[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).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \4\ See Gonzales v. Oregon, 546 U.S. 243, 269-71 (2006); see 
also OSC, at 2-3.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \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 <SUP>8</SUP>
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \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\
---------------------------------------------------------------------------

    \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.'')).
---------------------------------------------------------------------------

    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