines for Prescribing Controlled Substances
for Pain'' (hereinafter, MBC Guidelines for Prescribing). GX 18.
According to Dr. Munzing, this publication is ``not intended to mandate
the standard of care,'' but it provides examples of how the standard of
care captured in the MBC Guide to the Laws applies to the prescribing
of controlled substances for pain. Tr. 291-92, 567. Dr. Munzing
testified that the MBC Guidelines for Prescribing is ``a little bit
more expansive, but . . . in alignment with the [MBC Guide to the
Laws].'' Tr. 292. Additionally, in 2016, the Center for Disease Control
(hereinafter, CDC) issued ``Guidelines for Prescribing Opioids for
Chronic Pain'' (hereinafter, CDC Guidelines) which, according to Dr.
Polston, provide ``recommendations'' specifically for primary care
physicians, but that pain management ``[s]pecialists will take into
consideration all aspects in . . . the literature . . . and review
those documents.'' Tr. 550, 552; see also Tr. 1586.
1. Requirement To Keep Records
Dr. Munzing clearly testified that each element of the standard of
care ``must be documented in the medical records because [the
physician] may not be the only person managing that patient.'' Tr. 299.
Dr. Munzing testified ``[t]his patient may be seen by the emergency
room, may be seen by the primary care physician may be seen by other
sub-specialists, orthopedists, psychiatric
[[Page 8044]]
doctors.'' \17\ Id. at 299-300. Dr. Munzing further testified that if a
physician is not maintaining adequate and accurate medical records then
the physician is acting outside the standard of care. Id. at 301. Dr.
Polston agreed that ``[m]edical records are incredibly important for
physicians.'' Tr. 705.
---------------------------------------------------------------------------
\17\ According to Dr. Munzing, when prescribing high doses of
opioids, see infra II.D.3.a., the documentation should make ``very
clear that [the physician] understand[s] the added risks [of
prescribing over 80 MME] and . . . how [the physician] came to that
determination . . . knowing that [he or she is] putting the patient
at higher risk.'' Id. at 300.
---------------------------------------------------------------------------
Dr. Munzing's testimony is supported by the MBC Guide to the Laws,
which requires that the physician ``keep accurate and complete records
according to items above, including the medical history and physical
examination, other evaluations and consultations, treatment plan
objectives, informed consent, treatments, medications, rationale for
changes in the treatment plan or medications, agreements with the
patient, and periodic reviews of the treatment plan.'' \18\ GX 17, at
61; see also id. at 67. Additionally, the MBC Guide states that
``[d]ocumentation of the periodic reviews should be done at least
annually[;]'' and ``[p]ain levels, levels of function, and quality of
life should be documented. Medical documentation should include both
subjective complaints of patient and caregiver and objective findings
by the physician.'' Id.
---------------------------------------------------------------------------
\18\ Dr. Polston agreed that the MBC Guide to the Laws stated
this. Tr. 692.
---------------------------------------------------------------------------
Similarly, the MBC Guidelines for Prescribing explain that
for a physician treating a patient with opioids for chronic, non-
cancer pain, an adequate medical record includes, but is not limited
to, the documentation of: the patient's medical history; results of
the physical examination . . . ; patient consent; pain management
agreement; . . . description of treatments provided, including all
medications prescribed or administered (including the date, type,
dose and quantity); instructions to the patient, including
discussions of risks and benefits with the patient . . . ; results
of ongoing monitoring of patient progress (or lack of progress) in
terms of pain management and functional improvement; notes on
evaluations by, and consultations with, specialists; any 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 . . . ; . . . and results of
CURES/PDMP data searches.
GX 18, at 22.
Dr. Polston's opinion regarding the standard of care with regard to
recordkeeping was more focused on obstacles created by electronic
recordkeeping. See Tr. 619-21. Dr. Polston testified that through
``repopulation'' or copying and pasting, electronic records can ``make
clinic and visits more efficient.'' Tr. 527. However, he also
emphasized limitations in medical software because sometimes a
physician may not ``even attempt to copy it or however it was done, and
I see errors being repopulated.'' Tr. 615-16. He also explained that
some recordkeeping issues occur ``because the electronic record only
allows you to enter data in certain spots, and some of the electronic
record [do not] have the same amount of power or freedom to document
and change things.'' Tr. 616. Dr. Polston seemed to look at records in
totality, and seemed to find that here, where the conditions were
chronic, justification for a prescription on one date could justify
that same prescription on previous dates.\19\ Tr. 616, 618-19, 631,
716-17. Regarding recordkeeping, I find that Dr. Munzing's testimony is
more in line with California's law and guidance.
---------------------------------------------------------------------------
\19\ Dr. Munzing explicitly rejected the notion that something
documented later in time can justify what occurred prior in time and
testified; ``You have to treat a patient in real time. . . . You
have to document it [in] real time.'' Tr. 1233.
---------------------------------------------------------------------------
Based on the experts' testimony and California law and guidance, I
find that the applicable standard of care requires that a physician
collect a patient's history and perform a physical examination, create
treatment plan objectives, obtain informed consent, conduct a periodic
review, and consult with others when needed. The standard of care
further requires that the actions taken by the physician and
information obtained by the physician in completing each of the
standard of care requirements be accurately and completely recorded.
Tr. 287. The requirement that information be accurately and completely
recorded appears to apply equally to handwritten or electronic records.
Based on both Dr. Munzing and Dr. Polston's testimony and California
law and guidance, I find that accurate and complete records are an
important aspect of prescribing within the standard of care in
California.
2. History and Physical Examination
Dr. Munzing testified that obtaining a history and performing a
physical exam ``are critically important'' to get specific information
about the individual patient's pain, including the duration, location
and severity of the pain.\20\ Tr. 270. According to Dr. Munzing, the
history and exam are also necessary to determine the existence of
chronic illnesses, mental health disorders, or alcohol and drug use and
abuse. Id. Importantly, according to Dr. Munzing, ``[t]he physical exam
is important to find out specifically about if you can come up with the
most reasonable differential diagnosis or sometimes an exact
diagnosis.'' Tr. 270-71.
---------------------------------------------------------------------------
\20\ Dr. Polston cautioned that a patient's assessment of pain
``is a subjective response that . . . is very difficult . . . to
quantitate'' because patients are afraid that their medication will
be taken away ``[i]f they answer that they have too much pain . . .
[or] if they [do not] reflect pain.'' Tr. 817. Dr. Polston's
testimony demonstrates why a physical examination with objective
findings is important to complement subjective complaints of pain.
See GX 17, at 61.
---------------------------------------------------------------------------
Consistent with Dr. Munzing's testimony, the MBC Guide to the Laws
states that a ``medical history and physical examination must be
accomplished.'' GX 17, at 59; see also Tr. 271-72. ``This includes an
assessment of the pain, physical and psychological function; a
substance abuse history; history of prior pain treatment; as assessment
of underlying or coexisting diseases or conditions and documentation of
the presence of a recognized medical indication for the use of a
controlled substance.'' GX 17, at 59. Notably, the MBC Guidelines for
Prescribing state that ``[t]he complexity of the history and physical
examination may vary based on the practice location. . . . In
continuing care situations for chronic pain management, the physician
and surgeon should have a more extensive evaluation of the history,
past treatment, diagnostic tests, and physical exam.'' Id. See also, GX
18, at 54. Further, the requirement for a physical examination is
codified in California law. Cal. Bus & Prof. Code Sec. 2242(a) states
that it is unprofessional conduct to prescribe controlled substances
``without an appropriate prior examination and a medical indication.''
See also, Tr. 286.
The MBC Guide to the Laws also states the physician ``should keep
accurate and complete records . . . including the medical history and
physical examination.'' GX 17, at 61. It goes on to state that ``[p]ain
levels, levels of function, and quality of life should be documented.
Medical documentation should include both subjective complaints of
patient and caregiver, and objective findings by the physician.'' Id.
According to Dr. Munzing, the referenced documentation requirement
mandates that a physician keep progress notes or other ``documentation
verif[ying] what the history showed, what the exam showed . . . so one
can look at the documentation . . . and see how did the physician
decided that this is . . .
[[Page 8045]]
the right diagnoses or diagnosis.'' Tr. 272.
Dr. Polston agreed that there needs to be a physical exam to
prescribe within the standard of care. Tr. 694. However, he opined that
a physician can either perform a ``focused exam'' or can conduct an
examination ``just by looking at the patient and--and interacting. . .
.'' Tr. 618. According to Dr. Polston, ``physicians are conducting
exams just by interviewing and talking to a patient. We're always
looking at how [they are] walking, how [they are] . . . sitting, . . .
the degree of pain, . . . is it congruent with what [they are]
reporting?'' \21\ Tr. 718-19. Dr. Polston's latter definition of a
physical examination is inconsistent with Dr. Munzing's and I find Dr.
Munzing to be more credible. Dr. Munzing testified that the type of
information Dr. Polston described as an acceptable physical examination
is actually collecting information for the ``history of present
illness.'' See e.g. Tr. 1139-40. While collecting information regarding
the history of present illness is part of the standard of care, it is
separate and distinct from the physical examination requirement.\22\
Tr. 1143. According to Dr. Munzing, ``[t]he history of present illness
is not an exam . . . [it is] not actually examining the patient,
physically touching the patient, maneuvering the patient.'' Tr. 1143.
---------------------------------------------------------------------------
\21\ Elsewhere, Dr. Polston seemed to testify that how the
patient looks and talks is not a complete physical examination, but
only a part of the examination. See Tr. 730.
\22\ This distinction is also supported by the MBC Guide to the
Laws, which separates the history and presentation from the physical
examination, stating, ``[i]f a patient's request for opioid
medication for pain is inconsistent with the patient's history,
presentation, or physical findings, the physician may withhold the
medication but must document the reason for the decisions.'' GX 17,
at 59 (emphasis added).
---------------------------------------------------------------------------
I find that the applicable standard of care in California requires
a practitioner treating pain in chronically ill patients, to perform
and document an appropriate physical exam, including an assessment of
pain and physical and psychological function.
3. Treatment Plan Objectives
Dr. Munzing explained that the history and physical exam
requirements help a practitioner arrive at a diagnosis and that the
treatment plan is the ``assessment . . . based on what [a practitioner
has] determined is the diagnosis.'' Tr. 273. In addition, Dr. Munzing
explained that documentation is required ``[s]o one can look at the
documentation to . . . see how the physician decide[d] that this is . .
. the correct management plan, both initially [and on] an ongoing
basis.'' Tr. 272.
The MBC Guide to the Laws requires that the treatment plan ``state[
\23\] objectives by which the treatment plan can be evaluated'' such as
``control of pain, increase in function, and improved quality of
life.'' GX 17, at 59. ``Multiple treatment modalities and/or a
rehabilitation program may be necessary if the pain is complex or is
associated with physical and psychosocial impairment.'' Id. The MBC
Guidelines for Prescribing state that ``[p]ain relief is important, but
it is difficult to measure objectively. Therefore, it cannot be the
primary indicator to assess the success of the treatment. Effective
pain relief improves function, whereas addiction decreases
functionality.'' GX 18, at 13.
---------------------------------------------------------------------------
\23\ I find that the reference to what the treatment plan should
``state'' is a clear indication that the treatment plan must be
documented as is also indicated by Dr. Munzing's testimony.
---------------------------------------------------------------------------
a. Treatment Plans With >80 MME Prescribed
According to Dr. Munzing, morphine milligram equivalent
(hereinafter MME) is a term reflecting the ``common platform [used]
when looking at . . . the strength of opioid treatment.'' \24\ Tr. 294-
94. In California, according to Dr. Munzing, there is a ``yellow flag
warning'' meaning that physicians ``should be concerned if the total
dosage for a day is 80 milligrams or higher . . . [and] proceed
cautiously. Referral to an appropriate specialist should be considered
with higher doses.'' Tr. 296. Dr. Munzing explained that ``as one goes
higher on the MED or MME[ \25\], the . . . risk of the medication
increases.'' Tr. 296. The risk increases at higher MME levels
``regardless of how long'' a patient has been prescribed opioids,
although for patients on long-term opioids ``the risk probably is
somewhat less.'' \26\ Tr. 296-97. Dr. Munzing explained that the
``yellow flag warning'' applies equally to pain specialists, because
``the medication is [what is] putting the patient at risk . . . it
[does not] change based on the letters at the end of the name of the
person prescribing.'' Tr. 298. According to the CDC Guidelines,
``prescriptions opioid-related overdose mortality rates rose rapidly up
to prescribed doses of 200 MME/day, after which the mortality rates
continued to increase but grew more gradually.'' GX 19 (CDC
Guidelines), at 15; see also Tr. 306.
---------------------------------------------------------------------------
\24\ For additional information on how the MME is calculated,
see Tr. 311-16; GX 21 (Publication by Centers for Medicare &
Medicaid Services); GX 22 (Publication by Centers for Disease
Control & Prevention).
\25\ Dr. Munzing testified that morphine milligram equivalent or
MME and morphine equivalent dose or MED have ``identical'' meanings
and the two phrases are used interchangeably throughout the record.
Tr. 295.
\26\ Dr. Munzing explained that there are no studies that look
at the effects of a patient who is on, for example, ``300 [MME] for
3 months as opposed to a year,'' and they are ``not going to do that
study because of the inherent risks to patients.'' Tr. 297.
---------------------------------------------------------------------------
Dr. Munzing clarified that despite the ``yellow flag warning . . .
there are times when the indications are there and you weigh the
potential benefits with the potential risks and one decides that . . .
the potential benefits far outweigh the risks and you can proceed at
higher amounts.'' Tr. 298. Dr. Munzing testified that there is no cap
on the level of MME/day that can be prescribed, but as the dose and
``risk significantly goes up . . . one needs to justify'' the
prescribing. Tr. 308-09. Dr. Polston likewise explained that the intent
of the CDC Guidelines was not to set 50 or 90 MME as ``hard limits''
and agreed that ``when patients come to a physician already on high
doses of opioids, it is permissible to continue on those doses if the
doctor believes it is appropriate.'' Tr. 558, 564.\27\
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\27\ I conclude based on the testimony of both of the experts in
this case that the Government has not presented substantial evidence
of a MME ceiling above which a prescriber would be per se in
violation of the standard of care for prescribing controlled
substances. Accordingly, if the intent of the Government's
allegations regarding prescribing over 90 MME was that any such
prescribing per se violated the standard of care, such an inference
is unsupported by the record and is not sustained. See RD, at 178-
83. However, the Government has presented substantial evidence that
controlled substance prescriptions must be justified. Tr. 281 (Dr.
Munzing testified ``California . . . says that the prescribing must
be justified. It has to be in the usual course of professional
practice.''). Accordingly, where the evidence in the case
established that controlled substance prescribing was not justified
by appropriate documentation in the medical records, I have found
that the Government established a violation of the standard of care.
Dr. Munzing testified that, particularly for B.G. and E.N., the
documentation in the medical record did not come anywhere close to
justifying the ``extraordinarily high'' levels of opioids Respondent
prescribed. Tr. 389, 433-34, 912-13; infra II.E.1, II.E.3.
---------------------------------------------------------------------------
However, the fact that a patient was already on high doses of
controlled substances, alone, is not sufficient justification to
continue prescribing at that level. Tr. 1217-18. According to Dr.
Munzing, physicians who inherit patients on high levels of MME have an
obligation to attempt to try alternatives, whether alternative forms of
treatment or prescribing lower doses, to ``decrease the risk of the
patient while still certainly making every attempt to decrease pain,
improve activity.'' Tr. 1277, 1275, 2040-43.
Dr. Munzing explained that when prescribing opioids, it is
important to ``titrate up, so slowly adjust up or titrate down, slowly
adjusting'' the doses. Tr.
[[Page 8046]]
307; see also Tr. 700. Dr. Munzing agreed that titration is ``an
individual process that differs for each patient,'' and there are no
``evidence-based guidelines . . . that say, `This is the best way now.'
'' \28\ Tr. 2091, 2071. Even so, according to Dr. Munzing, it is
important to ``come up with a game plan . . . In one month, [we are]
going to go down X amount. The next month, [we are] going down X
amount. And then you may need to alter that over the way.'' Tr. 2044.
Dr. Polston further testified that the literature ``does not support
abrupt tapering or sudden discontinuation of opioids,'' which can
``cause health risk for patients.'' Tr. 558, 563; GX 19.
---------------------------------------------------------------------------
\28\ Both experts testified that there is not a firm titration
schedule that could be used to evaluate whether the applicable
standard of care is met. Accordingly, to the extent that the
Government intended to charge that the percentage of titration up or
down for any given prescription or that the titration schedule for
any particular individual was outside the standard of care, those
charges are not supported by the record here. See RD, at 183-87.
However, the Government has established that the standard of care
requires documentation of a treatment plan, which includes a
creation of and documentation of the titration strategy the
physician is using--those allegations are addressed below. See e.g.
infra II.E.1.
---------------------------------------------------------------------------
b. Prescribing Opioids and Benzodiazepines
Dr. Munzing testified that before opiates and benzodiazepines are
prescribed together, there should be an attempt to ``mitigate'' the
risks to the patient and ``try alternative methods that [are] safer.''
Tr. 388. According to Dr. Munzing, healthcare practitioners, including
specialists, are bound by the guidance, which states that practitioners
``should limit prescribing opioid pain medicines with benzodiazepines
or other CNS [(central nervous system)] depressants only to patients
for whom alternative treatment options are inadequate. If these
medicines are prescribed together, [practitioners should] limit the
dosages and duration of each drug to the minimum possible while
achieving the desired clinical effect.'' \29\ GX 20, at 1; see also Tr.
318-19. This is because, according to Dr. Munzing and the FDA Drug
Safety Communication located at GX 20, ``the co-prescribing of opioids
and benzodiazepine medications'' presents a ``serious risk of death.''
Tr. 317. Similarly, Dr. Polston testified that there is ``increased
risk when you use benzodiazepines . . . with opioids.'' Tr. 662.
---------------------------------------------------------------------------
\29\ The FDA Communication also requires additional warnings be
given for informed consent. It states that practitioners should
``[w]arn patients and caregivers about the risks of slowed or
difficult breathing and/or sedation, and the associated signs and
symptoms.'' GX 20, at 1.
---------------------------------------------------------------------------
4. Informed Consent
With regard to informed consent, Dr. Munzing testified that the
standard of care requires a practitioner ``to go through the risks, the
benefits, and the alternatives.'' Tr. 273. Dr. Munzing's testimony is
supported by the MBC Guide to the Laws which states that ``[t]he
physician and surgeon should discuss the risks and benefits of the use
of controlled substances and other treatment modalities with the
patient, caregiver, or guardian.'' GX 17, at 60. ``A written consent or
pain agreement for chronic use is not required but may make it easier
for the physician and surgeon to document patient education, the
treatment plan, and the informed consent.'' Id.
Dr. Polston testified that the patient medication agreements and
consent forms found throughout the record, standing alone, are
sufficient ``documentation of discussions [regarding what] the risks
and benefits of the medication were'' to satisfy the standard of care
regarding informed consent. Tr. 609-10. There was limited, if any,
evidence presented by the Government regarding whether the patient
agreements alone were sufficient to satisfy the informed consent aspect
of the standard of care. Here, Respondent's records contained patient
agreements for each individual at issue in this case. Accordingly, I
cannot find that Respondent violated the informed consent requirements
in the standard of care for these individuals.
5. Periodic Review
According to Dr. Munzing, periodic review for patients with chronic
pain conditions requires ``checking periodically to see how [they are]
doing: Are they getting better with your management? Are they getting
worse? Are they having side effects from your . . . management? Are
there alternatives that may be safer, may be better? And so looking
over time, re-examine them. Is there something new in . . . the medical
community that might benefit this person?'' Tr. 274. Periodic reviews
are necessary, according to Dr. Munzing, because ``pain, especially
chronic pain, usually does not stay exactly the same. It waxes and
wanes . . . it may be better one day, worse one day . . . [it is]
infrequent that every single day is exactly the same.'' Tr. 274.
Dr. Munzing's opinion is supported by the MBC Guide to the Laws,
which states ``[t]he physician and surgeon should periodically review
the course of pain treatment of the patient and any new information
about the etiology of the pain or the patient's state of health.
Continuation or modification of controlled substances for pain
management therapy depends on the physician's evaluation of progress
toward treatment objectives. If the patient's progress is
unsatisfactory, the physician and surgeon should assess the
appropriateness of continued use of the current treatment plan and
consider the use of other therapeutic modalities.'' GX 17, at 60.
``Patients with pain who are managed with controlled substances should
be seen monthly, quarterly, or semiannually, as required by the
standard of care.'' Id.
It is clear throughout the record that the ``periodic review''
portion of the standard of care also includes monitoring the patient.
Both experts referenced the ``four As'' as part of monitoring. The 4As
are: ``analgesia, activities of daily living, adverse side effects,
aberrant drug taking behaviors.'' Tr. 357, 608-09. While it is clear
that there is no set formula for monitoring an individual patient, some
of the tools physicians can use include, looking for compliance with
the pain agreement, running CURES reports, requiring urine drug
screens, checking respiration rate and O2 levels, and using an opioid
risk tool. See Tr. 604, 684. ``Monitoring can take many forms,
including regular visits, . . . updated histories, updated
examinations[,] . . . urine drug tests, CURES reviews[,] . . . pill
counts to ensure that [they are] taking what [they are] prescribed and
not taking potentially things that [you are] not prescribing.'' Tr.
299.
Dr. Munzing described a red flag as anything that comes up while
monitoring ``that catches your attention that says that this could be a
problem.'' Tr. 321. It could be laboratory results, certain symptoms,
something in the CURES database, or a wide variety of things. Id.
According to Dr. Munzing, red flags require a practitioner to
``investigate further,'' take appropriate action ``determined by what .
. . you found,'' and then ``all of that needs to be well-documented in
the chart so if someone else . . . can look at [the] records and go,
okay. He did this. He resolved that. It doesn't appear to be a
problem.'' Tr. 323-24.
Dr. Polston, used the term ``red flag'' in a different way that Dr.
Munzing. Dr. Polston differentiated, albeit imprecisely, between
``yellow flags'' and ``red flags'' and referred generally to ``aberrant
behavior.'' Tr. 799-800. Dr. Polston described a ``red flag'' as a
``severe deviation from the opioid agreement'' that requires immediate
action or even termination of care. Tr.
[[Page 8047]]
799-800, 802. Dr. Polston testified that regardless of ``whether [it
is] a yellow flag, a red flag, or any kind of aberrant behavior, we
would hope that [it is] recorded and [there is] some type of medical
reasoning applied as to how [you are] interpreting that particular
event.'' Tr. 800. He went on to testify ``that when you see something
that is considered aberrant in the sense that [it is] not [what is]
intended or shows signs of misuse or abuse, the . . . statute said that
that needs to be addressed. . . . Simply recording . . . that you [do
not] think that [the aberrancy] is significant or . . . [filing] that
as the first offence . . . in some ways resolv[es] that. . . . ``[I]f
other minor infractions keep occurring, that . . . [would] need[ ] to
be recorded and . . . show justification of why [you are] continuing
therapy for the patient.'' Tr. 801.
It appears that what Dr. Munzing refers to as a red flag
encompasses all of the various aberrancies identified by Dr. Polston.
Accordingly, the terms red flag and aberrancy appear interchangeably
throughout the record. Regardless of the terminology, both experts seem
to agree, and I find, that the applicable standard of care requires
that red flags or aberrancies be investigated and that the results of
that investigation be documented in the record.
a. Periodic Review With >80 MME Prescribed
Dr. Munzing particularly stressed the importance of monitoring for
patients that are on opioids, and stated that a practitioner needs to
``intensely monitor'' the patient when prescribing more than 80-90 MME
a day. Tr. 209. Dr. Polston likewise testified that ``[there are] more
things [to be] concerned about at higher doses'' of opioids and agreed
that there are ``more things [you are] tracking to ensure that the
patient's health and safety [is not] at risk.'' Tr. 768.
6. Consultation \30\
---------------------------------------------------------------------------
\30\ Although consultation is not a primary issue in this case,
I am including this discussion as helpful in fully understanding the
applicable standard of care for prescribing in California. See also,
infra II.E.
---------------------------------------------------------------------------
According to Dr. Munzing, consultation is the requirement that
physicians work ``much more in collaboration with each other,
especially with chronic conditions.'' Tr. 276-77. Dr. Munzing stated
that when ``managing a patient who is not getting better over time or
getting worse, [a physician should] seek consultation with'' a
specialist or a colleague for a ``second opinion.'' Id. The MBC Guide
to the Laws similarly explains that the standard of care requires
physicians to ``consider referring the patient as necessary for
additional evaluation and treatment in order to achieve treatment
objectives.'' GX 17, at 60. Additionally, the Guide notes that
``physicians should give special attention to those pain patients who
are at risk for misusing their medications including those whose living
arrangements pose a risk for medication misuse or diversion.'' Id.
Notably, the MBC Guide to the Laws states that ``[c]oordination of care
in prescribing chronic analgesics is of paramount importance.'' Id.
E. Patients
1. Patient B.G.
By way of background, B.G. was first seen by Respondent on August
12, 2013, for ``pain management consultation.'' GX 8 (Medical Records
for B.G.), at 1064. During that office visit, B.G. reported that he had
``been under care of Dr. [M] for pain management for 10 years. He is on
high dose of Methadone 240 mg per day. He gets 720 pills per month in
the last 7 years.'' Id. There are no records in the patient file
reflecting Dr. M's care of B.G., but Respondent testified that he
unsuccessfully attempted to get those records.\31\ See generally GX 8;
Tr. 341-42, 1449-50. At that time, B.G. complained of low back and leg
pain. GX 8, at 1064. The records reflect a note from Respondent
stating, ``I [Respondent] told him that he needs a primary care
physician [for] his regular medical conditions. And a neurologist for
MS in his care. Otherwise, I would not take over his care.'' Id. at
1067.
---------------------------------------------------------------------------
\31\ In his fourth exception, Respondent alleges that the ALJ
erred by including Respondent's failure to document a discussion
with Dr. M as an example of a deficient medical record because Dr.
M's died before Respondent took over care of B.G. ALJX 28, at 13. I
agree with Respondent on this issue and do not consider Respondent's
inability to discuss prior care of B.G. with Dr. M or his inability
to obtain records from Dr. M as rendering the relevant prescriptions
outside the standard of care.
---------------------------------------------------------------------------
Dr. Munzing testified that between February 14, 2017, and October
3, 2019, Respondent issued forty-three controlled substance
prescriptions to B.G. outside the usual course of professional practice
and beneath the standard of care in California. Tr. 421-22, 945; GX 24
(Chart of Prescriptions Reviewed by Dr. Munzing), at 1. The
prescriptions included prescriptions for Dilaudid 4 mg. ranging from 60
tablets in February 2017 to 30 tablets in August 2017 when the
prescription discontinued; Valium 10 mg. ranging from 90 tablets in
February 2017 to 45 tablets in October 2019; and Methadone 10 mg.
ranging from 600 tablets in February 2017 to 215 tablets in October
2019. GX 24, at 1. During the relevant period Respondent, as the expert
witnesses testified, reduced the prescribed controlled substances'
overall quantity of opioids from an ``astronomically high'' 2432 MME
per day, Tr. 387-88, to 1720 MME per day, Tr. 441 and GX 24, at 1, and
his function improved, Tr. 1099, 1191.\32\ Dr. Munzing opined that
Respondent failed to satisfy the standard of care with regard to
performance of physical examinations, treatment plans, periodic review
and monitoring, and recordkeeping.
---------------------------------------------------------------------------
\32\ Dr. Munzing explained that this sort of MME reduction
decreases the risk to the patient, Tr. 874, but the MME is still
high (in fact, ``anything over 120 MME is high dosage'' Tr. 304),
``and the prescriptions are not medically justified.'' Tr. 389; see
also id. at 309, 1216-17.
---------------------------------------------------------------------------
Dr. Munzing testified in great detail regarding why the February
14, 2017 prescriptions were issued outside the standard of care.
According to Dr. Munzing, none of the medical records between October
24, 2013, and February 14, 2017 ``confirm that there was [a physical]
exam performed.'' \33\ Tr. 379. Dr. Munzing testified that a standard
physical examination of a back that a pain specialist should perform
consists of ``observation, . . . touching the back, range of motion,
reflexes.'' Tr. 373. The physical examination notes on February 14,
2017, state:
---------------------------------------------------------------------------
\33\ Dr. Polston did not definitively testify regarding whether
during B.G.'s October 24, 2013 office visit, the records documented
a physical examination related to B.G.'s MS, but instead testified
``[there is] a lot of inference there'' such as ``good hygiene.''
Tr. 773.
Review: No significant changes noted in the patient's physical
examination in this follow-up visit.
General: The patient is well developed and well-nourished.
Patient is alert and oriented. He is in no acute distress. Patient
has good hygiene.
Cardiovascular: Cardiovascular examination revealed regular rate
and rhythm. No murmurs auscultated. There is no evidence of pedal
edema.
Abdomen: Not an obese person. The abdomen is soft, with no
masses palpated, no rebound, rigidity or tenderness.
Neurology-Coordination: Diadochokinesia is found to be normal.
Finger-to-nose testing is normal. Antalgic. The patient is unable to
do heel walk. The patient was unable to do toe walk.
Gait: He is on W/C.
GX 8, at 629 (emphasis removed from original). According to Dr.
Munzing, this medical record has ``very little there'' and ``no
documentation of any musculoskeletal exam, arm, leg, back, which were
the areas that were
[[Page 8048]]
complained at.'' \34\ Tr. 379-80. The records confirm Dr. Munzing's
testimony. Dr. Polston did not testify specifically regarding the
sufficiency of the physical examinations of B.G., but did testify
generally that ``[a]ll records show appropriate medical histories and
examination treatment plans.'' Tr. 684. I credit Dr. Munzing's more
specific opinion that this record did not document an adequate physical
examination of B.G.
---------------------------------------------------------------------------
\34\ Dr. Munzing testified there is ``no mention of the arms . .
. [no] mention [of] anything specific about the legs other than he
cannot do a heel or toe walk . . . no listing of the back.'' Tr.
384. In short, Dr. Munzing opined that the performance of the
physical examination, assuming it was performed as documented, was
still outside the standard of care for the patient. Id.
---------------------------------------------------------------------------
In addition to not covering the areas where B.G. complained of
pain, the exam notes were ``always the same.'' Tr. 379. I credit Dr.
Munzing's testimony that in complying with the applicable standard of
care pain management physicians should see ``some visit-to-visit
variability.[ \35\] So you might have two visits that might be
identical. But over three-and-a-half years, [it is] not going to be
identical.'' Tr. 380. According to Dr. Munzing, ``when you look at the
medical records . . . there really is no evidence that there is an
examination that verifies that this patient is in agony and extreme
pain, certainly from an exam standpoint.'' Tr. 388.
---------------------------------------------------------------------------
\35\ Dr. Polson's testimony on cross-examination seemed to
agree.
Q Do you typically see even for chronic pain patients over time,
some change in their medical condition?
A Somewhat. Some--sometimes not always.
. . .
Q And even if you were conducting the same physical examinations
month after month, you would occasionally see for some variance in
the results?
A Yes.
Tr. 717.
---------------------------------------------------------------------------
Dr. Munzing went on to testify that the remaining relevant
prescriptions issued between March 14, 2017, and October 3, 2019, were
issued outside of the standard of care for the same reasons as the
February 14, 2017 prescriptions. Tr. 405, 407, 409, 411, 415, 433, 438,
444. With regard to the mostly identical physical examination results,
Dr. Munzing's testimony is supported by Mr. Deshpande, who testified
that from February 14, 2017, to May 8, 2018, twenty-one physical tests
\36\ of B.G. were copied forward verbatim from prior medical visits
without any new information being added. Tr. 1920-22; GX 29b (Bizmatics
Subpoena Response), at 4-5. Eight physical tests were added on May 8,
2018, and then all twenty-nine of those physical tests were copied
forward verbatim until October 3, 2019. Id. Additionally, Dr. Munzing
clearly testified that even on the occasions where more information was
added, the records did not contain sufficient documentation to justify
the high dosages of controlled substances prescribed; therefore, the
prescriptions remain outside the standard of care. Tr. 438-39. He
stated, ``we have just a long cascade of exams that by and large have
been copy with slight variation at times . . . we're still over 2,000
methadone equivalent . . . combination with an opiate which still puts
the patient at very significant risk and again, if you look at the
medical records, the medical records certainly don't verify and support
a prescription at that extreme.'' Tr. at 433-434.
---------------------------------------------------------------------------
\36\ Mr. Deshpande testified that ``the number of physical tests
copied refers to the discrete number of questions or tests or
bullets that are part of the physical exam section that got copied
from the previous visit to this visit.'' Tr. 1911.
---------------------------------------------------------------------------
Dr. Munzing opined that the prescriptions were also beneath the
standard of care with regard to the documentation of treatment plan
objectives. He testified that for the February 14, 2017 prescriptions,
the ``total opiate dosage [was] extremely high [at 2,432 MMEs],
astronomically high'' given the lack of ``an examination that verified
that this patient is in agony and extreme pain.'' Tr. 387-88. Dr.
Munzing opined that he ``[did] not see anything in the records that
would justify medications anywhere in this range.'' Tr. 389. Moreover,
there is a ``combination of an opiate and benzodiazepine,'' but
``[t]here does not appear to be anything [that is] being done to
mitigate this and to try alternative methods that were safer.'' Tr.
388. Dr. Munzing repeated these concerns in support of his opinion that
the remaining relevant prescriptions between March 2017 and October
2019 were outside the standard of care. Tr. 405, 407, 409, 411, 415,
433, 438, 444.
Dr. Munzing also opined that the treatment plan lacked clarity as
to what conditions Respondent was using controlled substances to treat.
Dr. Munzing testified regarding this confusion, ``are we treating
lumbar pain, are we treating . . . multiple sclerosis pain, or [are]
you treating both? And . . . muscular sclerosis pain . . . typically
[does not] respond nearly as well to opiates as with other medications
that are focused on neuropathic pain.'' Tr. 390. This confusion is
further heightened by the Valium prescription, because, as he
explained, Valium, generically diazepam, is ``a longer acting
benzodiazep[ine] and which makes it many times more risky because it
stays in your system longer. [It has] been used for anxiety, [it has]
been used sometimes for muscle relaxation.'' Tr. 391. Dr. Munzing
confirmed that it is ``dangerous to prescribe Valium with opioids.''
Tr. 392.
According to Dr. Munzing, there is no real indication in B.G.'s
early medical records that Respondent was treating B.G. for his MS and
there is no indication of the purpose of the Valium prescription.\37\
Dr. Munzing testified that the initial exam lacked details regarding
the history of the multiple sclerosis condition and lacked
``information that one would expect if [Respondent was] going to take
over management of that condition.'' Tr. 342-43. According to a medical
record dated March 16, 2016, B.G. reported to another medical provider,
Dr. P., that he was taking Valium for ``irritability and depression,''
not for spasticity. GX 8, at 913. It was not until July 14, 2017, that
the medical records include a note stating, ``Valium 10 mg tid x 45 for
spasticity,'' with spasticity being an apparent reference to one of
B.G.'s multiple sclerosis symptoms.\38\ GX 8, 485; Tr. 416. But even
with the July note, according to Dr. Munzing, it was not clear that
Respondent was treating B.G.'s multiple sclerosis because the
neurological examination was insufficient to support the
prescription.\39\ Tr. 417. Dr. Polston was also left to speculate
regarding the Valium's purpose in the beginning, stating ``I think [it
is] pretty much for anxiety and depression, but [B.G.] also [has] prior
multiple back surgeries and spasms would not be irrelevant here.'' Tr.
782; see also 818.
---------------------------------------------------------------------------
\37\ The ALJ found that ``the failure to timely document that
[Respondent] was prescribing Valium to B.G. for spasticity
represents a violation of the California standard of care relating
to complete and accurate recordkeeping.'' Tr. 207. I agree.
\38\ In his Exceptions, Respondent argued that the medical
record has enough information generally to determine that the Valium
prescription was issued for spasticity prior to the 2017 medical
note. I find this argument to be without merit particularly because
the lack of clarity in the medical records left both Dr. Munzing and
Dr. Polston unsure of the exact purpose of the Valium prescription
until July 2017. Additionally, Respondent argued that ``there is no
nexus between the alleged failure to timely document the reason for
. . . [the] Valium, and the stated goals of the DEA to avoid
diversion.'' ALJX 30, at 13. I also find this argument, which is
based on a misunderstanding of the meaning of ``diversion,'' to be
without merit for the reasons set forth in infra, n.62.
\39\ Put another way, even though the purpose of the Valium
prescription is known by July 14, 2017, the subsequent Valium
prescriptions remain outside the standard of care for Respondent's
failure to perform a proper physical examination. Supra.
---------------------------------------------------------------------------
Dr. Munzing explained that, while Respondent reduced B.G.'s opioid
dosages, he did not document a
[[Page 8049]]
treatment plan for so doing. On February 14, 2017, the first set of
prescriptions for the relevant time period, Respondent prescribed B.G.
dilaudid 4 mg, 60 tablets; Valium 10 mg., 90 tablets; and methadone, 10
mg. 600 tablets. GX 24, at 1. Monthly from March 2017 through and
including August 2017, Respondent prescribed B.G. dilaudid 4 mg, 30
tablets; Valium 10 mg., 45 tablets; and methadone, 10 mg. 300 tablets.
Id. For the prescriptions between March 2018 and October 2018,\40\ the
dilaudid prescription was discontinued, Valium 10 mg. stayed constant
at 45 tablets, and methadone 10 m.g. reduced gradually from 270
tablets, to 250, to 230, to 225, and finally to 215. Id. Dr. Munzing
testified that early in B.G.'s treatment, Respondent had an obligation
to ``come up with a management strategy to mitigate the risks, to
decrease the risks, to bring [the high doses] down,'' it cannot be
``haphazard.'' Tr. 2041, 1072. Here, Dr. Munzing testified, ``there was
an initial drop, and then it was kept stable for an extended period of
time.'' Tr. 2045. ``Rather than we'll drop it a little bit, and then
continue for six months,'' Dr. Munzing testified, Respondent needed to
``come up with a game plan . . . whether it be a three-month, a six-
month plan of action, and then it may need to be tweaked along the way
. . . or alter[ed].'' Tr. 2044. Respondent's Exhibit SS, a California
Department of Public Health note to providers, confirms Dr. Munzing's
testimony about the need for a plan and states, with regard to tapering
patients on opioids, that physicians should ``[e]nsure patients
understand the risks and benefits of dose maintenance versus dose
tapering and develop an individualized plan in collaboration with
patients.'' RX SS, at 2. According to Dr. Munzing, while the record
occasionally documents that Respondent discussed tapering, Tr. 2098, it
does not document what specifically was discussed. And there is no
documented individualized treatment plan of action for reducing the
controlled substance dosage in the records for B.G. between February
2017 and August 2017. GX 8. For example, between the February 2017
visit and the March 2017 visit, the quantity of all controlled
substance prescriptions was cut in half without any explanation for the
reduction; both medical record records simply stated ``[p]atient to
continue on current medication regimen.'' GX 8, at 625. Beginning in
December 2017, Respondent documents a plan to ``bring down [Methadone]
5-10 tabs per visit'' and that plan appears in the records through
October 2019. GX 8, at 359; GX 9, at 2-6. Accordingly, I find in
accordance with Dr. Munzing's testimony, that the failure to document a
treatment plan for the reduction of controlled substance prescribing
between February 2017, and August 2017, was outside the standard of
care.
---------------------------------------------------------------------------
\40\ The prescriptions between August 2017 and March 2018 were
not identified as being at issue in this case. Id.
---------------------------------------------------------------------------
Dr. Munzing also explained that where Respondent did create what
could be considered a treatment plan for B.G., he did not always follow
it. He testified that, at Respondent's initial visit with B.G., he
documented that he would not treat B.G. without him having a
neurologist to manage the MS. Tr. 1067. On February 19, 2018, the
medical records prepared by a different provider state that B.G. ``has
been on valium tid[ \41\] for several years for spasticity of the LE.
Discussed today with [Respondent], who states that because this is a
PMR practice we will continue to prescribe this with the patient's
opioid pain medications provided that the patient bring[s] an annual
note from neurologist or neurosurgeon who currently sees him for MS if
the valium continues to be recommended.'' \42\ GX 8, 306. Again, the
Valium continued to be prescribed throughout the relevant period even
though Dr. Munzing agreed that he did not see notes from a neurosurgeon
or neurologist appear in B.G.'s records at any time. Tr. 427, see also
1728-35. Respondent himself testified that despite the note written by
his nurse practitioner, which Respondent admitted ``[he] missed,'' he
``do[es] not require neurology . . . [because] [he is] more specialized
than regular neurology to manage spasticity.'' Tr. 1739. This testimony
directly conflicts with Respondent's initial medical record for B.G.,
which stated that if B.G. did not see a neurologist for his MS,
Respondent ``would not take over his care.'' GX 8, at 1067. Notably,
Dr. Polston testified that he ``would insist'' that a pain patient with
MS see a neurologist. Tr. 772. Even if Respondent did not make that
note as he contests, it appeared in his treatment plan. Regardless of
whether or not a neurological consultation was required, it is clear
that the treatment plan is not clearly or consistently documented.
---------------------------------------------------------------------------
\41\ Dr. Munzing testified that ``tid'' means three times a day.
Tr. 424.
\42\ The record goes on to state ``[d]iscussed this with patient
who is upset he needs this note when previously neuro input was no
required. Discussed the latest opioid guidelines and the potential
for additive respiratory depression when benzodiazepines and opioids
are taken together. He verbalized understanding, states he was
previously on an additional benzodiazepine for anxiety and this was
stopped.'' GX 8, at 306.
---------------------------------------------------------------------------
Furthermore, Dr. Munzing opined that Respondent's records for B.G.
were beneath the standard of care regarding the requirement to conduct
periodic review and monitoring. Dr. Munzing repeatedly criticized that
Respondent put ``[B.G.] at significant risk'' by prescribing ``high
doses'' of opioids in ``combination with a benzodiazepine'' without any
evidence of ``attempting alternative medication that would be less
risky.'' Tr. 439, see also 434. Moreover, an office visit note for May
31, 2016, stated ``[t]he pt say Dr. [P], psych. About a couple of weeks
ago, report is recommending to continue Opioid Medications and taper
off benzos.'' GX 8, 797. Tr. 427-28. Dr. Munzing testified that Dr. P's
recommendation is a red flag and that the standard of care required
that Respondent resolve the red flag and document the resolution, which
was not done here. Tr. 359. Additionally, Dr. Munzing testified that
the notation regarding Dr. P's recommendation continued to be pasted in
the medical record until July 14, 2017, yet Respondent never documented
a resolution of the red flag and continued prescribing the valium
without change. Tr. 363, 368, 385, 402, 413-14. Dr. Munzing testified
that on April 29, 2019, when B.G. stated that he ``[could not] live
without Valium,'' it presented yet another red flag, and that
Respondent needed to ``explore'' whether that statement meant that
B.G.'s ``condition is such that he needs it'' or whether he is ``so
dependent on it that if he stops it, he has some symptoms [of]
withdrawal.'' Tr. 439; GX 8, at 12.
I note that the record contains many examples of appropriate steps
that Respondent took to monitor B.G. including running CURES reports,
requiring urinary drug screens, requiring regular follow-up
appointments, and administering the opioid risk tool questionnaire;
\43\ Respondent also referred B.G. to a cardiologist and to a pain
psychologist.\44\ Tr. 664, 1086, 1094, 1097-98. However, Dr. Munzing
testified that ``[s]olely that the fact that [they are] doing urine
drug screens and a CURES reports, those alone without the other
components . . . [do not] provide medically a justification for
prescribing.'' Tr. 422. There were also
[[Page 8050]]
additional inaccuracies with B.G.'s patient record. For example, on
June 15, 2017, the medical records for B.G.'s office visit on that date
do not include a prescription for Valium, GX 8, at 529, when Valium was
in fact prescribed, id., at 524. Tr. 408-09. The impact of this
inaccuracy is amplified due to the dangers presented by Respondent's
prescribing of Valium, a benzodiazepine, concurrently with opioids. See
supra II.D.3.b. Also, back in August 2013, during the initial
evaluation, Respondent noted that, ``[B.G.] gets 720 pills per month in
the last 7 years.'' GX 8, at 1064. This note was repeated verbatim
throughout Respondent's treatment of B.G. up-to-and-including the last
relevant record dated October 3, 2019. GX 9 (Medical Records for B.G.),
at 18). According to Dr. Munzing, while this statement may have been
accurate in 2013, Tr. 339, once it got carried over ``year after
year,'' it was no longer accurate and created an internal inconsistency
within the records. Tr. 332.
---------------------------------------------------------------------------
\43\ Dr. Munzing and Dr. Polston both testified that these are
appropriate tools to use for monitoring. See e.g. Tr. 605, 664,
1023, 1097-98.
\44\ Though, as addressed herein, Respondent did not resolve the
red flag arising from the pain psychologist's recommendation to
taper off benzos. Tr. 1086-89.
---------------------------------------------------------------------------
In accordance with Dr. Munzing's testimony and the record as a
whole, I find that, the forty-three relevant prescriptions issued to
B.G. for methadone, dilaudid, and Valium between February 14, 2017, and
October 3, 2019, were issued outside of the usual course of
professional practice and beneath the applicable standard of care in
California. Particularly, in accordance with Dr. Munzing's testimony,
the relevant prescriptions were issued beneath the standard of care and
outside the usual course of professional practice, because Respondent
failed to perform and/or document a proper physical examination,
develop and/or document treatment plan objectives, appropriately
monitor and resolve and/or document the resolution of red flags, and
maintain accurate and complete medical records.
2. Patient D.B.
D.B. first saw Respondent for pain management on January 3, 2017,
when she complained of pain in her low back and hip. Tr. 449, GX 4
(Medical Records for D.B.), at 1. At that time, according to her
medical records, D.B. had received ``three total hip revisions,'' the
last of which had complications with infection. Tr. 449. On September
8, 2018, Respondent implanted a pain pump for D.B. to address D.B.'s
continuing hip pain. Tr. 450-51; GX 4, at 401, 404. Over the course of
D.B.'s visits with Respondent, as the expert witnesses testified,
Respondent reduced the prescribed controlled substances' overall MME
(outside of the pain pump) from 191 to 90 MME per day and her function
improved.\45\ Tr. 582-83, 625, 1028, 1034.
---------------------------------------------------------------------------
\45\ Dr. Polston testified that the MME D.B. was receiving (for
the oral medication prescribed, not the medication in the pain pump)
``was cut in . . . more than a half,'' which, he acknowledged, was
an example of a ``pain management specialist doing a[n] outstanding
job in the reduction of the medication.'' Tr. 625. Dr. Munzing
testified that even though ``[it is] great that [Respondent was]
tapering down,'' Tr. 1218, prescriptions that are tapered down still
must have ``adequate[ ] justif[ication]'' other ``than just the fact
they were on a high dose.'' Tr. 1217.
---------------------------------------------------------------------------
Dr. Munzing testified that between January 23, 2017, and August 2,
2019, Respondent issued thirty-one controlled substance prescriptions
to D.B. beneath the standard of care in California. Tr. 945; GX 24, at
2. The prescriptions included fentanyl 25 mg./ml. in a 10 ml. vial;
hydromorphone 50 mg./ml. in a 10 ml. vial; OxyContin 30 mg., 60 tablets
issued roughly every other month between January 2017 and May 2017; and
finally oxycodone 15 mg. ranging from 135 tablets in January 2017 to 90
tablets in August 2019. GX 24, at 2. Dr. Munzing opined that Respondent
failed to satisfy the standard of care with regard to performance of
physical examinations, periodic review and monitoring, and
recordkeeping.
Dr. Munzing opined that the physical examinations in the record
were beneath the standard of care because the Respondent appeared to
have copied and pasted the physical examination repeatedly. Dr. Munzing
testified that at some point there was ``a documented hip exam which
got copied, copied, copied, copied, copied. So we [cannot] confirm that
[an exam] was done at all those times because it was a copy forward.
And then suddenly a month after the pump goes in, it drops off, which
is . . . curious timing . . . [because] [i]f [you are] really treating
hip pain, you want to try [to] find . . . some improvement in that.''
Tr. 1294-95. I credit Dr. Munzing's opinion and find that Respondent
failed to adequately perform physical examinations as required by the
standard of care for prescribing for pain in California. There are
additionally times in the records, where, according to Dr. Munzing,
``[d]espite some increase in hip pain, [there is] no documented exam of
the hip.'' Tr. 464, 466.
Dr. Munzing testified that an adequate physical examination of
D.B.'s hip would entail things like ``look[ing] for any redness,
swelling,'' ``palpat[ing] or touch[ing] it,'' ``somewhat of a range of
motion . . . rotational exams . . . [there is] a variety of things you
can do even when a patient is sitting there in the wheelchair.'' Tr.
1290-91. Dr. Munzing testified that performing a physical examination
was important to determine if, as a result of the pain pump, ``the
patient may have increased range of motion'' or if ``she may not have
pain when [you are] making some maneuvers, or the pain may change.''
Tr. 1296. Dr. Munzing further stressed the importance of a physical
exam because, ``[s]he had a history of an infection . . . [i]f an
abscess or other infection started happening, she may not recognize
that . . . this is infectious pain instead of other pain.'' Id.
Regarding the appropriateness of a physical examination of D.B.'s
hip, Dr. Polston testified that D.B. ``is a patient who has a lot of
pathology in her hip. She's had five surgeries and I would be very
cautious about any type of movement with this patient.'' Tr. 601. Dr.
Polston testified the physical examination would consist of ``is there
an infection there? . . . If the patient is saying . . . the hip is . .
. stable or that [she is] responding to some of the medicines . . .
[that is] the exam.'' Id. However, the physical examination portion of
the records subsequent to October 1, 2018, do not include any mention
of the hip whatsoever including mention of whether the hip was
evaluated for potential infection.\46\ See GX 4, at 331. Respondent
testified that following the October 1, 2018 physical examination of
D.B.'s hip, Tr. 1382-83, no further examination was necessary because
the patient's condition was ``permanent and stationary,'' and because
of her history, an examination could ``potentially cause another [hip]
dislocation right in the office.'' Tr. 1386. Based on Respondent's own
admission and a review of the medical records, it does not seem that
the Respondent conducted even the limited physical examination of
D.B.'s hip that Dr. Polston testified would satisfy the standard of
care. Regardless, I credit Dr. Munzing's testimony that Dr. Polston's
description of the physical examination requirement did not reflect the
standard of care. Tr. 1294.
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\46\ The History of Present Illness portion of the records
contain information like ``[t]he patient complains of pain in the
Hip pain [sic.] . . . [o]n average the pain is 7/10 . . . [p]t
reports increased pain in the mornings'' and arguably contains
information regarding the stability of the hip and D.B.'s response
to the medication, which Dr. Polston testified was also required.
---------------------------------------------------------------------------
Dr. Munzing also opined that Respondent issued prescriptions for
controlled substances beneath the standard of care due to his failure
to ``attempt to get prior medical records to confirm the accuracy of
what'' D.B. reported regarding ``her multiple surgeries and . . . an
infection . . . in
[[Page 8051]]
her hip.'' \47\ Tr. 869-70. Dr. Munzing explained that there is ``a
history that the patient has had multiple hip surgeries and presumably
. . . is being followed by someone else, but we really [do not] know
specifics. And [there is] no imaging.'' Tr. 461. Dr. Munzing opined
that Respondent had a ``responsibility to do a thorough history''
initially ``to confirm what [the patient was] saying.'' Tr. 1209.
Respondent countered this opinion with testimony that he had ``a brief
conversation with the patient transferring place, so you have to trust
that physician . . . Second, in pain management, . . . you have to
trust your patients.'' Tr. 1366. Notably, Respondent later confirmed
that his purported call with the referring physician was ``[n]ot
documented.'' Tr. 1692. Dr. Polston conclusively opined that
Respondent's failure to secure prior records or imaging did not mean
Respondent acted outside the standard of care. Tr. 603. However, Dr.
Polston later agreed that he has ``had patients who, in [his] opinion,
[were] trying to exaggerate their medical condition,'' and that you
must ``consider'' what patients tell you regarding their condition, but
that you ``just [cannot] take what they tell you at face value.'' Tr.
725. I credit Dr. Munzing's testimony \48\ and find that Respondent
failed to confirm D.B.'s prior medical history and/or failed to
document that confirmation--either way I find that this failure
violated the applicable standard of care.
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\47\ Dr. Munzing described this as a failure from a ``foundation
standpoint'' and explained that this failure applied to all of the
relevant prescriptions issued to this patient. Tr. 869-70.
\48\ I find that the MBC Guide to the Laws provides further
support to Dr. Munzing's testimony in stating that generally,
``[m]edical documentation should include both subjective complaints
of patient and caregiver and objective findings by the physician.''
GX 17, at 61. Therefore, the MBC Guide to the Laws makes it clear
that a physician has a duty to do more than rely on the subjective
position of the patient.
---------------------------------------------------------------------------
Dr. Munzing opined that Respondent's periodic review and monitoring
of D.B. was beneath the standard of care because Respondent failed to
resolve red flags arising from D.B.'s inconsistent urine drug screen
collected on July 7, 2017, and released on July 17, 2017.\49\ GX 4, at
715-16; Tr. 856-62. On July 7, 2017, D.B. was prescribed neither
carisoprodol (Soma) nor hydrocodone/codeine, yet, metabolites of those
two medications appeared in D.B.'s urine drug screen and were
documented as ``inconsistent'' results. Tr. 856, 858; GX 4, at 715. Dr.
Munzing confirmed that ``Soma, in particular, can be very dangerous
when prescribed with an opioid.'' Tr. 1246. According to Dr. Munzing,
it was ``incumbent upon [Respondent] to, in a very timely manner,[
\50\] call a patient, talk to the patient.'' Tr. 1249. Respondent
needed to figure out ``[what is] going on, and emphasize to the patient
that . . . if [she] . . . got some medication through someone else . .
. this can be a . . . fatal problem.'' Id. Furthermore, he had to
``document specifically what [he] did and [his] reasoning behind a
decision to keep on prescribing.'' Tr. 860. Here, as Dr. Munzing
confirmed, the medical record did not document any conversation with
the patient, Respondent's determination as to what caused the
inconsistent results, or what Respondent planned to do about it. Id.;
and at 1046, 2151-52.
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\49\ The OSC alleges other aberrant drug screens for D.B, which
the Government appeared to drop from its case in its posthearing
brief. OSC, at 6; ALJX 27 (Government's Posthearing), at 9-10. Dr.
Polston and Respondent both credibly testified that medication
infused through a pain pump does not pass through the blood/brain
barrier and as a result, will not necessarily show up in urine. RD,
at 194-96. Accordingly, D.B.'s UDS that showed a negative result for
prescribed substances were not necessarily aberrant. Id. I agree
with the ALJ and am not sustaining these allegations from the OSC.
See id.
\50\ Dr. Munzing testified that this UDS showed ``potentially
serious findings of aberrancies, and so typically one would not wait
[until] the next visit'' to discuss them with the patient. Tr. 1042.
Rather, ``[o]ne would pick up the phone and call and manage it over
the phone.'' Id. And the phone call needed to be in ``[s]hort
order,'' which could ``be hours or a couple of days'' but not to
wait weeks to the next visit. Tr. 1043.
---------------------------------------------------------------------------
According to Respondent, the aberrancy was addressed on August 3,
2017, as is documented in the note stating, ``MD reviewed LC/MS [liquid
chromatography-mass spectrometry] from the DOS of inconsistent 07/07.''
GX 4, at 708, 1053. Respondent testified that he did not need to
contact D.B. sooner following the UDS because there were other, less
sensitive drug screens run on the same day that did not show aberrant
results; therefore, it could have been ``a possible lab error'' and
``[that is] no reason to call a patient to say you could be in
danger.'' Tr. 1436. Respondent's argument is contradicted by the record
evidence that the other, ``less sensitive drug screens'' run on D.B. on
July 7, 2017, make no mention of, and do not appear to have tested for
Soma/carisoprodol or its metabolite meprobamate or hydrocodone and
codeine or their metabolite norhydrocodone. GX 4, at 719-20. The
possibility of a lab error is also less likely, given that, on cross
examination, Respondent confirmed that his office was prescribing Soma
to D.B.'s daughter around the time of June 7, 2017. Tr. 1687.
Respondent agreed that it was hypothetically ``possible that [D.B.]
obtained Soma from her daughter's prescription.'' Tr. 1688. However,
Respondent avoided a direct answer when asked whether D.B. could have
obtained the Soma unlawfully from her daughter. Tr. 1688. He testified,
``Let's put it this way. If [it is] a Soma, if you [are] so close to
each other, it could be from a liquid contamination [to] make her urine
positive too.'' Id. When pressed by the ALJ regarding how Soma could
show up in D.B.'s system unless D.B. took it,\51\ Respondent explained
how the daughter's Soma could accidentally be ingested if the daughter
dropped it in D.B.'s food. Tr. 1688-89. The scenario described by
Respondent to any logical person strains credulity. Further, there is
no evidence on the record that supports the notion that D.B.'s daughter
might have dropped her medication in her mother's food. If Respondent
had some information that this scenario explained the presence of the
Soma after talking to the patient, then in accordance with Dr.
Munzing's testimony, that should have been documented. There is no
dispute that the medical record did not capture any discussion
regarding a conversation with the patient, Respondent's determination
as to what caused the inconsistent results, or what Respondent planned
to do about it. Tr. 1690.
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\51\ Dr. Munzing testified that the only way a urine drug screen
would test positive for a substance is if the patient ingested that
substance. Tr. 2066, 2118; RD, at 77.
---------------------------------------------------------------------------
I credit Dr. Munzing's opinion and find that Respondent failed to
appropriately monitor D.B. in accordance with the standard of care when
he failed to timely follow up on the inconsistent drug screen; however,
even if waiting until the next appointment had been proper, Respondent
further issued the next prescription beneath the standard of care by
not adequately documenting resolution of the aberrant UDS in the
records. I note that the record contains many examples of appropriate
steps that Respondent took to monitor D.B. including running CURES
reports, requiring urinary drug screens, requiring regular follow-up
appointments, and administering the opioid risk tool questionnaire. Tr.
604-05; 1021-25. However, Respondent's actions with regard to this
aberrant UDS did not, and I have found his explanation to not be
credible. Therefore, I considered Respondent's failure in monitoring in
finding that the prescriptions for controlled substances
[[Page 8052]]
issued after the aberrant UDS were issued beneath the standard of care.
In accordance with Dr. Munzing's testimony, I find numerous
recordkeeping violations on top of those already addressed above, which
contribute to my finding that Respondent's controlled substance
prescribing to D.B. was beneath the standard of care and outside the
usual course of professional practice. For example, on May 12, 2017,
Respondent wrote in the medical records that he was prescribing 120
tablets of oxycodone, but he, in fact, prescribed 135 tablets. Compare
GX 4, at 761 with 757 and GX 6b (Prescription Records for D.B.), at 7-
8. Dr. Munzing opined that the prescriptions on this date were beneath
the standard of care for the above reasons and because ``the amount
prescribed is not consistent with what was written in the chart.'' Tr.
497. Second, different medical records dated January 7, 2019, January
21, 2019, and February 2, 2019, all state ``recheck today 1/3/18''
under ``Urine Drug Screening,'' GX 4, at 104, 128, 141, which Dr.
Munzing opined was an errant copy forward from prior examinations. Tr.
851-55. Ultimately, Dr. Munzing opined that the ``internal
inconsistency even within [D.B.'s] record'' and between the medical
record and accompanying prescriptions, demonstrated that the
prescriptions were issued beneath the standard of care. Tr. 871.
Dr. Polston, when asked, opined that ``[i]n totality, . . . the
standard of care . . . was . . . met by [Respondent] with regard[ ] to
record keeping and charting of this patient D.B.'' Tr. 618-19.
Respondent similarly testified that ``the totality of overall my charts
are good. Of course there [are] some mistakes. [But] I think my
chart[s] overall [are] above average.'' Tr. 1607.
I credit Dr. Munzing's more specific opinion, which more accurately
relies on the record evidence, and find that Respondent acted beneath
the standard of care when he failed to maintain complete and accurate
records for D.B. Although some of these mistakes by themselves might
not always amount to a particular prescription being issued beneath the
standard of care and outside the usual course of professional practice,
the fact that these mistakes were made on top of the other failures
further demonstrates that Respondent was not maintaining accurate
records or documentation. As Dr. Munzing described it, the ``supporting
information is just not there.'' Tr. 871.
In accordance with Dr. Munzing's testimony and the record as a
whole, I find that, the thirty-one prescriptions for Fentanyl,
oxycodone, hydromorphone and OxyContin issued to D.B. between January
23, 2017, and August 2, 2019, were issued outside of the usual course
of professional practice and beneath the applicable standard of care in
California. Particularly, in accordance with Dr. Munzing's credible
testimony and as supported by California law, the relevant
prescriptions were issued outside the standard of care because
Respondent failed to perform and/or document a proper physical
examination, obtain and/or document an adequate history, appropriately
monitor and resolve and/or document the resolution of red flags, and
keep accurate and complete records.
3. Patient E.N.\52\
---------------------------------------------------------------------------
\52\ Respondent's second Exception challenges the ALJ's finding
that Respondent did not re-evaluate the proper course of treatment
in the face of E.N.'s reports of increased pain in November 2015.
ALJX 30, at 7. Of note, the ALJ found that that re-evaluation did
occur, but that it was not documented in the treatment plan. RD, at
216. Regardless, I do not see anything in the record that ties these
facts from November 2015 to the legitimacy of the prescriptions from
2017-2019 that are at issue in this case. Accordingly, I consider
the matter to be irrelevant and I have not considered the ALJ's
finding on this particular matter in issuing my decision.
---------------------------------------------------------------------------
By way of background, E.N. had a history of back surgeries, severe
back pain, and weakness in the legs necessitating use of a wheelchair;
she became a patient of Respondent in 2006. Tr. 677, 1567. The first
medical documentation presented in the record evidence by the
Government was dated July 3, 2012, wherein E.N. complained of pain in
her low back and knees, complaints, which continued throughout
Respondent's treatment of E.N. Tr. 875; GX 12 (Medical Records for
E.N.), at 769. Tr. 1145-46; GX 12, at 770. Tr. 877-78; GX 12, p. 766.
Over the course of E.N.'s visits with Respondent, for which there are
medical records available, the experts testified that Respondent
reduced E.N.'s opioid prescriptions from 1,920 MME per day to 960 MME
per day \53\ and that E.M.'s function improved. Tr. 879, 903, 911,
1147, 1534, 1542.
---------------------------------------------------------------------------
\53\ Dr. Munzing explained that this sort of MME reduction is
commendable and reduces the risk to the patient; however, the MME
remains ``extraordinarily high'' and is not medically justified. Tr.
912-13; see also 681, 702, 1146, 1152-53.
---------------------------------------------------------------------------
Dr. Munzing testified that between February 3, 2017, and April 15,
2019, Respondent issued forty-three controlled substance prescriptions
to E.N. beneath the applicable standard of care in California. Tr. 945;
GX 24, at 3. The prescriptions included prescriptions for Methadone 10
mg. ranging from 360 tablets issued in February 2017 to 120 tablets
issued twice a month in April 2019; and a single prescription for
Dilaudid 4 mg., 14 tablets issued in January 2019. GX 24, at 3. Dr.
Munzing opined that, based on his review of the medical file for E.N.,
Respondent failed to satisfy the standard of care with regard to
performance of a physical examination, periodic review and monitoring,
and recordkeeping. Tr. 911, 927-28.
Dr. Munzing credibly testified that the ``extraordinarily high
amounts'' of opioids, with a MME ranging from 1440 to 960 per day
during the relevant period, Tr. 887, 903, ``would certainly not be
medically justified'' by the medical records he reviewed for E.N. Tr.
912-13. Dr. Munzing testified that while the section of the patient
records that covers the history of present illness for E.N. is
different from visit to visit,\54\ the physical examination has
``verbiage that is the same . . . word for word'' continuously between
May 25, 2016, and April 15, 2019. Tr. 1173, 1177-78. According to Dr.
Munzing, this repeated physical examination is outside the standard of
care because ``we [do not] know on any particular date, what truly was
the patient's condition at a certain date, and [that is] required to be
able to justify, are we going to continue using this, is this the right
treatment?'' Tr. 911-12. Dr. Munzing further confirmed that where the
physical examination notes were simply repopulated, the ``records do
not establish that a physical exam actually occurred.'' Tr. 1237.
---------------------------------------------------------------------------
\54\ In his Exceptions, Respondent argued that where the medical
records reflected changes to the history of present illness, vital
signs, and other sections, it ``clearly demonstrated that
Respondent, or other physicians or mid-level providers acting on his
behalf, had seen and evaluated the patients on a regular basis.''
ALJX 30, at 17. Even assuming that the information establishes that
the patient was seen, it does not establish that an adequate
physical examination to justify the prescription occurred. See supra
II.D.2. Therefore, although it is true that parts of the medical
record might have met the standard of care, those parts do not
impact my finding that, based on Dr. Munzing's testimony, the
physical examination records were not adequate.
---------------------------------------------------------------------------
Dr. Munzing testified generally that, with regard to E.N.'s
records, ``large portions of them, and almost entirely the physical
exam, appears to get cut-and-paste or are copied forward.'' Tr. 911.
Respondent's counsel pointed out and Dr. Munzing acknowledged that on
three dates (May 25, 2016, May 16, 2018, and December 27, 2018), ``new
information was put in'' alongside the repopulation. Tr. 1263; see also
GX 12, at 90, 216, 556. Regarding E.N., Dr. Munzing acknowledged that
it would be ``fair to say that on dates when new examination notes
appear, that [is] probably an indication there was a physical
examination [performed] that
[[Page 8053]]
matches what was described within the notes.'' Tr. 1238. The Government
notably did not allege that the prescriptions issued on May 25, 2016
(which were before the time period of the allegations) or the
prescriptions issued on December 27, 2018, were issued beneath the
applicable standard of care and outside the usual course of
professional practice, GX 24, at 3; therefore, I find that Dr.
Munzing's acknowledgement of the documented physical examination on May
16, 2018, only affects the prescription issued on that date. The
Government did not present any further testimony regarding the adequacy
of the note on May 16, 2018, in documenting the alleged physical
examination and therefore I am not finding that the prescription for
methadone issued on that date was issued beneath the standard of care.
With regard to the applicable standard of care's requirement to
conduct a periodic review and monitoring, the record contains several
examples of appropriate steps that Respondent took to monitor E.N. that
Dr. Munzing acknowledged met the applicable standard of care. Tr. 1165-
66, 1544, 1551, 1555. However, the Government alleged that Respondent's
prescriptions for controlled substances to E.N. fell beneath the
standard of care when he failed to resolve a particular red flag
related to an early refill request.\55\ OSC, at 12. On February 8,
2019, E.N. visited Respondent for a ``methodone refill. She can not
[sic.] get her previous RX filled due to pharmacy issues. It has tried
two different pharmacies without help. She is here for new rx for
refill.'' GX 12, at 58; Tr. 919. According to Dr. Munzing, this note
constitutes a ``red flag'' because it is ``something that catches [Dr.
Munzing's] attention that needs further exploration and
documentation.'' Tr. 920. Dr. Munzing testified that the pharmacies
could have refused to fill the prescriptions for ``suspicious [or] not-
suspicious reasons,'' and that it was therefore ``important . . . to
find out from the patient why . . . are they not filling it.'' Tr. 920.
Dr. Munzing confirmed that the medical record contains no ``notation or
documentation resolving that red flag'' and opined that this failure
was ``outside the standard of care.'' Tr. 927-28. Dr. Polston opined
that Dr. Munzing's opinion was ``very na[iuml]ve and shows limited
experience in the practice of pain medicine,'' because, at the time,
pharmacies were ``extremely concerned about prescribing'' and
``sometimes they [do not] have the medicines themselves.'' Tr. 683. Dr.
Polston's testimony seems to imply that because there could have been a
perfectly legitimate reason that E.N. required the refill, a scenario
Dr. Munzing also acknowledged, there was no red flag present. However,
Dr. Polston also acknowledged on cross-examination that there could
have been suspicious reasons why the prescription was not filled, such
as forgery or impairment (intoxication).\56\ Tr. 805, 808. Ultimately,
Dr. Polston admitted that he does not know why the prescription was
rejected by the pharmacies. Tr. 804, 808. I credit Dr. Munzing's
opinion that whether or not the reason for the refill request was
legitimate, the reason had to be documented, and I find that
Respondent's failure to document the resolution of this red flag was
beneath the standard of care and outside the usual course of the
professional practice.
---------------------------------------------------------------------------
\55\ The Government also alleged that Respondent failed to
resolve a red flag arising from his receipt of a ``Retrospective
Drug Utilization Review Program'' letter dated April 27, 2016, that
states that ``[E.N.] has filled medication(s) that may be of
concern.'' OSC, at 12. Dr. Munzing opined that to resolve this red
flag within the standard of care, Respondent would have had to
``document the fact that they . . . received this,'' determine that
``the potential risks of the medications are worth it, based on the
potential benefits to the patient,'' and document ``the
justification behind what I'm doing moving forward.'' Tr. 924-25.
Assuming that the Government established that Respondent failed to
resolve this red flag in accordance with the standard of care, the
Government has not tied Respondent's failure to resolve this
particular red flag to the specific prescriptions at issue in this
case, which do not begin until approximately nine months after the
date of this letter. Absent explanation as to how this particular
red flag ties to whether or not the relevant prescriptions were
issued within the standard of care, I decline to consider this
allegation.
\56\ Dr. Polston's opinion clearly suggests that if forgery or
impairment were the reasons why the prescription was not filled,
then there would be documentation of that in the record. Tr. 805,
808. The absence of this documentation seems to be what Dr. Polston
uses to support his opinion that the reasons why the prescription
were not filled were legitimate and his harsh criticism of Dr.
Munzing. Id. I cannot conclude that the absence of documentation
proves the legitimacy of the prescription, especially not in a case
as riddled with recordkeeping problems as this one. Supra II.E.;
infra III.A.2.
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In accordance with Dr. Munzing's testimony and the record as a
whole, I find that forty-two of the forty-three prescriptions issued to
E.N. relevant to this case were issued outside of the usual course of
professional practice and beneath the applicable standard of care in
California. Particularly, in accordance with Dr. Munzing's testimony,
the relevant prescriptions were issued outside the standard of care
because Respondent failed to perform and/or document a proper physical
examination, appropriately monitor and resolve and/or document the
resolution of a red flag, and keep accurate and complete records.
III. Discussion
A. Allegation That Respondent's Registration Is Inconsistent With the
Public Interest
Under Section 304 of the CSA, ``[a] registration . . . to . . .
dispense a controlled substance . . . may be suspended or revoked by
the Attorney General upon a finding that the registrant . . . has
committed such acts as would render his registration under section 823
of this title inconsistent with the public interest as determined by
such section.'' 21 U.S.C. 824(a)(4). In the case of a ``practitioner,''
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
[[Page 8054]]
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.
DEA regulations state, ``[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). I
find that the evidence satisfies the Government's prima facie burden of
showing that Respondent's continued registration would be
``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). I
further find that Respondent failed to produce sufficient evidence to
rebut the Government's prima facie case.
1. Factors One and Three: The Recommendation of the Appropriate State
Licensing Board or Professional Disciplinary Authority and Respondent's
Conviction Record Under Federal or State Laws Relating to Controlled
Substances
Respondent argued that a MBC decision regarding Respondent ``stands
in favor of Respondent's continued DEA Registration.'' ALJX 28
(Respondent's Posthearing), at 23. In this case, it is undisputed that
Respondent holds a valid state medical license in California. Supra
II.A. However, possession of a state license does not entitle a holder
of that license to a DEA registration. Mark De La Lama, P.A., 76 FR
20,011, 20,018 (2011). It is well established that a ``state license is
a necessary, but not a sufficient condition for registration.'' Robert
A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). The ultimate
responsibility to determine whether a DEA registration is consistent
with the public interest resides exclusively with the DEA, not to
entities within state government. Edmund Chien, M.D., 72 FR 6580, 6590
(2007), aff'd Chien v. DEA, 533 F.3d 828 (D.C. Cir. 2008).
In determining the public interest, the ``recommendation of the
appropriate State licensing board or professional disciplinary
authority . . . shall be considered.'' 21 U.S.C. 823(f)(1). Two forms
of recommendations appear in Agency decisions: (1) A recommendation to
DEA directly from a state licensing board or professional disciplinary
authority (hereinafter, appropriate state entity), which explicitly
addresses the granting or retention of a DEA COR; and (2) the
appropriate state entity's action regarding the licensure under its
jurisdiction on the same matter that is the basis for the DEA OSC. John
O. Dimowo, M.D., 85 FR 15,800, 15,810 (2020); see also Vincent J.
Scolaro, D.O., 67 FR 42,060, 42,065 (2002).
In this case, neither the MBC nor any other state entity has made a
direct recommendation to DEA regarding whether the Respondent's
controlled substances registration should be suspended or revoked.
There is evidence on the record that effective January 31, 2020, the
MBC found, amongst other things, that Respondent had violated state law
by committing gross negligence in violation of Cal. Bus. & Prof. Code
Sec. 2234 when he failed to recognize the risk to patients associated
with concurrent use of high dose opioids, benzodiazepines, and Soma,
and failed to perform ongoing patient assessments, GX 26 (MBC Decision
Involving Respondent), at 161-162; repeated negligence in violation of
Section 2234 when he failed to document certain prescriptions and
failed to maintain adequate records documenting his treatment of a
patient, id. at 163-64; and acted in violation of Sections 2234 and
2266 when he failed to maintain adequate and accurate records of his
care and treatment of the patients at issue, id. at 165. However, the
evidence demonstrates that the matter before the MBC involved entirely
different patients during an earlier time frame and was therefore
different from, the conduct alleged in this case. GX 26; 21 U.S.C.
823(f)(1). Following its evaluation, the MBC took disciplinary action
against Respondent, suspending his license and then probating the
suspension, which permitted the Respondent to practice medicine without
restriction. GX 26; ALJX 28, at 3-4; RD, at 233.
The evidence before me is different than what the MBC had at the
time that it made its decision because it demonstrates that Respondent
engaged in additional violations of state and federal law with respect
to his prescribing practices. Further, the fact that the MBC did not
choose to revoke Respondent's state medical registration carries
minimal to no weight under Factor One, because there is no evidence
that the MBC would have made the same decision in the face of the
continued misconduct found herein involving different patients and
continued recordkeeping violations.\57\ Accordingly, the terms of the
MBC Order have been considered, but I find that they have little impact
on the public interest inquiry in this case.\58\ See Jeanne E. Germeil,
85 FR 73,786, 73,799 (2020); see also John O. Dimowo, M.D., 85 FR
15,810. In sum, while the terms of the MBC Order are not dispositive of
the public interest inquiry in this case and are minimized due to the
differences between the evidence in the MBC Order and the record
evidence before me, I consider the MBC's Order's reprimand of
Respondent's California medical license and give it minimal weight in
Respondent's favor, because the charges could have resulted in the
suspension or revocation of his medical license. See Jennifer St.
Croix, 86 FR 19,010, 19,022 (2021).
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\57\ In Dimowo, the Acting Administrator found that ``[a]lthough
statutory analysis [of the CSA] may not definitively settle . . .
[the breadth of the cognizable state `recommendation' referenced in
Factor One], the most impartial and reasonable course of action is
to continue to take into consideration all actions indicating a
recommendation from an appropriate state;'' however, Dimowo also
limited the ``recommendations'' DEA would consider to the ``actions
of an appropriate state entity on the same matters, particularly
where it rendered an opinion regarding the practitioner's medical
practice in the state due to the same facts alleged in the DEA
OSC.'' John O. Dimowo, 85 FR at 15,810. Although the same
``matters'' may include similar types of violations, in this case, I
have no indication that the MBC would have made a similar decision
in the face of these additional violations and continued misconduct.
\58\ In his exceptions, Respondent argued that the ALJ, who
found that the MBC decision weighed slightly in Respondent's favor,
RD, at 233, should have given greater weight to the MBC's decision
and allowed Respondent to continue prescribing. ALJX 30, at 24. For
the reasons contained in this analysis, I disagree. I have weighed
this factor slightly in his favor, but I find that the fact that the
state permitted him to continue to practice of medicine is not
dispositive as to whether Respondent's continued controlled
substances registration is in the public interest.
---------------------------------------------------------------------------
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). 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.
[[Page 8055]]
2. Factors Two and Four--the Respondent's Experience in Dispensing
Controlled Substances and Compliance With Applicable Laws Related to
Controlled Substances
(a) Allegation That Respondent Issued Prescriptions for Controlled
Substances Outside the Usual Course of the Professional Practice
According to the Controlled Substances Act's (hereinafter, CSA)
implementing regulations, 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 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, 546 U.S. 243, 274 (2006).
I found above that the Government's expert credibly testified as
supported by California law, the MBC Guide to the Laws and Guidelines
for Prescribing, that the standard of care in California requires a
physician to, amongst other things, perform and document a physical
examination, develop and document a treatment pan, conduct periodic
review and monitoring of the patient, and have complete and accurate
records in order to prescribe controlled substances. See supra II.D. I
also found above that Respondent issued one-hundred and fifteen
controlled substance prescriptions, often extremely high doses of
opioids, to three patients without performing or documenting adequate
physical examinations, developing or documenting adequate treatment
plans, resolving or documenting resolution of red flags, and/or keeping
complete and accurate records as required by the standard of care. See
supra II.E.
Respondent repeatedly issued prescriptions without complying with
the applicable standard of care and state law thus demonstrating that
his conduct was not an isolated occurrence, but occurred with multiple
patients.\59\ See Kaniz Khan Jaffery, 85 FR 45,667, 45,685 (2020). For
example, Respondent's medical records for all three of the individuals
at issue had verbatim language repeated throughout the relevant time
frame (with very few exceptions) regarding the physical examination
allegedly performed.\60\ Dr. Munzing opined that the verbatim records
``do not establish that a physical exam actually occurred'' and they
prohibited us from ascertaining truly what ``the patient's condition
[was] at a certain date'' and whether the prescribing was
``justif[ied].'' Tr. 911-12, 1237; supra II.E.3. The California
standard of care clearly and indisputably requires a physical
examination including ``an assessment of pain, physical and
psychological function,'' and requires physicians to ``keep accurate
and completed records . . . including the . . . physical examination.''
GX 17, at 59, 61. In his exceptions, Respondent acknowledged that ``the
repopulation of his physical exam findings created inaccuracies and
were thus deficient. . . . [And] because of the repopulation of
physical exam findings [Respondent] cannot identify which portion or
portions of the physical examinations he conducted during his visits
with the patients.'' \61\ ALJX 30, at 23.
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\59\ And, as I discussed above, Respondent was disciplined by
the MBC for similar conduct against different patients than those
involved in this case during a prior timeframe. Supra III.A.1.
\60\ I have chosen this example because it was Respondent's most
frequently repeated and pervasive violation of the standard of care.
However, each and every instance where I found a violation of the
standard of care above, supra II.E.1-3, supports my decision in this
case.
\61\ In the same brief, Respondent took exception to the ALJ's
finding that he had ``rampantly neglected his recordkeeping
obligations by carrying forward verbatim entries for physical exam
findings.'' ALJX 30, at 14-18; RD, at 224-26. I note that ``rampant
neglect'' is not the applicable legal standard applied here--the
question is whether the records were sufficiently accurate and
complete to establish that the relevant prescriptions were issued
within the standard of care. They were not. Second, all of
Respondent's arguments regarding this exception are repetitive of
arguments Respondent has already made and that I have already
addressed. For example, Respondent argued the patients' physical
examinations would not be expected to change because of their
chronic conditions, addressed at supra II.E.1; argued Respondent
properly monitored the patients, addressed at supra II.E.1-3; argued
that updates to the history of present illness sections and vital
signs demonstrated that the patients were evaluated, addressed at
supra n. 54.
---------------------------------------------------------------------------
Agency decisions highlight the Agency's interpretation that
``[c]onscientious documentation is repeatedly emphasized as not just a
ministerial act, but a key treatment tool and vital indicator to
evaluate whether the physician's prescribing practices are `within the
usual course of professional practice.' '' Cynthia M. Cadet, M.D., 76
FR 19,450, 19,464 (2011). DEA's ability to assess whether controlled
substances registrations are consistent with the public interest is
predicated upon the ability to consider the evidence and rationale of
the practitioner at the time that he prescribed a controlled
substance--adequate documentation is critical to that assessment. See
Kaniz-Khan Jaffery, 85 FR 45,686. Here, Respondent's verbatim
recordkeeping, failure to document justification for the treatment
plan, failure to document resolution of red flags, and other errors,
made it impossible to evaluate Respondent's prescribing practices in
any meaningful way. See Mark A. Wimbley, M.D., 86 FR 20,713, 20,726
(2021). Further, as Dr. Munzing stated, complete and accurate
``[m]edical records are incredibly important for physicians'' and
inaccurate records could jeopardize ``patient safety'' particularly if
the ``patient rolls into the ER.'' Tr. 705, 1197. Therefore,
recordkeeping is not only important for compliance, but also for the
safety of the patients.
DEA decisions have found that ``just because misconduct is
unintentional, innocent, or devoid of improper motive, [it] does not
preclude revocation or denial. Careless or negligent handling of
controlled substances creates the opportunity for diversion and [can]
justify the revocation of an existing registration . . .'' Bobby D.
Reynolds, N.P., Tina L. Killebrew, N.P., & David R. Stout, N.P., 80 FR
28,643, 28662 (2015) (quoting Paul J. Caragine, Jr. 63 FR 51,592,
51,601 (1998). Diversion occurs whenever controlled substances leave
`the closed system of distribution established by the CSA . . . .' ''
Id. (citing Roy S. Schwartz, 79 FR 34,360, 34,363 (2014)).\62\ In this
case, I have found that Respondent issued controlled substance
prescriptions without complying with his obligations under the CSA and
California law. See George Mathew, M.D., 75 FR 66,138, 66,148 (2010)).
---------------------------------------------------------------------------
\62\ In his Exceptions, Respondent argues that the Government
has not made a prima facie case because there was ``no evidence of
diversion nor the risk of diversion of controlled substances.'' ALJX
30, at 20. Respondent supports this argument with Dr. Munzing's
testimony regarding a variety of red flags that were not present in
this case (such as patient reports of lost or stolen medication,
requests for early refills, inappropriate physical appearance). Id.
at 21. The Government, however, is not required to prove that
diversion resulted from the unauthorized issuance of prescriptions.
Arvinder Singh, M.D., 81 FR 8247, 8249 (2016). Rather, when a
practitioner violates the CSA's prescription requirement, set forth
in 21 CFR 1306.04(a), by issuing a prescription without a legitimate
medical purpose and outside the usual course of professional
practice, the DEA [essentially] considers the prescription to have
been diverted. George Mathew, M.D., 75 FR 66,146. I find
Respondent's argument to lack merit.
---------------------------------------------------------------------------
Respondent's additional arguments likewise lack merit. In his
Exceptions, Respondent argued that he has not
[[Page 8056]]
committed acts that render his Registration inconsistent with the
public interest. ALJX 30, at 21-22. He argued that there were no
``departures from the standard of care with the clinical decision-
making and prescribing; the only departures were found relating to
documentation.'' Id. Respondent also argued that because the ALJ found
that ``Respondent's care and treatment and prescribing to each patient
[was] appropriate and [met] the standard of care,'' it was ``puzzling''
that the ALJ then found that the ``record-keeping violations
delegitimize the controlled substance prescriptions the subject records
sought to justify.'' ALJX 30, at 19; RD, at 229.
The question at issue is whether the relevant prescriptions were
issued beneath the standard of care and outside of the usual course of
professional practice. In assessing whether the issued prescriptions
violated 21 CFR 1306.04, it is not essential to count how many elements
of the standard of care were violated for each prescription. The ALJ
determined that the relevant prescriptions were issued outside of the
standard of care due to incomplete and inaccurate record keeping, and
that defect cannot be cured by the fact that Respondent, as the ALJ
found, complied with other elements of the standard of care. DEA has
previously made clear that ``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.'' Lesly Pompy, M.D., 84 FR
57,749, 57,760 (2019). This principle was echoed in Dr. Munzing's
testimony stating that ``you have to be treating it [in] real time[,]
[y]ou have to document it [in] real time,'' you cannot say ``because of
this [justification] three years from now, everything before must be
that.'' Tr. 1233. What is essential in this case is whether at the time
Respondent issued each prescription for a controlled substance, he met
the standard of care in issuing that prescription--he had conducted the
physical examination, had a treatment plan, monitored the patient, and
documented such. California law and guidance emphasizes the importance
of documenting crucial aspects of the rationale for prescribing to
ensure that a practitioner is doing so in a manner that is transparent
and recorded and adequately cares for the patient. Dr. Munzing
testified that such practice is of particular importance where the
prescriptions for controlled substances are in such high dosages. Tr.
281; see also id. at 389, 348-39, 768, 912-13.
The expert testimony demonstrates repeatedly that the accurate
documentation of a physical examination and treatment plan that justify
the continued prescribing of these high volume controlled substances is
not merely a check-the-box exercise. And as explained above, it is
impossible for the Agency or anyone to assess the legitimacy of a
particular prescription without adequate recordkeeping. See Carol
Hippenmeyer, M.D., 86 FR 33,748, 33,772 (finding that ``documentation
is critical to effective enforcement of the CSA.'') With a regulated
community of nearly two million registrants,\63\ DEA must be able to
rely on physicians to maintain complete and accurate medical records
justifying their prescribing decisions.
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\63\ See DEA FY 2020 Budget Request available at https://www.justice.gov/jmd/page/file/1142431/download.
---------------------------------------------------------------------------
Additionally, I find that Respondent's actions as they are
documented in the medical records, not the actions he claimed with
limited credibility that he performed, provide the best evidence to
determine whether or not Respondent acted within the standard of care
in issuing these prescriptions. California's standard of care makes
clear that complete and accurate recordkeeping is tied to each other
element of the standard of care in California. See GX 17, at 60.
Ultimately, it is impossible to determine whether, as Respondent
claims, he did conduct the physical examinations, did have appropriate
treatment plans and did adequately address red flags, because he did
not document any of these things as he was required to do under state
law and the standard of care. Therefore, I cannot find definitively, as
Respondent suggests, that the prescriptions he issued were within the
usual course of professional practice and within the standard of care.
In fact, the record evidence demonstrates that he did not prescribe
within the standard of care. The standard of care in California for
prescribing controlled substances cannot be met if the justification
for those controlled substances is not properly documented.\64\
---------------------------------------------------------------------------
\64\ In his Exceptions, Respondent argued that ``[r]evoking
Respondent's certificates based upon recordkeeping violations alone
is not supported by Agency precedent,'' and he attempted to
distinguish his case from the cases the ALJ cited for the
proposition that ``record-keeping violations associated with
controlled substance prescriptions may render such prescriptions
outside the usual course of professional practice.'' ALJX 30, at 25-
26. Respondent's point was that each of the cases the ALJ cited had
more going on than record-keeping violations. Id., at 27-28.
Respondent's argument fails for the reasons set forth in this
paragraph. The Government has established that Respondent's record-
keeping violations rendered the relevant prescriptions outside the
standard of care, which is sufficient to determine a violation of 21
CFR 1306.04. Once the Government has established a prima facie case,
I will assess whether the Respondent has presented adequate evidence
that he can be entrusted with a registration. See infra IV.
---------------------------------------------------------------------------
Respondent repeatedly argued that the individuals ``were never
harmed and because [of Respondent's] care, all achieved positive
results.'' ALJX 30, at 26. Instead, Respondent claimed, the evidence
shows that Respondent significantly lowered each individual's opiate
dosage levels ``while allowing the patient[s] to maintain adequate pain
control and functionality.'' ALJX 30, at 21. I acknowledge that the
record evidence supports a finding that Respondent, in the big picture,
reduced the relevant individual's opioid levels with the benefits that
Respondent espoused. Respondent does not, however, cite legal authority
for the proposition that I must find harm occurred before I may suspend
or revoke a registration. And as Dr. Munzing testified, ``I would say
not only in pain manage[ment] but in medicine in general, you [cannot]
look back and say, based on the fact that there was no documented harm,
whatever happened before must be okay.'' Tr. 1298. Moreover, the
documentation is too deficient to conclusively determine that no harm
occurred. Dr. Munzing testified that he had ``significant concern[s]''
with the documentation, ``[s]o there may very well be things in this
case that we [do not] know . . . concerns that [do not just] go away
because the patient [has not] overdosed and you [do not] document that
[there are] adverse effects.'' Tr. 1034. Furthermore, the violations of
the standard of care in this case are not limited to one patient nor
are they limited to a specific timeframe. The record evidence
demonstrates that for B.G. for example, from February 14, 2017, to May
8, 2018, twenty-one physical tests were copied forward, verbatim from
prior medical visits without any new information being added. Tr. 1920-
22; GX 29b (Bizmatics Subpoena Response), at 4-5. Eight physical tests
were added on May 8, 2018, and then all twenty-nine of those physical
tests were copied forward verbatim until October 3, 2019. Id.
Additionally, each of the patients at issue in this case had many
instances of required recordkeeping copied forward. These recordkeeping
violations were not isolated: They were systematic; they spanned
patients; they spanned years; they spanned different elements of the
standard of care in California.
[[Page 8057]]
Additionally, the act of copying forward the examination made it more
difficult for the Agency to determine whether Respondent had violated
his legal obligations--the copy and forward served to hide the truth of
whether these important aspects of care had occurred. In this case, the
repeated and systematic violations of Respondent's obligations to
document required elements of the standard of care when prescribing
high dosages of opioids manifests a disturbing pattern of indifference
that weighs heavily against a finding that Respondent's continued
registration would be consistent with the public interest. Overall, I
find that in issuing one-hundred and fifteen prescriptions beneath the
applicable standard of care and outside the usual course of
professional practice in California, Respondent violated 21 CFR
1306.04(a) and these violations of law weigh against Respondent's
continued registration under Public Interest Factors 2 and 4.
(b) Violation of State Law
In addition to finding a violation of 21 CFR 1306.04(a), I also
find that the Government has proven by substantial evidence that
Respondent's prescribing violated state law. California law, just like
federal law, requires that a ``prescription for a controlled substance
shall only be issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his or her professional
practice.'' Cal. Health & Safety Code Sec. 11153(a). Therefore, for
the same reasons I found a violation of 21 CFR 1306.04(a), I find that
the record contains substantial evidence that Respondent violated this
state provision with respect to the relevant prescriptions issued to
B.G., D.B., and E.N. Supra III.A.2.a.
Cal. Bus. & Prof. Code Sec. 2242(a) states that it is
unprofessional conduct to ``prescribe[ ] . . . without an appropriate
prior examination and a medical indication.'' Dr. Munzing testified
that it means prescribers ``cannot prescribe controlled substances
without an appropriate medical examination and without medical
indication.'' Tr. 285. Consistent with my findings above, supra
II.A.2.a., I find that Respondent issued the relevant controlled
substance prescriptions without documenting an appropriate physical
examination and/or legitimate medical indication justifying the high
prescription doses in violation of Cal. Bus. & Prof. Code Sec.
2242(a).
I am not issuing a finding on the alleged violations of Cal. Health
& Safety Sec. 11154(a); Cal. Bus. Sec. Prof. Sec. Sec. 725(a) \65\
and 2234; or California Health & Safety Code Sec. 11190(a) because
neither the Government's Expert, nor the Government fully explained
their application to this proceeding.
---------------------------------------------------------------------------
\65\ The ALJ evaluated Cal. Bus. Sec. Prof. Sec. Sec. 725(a).
---------------------------------------------------------------------------
Ultimately I find that the record contains substantial evidence
that Respondent issued multiple prescriptions of controlled substances
to multiple patients beneath the applicable standard of care and
outside the usual course of the professional practice and in violation
of state law over the course of several years. I therefore find that
Factors Two and Four weigh in favor of revocation.
B. 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. I, therefore,
conclude that Respondent engaged in misconduct which supports the
revocation of his registration. 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 ``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 registration. Id. The risk of death was established in
this case. There was ample evidence introduced to establish that
``combined use of opioid medicines with benzodiazepines or other drugs
that depress the central nervous system has resulted in serious side
effects including slowed or difficult breathing and deaths.'' GX 20, at
1; Tr. 317-19, 1278.
Respondent argues in his Exceptions that the ``Government did not
prove, at any point, that [Respondent's] continued registration
constituted any danger to patients, or any threat of harm, much less
imminent danger or harm.'' ALJX 30, at 21. Dr. Munzing's testimony was
critical of the conclusion that these patients were not harmed. Dr.
Munzing testified, ``[we need to be cognizant whether [it is]
prescribing opiates, benzodiazepines, or anything else in medicine is
we need to recognize what the potential harms are. And even if that
patient so far [has not] experienced harm from whatever your management
is, one still needs to be cognizant that that risk is there and not
say, `Well, nothing's happened yet. So that means that everything must
be okay.' That certainly is not . . . the case.'' Tr. 1267. He further
stated that the patient could be ``stable, stable, stable, stable,
stable until they [did not] wake up.'' Tr. 1266.
Thus, as I have found above, at the time the Government issued the
OSC/ISO, the Government had clear evidence of violations of law based
on the one-hundred and fifteen controlled-substance prescriptions
Respondent issued without complying with the California standard of
care. See supra III.A.2.a.
IV. 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, the burden shifts to the Respondent to show why he
can be entrusted with a registration. Garrett Howard Smith, M.D., 83 FR
18,882, 18,910 (2018) (collecting cases). Respondent has made minimal
effort to establish that he can be entrusted with a registration.
The CSA authorizes the Attorney General to ``promulgate and enforce
any rules, regulations, and procedures which he may deem necessary and
appropriate for the efficient execution of his functions under this
subchapter.'' 21 U.S.C. 871(b). This authority specifically relates
``to `registration' and `control,' and `for the efficient execution of
his functions' under the statute.'' Gonzales v. Oregon, 546 U.S. 243,
259 (2006). A clear purpose of this authority is to ``bar[ ] doctors
from using their prescription-writing powers as a means to engage in
illicit drug dealing and trafficking.'' Id. at 270.
In efficiently executing the revocation and suspension authority
delegated to me under the CSA for the aforementioned purposes, I review
the evidence and arguments Respondent submitted to determine whether or
not he has presented ``sufficient mitigating evidence to assure the
Administrator that he can be trusted with the responsibility carried by
such a registration.'' Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853
(2007) (quoting Leo R. Miller, M.D., 53 FR 21,931, 21,932 (1988)). ``
`Moreover, because ``past performance is the best predictor of future
performance,'' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.
1995), [the Agency] has repeatedly held that
[[Page 8058]]
where a registrant has committed acts inconsistent with the public
interest, the registrant must accept responsibility for [the
registrant's] actions and demonstrate that [registrant] will not engage
in future misconduct.' '' Jayam Krishna-Iyer, 74 FR 459, 463 (2009)
(quoting Medicine Shoppe, 73 FR 364, 387 (2008)); see also Jackson, 72
FR 23,853; John H. Kennedy, M.D., 71 FR 35,705, 35,709 (2006); Prince
George Daniels, D.D.S., 60 FR 62,884, 62,887 (1995).
The issue of trust is necessarily a fact-dependent determination
based on the circumstances presented by the individual respondent;
therefore, the Agency looks at factors, such as the acceptance of
responsibility and the credibility of that acceptance as it relates to
the probability of repeat violations or behavior and the nature of the
misconduct that forms the basis for sanction, while also considering
the Agency's interest in deterring similar acts. See Arvinder Singh,
M.D., 81 FR 8247, 8248 (2016).
Here, I agree with the ALJ's statement: ``I cannot find that the
Respondent has unequivocally accepted responsibility for his proven
deficiencies.'' RD, at 240. In his exceptions, Respondent claimed that
``consistently throughout these proceedings . . . [Respondent]
recognized that his medical recordkeeping needed improvement.'' \66\
However when testifying in his own words, Respondent admitted there
were ``some mistakes'' in his recordkeeping, seeming to accept
responsibility in one breath, but then in the next maintained that
``overall [his] charts [were] good'' and ``above average.'' Tr. 1607.
Respondent's Exceptions also state, ``Respondent accepts that the
repopulation of his physical findings created inaccuracies and were
thus deficient.'' ALJX 30, at 23. This claim is not supported by
Respondent's own testimony that the physical findings were not
repopulated, but rather, Respondent conducted the same examination and
made the same selections every visit, which simply produced an
identical narrative. See supra II.C.; Tr. 1775-79; 1799-1801. I do not
credit the acknowledgment of responsibility made in Respondent's
Exceptions over Respondent's actual testimony, and I find that any of
Respondent's testimony that could be considered to be an acknowledgment
of responsibility in this case was both equivocal and not credible.
---------------------------------------------------------------------------
\66\ Respondent also argued that he had taken steps to mitigate
and remediate his recordkeeping issues. ALJX 30, at 22. One example
of these efforts included taking a course on medical recordkeeping
in 2013. Id. This does not seem to have been an effective remedial
effort given that the recordkeeping violations at issue in this
matter took place years later. Id. Regardless, where, as here, the
Respondent has not credibly accepted responsibility for his
misconduct, I do not generally consider evidence of remedial
measures. See Jones Total Health Care Pharmacy, L.L.C., 81 FR
79,202-03. Even if he had adequately accepted responsibility, I
cannot find that these remedial measures are adequate such that I
could entrust him with a registration.
---------------------------------------------------------------------------
In all, Respondent failed to explain why, in spite of his
misconduct, he can be entrusted with a registration. ``The degree of
acceptance of responsibility that is required does not hinge on the
respondent uttering ``magic words'' of repentance, but rather on
whether the respondent has credibly and candidly demonstrated that he
will not repeat the same behavior and endanger the public in a manner
that instills confidence in the Administrator.'' Jeffrey Stein, M.D.,
84 FR 46,968, 49,973 (2019). Here, having considered Respondent's case
and statements, I am still left with no confidence in Respondent's
future compliance with the CSA.
The Agency also looks to the egregiousness and extent of the
misconduct, which are significant factors in determining the
appropriate sanction. Garrett Howard Smith, M.D., 83 FR 18,910
(collecting cases). In this case, the ALJ found, and I agree, that the
record-keeping was so deficient that it ``delegitimize[d] the
controlled substance prescriptions the subject records sought to
justify.'' RD, at 229. Furthermore, the record evidence contains
testimony from the Government's expert that explains exactly why
recordkeeping is so important. In particular, Respondent was
prescribing a dangerous combination of high dose controlled substances
to a patient and his compliance with the state legal requirements
regarding recordkeeping was so egregiously bad that it is difficult to
determine what steps Respondent was taking to ensure this patient's
safety, or even why a particular controlled substance was being
prescribed. These are not solely recordkeeping requirements--these
requirements are in place to ensure that practitioners are actively
considering the safety of their patients and documenting that they did
so. As Dr. Munzing stated, the patient could be ``stable, stable,
stable, stable, stable until they [did not] wake up.'' Tr. 1266.
Respondent argues that the sole findings of departures are related
to documentation and therefore warrant a sanction less than revocation.
ALJX 30, at 25. Respondent's cavalier assumptions about his
documentation responsibilities and the fact that he did not undertake
this responsibility with seriousness weigh against my ability to
entrust him with a registration. See Singh, M.D., 81 FR 8248 (``[U]ntil
. . . [a] Respondent can convincingly show he accepts the authority of
the law and those bodies charged with enforcing it and regulating his
activities, granting [ ] a DEA registration will gravely endanger the
public.''). The truth is that it is not possible to tell whether
Respondent's care was as appropriate as he claims because his
recordkeeping was so abysmal.
In sanction determinations, the Agency has historically considered
its interest in deterring similar acts, both with respect to the
respondent in a particular case and the community of registrants. See
Joseph Gaudio, M.D., 74 FR 10,083, 10,095 (2009); Singh, 81 FR 8248. I
find that considerations of both specific and general deterrence weigh
in favor of revocation in this case. There is simply no evidence that
Respondent's behavior is not likely to recur in the future such that I
can entrust him with a CSA registration; in other words, the factors
weigh in favor of revocation as a sanction.
I will therefore order that Respondent's registration be revoked 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. 824(a) and 823(f), I hereby revoke DEA Certificate of
Registration Nos. FQ7186174, FQ7906968, and BQ7364970. Pursuant to 28
CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a) and
823(f), I hereby deny the pending application for a new DEA Certificate
of Registration, Application No. W18124091C, for John X. Qian, M.D.,
and hereby deny any pending application of John X. Qian, M.D. to renew
or modify these registrations, as well as any other pending application
of John X. Qian, M.D. for registration in California. This Order is
effective March 14, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2022-02973 Filed 2-10-22; 8:45 am]
BILLING CODE 4410-09-P