Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10337 

5Under the Administrative Procedure Act, an 

agency ‘‘may take official notice of facts at any stage 

in a proceeding—even in the final decision.’’ 

United States Department of Justice, Attorney 

General’s Manual on the Administrative Procedure 

Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 

1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an 

agency decision rests on official notice of a material 

fact not appearing in the evidence in the record, a 

party is entitled, on timely request, to an 

opportunity to show the contrary.’’ Accordingly, 

Registrant may dispute my finding by filing a 

properly supported motion for reconsideration of 

finding of fact within fifteen calendar days of the 

date of this Order. Any such motion shall be filed 

with the Office of the Administrator and a copy 

shall be served on the Government. In the event 

Registrant files a motion, the Government shall 

have fifteen calendar days to file a response. Any 

such motion and response shall be filed and served 

by email to the other party and to Office of the 

Administrator, Drug Enforcement Administration at 

dea.addo.attorneys@dea.usdoj.gov. 

medicine and surgery.’’ Id. at 18 

(emphasis in original). 

According to DI, on December 17, 

2019, DI queried the Pennsylvania 

Department of State licensing 

verification website at https://

www.pals.pa.gov/#/page/searchresult 

and determined that Registrant’s 

medical physician license was still 

suspended at that time and that 

Registrant was without authorization to 

handle controlled substances or practice 

medicine in Pennsylvania. RFAAX 10, 

at 3. According to Pennsylvania’s online 

records, of which I take official notice, 

Registrant’s license is still revoked.5

Pennsylvania Licensing System 

Verification, https://www.pals.pa.gov/#/ 

page/search (last visited date of 

signature of this Order). 

Accordingly, I find that Registrant 

currently is neither licensed to engage 

in the practice of medicine nor 

registered to dispense controlled 

substances in Pennsylvania, the state in 

which Registrant is registered with the 

DEA. 

III. Discussion 

Pursuant to 21 U.S.C. 824(a)(3), the 

Attorney General is authorized to 

suspend or revoke a registration issued 

under section 823 of the Controlled 

Substances Act (hereinafter, CSA) 

‘‘upon a finding that the registrant . . . 

has had his State license or registration 

suspended . . . [or] revoked . . . by 

competent State authority and is no 

longer authorized by State law to engage 

in the . . . dispensing of controlled 

substances.’’ With respect to a 

practitioner, the DEA has also long held 

that the possession of authority to 

dispense controlled substances under 

the laws of the state in which a 

practitioner engages in professional 

practice is a fundamental condition for 

obtaining and maintaining a 

practitioner’s registration. See, e.g., 

James L. Hooper, M.D., 76 FR 71,371 

(2011), pet. for rev. denied, 481 F. App’x 

826 (4th Cir. 2012); Frederick Marsh 

Blanton, M.D., 43 FR 27,616, 27,617 

(1978). 

This rule derives from the text of two 

provisions of the CSA. First, Congress 

defined the term ‘‘practitioner’’ to mean 

‘‘a physician . . . or other person 

licensed, registered, or otherwise 

permitted, by . . . the jurisdiction in 

which he practices . . . , to distribute, 

dispense, . . . [or] administer . . . a 

controlled substance in the course of 

professional practice.’’ 21 U.S.C. 

802(21). Second, in setting the 

requirements for obtaining a 

practitioner’s registration, Congress 

directed that ‘‘[t]he Attorney General 

shall register practitioners . . . if the 

applicant is authorized to dispense . . . 

controlled substances under the laws of 

the State in which he practices.’’ 21 

U.S.C. 823(f). Because Congress has 

clearly mandated that a practitioner 

possess state authority in order to be 

deemed a practitioner under the CSA, 

the DEA has held repeatedly that 

revocation of a practitioner’s registration 

is the appropriate sanction whenever he 

is no longer authorized to dispense 

controlled substances under the laws of 

the state in which he practices. See, e.g., 

James L. Hooper, 76 FR at 71,371–72; 

Sheran Arden Yeates, M.D., 71 FR 

39,130, 39,131 (2006); Dominick A. 

Ricci, M.D., 58 FR 51,104, 51,105 (1993); 

Bobby Watts, M.D., 53 FR 11,919, 11,920 

(1988); Frederick Marsh Blanton, 43 FR 

at 27,617. 

Under the Pennsylvania Controlled 

Substance, Drug, Device and Cosmetic 

Act, ‘‘no controlled substance in 

Schedule II shall be dispensed without 

an electronic prescription of a 

practitioner.’’ 35 PA. Stat. and Const. 

Stat. Ann. § 780–111(a) (West October 

24, 2019). Further, ‘‘no controlled 

substance in Schedule III, IV or V shall 

be dispensed without an electronic 

prescription of a practitioner.’’ Id. at 

§ 780–111(b). The definition of 

‘‘practitioner,’’ as used in the state Act, 

includes a ‘‘physician . . . or other 

person licensed, registered or otherwise 

permitted to distribute, dispense, 

conduct research with respect to or to 

administer a controlled substance . . . 

in the course of professional practice 

. . . in the Commonwealth of 

Pennsylvania.’’ Id. at 780–102(b). 

Here, the undisputed evidence in the 

record is that Registrant currently lacks 

authority to practice medicine in 

Pennsylvania. As already discussed, a 

physician must be a licensed 

practitioner to dispense a controlled 

substance in Pennsylvania. Thus, 

because Registrant lacks a license to 

practice medicine in Pennsylvania and, 

therefore, is not authorized to handle 

controlled substances in Pennsylvania, 

Registrant is not eligible to maintain a 

DEA registration. Accordingly, I will 

order that Registrant’s DEA registration 

be revoked. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 

824(a), I hereby revoke DEA Certificate 

of Registration No. FS1471818 issued to 

Milad I. Shaker, M.D. Further, pursuant 

to 28 CFR 0.100(b) and the authority 

vested in me by 21 U.S.C. 823(f), I 

hereby deny any pending application of 

Milad I. Shaker, M.D. to renew or 

modify this registration or for any other 

registration in Pennsylvania. This Order 

is effective March 22, 2021. 

D. Christopher Evans, 

Acting Administrator. 

[FR Doc. 2021–03358 Filed 2–18–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 17–33] 

Michael W. Carlton, M.D.; Decision and 

Order 

On April 18, 2017, a former Assistant 

Administrator, Diversion Control 

Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause (hereinafter, OSC) to Michael W. 

Carlton, M.D. (hereinafter, Respondent). 

Administrative Law Judge Exhibit 

(hereinafter, ALJX) 1 (Order to Show 

Cause), at 1. The OSC proposed the 

revocation of Respondent’s Certificate of 

Registration No. BC3579969 pursuant to 

21 U.S.C. 824(a)(4) ‘‘because [his] 

continued registration is inconsistent 

with the public interest . . . .’’ Id. 

(citing 21 U.S.C. 823(f)). 

I. Procedural History 

The OSC alleged that ‘‘between May 

8, 2015 and November 21, 2015, on 

approximately forty-two (42) occasions, 

[Respondent] unlawfully prescribed 

controlled substances to thirty-one (31) 

patients by issuing prescriptions for 

other than a legitimate medical purpose 

and outside the usual course of 

professional practice.’’ OSC, at 1–2. The 

OSC alleged violations of 21 U.S.C. 

841(a), 21 CFR 1306.04(a), and Ariz. 

Rev. Stat. Ann. § 32–1401(27). Id. at 2. 

The OSC stated that ‘‘a medical expert 

has concluded that [Respondent’s] 

issuance of the [forty-two] prescriptions 


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1 I find that the Government’s service of the OSC 

was adequate. 

2The Diversion Investigator testified that the 

subpoena request was for ‘‘all medical records for 

any patient who was treated at Recovery in Motion 

and received a controlled substance prescription 

from Dr. Carlton.’’ Tr. 164. She also testified that 

‘‘because of the privacy concerns with opioid 

patients . . . [DEA] had to apply for a court order 

that protected, saying that yes, in fact, we can have 

these, but we’ll handle these records in a particular 

way, and [DEA was] to get that court order.’’ Tr. 

156–57. Both the subpoena and the court order 

were served on RIM. Tr. 157, 165. Ultimately, I do 

not find that the missing behavioral health records, 

if they existed, are relevant to the standard of care 

as discussed in infra II.E.1 & n.13. 

3 It was alleged that Respondent exceeded the 

number of patients he was permitted to treat for 

addiction; he operated an illegal take-back program 

wherein he took patients’ unused controlled 

substances and redistributed them to other patients; 

and he failed to maintain required records. Tr. 150– 

52; GX 35, at 1–2. 

listed [in the OSC] violated minimal 

medical standards applicable to the 

practice of medicine in the state of 

Arizona.’’ Id. For each of the forty-two 

prescriptions listed in the OSC, the 

Government alleged that Respondent’s 

deficiencies ‘‘include [his] failure to 

conduct a physical examination, take an 

adequate medical history, and assess 

and discuss functional issues’’ prior to 

their issuance. Id. at 2; see also id. at 3– 

10. 

The OSC notified Respondent of the 

right to either request a hearing on the 

allegations or submit a written 

statement in lieu of exercising the right 

to a hearing, the procedures for electing 

each option, and the consequences for 

failing to elect either option. Id. at 10 

(citing 21 CFR 1301.43). The OSC also 

notified Respondent of the opportunity 

to submit a corrective action plan. Id. at 

11 (citing 21 U.S.C. 824(c)(2)(C)). 

By letter dated May 18, 2017, 

Respondent timely requested a hearing.1

ALJX 2 (Request for Hearing), at 1. The 

matter was placed on the docket of the 

Office of Administrative Law Judges and 

was initially assigned to Chief 

Administrative Law Judge John J. 

Mulrooney, II (hereinafter, the Chief 

ALJ). On May 22, 2017, the Chief ALJ 

established a schedule for the filing of 

prehearing statements. ALJX 3 (Order 

for Prehearing Statements), at 1. The 

Government filed its prehearing 

statement on May 31, 2017. ALJX 4 

(Government’s Prehearing Statement), at 

1. After twice requesting and receiving 

additional time, Respondent filed his 

Prehearing Statement on July 5, 2017. 

See ALJX 5 (Letter from Respondent 

dated June 9, 2017), ALJX 6 

(Government Opposition to 

Continuance Request), ALJX 7 (Order 

Granting Respondent’s First Extension 

Request), ALJX 8 (Respondent’s Request 

for Extension to File Prehearing 

Statement), ALJX 9 (Order Granting 

Respondent’s Second Extension 

Request), and ALJX 10 (Respondent’s 

Prehearing Statement). 

On July 6, 2017, the Chief ALJ issued 

a Prehearing Ruling that, among other 

things, set out one agreed upon 

stipulation and established schedules 

for the filing of additional joint 

stipulations and for the hearing. ALJX 

11 (Prehearing Ruling), at 1, 4. The 

Prehearing Ruling stated that ‘‘[n]o later 

than July 28, 2017, the parties are to 

serve each other with copies of all 

identifiable documents listed in their 

prehearing statements.’’ Id. at 2 

(emphasis omitted). The parties were 

also directed to file supplemental 

prehearing statements and exchange 

‘‘any additional documents identified in 

the parties’ supplemental prehearing 

statements’’ by no later than August 21, 

2017. Id. Thereafter, the matter was 

reassigned to Administrative Law Judge 

Mark M. Dowd (hereinafter, the ALJ). 

ALJX 15 (Order Reassigning Case). The 

Government timely served the exhibits 

identified in its prehearing statement on 

Respondent on July 28, 2017. 

Government’s Certificate of Service 

Regarding Government’s Proposed 

Exhibits 1–34; ALJX 11, at 2. 

Respondent did not serve the exhibits 

identified in its prehearing statement on 

the Government at that time. The 

Respondent filed a supplemental 

prehearing statement on July 27, 2017, 

which identified the same exhibits as 

were listed in his original prehearing 

statement. ALJX 16 (Respondent’s First 

Supplemental Prehearing Statement). 

The Government timely filed a 

supplemental prehearing statement on 

August 21, 2017. ALJX 17 

(Government’s Supplemental Prehearing 

Statement). The Respondent missed the 

July 28, 2017 deadline to exchange 

exhibits, which set off a variety of 

motions (including additional requests 

for continuances and a motion in 

limine) and a variety of procedural 

rulings. See ALJX 18–30. I have 

reviewed and agree with the procedural 

rulings of the ALJ during the 

administration of the hearing. 

The hearing in this matter took place 

in Phoenix, Arizona, and spanned two 

days. See generally Transcript of 

Proceedings in the Matter of Michael W. 

Carlton, M.D. (hereinafter, Tr.). Both 

parties filed posthearing briefs. See 

Government’s Proposed Findings of 

Fact, Conclusions of Law, and 

Argument (hereinafter, Govt 

Posthearing), and Respondent’s PostHearing Brief (hereinafter, Resp 

Posthearing). Both parties also briefed 

the issue of whether or not Respondent 

should receive an adverse inference for 

failing to provide behavioral health 

records, which Respondent claimed 

existed, but were not produced by RIM 

pursuant to the subpoena 2 or by 

Respondent on his own behalf. See Govt 

Posthearing, and Respondent’s Brief on 

RIM Medical Records. Then on April 12, 

2018, the ALJ issued his Recommended 

Rulings, Findings of Fact, Conclusions 

of Law and Decision (hereinafter, RD). 

The Government filed exceptions to the 

RD. See Government’s Exceptions to the 

Recommended Rulings, Findings of 

Fact, Conclusions of Law, and Decision 

of the Administrative Law Judge 

(hereinafter, Govt Exceptions). 

Having considered the record in its 

entirety, I find that Respondent issued 

forty prescriptions beneath the 

applicable standard of care and outside 

of the usual course of the professional 

practice in Arizona in violation of 

federal law, and I find that Respondent 

committed violations of state law. I 

agree with the ALJ that revocation is the 

appropriate sanction. RD, at 96. I make 

the following findings of fact. 

II. Findings of Fact 

A. DEA Registration 

The parties stipulated that 

Respondent is registered with DEA as a 

data-waived DW/100 practitioner able to 

handle controlled substances in 

schedules II through V under DEA 

Certificate of Registration No. 

BC3579969, at 15721 North GreenwayHayden Loop, Suite 205, Scottsdale, 

Arizona 85260. ALJX 11, at 1; and GX 

1 (Controlled Substance Registration 

Certificate). 

B. The Investigation 

The Diversion Investigator assigned to 

this matter (hereinafter, DI) first 

interacted with Respondent in 2007 for 

a ‘‘scheduled regulatory investigation.’’ 

Tr. 149. During the scheduled 

investigation, DI discovered potential 

violations,3 resulting in DEA’s issuance 

of an Order to Show Cause, which was 

dismissed following the execution of a 

Memorandum of Agreement 

(hereinafter, MOA) between Respondent 

and DEA. Tr. 150–52; GX 35 (MOA). 

The MOA did not require Respondent to 

admit any wrongdoing, but it did 

remind Respondent of his obligation to 

abide by all federal, state, and local laws 

and regulations pertaining to controlled 

substances and placed additional 

obligations and conditions on 

Respondent that remained in effect until 

2013. Tr. 151, 153–54, 213; GX 35. One 

of those obligations stated that 

‘‘[Respondent] must conduct an initial 

examination validating the necessity to 


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4The Government appears to have abandoned the 

allegations regarding one of the patients, A.A., 

because the expert testified that these prescriptions 

were issued within the standard of care; therefore, 

I am not including findings of fact related to patient 

A.A. RD, at 83; Tr. 316; see generally Gov 

Posthearing. See also, GX 2, at 22–23; GX 20 

(Patient Records for A.A.); GX 36, at 18. 

5 Dr. Loes worked with Respondent for 

approximately six months providing physician 

coverage at Phoenix Recovery at Ellsworth. Tr. 223, 

228, 381–82. Dr. Loes left, on good terms, to focus 

on private practice. Tr. 224. None of the parties 

raised any issues about Dr. Loes’ previous contact 

with Respondent. 

6The majority of Dr. Loes’ work since 1994 has 

been in Arizona, but he briefly relocated to 

Minnesota in 2012. Tr. 223. 

7 Dr. Loes identified the following controlled 

substances as being at issue in this case: 

Buprenorphine (Suboxone, Zubsolv), Category III; 

diazepam (Valium), Category IV; phenobarbital, 

Category IV; tramadol (Ultram), Category IV; 

hydrocodone (Vicodin), Category II; amphetamine 

salts (Adderall), Category II; pregabalin (Lyrica); 

Category V. GX 36, at 3. 

8But see infra. II.E.4, which discusses the 

Arizona regulations’ support of Dr. Loes’ opinion 

and addresses the 48-hour delay referenced here. 

prescribe Suboxone or Subutex to each 

[new] OBOT patient. This paragraph 

does not preclude initiation of 

medication in an emergent/urgent 

detoxification setting, provided Dr. 

Carlton conducts an examination within 

twenty-four (24) hours of initiation.’’ GX 

35, at 3. 

DEA opened this investigation into 

Respondent after DI received a call from 

a former employee of Recovery in 

Motion (hereinafter, RIM). Tr. 154–55, 

213–14. The former employee, who was 

a physician, expressed concerns that 

Respondent’s patients ‘‘were receiving 

drugs but had never received any sort of 

visit or examination from the doctor 

first.’’ Tr. 155. She told DI that she left 

RIM because she was concerned about 

the way the facility operated; more 

specifically, ‘‘[s]he was very concerned 

about patient welfare, and she was 

afraid that somebody was going to die.’’ 

Tr. 213–14. During the investigation, DI 

interviewed several employees of RIM, 

and DI stated that ‘‘every one of the 

employees that [she] spoke with was 

. . . concerned because the patients 

were starting drugs without ever having 

been treated or evaluated by the doctor 

first.’’ Tr. 156. DI also interviewed some 

of Respondent’s patients, none of whom 

‘‘said that they saw [Respondent] upon 

admission,’’ and most of whom ‘‘didn’t 

recall anything that would be a physical 

examination to include vital signs.’’ Tr. 

at 194. 

Thereafter, DEA subpoenaed RIM for 

the medical records of patients for 

whom Respondent had prescribed 

controlled substances. Tr. 156–57. RIM 

promptly responded to the subpoena, 

and DI reviewed the records that were 

produced. Tr. 157. DI believed that she 

had received all of the necessary records 

from RIM. Tr. 158, 161, 163. Thereafter, 

DEA retained a medical expert, Dr. Loes, 

to review the patient files and provide 

his expert opinion. Tr. 199–200. The 

Government expert concluded that 

Respondent’s prescribing of controlled 

substances fell below the standard of 

care, and the OSC forming the basis of 

this action was issued. OSC, at 2; GX 36 

(Government’s Expert Report), at 2. 

C. Government’s Case 

The Government’s documentary 

evidence consisted primarily of patient 

records for thirty-one 4 individuals 

prescribed controlled substances by 

Respondent between May 8, 2015, and 

November 21, 2015. The Government’s 

evidence also contained prescription 

records for those same thirty-one 

patients, the Curriculum Vitae and draft 

report for its expert witness, and a 

Memorandum of Agreement between 

the DEA and Respondent that predates 

the issues raised in this case. See GX 1– 

36. Additionally, the Government called 

three witnesses: Respondent (whose 

testimony is summarized in the 

Respondent’s Case, see infra Section 

II.D.), DI, and the Government’s expert 

Dr. Michael W. Loes. 

DI testified regarding her professional 

background, Tr. 147–49, and about her 

2007 interactions with Respondent that 

resulted in a Memorandum of 

Agreement between DEA and 

Respondent. See supra Section II.B; Tr. 

149–54; RD, at 3–4. She also testified 

about her investigation-related actions 

in this matter including her role in 

requesting and receiving records from 

RIM in connection with this matter. See 

supra Section II.B & n. 2; Tr. 154–201; 

RD, at 4–6. Having read and analyzed all 

of the record evidence, I agree with the 

ALJ that DI’s testimony ‘‘was candid 

and straightforward.’’ RD, at 6. I also 

agree that DI’s testimony was 

‘‘sufficiently objective, detailed, 

plausible, and internally consistent to 

be considered fully credible.’’ Id. 

Dr. Loes testified regarding his 

professional and educational 

background. Tr. 217–28. He obtained a 

medical doctorate from the University of 

Minnesota, completed a clinical 

pharmacology fellowship, and later an 

internal medicine residency. Tr. 219–21; 

GX 34 (Curriculum Vitae of Dr. Loes); 

RD, at 7. Dr. Loes is board certified in 

internal medicine, addiction medicine, 

and pain medicine. Tr. 221–22; GX 34; 

RD, at 7. Dr. Loes first began practicing 

medicine in Arizona in 1994, when he 

became the Director of the Maricopa 

County Pain Program. Tr. 222–23; RD, at 

7. He has held a variety of positions 

since then 5 in private practice, at 

inpatient treatment facilities, and at 

outpatient treatment facilities.6 Tr. 222– 

25; GX 34; RD, at 7. Dr. Loes is licensed 

in Arizona and was accepted in this 

matter ‘‘as an expert in the field of 

addiction medicine in the State of 

Arizona.’’ Tr. 234; RD, at 7. Dr. Loes’ 

remaining testimony covered the 

standard of care in Arizona and his 

professional opinion that Respondent 

failed to meet the standard of care with 

regard to all of the prescriptions at issue 

in this case.7 See infra Section II.F; Tr. 

234–424; RD, at 8–28, 70–83. ‘‘Dr. Loes 

testified that his opinion was based 

upon both his analysis of the Arizona 

and federal regulations, as well as his 

almost 40-years’ experience in the 

field.’’ RD, at 80. 

With regard to credibility, the ALJ 

found that ‘‘Dr. Loes demonstrated 

limited familiarity herein with the 

relevant Arizona regulatory scheme 

[which led the ALJ] to discount his 

opinion somewhat . . . where such 

opinion [was] contrary or unsupported 

by the text of the relevant Arizona 

regulatory scheme.’’ Id. For example, 

the ALJ found that the Arizona 

regulations did not support Dr. Loes’ 

testimony ‘‘that a physician at an 

outpatient facility can never prescribe a 

controlled substance before physically 

examining a patient.’’ RD, at 81. But see 

infra II.E.4. The ALJ did not discount 

Dr. Loes’ opinion as to the relevant 

standard of care on the basis of his 

experience. Id. The ALJ explained ‘‘[he 

was] convinced that Dr. Loes, by 

actively working in this field for nearly 

40-years, [was] familiar with acceptable 

standards of care within the relevant 

medical community in Arizona as [it] 

related to the general requirements for 

establishing a doctor-patient 

relationship, and the permissive 48- 

hour delay in examining patients 

admitted to inpatient facilities after 

[being] prescribed controlled 

substances.’’ 8 Id. 

As explained below, I find that Dr. 

Loes’ opinions regarding the standard of 

care as it applied outpatient facilities, 

such as the one in this case, were 

supported by Arizona law and 

regulations and I therefore find Dr. Loes’ 

testimony to be fully credible. See infra 

Section II.E. 

D. Respondent’s Case 

The Respondent’s documentary 

evidence consisted solely of what 

appears to be a scholarly article: Louis 

A. Trevisan et al., Complications of 

Alcohol Withdrawal: Pathophysiological 

Insights, 22 Alcohol Health & Res. 


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9Respondent offered this evidence to support his 

testimony regarding the potentially deadly side 

effects of withdrawal, and to support his argument 

that withdrawal treatment is always an emergency. 

Tr. 431–38. 

10Respondent’s exact words were ‘‘I evaluated a 

patient in person telephonically.’’ Tr. 72. When 

asked how he evaluated Patient A.H.’s appearance 

as being clean and neat with a telephonic 

evaluation, Respondent stated ‘‘I—I can’t answer 

that.’’ Tr. 73. 

11The Respondent was not offered as an expert 

witness; however, he was permitted to testify as to 

his understanding of the Arizona standards of care 

in order to explain why he believed his actions 

were in compliance with the Arizona standard of 

care. See 144, 435–37; RD, at 76–77. 

12Respondent testified that this practice was 

followed by several well-known outpatient 

addiction treatment facilities and a prominent 

physician. Tr. 438–40. 

13As the ALJ noted, Respondent did not produce 

any records to support his proposition that the 

medical justification for the controlled substance 

prescriptions was contained in the behavioral 

health portion of the patients’ corresponding 

electronic medical record. RD, at 29, 62–68. 

However, it is unclear how the behavior health 

records, if they exist, could have impacted the 

standard of care as I have found it. See infra II.E. 

Any records documenting what Respondent’s staff 

did to evaluate the patients upon admission are not 

relevant to determining whether or not a physician 

or a medical practitioner examined the patients 

prior to the issuance of the controlled substance 

prescriptions. See infra II.E & n.17. 

14There is no evidence of, nor has Respondent 

argued that, any mental exam was performed by 

Respondent in lieu of a physical exam prior to 

prescribing. The evidence establishes that 

Respondent did not see or perform any type of 

examination on the patients prior to prescribing. 

See supra II.F. 

World, 61 (1998).9 See Respondent’s 

Exhibit (hereinafter, RX) 1. Respondent 

testified on his own behalf and 

presented no other testimony in support 

of his case. 

Respondent testified that he 

completed a combined residency in 

internal medicine and pediatrics, that 

he is board certified in addiction 

medicine, and that he has been treating 

chemically dependent patients since 

1994. Tr. 78, 125–26, 429–31. 

Respondent testified that he has been 

the medical director at RIM since its 

inception in March of 2015. Tr. 23. As 

the medical director Respondent 

testified that it was his duty ‘‘[t]o make 

sure that medical policies [were] 

established and to see patients.’’ Tr. 23. 

RIM provided partial hospitalization 

and intensive outpatient therapy. RD, at 

41 (citing Tr. 66, 212–13). 

Respondent testified that he went to 

Europe between July 24, 2015, and 

August 8, 2015. Tr. 60, 260, 290. While 

in Europe, Respondent testified that he 

received phone calls and emails from 

his staff regarding patients, and he 

continued to treat those patients to 

include writing prescriptions for 

controlled substance. Tr. 61–64, 67, 71, 

81; RD, at 41. Respondent further 

testified that he conducted telephone 

evaluations (audio only) of patients 

while in Europe,10 but that he did not 

have video capabilities. Tr. 72–73. 

Respondent did not document in his 

medical records the fact that he was 

performing evaluations of patients 

remotely. Tr. 72. 

Throughout his testimony, 

Respondent maintained that he acted 

within the standard of care for two 

reasons. First, Respondent argued that 

the ‘‘trained staff’’ at RIM conducted a 

‘‘sufficient and appropriate evaluation’’ 

of each patient upon admission to 

constitute a physical examination. Tr. 

112–13. Second, Respondent argued 

that a physical examination of the 

patients identified in the OSC was not 

required because withdrawal is an 

emergent situation that qualifies as an 

‘‘emergency medical situation,’’ and 

therefore allows a physician to prescribe 

without first conducting an 

examination. Resp Posthearing, at 2. 

Respondent testified to an alternative 

version of the standard of care in 

Arizona.11 Tr. 144, 435–36; infra 

Section II.E. Respondent testified that at 

RIM, as he claimed was common within 

the industry,12 new patients would 

enter treatment and be examined by 

staff, then the doctor would consult the 

staff (over phone or email), authorize a 

prescription if appropriate, and would 

complete paperwork after the fact. Tr. 

108, 144–45. Respondent testified that 

not all of the staff at RIM held medical 

licenses, but that they were trained to 

‘‘take an appropriate history and 

physicals.’’ Tr. 145–46. Respondent 

testified that the staff’s admission notes, 

which he claimed justified the issuance 

of the initial prescriptions, were 

contained in the behavioral health 

portion of the medical record.13 Tr. 26– 

27, 33, 57–58. Respondent testified that 

he would see new patients anywhere 

between 8 hours and 96 hours after 

intake depending on when the patient 

entered the facility (as Respondent only 

saw patients twice a week). Tr. 23, 106. 

Respondent also testified that patients 

would typically complete the initial 

history and physical records on the day 

that Respondent saw the patient. Tr. 

106. 

I agree with the ALJ that the 

‘‘Respondent overall did not express 

any sense of wrongdoing.’’ RD, at 36. 

While at times Respondent 

acknowledged mistakes or deficiencies 

in recordkeeping (such as an undated 

record), he stated that it was an 

‘‘oversight’’ and that he otherwise had 

followed the standard of care. Tr. 121, 

122. 

The ALJ found, and I agree, that 

Respondent’s credibility was mixed. RD, 

at 38. The ALJ found that Respondent’s 

testimony regarding his background and 

experience was credible. RD, at 38. The 

ALJ found that Respondent did not 

testify credibly regarding: (1) His 

knowledge of RIM’s withholding of the 

behavioral health records, (2) his claim 

that all of the patients at issue had 

received physical exams within RIM’s 

protocol time period (ninety-six hours) 

where the evidence suggested that at 

least seven patients were not examined 

within ninety-six hours, (3) his claim 

that he properly reviewed the admission 

protocol, personally directed the 

ordering of medication, and actively 

monitored patients while he was in 

Europe. RD, at 38–39. I agree with the 

ALJ’s credibility findings on all of these 

matters. However, the ALJ found that 

the Respondent’s testimony regarding 

RIM’s policies and protocols was 

credible and I, as discussed below, find 

that testimony to not be credible. RD, at 

38; infra II.E.4. 

E. The Standard of Care in the State of 

Arizona 

The crux of this case is the 

appropriate standard of care in Arizona 

for prescribing controlled substances as 

it applies to outpatient treatment 

centers, such as RIM. In accordance 

with Dr. Loes’ testimony and the record 

as a whole, I find that the standard of 

care in Arizona requires that a physician 

perform a physical examination of a 

patient or otherwise develop a doctorpatient relationship prior to prescribing 

controlled substances when a relevant 

exception does not apply. In finding this 

standard of care, I note that there was 

significant confusion at the hearing 

stage regarding a number of issues: (1) 

Who can perform the physical 

examination; (2) when the exceptions 

apply, such as what constitutes an 

emergency medical situation or 

telemedicine appointment; (3) when the 

physical examination must be 

performed, such as whether Arizona law 

provides an exception that allows the 

examination to be performed later for 

addiction services. I will address each of 

these issues in turn. 

1. Generally, the Record Evidence 

Supports a Finding That the Standard of 

Care in Arizona Requires That a 

Physician Perform a Physical 

Examination of a Patient Prior To 

Prescribing Controlled Substances 

Dr. Loes testified that the general 

standard of care in Arizona requires that 

a doctor-patient relationship be 

established through a physical or 

mental 14 exam prior to a physician 


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15 Dr. Loes further testified that it is ‘‘common for 

a history to be taken by staffers . . . A staff might 

take vital signs, but that’s not a physical exam.’’ Tr. 

376. 16 Dr. Loes testified that it is permissible for one 

doctor to prescribe based on another doctor’s 

(which he called a coverage physician) performance 

of the physical examination. Tr. 254. This 

testimony appears consistent with the exception 

laid out in Ariz. Rev. Stat. Ann. § 32–1401(27)(ss)(i). 

17As noted throughout, Respondent raised an 

argument that his staff conducted physical 

examinations on his behalf and documented those 

examinations in records which had not been 

produced by RIM in response to the Government’s 

subpoena. If these records existed, in order for them 

to even be relevant to whether or not Respondent 

was acting within the standard of care, the staff 

would have had to fall within the Arizona state 

statutory definition of medical practitioner. The 

record evidence, based on Respondent’s own 

testimony does not indicate that these staff fell 

within the statutory definition, and therefore, I find 

that the records, if they existed, could have limited 

relevance to whether Respondent acted within the 

standard of care. 

18The same section defines an ‘‘[e]mergency 

receiving facility’’ as ‘‘a licensed health care 

institution that offers emergency medical services, 

that is staffed twenty-four hours a day and that has 

a physician who is licensed pursuant to title 32, 

chapter 13 or 17, on call.’’ Ariz. Rev. Stat. Ann. 

§ 41–1831(10) (2012). There is no evidence on the 

record, nor did Respondent make any argument, 

that RIM is an emergency receiving facility. 

19Although not specific to the statutory 

definition, the Arizona Medical Board (hereinafter, 

Board) discussed the application of a lifethreatening emergency in In the Matter of: Darrell 

J. Jessop, M.D., Respt., 11A–23441–MDX, 2012 WL 

432838 (Ariz.Med.Bd. Feb. 6, 2012). Jessop was a 

practitioner at an urgent care clinic who, pursuant 

to a consent agreement with the Board, was 

prohibited from prescribing or administering 

controlled substances for three years. Id. at 2. 

However, there was an exception in the agreement 

that allowed the Jessop to administer controlled 

Continued 

prescribing controlled substances. Tr. 

222–23, 234, 422–23. Dr. Loes’ opinion 

is supported by Arizona statute which 

states that it is ‘‘unprofessional 

conduct’’ to ‘‘[p]rescrib[e], dispens[e] or 

furnish[ ] a prescription medicine . . . 

to a person unless the doctor first 

conducts a physical or mental health 

status examination of that person or has 

previously established a doctor-patient 

relationship.’’ Ariz. Rev. Stat. Ann. 

§ 32–1401(27)(ss) (2014). 

According to Dr. Loes, a physical 

examination sufficient to create a 

doctor-patient relationship for the 

purposes of prescribing controlled 

substances, ‘‘requires that (1) the 

physician sees the patient, (2) 

examine[s] the patient, (3) assesses and 

diagnose[s] the condition(s) that 

establish the need for the controlled 

substance(s) and then (4) develops and 

executes an appropriate plan to improve 

or eliminate the medical condition 

wherein controlled substance(s) are 

integral to that plan.’’ GX 36, at 2. 

Similarly, Dr. Loes testified that in order 

to establish a doctor-patient relationship 

at an outpatient treatment facility, the 

physician must take a medical history, 

take an addiction history, review the 

patient’s symptoms, use the physical 

examination to determine whether the 

patient is in withdrawal, and develop a 

treatment plan—all prior to prescribing. 

Tr. 232–33. 

Respondent argued that in an 

outpatient treatment center, the 

standard of care does not require a 

physician to perform the physical 

examination, but instead the standard of 

care ‘‘is to take patients who get 

admitted in acute withdrawal settings 

and to treat them based on the history 

that—the history that’s obtained from 

the staff . . . .’’ Tr. 49. Respondent 

testified that his use of the word ‘‘staff’’ 

referred, not to persons with a medical 

license, but to people who were trained 

to ‘‘take an appropriate history and 

physicals’’ Tr. 145–46; see also Tr. 112– 

113. 

Dr. Loes opined unequivocally that 

‘‘it’s not appropriate for a staffer to do 

a physical exam.’’ 15 Tr. 376. Dr. Loes 

testified that the physical examination 

had to be performed by a physician, but 

that the authority to perform the 

physical examination could be 

delegated to another physician 16 or a 

nurse practitioner. Tr. 282, 398. Dr. 

Loes’ testimony appears to be supported 

by Arizona law and regulations. The 

plain language of the statute states that 

a doctor cannot prescribe controlled 

substances, ‘‘unless the doctor first 

conducts a physical or mental health 

status examination . . . .’’ Ariz. Rev. 

Stat. Ann. § 32–1401(27)(ss) (emphasis 

added). Additionally, the Arizona 

regulations governing outpatient 

treatment centers provide that, for a 

patient receiving opioid treatment 

services, ‘‘a physician, or a medical 

practitioner under the direction of a 

physician performs a medical history 

and physical examination on the patient 

. . . within 48 hours after admission.’’ 

Ariz. Admin. Code § R9–10–1020(c)(2) 

(2014). Medical practitioner is defined 

as ‘‘a physician, physician assistant, or 

registered nurse practitioner.’’ Ariz. 

Admin. Code § R9–10–101(128). Under 

Arizona state law, physicians, physician 

assistants, and registered nurse 

practitioners are required to be licensed 

as such. Ariz. Admin. Code § R9–10– 

101(128), citing to Ariz. Rev. Stat. Ann 

32–1601(21)&(22), and 32– 

2501(12)&(13). Based on Dr. Loes’ 

testimony and the record as a whole, I 

find that Respondent’s ‘‘staff’’ could not 

perform a physical examination to meet 

the requirements under Arizona law, 

unless the staff met the definition of a 

medical practitioner.17 During cross 

examination, Government’s attorney 

specifically asked Respondent whether 

these ‘‘trained staff’’ were licensed by 

‘‘some type of medical board in the state 

of Arizona’’ to which Respondent 

answered, ‘‘They were trained by our 

staff.’’ Tr. 112–13. 

Based on Dr. Loes’ testimony as 

supported by Arizona law, I find that 

the applicable standard of care in 

Arizona requires that a physician 

perform a physical examination of a 

patient or otherwise develop a doctorpatient relationship prior to prescribing 

controlled substances, unless an 

exception applies. 

2. Emergency Medical Situation 

Exception 

Neither the Government nor the 

Respondent disputed that the 

requirement that a physician conduct a 

physical or mental health status 

examination and develop a doctorpatient relationship before prescribing 

controlled substances does not apply in 

a medical emergency; however, the 

parties disagree over what qualifies as 

an ‘‘emergency medical situation.’’ See 

Govt Posthearing, at 26; Resp 

Posthearing, at 8–9. Ariz. Rev. Stat. 

Ann. § 32–1401(27)(ss) provides that a 

doctor is not required to conduct a 

physical or mental health status 

examination before prescribing when 

there is an ‘‘(ii) [e]mergency medical 

situation as defined in § 41–1831.’’ Ariz. 

Rev. Stat. Ann. § 32–1401(27)(ss). 

Section § 41–1831 states that 

‘‘[e]mergency medical situation means a 

condition of emergency in which 

immediate medical care or 

hospitalization,[18] or both, is required 

by a person or persons for the 

preservation of health, life, or limb.’’ 

Ariz. Rev. Stat. Ann. § 41–1831(9) 

(2012). 

Dr. Loes testified that an emergency 

occurs when there are ‘‘[u]nstable vital 

signs, . . . the Clinical Opioid 

Withdrawal Scale[ ] was done and was 

very elevated, showing a shaky, 

vomiting painful type patient that 

looked like they could seize.’’ Tr. 238– 

39. Respondent, on the other hand, 

testified that ‘‘the way that the statute 

defines emergency, it does not say that 

a patient has to be unstable for there to 

be an emergency . . . what we do is 

prevent instability by providing 

treatment.’’ Tr. 443. Respondent implies 

that treatment meant to prevent a 

patient from entering a state of medical 

emergency itself constitutes an 

‘‘emergency medical situation.’’ 19 Tr. 

431–35, 443. 


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substances in ‘‘life threatening emergencies.’’ Id. 

Jessop argued that a life-threatening emergency did 

not require that death be imminent and that a ‘‘lifethreatening emergency’’ existed ‘‘anytime that the 

practitioner . . . determines that the patient’s 

condition might deteriorate if he does not prescribe 

medication . . . .’’ Id. at 9; see also id. at 2. The 

Board disagreed and stated, ‘‘[u]nder Respondent’s 

own authorities, an urgent care clinic is not 

equipped to handle life-threatening emergencies 

and if such an emergencies [sic.] arise, the urgent 

care physician must refer the patients to an 

emergency room.’’ Id. at 9. 

20Moreover, the Arizona Supreme Court noted 

that although there are various definitions of 

emergency care, ‘‘the need for immediate attention 

seems to be the common thread.’’ Thompson v. Sun 

City Community Hospital, 688 P.2d 605, 611 (1984); 

see also Callen v. Rogers, 216 Ariz. 499, 509 (2007). 

21The ALJ stated that ‘‘[t]he Respondent’s 

testimony that RIM had policies and procedures 

governing aspects of treatment protocol were 

sufficiently credible to credit, as they appeared to 

be corroborated by the Arizona Administrative 

Code.’’ RD, at 38. I agree with the ALJ the 

regulations required RIM to have policies and 

procedures. 

22By regulation, these policies are required to, 

amongst other things: ‘‘a. [c]over patient screening, 

admission, assessment, . . . discharge plan, and 

discharge; . . . d. [c]over obtaining, administering, 

storing, and disposing of medications, including 

provisions for controlling inventory and preventing 

diversion of controlled substances; e. [c]over 

prescribing a controlled substance to minimize 

substance abuse by a patient; . . . g. [c]over 

telemedicine, if applicable.’’ Ariz. Admin. Code 

§ R9–10–1003(D)(2) (2015). 

23Respondent’s description of RIM’s policies was 

similar to Respondent’s version of the standard of 

care. Respondent testified that, ‘‘the standard of 

care is to take patients who get admitted in acute 

withdrawal settings and to treat them based on the 

history that—the history that’s obtained from the 

staff, and then see [the patient] afterwards. And in 

some programs, that is within 24 hours, and in 

some programs it’s within five to seven days.’’ Tr. 

at 49. 

24As already discussed, trained staff would be 

required to fall within the definition of medical 

practitioner under the statute. See supra II.E.1 & 

n.17. 

25Respondent first testified that a physician had 

72 hours to evaluate a patient after admission. Tr. 

107. He then testified that RIM changed its policies 

and procedures to say that a physician had 96 hours 

to evaluate a patient after admission. Id. 

Respondent did not clarify whether RIM’s policy 

was 72 hours or 96 hours at the time relevant to 

this case. The ALJ applied 96 hours to his standard 

of care. Ultimately this is irrelevant, because I do 

not find that RIM’s policies provide an exception 

to the requirement that a physician examine a 

patient prior to prescribing. 

26See also supra II.E.1. 

The ALJ found, and I agree, that ‘‘the 

plain language of the statute in limiting 

the covered conditions to those 

requiring ‘immediate’ medical care 

would rebut the Respondent’s overly 

broad interpretation of the statute . . . 

as encompassing potential or even nonmedical eventualities.’’ RD, at 82 (citing 

Ariz. Rev. Stat. Ann. § 41–1831).20 I find 

that Dr. Loes’ description of an 

emergency is in line with the statutory 

definition. 

Dr. Loes further testified that ‘‘an 

outpatient program doesn’t handle acute 

emergencies,’’ Tr. 226. Dr. Loes’ opinion 

appears to be supported by Arizona law 

and regulation. It appears that an 

outpatient treatment center is required 

to have additional authorization in 

order to provide emergency room 

services. See Ariz. Admin. Code § 09– 

10–1019 (An outpatient treatment center 

authorized to provide emergency room 

services must have emergency room 

services available on the premises at all 

times, and must ensure that both a 

physician and a registered nurse are 

present in the area designated for 

emergency room services). Respondent 

has not argued that RIM is authorized to 

provide emergency room treatment 

services, nor does it appear that RIM 

would qualify to provide emergency 

treatment services. 

I find that where an emergency 

medical situation—instability requiring 

immediate medical care—exists, the 

applicable standard of care as testified 

to by Dr. Loes and supported by Arizona 

law does not require a physician to 

conduct a physical or mental health 

status examination and develop a 

doctor-patient relationship before 

prescribing controlled substances; 

however, as explained further herein, 

Dr. Loes credibly testified that there is 

no evidence in this case to support that 

the prescriptions were issued pursuant 

to an emergency medical situation. 

3. Telemedicine Exception 

The second exception to the physical 

examination requirement that is 

potentially relevant to this case applies 

when there are ‘‘(viii) [p]rescriptions 

written by a licensee through a 

telemedicine program that is covered by 

the policies and procedures adopted by 

the administrator of a hospital or 

outpatient treatment center.’’ Ariz. Rev. 

Stat. Ann. § 32–1401(27)(ss). Arizona 

law states that ‘‘[t]he physical or mental 

health status examination may be 

conducted during a real-time 

telemedicine encounter with audio and 

video capability if the telemedicine 

audio and video capability meets the 

elements required by the centers for 

medicare and medicaid services . . . .’’ 

Id. Dr. Loes testified to the same, and 

indicated that telemedicine requires the 

use of a television portal or other video 

capability. Tr. 377–78. Dr. Loes testified 

that, ‘‘a telephonic call with the patient, 

in [his] opinion, is not sufficient to 

develop a . . . strategy for treatment 

and the . . . doctor patient 

relationship.’’ Tr. 233. In other words, 

‘‘a phone interview doesn’t entail a kind 

of physical exam,’’ and a physician 

cannot ‘‘start controlled substances 

without a physical exam.’’ Tr. 239. 

I find that where a facility has a 

telemedicine program, and a 

telemedicine visit has audio and video 

capability, the applicable standard of 

care as testified to by Dr. Loes and 

supported by Arizona law, does not 

require a physician to conduct an inperson physical or mental health status 

examination and develop a doctorpatient relationship before prescribing 

controlled substances; however, as 

further explained herein, there is no 

evidence that Respondent conducted 

physical examinations using 

telemedicine with audio and video 

capability in this case. See supra II.D & 

n.10. 

4. Respondent’s Claimed Regulatory/ 

Policy Exception 

Respondent argues that there is an 

additional exception to the statutory 

requirement that a physician first 

conduct a physical examination prior to 

prescribing controlled substances found 

in RIM’s policies, which were drafted 

pursuant to Arizona’s Health Care 

regulations.21 Arizona Regulations 

require an outpatient treatment facility, 

such as RIM, to ensure that ‘‘[p]olicies 

and procedures for services provided at 

or by an outpatient treatment center are 

established, documented, and 

implemented to protect the health and 

safety of a patient . . . .’’ 22 Ariz. 

Admin. Code § R9–10–1003(D)(2) 

(2015). 

Respondent argues that, under RIM’s 

policies, a physician at an outpatient 

treatment facility can prescribe 

medication to a patient for a limited 

period of time prior to the physician 

performing a physical examination so 

long as trained staff first evaluated the 

patient. Tr. 107–08. Respondent 

testified that RIM’s policy 23 was that 

upon admission, ‘‘trained staff’’ 24

would evaluate the patient and consult 

telephonically with the physician, then, 

if deemed appropriate, the physician 

would issue a prescription to the 

patient—the physician would conduct a 

physical examination of the patient up 

to seventy-two or ninety-six 25 hours 

after admission. Tr. 112–13; see also Tr. 

107–08. 

In contrast, Dr. Loes credibly testified 

that it was his expert opinion that no 

outpatient facility can prescribe to a 

patient without first having a physical 

examination performed by a 

physician.26 Tr. 396, 405, 407. Dr. Loes’ 

opinion of the standard of care as it is 

relevant to this case appears to be 

consistent with and supported by 

Arizona’s statutes and regulations, the 

application of which to outpatient 


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27The ALJ discounted ‘‘[Dr. Loes’] opinion 

somewhat . . . where such opinion was 

unsupported by the text of the relevant Arizona 

regulatory scheme.’’ RD, at 80. The ALJ was ‘‘unable 

to identify any provision in the Arizona 

Administrative Code, which specifically addressed 

[whether there could be a ‘‘delay between 

prescribing a controlled substance and the 

physician physically examining the patient’’] as to 

any of the various classes and subclasses of health 

care facilities in Arizona.’’ RD, at 78. Additionally, 

the RD was unable to find support within the 

regulations for Dr. Loes’ opinion that is was 

permissible for a physician to prescribe controlled 

substance prior to a physical exam in the inpatient, 

but not outpatient, context. RD, at 78–79. I find 

support in Arizona law for Dr. Loes’ testimony 

where there is an emergency, as Dr. Loes’ explained 

was frequent in the inpatient context; however, I 

agree with the ALJ that there was some confusion 

in Dr. Loes’ testimony about when treatment can be 

initiated in an inpatient facility when there is no 

emergency. RD, at 75–76. However, ultimately, 

based on my examination of Arizona law, I credit 

and do not discount Dr. Loes’ opinion regarding the 

applicable standard of care for the patients at issue 

in this case in the outpatient context, which, along 

with the substantial evidence in this case has led 

to my finding that prescriptions issued to thirty 

patients, instead of seven (RD, at 93), were issued 

outside the standard of care. 28With regard to inpatient facilities (unlike RIM), 

Dr. Loes opined that an emergency patient may be 

prescribed medication before a physical 

examination, which must be conducted within 

forty-eight hours, so long as the patient is examined 

by a registered nurse in direct communication with 

a physician. Tr. 405–09; RD, at 72, 74. Dr. Loes’ 

testimony appears to be mostly consistent with the 

inpatient regulations and with the emergency 

exception found in Ariz. Rev. Stat. Ann. § 32– 

1401(27)(ss)(ii) supra II.E.2. The inpatient 

regulations state that a ‘‘medical practitioner must 

perform a medical history and physical 

examination on a patient within . . . 72 hours after 

admission. . . .’’ Ariz. Admin Code § R9–10– 

307(8). The inpatient regulations state that ‘‘[e]xcept 

when a patient needs crisis services, a behavioral 

health assessment of a patient is completed before 

treatment for the patient is initiated.’’ Ariz. Admin 

Code § R9–10–307(10) (emphasis added). The 

inpatient regulations explicitly allow for a 

behavioral health technician, registered nurse, or 

behavioral health paraprofessional to conduct the 

initial behavioral health assessment necessary to 

initiate treatment. Id. at (11). There was some 

confusion in Dr. Loes’ testimony about when a 

physician can prescribe in an inpatient facility 

when there is no emergency. Tr. 407–08; see supra 

n.27. However, Dr. Loes’ testimony was clear 

regarding when a physician can prescribe in an 

outpatient facility, which according to Dr. Loes is 

not equipped to handle emergencies (Tr. 226, 230, 

407, 410–11) and is bolstered by Arizona law. Tr. 

396, 405–06. 

29Under the regulation, ‘‘ ‘[t]reatment’ means a 

procedure or method to cure, improve, or palliate 

an individual’s medical condition or behavioral 

health issue.’’ Ariz. Admin Code § R9–10–101(236). 

It appears that ‘‘treatment’’ includes, but is not 

limited to, prescribing medication (e.g. ‘‘ ‘[o]pioid 

treatment’ means providing medical services, 

nursing services, behavioral health services, healthrelated services, and ancillary services to a patient 

receiving an opioid agonist treatment medication 

for opiate addiction opioid-related substance use 

disorder.’’). Ariz. Admin Code § R9–10–101(151). 

See also id. at § R9–10–101(221). 

30As explained supra at II.E.1, the definition of 

medical practitioner is limited. There is nothing on 

the record to suggest that Respondent’s staff would 

have qualified as medical practitioners, nor is there 

any documentation suggesting that a physical 

examination was conducted. 

31The Government, in its exceptions, argued that 

that Respondent’s claim that he was permitted to 

prescribe 72 or 96 hours prior to conducting a 

physical examination of a patient is not relevant to 

this litigation because the inpatient licensing 

regulation ‘‘merely requires taking a medical history 

and performing a physical examination of a patient 

within 72 hours of admission. It neither addresses 

nor governs the prescribing or dispensing of 

controlled substances.’’ Gov Exceptions, at 5 & n.4. 

This argument is similar to what I have found 

regarding the outpatient licensing regulations 

which are applicable here (but within 48 hours). 

32Portions of RIM’s established policies, as 

required by Arizona regulations, are documented in 

the public record. According to these records, RIM’s 

policy (for much of the time relevant to this case) 

states that ‘‘[p]rior to initiation of treatment, all 

Clients will be assessed by a medical practitioner 

for a medical assessment which shall include: a. 

[m]edical history b. [p]hysical examination c. [p]ain 

screen d. [n]utrition screen.’’ Gov Exceptions, 

Attachment B, at 1. The RIM policy further states 

that ‘‘[a] Client admitted to Recovery in Motion will 

see the medical provider within 72 hours for a 

medical assessment.’’ Id. As such, the provider 

must see the client within 72 hours; however, the 

policy does not permit a provider to initiate 

treatment prior to the conduct of a physical 

examination. RIM’s established policies appear 

inconsistent with Respondent’s testimony, but 

appear more consistent with Arizona’s statute and 

regulations and the testimony of Dr. Loes regarding 

the applicable standard of care in Arizona. 

treatment centers is complex.27 Article 

9, Chapter 10 of Arizona’s 

Administrative Code covers 

‘‘Department of Health Services Health 

Care Institutions: Licensing’’ 

(hereinafter, licensing regulations). 

Chapter 10 of the licensing regulations 

sets forth the licensing requirements for, 

and a number of requirements covering 

various types of health care institutions. 

It seems likely that these are the 

‘‘licensing regulations’’ that Dr. Loes 

referenced, without citing, in his 

testimony. See Tr. 405, 407. Within the 

licensing regulations, there are subarticles for ‘‘Behavioral Health Inpatient 

Facilities’’ (Article 3) (hereinafter, 

inpatient regulations) and for 

‘‘Outpatient Treatment Centers’’ (Article 

10) (hereinafter, outpatient regulations). 

With regard to outpatient facilities,28

Dr. Loes opined that that no outpatient 

facility can prescribe to a patient 

without first having a physical 

examination performed by a physician. 

Tr. 396, 405, 407. Pursuant to Arizona’s 

regulations, an outpatient treatment 

center that provides opioid treatment 29

services: 

. . . shall ensure that for a patient receiving 

opioid treatment services: 

2. A physician or a medical practitioner[30] 

under the direction of a physician: 

a. Performs a medical history and physical 

evaluation on the patient within 30 calendar 

days before admission or within 48 hours 

after admission, and 

b. Documents the medical history and 

physical examination in the patient’s medical 

record within 48 hours after admission. 

Ariz. Admin. Code § R9–10–1020(C) 

(2014). See Ariz. Admin Code § R9–10– 

1020(C) and § R9–10–1003(D). Although 

the outpatient regulations permit the 

physical examination to occur within 48 

hours of admission, nowhere do they 

state that controlled substances can be 

prescribed before the physical 

examination is completed.31 The 

requirement to conduct a physical 

examination after admission is separate 

from the requirement to conduct one 

prior to prescribing controlled 

substances and the two should not be 

conflated. In light of the above, I find 

Respondent’s testimony regarding the 

substance of RIM’s policy, which was 

not supported by any corroborating 

evidence, to lack credibility; if I were to 

credit Respondent’s testimony, RIM’s 

policies would appear to be in conflict 

with the licensing regulations and 

statute.32 Tr. 107–08. Instead I credit Dr. 

Loes’ opinion, which appears to be more 

consistent with the licensing regulations 

and statute. Accordingly, I find that the 

standard of care in Arizona as described 

by Dr. Loes requires that, at an 

outpatient facility, a physician, not 

‘‘trained staff,’’ must conduct the 

physical examination, and that a 

physical examination is required before 

a physician can prescribe controlled 

substances. 

Indeed, there are a variety of options 

available for patients upon admission 

besides receiving controlled substances. 

Respondent testified that there are 12- 

step meetings, group meetings, therapy 

sessions, and other behavioral health 

counselings. Tr. 130. There is no 

evidence to give credence to 

Respondent’s claim that Arizona’s 

statutory requirements should be 

usurped by a health care facility’s 

policy, even where the existence of the 

policy is mandated by regulation. 

The outpatient regulations do not 

appear to conflict with, nor be an 

exception to, the statutory requirement 

that a physician must conduct a 

physical examination prior to treating a 

patient with controlled substances. 

Therefore, in accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that where, as in this case, there is 

not an emergency medical situation and 

no appropriate telemedicine 

examination was conducted, the 

applicable standard of care in Arizona 

requires that a physician perform a 

physical examination of a patient or 

otherwise develop a doctor-patient 

relationship prior to prescribing 

controlled substances. 


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33Patient L.H. is referred to by the initials E.H. 

in the OSC. See OSC, at 2. 

34 Dr. Loes testified that where there is an issue 

of resources in medical coverage, one physician, in 

this case Dr. T.J., can follow the treatment course 

established by the physician who issued the 

controlled substance prescription, in this case 

Respondent. Tr. 253–54; see also Ariz. Rev. Stat. 

Ann. § 32–1401(27)(ss)(i). However, in this case, 

this physical examination did not occur until well 

after the controlled substance prescription was 

issued by Respondent and therefore, the 

prescriptions were issued beneath the standard of 

care and outside of the usual course of the 

professional practice. 

F. Patients 

1. Patient L.H.33

On May 8, 2015, Respondent 

prescribed a controlled substance, 

Suboxone 8 mg., to Patient L.H. GX 2 

(Prescription Records), at 1; GX 3 

(Patient Record for L.H.), at 38; GX 36, 

at 7; RD, at 42. Dr. Loes testified that at 

the time the May 8, 2015 prescription 

was issued, there was no doctor-patient 

relationship between Respondent and 

Patient L.H. Tr. 237–38; see also GX 36, 

at 7. In support of his opinion, Dr. Loes 

testified that ‘‘there was no physical, 

. . . no documentation of [an] interview 

or exam or lab; no assessment . . . 

about what kind of state of withdrawal 

that patient was in and then, of course, 

no comprehensive plan prior to that 

prescription being started.’’ Tr. 238. Dr. 

Loes further testified that there was no 

evidence of an emergency medical 

situation. Tr. 238; RD, at 42. Respondent 

first examined Patient L.H. on May 9, 

2015, and Dr. Loes testified that a 

doctor-patient relationship was 

established at that time. GX 36, at 7; GX 

3, at 39; RD, at 42. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient L.H. at the time the prescription 

was issued, the Suboxone prescription 

that Respondent issued to Patient L.H. 

on May 8, 2015, was issued outside of 

the usual course of professional practice 

and beneath the applicable standard of 

care in Arizona. 

2. Patient D.P. 

On May 13, 2015, Respondent 

prescribed a controlled substance, 

diazepam (Valium) 5 mg., to Patient D.P. 

GX 2, at 2; GX 4 (Patient Record for 

D.P.), at 22–23; GX 36, at 7; RD, at 42; 

Tr. 41–43, 244–45. Dr. Loes testified that 

at the time the May 13, 2015 

prescription was issued, there was no 

doctor-patient relationship between 

Respondent and Patient D.P. Tr. 245, 

247; see also GX 36, at 7. In support of 

his opinion, Dr. Loes testified that ‘‘the 

patient was started on Valium on May 

13th and not seen until May 22nd.’’ Tr. 

245. Dr. Loes further testified that there 

was no evidence of an emergency 

medical situation. Tr. 250; RD, at 42. 

Respondent first examined Patient D.P. 

on May 22, 2015. GX 36, at 7; Tr. 245; 

GX 4, at 53; RD, at 42. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient D.P. at the time the prescription 

was issued, the diazepam prescription 

that Respondent issued to Patient D.P. 

on May 13, 2015, was issued outside of 

the usual course of professional practice 

and beneath the applicable standard of 

care in Arizona. 

3. Patient N.B. 

On June 1, 2015, Respondent 

prescribed a controlled substance, 

diazepam (Valium) 10 mg. tablets, to 

Patient N.B. GX 2, at 3; GX 5 (Patient 

Records for N.B.), at 84; GX 36, at 8; RD, 

at 42. Dr. Loes testified that at the time 

the June 1, 2015 prescription was 

issued, there was no doctor-patient 

relationship between Respondent and 

Patient N.B. Tr. 249; see also GX 36, at 

8. In support of his opinion, Dr. Loes 

testified that ‘‘[t]here was no 

documentation of anything that 

constituted an interview, physical exam, 

assessment, lab, urine, vitals, none of 

that was present that [Dr. Loes] could 

see to justify a doctor-patient 

relationship.’’ Tr. 249. Dr. Loes further 

testified that there was no evidence of 

an emergency medical situation. Tr. 

250; RD, at 42. Respondent first 

examined Patient N.B. on June 3, 2015. 

GX 36, at 8; GX 5, at 1–4; RD, at 42. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient N.B. at the time the prescription 

was issued, the diazepam prescription 

that Respondent issued to Patient N.B. 

on June 1, 2015, was issued outside of 

the usual course of professional practice 

and beneath the applicable standard of 

care in Arizona. 

4. Patient A.J.C. 

On June 28, 2015, Respondent 

prescribed a controlled substance, 20 

tablets of phenobarbital 64.8 mg., to 

Patient L.H. GX 2, at 4; GX 6 (Patient 

Records for A.J.C.), at 26; GX 36, at 8; 

RD, at 43. Dr. Loes testified that at the 

time the June 28, 2015 prescription was 

issued, there was no doctor-patient 

relationship between Respondent and 

Patient A.J.C. Tr. 251; see also GX 36, 

at 8. In support of his opinion, Dr. Loes 

testified that ‘‘there’s no documentation 

of a telephonic or a physical exam or 

assessment or treatment plan to justify 

this particular prescription.’’ Tr. 251– 

52. Dr. Loes further testified that there 

was no evidence of an emergency 

medical situation. Tr. 376–77. A.J.C. 

was first examined by a physician (not 

by Respondent, but by a collaborating 

physician Dr. T.J.) 34 on July 2, 2015. GX 

36, at 8; GX 6, at 87–116; RD, at 43. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient A.J.C. at the time the 

prescription was issued, the 

phenobarbital prescription that 

Respondent issued to Patient A.J.C. on 

June 28, 2015, was issued outside of the 

usual course of professional practice 

and beneath the applicable standard of 

care in Arizona. 

5. Patient S.S. 

On July 4, 2015, Respondent 

prescribed a controlled substance, 45 

tablets of buprenorphine 8 mg., to 

Patient S.S. GX 2, at 5; GX 7 (Patient 

Records for S.S.), at 79; GX 36, at 9; RD, 

at 43. Dr. Loes testified that at the time 

the July 4, 2015 prescription was issued, 

there was no doctor-patient relationship 

between Respondent and Patient S.S. 

Tr. 255; see also GX 36, at 9. In support 

of his opinion, Dr. Loes testified that 

‘‘[t]here’s no information that a patient 

visit, interview, examination, 

assessment, lab, collaborating lab or 

urine test was done prior to this 

[prescription] . . .’’ Tr. 255. Dr. Loes 

further testified that there was no 

evidence of an emergency medical 

situation. Tr. 376–77. S.S. was first 

examined by a physician (not by 

Respondent, but by collaborating 

physician T.J.) on July 6, 2015. GX 36, 

at 9; GX 7, at 25–54; RD, at 43. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient S.S. at the time the prescription 

was issued, the buprenorphine 

prescription that Respondent issued to 

Patient S.S. on July 4, 2015, was issued 

outside of the usual course of 

professional practice and beneath the 

applicable standard of care in Arizona. 

6. Patient J.L. 

On July 5, 2015, Respondent 

prescribed a controlled substance, 20 

tablets of diazepam (Valium) 10 mg., to 


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35 Dr. Loes later testified that Respondent’s 

treatment of each one of the patients at issue in this 

case fell below the standard of care because in all 

the cases the Respondent did not establish a doctorpatient relationship before prescribing. Tr. 404. 

36 Dr. Loes pointed out that the medical records 

suggest that Respondent evaluated Patient A.H. on 

July 31, 2015. This is because the ‘‘Comprehensive 

Physical Evaluation and Examination’’ record in the 

file is dated July 31, 2015, on the first page and is 

signed by Respondent on the last page (which is 

undated). Tr. 272–73; GX 36, at 12; GX 11, 34–63. 

However, Respondent was out of the country on 

July 31, 2015, and according to Dr. Loes, the RIM 

staff could not have transmitted sufficient material 

to Respondent to justify the creation of a doctorpatient relationship on July 31, 2015. Tr. 71–73, 

281. I find that the evidence does not support a 

finding that Respondent or any other physician 

performed a physical examination of A.H. on July 

31, 2015. Tr. 71–73, 272–273, 276, 278–79. 

Patient J.L. GX 2, at 6; GX 8 (Patient 

Records for J.L.), at 39; GX 36, at 9; RD, 

at 43. Dr. Loes testified that at the time 

the July 5, 2015 prescription was issued, 

there was no doctor-patient relationship 

between Respondent and Patient J.L. Tr. 

257, 259; see also GX 36, at 10. In 

support of his opinion, Dr. Loes testified 

that there was ‘‘no doctor presence 

interview, physical exam, corroborating 

lab assessment or plan.’’ Tr. 257. Dr. 

Loes further testified that there was no 

evidence of an emergency medical 

situation. Tr. 376–77. J.L. was first 

examined by a physician (not by 

Respondent, but by collaborating 

physician T.J.) on July 6, 2015. GX 36, 

at 10; GX 8, at 40–69; RD, at 43. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient J.L. at the time the prescription 

was issued, the diazepam prescription 

that Respondent issued to Patient J.L. on 

July 5, 2015, was issued outside of the 

usual course of professional practice 

and beneath the applicable standard of 

care in Arizona. 

7. Patient K.R.K. 

On July 15, 2015, Respondent 

prescribed a controlled substance, 23 

tablets of buprenorphine 2 mg., to 

Patient K.R.K. GX 2, at 7; GX 9 (Patient 

Records for K.R.K.), at 80; GX 36, at 10; 

RD, at 44. Dr. Loes testified that at the 

time the July 15, 2015 prescription was 

issued, there was no doctor-patient 

relationship between Respondent and 

Patient K.R.K. Tr. 260–61; see also GX 

36, at 11. In support of his opinion, Dr. 

Loes testified that there was ‘‘[n]o faceto-face interview, exam; no 

corroborating lab, urine, no assessment 

or plan.’’ Tr. 261. Dr. Loes further 

testified that there was no evidence of 

an emergency medical situation. Tr. 

376–77. Respondent first examined 

Patient K.R.K. on July 18, 2015. GX 36, 

at 10; GX 9, at 81–110; RD, at 44. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient K.R.K. at the time the 

prescription was issued, the 

buprenorphine prescription that 

Respondent issued to Patient K.R.K. on 

July 15, 2015, was issued outside of the 

usual course of professional practice 

and beneath the applicable standard of 

care in Arizona. 

8. Patient J.Z. 

On July 15, 2015, Respondent 

prescribed a controlled substance, 23 

tablets of buprenorphine 2 mg., to 

Patient J.Z. GX 2, at 8; GX 10 (Patient 

Records for J.Z.), at 35; GX 36, at 11; RD, 

at 44. Dr. Loes testified that at the time 

the July 15, 2015 prescription was 

issued, there was no doctor-patient 

relationship between Respondent and 

Patient J.Z. Tr. 270; see also GX 36, at 

11. In support of his opinion, Dr. Loes 

testified that there was ‘‘no evidence of 

an interview, a history by the doctor, a 

physical exam, any lab or diagnosis, 

comprehensive evaluation of the 

clinical situation or treatment plan 

documented.’’ Tr. 270–71. Dr. Loes 

further testified that there was no 

evidence of an emergency medical 

situation. Tr. 311. For these reasons, Dr. 

Loes opined that the treatment provided 

to J.Z. with regard to the July 15, 2015 

prescription was outside of the standard 

of care in Arizona.35 Tr. 271–72. 

Respondent first examined Patient J.Z. 

on July 18, 2015. GX 36, at 11; GX 10, 

at 36–65; RD, at 44. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient J.Z. at the time the prescription 

was issued, the buprenorphine 

prescription that Respondent issued to 

Patient J.Z. on July 15, 2015, was issued 

outside of the usual course of 

professional practice and beneath the 

applicable standard of care in Arizona. 

9. Patient A.H. 

On July 31, 2015, Respondent (while 

outside of the country) issued two 

prescriptions for controlled substances, 

one for 9 tablets of buprenorphine 8 mg. 

and one for 9 tablets of buprenorphine 

2 mg, to Patient A.H. GX 2, at 9–10; GX 

11 (Patient Records for A.H.), at 33; GX 

36, at 11; RD, at 44. Dr. Loes testified 

that at the time the July 31, 2015 

prescriptions were issued, there was no 

doctor-patient relationship between 

Respondent and Patient A.H. Tr. 273; 

see also GX 36, at 12. In support of his 

opinion, Dr. Loes testified that there was 

‘‘no history, physical exam, or diagnosis 

or treatment plan that was done prior to 

the prescription.’’ Tr. 274. Dr. Loes 

further testified that there was no 

evidence of an emergency medical 

situation. Tr. 279–280, 311. Respondent 

appears to have first examined Patient 

A.H. on August 29, 2015.36 GX 36, at 12; 

GX 11, at 2–9; RD, at 44. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient A.H. at the time the prescription 

was issued, the two buprenorphine 

prescriptions that Respondent issued to 

Patient A.H. on July 31, 2015, were 

issued outside of the usual course of 

professional practice and beneath the 

applicable standard of care in Arizona. 

10. Patient C.S. 

On August 2, 2015, Respondent 

(while outside of the country) 

prescribed a controlled substance, 20 

tablets of diazepam 10 mg., to Patient 

C.S. GX 2, at 11; GX 12 (Patient Records 

for C.S.), at 57; GX 36, at 12; RD, at 45. 

Dr. Loes testified that at the time the 

August 2, 2015 prescription was issued, 

there was no doctor-patient relationship 

between Respondent and Patient C.S. 

Tr. 286–87; see also GX 36, at 13. In 

support of his opinion, Dr. Loes testified 

that there was no record of a physical 

exam, mental exam, medical history, or 

assessment of the patient’s function. Tr. 

287–88. Dr. Loes further testified that 

there was no evidence of an emergency 

medical situation. Tr. 311. Respondent 

first examined Patient C.S. on August 

18, 2015. GX 36, at 12; GX 12, at 1–8; 

RD, at 45. Dr. Loes opined that the 

treatment provided to C.S. was beneath 

the standard of care in Arizona. Tr. 288. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient C.S. at the time the prescription 

was issued, the diazepam prescription 

that Respondent issued to Patient C.S. 

on August 2, 2015, was issued outside 

of the usual course of professional 

practice and beneath the applicable 

standard of care in Arizona. 

11. Patient J.A. 

On August 7, 2015, Respondent 

(while outside of the country) 

prescribed a controlled substance, 

namely 64 tablets of buprenorphine 2 

mg., to Patient J.A. GX 2, at 12; GX 13 

(Patient Records for J.A.), at 23; GX 36, 


tkelley on DSKBCP9HB2PROD with NOTICES
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37Patient L.O. (referencing her nickname) is 

referred to by the initials E.O. (referencing her legal 

name) in the OSC. See OSC, at 4. 

38The pharmacy records indicate that the 

prescription was dated August 12, 2015, but not 

picked up until August 13, 2015. GX2, at 14. The 

August 13, 2015 was used in the Recommended 

Decision and Expert Report. RD, at 46; GX 36, at 

14. Regardless of whether the prescription was 

issued on August 12th or 13th, Respondent did not 

perform a physical examination until August 15, 

2015. 

39T.G., the initials used in the Recommended 

Decision, is referred to as R.G. in the OSC, and as 

R.T.G. in the Expert’s Report—all three identify the 

same patient. See RD, at 46; OSC, at 4; GX 36, at 

15. 

at 13; RD, at 45. Dr. Loes testified that 

at the time the August 7, 2015 

prescription was issued, there was no 

doctor-patient relationship between 

Respondent and Patient J.A. Tr. 290; see 

also GX 36, at 13. In support of his 

opinion, Dr. Loes testified that there was 

‘‘no doctor-patient relationship 

established based on the records, the 

absence of a history, the physical by the 

physician, and any associated lab or 

other documentation wasn’t there.’’ Tr. 

290. Dr. Loes further testified that there 

was no evidence of an emergency 

medical situation. Tr. 311. Respondent 

first examined Patient J.A. on August 

27, 2015. GX 36, at 13; GX 13, at 2–8; 

RD, at 45. Dr. Loes opined that the 

treatment provided to J.A. was beneath 

the standard of care in Arizona. Tr. 291. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient J.A. at the time the prescription 

was issued, the buprenorphine 

prescription that Respondent issued to 

Patient J.A. on August 7, 2015, was 

issued outside of the usual course of 

professional practice and beneath the 

applicable standard of care in Arizona. 

12. Patient Z.J. 

On August 7, 2015, Respondent 

(while outside of the country) 

prescribed a controlled substance, 

namely 45 tablets of buprenorphine 2 

mg., to Patient Z.J. GX 2, at 13; GX 14 

(Patient Records for Z.J.), at 7; GX 36, at 

13; RD, at 45. Dr. Loes testified that at 

the time the August 7, 2015 prescription 

was issued, there was no doctor-patient 

relationship between Respondent and 

Patient Z.J. Tr. 293–94; see also GX 36, 

at 14. In support of his opinion, Dr. Loes 

testified that there was a ‘‘lack of 

history, physical, and diagnosis, 

treatment plan, and associated lab.’’ Tr. 

294. Dr. Loes further testified that there 

was no evidence of an emergency 

medical situation. Tr. 311. Also, ‘‘[t]here 

is no documentation that this patient 

was ever seen by a physician.’’ GX 36, 

at 14; see also GX 14; RD, at 45; Tr. 293. 

Dr. Loes opined that the treatment 

provided to Z.J. was beneath the 

standard of care in Arizona. Tr. 294. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient Z.J. at the time the prescription 

was issued, the buprenorphine 

prescription that Respondent issued to 

Patient Z.J. on August 7, 2015, was 

issued outside of the usual course of 

professional practice and beneath the 

applicable standard of care in Arizona. 

13. Patient L.O.37

On August 12, 2015,38 Respondent 

prescribed a controlled substance, 20 

tablets of diazepam 10 mg., to Patient 

L.O. GX 2, at 14; GX 15 (Patient Records 

for L.O.), at 105; GX 36, at 14; RD, at 46. 

Dr. Loes testified that at the time the 

August 12, 2015 prescription was 

issued, there was no doctor-patient 

relationship between Respondent and 

Patient L.O. Tr. 298; see also GX 36, at 

14. In support of his opinion, Dr. Loes 

testified that at the time of the 

prescription there was not an adequate 

medical history taken, adequate 

physical exam, or adequate mental exam 

to establish a doctor-patient 

relationship. Tr. 298. Dr. Loes further 

testified that there was no evidence of 

an emergency medical situation. Tr. 

311. Respondent first examined Patient 

L.O. on August 15, 2015. GX 36, at 14; 

GX 15, at 1–30; RD, at 46. Accordingly, 

Dr. Loes opined that Respondent’s 

August 13, 2015 prescription to L.O. 

‘‘fell below the standard of care.’’ Tr. 

298. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient L.O. at the time the prescription 

was issued, the diazepam prescription 

that Respondent issued to Patient L.O. 

on August 13, 2015, was issued outside 

of the usual course of professional 

practice and beneath the applicable 

standard of care in Arizona. 

14. Patient T.G.39

On, August 21, 2015, Respondent 

prescribed two controlled substances, 

ten tablets of buprenorphine 8 mg. and 

nine tablets of buprenorphine 2 mg., to 

Patient T.G. GX 2, at 15–16; GX 16 

(Patient Records for T.G.), at 113; GX 36, 

at 15; RD, at 46. Dr. Loes testified that 

at the time the August 21, 2015 

prescription was issued, there was no 

doctor-patient relationship between 

Respondent and Patient T.G. Tr. 301; 

see also GX 36, at 15. In support of his 

opinion, Dr. Loes testified that there was 

an ‘‘[a]bsence of physical exam and 

associated labs and assessment and a 

treatment plan.’’ Tr. 301. Dr. Loes 

further testified that there was no 

evidence of an emergency medical 

situation. Tr. 311. Respondent first 

examined Patient T.G. on August 23, 

2015. GX 36, at 15; GX 16, at 1–30; RD, 

at 46. Accordingly, Dr. Loes opined that 

Respondent’s treatment of T.G. fell 

beneath the standard of care in Arizona. 

Tr. 301–02. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient T.G. at the time the prescriptions 

were issued, the buprenorphine 

prescriptions that Respondent issued to 

Patient T.G. on August 13, 2015, were 

issued outside of the usual course of 

professional practice and beneath the 

applicable standard of care in Arizona. 

15. Patient A.S. 

On August 25, 2015, Respondent 

issued two prescriptions for controlled 

substances, 22 tablets of buprenorphine 

2 mg. and 30 tablets of phenobarbital 

32.4 mg., to Patient A.S. GX 2, at 17–18; 

GX 17 (Patient Records for A.S.), at 9– 

10; GX 36, at 16; RD, at 47. Although the 

prescriptions were dated August 25, 

2015, the medical records reflect that 

Patient A.S. began taking both 

controlled substances on August 24, 

2015. GX 17, at 9–10; GX 36, at 16; RD, 

at 47. Dr. Loes testified that at the time 

the August 25, 2015 prescriptions were 

issued, there was no doctor-patient 

relationship between Respondent and 

Patient A.S. Tr. 304–05; see also GX 36, 

at 16. In support of his opinion, Dr. Loes 

testified that there was not an adequate 

medical history, physical examination, 

or mental examination performed prior 

to August 25, 2015. Tr. 305. Dr. Loes 

further testified that there was no 

evidence of an emergency medical 

situation. Tr. 311. Patient A.S. 

discontinued her treatment on August 

25, 2015, and was never seen by 

Respondent. GX 36, at 16; GX 17, at 1, 

3; RD, at 47. Accordingly, Dr. Loes 

opined that Respondent’s treatment of 

A.S. fell beneath the standard of care in 

Arizona. Tr. 305. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient A.S. at the time the prescriptions 

were issued, the buprenorphine and 

phenobarbital prescriptions that 


tkelley on DSKBCP9HB2PROD with NOTICES
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40Patient B.F. (referencing her nickname) is 

referred to by the initials E.F. (referencing her legal 

name) in the OSC. See OSC, at 6. 

41 I note that the record is unclear as to whether 

the patient took Zubsolv; however, the pharmacy 

records indicate that the Zubsolv prescriptions were 

issued and dispensed and, therefore, Dr. Loes 

testified that they were issued outside the standard 

of care. See GX 2, at 26–28; GX 23; GX 36, at 20; 

Tr. 325. The record clearly indicates that the patient 

took buprenorphine. GX 23, at 24. 

Respondent issued to Patient A.S. on 

August 25, 2015, were issued outside of 

the usual course of professional practice 

and beneath the applicable standard of 

care in Arizona. 

16. Patient J.P. 

On September 4, 2015, Respondent 

prescribed two controlled substances, 

40 tablets of phenobarbital 32.4 mg. and 

15 tablets of buprenorphine (Zubsolv) 

5.7 mg., to Patient J.P. GX 2, at 19–20; 

GX 18 (Patient Records for J.P.), at 166– 

68; GX 36, at 17; RD, at 47. Dr. Loes 

testified that at the time the September 

4, 2015 prescription was issued, there 

was no doctor-patient relationship 

between Respondent and Patient J.P. Tr. 

309; see also GX 36, at 17. In support 

of his opinion, Dr. Loes testified that 

there was a ‘‘lack of history, physical 

examination, assessment, [and] 

associated lab.’’ Tr. 310. Dr. Loes further 

testified that there was no evidence of 

an emergency medical situation. Tr. 

311. Respondent first examined Patient 

J.P. on September 5, 2015. GX 36, at 17; 

GX 18, at 97–127; RD, at 47. 

Accordingly, Dr. Loes opined that 

Respondent’s treatment of A.S. fell 

beneath the standard of care in Arizona. 

Tr. 311. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient J.P. at the time the prescriptions 

were issued, the phenobarbital and 

buprenorphine prescriptions that 

Respondent issued to Patient J.P. on 

September 4, 2015, were issued outside 

of the usual course of professional 

practice and beneath the applicable 

standard of care in Arizona. 

17. Patient K.M. 

On September 8, 2015, Respondent 

prescribed a controlled substance, 20 

tablets of diazepam (Valium) 10 mg., to 

Patient K.M. GX 2, at 21; GX 19 (Patient 

Records for K.M.), at 36; GX 36, at 17; 

RD, at 47. Dr. Loes testified that at the 

time the September 8, 2015 prescription 

was issued, there was no doctor-patient 

relationship between Respondent and 

Patient K.M. Tr. 313; see also GX 36, at 

18. In support of his opinion, Dr. Loes 

testified that there was not an adequate 

medical history, physical examination, 

or mental examination performed, nor 

any attempt to assess K.M.’s 

psychological or physical function prior 

to September 8, 2015. Tr. 313. Dr. Loes 

further testified that there was no 

evidence of an emergency medical 

situation. Tr. 314. Respondent first 

examined Patient K.M. on September 

11, 2015. GX 36, at 17; GX 19, at 37– 

66; RD, at 47. Accordingly, Dr. Loes 

opined that Respondent’s treatment of 

K.M. fell beneath the standard of care in 

Arizona. Tr. 314. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient K.M. at the time the prescription 

was issued, the diazepam prescription 

that Respondent issued to Patient K.M. 

on September 8, 2015, was issued 

outside of the usual course of 

professional practice and beneath the 

applicable standard of care in Arizona. 

18. Patient T.K. 

On September 11, 2015, Respondent 

prescribed a controlled substance, 20 

tablets of Valium 10 mg., to Patient T.K. 

GX 2, at 24; GX 21 (Patient Records for 

T.K.), at 30; GX 36, at 18–19; RD, at 48. 

Dr. Loes testified that at the time the 

September 11, 2015 prescription was 

issued, there was no doctor-patient 

relationship between Respondent and 

Patient T.K. Tr. 317; see also GX 36, at 

19. In support of his opinion, Dr. Loes 

testified that there was not an adequate 

medical history, physical examination, 

or mental examination performed prior 

to the September 11, 2015 prescription. 

Tr. 317–18. Dr. Loes further testified 

that there was no evidence of an 

emergency medical situation. Tr. 318. 

Respondent first examined Patient T.K. 

on September 12, 2015. GX 36, at 19; GX 

21, at 141–170; RD, at 48. Accordingly, 

Dr. Loes opined that Respondent’s 

treatment of T.K. fell beneath the 

standard of care in Arizona. Tr. 318. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient T.K. at the time the prescription 

was issued, the Valium prescription 

Respondent issued to Patient T.K. on 

September 11, 2015, was issued outside 

of the usual course of professional 

practice and beneath the applicable 

standard of care in Arizona. 

19. Patient B.F.40

On September 12, 2015, Respondent 

prescribed a controlled substance, 20 

tablets of Valium 10 mg., to Patient B.F. 

GX 2, at 25; GX 22 (Patient Records for 

B.F.), at 259; GX 36, at 19; RD, at 48. Dr. 

Loes testified that at the time the 

September 12, 2015 prescription was 

issued, there was no doctor-patient 

relationship between Respondent and 

Patient B.F. Tr. 321; see also GX 36, at 

20. In support of his opinion, Dr. Loes 

testified that there was ‘‘no history of 

physical or exam of any sort prior to the 

prescribing.’’ Tr. 321. Dr. Loes further 

testified that there was no evidence of 

an emergency medical situation. Tr. 

322. Respondent first examined Patient 

B.F. on September 24, 2015. GX 36, at 

19; GX 22, at 261–77; RD, at 48. 

Accordingly, Dr. Loes opined that 

Respondent’s treatment of B.F. fell 

beneath the standard of care in Arizona. 

Tr. 321. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient B.F. at the time the prescription 

was issued, the Valium prescription 

Respondent issued to Patient B.F. on 

September 12, 2015, was issued outside 

of the usual course of professional 

practice and beneath the applicable 

standard of care in Arizona. 

20. Patient J.G. 

On September 16, 2015, Respondent 

prescribed three controlled substances, 

13 tablets of buprenorphine 8 mg., 10 

tablets of Zubsolv 5.7 mg./1.4 mg., and 

12 Zubsolv 1.4 mg./.36 mg., to Patient 

J.G. GX 2, at 26–28; GX 23 (Patient 

Records for J.G.), at 24–25; GX 36, at 20; 

RD, at 49. Dr. Loes testified that at the 

time the September 16, 2015 

prescriptions were issued, there was no 

doctor-patient relationship between 

Respondent and Patient J.G.41 Tr. 325; 

see also GX 36, at 20. In support of his 

opinion, Dr. Loes testified that there was 

not an adequate medical history, 

physical examination, mental 

examination, or attempt to assess 

psychological and physical function 

prior to the September 16, 2015 

prescriptions. Tr. 325. Dr. Loes further 

testified that there was no evidence of 

an emergency medical situation. Tr. 

325–26. Respondent first examined 

Patient J.G. on October 3, 2015. GX 36, 

at 20; GX 23, at 27–58; RD, at 49. 

Accordingly, Dr. Loes opined that 

Respondent’s treatment of J.G. fell 

beneath the standard of care in Arizona. 

Tr. 325. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 


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42Even if the patient records are incorrect and 

N.R. did not begin receiving the controlled 

substance until September 28, 2015, the delay in 

conducting the physical exam on October 3, 2015, 

was still outside the standard of care. 

43Patient A.C.F. is referred to by the initials A.F. 

in the OSC. See OSC, at 7. 

established between Respondent and 

Patient J.G. at the time the prescriptions 

for buprenorphine and Zubsolv were 

issued, the buprenorphine and two 

Zubsolv prescriptions that Respondent 

issued to Patient J.G. on September 16, 

2015, were issued outside of the usual 

course of professional practice and 

beneath the applicable standard of care 

in Arizona. 

21. Patient N.R. 

On September 26, 2015, Respondent 

prescribed a controlled substance, 12 

tablets of buprenorphine 2 mg., to 

Patient N.R. GX 2, at 29; GX 24 (Patient 

Records for N.R.), at 53; GX 36, at 21; 

RD, at 49. The pharmacy records show 

that the prescription was picked up on 

September 28, 2015; however, the 

patient records show that Patient N.R. 

began receiving buprenorphine on 

September 24, 2015, prior to the 

prescription being picked up. GX 2, at 

29; GX 24, at 53; GX 36, at 21; RD, at 

49. Dr. Loes testified that at the time the 

September 26, 2015 prescription was 

issued, there was no doctor-patient 

relationship between Respondent and 

Patient N.R. Tr. 327; see also GX 36, at 

21. In support of his opinion, Dr. Loes 

testified that there was no 

documentation in the patient record to 

indicate that there was any kind of 

examination of N.R. prior to September 

28, 2015. Tr. 328. Dr. Loes further 

testified that there was no evidence of 

an emergency medical situation. Tr. 

333. The date Respondent first 

examined N.R. is unknown as the 

corresponding medical records were 

undated—the first dated examination of 

N.R. was October 3, 2015.42 GX 36, at 

21; GX 24, at 61–91; 92; RD, at 49. 

Accordingly, Dr. Loes opined that 

Respondent’s treatment of N.R. fell 

beneath the standard of care in Arizona. 

Tr. 330. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there is no evidence 

of a legitimate doctor-patient 

relationship established between 

Respondent and Patient N.R. at the time 

the prescription was issued, the 

buprenorphine prescription that 

Respondent issued to Patient N.R. on 

September 26, 2015, was issued outside 

of the usual course of professional 

practice and beneath the applicable 

standard of care in Arizona. 

22. Patient A.C.F.43

On October 17, 2015, Respondent 

prescribed a controlled substance, 15 

tablets of buprenorphine (Zubsolv) 5.7/ 

1.4 mg., to Patient A.C.F. GX 2, at 30; 

GX 25 (Patient Records for A.C.F.), at 

46; GX 36, at 21; RD, at 49. Dr. Loes 

testified that at the time the October 17, 

2015 prescription was issued, there was 

no doctor-patient relationship between 

Respondent and Patient A.C.F. Tr. 334; 

see also GX 36, at 22. In support of his 

opinion, Dr. Loes testified that at the 

time of the prescription, there was not 

an adequate medical history taken, 

adequate physical or mental 

examination performed, nor attempt to 

assess A.C.F.’s physical or psychological 

function. Tr. 334–35. Dr. Loes further 

testified that there was no evidence of 

an emergency medical situation. Tr. 

335. Respondent first examined Patient 

A.C.F. on October 20, 2015. GX 36, at 

20; GX 25, at 62–80; RD, at 49. 

Accordingly, Dr. Loes opined that 

Respondent’s treatment of A.C.F. fell 

beneath the standard of care in Arizona. 

Tr. 335. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient A.C.F. at the time the 

prescription was issued, the 

buprenorphine prescription that 

Respondent issued to Patient A.C.F. on 

October 17, 2015, was issued outside of 

the usual course of professional practice 

and beneath the applicable standard of 

care in Arizona. 

23. Patient L.R. 

On October 23, 2015, Respondent 

issued prescriptions for two controlled 

substances, 12 tablets of buprenorphine 

8 mg. and 12 tablets of buprenorphine 

2 mg., to Patient L.R. GX 2, at 31–32; GX 

26 (Patient Records for L.R.), at 64; GX 

36, at 22; RD, at 50. Dr. Loes testified 

that at the time the October 23, 2015 

prescriptions were issued, there was no 

doctor-patient relationship between 

Respondent and Patient L.R. Tr. 337; see 

also GX 36, at 22. In support of his 

opinion, Dr. Loes testified that there was 

‘‘no doctor-patient relationship 

documented to [have been] 

established.’’ Tr. 337. Dr. Loes further 

testified that there was no evidence of 

an emergency medical situation. Tr. 

340. Respondent first examined Patient 

L.R. on October 24, 2015. GX 36, at 22; 

GX 26, at 74–103; RD, at 50. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient L.R. at the time the two 

prescriptions were issued, the 

buprenorphine prescriptions that 

Respondent issued to Patient L.R. on 

October 23, 2015, were issued outside of 

the usual course of professional practice 

and beneath the applicable standard of 

care in Arizona. 

24. Patient F.H. 

On October 24, 2015, Respondent 

issued prescriptions for two controlled 

substances, 12 tablets of buprenorphine 

8 mg. and 12 tablets of buprenorphine 

2 mg., to Patient F.H. GX 2, at 33–34; GX 

27 (Patient Records for F.H.), at 33; GX 

36, at 22; RD, at 50. Dr. Loes testified 

that at the time the October 24, 2015 

prescriptions were issued, there was no 

doctor-patient relationship between 

Respondent and Patient F.H. Tr. 343; 

see also GX 36, at 23. In support of his 

opinion, Dr. Loes testified that there was 

‘‘[a] lack of documentation for 

physical[,] interview, assessment, [and] 

plan’’ and there was no evidence that 

any examination was performed. Tr. 

343. Dr. Loes further testified that there 

was no evidence of an emergency 

medical situation. Tr. 343–44. 

Respondent first examined Patient F.H. 

on October 27, 2015. GX 36, at 22; GX 

27, at 40–73; RD, at 50. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient F.H. at the time the prescriptions 

were issued, the buprenorphine 

prescriptions that Respondent issued to 

Patient F.H. on October 24, 2015, were 

issued outside of the usual course of 

professional practice and beneath the 

applicable standard of care in Arizona. 

25. Patient A.J. 

On October 24, 2015, Respondent 

prescribed a controlled substance, 20 

tablets of Valium 10 mg., to Patient A.J. 

GX 2, at 35; GX 28 (Patient Records for 

A.J.), at 46; GX 36, at 23; RD, at 50. On 

October 25, 2015, Respondent 

prescribed another controlled substance, 

12 tablets of Zubsolv .36/1.4 mg., to 

Patient A.J. GX 2, at 35; GX 28, at 42; 

GX 36, at 23; RD, at 50. Dr. Loes testified 

that at the time the October 24 and 25, 

2015 prescriptions were issued, there 

was no doctor-patient relationship 

between Respondent and Patient A.J. Tr. 

346; see also GX 36, at 23. In support 

of his opinion, Dr. Loes testified that 

‘‘[t]he first medical visit [was] October 

27th, so there is no evidence that a 

doctor-patient relationship was 


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44Patient J.A.2 is referred to by the initials J.A. 

in the OSC. See OSC, at 9. 

45 Dr. Loes testified that, regardless of whether or 

not H.S. received the controlled substance, the 

prescription ‘‘was ordered prior to a doctor-patient 

relationship being established. So, therefore, it fell 

below the standard of care because of the actual 

ordering of the prescription.’’ Tr. 355. Here the 

pharmacy records indicate that the Zubsolv 

prescription was issued and dispensed. GX 2, at 38. 

46The record indicates that there may have been 

other controlled substances issued by Respondent 

to Patient J.W. prior to him being evaluated by a 

physician; however, they were not included in the 

OSC or prehearing filings and I have not considered 

them as part of my analysis. See GX 36, at 25; OSC, 

at 9. 

established prior to those 

prescriptions.’’ Tr. 346. See also GX 36, 

at 23; GX 28, at 102–107, 110–113, 127– 

148; RD, at 50. Dr. Loes further testified 

that there was no evidence of an 

emergency medical situation. Tr. 347. 

Accordingly, Dr. Loes opined that 

Respondent’s treatment of A.J. fell 

beneath the standard of care in Arizona. 

Tr. 347. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient A.J. at the time the prescriptions 

were issued, the Valium and Zubsolv 

prescriptions that Respondent issued to 

Patient A.J. on October 24 and 25, 2015, 

respectively, were issued outside of the 

usual course of professional practice 

and beneath the applicable standard of 

care in Arizona. 

26. Patient J.A.2 44

On October 27, 2015, Respondent 

prescribed a controlled substance, 9 

tablets of buprenorphine 8 mg., to 

Patient J.A.2. GX 2, at 37; GX 29 (Patient 

Records for J.A.2), at 86; GX 36, at 23; 

RD, at 51. Dr. Loes testified that at the 

time the October 27, 2015 prescription 

was issued, there was no doctor-patient 

relationship between Respondent and 

Patient J.A.2. Tr. 349; see also GX 36, at 

24. In support of his opinion, Dr. Loes 

testified that ‘‘[t]here was no doctorpatient relationship prior to prescribing 

or the initiation of that medication.’’ Tr. 

349. Dr. Loes further testified that there 

was no evidence of an emergency 

medical situation. Tr. 351–52. 

Respondent first examined Patient J.A.2 

on October 31, 2015. GX 36, at 22; GX 

29, at 2–39; RD, at 51. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient J.A.2 at the time the prescription 

was issued, the buprenorphine 

prescription that Respondent issued to 

Patient J.A.2 on October 27, 2015, was 

issued outside of the usual course of 

professional practice and beneath the 

applicable standard of care in Arizona. 

27. Patient H.S. 

On October 28, 2015, Respondent 

prescribed a controlled substance, 12 

tablets of buprenorphine (Zubsolv) 5.7/ 

1.4 mg., to Patient H.S. GX 2, at 38; GX 

30 (Patient Records for H.S.), at 43; GX 

36, at 24; RD, at 51. Although there is 

no record that H.S. ever received the 

Zubsolv tablets (see GX 30, at 111 and 

113), Dr. Loes testified that at the time 

the October 28, 2015 prescription was 

issued, there was no doctor-patient 

relationship between Respondent and 

Patient H.S.45 Tr. 354; see also GX 36, 

at 24. In support of his opinion, Dr. Loes 

testified that as of October 28, 2015, 

there was no documentation of a 

medical history, physical or mental 

examination, or assessment of physical 

or psychological function. Tr. 354. Dr. 

Loes further testified that there was no 

evidence of an emergency medical 

situation. Tr. 354–55. Respondent first 

examined Patient H.S. on October 31, 

2015. GX 36, at 24; GX 30, at 114–143; 

RD, at 51. Accordingly, Dr. Loes opined 

that Respondent’s treatment of H.S. fell 

beneath the standard of care in Arizona. 

Tr. 355. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient H.S. at the time the prescription 

was issued, the Zubsolv prescription 

that Respondent issued to Patient H.S. 

on October 28, 2015, was issued outside 

of the usual course of professional 

practice and beneath the applicable 

standard of care in Arizona. 

28. Patient J.K. 

On November 5, 2015, Respondent 

prescribed two controlled substances, 

15 tablets of Zubsolv 5.7/1.4 mg. and 15 

tablets of Zubsolv 1.4/.36 mg., to Patient 

J.K. GX 2, at 39–40; GX 32 (Patient 

Records for J.K.), at 27; GX 36, at 25; RD, 

at 51. Dr. Loes testified that at the time 

the November 5, 2015 prescriptions 

were issued, there was no doctor-patient 

relationship between Respondent and 

Patient J.K. Tr. 358; see also GX 36, at 

25. In support of his opinion, Dr. Loes 

testified that there was ‘‘no 

documentation of the history, physical, 

no associated labs, and no associated 

interaction.’’ Tr. 358. Dr. Loes further 

testified that there was no evidence of 

an emergency medical situation. Tr. 

359. Respondent first examined Patient 

J.K. on November 7, 2015. GX 36, at 25; 

GX 32, at 36–69; RD, at 51. Accordingly, 

Dr. Loes opined that Respondent’s 

treatment of J.K. fell beneath the 

standard of care in Arizona. Tr. 359. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient J.K. at the time the prescriptions 

were issued, the Zubsolv prescriptions 

that Respondent issued to Patient J.K. 

on November 5, 2015, were issued 

outside of the usual course of 

professional practice and beneath the 

applicable standard of care in Arizona. 

29. Patient J.W. 

On November 21, 2015, Respondent 

prescribed a controlled substance,46 20 

tablets of diazepam 10 mg., to Patient 

J.W. GX 2, at 41; GX 31 (Patient Records 

for J.W.), at 6; GX 36, at 25; RD, at 52. 

Dr. Loes testified that at the time the 

November 21, 2015 prescription was 

issued, there was no doctor-patient 

relationship between Respondent and 

Patient J.W. Tr. 360–61; see also GX 36, 

at 25. In support of his opinion, Dr. Loes 

testified that there was ‘‘no 

documentation for the history, physical, 

evaluation, [or] treatment initiation.’’ Tr. 

361. Dr. Loes further testified that there 

was no evidence of an emergency 

medical situation. Tr. 363. Respondent 

was discharged on November 24, 2015, 

and there is no record of him ever being 

seen by a physician between his 

November 21, 2015 admission and 

November 24, 2015 discharge. GX 36, at 

25; GX 31; RD, at 52. Accordingly, Dr. 

Loes opined that Respondent’s 

treatment of J.W. fell beneath the 

standard of care in Arizona. Tr. 364–65. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient J.W. at the time the prescription 

was issued, the diazepam prescription 

that Respondent issued to Patient J.W. 

on November 21, 2015, was issued 

outside of the usual course of 

professional practice and beneath the 

applicable standard of care in Arizona. 

30. Patient K.C. 

On November 21, 2015, Respondent 

prescribed a controlled substance, 15 

tablets of Zubsolv 5.7/1.4 mg., to Patient 

K.C. GX 2, at 42; GX 33 (Patient Records 

for K.C.), at 15; GX 36, at 26; RD, at 52. 

Dr. Loes testified that at the time the 

November 21, 2015 prescription was 

issued, there was no doctor-patient 

relationship between Respondent and 

Patient K.C. Tr. 366; see also GX 36, at 


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47As to Factor One, the evidence in the record 

is that Respondent has an Arizona medical license, 

Tr. 431, and there is no evidence in the record of 

any recommendation from Respondent’s state 

licensing board or professional disciplinary 

authority. 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 Agency cases have noted, there are a 

number of reasons why a person who has engaged 

in criminal misconduct may never have been 

convicted of an offense under this factor, let alone 

prosecuted for one. Dewey C. MacKay, M.D., 75 FR 

49956, 49973 (2010). Agency cases have therefore 

held that ‘‘the absence of such a conviction is of 

considerably less consequence in the public interest 

inquiry’’ and is therefore not dispositive. Id. 

26. In support of his opinion, Dr. Loes 

testified that there was ‘‘no evidence in 

the chart that this patient was ever seen 

by a physician.’’ Tr. 366. Dr. Loes 

further testified that there was no 

evidence of an emergency medical 

situation. Tr. 368. Respondent was 

discharged on November 23, 2015, and 

there is no record of her ever being seen 

by a physician between her November 

21, 2015 admission and November 23, 

2015 discharge. GX 36, at 26; GX 33; RD, 

at 52. Accordingly, Dr. Loes opined that 

Respondent’s treatment of K.C. fell 

beneath the standard of care in Arizona. 

Tr. 367. 

In accordance with Dr. Loes’ 

testimony and the record as a whole, I 

find that, because there was no 

legitimate doctor-patient relationship 

established between Respondent and 

Patient K.C. at the time the prescription 

was issued, the Zubsolv prescription 

that Respondent issued to Patient K.C. 

on November 21, 2015, was issued 

outside of the usual course of 

professional practice and beneath the 

applicable standard of care in Arizona. 

31. Summary of Fact Findings Relevant 

to All Patients 

I find that forty prescriptions were 

issued by Respondent to thirty patients 

without Respondent having first 

performed a physical or mental 

examination. I find that forty 

prescriptions were issued by 

Respondent to patients without first 

developing a doctor-patient 

relationship. I credit Dr. Loes’ opinion 

‘‘that none of the cases that [he] 

reviewed would have qualified [as 

emergency medical situations].’’ Tr. 401, 

see also Tr. 376–77, 402. Accordingly, I 

find that none of the thirty patients at 

issue in this case were suffering from an 

emergency medical situation at the time 

that Respondent prescribed the 

controlled substances at issue in this 

case. Ultimately, I find that there is 

substantial evidence that Respondent 

issued forty prescriptions without a 

legitimate medical purpose and outside 

the usual course of professional practice 

and beneath the applicable standard of 

care in Arizona. 

III. Discussion 

A. Allegation That Respondent’s 

Registration Is Inconsistent With the 

Public Interest 

Under Section 304 of the CSA, ‘‘[a] 

registration . . . to . . . dispense a 

controlled substance . . . may be 

suspended or revoked by the Attorney 

General upon a finding that the 

registrant . . . has committed such acts 

as would render his registration under 

section 823 of this title inconsistent 

with the public interest as determined 

by such section.’’ 21 U.S.C. 824(a)(4). In 

the case of a ‘‘practitioner,’’ defined in 

21 U.S.C. 802(21) to include a 

‘‘physician,’’ Congress directed the 

Attorney General to consider the 

following factors in making the public 

interest determination: 

(1) The recommendation of the appropriate 

State licensing board or professional 

disciplinary authority. 

(2) The applicant’s experience in 

dispensing . . . controlled substances. 

(3) The applicant’s conviction record under 

Federal or State laws relating to the . . . 

distribution[ ] or dispensing of controlled 

substances. 

(4) Compliance with applicable State, 

Federal, or local laws relating to controlled 

substances. 

(5) Such other conduct which may threaten 

the public health and safety. 

21 U.S.C. 823(f). These factors are 

considered in the disjunctive. Robert A. 

Leslie, M.D., 68 FR 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 

of a registration. MacKay, 664 F.3d at 

821. 

Respondent has argued broadly that 

he has not committed acts that render 

his Registration inconsistent with the 

public interest. Resp Posthearing, at 16. 

Rather, Respondent argued, the 

evidence in the record was that the 

patients identified in the OSC suffered 

from addiction and were medically 

benefitted by the treatment provided by 

Respondent. Id. at 6–7, 16. The CSA 

requires me to consider Respondent’s 

controlled substance dispensing 

experience, among other things, not 

whether Respondent’s practice of 

medicine as a whole was beneficial to 

the community. 21 U.S.C. 823(f)(2); see 

Frank Joseph Stirlacci, M.D., 85 FR 

45229, 45239 (2020) (declining to accept 

community impact arguments); see also 

Richard J. Settles, D.O., 81 FR 64940, 

n.16 (2016). 

DEA regulations state, ‘‘[a]t any 

hearing for the revocation . . . of a 

registration, the . . . [Government] shall 

have the burden of proving that the 

requirements for such revocation . . . 

pursuant to . . . 21 U.S.C. [§ ] 824(a) 

. . . are satisfied.’’ 21 CFR 1301.44(e). 

In this matter, while I have considered 

all of the factors,47 the relevant evidence 

is confined to Factors Two and Four. I 

find that the evidence satisfies the 

Government’s prima facie burden of 

showing that Respondent’s continued 

registration would be ‘‘inconsistent with 

the public interest.’’ 21 U.S.C. 824(a)(4). 

I further find that Respondent failed to 

produce sufficient evidence to rebut the 

Government’s prima facie case. 

1. Factors Two and Four—the 

Respondent’s Experience in Dispensing 

Controlled Substances and Compliance 

With Applicable Laws Related to 

Controlled Substances 

(a) Allegation That Respondent Issued 

Prescriptions for Controlled Substances 

Outside the Usual Course of the 

Professional Practice 

According to the Controlled 

Substances Act’s (hereinafter, CSA) 

implementing regulations, a lawful 


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48Respondent suggested that the only ground for 

revocation was Ariz. Rev. Stat. Ann. § 32–1401(27). 

Tr. 191; Resp Posthearing, at 4. The ALJ thoroughly 

analyzed the notice allegation and found that there 

were multiple instances where the Respondent was 

placed on notice of the factual and legal basis upon 

which the government relied in proposing to revoke 

Respondent’s Registration including, amongst other 

things, 21 CFR 1306.04. RD, at 56–62. Respondent’s 

Posthearing Brief alone makes clear that 

Respondent understood the basis of the allegations 

against him, had the opportunity to litigate those 

allegations, and did, in fact, litigate those 

allegations. See Resp Posthearing, at 2–4. Like the 

ALJ, I am not persuaded by Respondent’s notice 

argument. 

49Similarly, the law in Arizona states that it is 

‘‘unprofessional conduct’’ to ‘‘[p]rescrib[e], 

dispens[e], or administer [ ], any controlled 

substance or prescription-only drug for other than 

accepted therapeutic purposes.’’ Ariz. Rev. Stat. 

Ann. § 32–1401(27)(j) (year). 

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).48 49 Under 

the CSA, it is fundamental that a 

practitioner must establish and maintain 

a bona fide doctor-patient relationship 

in order to act ‘‘in the usual course of 

. . . professional practice’’ and to issue 

a prescription for a ‘‘legitimate medical 

purpose.’’ Laurence T. McKinney, 73 FR 

43260, 43365 n. 22 (2008); see also 

United States v. Moore, 423 U.S. 122, 

142–43 (1975). The CSA generally looks 

to state law to determine whether a 

doctor and patient have established a 

doctor-patient relationship. See Kamir 

Garces-Mejias, 72 FR 54931, 54935 

(2007); United Prescription Services, 

Inc., 72 FR 50397, 50407 (2007). 

I found above that the Government’s 

expert credibly testified as supported by 

Arizona law that the standard of care in 

Arizona is that a physician must 

perform a physical examination of a 

patient or otherwise develop a doctorpatient relationship prior to prescribing 

controlled substances unless one of the 

statutory exceptions applies. See supra 

II.E. I also found above that Respondent 

issued forty prescriptions to thirty 

patients without first performing a 

physical examination or otherwise 

establishing a doctor-patient 

relationship. See supra II.F.31. 

Accordingly, I found that Respondent 

dispensed controlled substances 

beneath the applicable standard of care 

and outside of the usual course of the 

professional practice in Arizona. See 

supra II.F.31. I find that in issuing forty 

prescriptions beneath the applicable 

standard of care and outside the usual 

course of professional practice in 

Arizona, Respondent violated 21 CFR 

1306.04(a). 

Respondent’s arguments otherwise are 

without merit. Respondent testified that 

he believed that it was proper ‘‘to take 

patients who get admitted in acute 

withdrawal settings and to treat them 

based on the history . . . that [is] 

obtained from the staff, and then see 

[the patient] afterwards.’’ Tr. 49. 

Respondent testified that his practice 

was followed by several well-known 

outpatient addiction treatment facilities 

and a prominent physician, but he 

provided no corroborating evidence of 

this assertion. Tr. 438–40. Even if 

Respondent believed his dispensing was 

within the usual course of professional 

practice, DEA has found that ‘‘just 

because misconduct is unintentional, 

innocent, or devoid of improper motive, 

[it] does not preclude revocation or 

denial. Careless or negligent handling of 

controlled substances creates the 

opportunity for diversion and [can] 

justify the revocation of an existing 

registration . . .’’ Bobby D. Reynolds, 

N.P., Tina L. Killebrew, N.P., & David R. 

Stout, N.P., 80 FR 28643, 28662 (2015) 

(quoting Paul J. Caragine, Jr. 63 FR 

51592, 51601 (1998). And in fact, four 

of the thirty patients (Patients Z.J, A.S., 

J.W., and K.C.) were issued controlled 

substances by Respondent and left 

treatment without ever being physically 

examined by or developing a doctorpatient relationship with Respondent. 

See supra II.F. 

The Respondent asserted that ‘‘[t]he 

government provided no testimony or 

evidence that any patient suffered harm 

or even potential harm from 

[Respondent’s] practice of medicine[,] 

. . . [and that] [w]ithout this, the 

government cannot prove that 

[Respondent’s] practice is inconsistent 

with the public interest.’’ Resp 

Posthearing, at 16 (internal quotations 

omitted). Respondent does not, 

however, cite legal authority for the 

proposition that I must find harm before 

I may suspend or revoke a registration. 

Agency decisions have found that 

‘‘diversion occurs whenever controlled 

substances leave ‘the closed system of 

distribution established by the CSA 

. . . .’ ’’ Id. (citing Roy S. Schwartz, 79 

FR 34360, 34363 (2014)). In this case, I 

have found that Respondent issued 

prescriptions without complying with 

his obligations under the CSA and 

Arizona law. See George Mathew, M.D., 

75 FR 66138, 66148 (2010)). I therefore 

find that Factors Two and Four weigh 

in favor of revocation. 

(b) Violation of State Law 

In addition to finding a violation of 21 

CFR 1306.04(a), I also find that the 

Government has proven by substantial 

evidence that Respondent’s failure to 

physically examine or otherwise 

establish a doctor-patient relationship 

prior to prescribing controlled 

substances violated Ariz. Rev. Stat. Ann. 

§ 32–1401(27). Arizona law states that it 

is ‘‘unprofessional conduct’’ to 

‘‘[p]rescrib[e], dispens[e] or furnish[] a 

prescription medicine . . . to a person 

unless the doctor first conducts a 

physical or mental health status 

examination of that person or has 

previously established a doctor-patient 

relationship.’’ Ariz. Rev. Stat. Ann. 

§ 32–1401(27)(ss) (2014). Respondent 

argues that in spite of this Arizona 

statute, Arizona law allows a doctor to 

‘‘take patients who get admitted in acute 

withdrawal settings and to treat them 

based on the history . . . that [is] 

obtained from the staff, and then see 

[the patient] afterwards . . . within 24 

hours . . . [or] within five to seven 

days.’’ Tr. 49. 

Respondent’s argument would 

necessitate a finding that the statutory 

term in Ariz. Rev. Stat. Ann. § 32– 

1401(27) ‘‘the doctor’’ includes what 

Respondent described as ‘‘staff who had 

training at taking a history and physical 

from a patient.’’ Tr. 113. Further, in this 

case, Respondent’s staff did not appear 

to take a full physical examination of 

the patients; therefore, his interpretation 

would require that the statutory phrase 

‘‘physical or mental health status 

examination’’ must be able to be 

satisfied by trained staff taking an 

‘‘appropriate evaluation,’’ which, 

according to Respondent, could include 

vital signs and soliciting a medical 

history from the patient. Tr. 112. 

Respondent made an alternative 

argument that RIM’s purported policies 

permitted treatment of patients followed 

by an examination within a certain 

timeframe. Such an interpretation of the 

Arizona statute would necessitate a 

reading of the statutory phrases ‘‘first’’ 

and ‘‘previously’’ to be replaced with 

whatever timeline may be established 

by the facility’s individual policies. 

Respondent’s interpretation conflicts 

with the plain language of Ariz. Rev. 

Stat. Ann. § 32–1401(27)(ss). 

Arizona interprets Ariz. Rev. Stat. 

Ann. § 32–1401(27)(ss), in Golob v. 

Arizona Medical Bd. of State, 217 Ariz. 

505 (2008). In Golob, the Arizona Court 

of Appeals evaluated the establishment 

of the doctor-patient relationship in the 

context of a physician who was 

prescribing medication over the 

internet. Id. at 508. After conceding that 

she performed no physical 

examinations, Dr. Golob argued that she 

fulfilled the requirements of Ariz. Rev. 

Stat. Ann. § 32–1401(27)(ss) because she 

created ‘‘a previously established . . . 

doctor-patient relationship’’ in each 

case by accepting a consultation fee and 

reviewing the individual’s responses to 


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50When asked whether a valid doctor patient 

relationship existed with these patients prior to 

Respondent’s prescriptions, Respondent did not 

directly answer the question and replied: ‘‘I believe 

that when you walk into a treatment program and 

you begin getting evaluated by the treatment staff, 

that that is the first step—that, that, that is—that 

that is the initial process that has—that is the initial 

step that evaluates, that determines the doctorpatient relationship.’’ Tr. 112. 

the questionnaire, occasionally directing 

an operator to ask the person additional 

questions before she prescribed. Id. at 

510. The court wholly rejected her 

argument and upheld the state board’s 

finding that Dr. Golob deviated from the 

standard of care because she prescribed 

medication over the internet without 

establishing an appropriate physicianpatient relationship. Id. at 508–09. The 

court found that the state board’s 

interpretation of Ariz. Rev. Stat. Ann. 

§ 32–1401(27)(ss), was aligned with the 

American Medical Association’s 

Guidance for Physicians on internet 

Prescribing stating that a ‘‘valid patientphysician relationship’’ is formed when 

the physician, among other things, 

‘‘obtain[s] a reliable medical history and 

perform[s] a physical examination of the 

patient’’ and has ‘‘sufficient dialogue 

with the patient regarding treatment 

options.’’ Id. at 511 (citing American 

Medical Association’s Guidance for 

Physicians on Internet Prescribing, H– 

120.949 (June 2003)). Although not 

directly applicable to the facts here, the 

finding in Golob is consistent with my 

finding that the standard of care in 

Arizona requires that a physician 

perform a physical examination of a 

patient or otherwise develop a doctorpatient relationship prior to prescribing 

controlled substances. 

I have found that Respondent did not 

personally examine any of the thirty 

patients at issue in this case nor 

otherwise establish a doctor-patient 

relationship with those patients prior to 

prescribing.50 Next I must consider 

whether or not an exception to Ariz. 

Rev. Stat. Ann. § 32–1401(27)(ss) 

applies. 

While there are several statutory 

exceptions to Ariz. Rev. Stat. Ann. § 32– 

1401(27)(ss), one that could arguably be 

relevant to these facts is that a doctor is 

not required to conduct a physical or 

mental health status examination before 

prescribing when there is an ‘‘(ii) 

[e]mergency medical situation as 

defined in § 41–1831.’’ Ariz. Rev. Stat. 

Ann. § 32–1401(27)(ss). Section § 41– 

1831 states that ‘‘[e]mergency medical 

situation means a condition of 

emergency in which immediate medical 

care or hospitalization, or both, is 

required by a person or persons for the 

preservation of health, life, or limb.’’ 

Ariz. Rev. Stat. Ann. § 41–1831(9) 

(2012). As I discussed above, 

Respondent argued that an ‘‘emergency 

medical situation’’ should be 

interpreted to include preventing a 

patient from entering a state of medical 

emergency itself. See supra II.E.2. To 

adopt Respondent’s definition of 

medical emergency, I would have to 

ignore the statutory requirement of 

‘‘immediate medical care or 

hospitalization.’’ Again, Respondent’s 

interpretation is irreconcilable with the 

plain language of Ariz. Rev. Stat. Ann. 

§ 32–1401(27)(ss) (incorporating Ariz. 

Rev. Stat. Ann. § 41–1831(9)). Moreover, 

based on the credible opinion of Dr. 

Loes, I found above that there is no 

evidence in the patient records or 

otherwise that any of the thirty patients 

at issue in this case were suffering from 

an emergency medical situation at the 

time that the prescriptions at issue in 

this case were issued. See supra II.F.31. 

For all these reasons, I find that the 

Government has proven by substantial 

evidence that Respondent violated Ariz. 

Rev. Stat. Ann. § 32–1401(27)(ss). 

In conclusion, I find that the 

Government has proven by substantial 

evidence that Respondent issued forty 

controlled substance prescriptions 

without a legitimate medical purpose 

and outside of the usual course of 

professional practice and beneath the 

applicable standard of care in the State 

of Arizona in violation of 21 CFR 

1306.04(a) and Ariz. Rev. Stat. Ann. 

§ 32–1401(27)(ss). Overall, I find that 

the Government has established a prima 

facie case that Respondent’s continued 

registration is inconsistent with the 

public interest. 

IV. Sanction 

Where, as here, the Government has 

met its prima facie burden of showing 

that Respondent’s continued registration 

is inconsistent with the public interest, 

the burden shifts to the Respondent to 

show why he can be entrusted with a 

registration. Garrett Howard Smith, 

M.D., 83 FR 18882, 18910 (2018) 

(collecting cases). Respondent has made 

no effort to establish that he can be 

trusted with a registration. 

The CSA authorizes the Attorney 

General to ‘‘promulgate and enforce any 

rules, regulations, and procedures 

which he may deem necessary and 

appropriate for the efficient execution of 

his functions under this subchapter.’’ 21 

U.S.C. 871(b). This authority 

specifically relates ‘‘to ‘registration’ and 

‘control,’ and ‘for the efficient execution 

of his functions’ under the statute.’’ 

Gonzales v. Oregon, 546 U.S. 243, 259 

(2006). A clear purpose of this authority 

is to ‘‘bar[ ] doctors from using their 

prescription-writing powers as a means 

to engage in illicit drug dealing and 

trafficking.’’ Id. at 270. 

In efficiently executing the revocation 

and suspension authority delegated to 

me under the CSA for the 

aforementioned purposes, I review the 

evidence and arguments Respondent 

submitted to determine whether or not 

he has presented ‘‘sufficient mitigating 

evidence to assure the Administrator 

that he can be trusted with the 

responsibility carried by such a 

registration.’’ Samuel S. Jackson, D.D.S., 

72 FR 23848, 23853 (2007) (quoting Leo 

R. Miller, M.D., 53 FR 21931, 21932 

(1988)). ‘‘ ‘Moreover, because ‘‘past 

performance is the best predictor of 

future performance,’’ ALRA Labs, Inc. v. 

DEA, 54 F.3d 450, 452 (7th Cir. 1995), 

[the Agency] has repeatedly held that 

where a registrant has committed acts 

inconsistent with the public interest, the 

registrant must accept responsibility for 

[the registrant’s] actions and 

demonstrate that [registrant] will not 

engage in future misconduct.’ ’’ Jayam 

Krishna-Iyer, 74 FR 459, 463 (2009) 

(quoting Medicine Shoppe, 73 FR 364, 

387 (2008)); see also Jackson, 72 FR at 

23853; John H. Kennnedy, M.D., 71 FR 

35705, 35709 (2006); Prince George 

Daniels, D.D.S., 60 FR 62884, 62887 

(1995). 

The issue of trust is necessarily a factdependent determination based on the 

circumstances presented by the 

individual respondent; therefore, the 

Agency looks at factors, such as the 

acceptance of responsibility and the 

credibility of that acceptance as it 

relates to the probability of repeat 

violations or behavior and the nature of 

the misconduct that forms the basis for 

sanction, while also considering the 

Agency’s interest in deterring similar 

acts. See Arvinder Singh, M.D., 81 FR 

8247, 8248 (2016). 

Here, I agree with the ALJs’s finding 

that ‘‘[t]he Respondent overall did not 

express any sense of wrongdoing.’’ RD, 

at 36. Even if I had accepted 

Respondent’s version of the standard of 

care in Arizona that, pursuant to RIM 

policies, trained staff can perform an 

initial assessment of a patient to support 

the issuance of a controlled substance 

prescription and the physician can 

perform the physical examination up to 

ninety-six hours later, his actions on 

many occasions fell outside of his 

version of the standard. Tr. 144; supra 

II.D–E; see RD, at 93 (ALJ finding that 

Respondent failed to physically 

examine seven patients within ninetysix hours of prescribing controlled 

substances.) Despite the fact that the 

prescriptions he issued to these patients 

clearly did not fall within even his own 

characterization of the standard of care, 


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Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10353 

51 Generally, Respondent described his failures as 

being an ‘‘[o]versight.’’ Tr. 122; see also Tr. 123; RD, 

at 36. 

Respondent did not accept any 

responsibility for his failure to 

physically examine those seven patients 

within ninety-six hours of admission. 

The ALJ also found that four of the 

seven patients were admitted for 

treatment at RIM and received 

controlled substance prescriptions 

while the Respondent was out of the 

country and there was no other 

physician coverage provided. RD, at 94; 

see also supra II.F. Respondent not only 

failed to accept responsibility for his 

failures here, he seemed to pass blame 

for his lack of coverage onto another 

physician who left the practice shortly 

before Respondent’s trip abroad. Tr. 74; 

RD, at 94. Additionally, the ALJ found, 

and I agree, that Respondent’s testimony 

regarding the work he did perform 

while in Europe lacked credibility.51

RD, at 38, 95. 

In all, Respondent failed to explain 

why, in spite of his misconduct, he can 

be entrusted with a registration. ‘‘The 

degree of acceptance of responsibility 

that is required does not hinge on the 

respondent uttering ‘‘magic words’’ of 

repentance, but rather on whether the 

respondent has credibly and candidly 

demonstrated that he will not repeat the 

same behavior and endanger the public 

in a manner that instills confidence in 

the Administrator.’’ Jeffrey Stein, M.D., 

84 FR 46,968, 49,973. 

The Agency also looks to the 

egregiousness and extent of the 

misconduct which are significant factors 

in determining the appropriate sanction. 

Garrett Howard Smith, M.D., 83 FR at 

18910 (collecting cases). Here, the ALJ 

found, and I agree, that the evidence 

suggests that Respondent’s ‘‘offending 

practices had been ongoing and 

patterned behavior.’’ RD, at 89. The ALJ 

found that Respondent’s care for four 

patients while he was in Europe was a 

‘‘particularly aggravating circumstance.’’ 

RD, at 94. I agree with the ALJ that 

Respondent’s conduct was egregious, 

particularly in the prescriptions issued 

while in Europe and those where he 

delayed seeing the patients for long 

periods of time. Additionally, I have 

found many more instances of 

misconduct than the ALJ, who 

nonetheless recommended revocation. 

The Government argued that the 

Respondent was on notice, by virtue of 

the 2010 MOA, that he could not 

prescribe controlled substances prior to 

personally examining his patients. Tr. 

12; RD, at 69. The MOA stated that 

‘‘Respondent must conduct an initial 

examination validating the necessity to 

prescribe Suboxone or Subatex to each 

[new] OBOT patient.’’ I agree with the 

ALJ that the MOA does not clearly 

indicate that the examination was 

required by existing law and that 

Respondent could have read it to be 

merely an enhanced requirement placed 

on Respondent only for the length of the 

agreement. RD, at 69–70. As such, I will 

agree with the ALJ and find that the 

MOA, in and of itself, does not put 

Respondent on notice that his conduct 

was illegal per se, even though state law 

on this matter certainly should have. 

However, I find the fact that DEA 

previously gave Respondent an 

opportunity to correct his behavior and 

Respondent reverted back to his prior 

practices upon the expiration of the 

MOA to be relevant to whether I can 

entrust the Respondent with a 

registration. As Respondent did not 

seem to learn from his prior experience 

and, as discussed, made no efforts to 

accept responsibility, I do not trust that 

a sanction less than revocation will 

deter Respondent from engaging in this 

behavior again in the future. 

In sanction determinations, the 

Agency has historically considered its 

interest in deterring similar acts, both 

with respect to the respondent in a 

particular case and the community of 

registrants. See Joseph Gaudio, M.D., 74 

FR 10083, 10095 (2009); Singh, 81 FR at 

8248. I find that considerations of both 

specific and general deterrence weigh in 

favor of revocation in this case. There is 

simply no evidence that Respondent’s 

egregious behavior is not likely to recur 

in the future such that I can entrust him 

with a CSA registration; in other words, 

the factors weigh in favor of revocation 

as a sanction. 

I will therefore order that 

Respondent’s registration be revoked as 

contained in the Order below. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 

824(a), I hereby revoke DEA Certificate 

of Registration No. BC3579969 issued to 

Michael W. Carlton, M.D. This Order is 

effective March 22, 2021. 

D. Christopher Evans, 

Acting Administrator. 

[FR Doc. 2021–03359 Filed 2–18–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–788] 

Bulk Manufacturer of Controlled 

Substances Application: Patheon API 

Manufacturing, Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Patheon API Manufacturing, 

Inc., has applied to be registered as a 

bulk manufacturer of basic class(es) of 

controlled substance(s). Refer to 

Supplemental Information listed below 

for further drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration on 

or before April 20, 2021. Such persons 

may also file a written request for a 

hearing on the application on or before 

April 20, 2021. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on November 12, 2020, 

Patheon API Manufacturing, Inc., 309 

Delaware Street, Greenville, South 

Carolina 29605, applied to be registered 

as an bulk manufacturer of the following 

basic class(es) of controlled 

substance(s): 

Controlled substance Drug 

code Schedule 

Tetrahydrocannabinols ... 7370 I 

5-Methoxy-N-NDimethyltryptamine.7431 I 

Psilocybin ....................... 7437 I 

Oxymorphone ................. 9652 II 

The company plans to bulk 

manufacture the listed controlled 

substances as an Active Pharmaceutical 

Ingredient (API) for distribution to its 

customers. In reference to dug code 

7370 (Tetrahydrocannabinols), the 

company plans to bulk manufacture 

these drugs as synthetic. No other 

activities for these drug codes are 

authorized for this registration. 

William T. McDermott, 

Assistant Administrator. 

[FR Doc. 2021–03363 Filed 2–18–21; 8:45 am] 

BILLING CODE P 


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