[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Notices]
[Pages 21181-21209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07727]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 19-38]
Craig S. Rosenblum, M.D.; Decision and Order
I. Introduction
On August 8, 2019, a former Acting Administrator of the Drug
Enforcement Administration (hereinafter, DEA or Government), issued an
Order to Show Cause and Immediate Suspension of Registration to Craig
S. Rosenblum, M.D. (hereinafter, Respondent), of Palm Desert,
California. Administrative Law Judge Exhibit (hereinafter, ALJX) 1
(Order to Show Cause and Immediate Suspension of Registration
(hereinafter collectively, OSC)), at 1. The OSC informed Respondent of
the immediate suspension of his DEA Certificates of Registration
BR0869719, BA7661564, and DATA-Waiver No. XR0869719 ``because . . .
[his] continued registration constitute[d] `an imminent danger to the
public health and safety.' '' \1\ Id.
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\1\ Registration No. BR0869719 is assigned to Respondent.
Registration No. BA7661564 is assigned to Aurora Surgery Center.
OSC, at 2. Nothing in the record transmitted to me challenges
Respondent's responsibility for both of these registrations. See
also infra section III.A.
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The substantive ground for the proceeding, as alleged in the OSC,
is that Respondent ``committed such acts as would render . . . [his]
registration under 21 U.S.C. 823(f) inconsistent with the public
interest. See 21 U.S.C. 824(a)(4).'' Id. at 2. Specifically, the OSC
alleges that Respondent issued unlawful controlled substance
prescriptions, that this ``conduct reflects negative experience in
prescribing with respect to controlled substances in violation of 21
U.S.C. 823(f)(2),'' and that Respondent ``failed to comply with
applicable federal and state laws relating to controlled substances in
violation of 21 U.S.C. 823(f)(4).'' Id. The OSC also alleges that a
California medical expert reviewed Respondent's medical files and
Controlled Substance Utilization Review and Evaluation System
(hereinafter, CURES) reports and concluded that Respondent's ``issuance
of each prescription fell below minimal
[[Page 21182]]
medical standards applicable to the practice of medicine in
California.'' Id. at 3. The OSC sets out specifics of Respondent's
alleged prescribing for six individuals to support its allegations. Id.
at 4-10.
According to the OSC, in view of the information before the DEA at
the time, the former Acting Administrator preliminarily found that
Respondent's continued registration was ``inconsistent with the public
interest,'' that Respondent's issuance of multiple controlled substance
prescriptions was ``without any legitimate medical purpose,'' and that
his ``continued registration during the pendency of these proceedings
would constitute `an imminent danger to the public health or safety'
because of the substantial likelihood of an imminent threat that death,
serious bodily harm, or abuse of a controlled substance will occur in
the absence of . . . suspension.'' Id. at 10-11. Citing 21 U.S.C.
824(d), 21 CFR 1301.36(e), and other authorities, the former Acting
Administrator suspended, ``effective immediately'' and ``until a final
determination is reached in these proceedings,'' BR0869719, BA7661564,
and DATA-Waiver No. XR0869719, and directed the DEA Special Agents and
Diversion Investigators serving the OSC to take possession of those
certificates. Id. at 11.
The OSC notified Respondent of his right to request a hearing on
the allegations or to submit a written statement while waiving his
right to a hearing, the procedures for electing each option, and the
consequences for failing to elect either option. Id. (citing 21 CFR
1301.43). According to the Government's Notice of Service, a member of
the DEA Riverside District Office personally served the OSC on
Respondent on August 9, 2019. ALJX 2 (Government's Notice of Service of
Order to Show Cause and Immediate Suspension of Registration dated
August 12, 2019), at 1.
By letter dated August 20, 2019, Respondent timely requested a
hearing. ALJX 3, at 1. The matter was placed on the docket of the
Office of Administrative Law Judges and assigned to Administrative Law
Judge Charles Wm. Dorman (hereinafter, ALJ). During the pre-hearing
phase of this proceeding, the parties agreed to and submitted 116 joint
stipulations (hereinafter, Jt. Stip.) that, at the hearing, the parties
accepted as ``binding facts in these proceedings.'' Prehearing Ruling
dated September 20, 2019, at 2-10; Parties' Additional Joint
Stipulations dated October 28, 2019, at 1-13; Transcript page number
(hereinafter, Tr.) 9. The final, agreed-to Stipulations as set out by
the ALJ are:
Controlled Substances
1. Tetrahydrocannabinol (hereinafter, THC) is an illicit Schedule I
Controlled Substance pursuant to 21 CFR 1308.11(d)(31).
2. Amphetamine salts (Adderall) are Schedule II Controlled
Substances pursuant to 21 CFR 1308.12(d)(1).
3. Fentanyl (Duragesic patch) is a Schedule II Controlled Substance
pursuant to 21 CFR 1308.12(c)(9).
4. Hydrocodone (Norco) is a Schedule II Controlled Substance
pursuant to 21 CFR 1308.12(b)(1)(vi).
5. Hydromorphone (Dilaudid) is a Schedule II Controlled Substance
pursuant to 21 CFR 1308.12(b)(1)(vii).
6. Methadone is a Schedule II Controlled Substance pursuant to 21
CFR 1308.12(c)(15).
7. Oxycodone (Oxycontin or Roxicodone) is a Schedule II Controlled
Substance pursuant to 21 CFR 1308.12(b)(1)(xiii).
8. Oxycodone-acetaminophen (Percocet) is a Schedule II Controlled
Substance pursuant to 21 CFR 1308.12(b)(1)(xiii).
9. Alprazolam (Xanax) is a Schedule IV Controlled Substance
pursuant to 21 CFR 1308.14(c)(2).
10. Carisoprodol (Soma) is a Schedule IV Controlled Substance
pursuant to 21 CFR 1308.14(c)(6).
11. Clonazepam (Klonopin) is a Schedule IV Controlled Substance
pursuant to 21 CFR 1308.14(c)(11).
12. Diazepam (Valium) is a Schedule IV Controlled Substance
pursuant to 21 CFR 1308.14(c)(16).
13. Promethazine with codeine is a Schedule V Controlled Substance
pursuant to 21 CFR 1308.15(c)(1).
Registrations Associated With Respondent
14. Respondent is registered as a practitioner with the DEA to
handle controlled substances in Schedules II through V under DEA COR
number BR0869719 at 73-950 Alessandro Drive, Suite 4, Palm Desert,
California 92260.
15. Respondent's DEA COR expires by its terms on April 30, 2021.
16. Government Exhibit 1 contains a true and correct copy of
Respondent's DEA COR number BR0869719.
17. Respondent operates Aurora Surgery Center LP.
18. Aurora Surgery Center LP is organized in the State of
California as a Limited Partnership.
19. Respondent is listed as the one and only General Partner on
Aurora Surgery Center LP's Certificate of Limited Partnership.
20. Government Exhibit 2 contains a true and correct copy of the
Certificate of Limited Partnership for Aurora Surgery Center LP.
21. Aurora Surgery Center LP is registered as a hospital/clinic
with the DEA to handle controlled substances in Schedules II through V
under DEA COR number BA7661564 at 73-950 Alessandro Drive, Palm Desert,
California 92260.
22. Aurora Surgery Center LP's DEA COR expires by its terms on June
30, 2020.
23. Government Exhibit 1 contains a true and correct copy of Aurora
Surgery Center LP's DEA COR number BA7661564.
24. Respondent is a DATA-waived (Drug Addiction Treatment Act)
physician certified to treat 100 patients for substance abuse.
25. Respondent's DATA-Waiver Identification number is XR0869719.
26. Respondent is licensed in the State of California to practice
medicine pursuant to state license number G59060.
27. Respondent's state medical license expires by its terms on
February 29, 2020.
Investigation
28. Government Exhibit 3 contains true and correct copies of the
administrative subpoenas issued to Respondent, dated January 16, 2019.
29. Government Exhibit 4 contains true and correct copies of the
administrative subpoenas issued to various pharmacies, dated April 19,
2019.
30. Government Exhibit 6 is a true and correct copy of the ``Guide
to the Laws Governing the Practice of Medicine by Physicians and
Surgeons'' published by the Medical Board of California in 2013.
31. Government Exhibit 7 is a true and correct copy of the
``Guidelines for Prescribing Controlled Substances for Pain'' published
by the Medical Board of California in November 2014.
32. Government Exhibit 8 is a true and correct copy of
``Calculating Total Daily Dose of Opioids for Safer Dosage'' published
by the Centers for Disease Control and Prevention (CDC).
33. Government Exhibit 9 contains a true and correct copy of ``New
Safety Measures Announced for Opioid Analgesics, Prescription Opioid
Cough Products, and Benzodiazepines'' published by the Food and Drug
Administration (FDA).
34. Government Exhibit 9 contains true and correct copies of the
FDA labels for Klonopin, Valium, and Xanax.
35. Government Exhibits 10A and 10B contain true and correct copies
of the
[[Page 21183]]
CURES reports for Respondent's prescribing behavior between January 1,
2018 and August 20, 2019.
Patient A.A.
36. Government Exhibits 12A and 12B contain true and correct copies
of Respondent's patient medical file for Patient A.A.
37. On the following 16 occasions, Respondent issued a prescription
for 180 tablets of Percocet 10-325 mg, a prescription for 60 tablets of
Xanax 2 mg, and a prescription for 180 tablets of methadone 10 mg for
Patient A.A.:
a. December 26, 2017
b. February 2, 2018
c. March 7, 2018
d. April 3, 2018
e. May 1, 2018
f. June 1, 2018
g. July 2, 2018
h. August 1, 2018
i. August 31, 2018
j. September 28, 2018
k. October 31, 2018
l. November 30, 2018
m. January 3, 2019
n. January 28, 2019
o. February 27, 2019
p. March 25, 2019
38. Government Exhibit 11 contains true and correct copies of the
prescriptions listed in Stipulation 37.
Patient R.B.
39. Government Exhibits 14A and 14B contain true and correct copies
of Respondent's patient medical file for Patient R.B.
40. Respondent issued the following 44 prescriptions for Patient
R.B.:
a. January 10, 2018: 120 tablets of oxycodone 30 mg and 90 tablets of
ibuprofen 800 mg
b. February 7, 2018: 120 tablets of oxycodone 30 mg, 120 ml
promethazine with codeine 6.25-10 mg syrup, and 90 tablets of ibuprofen
800 mg
c. March 7, 2018: 120 tablets of oxycodone 30 mg, 120 ml promethazine
with codeine 6.25-10 mg syrup, and 90 tablets of ibuprofen 800 mg
d. April 4, 2018: 120 tablets of oxycodone 30 mg, 120 ml promethazine
with codeine 6.25-10 mg syrup, and 90 tablets of ibuprofen 800 mg
e. May 1, 2018: 120 tablets of oxycodone 30 mg, 120 ml promethazine
with codeine 6.25-10 mg syrup, and 90 tablets of ibuprofen 800 mg
f. May 31, 2018: 120 tablets of oxycodone 30 mg, 120 ml promethazine
with codeine 6.25-10 mg syrup, and 90 tablets of ibuprofen 800 mg
g. June 27, 2018: 120 tablets of oxycodone 30 mg, 120 ml promethazine
with codeine 6.25-10 mg syrup, and 90 tablets of ibuprofen 800 mg
h. July 25, 2018: 120 tablets of oxycodone 30 mg, 120 ml promethazine
with codeine 6.25-10 mg syrup, and 90 tablets of ibuprofen 800 mg
i. August 22, 2018: 120 tablets of oxycodone 30 mg, 120 ml promethazine
with codeine 6.25-10 mg syrup, and 90 tablets of ibuprofen 800 mg
j. September 17, 2018: 120 tablets of oxycodone 30 mg and 90 tablets of
ibuprofen 800 mg
k. October 12, 2018: 120 tablets of oxycodone 30 mg and 90 tablets of
ibuprofen 800 mg
l. November 9, 2018: 120 tablets of oxycodone 30 mg and 90 tablets of
ibuprofen 800 mg
m. December 10, 2018: 120 tablets of oxycodone 30 mg, 120 ml
promethazine with codeine 6.25-10 mg syrup, and 90 tablets of ibuprofen
800 mg
n. January 9, 2019: 120 tablets of oxycodone 30 mg and 90 tablets of
ibuprofen 800 mg
o. February 8, 2019: 120 tablets of oxycodone 30 mg, 120 ml
promethazine with codeine 6.25-10 mg syrup, and 90 tablets of ibuprofen
800 mg
p. March 8, 2019: 120 tablets of oxycodone 30 mg and 90 tablets of
ibuprofen 800 mg
q. April 5, 2019: 120 tablets of oxycodone 30 mg and 60 tablets of
ibuprofen 800 mg
41. Government Exhibit 13 contains true and correct copies of the
prescriptions listed in Stipulation 40.
Patient S.D.
42. Government Exhibits 16A, 16B, 16C, and 16D contain true and
correct copies of Respondent's patient medical file for Patient S.D.
43. Respondent issued the following 41 prescriptions for Patient
S.D.:
a. January 16, 2018: 180 tablets of methadone 10 mg, 180 tablets of
Roxicodone 15 mg, and 60 tablets of Soma 350 mg
b. February 14, 2018: 180 tablets of methadone 10 mg, 180 tablets of
Roxicodone 15 mg, and 60 tablets of Soma 350 mg
c. March 21, 2018: 180 tablets of methadone 10 mg, 180 tablets of
Roxicodone 15 mg, and 60 tablets of Soma 350 mg
d. April 20, 2018: 270 tablets of methadone 10 mg, 180 tablets of
Roxicodone 15 mg, and 60 tablets of Soma 350 mg
e. May 18, 2018: 270 tablets of methadone 10 mg, 180 tablets of
Roxicodone 15 mg, and 60 tablets of Soma 350 mg
f. June 14, 2018: 270 tablets of methadone 10 mg, 180 tablets of
Roxicodone 15 mg, and 60 tablets of Soma 350 mg
g. July 18, 2018: 270 tablets of methadone 10 mg, 180 tablets of
Roxicodone 15 mg, and 60 tablets of Soma 350 mg
h. August 15, 2018: 270 tablets of methadone 10 mg, 180 tablets of
Roxicodone 15 mg, and 60 tablets of Soma 350 mg
i. September 18, 2018: 270 tablets of methadone 10 mg, 180 tablets of
Roxicodone 15 mg, and 60 tablets of Soma 350 mg
j. October 19, 2018: 270 tablets of methadone 10 mg, 180 tablets of
Roxicodone 15 mg, and 60 tablets of Soma 350 mg
k. November 19, 2018: 270 tablets of methadone 10 mg, 180 tablets of
Roxicodone 15 mg, and 60 tablets of Soma 350 mg
l. January 2, 2019: 270 tablets of methadone 10 mg, 180 tablets of
Roxicodone 15 mg, and 120 tablets of Soma 350 mg
m. February 4, 2019: 180 tablets of Roxicodone 15 mg and 120 tablets of
Soma 350 mg
n. March 1, 2019: 180 tablets of Roxicodone 15 mg and 120 tablets of
Soma 350 mg
o. April 2, 2019: 180 tablets of Roxicodone 15 mg
44. Government Exhibit 15 contains true and correct copies of the
prescriptions listed in Stipulation 43.
Patient L.D.
45. Government Exhibits 18A and 18B contain true and correct copies
of Respondent's patient medical file for Patient L.D.
46. Respondent issued the following 28 prescriptions for Patient
L.D.:
a. January 8, 2018: 120 tablets of Valium 5 mg, 360 tablets of Dilaudid
8 mg, 60 tablets of amphetamine salts 30 mg, and 30 Duragesic patches
100 mcg/hour
b. March 5, 2018: 120 tablets of Valium 5 mg, 360 tablets of Dilaudid 8
mg, 60 tablets of amphetamine salts 30 mg, and 30 Duragesic patches 100
mcg/hour
c. May 4, 2018: 120 tablets of Valium 5 mg, 360 tablets of Dilaudid 8
mg, 60 tablets of amphetamine salts 30 mg, and 30 Duragesic patches 100
mcg/hour
[[Page 21184]]
d. July 5, 2018: 120 tablets of Valium 5 mg, 360 tablets of Dilaudid 8
mg, 60 tablets of amphetamine salts 30 mg, and 30 Duragesic patches 100
mcg/hour
e. September 5, 2018: 120 tablets of Valium 5 mg, 360 tablets of
Dilaudid 8 mg, and 30 Duragesic patches 100 mcg/hour
f. November 5, 2018: 120 tablets of Valium 5 mg, 360 tablets of
Dilaudid 8 mg, and 30 Duragesic patches 100 mcg/hour
g. January 4, 2019: 120 tablets of Valium 5 mg, 360 tablets of Dilaudid
8 mg, and 30 Duragesic patches 100 mcg/hour
h. March 4, 2019: 120 tablets of Valium 5 mg, 360 tablets of Dilaudid 8
mg, and 20 Duragesic patches 100 mcg/hour
47. Government Exhibit 17 contains true and correct copies of the
prescriptions listed in Stipulation 46.
Patient S.H.
48. Government Exhibit 20A and 20B contains true and correct copies
of Respondent's patient medical file for Patient S.H.
49. On the following 17 occasions, Respondent issued a prescription
for 90 tablets of Roxicodone 30 mg, a prescription for 90 tablets of
Dilaudid 8 mg, and a prescription for 60 tablets of methadone 10 mg for
Patient S.H.
a. December 26, 2017
b. January 29, 2018
c. February 20, 2018
d. March 23, 2018
e. April 23, 2018
f. May 21, 2018
g. June 18, 2018
h. July 18, 2018
i. August 15, 2018
j. September 12, 2018
k. October 10, 2018
l. November 7, 2018
m. December 5, 2018
n. January 2, 2019
o. January 30, 2019
p. February 27, 2019
q. March 27, 2019
50. Government Exhibit 19 contains true and correct copies of the
prescriptions listed in Stipulation 49.
Patient J.M.
51. Government Exhibits 22A, 22B, 22C, and 22D contain true and
correct copies of Respondent's patient medical file for Patient J.M.
52. Respondent issued the following 33 prescriptions for Patient
J.M.
a. January 26, 2018: 180 tablets of OxyContin 80 mg and 240 tablets of
Roxicodone 30 mg
b. February 23, 2018: 180 tablets of OxyContin 80 mg and 240 tablets of
Roxicodone 30 mg
c. March 22, 2018: 180 tablets of OxyContin 80 mg and 240 tablets of
Roxicodone 30 mg
d. April 19, 2018: 180 tablets of OxyContin 80 mg and 240 tablets of
Roxicodone 30 mg
e. May 16, 2018: 180 tablets of OxyContin 80 mg and 240 tablets of
Roxicodone 30 mg
f. June 13, 2018: 180 tablets of OxyContin 80 mg and 240 tablets of
Roxicodone 30 mg
g. July 13, 2018: 180 tablets of OxyContin 80 mg and 240 tablets of
Roxicodone 30 mg
h. August 9, 2018: 180 tablets of OxyContin 80 mg and 240 tablets of
Roxicodone 30 mg
i. September 6, 2018: 180 tablets of OxyContin 80 mg and 240 tablets of
Roxicodone 30 mg
j. September 27, 2018: 90 tablets of alprazolam 2 mg
k. October 5, 2018: 180 tablets of OxyContin 80 mg and 240 tablets of
Roxicodone 30 mg
l. November 5, 2018: 180 tablets of OxyContin 80 mg and 240 tablets of
Roxicodone 30 mg
m. November 26, 2018: 180 tablets of OxyContin 80 mg and 240 tablets of
Roxicodone 30 mg
n. January 4, 2019: 180 tablets of OxyContin 80 mg and 240 tablets of
Roxicodone 30 mg
o. January 31, 2019: 180 tablets of OxyContin 80 mg and 240 tablets of
Roxicodone 30 mg
p. February 26, 2019: 180 tablets of OxyContin 80 mg and 150 tablets of
Roxicodone 30 mg
q. March 28, 2019: 180 tablets of OxyContin 80 mg and 150 tablets of
Roxicodone 30 mg
53. Government Exhibit 21 contains true and correct copies of the
prescriptions listed in Stipulation 52.
Exhibits
54. Respondent stipulates to the admissibility of Government
Exhibits 1-4 and 6-22.
55. Xanax (alprazolam) is a benzodiazepine.
56. Valium (diazepam) is a benzodiazepine.
57. Klonopin (clonazepam) is a benzodiazepine.
Patient A.A.
58. On the following 16 occasions, Respondent prescribed for
Patient A.A. oxycodone for 60 mg a day and methadone for 60 mg a day:
a. December 26, 2017
b. February 2, 2018
c. March 7, 2018
d. April 3, 2018
e. May 1, 2018
f. June 1, 2018
g. July 2, 2018
h. August 1, 2018
i. August 31, 2018
j. September 28, 2018
k. October 31, 2018
l. November 30, 2018
m. January 3, 2019
n. January 28, 2019
o. February 27, 2019
p. March 25, 2019
59. On June 5, 2013, Respondent increased Patient A.A.'s dosage of
Percocet (oxycodone-acetaminophen) 10-325 from 90 tablets to 120
tablets.
60. On July 23, 2013, Respondent increased Patient A.A.'s dosage of
Percocet (oxycodone-acetaminophen) 10-325 from 120 tablets to 180
tablets.
61. On January 11, 2013, Respondent increased Patient A.A.'s dosage
of methadone 10 mg from 90 tablets to 120 tablets.
62. On June 2, 2014, Respondent increased Patient A.A.'s dosage of
methadone 10 mg from 120 tablets to 180 tablets.
Patient R.B.
63. Respondent's first documented visit with Patient R.B. occurred
on January 8, 2016.
64. During Respondent's January 8, 2016 initial visit with Patient
R.B., Patient R.B. reported to Respondent that he was constantly in
pain and had previously taken oxycodone and was then currently taking
six tablets of Norco (hydrocodone-acetaminophen) 10-325 mg a day.
65. During Respondent's January 8, 2016 initial visit with Patient
R.B., Patient R.B. tested positive for THC in a urine drug screen.
66. On January 8, 2016, Respondent issued a prescription for 90
tablets of oxycodone 30 mg to Patient R.B.
67. On February 8, 2016, Respondent had a second visit with Patient
R.B.
68. On Respondent's February 8, 2016 second visit with Patient
R.B., Patient R.B. reported to Respondent feeling much improved, with a
pain level of one or two out of 10.
69. On Respondent's February 8, 2016 second visit with Patient
R.B., Patient R.B. tested positive for THC and for a benzodiazepine.
70. On Respondent's February 8, 2016 second visit with Patient
R.B., Respondent issued a prescription for 90 tablets of oxycodone 30
mg.
71. On the following occasions, Patient R.B. tested positive for
THC in a urine drug screen:
a. January 8, 2016
b. February 8, 2016
[[Page 21185]]
c. April 6, 2016
d. May 4, 2016
e. June 7, 2016
f. July 11, 2016
g. August 8, 2016
h. September 7, 2016
i. October 5, 2016
j. November 2, 2016
k. December 2, 2016
l. January 2, 2017
m. January 30, 2017
n. March 1, 2017
o. March 29, 2017
p. April 26, 2017
q. May 24, 2017
r. June 26, 2017
s. July 24, 2017
t. August 23, 2017
u. September 18, 2017
v. October 16, 2017
w. November 15, 2017
x. December 13, 2017
y. February 7, 2018
72. Respondent did not document in Patient R.B.'s patient file any
urine drug screens performed for Patient R.B. on January 10, 2018 and
between March 7, 2018 and February 8, 2019.
73. On the following 17 occasions, Respondent prescribed Patient
R.B. oxycodone of 120 mg a day:
a. January 10, 2018
b. February 7, 2018
c. March 7, 2018
d. April 4, 2018
e. May 1, 2018
f. May 31, 2018
g. June 27, 2018
h. July 25, 2018
i. August 22, 2018
j. September 17, 2018
k. October 12, 2018
l. November 9, 2018
m. December 10, 2018
n. January 9, 2019
o. February 8, 2019
p. March 8, 2019
q. April 5, 2019
74. On an April 6, 2016 visit with Patient R.B., Respondent
increased Patient R.B.'s oxycodone 30 mg prescription from 90 tablets
to 120 tablets.
75. On an April 6, 2016 visit with Respondent, Respondent
documented in R.B.'s medical file that Patient R.B. reported feeling
improved.
Patient S.D.
76. On the following occasions, Patient S.D. tested positive for
THC:
a. June 19, 2012
b. October 10, 2012
c. December 13, 2012
d. January 11, 2013
e. February 8, 2013
f. March 8, 2013
g. July 12, 2013
h. August 9, 2013
i. September 9, 2013
j. October 7, 2013
k. March 18, 2014
l. April 15, 2014
m. May 14, 2014
n. August 8, 2014
o. October 7, 2014
p. December 9, 2014
q. February 6, 2015
r. March 6, 2015
s. April 29, 2015
t. June 5, 2015
u. July 1, 2015
v. July 29, 2015
w. September 29, 2015
x. December 23, 2015
y. February 24, 2016
z. March 21, 2016
aa. May 23, 2016
bb. July 20, 2016
cc. August 17, 2016
dd. September 16, 2016
ee. October 17, 2016
ff. January 13, 2017
gg. February 13, 2017
hh. March 13, 2017
ii. April 10, 2017
jj. July 5, 2017
kk. August 28, 2017
ll. September 27, 2017
mm. November 22, 2017
nn. December 19, 2017
oo. February 14, 2018
pp. March 21, 2018
qq. April 20, 2018
rr. May 21, 2018
ss. June 14, 2018
tt. August 15, 2018
uu. November 19, 2018
77. On the following three occasions, Respondent prescribed Patient
S.D. methadone at 60 mg a day and oxycodone at 90 mg a day:
a. January 16, 2018
b. February 14, 2018
c. March 21, 2018
78. On the following nine occasions, Respondent prescribed Patient
S.D. methadone for 90 mg a day and oxycodone for 90 mg a day:
a. April 20, 2018
b. May 18, 2018
c. June 14, 2018
d. July 18, 2018
e. August 15, 2018
f. September 18, 2018
g. October 19, 2018
h. November 19, 2018
i. January 2, 2019
79. On the following three occasions, Respondent prescribed Patient
S.D. oxycodone at 90 mg a day:
a. February 4, 2019
b. March 1, 2019
c. April 2, 2019
80. On February 24, 2016, Respondent increased Patient S.D.'s
methadone 10 mg prescription from 120 tablets to 180 tablets.
81. On April 20, 2018, Respondent increased Patient S.D.'s
methadone 10 mg prescription from 180 tablets to 270 tablets.
Patient L.D.
82. Respondent's first documented visit with Patient L.D. occurred
on June 20, 2011.
83. On Respondent's initial June 20, 2011 visit with Patient L.D.,
Respondent documented in Patient L.D.'s patient file that Patient L.D.
was taking amphetamine.
84. During a September 23, 2011 visit, L.D. tested positive for
amphetamine on a urine drug screen.
85. As of the September 23, 2011 visit, Respondent had prescribed
Patient L.D. amphetamine, hydromorphone, fentanyl, and clonazepam.
86. On the following eight occasions, Respondent prescribed Patient
L.D. Duragesic patches at 100 mcg per hour every two days and Dilaudid
for 48 mg a day:
a. January 8, 2018
b. March 5, 2018
c. May 4, 2018
d. July 5, 2018
e. September 5, 2018
f. November 5, 2018
g. January 4, 2019
h. March 4, 2019
87. On January 16, 2012, Respondent increased Patient L.D.'s
prescription for Dilaudid 8 mg from 90 tablets to 180 tablets.
88. On July 14, 2015, Respondent increased Patient L.D.'s
prescription for Duragesic patches 100 mcg/hour from 10 patches (1
patch every 72 hours) to 15 patches (1 patch every 48 hours) for a
thirty day supply.
89. In May and July 2014, Respondent documented in Patient L.D.'s
patient file that Patient L.D. and her husband had been criminally
convicted.
Patient S.H.
90. Respondent's first documented visit with Patient S.H. occurred
on August 24, 2010.
91. On Respondent's visit with Patient S.H. on August 4, 2015,
Patient S.H. tested positive only for oxycodone.
92. On Respondent's visit with Patient S.H. on August 4, 2015,
Patient S.H. reported to Respondent that he was taking Adderall,
hydromorphone, methadone, and oxycodone.
93. An X-Ray taken for Patient S.H. on October 7, 2010 reported
normal results for neck and spine.
94. An MRI taken for Patient S.H. on April 26, 2011 reported normal
results for the spine.
[[Page 21186]]
95. An MRI taken for Patient S.H. on January 17, 2012 reported
normal results for the neck.
96. On the following occasions, Patient S.H. had been prescribed
methadone by Respondent:
a. August 4, 2015
b. September 1, 2015
c. April 24, 2017
d. December 4, 2017
Patient J.M.
97. Respondent's first documented visit with Patient J.M. occurred
on May 17, 2011.
98. On Respondent's initial visit with Patient J.M. on May 17,
2011, Patient J.M. reported to Respondent that he had difficulty
getting OxyContin authorized and wanted to try oxycodone instead.
99. During a June 17, 2011 visit with Patient J.M., Respondent
documented in Patient J.M.'s patient file that Patient J.M. came to the
office with his mother.
100. During a June 17, 2011 visit with Patient J.M., Respondent
documented in Patient J.M.'s patient file that Patient J.M. came to
``plead mercy'' and ask for a second chance at being treated.
101. During a June 17, 2011 visit with Patient J.M., Respondent
issued Patient J.M. a prescription for 180 tablets of oxycodone 30 mg
102. During a June 17, 2011 visit with Patient J.M., Respondent
noted in Patient J.M.'s patient file that he would give Patient J.M.
``[o]ne final chance.''
103. On the following occasions, Respondent checked the CURES
database for Patient J.M.:
a. May 17, 2011
b. June 13, 2011
c. July 15, 2011
d. September 9, 2011
e. August 10, 2012
f. October 12, 2012
g. March 4, 2013
h. June 28, 2013
i. February 28, 2014
j. November 10, 2014
k. May 4, 2016
l. September 6, 2018
104. On March 23, 2012, Respondent increased Patient J.M.'s
oxycodone 30 mg prescription from 180 tablets to 240 tablets.
105. On September 4, 2012, Respondent decreased Patient J.M.'s
oxycodone 30 mg prescription from 240 tablets to 180 tablets.
106. On September 21, 2012, Respondent increased Patient J.M.'s
oxycodone 30 mg prescription from 180 tablets to 240 tablets.
107. Between August and September 2012, Respondent increased
Patient J.M.'s prescription for 90 tablets of OxyContin 60 mg to 180
tablets of OxyContin 80 mg.
108. On the following occasions, Patient J.M. tested positive for
the following controlled substances in a urine drug screen:
a. July 15, 2011: benzodiazepine
b. August 12, 2011: THC
c. September 9, 2011: THC
d. December 2, 2011: THC and benzodiazepine
e. January 27, 2012: benzodiazepine
f. March 23, 2012: THC and benzodiazepine
g. May 18, 2012: THC
h. July 12, 2012: THC and benzodiazepine
i. August 10, 2012: THC
j. September 21, 2012: THC and benzodiazepine
k. November 7, 2012: THC and benzodiazepine
l. December 7, 2012: THC
m. January 7, 2013: THC
n. March 4, 2013: THC
o. March 29, 2013: THC and benzodiazepine
p. May 3, 2013: THC
q. June 28, 2013: THC
r. August 27, 2013: THC
s. November 5, 2013: THC
t. December 3, 2013: THC and benzodiazepine
u. December 27, 2013: THC and benzodiazepine
v. January 30, 2014: THC and benzodiazepine
w. February 28, 2014: THC and benzodiazepine
x. April 1, 2014: THC
y. April 30, 2014: THC and benzodiazepine
z. July 23, 2014: THC and benzodiazepine
aa. August 14, 2014: THC and benzodiazepine
bb. October 13, 2014: THC and benzodiazepine
cc. December 8, 2014: THC and benzodiazepine
dd. March 31, 2015: benzodiazepine
ee. April 29, 2015: THC
ff. June 24, 2015: benzodiazepine
gg. August 21, 2015: THC
hh. November 12, 2015: THC and benzodiazepine
ii. April 4, 2016: THC and benzodiazepine
jj. May 4, 2016: benzodiazepine
kk. September 16, 2016: THC and benzodiazepine
ll. October 13, 2016: THC and benzodiazepine
mm. December 12, 2016: benzodiazepine
nn. May 5, 2017: THC and benzodiazepine
oo. August 4, 2017: THC and benzodiazepine
pp. September 29, 2017: THC and benzodiazepine
qq. October 27, 2017: THC and benzodiazepine
rr. November 27, 2017: THC and benzodiazepine
ss. December 21, 2017: THC and benzodiazepine
tt. January 26, 2018: THC and benzodiazepine
uu. September 6, 2018: THC and benzodiazepine
109. During the periods referenced in Paragraph 108, Respondent had
not prescribed Patient J.M. a benzodiazepine.
110. On a May 5, 2017 visit with Respondent, Respondent documented
in Patient J.M.'s patient file that Patient J.M. had taken a ``headache
pill'' from his mother.
111. On a May 5, 2017 visit with Respondent, Patient J.M. tested
positive for morphine.
112. As of the May 5, 2017 visit with Respondent, Respondent had
not prescribed Patient J.M. any morphine.
113. Respondent's Exhibit 1 is a true and correct copy of the New
England Journal of Medicine article ``No Shortcuts to Safer Opioid
Prescribing.''
114. Respondent's Exhibit 2 is a true and correct copy of an April
10, 2019 letter from the Center for Disease Control and Prevention to
Dr. Alford.
115. Respondent's Exhibit 3 is a true and correct copy of a media
statement from the Center for Disease Control and Prevention titled
``CDC Advises Against Misapplication of the Guidelines for Prescribing
Opioids for Chronic Pain.''
116. Respondent's Exhibit 4 is a true and correct copy of the
American Medical Association Resolution 235 ``Inappropriate Use of CDC
Guidelines for Prescribing Opioids D-120.932.''
ALJ's Recommended Rulings, Findings of Fact, Conclusions of Law and
Decision dated February 25, 2020 (hereinafter, RD), at 24-40.
The hearing in this matter was held in Los Angeles, California,
and, although originally scheduled for four days, lasted five days,
November 18-22, 2019. Notice of Hearing dated October 28, 2019, at 1;
Transcripts Received dated November 18-22, 2019, at 1-5. The RD is
dated February 25, 2020. It recommends that the three registrations at
issue be suspended until August 8, 2021, ``but that . . . [the]
suspensions not be lifted until . . . [Respondent] has met . . . [two]
conditions.'' \2\ RD, at 161. The two conditions are (1) completion of
courses, other than courses used to
[[Page 21187]]
meet any continuing medical education requirement, approved in advance
by DEA in prescribing controlled substances and in preparing and
maintaining patient medical records, and (2) submission to DEA of a
signed ``consent[ ] to inspections by DEA personnel of . . .
[Respondent's] medical practice without the need for DEA personnel to
obtain an administrative inspection warrant prior to conducting an
inspection'' that ``shall be valid for three years from the date . . .
[Respondent's registrations] are restored or renewed, whichever occurs
latest in time.'' \3\ Id. The Government filed exceptions to the RD,
dated March 16, 2020 (hereinafter, Govt Exceptions).
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\2\ The ALJ ``note[d] that . . . [his] Recommendation would be
the same had . . . [he] sustained all of the allegations to which
the Government presented expert testimony.'' RD, at 161.
\3\ The RD ``further recommended that if the Administrator has
not issued a Final Order . . . prior to the dates that . . .
[Respondent's] current . . . [registrations] expire by their own
terms, that if . . . [Respondent] has submitted renewal
applications, that those renewal applications be approved[,] . . .
subject [also] to the two conditions . . . and subject to the
condition that . . . [Respondent] not commit any further violations
of the . . . [Controlled Substances Act (hereinafter, CSA)] between
now and the date of the Final Order.'' RD, at 161.
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Having considered the record in its entirety, I conclude that the
record establishes, by substantial evidence, that Respondent committed
acts rendering his continued registration inconsistent with the public
interest. I further conclude that Respondent did not unequivocally
accept responsibility for the founded violations and that, even if he
had, Respondent did not offer adequate remedial measures.
Accordingly, I conclude that the appropriate sanctions are (1) the
revocation of BR0869719 and BA7661564, along with DATA-Waiver No.
XR0869719; (2) the denial of any pending application(s) to renew or
modify these registrations; (3) the denial of any other pending
application(s) by Respondent or by Respondent on behalf of Aurora
Surgery Center LP for registration in California; and (4) affirmance of
the already issued Order of Immediate Suspension of Registrations. I
make the following findings.
II. California Physicians' and Surgeons' Standard of Care
According to the Controlled Substances Act (hereinafter, CSA),
``Except as authorized by this subchapter, it shall be unlawful for any
person knowingly or intentionally . . . to . . . distribute, . . .
dispense, or possess with intent to . . . distribute[ ] or dispense, a
controlled substance.'' 21 U.S.C. 841(a)(1). The CSA's implementing
regulations state that a lawful controlled substance order or
prescription is one that is ``issued for a legitimate medical purpose
by an individual practitioner acting in the usual course of his
professional practice.'' 21 CFR 1306.04(a).
The OSC is addressed to Respondent at his registered medical
practice in California. Therefore, I also evaluate Respondent's actions
according to California law and the applicable California standard of
care.\4\ California, similar to the CSA, requires, during the time
period at issue in this adjudication through to the present, 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) (Effective April 4, 2011, operative Oct. 1,
2011). This statute explicitly includes two examples of prescriptions
that are not legal. First, in salient part, ``an order purporting to be
a prescription which is issued not in the usual course of professional
treatment'' and, second, ``an order for an addict or habitual user of
controlled substances, which is issued not in the course of
professional treatment or as part of an authorized narcotic treatment
program, for the purpose of providing the user with controlled
substances, sufficient to keep him or her comfortable by maintaining
customary use.'' Id. California makes the violation of this provision a
criminal offense punishable by imprisonment, fine, or both. Id.
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\4\ See Gonzales v. Oregon, 546 U.S. 243, 269-71 (2006); see
also OSC, at 2-3.
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Other provisions of the California Code further address the
characteristics of a lawful controlled substance prescription. For
example, the Health and Safety Code prohibits the knowing prescribing
of a controlled substance ``to or for any person'' ``[e]xcept in the
regular practice of his or her profession.'' Cal. Health & Safety Code
Sec. 11154(a) (Current with urgency legislation through Ch. 145 of
2021 Reg.Sess.). Another example is a provision of the Business and
Professions Code, in effect during the period of the violations alleged
in the OSC, which stated that ``[p]rescribing . . . dangerous drugs . .
. without an appropriate prior examination and a medical indication,
constitutes unprofessional conduct.'' \5\ Cal. Bus. and Prof. Code
Sec. 2242(a) (Effective Jan. 1, 2007 to Oct. 10, 2019). By way of
further example, section 725(a) of the Business and Professions Code
states that ``[r]epeated acts of clearly excessive prescribing . . . of
drugs or treatment . . . is unprofessional conduct for a physician.''
Cal. Bus. & Prof. Code Sec. 725(a) (Effective Jan. 1, 2008 to the
present). Section 725 makes such clearly excessive prescribing a
misdemeanor punishable by fine, imprisonment, or both. The provision
explicitly states that a ``practitioner who has a medical basis for
prescribing, furnishing, dispensing, or administering dangerous drugs
or prescription controlled substances shall not be subject to
disciplinary action or prosecution,'' and ``[n]o physician and surgeon
shall be subject to disciplinary action pursuant to this section for
treating intractable pain in compliance with section 2241.5.'' \6\ Id.
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\5\ The California statutory definition of ``dangerous drug''
includes any drug whose dispensing without a prescription is
prohibited by federal law. Cal. Bus. & Prof. Code Sec. 4022
(Effective Jan. 1, 2004 to the present).
\6\ Section 2241.5 of the California Business & Professions
Code, during the time at issue in this proceeding, concerned a
physician's prescribing of controlled substances for the treatment
of pain or a condition causing pain, including intractable pain.
Cal. Bus. & Prof. Code Sec. 2241.5(a) (Effective Jan. 1, 2007 to
the present). According to that provision, ``[n]o physician . . .
shall be subject to disciplinary action for prescribing dangerous
drugs or prescription controlled substances in accordance with this
section,'' among other things. Cal. Bus. & Prof. Code Sec.
2241.5(b) (Effective Jan. 1, 2007 to the present). The provision
explicitly excepts from its disciplinary action prohibition
violations of section 2234 (regarding gross negligence, repeated
negligent acts, or incompetence), section 2241 (regarding treatment
of an addict), and 2242 (regarding performing an appropriate prior
examination and the existence of a medical indication for
prescribing dangerous drugs), among others. Cal. Bus. & Prof. Code
Sec. 2241.5(c) (Effective Jan. 1, 2007 to the present).
---------------------------------------------------------------------------
The ``Guide to the Laws Governing the Practice of Medicine by
Physicians and Surgeons'' published by the Medical Board of California
(hereinafter, MBC) (7th ed. 2013) (hereinafter, MBC Guide to the Laws),
informs my interpretation of these California statutes and the
applicable California standard of care.\7\ According to the MBC Guide
to the Laws, ``[o]nly physicians . . . are authorized to write
prescriptions under California law'' and ``may prescribe only in the
regular practice of their profession, after an appropriate prior
examination, and may not furnish any controlled substance to persons
not under their care.'' MBC
[[Page 21188]]
Guide to the Laws, at 53. The MBC Guide to the Laws explains that the
``[i]nappropriate prescribing of controlled substances, including
opioids, can lead to drug abuse or diversion and can also lead to
ineffective management of pain, unnecessary suffering of patients, and
increased health costs.'' Id. at 55. It reiterates the statutory
permission, supra, that a ``physician and surgeon . . . may prescribe
for . . . a person under his or her treatment for a medical condition
dangerous drugs or prescription controlled substances for the treatment
of pain or a condition causing pain, including, but not limited to,
intractable pain.'' Id. at 56.
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\7\ GX 6. Respondent did not object to the admission into
evidence of the MBC Guide to the Laws. Tr. 29-30. California law
assigns the MBC the responsibilities of, among other things,
enforcing the disciplinary and criminal provisions of the California
Medical Practice Act, revoking or otherwise limiting certificates
after the conclusions of disciplinary actions, reviewing the quality
of medical practice carried out by physician and surgeon certificate
holders under its jurisdiction, and issuing licenses and
certificates under its jurisdiction. Cal. Bus. & Prof. Code Sec.
2004 (Current with urgency legislation through Ch. 145 of 2021
Reg.Sess). Accordingly, the MBC Guide to the Laws informs my
understanding of the standard of care applicable in this matter.
---------------------------------------------------------------------------
The MBC Guide to the Laws sets out the California Medical Board's
expectation that ``physicians . . . follow the standard of care in
managing pain patients.'' Id. at 57. The MBC Guide to the Laws states
that the standard of care includes the ``accomplish[ment] of a medical
history and physical examination,'' meaning ``an assessment of the
pain, physical and psychological function; a substance abuse history;
history of prior pain treatment; an 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.'' Id. It explains, among other things, that the ``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.
The MBC Guide to the Laws discusses the treatment plan, advising
that it ``should state objectives by which the treatment plan can be
evaluated, such as pain relief and/or improved physical and
psychosocial function, and indicate if any further diagnostic
evaluations or other treatments are planned.'' Id. It explicitly points
out that ``the physician and surgeon should tailor pharmacological
therapy to the individual medical needs of each patient'' and that
``[m]ultiple 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 ``annotations'' associated with this
section of the MBC Guide to the Laws state that ``[p]hysicians and
surgeons may use control of pain, increase in function, and improved
quality of life as criteria to evaluate the treatment plan'' and
``[w]hen the patient is requesting opioid medications for his or her
pain and inconsistencies are identified in the history, presentation,
behaviors or physical findings, physicians and surgeons who make a
clinical decision to withhold opioid medications should document the
basis for their decision.'' Id.
The next section of the MBC Guide to the Laws concerns ``informed
consent.'' Id. at 58. This section states that the ``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.'' Id. The annotation for this section states, in part,
that 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.
The MBC Guide to the Laws next addresses the matter of ``periodic
review.'' Id. It makes three points. First, it states that the
``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.'' Id. Second, it explains
that ``[c]ontinuation or modification of controlled substances for pain
management therapy depends on the physician's evaluation of progress
toward treatment objectives.'' Id. Third, it elaborates by stating
that, ``[i]f 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.'' Id. Regarding the process of determining whether the
response to treatment is satisfactory, the MBC Guide to the Laws states
that satisfactory response to treatment ``may be indicated by the
patient's decreased pain, increased level of function, or improved
quality of life.'' Id. It also notes that physicians and surgeons
``should . . . consider[ ]'' ``[i]nformation from family members or
other caregivers . . . in determining the patient's response to
treatment.'' Id.
The next part of the MBC Guide to the Laws is about consultation.
Id. It states that physicians and surgeons ``should consider referring
the patient as necessary for additional evaluation and treatment in
order to achieve treatment objectives.'' Id. It addresses abuse and
diversion by stating 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. It also warns that the ``management of pain
in patients with a history of substance abuse requires extra care,
monitoring, documentation, and consultation with addiction medicine
specialists, and may entail the use of agreements between the provider
and the patient that specify the rules for medication use and
consequences for misuse.'' Id.
The last section in this part of the MBC Guide to the Laws is
entitled, ``Records.'' Id. at 59. It states that physicians and
surgeons ``should 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.'' Id. The MBC Guide to the Laws
also states that ``[t]here is not a minimum or maximum number of
medications which can be prescribed to the patient under either federal
or California law.'' Id.
In compiling the California standard of care applicable to this
matter, I looked for, but did not find, any relevant exceptions to the
applicable California standard of care I set out above, such as those
suggested by Respondent's Case. Infra sections III.E. and III.F.
The record that the ALJ transmitted to me includes opposing
interpretations of the applicable California standard of care. See,
e.g., RD, at 16-17. My adjudication of these differences begins with
the appropriate scope of the testimony of the Government's expert
witness, includes comparing the testimony of the parties' experts with
the applicable California standard of care I set out above, and
concludes with my determinations of which expert's testimony to credit.
Infra sections III.D., III.E., and III.F.
III. Findings
A. Respondent's DEA Registrations
The parties stipulated that Respondent was registered as a
practitioner in schedules II through V under DEA Certificate of
Registration No. BR0869719 at 73-950 Alessandro Drive, Suite 4, Palm
Desert, California 92260. Jt. Stip. Nos. 14, 16; see also Government
Exhibit (hereinafter, GX) 1, at 3-4. The parties stipulated that
Respondent was also registered as a DATA-waived (Drug Addiction
Treatment Act) physician certified to treat 100 patients for substance
abuse under DATA-Waiver No. XR0869719. Jt. Stip. Nos. 24-25; see also
GX 1, at 3-
[[Page 21189]]
4. This registration expired on April 30, 2021. Jt. Stip. 15; GX 1, at
3-4.
The parties stipulated that Respondent operated Aurora Surgery
Center LP and that Aurora Surgery Center LP was registered as a
hospital/clinic in schedules II through V under DEA Certificate of
Registration No. BA7661564 at 73-950 Alessandro Drive, Palm Desert,
California 92260. Jt. Stip. Nos. 17-21; see also GX 1, at 1-2. This
registration expired on June 30, 2020. Jt. Stip. 22; GX 1, at 1-2.
The OSC suspended all of these authorities. OSC, at 11. While
Respondent disputes the immediate suspensions of these authorities and
the allegations in the OSC, he did not submit arguments challenging the
propriety of the OSC's inclusion of registration No. BA7661564 in its
requested relief. See, e.g. Tr. 5; id. at 43-47; id. at Tr. 47-61;
supra n.1.
B. The Investigation of Respondent
The Diversion Investigator (hereinafter, DI) began investigating
Respondent in March 2018 after several databases flagged Respondent as
a ``high-risk opioid prescriber.'' Tr. 27; see also, e.g., Jt. Stip.
Nos. 37, 40, 43, 46, 49, 52, 58-62, 76-81, 91-95, 98-102, 104, 106-112.
The DI's investigative work regarding Respondent, among other things,
showed a ``high volume of [opioid] prescriptions, in the thousands, . .
. at maximum dosages with little or no change and several months at a
time[,] . . . a lot of drug combinations, opioids with benzodiazepines
and opioids with stimulants[, and] . . . the holy trinity of an opioid,
. . . a muscle relaxer and a benzodiazepine.'' Tr. 33. The DI testified
that ``those stood out immediately. . . . [T]hose are the things that
we've been trained to look for in analyzing . . . possible diversion or
misuse of controlled substances.'' Id.
C. The Allegations of Dispensing Violations 8
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\8\ ``Dispense,'' among other things, means ``to deliver a
controlled substance to an ultimate user . . . by, or pursuant to
the lawful order of, a practitioner, including the prescribing . . .
of a controlled substance.'' 21 U.S.C. 802(10).
---------------------------------------------------------------------------
Citing 21 U.S.C. 824(a)(4) and 823(f)(2) and (4), the OSC alleges
that Respondent's continued registration is inconsistent with the
public interest due to his having issued multiple controlled substance
prescriptions outside the usual course of professional practice and
without any legitimate medical purpose. OSC, at 2, 3, 10. As already
discussed, the parties agreed to and submitted 116 joint stipulations.
Supra section I. Accordingly, there is factual agreement on a
significant number of matters.\9\ When there is legally relevant
factual disagreement, my resolution of the disagreement involves the
applicable law and my credibility assessments.
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\9\ Although he stated that he ``would normally accept
stipulations between the parties without question,'' the ALJ
``cannot accept'' Stipulation 52j because ``[a]ll parties apparently
missed the fact that the actual prescription for alprazolam in
September 2018, that is contained in the administrative record, was
[not] written by . . . [Respondent]. RD, at 148. I agree with the
ALJ, although I note that Stipulation 52j is irrelevant to my
Decision/Order given the magnitude and seriousness of the unlawful
controlled substance prescribing evidenced elsewhere in the record.
---------------------------------------------------------------------------
D. The Government's Case
The Government stated its case as being that Respondent ``churn[ed]
out dangerously high dosages of controlled substances month after month
without any medical justification.'' Government's Proposed Findings of
Fact and Conclusions of Law dated January 24, 2020 (hereinafter, Govt
Posthearing), at 1. The Government's arguments include that Respondent
prescribed dangerously high dosages of controlled substances for years
without performing initial physical examinations and evaluations,
without performing periodic urine drug screens (hereinafter, UDSes),
without addressing aberrant UDSes, without justifying increased
dosages, without justifying dangerous controlled substance combination
prescribing, and without adequately resolving indicia of abuse and
diversion. Id. The Government presented its case with two witness, the
DI and its expert witness, Timothy Munzing, M.D., and with about 1,750
pages from Respondent's medical records. See id. at 43. According to
the Government, Respondent's ``insistence that he simply did not
document his reasoning or actions was not credible,'' his
``recollection was faulty,'' he ``essentially admitted that he knew and
was okay with his patient's drug abuse,'' and was ``nowhere near
contrite.'' Id. at 1.
Regarding its expert, the Government offered Dr. Munzing ``as a
medical expert in the treatment of pain with controlled substances in
the State of California.'' Tr. 68. According to the RD, Dr. Munzing
``is not listed as a pain specialist'' on Kaiser's roster of pain
specialists, ``does not have fellowship training in pain management,''
and was accepted ``as a medical expert in the treatment of pain with
controlled substances in the State of California'' over Respondent's
objection. RD, at 12. According to the RD's third footnote,
``[s]ignificantly, Dr. Munzing was not proffered as an expert in the
standard of care in California, or as an expert concerning the usual
course of professional practice in California.'' Id. at 12, n.3; see
also id. at 13 (``Although not proffered as an expert in such, Dr.
Munzing provided extensive testimony in general terms about the
standard of care in California.''); id. at 17 (``I find Dr. Munzing's
testimony concerning the general standard of care to be credible. Since
he was not proffered as an expert in the standard of care in
California, or in the usual course of professional practice in
California, I give limited weight to that testimony.''). The RD's third
footnote also records the ALJ's awareness that the ``Acting
Administrator previously accepted Dr. Munzing as an `expert in standard
of care for prescribing controlled substances in California,' in a
previously published Agency decision.'' Id. at 12, n.3. The footnote
elaborates by stating that ``[t]here was no hearing in that case,
however, and the Acting Administrator relied on Dr. Munzing's
declaration, with no expert evidence presented by the respondent.'' Id.
As the RD also notes, Respondent objected to the Government's
proffer of Dr. Munzing and the ALJ determined that Respondent wanted to
voir dire Dr. Munzing. Tr. 68. Voir dire ensued.\10\ Id. at 69-83.
Respondent's voir dire addressed Dr. Munzing's exposure to, and
knowledge of, the applicable standard of care. See, e.g., id. at 71
(Respondent during voir dire: ``Now you mentioned that you took a
couple of courses on pain management and that's how you began to get
your exposure to pain . . . standards of care?''); id. at 72 (Dr.
Munzing during voir dire: ``I am considered to be a specialist in the
prescribing of opiates as far as for pain.''); id. at 81 (Respondent
during voir dire: ``Do you believe as a physician . . . that a
physician who's treating 30 patients for a particular condition over
[[Page 21190]]
10 years and a patient [sic] who has treated 3,000 patients, that the
person who treated the 3,000 patients might have a better understanding
of the medications and the impacts and the standard of care?''). After
the conclusion of Respondent's voir dire, the Government again offered
Dr. Munzing ``as an expert on the treatment of pain with controlled
substances in California.'' Id. at 83. The ALJ ruled immediately,
stating that he ``recognize[d] Dr. Munzing as an expert, relying upon
the Gonzalez case, 76 FR [63118], a 2011 case from DEA'' and ordered
the Government to proceed with questioning. Id. at 83-84. I find
substantial evidence in Respondent's voir dire of Dr. Munzing that it
was clear to Respondent that the Government was offering Dr. Munzing as
an expert in the applicable standard of care.\11\
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\10\ During Dr. Munzing's direct testimony and during
Respondent's cross examination of Dr. Munzing, Respondent moved to
strike portions of Dr. Munzing's testimony. I do not always agree
with the ALJ's decisions to sustain Respondent's objections and to
strike Dr. Munzing's testimony. See, e.g., Tr. 305-06 (Respondent's
interruption of Dr. Munzing's response to Respondent's question with
his motion to strike Dr. Munzing's in-process answer as non-
responsive and the ALJ sustaining the motion); id. at 384-85; id. at
562-63; but see id. at 387-88. Other times, I agree with the ALJ's
handling of Respondent's motions to strike Dr. Munzing's testimony.
See, e.g. id. at 334-35 (ALJ's second and third rulings during a
line of questioning denying motions to strike because the ALJ
``ha[s]n't heard the rest of the answer yet'' and because the ALJ
``think[s] it's not as responsive as . . . [Respondent] wanted'').
To benefit Respondent, despite my disagreement, I accept all of the
ALJ's rulings on Respondent's objections and I do not consider any
of Dr. Munzing's stricken testimony in my Decision/Order.
\11\ See also United States v. Diaz, 876 F.3d 1194, 1199 (9th
Cir. 2017) (citing United States v. Chube, 538 F.3d 693, 698 (7th
Cir. 2008) (``When all is said and done, we agree with the
Government that it is impossible sensibly to discuss the question
whether a physician was acting outside the usual course of
professional practice and without a legitimate medical purpose
without mentioning the usual standard of care.'')).
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While the RD finds ``Dr. Munzing's testimony to be thorough,
detailed, and internally consistent,'' it is also critical of it and
lists ``several aspects'' of Dr. Munzing's ``testimony and
qualifications'' that ``detract from his overall credibility.'' RD, at
14; see also id. at 15-17. For example, the RD states that Dr. Munzing
``was going out of his way to assist the Government in presenting its
case,'' ``was not simply stating his professional expert opinion in an
unbiased manner,'' ``refused to concede rather obvious points,''
``frequently volunteered testimony beyond a pending question, testimony
beneficial to the Government . . . [that] was distracting and
unnecessarily extended the hearing,'' and ``did not seem as familiar
with the facts or the law as he should have been as an expert
witness.'' Id. at 14-16.
I do not share all of the RD's perspectives and conclusions about
Dr. Munzing.\12\ Regarding the ``rather obvious points'' that the RD
states Dr. Munzing ``refused to concede,'' the RD cites Dr. Munzing's
refusal to state that Respondent ``had more experience treating chronic
pain patients than he did.'' Id. The RD correctly characterizes Dr.
Munzing's testimony to be that Respondent ``may have more experience in
the procedural end of it, but `in the area of appropriate pain
management, I, not sure I would say that.' '' Id. The RD criticizes Dr.
Munzing by stating that ``the questions asked nothing about appropriate
care.'' \13\ Id.
---------------------------------------------------------------------------
\12\ Regarding ``not seem[ing] as familiar with the facts or the
law as he should have been as an expert witness,'' the RD states
``[f]or example, Dr. Munzing relied on the . . . [Centers for
Disease Control and Prevention's Guideline for Prescribing Opioids
for Chronic Pain--United States (2016) (hereinafter, CDC
Guidelines)] when formulating his opinions in this case'' and ``[i]t
is obvious that he did not learn that those Guidelines did not apply
to . . . [Respondent] until after he began to testify.'' RD, at 16.
On these points, I note several occasions during voir dire when Dr.
Munzing provided his view of the CDC Guidelines, Respondent objected
as ``not responsive,'' and the ALJ sustained the objection. For
example, on voir dire, Respondent asked Dr. Munzing: ``With respect
to the CDC guidelines, is it your opinion they apply to pain
specialists or not?'' Tr. 82. Dr. Munzing responded by stating that
``these are guidelines. These are not required. But the general
principles, I think, are good principles for everyone who is
prescribing controlled substances. Again, they're not required.''
Id. When Respondent moved to strike ``as not responsive,'' the ALJ
sustained his motion. Id.; see also id. at 77 (Respondent's
questioning of Dr. Munging: ``Q: Are you aware that the CDC
guidelines in 2016 applied to primary care and to family medicine
but are not intended to apply to pain specialists? A: Well, the CDC
guidelines are guidelines strictly. They're not standard of care.
And so the intent is to protect patients and patient safety.''
Respondent: ``Move to strike as not responsive, Your Honor. Judge
Dorman: Granted.''). These struck responses of Dr. Munzing
concerning the CDC Guidelines do state that the CDC Guidelines are
not the standard of care, that there is no requirement for
Respondent to have followed them, and, nevertheless, that they are
``good principles'' commended to ``everyone who is prescribing
controlled substances.'' Id. at 77, 82. Accordingly, I disagree with
the RD that Dr. Munzing is ``not . . . as familiar with the facts or
the law as he should have been as an expert witness,'' impacting Dr.
Munzing's ``overall credibility.'' RD, at 16; see also, e.g., Tr.
532 (Dr. Munzing's testimony that his opinion does not depend on the
strict application of the CDC guidelines); id. at 533 (Dr. Munzing's
testimony that CDC is only one of many entities that issue
controlled substance related guidelines, along with the American
Academy of Pain Medicine, the American Pain Society, and the Agency
Directors in Washington, and noting that only one aspect of his
report dealt with the CDC's perspective on Morphine Milligram
Equivalents).
\13\ I note that ``appropriate pain management'' and
``appropriate care'' are relevant to my adjudication of the OSC.
---------------------------------------------------------------------------
By way of further example, the RD states that, ``when asked the
general question of whether a doctor [Respondent] who had treated 3,000
patients for a particular condition might have a better understanding
of how to treat those patients than a doctor who had only treated 30,
Dr. Munzing would not agree.'' Id. at 14-15. ``Rather,'' the RD
criticizes Dr. Munzing, stating ``he answered another question. `Having
reviewed some of those patients I have great concern . . . .' It was a
general question, but even during voir dire Dr. Munzing was testifying
about how bad of a doctor he believed . . . [Respondent] to be.'' \14\
Id. at 15.
---------------------------------------------------------------------------
\14\ The question Respondent asked that the RD quotes Dr.
Munzing as answering was: ``Do you believe as a physician that a
patient--that a physician who's treating 30 patients for a
particular condition over 10 years and a patient [sic] who has
treated 3,000 patients, that the person who treated the 3,000
patients might have a better understanding of the medications and
the impacts and the standard of care?'' Tr. 81. In other words,
contrary to what the RD suggests, Respondent did ask Dr. Munzing
about Respondent's ``understanding of . . . the standard of care,''
as well as Respondent's ``understanding of'' controlled substances
and the impact of controlled substances. Id. According to the
transcript, I also note, Dr. Munzing did not state that he treated
``30 patients for a particular condition over 10 years.'' Instead,
after Respondent asked Dr. Munzing, ``Since 2011, approximately how
many patients have you managed for chronic pain,'' Dr. Munzing
responded ``[p]robably in the neighborhood of 30 to 50 on an ongoing
basis.'' Id. at 71. Respondent followed up, asking, ``With respect
to, I think you said between 30 and 50 patients total that you've
managed in the last 10 years with chronic pain, what percentage of
those were you prescribing medications to?'' Id. at 72 (emphasis
added). Dr. Munzing responded that, ``I should probably rephrase
that, is [sic] those are the ones who probably were being prescribed
probably about 30 opiates on an ongoing basis. If you want to know
total patients with chronic pain at any time, that would be
hundreds.'' Id.
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I do not share these RD criticisms. For example, when Respondent
asked Dr. Munzing whether Respondent ``has significantly more
experience treating chronic pain patients than you do,'' Dr. Munzing's
response agreed, in part, when he said that Respondent did have more
experience ``especially in the procedural end of it.'' Tr. 80. I credit
Dr. Munzing because he gave an honest answer, even admitting the dearth
of his experience ``in the procedural end of it.'' Id. In the context
of this proceeding, I further note Dr. Munzing's obvious appreciation
that my responsibilities under the CSA do not call for me to rubber
stamp a registrant's controlled substance prescribing based on the
``significantly more experience'' he might have ``treating chronic pain
patients than'' the Government's expert witness. Id. Instead, Dr.
Munzing's responses to Respondent's voir dire show me that Dr. Munzing
knows to distinguish between the number of individuals a registrant has
seen in his practice and the registrant's compliance with the
applicable standard of care when ``treating'' those individuals. See
id.
As already discussed, when the ALJ recognized Dr. Munzing as an
expert, he stated that he was doing so ``relying upon the Gonzalez
case.'' \15\ Id. at 84. He did not, however, identify the relevant
portion of Gonzalez upon which he was relying. Id. My review of the
Chief ALJ's (adopted) Recommended Decision in Gonzalez, as I endeavor
to understand the ALJ's thought process, indicates that
[[Page 21191]]
the Government expert ``was offered and accepted as an expert in the
area of pain management.'' 76 FR at 63125. I note that the Government,
in this matter, similarly offered Dr. Munzing ``as an expert in the
treatment of pain with controlled substances in California.'' Tr. 68.
---------------------------------------------------------------------------
\15\ In Carlos Gonzalez, M.D., 76 FR 63118 (2011), the then-
Administrator adopted the Recommended Decision of the Chief
Administrative Law Judge, John J. Mulrooney, II, ``except as
discussed below.'' 76 FR at 63118.
---------------------------------------------------------------------------
In Gonzalez, the Chief ALJ criticized the report of the
Government's expert witness as being ``confusing and singularly
unhelpful,'' and ``disorganized, unfocused, and written in a manner
that bespeaks a free association narration of documents and other items
provided to him by the Government in no particular order.'' 76 FR at
63125. The Chief ALJ was also critical that the Government's expert in
Gonzalez was ``asked to review a mass of paper wherein patient charts
that were eventually properly admitted into evidence are interspersed
with DEA investigative reports and other documents that were not.'' Id.
The RD in this matter gives no indication that the ALJ has these, or
similar, criticisms.
At the same time, the Chief ALJ's (adopted) Recommended Decision in
Gonzales attributes to the Government's expert witness, and relies on,
input regarding the applicable standard of care and whether the
respondent prescribed and dispensed controlled substances other than
for a legitimate medical purpose or outside the usual course of
professional practice. See, e.g., 76 FR at 63145-46 (``The
uncontroverted and persuasive testimony of the Government's expert . .
. established, by a preponderance of the evidence, that the
Respondent's prescribing practices fell well below the applicable
standard in Florida regarding the controlled substances prescribed and
dispensed to the undercover agents, as well as to the patients whose
charts he reviewed. On this record, the Government has established that
the Respondent employed his . . . [registration] and/or allowed/enabled
others to do so in a manner where controlled substances were prescribed
and dispensed for other than a legitimate medical purpose or outside
the usual course of professional practice, based on the absence of
acceptable physician-patient relationships and even minimal due care in
documentation as those concepts are dealt with under federal and
Florida state law.''). In other words, despite concerning issues, such
as with the expert's report, the Chief ALJ, in Gonzalez, credited the
testimony of the Government's expert witness in his (adopted)
Recommended Decision.
In sum, the meaning of the ALJ's statement, that he admitted Dr.
Munzing as an expert witness ``relying upon the Gonzalez case,'' is not
apparent from the RD. It is clear, though, that the words the
Government used at this and the Gonzalez hearings to proffer its expert
witnesses are strikingly similar. It is also clear that the Chief ALJ
relied on the testimony of the Government's expert witness in Gonzalez
about the applicable standard of care, respondent's compliance with the
applicable standard of care, and whether respondent's controlled
substance prescribing and dispensing were for other than a legitimate
medical purpose or outside the usual course of professional practice.
Supra. The RD's third footnote and other statements about the scope of
Dr. Munzing's proffered expertise, therefore, do not appear to be
consistent with the ALJ's reliance on Gonzalez when accepting Dr.
Munzing as an expert witness.\16\ Supra. I conclude and find, including
based on the Government's proffer of Dr. Munzing as ``an expert in the
treatment of pain with controlled substances in California'' and on the
ALJ's identification of Gonzalez, that the appropriate scope of Dr.
Munzing's expert witness testimony includes the applicable standard of
care for Respondent's controlled substance prescribing in California,
whether Respondent's controlled substance prescribing complied with the
applicable standard of care, and whether Respondent's controlled
substance prescribing was outside the usual course of professional
practice.
---------------------------------------------------------------------------
\16\ In addition, I note that the ALJ explicitly allowed Dr.
Munzing to give his opinion about the standard of care and the usual
course of professional practice, without raising the scope of Dr.
Munzing's expert testimony. See, e.g., Tr. 206 (ALJ overruling
Respondent's ``vague and ambiguous as to time, and asked and
answered'' objection to the Government's question to Dr. Munzing of
whether ``[i]n . . . [his] opinion, did that combination of
prescriptions [methadone, Roxicodone, and Soma] issued by . . .
[Respondent] meet the standard of care or was issued in the usual
course of professional practice?'').
---------------------------------------------------------------------------
The RD further minimizes Dr. Munzing as an expert witness by
concluding that the ``expert qualifications'' of Respondent's expert
witness, Dr. Standiford Helm, II, are ``superior qualifications to
testify concerning pain management'' and that, ``[i]n fact, . . .
[Respondent's] credentials, based upon experience and training, surpass
Dr. Munzing's credentials with respect to pain management.'' RD, at 16.
The RD, adding the ``standard of care'' to these ``pain management''
conclusions, then states that, ``Thus, on issues of pain management,
and the standard of care concerning pain patients, I will give greater
weight to the testimonies of Dr. Helm and to that of . . .
[Respondent]'' than to Dr. Munzing.\17\ Id. at 16-17. Based on my
analysis of the applicable standard of care, supra, and my review of
the entire record transmitted to me, I reach a different conclusion.
---------------------------------------------------------------------------
\17\ The RD continues, ``[t]hat being said, I find Dr. Munzing's
testimony concerning the general standard of care to be credible.
Since he was not proffered as an expert in the standard of care in
California, or in the usual course of professional practice in
California, I give limited weight to that testimony.'' RD, at 17.
---------------------------------------------------------------------------
My responsibilities under the CSA and the content of the OSC issued
to Respondent mean that the focuses of my adjudication of this matter
include the applicable standard of care for controlled substance
prescribing, whether Respondent issued controlled substance
prescriptions in compliance with the applicable standard of care, and
whether Respondent issued controlled substance prescriptions outside
the usual course of professional practice. While the experience of an
expert is important in my assessment of the weight to give the expert's
testimony, the reliability of that testimony is paramount. According to
the Supreme Court, evidence and expert testimony must `` `assist the
trier of fact to understand the evidence or to determine a fact in
issue.' This condition goes primarily to relevance,'' and ``any and all
scientific testimony or evidence admitted . . . [must] not only [be]
relevant, but reliable.'' Daubert v. Merrell Dow Pharmaceuticals, Inc.,
509 U.S. 579, 589, 591 (1993). In assessing reliability, an expert's
experience, standing alone, is not a sufficient foundation for
rendering reliable any conceivable opinion an expert may express. See,
e.g., United States v. Frazier, 387 F.3d 1244, 1261 (11th Cir. 2004).
Further, an expert's overwhelming qualifications may bear on the
reliability of his testimony, but they are by no means a guarantor of
reliability. See, e.g., Quiet Technology DC-8, Inc. v. Hurel-Dubois UK
Ltd., 326 F.3d 1333, 1341 (11th Cir. 2003). Accordingly, I use ``what
is known,'' in this situation, the applicable standard of care drawn
from California law and issuances of the MBC, supra section II, to
evaluate the reliability of the record expert witness testimony, not
merely each expert's experience and training. See, e.g., United States
v. Frazier, 387 F.3d at 1261.
Dr. Munzing testified that the MBC Guide to the Laws ``informed . .
. [his] opinion on what the standard of care is in California and what
is done in the usual course of professional practice.''
[[Page 21192]]
Tr. 85. He also testified that the ``main categories'' of the MBC Guide
to the Laws are ``very consistent with the general practice of medicine
. . . even though the fine details may pertain to controlled
substances.'' Id. at 87-88. Dr. Munzing testified about the main
categories of the applicable standard of care as addressed in the MBC
Guide to the Laws and the ``fine details.'' Id. at 528 (Dr. Munzing's
testimony identifying history, physical examination, evaluation,
minimizing risk, and the dangers of combination of medicines); see
also, e.g., id. at 87-89 (Dr. Munzing specifically agreeing with the
Annotation in the MBC Guide to the Laws that ``[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'').\18\
---------------------------------------------------------------------------
\18\ Dr. Munzing defined ``chronic pain'' as ``probably over
three months in nature . . . [although] [s]ome may use a shorter
time frame or longer, but . . . three months is a time frame that
many people will utilize. And so acute pain is what suddenly
happens. It usually gets better, but sometimes it reverts into an
ongoing, . . . chronic pain, and that's for a longer period of
time.'' Tr. 89.
---------------------------------------------------------------------------
Dr. Munzing's testimony in response to questions about whether the
applicable standard of care or the usual course of professional
practice in California for the treatment of pain with controlled
substances depends on the specialty of the prescribing physician is
consistent with the MBC Guide to the Laws.\19\ Dr. Munzing testified
that the applicable standard of care and usual course of professional
practice in California apply equally to any physician prescribing
controlled substances for chronic pain over a long period of time
regardless of the physician's specialty. Id. at 123-25. He specifically
testified that ``taking history, do[ing] an exam, trying to mitigate
risk, informed consent, those key aspects are really whether you're in
family medicine, internal medicine, pain management, whoever is doing
that, whoever's prescribing those medications.'' Id. at 124; see also
id. at 124-25 (``[W]hen I'm working hand in hand with our pain
management specialist, . . . we basically are following the same
standards.''); id. at 528 (Dr. Munzing's testimony that the basic
elements of the applicable standard of care are the same regardless of
prescriber's medical specialty).
---------------------------------------------------------------------------
\19\ The Medical Board of California ``expects physicians and
surgeons to follow the standard of care in managing pain patients.''
MBC Guide to the Laws, at 59 (emphases added). I see nothing in the
MBC Guide to the Laws that states, allows, or suggests a different
application of its contents based on the prescriber's medical
specialty.
In the second annotation to the section entitled ``History/
Physical Examination,'' the MBC Guide to the Laws notes a
differentiation based on where the medical treatment is provided.
Id. That differentiation concerns the complexity of the history and
physical examination ``based on the practice location,'' not based
on the specialty of the physician or surgeon. Id. (emphasis added).
``In the emergency department, the operating room, at night or on
the week-ends,'' the MBC Guide to the Laws states, ``the physician
and surgeon may not always be able to verify the patient's history
and past medical treatment.'' Id. This annotation in the MBC Guide
to the Laws elaborates, without making a distinction based on the
specialty of the treating physician/surgeon, stating ``[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.'' Id.;
see also supra section II.
---------------------------------------------------------------------------
Dr. Munzing testified that the applicable standard of care
addresses taking history, doing a physical examination, developing a
treatment plan and objectives, obtaining informed consent, conducting
periodic reviews, consulting, and record documentation. Id. at 531,
citing MBC Guide to the Laws, at 57-61; see also Tr. 575-80 (Dr.
Munzing responding to the ALJ's questions about what a doctor is
required to do when issuing a new controlled substance prescription and
what, if anything, a doctor is required to document when increasing the
strength or the quantity of a previously prescribed controlled
substance).
Regarding the applicable standard of care first prong of ``History/
Physical Examination,'' Dr. Munzing's testimony tracked and elaborated
on the MBC Guide to the Laws. He testified that ``certainly one would
do a general exam looking at are the medications affecting you in
general,'' specifically mentioning an exam of the heart and lung. Tr.
361. Regarding the specifics of the musculoskeletal exam, Dr. Munzing
testified that the physician looks at the patient ``at rest and seeing
certain movement, flexion, extension, lateral extension, rotation,
straight leg raising test.'' Id. Dr. Munzing testified that
neurological function is also part of the requisite examination to
inform the physician about how the patient is doing, specifically
mentioning sensory motor and deep tendon reflexes. Id. Dr. Munzing
specifically testified that part of the physician's physical
examination is ``actually touch[ing]'' the patient to discern
abnormalities and areas of tenderness, and the change in those
abnormalities and tender areas over time. Id. at 362. I find that Dr.
Munzing's testimony is consistent with, and usefully and helpfully
elaborates on, the ``History/Physical Examination'' section of the MBC
Guide to the Laws. MBC Guide to the Laws, at 59.
Regarding the applicable standard of care third prong of Informed
Consent, Dr. Munzing explained that ``for most of us, the most
dangerous thing that we do is write a prescription for a controlled
substance.'' Tr. 89. He testified that ``consistent with the practice
of medicine, . . . we need to inform the patient about . . . the
potential risks, the potential benefits, the alternatives.'' Id. at 89-
90. He stated that, for controlled substances, an informed consent
includes why the controlled substance is being prescribed, what the
potential risks are, what the side effects, from mild to addiction,
overdose, and death, could include, and that there are potential
complications. Id. at 90-91. Dr. Munzing also testified that it is
insufficient only to give a patient a document that says these are the
potential hazards or benefits and risks of taking this particular drug
and to maintain that document in the medical record. Id. at 596 (Dr.
Munzing's testimony that if a doctor documents that he gave the patient
the informed consent and they discussed it, that ``shows that you
actually did that rather than someone at the front desk just saying
sign this, it's one of 10 forms you find when you come to the office''
and the doctor need not write down everything discussed).\20\
---------------------------------------------------------------------------
\20\ When the ALJ asked Dr. Munzing whether, if a doctor fails
to document informed consent to a controlled substance prescription,
that prescription is issued outside the usual course of professional
practice and for no legitimate medical purpose, Dr. Munzing
responded that he ``would say that if that's the only thing that's
missing, . . . [he] would probably not call it outside--. . . [he]
would be concerned, but . . [he] wouldn't strictly--and also it
depends on the dosages. . . . [I]f we're on huge amounts, then yes.
. . . [I]f we're on large amounts, combination, things like that,
but if someone is on again, hydrocodone five milligrams twice a day,
no, I wouldn't say that if everything else looks fine, but if you're
on high dosages, which are defined whether it be 90, 120, 200, if
you're on dangerous combinations, then yes, you must have, like
anything else that is potentially hazardous, even taking off a mole
off your arm which is pretty minimal, you must have some informed
consent.'' Tr. 594-95.
---------------------------------------------------------------------------
Dr. Munzing testified about the fourth prong of the applicable
standard of care, Periodic Review, describing it as how to see
``whether or not . . . our [chronic pain] management [is] working . .
.[,] [a]re they getting better?'' Id. at 91. He explained that the
Periodic Review involves determining whether there are ways to decrease
pain, to improve function, to mitigate the risk, and to assess
compliance. Id. He also testified that urine drug tests and checking
CURES are part of Periodic Reviews. Id. When the pain improves, Dr.
Munzing testified, ``many times we can then, and really should, try to
decrease the risk by decreasing the medication and looking for safer
alternatives.'' Id.
Regarding the meaning of the fifth prong of the applicable standard
of care,
[[Page 21193]]
Consultation, Dr. Munzing's testimony described it as ``if people are
not getting better . . . or they're getting worse,'' then there is a
consultation with the appropriate specialist. Id. at 92-93. In addition
to giving examples of a need for a cardiology, pain management, and
interventionalist consultation, he testified that ``it may very well be
an addiction medicine specialist to see whether or not they feel
there's evidence that this person may have, in addition to a pain
issue, . . . an opioid use disorder or addictive . . . issue.'' Id. at
93. Concerning the ``special attention'' called for by the Consultation
prong of the applicable standard of care ``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,'' Dr.
Munzing testified that ``[w]hen you're looking at patients, you also
have to look at their social situation and who they're living with or
they're being around.'' Id. He elaborated by testifying that there are
``certain situations where someone may be at risk for having
medications stolen . . . whether it be family members or someone in
their social milieu.'' Id. Dr. Munzing further elaborated by stating
that being around ``people who potentially have legal issues, unless
you know the specifics, it may be that they may be congregating with
people who are putting the medications at higher risk for being
diverted from a legitimate to an illegitimate basis.'' Id. at 93-94.
Concerning records, the sixth prong of the applicable standard of
care, Dr. Munzing testified that ``[i]t's vitally important to have
accurate, complete medical records.'' Id. at 115. ``This is not an area
where you want to skimp,'' he stated. Id. Specifically, according to
Dr. Munzing, ``at every visit one needs to make sure that they document
what they do and don't document things that weren't done.'' \21\ Id.
Dr. Munzing highlighted two areas for medical record documentation.
First, he testified that ``it's important to document what you do when
you have that variances [sic] to explain those so people can look at it
and go, okay, the doctor paid attention to it, whether it be an
abnormal lab test, imaging test, urine drug test, CURES that doesn't
look right, and so the doctor paid attention to it, addressed it.'' Id.
Second, Dr. Munzing identified addressing the pain management plan and
the management of the patient in the records, testifying that the
records need to show that the physician is ``not just throwing [a]
controlled substance at it but in the great scheme of things and making
efforts to try to mitigate the risk . . . making attempts to try to
bring down the medications whenever possible and reduce the potential
interactions between opiates and other medications.'' Id. at 115-16.
---------------------------------------------------------------------------
\21\ Dr. Munzing testified that, with electronic medical
records, ``it's sometimes easy to get things in the records that
didn't really happen.'' Tr. 115.
---------------------------------------------------------------------------
Dr. Munzing testified about the medical care Respondent provided,
and controlled substance prescriptions Respondent issued to, A.A.,
R.B., S.D., L.D., S.H., and J.M. Id. at 125-301). He testified about
why the applicable standard of care requires physicians to reduce the
daily morphine milligram equivalents (hereinafter, MME) they
prescribe.\22\ Id. at 113. He framed his testimony by stating that
physicians ``take care of patients for all kinds of issues that are
inherently dangerous, and constantly look[ ] at how can we minimize and
reduce the risk to the patient.'' \23\ Id. at 112. He stated that
``really . . . there is no safe, inherent safe dosage in opiate.'' Id.
at 119. Dr. Munzing cited studies showing that opiates, ``even at the
level of 50 . . . [MME/day, increase] the risk for overdose and
death.'' Id. at 113. He continued his testimony by stating that
``[o]nce you get to 100 [MME/day], it goes up even farther. It's
approximately 8.9 times more risky for overdose than someone who is on
a very low dosage.'' Id.; see also id. at 120 (Dr. Munzing's testimony
that ``[s]tudies have shown that when you go over 120, the risk of
developing opiate abuse or opiate use disorder goes up . . .[,] [t]he
numbers are as high as 20 to 30 percent over that amount''). Dr.
Munzing testified that the applicable standard of care ``requires that
we try to mitigate the risk any way possible.'' Id. He testified that
there are patients for whom opiates cannot be reduced and that there
are patients who are ``optimized'' at a low dosage that is ``not a very
dangerous level, and so it may be that you continue.'' Id. ``But,'' Dr.
Munzing testified, ``when someone's on the higher end, probably, you
know, somewhere over 100, 120, 150 . . . [MME/day], if there are ways
we can bring them down, you're greatly benefitting them because they
are in the higher risk kind of category.'' \24\ Id. at 114; see also
id. at 807-10 (Dr. Helm's testimony that he thinks it is ``obvious''
that higher doses of controlled substances carry higher risk and that,
if a physician is going to prescribe high doses, the physician has
``got to document why these doses are appropriate'').
---------------------------------------------------------------------------
\22\ Dr. Munzing also testified that there is no ``maximum MME .
. . that a physician can no longer prescribe,'' that ``there are
medically necessary reasons for why a physician might prescribe more
than 90 MME to treat pain,'' but that ``[n]inety is certainly
recognizing that the risks kind of continue going up, and so one
constantly needs to look at the potential risks and potential
benefits.'' Tr. 118-19.
\23\ A non-controlled substance example that Dr. Munzing offered
is the use of chemotherapy. Tr. 113. While chemotherapy has risks,
he stated, it is given to cancer patients. Id. As soon as possible,
he added, the patient is taken off chemotherapy to discontinue those
risks. Id. ``[S]o that really pertains to medicine in general, not
only to controlled substances,'' Dr. Munzing testified. Id.
\24\ The Government asked Dr. Munzing whether ``Calculating
Total Daily Dose of Opioids for Safer Dosage,'' GX 8, a two-page CDC
document, ``inform[ed] . . . [his] opinion on what the standard of
care is for what physicians should do in the usual course of
professional practice in California.'' Tr. 116. Dr. Munzing answered
that ``I don't know that this document does, but the general
concepts do because they're consistent with a lot of other--the CDC
guidelines and others. And so I don't know that this sheet of paper
did, but the concepts certainly do.'' Id. This and other testimony
show that Dr. Munzing familiarizes himself with relevant published
literature and uses material in that literature that is consistent
with the applicable standard of care to assist his implementation of
the applicable standard of care. See, e.g., id. at 110 (Dr.
Munzing's testimony referring to published literature, in this
instance, about the frequency of conducting UDSes based on the
dosage of the prescribed controlled substance); id. at 112-13 (Dr.
Munzing's reference to studies showing that opiates increase the
risk for overdose and death and that twice the MME per day of those
opiates increases that risk about 8.9 times); id. at 113-14 (Dr.
Munzing's reference to two entities' definitions of ``high'' opiate
ranges, analysis of those ranges, and use of that authoritative
input to implement the applicable standard of care to reduce the
risk to, and benefit, patients); id. at 119-20 (Dr. Munzing's
reference to organizations and agencies that are now recommending
more frequent urine drug tests when high dosages of opiates are
being prescribed); id. at 335. Dr. Munzing's practice of
familiarizing himself with relevant published literature and using
material in that literature that is consistent with the applicable
standard of care to assist his implementation of that standard of
care contributes to the value of his testimony to my adjudication of
the OSC. Accordingly, as already discussed, I disagree with the RD's
conclusion that Dr. Munzing ``did not seem as familiar with the
facts or the law as he should have been as an expert witness,''
citing, as an example, Dr. Munzing's statements about the CDC
Guidelines. RD, at 16.
---------------------------------------------------------------------------
Similarly, Dr. Munzing also testified about how, consistent with
the applicable standard of care and the usual course of professional
practice, a physician increases the dosage of a controlled substance.
Id. at 91-92. According to Dr. Munzing, a physician would increase the
dosage of a controlled substance due to ``continued symptoms and . . .
potentially worsening symptoms.'' Id. at 92. Before increasing the
dosage of a controlled substance, the applicable standard of care calls
for an updated history to determine, for example, whether there was a
sudden injury or accident, and an evaluation of the severity of the
associated symptoms, for example, determining whether there are
neurological and other symptoms. Id. Following the applicable standard
of
[[Page 21194]]
care, the physician would do a thorough exam of the pained area, which
may or may not call for imaging and laboratory testing. Id. According
to Dr. Munzing, under the applicable standard of care, the physician is
``to determine that what . . . [the physician is] doing needs to be
increased[, to] weigh that with the increased risk or potential risk .
. . [to] the patient, . . . typically looking at kind of a
multidisciplinary, multimodal way of managing[, and to determine] are
there safer alternatives that we can bring in, whether it be physical
therapy or others, that might be of benefit that may be safer.'' Id.
Dr. Munzing also stated that ``certainly, when you go over 90 [MME],
one needs to make it clear to the patient that . . . the risk . . . is
higher and so, again, the informed consent.'' Id. at 119.
Regarding monitoring, given the increased risk that increased MME
may lead to opiate abuse or opioid use disorder, Dr. Munzing testified
about the physician's continuing need to look for whether there is
``any evidence that there's any opioid abuse going on, addiction going
on.'' Id. at 120. ``[S]o,'' he stated, ``it's more intense monitoring
once you're over'' 120 MME. Id. Referencing ``a number of organizations
and agencies . . . [that] are recommending more frequent urine drug
tests,'' Dr. Munzing's testimony stated that ``monitoring . . .
[patients] more closely . . . , seeing them more frequently, urine drug
tests more frequently, checking CURES or the PDMPs more frequently to
ensure that they're actually complying with what you're doing.'' \25\
Id. at 119-20. Dr. Munzing stated that there are patients who
``desperately need'' high dosages of opioids, ``but one would want to
ensure that they're in full compliance with what you're prescribing and
that you're benefitting [them]--and, again, once you're over . . . [120
MME] constantly trying to see when can we start to step down if at all
possible.'' \26\ Id. at 120.
---------------------------------------------------------------------------
\25\ ``PDMP'' means a Prescription Drug Monitoring Program, such
as CURES.
\26\ I note that there are instances when Dr. Munzing's
testimony sets out the applicable standard of care even though he
does not explicitly state that he is doing so. See, e.g., Tr. 119-
20.
---------------------------------------------------------------------------
Dr. Munzing also testified about the need for physicians to be
looking out for red flags of abuse or diversion.\27\ Id. at 95-96; see
also id. at 581-82 (Dr. Munzing responding to the ALJ's question about
what, if anything, a doctor should do if a patient requests a
particular medication). Stating that ``there's probably a list of at
least 20 or more'' red flags, Dr. Munzing specifically identified
refilling medications early; escalating dosages of opiates; seeing
multiple physicians to get controlled substances; using multiple
pharmacies; driving long distances to see the physician or provider;
and having opiates in combination with benzodiazepines, with
benzodiazepines and muscle relaxants, and with stimulants.\28\ Id. at
95.
---------------------------------------------------------------------------
\27\ Regarding the section in the MBC Guidelines for Prescribing
Controlled Substances for Pain (2014) (hereinafter, MBC Guidelines
for Prescribing) addressing ``Ongoing Patient Assessment'' and Dr.
Munzing's testimony about it, they also are consistent with the MBC
Guide to the Laws. See, e.g., MBC Guide to the Laws, at 58 (material
addressing periodic reviews).
The Government also asked Dr. Munzing to testify about the
section called ``Compliance Monitoring'' in the MBC Guidelines for
Prescribing. Tr. 100-01. Dr. Munzing testified that ``compliance
monitoring'' is ``trying to do the best that we can as prescribers
to ensure that the patient is complying with what we're
prescribing.'' Id. at 100. When asked for examples of what
physicians can do to ensure compliance, Dr. Munzing's testimony
addressed ``monitoring and checking'' CURES which, he stated, is
``[n]ow . . . mandatory in the State of California . . . whether it
be in primary care, specialty care, pain medication--pain
management, we have to check all patients on chronic controlled
substance medications on at least an every four-month basis.'' Id.
at 101. ``And,'' he testified, ``if you start a new medication,
you've got to check it again.'' Id. In response to the ALJ's
questioning, Dr. Munzing testified that checking CURES became
mandatory on October 2, 2018. Id. Some of the controlled substance
prescribing about which the parties stipulated occurred after
October 2, 2018. See, e.g., Stipulations 37 (A.A.), 40 (R.B.), 43
(S.D.), 49 (S.H.), and 52 (J.M.).
\28\ Dr. Munzing's testimony is consistent with the section
called ``Important Information for Patients'' in the Food & Drug
Administration's (hereinafter, FDA) publication entitled ``New
Safety Measures Announced for Opioid Analgesics, Prescription Opioid
Cough Products, and Benzodiazepines'' August 31, 2016, GX 9, at 1-2.
That section states, in part, that ``FDA is warning patients and
their caregivers about the serious risks of taking opioids along
with benzodiazepines or other central nervous system (CNS)
depressant medicines, including alcohol. Serious risks include
unusual dizziness or lightheadedness, extreme sleepiness, slowed or
difficult breathing, coma, and death. These risks result because
both opioids and benzodiazepines impact the CNS, which controls most
of the functions of the brain and body. . . . If you are taking both
opioids and benzodiazepines together, consult your health care
provider to see if continued combined use is needed.'' Id.
---------------------------------------------------------------------------
The Government asked Dr. Munzing to address urine drug testing. Id.
at 102. Dr. Munzing explained that controlled substances are
``scheduled because they're dangerous drugs in many ways.'' Id. at 100.
According to his testimony, ``[i]t's vitally important when you're
prescribing controlled substances . . . to do the best that we can as
prescribers to ensure that the patient is complying with what we're
prescribing'' to determine, for example, ``if there's any conflicts
between medications'' and to try to ``mitigate the risk of the
treatments'' and to ``optimize treatment.'' Id. at 100, 102. Dr.
Munzing testified that drug testing indicates ``whether or not . . .
medications that you're prescribing [are] showing up as they should . .
. [and whether] other things [are] showing up that shouldn't be
there.'' \29\ Id. at 102.
---------------------------------------------------------------------------
\29\ Dr. Munzing testified that the frequency of conducting
urine drug testing ``depends on a lot of issues.'' Tr. 109. Dr.
Munzing stated that ``a lot depends on the dosage that they're on.
Are they on a low dosage, a medium dosage, a high dosage? And are
they on multiple controlled substances? Is it just one opiate, or is
it an opiate and other medications? And so a lot goes into the
determination, but at least once a year, and on high dosage,
probably once a month.'' Id. at 110.
---------------------------------------------------------------------------
Dr. Munzing described aberrant drug test results. Id. at 103-09. He
testified that a positive test for a substance that the physician did
not prescribe is an aberrant result, that ``it's your responsibility to
try to find out why that is there,'' that the result of the inquiry
``should be very well documented in the record,'' and that, ``if it's
not legitimate, then what are your actions based on the non-legitimate
result?'' Id. at 103-04; see also id. at 584-85 (Dr. Munzing's
testimony responding to the ALJ's question about whether the applicable
standard of care requires a doctor to document an aberrant UDS result);
id. at 775 (Dr. Helm's testimony ``agree[ing] that there should be, and
this holds throughout whenever there's a UDS which is not consistent
for whatever reason, including this one, that yes, there should be a
discussion of your findings on the UDS''). Dr. Munzing also testified
that a negative test for a drug that the physician prescribed, when the
testing took place less than 30 days after a 30-day prescription was
filled, is aberrant. Id. at 104. He testified that it's ``incumbent''
on the physician ``to try to investigate'' the negative result. Id.;
see also id. at 111 (Dr. Munzing's testimony equating his use of the
word ``incumbent'' with the ``standard of care in the usual course of
professional practice''). For example, he testified, it could be
negative due to the ``sensitivity of the test, if they're on a fairly
low dosage.'' Id. at 105; see also id. at 110-11 (citing GX 7, at 19).
In such a situation, Dr. Munzing stated that he has ``called the
toxicology lab, talked to the person, and they said, oh, well, the
number was this[, . . .] [i]t's just under that and so they're really
taking it, but it comes across negative.'' Id. at 105; see also id. at
110-11. Dr. Munzing again testified that the physician's inquiry would
be ``well documented in the record so someone looking at it . . .
[knows] that they are taking it, but it just doesn't test positive
because we're looking at a negative positive, not at a
[[Page 21195]]
numerical number.'' Id. at 105; see also id. at 111-12.
Dr. Munzing testified that a negative UDS result for a prescription
drug, filled more than thirty days before the UDS, is aberrant. Id. at
106. He stated that the way such an aberrant result is handled depends
on the circumstances. Id. When the drug that tested negative is a very
high dose of a prescription drug, the individual for whom the drug was
prescribed is ``probably going through withdrawal'' if the individual
is ``really . . . out'' of the drug. Id. at 106-07. Consequently, ``you
need to inquire of them, are you having withdrawal symptoms?'' and
employ one of the standardized objective withdrawal scales to assess
the presence of withdrawal. Id. at 107. Dr. Munzing also testified that
``if people desperately need these medications, they usually will do
everything possible not to run out.'' Id. With that starting point, Dr.
Munzing testified that he would ``use that as an opportunity . . . to
start bringing you down, not necessarily to zero, but start cranking it
down a little bit over time and using that as an opportunity.'' Id. Dr.
Munzing immediately added, ``[b]ut that again would be well documented
in the records.'' Id.
Dr. Munzing also testified that, for non-cancer pain patients, it
is not safe to use marijuana while also taking prescribed opioids due
to the ``inherent risks of THC'' and ``it's . . . [his] responsibility
as a treating physician to try to keep you as safe as possible in . . .
managing . . . patients . . . [a]nd if there's something else coming
into that that . . . [he] can't determine what dosage of THC, . . . it
just puts the patient at much higher risk.'' Id. at 108-09; see also
id. at 701-02 (Dr. Helm's testimony about THC). He also testified that
he has ``seen a few people where they encourage the use of THC as they
are tapering down significantly, and so you can see that this is part
of their management plan.'' Id. at 109. In this instance, ``[a]gain,
that would be very well documented in the medical records exactly what
the plan is, how we're going to reduce that.'' Id.
When the aberrant result is due to non-compliance with the
treatment, the applicable standard of care informs the physician's
response based on the cause of the aberrancy, Dr. Munzing testified.
Id. at 106. For example, Dr. Munzing testified, the physician may treat
for addiction, do more frequent compliance monitoring, or change
treatment. Id. ``So,'' Dr. Munzing testified, ``it all depends on what
you determined was the cause of the aberrancy . . . [b]ut whatever you
choose to do, it needs to be well documented so it's obvious for anyone
else looking at it.'' Id.
E. Respondent's Case
Respondent testified and called one witness, Dr. Standiford Helm,
II, his expert. Id. at 628. According to Respondent's case, he, as a
fellowship-trained pain specialist, received extensive training in both
medication and procedural pain treatments, has an unblemished medical
record, has never been sued for medical malpractice, and has never had
any disciplinary action brought against his license, presumably meaning
his medical license. Respondent's Post-Hearing Brief dated January 24,
2020 (hereinafter, Resp Posthearing), at 2, 21-22. His position is
that, due to the ``totally inaccurate and baseless opinion'' of the
Government expert, eight ``DEA agents raid[ed] his office and then had
his DEA certificate suspended.'' Id. at 2. According to Respondent,
``[t]here was never any malpractice lawsuit; no patient overdose; no
patient harm; no adverse Medical Board action; nor any criminal
activity or even suspicion of malfeasance.'' Id. Respondent's position
is that ``this process has been ruinous to . . . [his] career and
dangerous to his patients'' and the ``destruction of a fellowship-
trained professional all occurred because a family doctor offered
inaccurate opinions without bothering to read the complete medical
records and who lacked basic knowledge on many topics related to
opiates.'' Id. Respondent testified that ``[u]nfortunately, everything
has become so difficult these days. And again, . . . [he has] been
doing this for 30 years, and . . . [his] training is very, very
different.'' Tr. 920.
Respondent testified about each of his medical files at issue in
the OSC and, in the process, gave his perspective on many matters
relevant to this adjudication. Regarding UDSes, Respondent testified
about his use of UDSes in his practice, stating that ``we do our very
best to check'' UDSes and ``have done it for years and years and
years,'' and that they are ``just one component of patient
compliance.'' Id. at 1099-100; see also id. (Respondent's testimony
that CURES is another way to check compliance although he ``clearly
understand[s]'' that CURES only shows prescriptions that are filled,
not prescribed drugs that are being ingested); id. at 1120-22
(Respondent's testimony confirming that S.D. received carisoprodol
prescription from him and from another physician within two weeks of
each other, and admitting that he has no recollection of addressing
that with S.D.).
According to Respondent's testimony, ``under the best
circumstances'' it ``would be preferable'' to have UDS results before
seeing the patient ``but [that] didn't always happen.'' Id. at 1098. He
testified that he did not recall whether he conducted a UDS and did not
document it, or whether he did not conduct a UDS. Id. at 933
(Respondent's testimony that it does not appear that he ordered a UDS
for A.A. in 2011); id. at 935-41 (Respondent's testimony that he was
ordering UDSes in 2011 but that he did not recall whether he had A.A.
take a UDS on her first two visits with him and did not document having
done so, or whether he did not have A.A. take a UDS on those first two
visits).
Respondent testified that he did not consider a UDS to be aberrant
if it is negative for a substance he prescribed, admitting that his
``attorney then, you know, corrected me on that statement.'' Id.; see
also, e.g., id. at 1077-78, 1085; but see id. at 1144-51 (Respondent's
testimony that UDSes are ``appropriate'' when a drug he prescribed is
missing because, even though it was not documented, he ``discussed with
the patient every single time'' and because Respondent had a ``clear
understanding'' with at least one of his patients that the patient
``only took medication that was needed'' and that he ``could afford''
financially). Instead, Respondent testified, he used UDS to look for
the presence of substances that he had not prescribed. Id. at 1098; id.
at 910-15 (Respondent's testimony that he ``wanted to make sure that
there was no illicit substances being used'').
Regarding an A.A. visit when her UDS was aberrant because it was
negative for the Percocet he had prescribed, Respondent testified that
``she only had three Percocet a day . . . [a]nd if she had excessive
knee pain, for the last two weeks, she obviously finished her Percocet
early.'' Id. at 938. When asked if taking medication early was a
deviation from his prescribing instructions, Respondent testified that
it ``[m]ight be a deviation from instructions, but she had an acute
exacerbation of pain that she was trying to treat.'' Id. at 938-39; see
also id. at 950 (Respondent's testimony about another aberrant A.A.
UDS). Regarding A.A.'s methadone-negative UDS in February of 2013,
Respondent testified that ``in this particular case, she took more
[m]ethadone. And she saved the Oxy for the end. So she's playing
around--again assuming no operator error. Assuming no manufacturer's
error. Assuming they didn't read the fake lines. I mean I have to
assume all these things.'' Id. at 957. Respondent testified that he had
no problem with
[[Page 21196]]
A.A.'s ``playing around'' with the controlled substances he had
prescribed for her, testifying that ``she had an allowance of four
[m]ethadone a day. And she took them earlier because she was having
these issues with pain, and she was saving the Oxycodone for later. But
she was using her allowance.'' Id. at 958. He compared A.A.'s ``us[ing]
her allowance'' of controlled substances with a child who receives a
$5.00 allowance, uses it all on Monday, and does not have ``any money
the rest of the week,'' testifying that A.A. is a ``grown-up . . .
[who] can make . . . those [controlled substance dosing] decisions.''
Id. at 946.
When asked if such a deviation from his prescribed controlled
substance dosing was grounds for terminating the doctor-patient
relationship, Respondent interrupted the question, responding ``[u]nder
no . . . circumstances.'' Id. at 939. He testified that A.A. ``had
three Percocet a day . . . [,] 30 milligrams. I know in today's world
three Percocet is devastating. I get it. But three Percocet is not
devast[at]ing to an opioid-tolerant patient who's had three back
surgeries, has significant pain, and has been on pain medication for a
long time.'' Id. According to Respondent's testimony, A.A.'s negative
UDSes ``tell[ ] me that she's not taking any medications that she
wasn't prescribed. And that's what's important.'' Id. at 953; see also
id. at 944-45 (Respondent's testimony that ``if she was taking more
Percocet, that's fine. . . . It's a sign not of abuse, and not of
diversion. It's a sign that she's not having adequate pain relief'');
id. at 964 (Respondent's testimony describing A.A. as someone who ``is
following the rules'' and, therefore, her increasing the Percocet
dosage he prescribed for her ``was no issue'').
When asked why he did not document his thoughts about A.A.'s
aberrant UDS, Respondent testified that ``[b]ecause I'm sure this visit
went on forever and ever. And I'm injecting her knee, and I'm doing
everything. And it was just, it was not of significance to me. . . .
I'm just saying, it was not of concern to me.'' Id. at 940. Also during
his testimony, Respondent dismissed his inaccurately documented medical
records by stating that he was ``so busy talking to the patient'' and
``again, from this chart, that's not a big problem, because it's
historically her left knee,'' not her right knee as he had inaccurately
documented. Id. at 962-63. In his testimony, Respondent admitted that
he is ``the keeper of . . . [his medical] records'' and stated that he
was ``not restoring backwards.'' Id. at 972. According to Respondent's
testimony, ``a lot of the [medical] records have been read wrong and
interpreted wrong because I'm doing a million things at once, and
people are trying to read the exact word.'' Id.
Additionally, Respondent's case highlighted that his medical
records show he explored surgical options, physical therapy, and the
like, reduced the controlled substances he prescribed, complied with
documentation requirements, and reduced pain.\30\ See, e.g., id. at 377
(surgery option explored); id. at 738 (surgery option explored); id. at
437 (injection); id. at 451-52 (injection); id. at 453 (physical
therapy); id. at 742-43 (intrathecal pump); id. at 461-62 (increase
non-opioid therapy); id. at 446 (decrease controlled substances
prescribed); id. at 478-80 in conjunction with GX 14B, at 31-42
(Respondent's medical records for R.B. showing that Respondent
increased oxycodone 30 mg prescription to 150 tablets on June 26, 2017,
due to new ``hand pain'' (finger fracture) injury, reissued the
increased number of oxycodone 30 mg tablets on July 24, 2017, reduced
the number of oxycodone 30 mg tablets prescribed to 140 tablets on
August 23, 2017, and returned the number of oxycodone 30 mg prescribed
to the prescription's May 24, 2017 amount of 120 tablets on October 16,
2017); \31\ Tr. 692 (Dr. Helm's testimony that Respondent, for S.D.,
substituted Zanaflex for Soma and tried to wean S.D. off Norco); id. at
434-35, 663 (spinal cord stimulator trial); id. at 488-89 in
conjunction with GX 18B, at 141 (Respondent's medical records for L.D.
stating ``[w]ould like to attempt to decrease narcotics'' and showing
that Respondent decreased the Fentanyl patch he prescribed for her from
100 micrograms every other day to 75 micrograms every other day); see
also Tr. 490 (discontinuation of Fentanyl patch); but see id. at 504-05
in conjunction with GX 18B, at 76-81 (showing that Respondent resumed
prescribing Fentanyl patches (every three days) after L.D. slipped and
sprained her left knee, and then increased the prescription to every
other day); \32\ Tr. 414-15 (documentation of A.A.'s daughter stealing
controlled substances Respondent prescribed for A.A.); id. at 476
(medical records showing that the controlled substances Respondent
prescribed ``appeared to be reducing'' R.B.'s pain); id. at 485 (Dr.
Munzing's testimony that Respondent managed R.B.'s pain); id. at 515
(Dr. Munzing's testimony that, based on Respondent's notes, L.D.'s pain
appeared to decrease); id. at 519-20 (Dr. Munzing's testimony that
S.H.'s function improved over time); id. at 526 (Dr. Munzing's
testimony that ``pain medication is helping . . . [S.H.] be more
productive'').
---------------------------------------------------------------------------
\30\ I note, however, that Dr. Helm, Respondent's expert,
testified that the difference between when a physician first writes
a prescription for an opioid patient versus when a pain specialist
assumes care of the patient is that the ``option we have of looking
at non-opioid alternatives has been taken away from us.'' Tr. 631-
32.
\31\ See also Tr. 558-60 (Dr. Munzing's testimony) and id. at
684 (Dr. Helm's testimony).
I note that Respondent's medical records for R.B. on this point
are not accurate and, therefore, that they do not comply with the
applicable standard of care. MBC Guide to the Laws, at 61 (accurate
and complete medical records). For four visits, from July 24, 2017
through October 16, 2017, Respondent inaccurately stated under
``Current Medications'' the number of oxycodone 30 mg tablets he
last prescribed for R.B. GX 14B, at 32-38; see also GX 18B, at 70-78
(inaccuracies in medical records concerning Respondent's prescribing
of Fentanyl patches to L.D.). I further note that I did not consider
these matters in my Decision/Order because they were not noticed or
litigated by consent.
\32\ See also Tr. 554-58 (Dr. Munzing's testimony that, although
the x-ray of L.D.'s knee was ``normal'' (GX 18A, at 39), an x-ray
may not show all injuries, and that a Fentanyl patch is a controlled
substance for chronic pain, not for treating an acute injury, such
as a knee injured due to a slip, for a brief period of time); id. at
570-71 (re-cross); id. at 573, 614 (re-direct).
I credit Dr. Munzing's testimony that Fentanyl patches are
normally written for every three days, not every other day as
Respondent prescribed them for L.D. Tr. 489.
---------------------------------------------------------------------------
Based on substantial record evidence, however, Respondent was not
successful at rebutting the OSC's allegations that he prescribed
controlled substances beneath the applicable standard of care and
outside the usual course of professional practice, including that
Respondent failed to conduct the requisite physical examinations,
failed to obtain the requisite history, failed to develop an
appropriate treatment plan, failed to conduct appropriate monitoring of
those for whom Respondent prescribed controlled substances, and failed
to comply with recordkeeping requirements. Supra section II.; infra
section III.F.
[[Page 21197]]
Further, there is substantial record evidence that Respondent did
not identify as problematic requests for specific controlled substances
by name and self-dosing contrary to his prescribed dosing orders. See,
e.g., Tr. 966 (Respondent's testimony that A.A. ``all of a sudden''
said she would like to try Oxycodone instead of Methadone and that is
``perfectly fine'' with him); id. at 1030-32 (Respondent's testimony
about L.D.'s non-appointment appearance at Respondent's office ``with a
crippling illness'' for which she asked Respondent, and received, a
Fentanyl patch (12.5 microgram) prescription, her ensuing complaint
that the dosage he issued for her was too low, L.D.'s subsequent
``classic'' self-dosing ``up to 75 micrograms,'' and his description of
L.D. as ``an actress, to be honest''); see also id. at 1124-28 in
conjunction with GX 18B, at 79-81 (Respondent's testimony that L.D.
``historically treated her pain with either 75 microgram or 100
microgram [Fentanyl] patches,'' that he re-started L.D. on 12.5
microgram per hour Fentanyl patches ``because she had not been on it
for quite some time,'' that L.D. ``found the dosage strength of 75
micrograms per hour helpful in this--what turned out to be a very
devastating injury and cascade of events, this all made absolute
perfect sense,'' and that he was thus justified to prescribe 75
micrograms per hour Fentanyl patches on a visit when L.D.'s UDS was
positive only for benzodiazepine); Tr. 1101-04 (Respondent's testimony
that it is not unusual for his patients, ``within . . . [the] allotted
allowance of the month'' to choose to ``vary,'' despite his prescribing
instructions, the amount of controlled substances ingested each day
``based on . . . activity level and based on what . . . needed to [be]
accomplish[ed] that day'' and that he would tell them ``there would be
a maximum amount that . . . [he] would be comfortable with'' their
ingesting each day); id. at 1039-42, 1108 (Respondent's testimony that
he complied with R.B.'s request for a specific controlled substance
prescription--stating that he ``felt for this man'' given his
experiences with his 86 year-old father whom he ``can't really take
anywhere because he has this cough that embarrasses the entire family
in a restaurant and everything else like that,'' minimizing the
controlled substance prescribing as ``22 doses of cough syrup a
month,'' and pointing out that he stopped prescribing controlled
substances on behalf of other doctors because he ``didn't want to be
further involved in it'').
I decline to adopt Respondent's excuses and arguments to overlook
his failures to follow the applicable standard of care and to act
within the usual course of professional practice. See, e.g., id. at 452
(the prolonged use of anti-inflammatories can cause serious organ
damage); id. at 456 (a loose screw was subsequently discovered in
S.D.'s spine justifying Respondent's ``dramatically increased''
controlled substance prescribing); id. at 481-83 in conjunction with GX
14B, at 11 (a pulmonologist may have subsequently prescribed
Promethazine); Tr. 419-20 (there is no record evidence that
Respondent's controlled substance prescribing led to respiratory
depression, overdose, or side effects); see also id. at 535 (Dr.
Munzing's testimony that ``just because someone doesn't have a terrible
outcome doesn't mean that what you did was correct and right''); id. at
1153-54 (Respondent's testimony stating his belief that another pain
doctor picking up his medical records ``would gain a much greater
knowledge from . . . [his] records than they would many other
physician's records,'' instead of answering the ALJ's direct questions
of whether ``they would be able to pick up from where you left off
based on the content of your records'' and whether ``they [would]
understand what you had'').
Having read and analyzed all of the record evidence, I find that
Respondent is the witness with the most at stake in this adjudication.
I find that, while Respondent's testimony does include reliable
statements, it also includes statement that lack credibility, are
implausible, and/or are not persuasive. I find that Respondent's
testimony must be considered with much caution, and where his testimony
conflicts with credible record evidence and the applicable standard of
care, I do not credit it. Supra section II and section III.D.; infra.
According to Respondent's case, the Government's expert witness is
trained in family medicine, not in pain medicine, and did not do, let
alone complete, a fellowship in pain management. Resp Posthearing, at
23. The testimony of the Government's expert witness, Respondent
charges, ``was rife with error,'' including its reference to the CDC
Guidelines during his evaluation of the controlled substance
prescribing of Respondent, a pain management specialist. Id.
According to Respondent's case, his expert witness, Dr. Standiford
Helm, II, is a ``pre-eminent expert in the area of pain management,''
``holds diplomate status with a number of organizations specializing in
the treatment of pain,'' and has affiliations with various pain
organizations and ``top journals in the area of pain management.'' Id.
at 25-26. Dr. Helm, according to Respondent, ``is one of the authors of
pain guidelines for . . . [the American Society of Interventional Pain
Physicians (hereinafter, ASIPP)], and those guidelines were used as
evidence in this hearing'' and ``has served as an expert reviewer for
the Medical Board of California for pain specialists, because he is a
pain specialist.'' \33\ Id. at 26. Respondent offered, and the ALJ
accepted, Dr. Helm ``as an expert in support of . . . [Respondent] and
the care rendered by . . . [Respondent] to the patients in the areas of
pain management and for these specific treatments for the patients at
issue.'' Tr. 628.
---------------------------------------------------------------------------
\33\ Dr. Helm testified that, as an author of the ASIPP
Guidelines, he agrees with their content, specifically addressing
the ASIPP Guidelines' statements about pain contracts and obtaining
informed consent. Tr. 758. Yet, Dr. Helm testified that Respondent's
pain contract, while not in compliance with the ASIPP Guidelines,
``can be accepted as an informed consent agreement although it . . .
could be more fully documented and, you know, if you wanted to, the
language could be changed from any form of . . . opioids or
narcotics to any controlled substances, you know, there is that
variation.'' Id. at 758-59; see also id. at 748-50 (Dr. Helm's
testimony about Respondent's pain contract and its non-compliance
with the MBC Guidelines for Prescribing concerning obtaining a
patient's informed consent about the ``risk'' of using controlled
substances). Dr. Helm's testimony also stated that ``not complying
with this [sic] specific guidelines and deviating from standard of
care are two different--two different entities, two different thesis
[sic].'' Id. at 759.
---------------------------------------------------------------------------
According to Dr. Helm's testimony, he was trained in internal
medicine and anesthesiology, became involved in pain management
``[p]robably about '82,'' and ``evolved'' with the field as the field
evolved.\34\ Id. at 620-21. He was ``able to be grandfathered'' when
``the first boarding became available in 1993'' and ``then just
continued from there to the point where since then . . . [he has] been
very active nationally and internationally, lectured and written and
continued to do those things.'' Id. at 621. Dr. Helm testified that he
received research support from the manufacturer of opioids in this
case, Purdue Pharma, one of whose founders was a ``marketing genius''
who ``probably helped develop the [opioid] problem.'' Id. at 626-27.
---------------------------------------------------------------------------
\34\ Respondent's Exhibit (hereinafter, RX) 5 is Dr. Helm's
curriculum vitae.
---------------------------------------------------------------------------
Dr. Helm testified that a doctor is required to do several things
when issuing a new controlled substance prescription: ``review whatever
records are available,'' including ``whatever past medical records you
have and have
[[Page 21198]]
access to;'' ``meet with the patient;'' ``obtain a thorough history;''
``perform an exam, really focused on, attempting to find out what the
cause of the pain is, if you can;'' ``integrate that data, come up with
a treatment plan;'' ``get[ ] a urine drug screen;'' ``risk
stratification;'' and ``obtain[ ] informed consent and pain
agreement.'' \35\ Id. at 864-65. I find that Dr. Helm's response lists
half of the elements of the applicable standard of care.\36\ Supra
section II.
---------------------------------------------------------------------------
\35\ Dr. Helm also stated that a pain management doctor is to
``review a CURES Report.'' Tr. 864-65.
\36\ Dr. Helm was also asked ``[w]hat, if anything, [is] a
doctor acting with [sic] the usual course of professional practice
required to do . . . to document an increase in strength or quantity
of a previously prescribed prescription?'' Tr. 873-74. Since the
question is not specifically about controlled substance
prescriptions, Dr. Helm's response is not relevant to my
adjudication of this matter.
---------------------------------------------------------------------------
Dr. Helm's testimonial elaboration on, and application of, these
elements and on other matters pertaining to the applicable standard of
care, however, fall far short and I do not credit them.\37\ For
example, Dr. Helm's testimony was inconsistent. While initially
testifying that a UDS is one of the things a doctor is required to do
when issuing a new controlled substance prescription, he subsequently
testified that ``as long as the physician is seeing the patient and
carrying out an exam and coming to a determination absent either one of
those data points--either the CURES or the UDS, it is still within the
course of professional practice.'' Tr. 870-71. Further, Dr. Helm
testified that a doctor is required to have a ``legitimate encounter''
with the individual before he writes a controlled substance
prescription and, during that ``legitimate encounter,'' is to get a
``current history,'' ``perform[ ] [an] appropriate exam,'' and ``com[e]
to a determination.'' Id. at 871. According to Dr. Helm, then, if one
of the elements he initially testified to being required before the
issuance of a new controlled substance prescription is not performed,
``even if those errors are made, you're still within the professional
practice.'' Id.
---------------------------------------------------------------------------
\37\ I credit none of Dr. Helm's responses to questions calling
for a legal analysis as it is not in his expertise to provide a
legal opinion. See, e.g., Tr. 864-892. To his credit, Dr. Helm
testified that he ``attempted'' to read Gonzales v. Oregon, found it
``very hard to read,'' called it ``interesting'' that ``DEA deferred
to the state'' about the ``usual course of professional practice
within California,'' and ``defer[red] to the Court'' on such
matters. Id. at 870, 884, 873. Dr. Helm's ``deferral'' testimony and
other testimony about the meaning and scope of the ``usual course of
professional practice'' and the applicable standard of care support
my decision to give limited weight to Dr. Helm's testimony. See,
e.g., id. at 867-68, 870-73.
---------------------------------------------------------------------------
By way of further example, Dr. Helm was asked whether Respondent's
patient contracts satisfy informed consent. Id. at 876. Dr. Helm
testified that those contracts ``referred to side effects'' but ``they
didn't specifically discuss some of the specific risks, tolerance,
death.'' Id. Dr. Helm testimony concluded, though, that, although they
are not ``optimal,'' the contracts are ``close enough to at least be
acceptable.'' Id.
Regarding his testimony that a doctor must ``perform an exam,
really focused on, attempting to find out what the cause of the pain
is, if you can'' and ``integrate that data, come up with a treatment
plan,'' Dr. Helm testified that Respondent's initial prescribing of
amphetamine salts for L.D. preceded Respondent's noting the chronic
fatigue syndrome diagnosis in the medical records for L.D.'s third
visit. Id. at 879-82; accord id. at 1122-24 (Respondent's testimony).
Nevertheless, Dr. Helm excused Respondent's failure, testifying that
Respondent was ``maintaining a medication'' that a different medical
professional had previously prescribed. Id. at 880; but see id. at
1135-36 (Respondent's failure to answer fully the ALJ's question about
the purported ``list of . . . [L.D.'s] meds'' and physicians at GX 18A,
82-83) and infra n.38. Dr . Helm testified that he viewed Respondent's
failure as ``an error in documentation,'' but not an ``error in
documentation [that] takes it outside the usual course of professional
practice.'' \38\ Tr. 880.
---------------------------------------------------------------------------
\38\ Respondent subsequently testified that the only refill L.D.
said she needed during her first visit with Respondent was
amphetamine salts. Tr. 1019. Respondent testified that ``[m]aybe
this [medical record] note is not as long as it should be. But
obviously this was a very complex patient . . . [a]nd so . . . a lot
of time was taken in the history and establishing a relationship.''
Id. 1020; see also id. at 1020-21 (Respondent's testimony, when
asked if it was an oversight for him not to document that chronic
fatigue syndrome was the diagnosis on which his amphetamine salts
prescription for L.D. was based, that he ``was so busy writing down,
you know, symptoms, and so busy doing other things, that . . . [he]
just really didn't get to the problem list at the time'').
Respondent testified that he ``was comfortable with'' issuing L.D. a
prescription for amphetamine salts because he ``had a list of all of
her physicians'' and ``[t]here's the CURES Report in the chart that
confirms all of that information.'' Id. at 1020. Respondent's
testimony does not include details about the source of the list of
L.D.'s physicians, does not explain how the CURES Report confirms
``all of that information,'' and does not include information
showing that the first visit amphetamine salt prescription complies
with the applicable standard of care.
---------------------------------------------------------------------------
Regarding UDSes, Dr. Helm testified that the controlled substance
prescriptions Respondent issued on the visit at which L.D.'s UDS was
positive for cocaine were issued within the usual course of
professional practice, even though Respondent did not ``resolv[e]'' the
cocaine aberrancy. Id. at 882. Dr. Helm's testimony was that
Respondent's actions were a ``documentation problem, rather than taking
[sic] outside the practice of medicine.'' Id. at 885; but see id. at
1136-37 (Respondent's testimony that the cocaine-positive UDS of L.D.
``must have been a click of the box error'' because ``one thing my boys
did if there was ever an elicit [sic] drug, they immediately brought
the dipstick to me and we evaluated it together''); id. at 1025-26
(Respondent's testimony that L.D. ``did not use cocaine,'' that he
phoned L.D. after reviewing the medical records the week before the
hearing and received L.D.'s ``confirmation'' that she did not use
cocaine, that he trusts his patients because they are ``honest'' with
him, and that he has to ``assume'' the cocaine-positive result was the
error of one of his employees who ``clicked the wrong box''). Instead
of explaining his ``documentation problem'' assessment, however, Dr.
Helm warned against stopping opioid prescriptions ``abruptly unless you
had documentation that the[y] weren't taking the opioids just because
of the withdrawal issue.'' Id. at 883. Dr. Helm's testimony did not
elaborate on what ``documentation that the[y] weren't taking the
opioids'' he believes is needed, how a physician would obtain that
documentation, and the bases for his conclusion that Respondent's
failure to address the cocaine UDS aberrancy was a ``documentation
problem.'' Id. at 882-83, 885. He did testify, however, that he is
``not aware of anywhere where it is codified that one needs to--and
forget UDS--any inappropriate result or after, whether again,
malignancy, tests, whatever it's going to be--anything that would
require--high blood pressure--it would require a response despite the
absence of codification.'' Id. at 884-85.
Dr. Helm testified that there is no upper limit for the MME dosages
a physician can prescribe, stated that guidelines exist but do not
determine the standard of care, and defined the standard of care as
``what a reasonably trained physician in the community would do in
similar circumstances at a similar time.'' Id. at 625-26; see also id.
at 630; id. at 807-11. According to his testimony, guidelines do not
apply equally to all specialties in the area of opioid prescribing,
stating that the CDC guidelines, explicitly, and MBC guidelines,
implicitly, apply to primary care physicians.\39\ Id. at 630. Dr.
Helm's testimony was that the MBC guidelines implicitly apply to
primary care physicians ``because they refer repeatedly to
consultations not only to pain management but to other
[[Page 21199]]
specialties, too.'' Id. Dr. Helm was asked, but did not answer, whether
the MBC Guidelines for Prescribing are relevant to pain care
specialists.\40\ Id. at 762. He testified that ``pain physicians can
take it wherever we want to, but you've got to justify why you're so
doing.'' Id. at 763. Respondent asked Dr. Helm if he ``would say that a
pain care specialist has an even higher standard of care that they
should follow rather than just the primary care physician,'' and Dr.
Helm stated in agreement, ``Basically.'' Id.
---------------------------------------------------------------------------
\39\ Dr. Helm did not further identify the ``CDC guidelines'' he
was referencing.
\40\ See also Tr. 530 (Dr. Munzing's testimony, stating that
``the guidelines aren't the standard of care and if one is in
substantial compliance with the guidelines, and with any other laws
that dictate the prescribing, one would be compliant with the
standard of care. But could one be within the standard of care and
not do one little thing within the guidelines? In my mind, yes it
could be, but a substantial compliance with the guidelines, which is
what . . . we all do when we're practicing is we are in substantial
compliance with whatever the guidelines are for taking care of the
patients for whichever problems'').
---------------------------------------------------------------------------
Dr. Helm testified about the medical care Respondent provided, and
controlled substance prescriptions Respondent issued to, A.A., R.B.,
S.D., L.D., S.H., and J.M. Tr. 632-897; infra section III.F. I find
that Dr. Helm's testimony focused largely on describing, explaining,
and even justifying or excusing Respondent's medical records and
actions those medical records state that Respondent took, as opposed to
addressing Respondent's compliance or non-compliance with the
applicable standard of care and the usual course of professional
practice and whether the OSC's allegations are founded and whether I
should entrust Respondent with a controlled substance registration. For
example, when Respondent's counsel specifically asked Dr. Helm whether
Respondent's treatment plan for A.A. was appropriate, Dr. Helm
responded that ``he gave early refills,'' ``[p]ost-dated triplicate for
the Methadone, and then it was just continued following up for the
psychological evaluation and plan to proceed to the epidural'' before
being cut off by Respondent's counsel's next question. Tr. 646-47; see
also id. at 680-81 (Dr. Helm's not responding to a question about
Respondent's compliance with the standard of care, Respondent's
counsel's rephrasing the question to ask about whether Respondent's
controlled substance prescribing was ``acceptable,'' and Dr. Helm's
response to the re-phrased question); id. at 731-32 (Dr. Helm's
testimony, when asked, ``[i]n view of the totality of the care and the
notes and the history and the information provided, how would you
describe . . . [Respondent's] treatment, of this patient,'' that
``[y]ou know, I think he's allowing this gentleman to function, to
support a multi-generational essentially family, although the
girlfriend's not married. But he's supporting the kids, her and his
grandmother, and he surely is, you know, providing a benefit to them,
and there's no threat here or risk to public safety''); id. at 683 (Dr.
Helm, answering Respondent's counsel's question about if there is any
reason to doubt R.B. was in increased pain and would benefit from more
medication, by stating that it is ``[r]easonable to have increased pain
after a car accident''); id. at 715 (Dr. Helm's testimony that
Respondent's medical records ``clearly showed'' that L.D.'s criminal
involvement was ``business,'' but no direct response to Respondent's
counsel's question of whether Respondent ``adequately document[ed]''
L.D.'s criminal status); id. at 687 (Dr. Helm's summary testimony,
without explanation, after Respondent's counsel asked if the controlled
substance prescriptions that Respondent issued to R.B. were ``medically
justified,'' that ``[t]here was a legitimate medical purpose and they
were done in the course of professional practice''); id. at 741 (Dr.
Helm's conclusory testimony that continuing controlled substance
prescriptions ``to allow . . . [J.M.] to perform [activities of daily
living] and have quality of life despite his physical limitations'' is
``an appropriate goal for the opioid therapy'').
Another example, regarding the requisite physical examination, is
Dr. Helm's testimony about Respondent's medical records for A.A. He
testified about the ``type of exams done by pain specialists in the
treatment of chronic pain,'' stating that Respondent conducted an
``appropriate lumbar exam'' of A.A. that was a ``focused
musculoskeletal exam.'' Id. at 635-36; see also id. at 644. Dr. Helm
approvingly testified about Respondent's focus on A.A.'s back, gait,
response to palpation of ``various areas of the back,'' range of
motion, lower extremity exam, muscle strength, reflexes, and sensation,
concluding ``that's really the gist of it.'' Id. at 636; see also id.
at 740 (Dr. Helm's agreement with Respondent's counsel that
Respondent's examination of J.M. on all visits was ``appropriate''
without testimony about the applicable standard of care and the usual
course of professional practice). Dr. Helm mentioned the heart and
lungs ``because the surgery centers want[ ]'' that information ``but
it's not, you know, that doesn't influence the diagnosis.'' Id. Dr.
Helm did not address the applicable standard of care and the usual
course of professional practice regarding a pain management physician's
conduct of a heart or lung examination, let alone testify about the
connection between the condition of a patience's heart or lung and a
pain management physician's assessment of the appropriateness of
prescribing a controlled substance.
A further example is Dr. Helm's testimony about the reasonableness
and consistency with the standard of care of Respondent's controlled
substance prescribing. Regarding A.A., for example, Dr. Helm testified
that, ``[s]ure,'' the controlled substances Respondent prescribed
during A.A.'s first two visits were ``reasonable and consistent with
the standard of care as a pain physician,'' elaborating only that ``as
long as she was getting pain relief and increased function with the
medications with no side effects and there are no signs of aberrancy.''
Id. at 639.
Also regarding A.A., as another example, Dr. Helm testified that it
was appropriate for Respondent to increase the methadone he prescribed
for her on January 11, 2013, stating that ``the pain meds are worse''
and Respondent is ``carrying out a further evaluation to solve--to see
if there's anything that could be identified and in the interim
increasing the medications.'' Id. at 658. Dr. Helm testified that one
methadone-negative UDS ``really it isn't a basis for . . . [a] run to
action on because of one negative in the face of multiple positives.''
Id. at 892. He did not explain his testimony that increased methadone
prescribing was ``appropriate'' in the context of Respondent's
continuation of it through June 5, 2013, despite one UDS that was
negative for methadone, and of Respondent's discontinuation of it, on
June 28, 2013, based on a note that ``Pt would like to try Oxycontin''
and prescribing ``Oxycontin 10 mg[ ] #120 1 QID'' and ``Percocet 10/325
#120 1 QID prn.'' GX 12B, at 114; Tr. 658-60 (Dr. Helm's testimony
about June 5, 2013, including A.A.'s subsequent hospitalization ``for
concern of suicide''); see also id. 740-41 (Dr. Helm's testimony,
without elaboration, that it was ``appropriate and reasonable'' for
Respondent to prescribe ``anxiety-provoking . . . large quantities of
narcotics'' to J.M.). Dr. Helm also did not explain his repeated
testimony that Respondent's methadone prescribing for A.A. was
appropriate in the face of his testimony that methadone is
``disproportionately a cause of death because the half[-]life in the
body is longer than the period of pain relief'' and his agreement that
there is no evidence in A.A.'s medical records that
[[Page 21200]]
Respondent had A.A. undergo an electrocardiogram, as the ASIPP
guidelines that Dr. Helm co-authored recommend, to prevent such ``big
problem[s]'' as cardiac arrythmia and heart pump failure. Id. at 842-
45; see also id. at 842 (Dr Helm's testimony that ``[m]ethadone's great
advantage is that it's cheap'').
Regarding Respondent's monitoring of those for whom he prescribed
controlled substances and his use of UDSes, Dr. Helm agreed with
Respondent's counsel that there were ``several'' aberrant UDSes in
Respondent's medical files. Id. at 650. He testified that an aberrant
UDS is the ``absence of what's prescribed or the presence of what is
not prescribed.'' Id. at 846. Regarding how to handle aberrant UDSes,
Dr. Helm testified that, ``as a pain physician,'' he would ``want to
discuss with the patient . . . two things.'' Id. at 648. First, he
testified, a pain physician would want to ``find out what's going on,''
document awareness of the aberrancy, and provide counseling about how
to ingest the controlled substance. Id. Second, Dr. Helm testified that
a pain physician would want to send the urine sample out for
confirmatory testing.'' Id. at 648-49. Dr. Helm clearly testified an
aberrant UDS is ``obviously something that should be--I, you know, I
have in other scenarios and continue here to say that these results
need to be documented, these findings need to be documented . . . [and]
[t]hey're not.'' \41\ Id. at 651; see also id. at 833 (Dr. Helm's
testimony that ``every aberrancy on the UDS should be documented'');
id. at 831 (Dr. Helm's testimony that his position is ``if it's not
documented it didn't happen'').
---------------------------------------------------------------------------
\41\ Dr. Helm did not agree with Respondent's counsel that
Respondent ``was ahead of the curve in terms of what he was doing to
monitor patients.'' Tr. 652. Instead, Dr. Helm's responded: ``I
would say that he and I are some of the few doctors in the state who
still remember that back in the day you had to fax in requests for
the CURES back before then Attorney General Brown went electronic
with it in 2009.'' Id.
---------------------------------------------------------------------------
After specifically criticizing Respondent's handling of aberrant
UDSes, however, Dr. Helm minimized Respondent's failures, testifying
that the instances of aberrant UDSes in Respondent's medical records
are ``unlikely to represent any abuse or diversion or present any risk
to the public'' due to the ``analysis of the patient, and these
patients, there seems to be all the confirmatory evidence from the
social environment and the CURES.'' Id. at 649-51; see also id. at 896
(Dr. Helm's testimony that ``we're looking at documentation errors
rather than a causative concern for public safety''). When asked about
Respondent's failure to conduct UDSes for a year, Dr. Helm testified
that Respondent's previous ``custom and practice was to do them, so not
doing them is not related to a failure, indifference to urine drug
screens.'' Id. at 765. Dr. Helm declined to conclude that Respondent's
re-prescribing of methadone after repeated non-negative methadone UDSes
was more than a ``consistent lack of documentation on that issue, and
throughout all the charts.'' Id. at 851. Instead, Dr. Helm testified
that an aberrant UDS is ``not one that in isolation should be the
determinate as to what you do'' and that he ``look[s] at the totality
of the data,'' including ``the patient's response to the medications,
ability to function, reported decreased pain, reported increased
function'' and would ``continue it.'' \42\ Id. at 846-51; see also id.
at 897.
---------------------------------------------------------------------------
\42\ See also Tr. 746-47 (Dr. Helm's testimony about J.M.'s July
13, 2018 visit with Respondent and CURES reports, stating that they
``are all consistent and compliant suggest[ing] that the UDS
results, while they should be more clearly documented, . . . do not
. . . provide any evidence of risk to the public, so he's really
doing well''); see also id. at 768-69.
---------------------------------------------------------------------------
At the end of his direct testimony, Dr. Helm stated his views of
Respondent as a pain physician. Id. at 746-47. He testified that
Respondent prescribed high doses of controlled substances, justifying
that prescribing by stating ``but . . . his patients on high doses are
having functional improvement.'' Id. at 746. Dr. Helm testified that
Respondent monitored his patients, adding the excuse that the UDSes
Respondent conducted were ``hampered by the inability to get
confirmatory tests.'' \43\ Id. He testified that Respondent ``strongly
documented'' psycho-social status, which was ``confirmed by the
presence of family members.'' \44\ Id. Dr. Helm added that Respondent's
medical record ``documentation is far better than that which . . . [he
has] seen in many, many records that . . . [he has] reviewed.'' Id. at
747.
---------------------------------------------------------------------------
\43\ Dr. Helm testified that it is expensive to send UDS results
for confirmation. Tr. 642.
\44\ Dr. Helm agreed, however, that family and friends ``may not
necessarily be a good source of checking for compliance'' as ``they,
too, might be abusing or diverting,'' and that family and friends
attending a visit with Respondent is ``not really a substitute'' for
not doing UDSes. Tr. 766-67.
---------------------------------------------------------------------------
Dr. Helm disagreed with Dr. Munzing's ``criticisms overall'' of
Respondent. Id. He testified that Respondent's pain medicine
adjustments ``were not arbitrary'' and that ``the notes document
rationales for the adjustments.'' Id. Dr. Helm testified that
Respondent's ``high doses are high,'' that ``we know [high doses] do
have increased risks,'' but that Respondent ``is providing the
monitoring, which the author of the CDC guidelines requests be done.''
\45\ Id. He concluded his direct testimony by referencing Respondent's
UDSes and stating that he does not ``see'' that Respondent ``represents
a risk.'' Id.
---------------------------------------------------------------------------
\45\ Again, Dr. Helm did not further identify the ``CDC
guidelines'' he was referencing. I note, though, that Respondent's
position in this matter is that the ``CDC Guidelines'' do not apply
to Respondent.
---------------------------------------------------------------------------
Although Dr. Helm's testimony specifically addressed Respondent's
high dose prescribing, ``pain medicine adjustments,'' UDS practices,
monitoring, use of CURES, and medical record documentation, it did not
address them squarely in the context of the applicable standard of care
and the usual course of professional practice. As already discussed,
Dr. Helm's testimony contained limited and unconvincing evaluations of
Respondent's controlled substance prescribing against the applicable
standard of care and the usual course of professional practice.
Accordingly, I give Dr. Helm's testimony limited weight in this
Decision/Order.
Based on my analysis of the applicable standard of care and the
existence of substantial record evidence, I credit the standard of
care-related testimony of Dr. Munzing when there is a conflict between
his testimony and the standard of care-related testimony of Dr. Helm or
of Respondent. Supra sections II, III.D., and III.E.
Respondent also submitted documentary evidence, including about
seventy-five pages of letters from supporters who describe themselves
as physicians, patients, or family members of patients whom Respondent
has treated. RX 8, at 1-76. It appears, from my having read the legible
portions of the letters, that Respondent reached out regarding his
``alleged misuse of prescribing drugs.'' \46\ RX 8, at 74. Although the
content of RX 8 indicates the strong and positive feelings and opinions
of many individuals about Respondent, I can only afford that content
limited weight in this adjudication because of my limited ability to
assess the credibility of the letters given their written form. See
Michael S. Moore, M.D., 76 FR 45867, 45873 (2011) (evaluating the
weight to be attached to letters provided by the respondent's hospital
administrators and peers in light of the fact that the authors were not
subjected to the rigors of cross examination). Further, the content of
RX 8 provides limited evidence about whether Respondent
[[Page 21201]]
prescribed controlled substance in conformity with the applicable
standard of care, an issue central to my legal responsibilities in this
adjudication. Heart-felt statements of individuals who have suffered,
or who continue to suffer, tremendously from pain, if not specific or
presented in a context that allows me to apply the controlling legal
standards, are of limited value in an adjudication such as this one.
Accordingly, I find that the substantial record evidence of
Respondent's multiple controlled substance-related violations outweighs
the evidence in RX 8.
---------------------------------------------------------------------------
\46\ The content of RX 8 alludes to the communication but does
not include it.
---------------------------------------------------------------------------
F. Allegation That Respondent Issued Controlled Substance Prescriptions
Beneath the Applicable Standard of Care and Outside the Usual Course of
Professional Practice
Having read and analyzed all of the record evidence, I find
substantial record evidence that Respondent issued many controlled
substance prescriptions beneath the applicable standard of care and
outside the usual course of professional practice. Accordingly, I find
that the Government has presented a prima facie case, as outlined
below.\47\
---------------------------------------------------------------------------
\47\ The OSC's allegations include that Respondent prescribed
controlled substances at daily MME levels above 90 mg per day
although the CDC ``recommends avoiding or carefully justifying''
doing so. See, e.g., OSC, at 4-7, 9-10. The Government's questioning
of Dr. Munzing included asking him whether Respondent's medical
records documented reasons or justifications for prescribing the
specific MME value associated with specific controlled substance
prescriptions. See, e.g., Tr. 128-31, 167, 185. This questioning by
the Government, though, followed Dr. Munzing's testimony that, for
example, there is no maximum MME above which a physician may
prescribe and ``[t]here are occasions when one needs to go beyond
the 90.'' Id. at 118. Dr. Munzing's testimony, when he offered to
explain his response with an analogy, was cut off by a
``nonresponsive'' objection by Respondent. Id. at 119-22 (colloquy
including ALJ's ruling sustaining the objection and his subsequent
recap and explanation of his ruling). Given the entirety of the
record transmitted to me, including the many examples of
Respondent's controlled substance prescribing beneath the applicable
standard of care and outside the usual course of professional
practice, there is no need for me to consider the OSC's MME-levels-
above-90-mg/day allegations, I am not doing so, and those
allegations play no role in this Decision/Order. Cf. id. at 188 in
conjunction with Jt. Stip. 79 (Dr. Munzing's testimony that
Respondent's prescribing 90 mg/day of oxycodone for S.D. on February
4, 2019, March 1, 2019, and April 2, 2019, was beneath the
applicable standard of care and outside the usual course of
professional practice ``because we just don't have any
information'').
---------------------------------------------------------------------------
Regarding the Xanax 2 mg controlled substance prescription that
Respondent issued to A.A. on October 8, 2013, I credit Dr. Munzing's
testimony. Tr. 132-36; supra sections II, III.D., and III.E; see GX
12B, at 104-06. I find substantial record evidence that Respondent's
first prescribing of Xanax to A.A. was at its ``highest dosage'' for
anxiety, was at A.A.'s request (``Cannot afford to see PCP; only sees
him for Prilosec and Xanax. Would like me to prescribe her these
meds.''), was not associated with a ``real detailed history regarding
anxiety as should be included if one is going to take over the
management of prescribing a benzodiazepine such as Xanax for anxiety,''
was not issued after documented consideration of a ``safer,
noncontrolled medication[ ] that can be used for anxiety,'' was issued
``in conjunction with an opiate'' and, therefore, posed a
``significantly increased risk'' to A.A. and was a ``significant red
flag for abuse or diversion.'' Tr. 133-36; GX 12B, at 104-06; see also
Tr. 431-33; id. at 228-29 (L.D.).
Respondent testified about his decision to do A.A. that ``favor,''
to ``accommodate'' her. Tr. 1106-08. He testified that even though
prescribing benzodiazepines was ``something . . . [he'd] really never
done in . . . [his] practice,'' he had a ``relationship'' with A.A.,
seeing A.A. ``monthly for at least two years.'' Id. at 1106. Respondent
testified that he ``did not see where . . . [Xanax] was interfering
with her function.'' Id. at 1106-07. ``In fact,'' he testified, Xanax
``improved her anxiety and it improved her level of functioning and the
like.'' Id. at 1107. Accordingly, when A.A. said that she ``could save
some money as her funds were limited,'' Respondent decided to
``accommodate'' her. Id. Respondent admitted that he continued to
prescribe Xanax for A.A. ``in the face of UDSes that did not detect
levels of . . . [Xanax] in her body.'' Id. When asked whether it ``was
ever a concern to him'' that A.A.'s UDSes ``did not detect levels'' of
Xanax in her body, Respondent testified that A.A. ``never obtained that
medication from anyone else,'' and ``if the time came at the visit
where it had already been out of her system, which implied that she
took a little bit more earlier in the month[,] she had her monthly
allowance and she did with it what she pleased.'' Id.; see also supra
section III.E.
Accordingly, I find substantial record evidence that Respondent's
first issuance of Xanax 2 mg to A.A. was beneath the applicable
standard of care and outside the usual course of professional practice.
Regarding the parties' stipulations that, on June 5, 2013,
Respondent increased the monthly amount of Percocet 10/325 he
prescribed for A.A. from 90 to 120 tablets, and that the next month, on
July 23, 2013, Respondent again increased the monthly amount of
Percocet 10/325 he prescribed for A.A. from 120 to 180 tablets, I
credit Dr. Munzing's testimony responding to whether the prescriptions
``met the standard of care in California and were issued in the usual
course of professional practice.'' \48\ Supra sections II, III.D., and
III.E. Dr. Munzing testified that Respondent's Percocet prescriptions
for A.A. did not meet the standard of care in California and were not
issued in the usual course of professional practice. Jt. Stips. 59 and
60; Tr. 137-41 (Dr. Munzing's testimony that A.A. is ``already on an
extremely high dosage of opioids and no real justification [in the
medical records] to increase that,'' ``it appeared to have been
increased . . . without medical justification and essentially increased
it and then just kept on going rather than looking for an opportunity
to over time gradually reduce it by some other management of the need
other than just . . . prescribing opioids,'' and ``they're not
medically justified, not used in professional practice, but it's not
just because of that one visit. It's because other visits that I
reviewed, my opinion was the same, is that, both where it went up but
also ongoing, there wasn't an ongoing plan and the patient was being
put at risk over long periods of time . . . . I could easily conclude
that they were not medically justified.''); but cf. Tr. 661-63 (Dr.
Helm's testimony that Respondent's increasing the Percocet prescription
was ``medically justified based upon . . . [A.A.'s] complaints and
examination and history'' and the side effects she experienced from
Gabapentin). I credit Dr. Munzing's testimony over Dr. Helm's testimony
when the two conflict. Supra sections II, III.D., and III.E.
---------------------------------------------------------------------------
\48\ The medical records for the June 5, 2013 visit state that
A.A. experienced left knee pain for three weeks and that Respondent
gave A.A. an intra-articular steroid knee injection under ``strict
aseptic technique'' during that visit. GX 12B, at 115-17.
---------------------------------------------------------------------------
Accordingly, I find substantial record evidence that Respondent's
prescription of 120 tablets of Percocet 10/325 for A.A. on June 5,
2013, an increase from 90 tablets, and his prescriptions of 180 tablets
of Percocet 10/325 for A.A. the next month on July 23, 2013, through
March 25, 2019, were issued beneath the applicable standard of care and
outside the usual course of professional practice. GX 11, at 1-31.
The parties also stipulated that, on January 11, 2013, Respondent
increased the monthly amount of methadone 10 mg he prescribed for A.A.
from 90 to 120 tablets, and that on June 2, 2014, Respondent again
increased the monthly amount of methadone 10 mg he prescribed for A.A.
from 120 tablets to 180 tablets. Jt. Stips. 61 and 62. According to
Respondent's testimony, ``one source of pain in the back could
[[Page 21202]]
be adhesions in the epidural space'' from ``inserting these
percutaneous leads into the epidural space'' that ``do break up
adhesions and stuff like that'' and ``there is a tiny bit of a
therapeutic kind of thing there when you break up some adhesions.'' Tr.
1141. He testified that A.A. ``varied her dose from three to six
tablets [of methadone] a day'' meaning that she ``had increased her
activity level because she was doing things at--that she didn't
necessarily do'' because ``she was able to figure out, `If I took more
medication on a particular day, I was able to accomplish greater
tasks.' '' Id. at 1142. Respondent's testimony about this matter
included an example: ``I can go to Costco if I take an extra
[methadone] tablet.'' \49\ Id.; see also id. at 141-44; id. at 665-74
(Dr. Helm's testimony stating Respondent ``documented increased pain
reports and that would provide the basis for an increase'' and
concluding that ``someone could argue should you increase or not, but
that's a medical judgment''). Respondent's testimony about these
matters did not address safety concerns or risks to A.A. of her self-
dosing methadone. Supra section III.E. (Dr. Helm's testimony that
methadone is disproportionately a cause of death because its half-life
in the body is longer than the period of pain relief).
---------------------------------------------------------------------------
\49\ The ALJ stated, after hearing this portion of Respondent's
testimony, that ``I don't understand your answer.'' Tr. 1142.
---------------------------------------------------------------------------
I credit Dr. Munzing's testimony regarding the medical records
Respondent created about these methadone increases. Supra sections II,
III.D., and III.E. Dr. Munzing addressed the first part of the
paragraph called ``Pain HPI'' for the January 11, 2013 visit, which
states A.A. ``appeared to be improved after the stimulator was tried.''
GX 12B, at 80. He testified that ``one would not certainly want to
increase . . . [methadone] when there's improvement.'' Tr. 142; see
also id. at 551-52; id. at 566-67. Regarding the last part of the same
``Pain HPI'' paragraph which states ``[h]igher dose of MTD necessary
lately due to the intensity of her complaints,'' Dr. Munzing testified
that A.A. was already at high risk due to very high dosages and the
combination of medicines. Id. at 143; GX 12B, at 80; see also Tr. 551
(Dr. Munzing's testimony that increasing methadone from four a day to
six a day is a ``large jump''); id. at 666 (Dr. Helm's testimony that
``some consider'' Respondent's doses high). Dr. Munzing testified that
``there are other alternatives, safer alternatives than just continuing
to increase the dosage of medicine and putting a patient at much higher
risk than they already are.'' Tr. 143; see also id. at 673 (Dr. Helm's
testimony that, although A.A. reported benefits at the higher dose,
``it's something you don't want to encourage going forward'' because
``patient safety is the number one concern''); id. at 773 (Dr. Helm's
testimony that ``there's no question you don't want patients taking
meds ad lib, and I would share that, you know, while I get somebody who
tells me that they have to do something it really raises an eyebrow
because I don't want them to be just doing whatever it is they feel to
do because--what they feel like they should do because that does create
great risk''); id. at 773, 778 (Dr. Helm's testimony that Respondent
did not document a conversation with A.A. about her not having taken
the methadone as prescribed, that Dr. Helm agrees ``that is a
documentation issue,'' and, consequently, that ``[w]e don't know what's
going on'') in conjunction with id. at 782 (Dr. Helm's testimony,
positing without a factual basis, that Respondent's failure to document
is not a public health issue, but that Dr. Helm's ``practice would be .
. . if she'[s] taking less to provide less'') and id. at 674 (Dr.
Helm's testimony that ``what's remarkable about these patients is that
by and large they did present improved benefit, which is unusual for
the high-dose opioid patients,'' citing the Opioid Pain Consortium FDA-
mandated study about opioid-induced hyperalgesia); id. at 885-889. I
credit Dr. Munzing's testimony over Dr. Helm's testimony when the two
conflict, and I afford Respondent's testimony limited credibility as
the respondent in this adjudication. Supra sections II, III.D., and
III.E.
Accordingly, I find substantial record evidence that Respondent
issued the methadone prescriptions for A.A. in GX 11 beneath the
applicable standard of care and outside the usual course of
professional practice.\50\ Tr. 144; GX 11, at 1-31.
---------------------------------------------------------------------------
\50\ The Government alleged that Respondent's Xanax
prescriptions were not legitimate because he continued them in the
face of A.A.'s aberrant urine drug screens. Tr. 144-53. The
Government's case did not note, analyze, or address the ``prn''
notation on the Xanax prescriptions. Accordingly, I find that the
Government did not present a prima facie case on this allegation.
See, e.g., GX 11, 1-31.
The record evidence, though, that Respondent conducted urine
drug screens, yet did not analyze and note, let alone act on, the
results is puzzling at best. At worst, it raises serious questions
about Respondent's knowledge about, and implementation of,
controlled substance-related best practices. Supra section III.E.
The Government did not pursue these matters and, accordingly, they
play no role in my Decision/Order.
---------------------------------------------------------------------------
The parties stipulated that Respondent's first medical record-
documented visit with R.B. took place on January 8, 2016. Jt. Stip. 63.
During that initial visit, the parties stipulated, R.B. told Respondent
that he ``was constantly in pain and had previously taken oxycodone and
was then currently taking six tablets of Norco (hydrocodone-
acetaminophen) 10/325 mg[ ] a day.'' Jt. Stip. 64. R.B.'s urine drug
screen from that first visit, according to the parties' stipulation,
was positive for THC. Jt. Stip. 65. The urine drug screen results did
not corroborate R.B.'s statement to Respondent that he ``was then
currently taking six tablets of Norco . . . a day.'' Jt. Stip. 64. The
parties further stipulated that Respondent issued R.B. a controlled
substance prescription for 90 tablets of oxycodone 30 mg at this
initial visit. Jt. Stip. 66.
Based on my review of the record evidence regarding R.B.'s first
visit with Respondent, I find substantial record evidence that
Respondent issued a controlled substance prescription to R.B., for 90
tablets of oxycodone 30 mg, without documenting his knowledge of R.B.'s
medical history based on input directly from R.B.'s previous physician
or physician assistant, without documenting that he addressed R.B.'s
in-house, positive THC urine drug screen, and without documenting that
he assessed R.B. for the risk of opioid abuse. Tr. 155-56 (Dr.
Munzing's testimony, including that he ``do[es]n't see any further
history and specifics in detail regarding other drug use,'' that
``there's no kind of detailed evaluation of both current and also past
drug use and is there any history,'' that he ``do[es]n't see any kind
of opioid risk tool or other screening for--there's SOAPP . . . and
also the ORG, Opioid Risk Tool, that gives you an idea about risk for
abuse,'' and that he ``do[es]n't see any specifics in past medical
records that would verify a lot of this . . . [s]o you're going
essentially from zero . . . immediately to 135, so . . . [he has] great
concerns about that visit''); MBC Guide to the Laws, at 59-61; see also
GX 14B, at 72-74; compare Tr. 675-78 (Dr. Helm's testimony that it was
``medically appropriate'' to ``initiate care'' and ``appropriate
treatment'' for Respondent to prescribe oxycodone because it was of
benefit in the past and the R.B. reported he was not benefitting from
Norco) with id. at 784-85 (Dr. Helm's testimony agreeing that a
physician ``can't just rely on what another physician did in . . .
[his] own decisions to prescribe a particular controlled substance'').
I credit Dr. Munzing's testimony.
Accordingly, I find substantial record evidence that Respondent
issued the first 90 tablet oxycodone 30 mg
[[Page 21203]]
prescription for R.B. beneath the applicable standard of care and
outside the usual course of professional practice. MBC Guide to the
Laws, at 59-61.
Regarding the record evidence concerning R.B.'s second visit with
Respondent, I find substantial record evidence that R.B. reported
feeling ``much improved'' with ``[s]ome of . . . [his] pain . . . even
down to a 1-2/10.'' GX 14B, at 70; see also Tr. 156, 159-60. I credit
Dr. Munzing's testimony that ``you have to take in the whole context .
. . [a]nd . . . [Respondent] should not have issued that prescription.
You have . . . aberrant urine drug tests that aren't being explained .
. . [and R.B.] starts out [saying he] is much improved. Well, if you're
much improved, then maybe we've overshot and we can . . . give you much
less.'' Tr. 159-60. I find no record evidence that Respondent
documented use of his professional judgment to evaluate R.B.'s changed
pain report and to consider adjusting the 90 tablet oxycodone 30 mg
therapy he initiated on R.B.'s prior visit. GX 14B, at 70-71.
Accordingly, I find substantial record evidence that Respondent
issued the second 90 tablet oxycodone 30 mg prescription for R.B.
beneath the applicable standard of care and outside the usual course of
professional practice. MBC Guide to the Laws, at 59-61.
Also concerning R.B.'s second visit with Respondent, there is
substantial record evidence that the in-house UDS was again positive
for THC and was also positive for oxycodone, opioid, and
benzodiazepine. GX 14B, at 71; see also Tr. 157-58. However, there is
no record evidence that Respondent ever issued R.B. a prescription for
THC or for a benzodiazepine. See, e.g., Tr. 1114-15. I credit Dr.
Munzing's testimony, and I find substantial record evidence that this
second-visit, in-house UDS was aberrant and that Respondent's medical
record for this visit with R.B. does not document that he addressed
this aberrancy in any way. Id. at 157-58; supra sections II, III.D.,
and III.E.
Accordingly, I find further substantial record evidence that
Respondent issued the second 90 tablet oxycodone 30 mg prescription for
R.B. beneath the applicable standard of care and outside the usual
course of professional practice. GX 14B, at 71; MBC Guide to the Laws,
at 60-61.
Further, the parties stipulated that Respondent increased the
oxycodone 30 mg prescription for R.B. from 90 tablets to 120 tablets on
April 6, 2016. Jt. Stip. 74; GX 14B, at 69. During the same visit,
however, the substantial record evidence shows that Respondent
documented in R.B.'s medical record that R.B. reported ``[f]eeling much
improved,'' that ``all complaints of pain are less,'' and that R.B.
exercised daily, predominantly by walking four to six miles. GX 14B, at
68; see also Jt. Stip. 75. I find no evidence in Respondent's medical
record for the April 6, 2016 visit with R.B. that Respondent documented
the professional judgment and analysis that led him to increase the
oxycodone 30 mg prescription he issued for R.B. from 90 to 120 tablets.
Tr. 170-71; see also GX 14B, at 68-69; Tr. 678-79 (Dr. Helm's testimony
that the rationale for Respondent's prescribing ``would have to be . .
. decrease pain and increase function'').
Accordingly, I find substantial record evidence that Respondent
issued the April 6, 2016 120 tablet oxycodone 30 mg prescription for
R.B. beneath the applicable standard of care and outside the usual
course of professional practice. GX 14B, at 68-69; MBC Guide to the
Laws, at 59-61.
I find substantial record evidence that Respondent prescribed R.B.
the controlled cough medicine promethazine with codeine. See, e.g., GX
14B, at 13-24. According to Dr. Munzing's testimony, which I credit,
promethazine with codeine is a highly abused controlled substance. Tr.
172; supra sections II, III.D., and III.E. I find substantial record
evidence that Respondent's medical record for R.B.'s February 7, 2018
visit states that R.B.'s primary care physician ``will no longer
prescribe . . . [R.B.] the cough syrup'' and that Respondent issued
R.B. a prescription for that controlled substance, including a refill,
on that day. GX 14B, at 24; see also Tr. 1108. Dr. Munzing's analysis
of Respondent's medical records for R.B., which I credit, includes that
Respondent did not document conducting a lung examination or evaluation
of R.B. prior to issuing this controlled substance prescription. Tr.
173; supra sections II, III.D., and III.E.; see also Tr. 480-81 and id.
at 1109 (Respondent's testimony that he ``never delved into'' why R.B.
had the cough and the ``bottom line is, he had a cough''). Dr.
Munzing's testimony about Respondent's medical records states, and I
credit his testimony, that the ``primary physician has cut . . . [R.B.]
off[, w]e don't know why[, i]t's not explored[,] and it's not
documented why the primary physician cut him off.'' Id. at 174; supra
sections II, III.D., and III.E. I also find that Dr. Munzing credibly
testified that Respondent is a pain management doctor, not a
pulmonologist, and credibly questioned whether Respondent is the
``right person'' to diagnose a pulmonary matter and to evaluate whether
this controlled substance is the appropriate way to treat this
pulmonary matter. Tr. 174; see also id. at 481. Specifically, Dr.
Munzing testified, and I credit his testimony, that ``prescribing
promethazine with codeine on a chronic, ongoing basis is not the
treatment for anything and is high risk for abuse.'' Id. at 176; supra
sections II, III.D., and III.E.; but cf. Tr. 684-85 (Dr. Helm's
testimony answering ``[s]ure'' when asked whether it was ``within the
standard of care'' for Respondent to ``agree to take over prescribing''
the promethazine with codeine because ``the primary care physician
bluntly had been low-hanging fruit for the Medical Board in terms of
their prescribing, so . . . many of them just don't want to prescribe
controlled substances, and it is very consistent with the
environment'') and id. at 1108 (Respondent's similar testimony).
Accordingly, I find substantial record evidence that Respondent
issued the February 7, 2018 promethazine with codeine prescription for
R.B. beneath the applicable standard of care and outside the usual
course of professional practice. MBC Guide to the Laws, at 59-61.
In sum, based on all of the record evidence, I find substantial
record evidence that Respondent issued controlled substance
prescriptions for R.B. below the applicable standard of care and
outside the usual course of professional practice. MBC Guide to the
Laws, at 59-61; see also, e.g., Tr. 164; id. at 166; id. at 175-77.
There is substantial record evidence that Respondent's controlled
substance prescribing for S.D. was below the applicable standard of
care and outside the usual course of professional practice. For
example, there is substantial record evidence that Respondent
concurrently issued on twelve occasions between January 2018 and
January 2019, and S.D. filled, controlled substance prescriptions for
methadone 10 mg, Roxicodone 15 mg, and carisoprodol 350 mg. GX 15, at
1-24. There is also substantial record evidence that the number of
tablets Respondent prescribed for S.D. during this period increased
from 180 to 270 tablets of methadone and from 60 to 120 tablets of
carisoprodol. Id. According to Dr. Munzing's testimony, which I credit,
Respondent issued these prescriptions beneath the applicable standard
of care and outside the usual course of professional practice. Tr. 206-
207 (Dr. Munzing's testimony that ``based on not just the prescription
but . . . what we've reviewed, the medical records, is that that's not
medically justified, not
[[Page 21204]]
usual professional practice); supra sections II, III.D., and III.E.
Accordingly, I find substantial record evidence that Respondent
issued these controlled substance prescriptions for S.D. below the
applicable standard of care and outside the usual course of
professional practice. MBC Guide to the Laws, at 59-61.
The parties stipulated that Respondent prescribed 90 mg of
oxycodone/day for S.D. on February 4, 2019, March 1, 2019, and April 2,
2019. Jt. Stip. 79. According to Dr. Munzing's testimony, which I
credit, Respondent's issuance of these three stipulated prescriptions
did not comply with the applicable standard of care and was outside the
usual course of professional practice because Respondent did not
document their issuance in S.D.'s medical records. Tr. 188 (Dr.
Munzing's testimony that these prescriptions were issued beneath the
applicable standard of care and outside the usual course of
professional practice); supra sections II, III.D., and III.E.
Accordingly, I find substantial record evidence that Respondent
issued these controlled substance prescriptions for S.D. below the
applicable standard of care and outside the usual course of
professional practice. MBC Guide to the Laws, at 59-61.
The parties stipulated that, on February 24, 2016, Respondent
increased the methadone prescription for S.D. from 120 tablets to 180
tablets. Jt. Stip. 80; GX 16D, at 76-77. According to Dr. Munzing's
testimony, which I credit, the medical record Respondent created for
S.D.'s February 24, 2016 visit, documents a ``very minimal exam'' on
which the increased dosage ``couldn't be based.'' GX 16D, at 76-77; Tr.
188-89 (Dr. Munzing's testimony, including that, ``without an exam,
without a lot of details . . . I don't see anything that would justify
that increase''); supra sections II, III.D., and III.E.
Similarly, the parties stipulated that, on April 20, 2018,
Respondent increased the methadone prescription for S.D. from 180
tablets to 270 tablets. Jt. Stip. 81; GX 16D, at 23-25 (``current meds
are inadequate in controlling her pain even if she takes them exactly
on schedule'' and ``[d]ue to inadequate pain relief, increase MTD 10 mg
to #270 3 tabs TID prn. Continue other meds; appropriate refills
given''). According to Dr. Munzing's testimony, which I credit,
Respondent's April 20, 2018 prescription for S.D., increasing the
methadone prescribed from 180 tablets to 270 tablets, was issued
beneath the applicable standard of care and outside the usual course of
professional practice. Tr. 190-91; supra sections II, III.D., and
III.E. Dr. Munzing testified, regarding these methadone tablet
increases, that they put S.D. ``at incredibly high risk,'' particularly
because of S.D,'s age, and that there is no medical record
documentation that S.D. was made aware of and consented to that
``incredibly high risk.'' Tr. 191-92.
Accordingly, I find substantial record evidence that Respondent
issued his February 24, 2015 and April 20, 2018 methadone prescriptions
for S.D. below the applicable standard of care and outside the usual
course of professional practice.\51\ MBC Guide to the Laws, at 59-61.
---------------------------------------------------------------------------
\51\ See also Tr. 190 (Dr. Munzing's testimony that S.D. ``has
chronic significant medical problem[s]'' and ``[n]o one's arguing
that'').
---------------------------------------------------------------------------
The parties stipulated that the first visit of Respondent with L.D.
was on June 20, 2011. Jt. Stip. 82; see also GX 18B, at 145-46. The
parties also stipulated, about this first visit, that Respondent
documented that L.D. was ``taking amphetamine.'' Jt. Stip. 83; see also
GX 18B, at 145. According to his medical records for L.D.'s first visit
on June 20, 2011, Respondent documented ``[r]efill of Amphetamine salts
given.'' GX 18B, at 146. Dr. Munzing testified, and I credit his
testimony, that Respondent's medical record for L.D.'s first visit is
``completely unclear '' about why L.D. was taking amphetamine. Tr. 208;
see also id. at 491-92 (Dr. Munzing's testimony that Respondent's
medical records document that L.D. complained of pain, do not document
that L.D. complained of fatigue, do not document an exhaustive review
of symptoms, and do not document an evaluation or diagnosis of chronic
fatigue syndrome); id. at 568-69; id. at 709-10 (Dr. Helm's testimony
that the medical records for L.D.'s first visit with Respondent show no
diagnosis for which Respondent prescribed amphetamine salt); id. at
797-99 (Dr. Helm's testimony that a diagnosis (chronic fatigue
syndrome) that might call for treatment with amphetamine salt first
appears in the medical records for L.D.'s third visit). Dr. Munzing
further testified that Respondent's medical records for L.D.'s June 20,
2011 visit include ``no diagnosis of ADHD, attention deficit
hyperactivity disorder, or similar'' diagnosis. Id. at 208. Dr. Munzing
also testified that, ``typically, for most conditions, including the
one that it's typically prescribed for, ADHD, when someone is on high
doses of opioids, there are alternatives which generally are not
controlled and are much safer, not addicting. And so one would
typically not use . . . an amphetamine salt.'' Id. at 212-13. Dr.
Munzing additionally testified that amphetamine salt ``would not
typically be a medication prescribed by a pain medication pain
management doctor.'' \52\ Id. at 209; see also id. at 491 (amphetamine
salt is not a regularly labeled treatment for chronic fatigue
syndrome); id. at 573-75. I credit Dr. Munzing's testimony. Supra
sections II, III.D., and III.E. In addition, I note that there is
agreement between Dr. Munzing and Dr. Helm on some of these matters.
Supra.
---------------------------------------------------------------------------
\52\ According to a document in GX 18A entitled ``[L.D.'s]
Doctors & Medication List,'' a pulmonologist prescribed L.D.
amphetamine. GX 18A, at 82. The document is not dated and does not
indicate its origin. Although Respondent testified about the
document, his testimony did not address the document's origin. Supra
section III.E.
---------------------------------------------------------------------------
Accordingly, I find, based on substantial record evidence, that
Respondent's issuance to L.D. of a prescription for amphetamine salt on
L.D.'s first visit with him was beneath the applicable standard of care
and outside the usual course of professional practice. MBC Guide to the
Laws, at 59.
Although Respondent's medical records for L.D. reference the
criminal incarceration, up-coming trial, conviction, and sentencing of
L.D.'s former spouse and L.D.'s up-coming sentencing hearing, I find no
credible record evidence that they address whether the underlying
criminal bases for these events were related to drugs.\53\ GX 18B, at
82, 88. Dr. Munzing testified that such criminal-related litigation is
a ``huge red flag'' that Respondent ``left wide open'' and ``all one
needs to do is document and resolve the red flag.'' Tr. 232, 496-99;
see also id. at 504. He testified that a ``medical record doesn't need
the specifics, but it certainly does need to know does it have anything
to do with the issues that we're dealing with here, and it was silent
to that effect.'' Id. at 231; cf. id. at 715 (Dr. Helm's testimony that
Respondent's medical records ``clearly showed'' that L.D.'s criminal
involvement was ``business,'' but no direct response to Respondent's
counsel's question of
[[Page 21205]]
whether Respondent ``adequately document[ed]'' L.D.'s criminal status).
``[I]t's something that would be fairly simple to close that red flag,
but was not addressed, was not done,'' Dr. Munzing further testified.
Id. at 232. I credit Dr. Munzing's testimony that these criminal
litigation-related medical records of Respondent are beneath the
applicable standard of care and outside the usual course of
professional practice. Supra sections II, III.D., and III.E.
---------------------------------------------------------------------------
\53\ I note, in contrast, that Respondent's medical records for
A.A. state that A.A.'s ``[d]aughter has been stealing her
medications regularly, police report filed. Patient will now file a
restraining order against her daughter,'' and that Dr. Munzing's
testimony agrees with Respondent's counsel that ``[t]hat's all a
very reasonable explanation to deal with stolen medication.'' GX
12B, at 154; Tr. 415. For A.A.'s next visit, Respondent wrote in the
medical record that ``[d]aughter no longer living with her and
therefore no further issues with meds being stolen,'' and that Dr.
Munzing's testimony agrees with Respondent's counsel that that ``was
good follow[-]up with respect to the daughter having stolen
medications.'' GX 12B, at 151; Tr. 416; see also id. at 639-40 (Dr.
Helm's testimony).
---------------------------------------------------------------------------
Accordingly, I find substantial record evidence that Respondent's
medical records pertaining to these criminal litigation-related matters
are beneath the applicable standard of care and outside the usual
course of professional practice. MBC Guide to the Laws, at 61.
As already discussed, the record evidence addresses the UDSes that
Respondent conducted. Supra sections III.D. and III.E; see also, e.g.,
GX 12, 14, 16, 18, 20, 22. Regarding Respondent's January 9, 2017 visit
with L.D., for example, I find substantial record evidence that
Respondent conducted a UDS and that Respondent's medical records show
the UDS results to have been positive for benzodiazepine and opioid. GX
18B, at 35. I further find substantial record evidence that
Respondent's medical records for that visit with L.D. also show that
L.D.'s ``[m]eds include . . . [a]mphetamine salt 30 mg qd,'' that
L.D.'s ``Current Medications'' section includes ``Amphetamine Salt
Combo 30 mg Tab--Dispense: 30: 1 TABLET ORAL Q Day; Started: 06/20/
2011,'' and that the ``Working Treatment Plan'' section states ``2
months scripts given for Amp Salt, DP, and Dilaudid 8 mg[ ]'' \54\ Id.
at 34-36. According to Dr. Munzing's testimony, which I credit, L.D.'s
January 9, 2017 UDS result is ``[a]bsolutely'' aberrant--because it did
not show a positive result for amphetamine salt--and Respondent did not
address the aberrancy in the medical record. Tr. 234-35; supra sections
II, III.D., and III.E.; see also Tr. 234-35 (Dr. Munzing's testimony
that Respondent's compliance monitoring, including 2017 aberrant UDSes,
``certainly falls far short of the standard of care''), id. at 502-03
and GX 18B, at 101 (Respondent's May 14, 2013 medical records for L.D.
noting ``[i]ntolerable'' pain, spasm, ``exacerbating RUE pain,'' and
tension headache, yet recording UDS results as negative for prescribed
controlled substances and being ``silent'' about, and recording no
explanation for, the aberrancy, particularly when viewed in conjunction
with the noted ``[i]ntolerable'' pain), and Tr. 236-37 (S.H.).\55\
---------------------------------------------------------------------------
\54\ According to the testimony of Dr. Munzing, ``DP'' means
Duragesic Patch, or fentanyl patch. See, e.g., Tr. 208.
\55\ According to the record evidence, Respondent failed to
document and address, explicitly, negative UDS results for
controlled substances that he prescribed ``prn.'' See, e.g., GX 20B,
at 67-69 (S.H./methadone). While the analysis of UDS results for
controlled substances issued ``prn'' differs from the analysis of
UDS results for controlled substances not issued ``prn,'' an
analysis would still ensue including, if appropriate, an assessment
of whether to issue another prescription for the ``prn'' controlled
substance if the controlled substance was not being ingested with
the frequency the prescription allowed. The record evidence does not
document that Respondent conducted any such analysis; however, I do
not consider these matters in this Decision/Order.
---------------------------------------------------------------------------
Accordingly, I find substantial record evidence that Respondent
acted beneath the applicable standard of care and outside the usual
course of professional practice by failing to address an aberrant UDS
and, despite the aberrancy, issued for L.D. a prescription for a two-
month supply of amphetamine salt.\56\ See, e.g., MBC Guide to the Laws,
at 60.
---------------------------------------------------------------------------
\56\ I note that Respondent's medical records state that, on
June 18, 2012, he issued L.D. refills of Dilaudid, Klonopin, and
amphetamine salt and that L.D. would see him again in two months. GX
18B, at 118. Respondent's medical records for L.D. on that date also
document that L.D.'s UDS was positive for cocaine. Id.; see also Tr.
594 (Dr. Munzing's testimony that a cocaine-positive UDS is
``[s]uper aberrant''). I see nothing in the medical records
documenting Respondent's review, consideration, evaluation,
assessment, or addressing of L.D.'s cocaine-positive UDS. I find
that these medical records are substantial record evidence of
Respondent's failure to comply with the applicable standard of care
and the usual course of professional practice. See, e.g., MBC Guide
to the Laws, at 60-61; see also Tr. 584-85, 610-12 (Dr. Munzing's
testimony); but see id. at 713-14 (Dr. Helm's testimony that the
cocaine-positive UDS was ``probably a false positive'' because
``[t]his is not a patient who--one would think would be getting
cocaine,'' that he ``would have preferred to see a note in the chart
just acknowledging that the finding is there,'' and that he
``think[s] there should have been more steps to confirm'' that the
cocaine-positive UDS was a ``false positive'').
---------------------------------------------------------------------------
According to the parties' stipulation, J.M.'s first documented
visit with Respondent was on May 17, 2011. Jt. Stip. 97. At that time,
the parties further stipulated, J.M. ``reported to Respondent that he
had difficulty getting OxyContin authorized and wanted to try oxycodone
instead.'' Jt. Stip. 98. The parties also stipulated that Respondent
checked CURES for J.M. on May 17, 2011. Jt. Stip. 103.a. I find, based
on substantial record evidence, that Respondent issued a controlled
substance prescription for J.M. on May 17, 2011. GX 22B, at 133
(Roxicodone 30 mg 180 tablets 1 q4-6 prn to a max of 6/day).
I find, based on substantial record evidence including Respondent's
medical records for J.M., that the medical office that treated J.M.
before Respondent's treatment transmitted a seven-page fax to
Respondent on June 14, 2011. GX 22A, at 71-77. I find substantial
record evidence that the fax cover sheet states ``[p]lease see attached
medical records for . . . [J.M.] per your request.'' Id. at 71. I find
substantial record evidence that the transmittal includes a letter from
the medical practice to J.M. dated June 1, 2011. Id. at 72. I find
substantial record evidence that the letter states that ``[i]t has been
brought to . . . [the] attention'' of the medical office that J.M.
``violated our Controlled Substance Policy by receiving medications
from multiple physicians per the DOJ report from 05/31/2011.'' Id. I
find substantial record evidence that, after stating that the practice
has ``nothing further to offer'' J.M. due to the ensuing
``eliminat[ion] of trust,'' the letter states that J.M. ``will receive
a 30-day supply of . . . Oxycontin, and Roxicodone today,'' which will
be J.M.'s ``final prescriptions filled by . . . [that] office.'' Id.
The parties stipulated that Respondent's medical records for J.M.'s
June 17, 2011 visit document that J.M.'s mother ``came to the office''
with J.M. Jt. Stip. 99; see also Jt. Stip. 100 and GX 22B, at 128
(``Here with mother to plead mercy. Needs a doctor close to home. Wants
a second chance.''). I find substantial record evidence that, in the
``Working Treatment Plan'' section of Respondent's medical records for
J.M. for the June 17, 2011 visit, Respondent wrote ``One final chance;
script for #180 Roxi given.'' GX 22B, at 129; see also Jt. Stip. 101-
02.
Respondent testified about these initial visits with J.M. Among
other things, Respondent admitted in his testimony that J.M. was on a
high dose of oxycodone. Tr. 1097. Regarding J.M.'s visit with
Respondent on May 17, 2011, Respondent testified that he ``was trying
to put the pieces of the puzzle together'' and that he was with J.M.
``for excess of an hour, observing the way . . . [J.M.] walked into the
room, observing the way he left the room, [and] observing the way that
he remained seated for an excess of an hour.'' Id. at 1138. Respondent
testified that he ``felt that that was adequate exam for these
particular diagnoses'' and that he ``would not expect anything acute on
exam'' related to J.M.'s ``long history of compression fractures.'' Id.
Regarding J.M.'s June 17, 2011 visit, Respondent testified,
defending his issuance of a controlled substance prescription for J.M.
without having conducted a physical exam, that ``nothing had changed in
these few weeks and there were no acute findings'' and that he ``again,
. . . would expect absolutely nothing acute
[[Page 21206]]
on the exam'' because he was ``only treating chronic pain.'' Id. at
1139.
Respondent also testified about J.M.'s July 15, 2011 visit with
him. According to Respondent, he conducted a comprehensive physical
examination of J.M. at that visit ``[b]ecause now the dust had
settled,'' ``everything's organized,'' ``we're all in agreement,''
``[w]e understand everything that's going on,'' ``[t]here was time, and
it was time to carry on with this . . . situation,'' and ``[w]e had
time to develop a baseline exam and everything like that.'' Id. at
1139-40. Respondent also testified that, during the July 15, 2011
visit, J.M. reported experiencing ``an exacerbation of pain,''
``changes in his range of motion,'' and ``changes in his body
movement,'' and ``so then we carry on with the full exam.'' Id. at
1140.
Dr. Helm also testified about Respondent's initial visits with
J.M.\57\ According to Dr. Helm, it is ``acceptable'' to ``defer'' a
physical examination for a patient who is already on medications issued
by another provider. Id. at 733. He testified that the physician is
``deferring the bulk of the exam'' due to being ``so busy . . .
collecting the history and determining on the basis of histories or
[sic] legitimate medical purpose for the medications'' and
``document[s] why'' the exam is being deferred. Id. at 733-34. Dr. Helm
testified that he ``understands'' what Respondent's documentation of
``one final chance'' means, ``that . . . [Respondent] is willing to go
forward with . . . [J.M.] on a, you know, if you will, a tight leash
where he's really got to continue with the meds or continue with
compliance and he can't be doing what he just did.'' Id. at 806.
---------------------------------------------------------------------------
\57\ While not explicitly addressed in the record evidence, Dr.
Helm's testimony appears plausible that J.M. returned to his prior
physician's medical practice after seeing Respondent on May 17,
2011, the prior physician's medical practice discovered from CURES
that J.M. filled Respondent-issued controlled substance
prescriptions, and the prior physician's medical practice dismissed
J.M. for violating the policy of receiving medications from only one
physician. Tr. 734-35. Dr. Helm's suppositions on these matters are
irrelevant to, and therefore do not impact, my Decision/Order.
---------------------------------------------------------------------------
Dr. Munzing also testified about Respondent's initial visits with
J.M. Regarding J.M.'s May 17, 2011 visit with Respondent, Dr. Munzing
testified that Respondent prescribed controlled substances for J.M.
even though ``[w]e just don't know . . . [if J.M. was] actually taking
all that medication'' based on J.M.'s own documented statement to
Respondent that ``he had difficulty getting OxyContin authorized and
wanted to try oxycodone instead.'' Id. at 548; Jt. Stip. 98; see also
Tr. 548 (Dr. Munzing's testimony that ``[t]here's no documentation in
here regarding urine drug test [sic], regarding prior records at this
point, regarding any of that, and so that medication was prescribed
strictly based on whether a patient told you without any other
investigation, without a detailed review of the patient from what we
can see, from what's documented, and without doing any examination of
the patient''), id. at 547 (Dr. Munzing's testimony that ``[t]here's
nothing--it does not appear based on what's documented that actually
the Respondent even actually touched the patient, had him do any
specific maneuvers . . . none of [what is done during a back exam]
existed. None of that was documented.''), id. at 563-64 (same).
Regarding J.M.'s June 17, 2011 visit with Respondent, Dr. Munzing
testified that ``it's a significant red flag that here [sic] pleading
for mercy, one more chance . . . [and] no other significant information
is documented. That's a great concern.'' Tr. 267. Dr. Munzing also
addressed Respondent's issuance of Roxicodone 30 mg (180 tablets) and
oxycodone 30 mg (180 tablets) to J.M. during their initial visits. Dr.
Munzing testified that ``here we're three visits into it at least, and
we have no exam at all but you're prescribing extremely high dosages of
medication,'' that ``here we are just over two weeks later [from when
J.M. received controlled substance prescriptions from his prior
physician] and you're giving some more . . . [even though h]e should
still have . . . at least another couple of weeks left, and so there's
no indication to get more,'' and that ``there's a cascade of things
that ought to be here,'' specifically listing information about mental
health issues and about drug and alcohol current or past history, or
use. Id. at 267-68.
I credit Dr. Munzing's testimony. Supra sections II, III.D., and
III.E.
Accordingly, I find substantial record evidence that Respondent
acted beneath the applicable standard of care and outside the usual
course of professional practice by, for example, issuing J.M.
controlled substance prescriptions at J.M.'s first two documented
visits. E.g., MBC Guide to the Laws, at 59.
As already discussed, based on these founded violations alone, I
find that the Government presented a prima facie case. Accordingly, I
see no need, and I decline, to discuss and assess the other OSC
allegations and the other elements of the Government's case.
IV. Discussion
A. The Controlled Substances Act
Under Section 304 of the CSA, ``[a] registration . . . to . . .
distribute[ ] or dispense a controlled substance . . . may be suspended
or revoked by the Attorney General upon a finding that the registrant .
. . has committed such acts as would render his registration under
section 823 of this title inconsistent with the public interest as
determined by such section.'' 21 U.S.C. 824(a)(4). In the case of a
``practitioner,'' which is defined in 21 U.S.C. 802(21) to include a
``physician,'' Congress directed the Attorney General to consider the
following factors in making the public interest determination:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing . . . controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the . . . distribution[ ] or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f). These factors are considered in the disjunctive.
Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003).
According to Agency decisions, I ``may rely on any one or a
combination of factors and may give each factor the weight [I] deem[ ]
appropriate in determining whether'' to revoke a registration. Id.; see
also Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881
F.3d 823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't
Admin., 841 F.3d 707, 711 (6th Cir. 2016); MacKay v. Drug Enf't Admin.,
664 F.3d 808, 816 (10th Cir. 2011); Volkman v. U. S. Drug Enf't Admin.,
567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin., 419 F.3d
477, 482 (6th Cir. 2005). Moreover, while I am required to consider
each of the factors, I ``need not make explicit findings as to each
one.'' MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see
also Hoxie, 419 F.3d at 482. ``In short, . . . the Agency is not
required to mechanically count up the factors and determine how many
favor the Government and how many favor the registrant. Rather, it is
an inquiry which focuses on protecting the public interest; what
matters is the seriousness of the registrant's misconduct.'' Jayam
Krishna-Iyer, M.D., 74 FR 459, 462 (2009). Accordingly, as the Tenth
Circuit has recognized, findings under a single factor can support the
revocation
[[Page 21207]]
of a registration. MacKay, 664 F.3d at 821.
According to DEA regulations, ``[a]t any hearing for the revocation
. . . of a registration, the . . . [Government] shall have the burden
of proving that the requirements for such revocation . . . pursuant to
. . . 21 U.S.C. [Sec. ] 824(a) . . . are satisfied.'' 21 CFR
1301.44(e). In this matter, while I have considered all of the factors,
the Government's evidence in support of its prima facie case is
confined to Factors Two and Four.\58\ Govt Posthearing, at 31. As
already discussed, I find that a segment of the Government's case
includes sufficient evidence with respect to Factors Two and Four to
satisfy its prima facie burden of showing that Respondent's continued
registration would be ``inconsistent with the public interest'' without
my needing to consider its entire case, some of which is insufficiently
developed. 21 U.S.C. 823(f). I further find that Respondent failed to
produce sufficient evidence to rebut the Government's prima facie case.
---------------------------------------------------------------------------
\58\ As to Factor One, the Government does not dispute, and
there is no record evidence disputing, Respondent's claims that he
has an unblemished medical record and has never had any disciplinary
action brought against his license, presumably meaning his medical
license. Resp Posthearing, at 2, 21-22; 21 U.S.C. 823(f)(1). State
authority to practice medicine is ``a necessary, but not a
sufficient condition for registration . . . .'' Robert A. Leslie,
M.D., 68 FR at 15230. Therefore, ``[t]he fact that the record
contains no evidence of a recommendation by a state licensing board
does not weigh for or against a determination as to whether
continuation of Respondent's DEA certification is consistent with
the public interest.'' Roni Dreszer, M.D., 76 FR 19434, 19444
(2011).
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 prior
Agency decisions 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 49956, 49973 (2010), pet. for rev.
denied, MacKay v. Drug Enf't Admin., 664 F.3d 808 (10th Cir. 2011).
Those Agency decisions have therefore concluded that ``the absence
of such a conviction is of considerably less consequence in the
public interest inquiry'' and is therefore not dispositive. Id.
The Government's case includes no allegation under Factor Five.
---------------------------------------------------------------------------
B. Factors Two and/or Four--The Respondent's Experience in Dispensing
Controlled Substances and Compliance With Applicable Laws Related to
Controlled Substances
Allegation That Respondent's Registrations Are Inconsistent With the
Public Interest
According to the CSA's implementing regulations, a lawful
prescription for controlled substances is one that is ``issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.'' 21 CFR 1306.04(a). The
Supreme Court has stated, in the context of the CSA's requirement that
schedule II controlled substances may be dispensed only by written
prescription, that ``the prescription requirement . . . ensures
patients use controlled substances under the supervision of a doctor so
as to prevent addiction and recreational abuse . . . [and] also bars
doctors from peddling to patients who crave the drugs for those
prohibited uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006).
Respondent engaged a skillful team and defended himself against all
of the OSC's allegations. I read and analyzed every aspect of
Respondent's defense including his record evidence. As already
discussed, Respondent's evidence and argument are not persuasive on the
founded violations. Supra section III.F.
Respondent's case admits that some of Respondent's medical
recordkeeping is substandard. See, e.g. supra section III.F; Tr. 773,
778 (Dr. Helm's testimony about the lack of Respondent's documentation
and, in the absence of his documentation, ``[w]e don't know what's
going on''). Respondent's case and hearing testimony about the
existence, content, and accuracy of his medical records, however,
largely excuse his documentation failures. See, e.g., supra section
III.E.; Tr. 940 (Respondent's testimony that A.A.'s aberrant UDS ``was
not of significance to me'' and ``was not of concern to me'' because
``she is my patient,'' ``I'm her doctor,'' and ``I have a relationship
with her . . . an understanding with her . . . [a]nd this was not a
cause for alarm''); id. at 962-63 (Respondent's testimony that his
``record is wrong because I'm so busy talking to the patient . . .
[b]ut again, from this chart, that's not a big problem, because it's
historically her left knee''); id. at 972 (Respondent's testimony that
``a lot of [his medical] records have been read wrong and interpreted
wrong [at the hearing] because I'm doing a million things at once, and
people are trying to read the exact word''). Respondent's case does not
include citation to the applicable standard of care's allowance for
such excuses, and I found none. See supra section II.
By way of further example, Respondent's case admits that some of
Respondent's controlled substance prescription monitoring is
substandard. See, e.g., supra section III.E; Tr. 1098 (Respondent's
testimony that he did not consider a UDS to be aberrant if it is
negative for a substance he prescribed, admitting that his ``attorney
then, you know, corrected me on that statement''). Respondent testified
that he used UDSes to look for the presence of substances that he had
not prescribed. Tr. 1098. Yet, despite this testimony, by his own
admission he did not follow up on L.D.'s cocaine-positive UDS
documented in the medical records until during preparations for this
hearing. Supra section III.E.
As already discussed, there is substantial record evidence that
Respondent issued controlled substance prescriptions before conducting
the requisite physical examination and before documenting a diagnosis.
Supra section III.F. There is substantial record evidence that he
prescribed controlled substances as favors or accommodations. Id. There
is substantial record evidence that Respondent increased the dosages of
controlled substances he was prescribing, even controlled substances
that are highly abused and diverted and that are a disproportionate
cause of death, without the requisite documentation. Id. There is even
substantial record evidence that Respondent increased the dosage of a
controlled substance on the recipient's demand, against his previous
medical analysis and medical judgment, and increased the dosage of
other controlled substances based on ``ad lib'' self-dosing. Id. There
is substantial record evidence that Respondent issued controlled
substance prescriptions without accurate and complete documentation and
based on the representations of others, as opposed to basing it on his
independent medical analysis and judgment. Id. There is substantial
record evidence that Respondent failed correctly to identify aberrant
UDSes, to document them, and to resolve them before further prescribing
the controlled substance at issue in the aberrancy. Id. There is
substantial record evidence that Respondent failed to identify and
resolve other red flags of abuse and diversion before further
prescribing the controlled substance. Id.
As already discussed, I find that these unrebutted actions and
inactions by Respondent in his controlled-substance related prescribing
are violations of the applicable standard of care and are outside the
usual course of professional practice and, therefore, are CSA
violations. 21 CFR 1306.04(a). Accordingly, I find that it is
appropriate to sanction Respondent for these violations.
[[Page 21208]]
Summary of Factors Two and Four and Imminent Danger
As already discussed, Respondent's case does not successfully rebut
the Government's prima facie case, established by substantial record
evidence, that Respondent issued controlled substance prescriptions
beneath the applicable standard of care and outside the usual course of
professional practice. Accordingly, I find that Respondent engaged in
egregious misconduct which supports the revocation of his
registrations. See Wesley Pope, 82 FR 14944, 14985 (2017).
For purposes of the imminent danger inquiry, my findings also lead
to the conclusion that Respondent ``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 record evidence that Respondent issued controlled substance
prescriptions beneath the applicable standard of care and outside the
usual course of professional practice establishes that there was ``a
substantial likelihood of an immediate threat that death, serious
bodily harm, or abuse of a controlled substance . . . [would] occur in
the absence of the immediate suspension'' of Respondent's
registrations. Id.; see, e.g., Tr. 1030-32 (Respondent's testimony
about his prescribing Duragesic patch when ``you haven't been on it for
a while, and you might not even need that much'' and then increasing
the dosage based on self-dosing reports); id. at 842 (the testimony of
Dr. Helm that methadone is a disproportionate cause of death). Thus, I
find that, at the time the OSC was issued, there was clear evidence of
imminent danger.
V. Sanction
Where, as here, the Government has met its prima facie burden of
showing that Respondent's continued registration is inconsistent with
the public interest due to his numerous violations pertaining to
controlled substance prescribing, the burden shifts to the Respondent
to show why he can be entrusted with a new registration. Garrett Howard
Smith, M.D., 83 FR 18,882, 18,910 (2018) (collecting cases). Moreover,
as past performance is the best predictor of future performance, DEA
Administrators have required that a registrant who has committed acts
inconsistent with the public interest must accept responsibility for
those acts and demonstrate that he will not engage in future
misconduct. Id. A registrant's acceptance of responsibility must be
unequivocal. Id. In addition, a registrant's candor during the
investigation and hearing has been an important factor in determining
acceptance of responsibility and the appropriate sanction. Id.
(collecting cases). In addition, DEA Administrators have found that the
egregiousness and extent of the misconduct are significant factors in
determining the appropriate sanction. Id. DEA Administrators have also
considered the need to deter similar acts by the respondent and by the
community of registrants. Id.
Regarding these matters, I find that Respondent did not take
responsibility, let alone unequivocal responsibility, for the founded
violations. Tr. 1116 (Respondent's ``I don't'' response during his
testimony when asked ``Do you accept responsibility for the
prescriptions at issue not being issued in the usual course of
professional practice? ''). Concerning his medical recordkeeping, while
Respondent ``acknowledged'' that it ``could be improved,'' this
acknowledgement is not an acceptance of responsibility, let alone an
unequivocal acceptance of responsibility. Id. at 1133. Further,
Respondent's testimony after ``acknowledging'' that his medical
recordkeeping could be improved was that ``in retrospect, thinking last
night, I could have actually--even with what I have, I could have
improved my recordkeeping because it's part of my electronic medical
record under treatment plan where you click boxes. . . . [T]here is a
section where you can click that the urine drug screens were checked.''
Id. at 1133-34. The ALJ followed up with the Respondent on this portion
of his testimony, stating that ``these medical records that you have .
. . the capability of checking a box that shows that you checked the
CURES report or checking a box to show that you had conducted a UDS . .
. really is not the problem with this case.'' Id. at 1134. ``The
problem with this case,'' the ALJ continued, ``is that--it doesn't show
that you did anything with it.'' Id. When Respondent reacted to the ALJ
by stating ``[t]hat I discussed it,'' the ALJ stated ``Yes. So that's
not checking a box.'' Id. at 1135. I agree with the ALJ. Accordingly,
even if it were appropriate to consider Respondent's electronic medical
record testimony to be Respondent's proposed remedial measures, I would
find Respondent's proposal to be insufficient.
I also note that Respondent testified further about his substandard
recordkeeping and the ways he will improve. Id. at 1086. Respondent
testified that he ``need[s] to learn to type and speak at the same
time'' instead of ``spending so much time discussing with the patient's
issues.'' Id. He also testified that he ``guess[es]'' he could hire a
scribe, ``somebody who is sitting there typing while you talk,'' but
that he's ``not interested in having someone interfere with . . . [his]
relationship with . . . [his] patient.'' Id. Respondent further
testified that ``the world has changed'' and that he ``now need[s] to
think of . . . [his medical records] as not about . . . [him but as a]
document [that] is going to be scrutinized by everyone.'' Id. at 1087.
I reject the suggestion that the applicable standard of care forces a
physician to choose between compliance with that standard of care and
providing patients medical care that complies with the applicable
standard of care within the usual course of professional practice. I
find that Respondent's suggestion of this false choice reflects an
insufficient appreciation and understanding of medical recordkeeping
standards of care and the responsibilities of a registrant.
In sum, I find that the record supports the imposition of a
sanction because Respondent did not unequivocally accept responsibility
and because Respondent has not convinced me that he can be entrusted
with a registration.
The interests of specific and general deterrence weigh in favor of
revocation. Respondent explicitly refused to accept responsibility for
his substandard controlled substance prescribing. Id. at 1116.
Respondent has not convinced me that he understands that his controlled
substance prescribing fell short of the applicable standard of care and
that this substandard controlled substance prescribing has serious
negative ramifications for the health, safety, and medical care of
individuals who come to him for medical care. As such, it is not
reasonable for me to believe that Respondent's future controlled
substance prescribing and recordkeeping will comply with legal
requirements. Further, given the nature and number of Respondent's
violations, a sanction less than revocation would send a message to the
existing and prospective registrant community that compliance with the
law is not a condition precedent to maintaining a registration.
Accordingly, I shall order the sanctions the Government requested,
as contained in the Order below.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(f) and 824(a), I hereby revoke DEA Certificates of
Registration BR0869719 and BA7661564 along with DATA-
[[Page 21209]]
Waiver No. XR0869719 issued to Craig S. Rosenblum, M.D. I further
hereby deny any pending application(s) of Craig S. Rosenblum, M.D., to
renew or modify these registrations, as well as any other pending
application(s) of Craig S. Rosenblum, M.D., or Aurora Surgery Center LP
for registration in California. This Order is effective May 9, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2022-07727 Filed 4-8-22; 8:45 am]
BILLING CODE 4410-09-P