33748 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

20There is also evidence on the record that at the 

time of the hearing that Respondent might not have 

been in compliance with his monitoring 

requirements due to his monitor’s illness and that 

he did not inform the state board or the Tennessee 

Medical Foundation of the lapse in monitoring. See 

supra n.14. I find that this lapse is mitigated by its 

circumstances, but that it is further evidence that 

Respondent has repeatedly demonstrated disregard 

for accountability measures. 

respondent for the protection of the 

public at large. Id. In this case, I agree 

with the Chief ALJ that ‘‘the absence of 

a sanction where a DEA registrant has 

been convicted of actually intentionally 

distributing crack cocaine would send a 

powerful message to the regulated 

community that even the most blatant 

intentional diversion will carry no 

consequences.’’ RD, at 40. 

In Respondent’s favor, Respondent 

has been held accountable for his 

criminal behavior—having been 

sentenced to prison and temporarily 

losing his medical license. He has met 

the requirements for rehabilitation and 

for obtaining a conditional medical 

license. However, based on the facts of 

this case, I find it difficult to find that 

this accountability will have a deterrent 

effect on the potential for Respondent’s 

relapse, because he has faced serious 

consequences many times in his life— 

losing his wife and family, getting 

expelled from medical school, losing his 

job, getting arrested, going to jail, etc.— 

and none of those things seemed to 

deter him from repeating his behavior 

until now. 

Although Respondent testified 

extensively about the accountability to 

which he is held pursuant to his 

agreement with the Tennessee Medical 

Foundation, and many of his character 

witnesses testified about how much that 

accountability comforted them, I cannot 

find that accountability necessarily to be 

a sufficient deterrent from abuse of his 

controlled substances registration due to 

his history of repeatedly ignoring 

accountability measures,20 even at the 

risk of incarceration. Therefore, in spite 

of his commendable sobriety thus far, I 

have reason to doubt his claim that he 

would always be a compliant registrant. 

See George R. Smith, M.D., 78 FR 44972, 

44980 (2013). Particularly, I remain 

concerned that if he relapsed, which the 

record has demonstrated previously 

occurred on several occasions, while 

entrusted with a controlled substances 

registration, he could harm himself and 

others too quickly for detection by this 

Agency or his monitoring. Ensuring that 

a registrant is trustworthy to comply 

with all relevant aspects of the CSA 

without constant oversight is crucial to 

the Agency’s ability to complete its 

mission of preventing diversion within 

such a large regulated population. 

Jeffrey Stein, M.D., 84 FR at 46974. 

As discussed above, to receive a 

registration when grounds for denial 

exist, a respondent must convince the 

Administrator that his acceptance of 

responsibility and remorse are 

sufficiently credible to demonstrate that 

the misconduct will not reoccur and 

that he can be entrusted with a 

registration. Having reviewed the record 

in its entirety, I find that Respondent 

has not met this burden. Accordingly, I 

will order the denial of Respondent’s 

application for a certificate of 

registration. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

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

823(f), I hereby deny the pending 

application for a Certificate of 

Registration, Control Number 

W18124612C, submitted by Robert 

Wayne Locklear, M.D., as well as any 

other pending application of Robert 

Wayne Locklear, M.D. for additional 

registration in Tennessee. This Order is 

effective July 26, 2021. 

D. Christopher Evans, 

Acting Administrator. 

[FR Doc. 2021–13525 Filed 6–24–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 18–50] 

Carol Hippenmeyer, M.D.; Decision and 

Order 

On August 20, 2018, a former Acting 

Assistant Administrator, Diversion 

Control Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause (hereinafter, OSC) to Carol 

Hippenmeyer, M.D. (hereinafter, 

Respondent). Administrative Law Judge 

Exhibit (hereinafter, ALJX) 1 (OSC), at 1. 

The OSC proposed the revocation of 

Respondent’s DEA Certificates of 

Registration BH3877733, FH2922119, 

FH2922121, FH2922133, FH2922157, 

and FH2922169, on the ground that her 

‘‘continued registrations are 

inconsistent with the public interest.’’ 

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

824(a)(4)). 

I. Procedural History 

The OSC alleged that Respondent 

‘‘violated Federal and Arizona state law 

by issuing controlled substance 

prescriptions outside the usual course of 

professional practice and for other than 

a legitimate medical purpose’’ to three 

patients between February 3, 2017, and 

December 6, 2017. Id. at 3–5 (citing 

violations of 21 U.S.C. 841(a)(1), 21 CFR 

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

§ 32–1401(27)). The OSC alleged that 

Respondent issued these prescriptions 

‘‘without performing an adequate 

physical exam, without taking a 

sufficient patient history, without 

determining the frequency and intensity 

of the patient’s pain, without arriving at 

a legitimate diagnosis, and without 

maintaining adequate medical records.’’ 

Id. at 5. The OSC also alleged that 

Respondent issued these prescriptions 

‘‘despite the fact that all three of these 

individuals had manifested one or more 

‘red flags’ for abuse and/or diversion.’’ 

Id. at 5. The OSC stated that by issuing 

these prescriptions, Respondent 

committed ‘‘numerous acts of unlawful 

prescribing, any one of which could 

independently establish the sort of 

intentional diversion . . . that would 

justify the revocation of [her] DEA 

registrations.’’ Id. at 6. 

The OSC notified Respondent of her 

right to request a hearing on the 

allegations or to submit a written 

statement while waiving her right to a 

hearing, the procedures for electing each 

option, and the consequences for failing 

to elect either option. Id. at 6 (citing 21 

CFR 1301.43). Applicant timely 

requested a hearing by letter dated 

September 19, 2018. ALJX 3 (Order for 

Prehearing Statements), at 1 

(interpreting ALJX 2 (Request for 

Hearing)). 

The matter was placed on the docket 

of the Office of Administrative Law 

Judges and assigned to Administrative 

Law Judge Charles Wm. Dorman 

(hereinafter, the ALJ). On September 25, 

2018, the ALJ established a schedule for 

the filing of prehearing statements. 

Order for Prehearing Statements, at 1. 

The Government filed its Prehearing 

Statement on October 5, 2018, and its 

Supplemental Prehearing Statement on 

October 30, 2018. ALJX 4 (Government’s 

Prehearing Statement) and 7 

(Government’s Supplemental Prehearing 

Statement), respectively. Respondent 

filed her Prehearing Statement on 

October 19, 2018, and her Supplemental 

Prehearing Statement on October 30, 

2018. ALJX 5 (Respondent’s Prehearing 

Statement) and 8 (Respondent’s 

Supplemental Prehearing Statement), 

respectively. 

On October 23, 2018, the ALJ issued 

a Prehearing Ruling that, among other 

things, set out the thirteen stipulations 

already agreed upon and established 

schedules for the filing of additional 

joint stipulations and supplemental 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33749 

1The parties subsequently agreed to two 

additional stipulations concerning the Respondent’s 

registered addresses. The fifteen final stipulations 

are set out on pages 26 and 27 of the ALJ’s 

Recommended Rulings, Findings of Fact, 

Conclusions of Law, and Decision, and I hereby 

incorporate them in this Decision. 

2 I have reviewed and agree with the procedural 

rulings of the ALJ during the administration of the 

hearing, including his decision to grant 

Respondent’s unopposed request for a three-week 

extension to file Posthearing Briefs. See ALJX 20 

(Order Granting Respondent’s Motion for Extension 

of Time and Order Scheduling Telephonic 

Conference); see also ALJX 12 (Order Granting 

Respondent’s Motion for Leave to File Affidavit Out 

of Time and Order to Government); ALJX 13 

(Amended Notice of Hearing); ALJX 14 (Letter 

Enclosing Subpoenas); ALJX 16 (Joint Stipulated 

Protective Order); ALJX 17 (Order Amending PostHearing Briefing Schedule); ALJX 20 (Order 

Granting Respondent’s Motion for Extension of 

Time and Order Scheduling Telephonic 

Conference); ALJX 21 (Order Correcting the 

Transcript). 

3The parties stipulated that the registered address 

for BH3877733 is 1800 East Florence Blvd., Casa 

Grande, AZ 85123. See RD, at 26 (Stipulation No. 

1); see also Government Exhibit (hereinafter, GX) 1, 

at 5. However, Agency Records list the registered 

address as 6530 N. Calle Lottie, Tucson, AZ 85718– 

190. 

4Respondent’s registration was ‘‘automatically [ ] 

extended’’ when she submitted a renewal 

application 45 days before her registration was due 

to expire. 21 CFR 1301.36(i). 

5The parties stipulated that each of Respondent’s 

DEA registrations authorized her to handle 

controlled substances in Schedules II through V. 

RD, at 26 (Stipulation No. 1). However, according 

to Agency Records and Government Exhibit 1, 

registration numbers FH2922169, FH2922157, 

FH2922133, FH2922121, FH2922119, and 

BH3877733 do not include Schedule V authority. 

See GX 1, at 1–4, 6. The parties stipulated that the 

registered addresses for these registrations were 

5301 E. Grant Road, Tucson, AZ 85712–2874 

(registration number FH2922157); 333 Camino 

Josephina, Rio Rico, AZ 85648 (registration number 

FH2922133); 901 Rex Allen Drive, Willcox, AZ 

85643 (registration number FH2922121); 2023 W. 

Relation Street, Safford, Arizona 85546 (registration 

number FH2922119). See RD, at 26 (Stipulation 

Nos. 1–3). The parties stipulated that the registered 

address for FH2922169 was 185 S. Mulberry Street, 

Florence, Arizona, 85132. However, Agency 

Records list the registered address as 4545 N Hunt 

Highway, Florence, AZ 85132. 

6See GX 4, at 8 (confirming that she does not 

have ‘‘a medical file for [M.D.] at [her] home’’); id. 

at 8 (confirming that she does not keep medical 

records for the people she treats at home); id. at 13 

(confirming that she did not ‘‘have a medical file 

at all’’ for Patient M.D.); id. at 13 (confirming that 

‘‘there’s no medical record’’ for M.D. ‘‘that shows 

. . . like the diagnostic exam . . . and all that’’); 

id. at 15–16 (confirming that ‘‘there[’s] no record of, 

like . . . current medical record or, um, like vital 

signs taken or . . . any of that’’ for M.D. or H.D.); 

see also Tr. 32 (Respondent’s trial testimony 

confirming that she told Investigators during the 

Interview that she did not have medical records for 

H.D. and M.D.). 

prehearing statements.1 ALJX 6 

(Prehearing Ruling) at 1–2. 

The hearing in this matter spanned 

three days and took place in Tucson, 

Arizona. See generally Transcript of 

Proceedings in the Matter of Carol 

Hippenmeyer, M.D. (hereinafter, Tr.). 

Both parties filed posthearing 

briefs.2 See ALJX 23 (Government’s 

Proposed Findings of Fact, Conclusions 

of Law, and Argument (hereinafter, Govt 

Posthearing)), and ALJX 22 

(Respondent’s Proposed Findings of 

Fact and Conclusions of Law 

(hereinafter, Resp Posthearing)). Then, 

on March 29, 2019, 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 

two hundred and nine prescriptions 

beneath the applicable standard of care 

in Arizona and outside of the usual 

course of the professional practice, in 

violation of federal and state law. I 

disagree with the RD’s recommended 

sanction of a three-month suspension 

followed by registration restrictions. RD, 

at 127–28. Rather, I find that revocation 

is the appropriate sanction. 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 

practitioner in Schedules II through V 

under DEA registration number 

BH3877733, at 6530 N Calle Lottie, 

Tucson, AZ 85718–190.3 This 

registration was set to expire on October 

31, 2020, but Agency Records show that 

Respondent submitted a renewal 

application on September 16, 2020.4

Respondent was previously registered 

with the DEA as a practitioner in 

Schedules II through IV under DEA 

registration numbers FH2922169, 

FH2922157, FH2922133, FH2922121, 

and FH2922119. 5 According to Agency 

Records, registration number 

FH2922169 expired on October 31, 

2020, and Respondent did not submit a 

renewal application. The remaining 

three DEA registrations—FH2922157, 

FH2922133, FH2922121, and 

FH2922119—were retired on July 22, 

2020. 

B. The Investigation 

DEA’s investigation of Respondent 

began in approximately December 2017, 

when a detective from the Pima County 

Sheriff’s Department received an 

anonymous complaint that Respondent 

was ‘‘prescribing controlled substances 

without a legitimate purpose or outside 

the scope of her practice.’’ Tr. 66–67. 

The Diversion Investigator assigned to 

this matter (hereinafter, DI) and the 

detective (hereinafter, Investigators) 

interviewed Respondent on December 

19, 2017, at DEA’s office in Tucson, 

Arizona (hereinafter, 2017 Interview). 

Id. at 32, 68–69; Government Exhibit 

(hereinafter, GX) 3 (Audio recording of 

the Interview); GX 4 (Transcript of the 

Interview). 

During the Interview, Investigators 

asked Respondent about prescriptions 

that she had issued to M.D., a former 

intimate partner who had lived with 

Respondent until about eight months 

before. GX 4, at 2–8, 12–13, 17–20. 

Investigators asked Respondent whether 

M.D. was a ‘‘patient at [Respondent’s] 

practice’’ or ‘‘kind of an on the side 

thing,’’ and Respondent said she 

‘‘would call it more on the side.’’ Id. at 

5. Respondent told Investigators that 

M.D. had many problems, including 

alcohol problems, endometriosis, gastric 

issues, anxiety, and a shoulder issue. Id. 

Respondent said that she had treated 

M.D., but ‘‘[o]nly in an effort to get her 

treatment,’’ and ‘‘not for alcohol related 

stuff.’’ Id. 

Investigators asked Respondent how 

many patients she treated out of her 

home. Although she offered various 

estimates during the Interview—ranging 

from ‘‘[m]aybe a dozen [patients], if 

that,’’ to probably less than five— 

Respondent eventually confirmed that 

she only treated M.D. and one other 

individual, H.D., from her home. Id. at 

8, 14–15, 28, 30. Investigators asked 

Respondent whether the people that she 

was ‘‘treating out of [her] home’’ were 

‘‘patients of [her] practice location,’’ and 

Respondent said they were ‘‘[m]ore 

friends.’’ Id. at 11. 

Investigators questioned Respondent 

about a prescription that Respondent 

had received from S.P., a neurosurgery 

nurse practitioner. GX 4, at 33–34. 

Respondent did not recall having 

received the prescription. Id. Although 

S.P. was discussed at the Interview, 

Respondent did not tell Investigators 

that she had prescribed controlled 

substances to S.P. Tr. 77–79. 

Investigators asked Respondent 

several times whether she maintained 

medical records for M.D., H.D., or the 

other patients that she treated at home. 

Each time, Respondent confirmed that 

she did not.6 However, approximately 6 

months after the Interview, Respondent 

produced medical records for H.D., 

M.D., and S.P. in response to a DEA 

subpoena dated July 26, 2018. GX 6 

(M.D. medical record), GX 7 (H.D. 

medical record), GX 8 (S.P. medical 

record), GX 10 (subpoena). Respondent 

sent Investigators a letter dated August 


lotter on DSK11XQN23PROD with NOTICES1
33750 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

7The Arizona PMP is a ‘‘program administered by 

the State of Arizona Board of Pharmacy that collects 

the data from pharmacies for all controlled 

substance prescriptions filled at pharmacies in 

Arizona.’’ Tr. 95. 

8 I agree with the ALJ that DI was not qualified 

to opine on the requirements of a valid doctorpatient relationship in Arizona. RD, at 9 

(referencing Tr. 87, 90, 130–31, 134). Therefore, to 

the extent that the record contains testimony by DI 

that could be construed as opinion testimony, I will 

not consider that testimony in my standard of care 

analysis. 

1, 2018, explaining the contents of the 

medical records. GX 9. The letter 

explained that each record has ‘‘a brief 

introduction and discussion of care’’ 

and a narcotic log ‘‘reflect[ing] the 

trends and management of these 

patients.’’ Id. Respondent generated 

these documents after being interviewed 

by DEA based on her ‘‘recall of 

encounters with patients.’’ Id. The letter 

explained that the medical records also 

include ‘‘pathological, surgical and 

laboratory data [that] was reviewed at 

the time it was generated.’’ Id. 

Investigators attempted to interview 

H.D., M.D., and S.P. during the 

investigation. Tr. 74. They opted not to 

be interviewed, but they wrote letters 

about Respondent’s treatment of them, 

which were provided to DEA. Tr. 74–75, 

94; GX 12. The letters emphasized that 

Respondent treated them for legitimate 

medical conditions and they did not 

abuse the medication that she 

prescribed. GX 12. 

DEA also received a letter from 

Respondent’s attorney on August 22, 

2018, aimed at ‘‘correct[ing] the 

apparent misperceptions about 

[Respondent’s] medical practice which 

have developed from her initial 

interview by the DEA.’’ GX 13, at 1. 

Among other things, the letter stated 

that Respondent’s ‘‘standard practice 

has always been to prioritize patient 

care and safety’’ and emphasized that 

Respondent established valid doctorpatient relationships with H.D., M.D., 

and S.P. and treated them for legitimate 

medical conditions. Id. at 1–5. 

C. The Government’s Case 

The Government’s documentary 

evidence consisted primarily of patient 

files, prescription records, and data 

from the Arizona Controlled Substance 

Prescription Monitoring Program 

(hereinafter, Arizona PMP) 7 for H.D., 

M.D., and S.P., the three individuals 

who received controlled substances 

prescriptions from Respondent between 

January 2013 and December 2017. See 

GX 5–8, 18. The Government’s evidence 

also included Arizona opioid 

prescribing guidelines; an audio 

recording and transcript of 

Respondent’s 2017 Interview with 

Investigators; a subpoena requesting 

medical records; and letters submitted 

by H.D., M.D., S.P., and Respondent’s 

attorney. See GX 3–4, 9, 10, 12, 14–16. 

Finally, the Government’s evidence 

included copies of Respondent’s DEA 

Certificates of Registration and a 

Curriculum Vitae for the Government’s 

expert witness. See GX 1–2. The 

Government called three witnesses to 

testify at the hearing: Respondent 

(whose testimony is summarized in the 

Respondent’s case, see infra II.D), DI, 

and the Government’s expert, Dr. Lynch. 

DI testified about her investigationrelated actions, including her role in 

interviewing Respondent and obtaining 

evidence. Tr. 64–163; see also RD, at 

8–9. Having read and analyzed all of the 

record evidence, I agree with the RD 

that DI testified in a ‘‘professional, 

candid, and straightforward manner’’ 

and that her testimony was ‘‘sufficiently 

objective, detailed, plausible, and 

internally consistent.’’ RD, at 9. 

Although the ALJ concluded that DI 

‘‘was an unnecessary witness,’’ ‘‘other 

than identifying documents,’’ I credit 

DI’s testimony about the Agency’s 

investigation and about aspects of the 

December 2017 Interview that were not 

captured in the audio recording or 

transcript.8 Id. 

Dr. Lynch testified about his 

professional and educational 

background. Tr. 166–69; see also RD, at 

10; GX 2 (Curriculum Vitae of Dr. 

Lynch). After completing medical 

school, he completed an internship in 

surgery and anesthesiology at New York 

University and a fellowship in pain 

management at Texas Tech Health 

Sciences Center. Tr. 167; GX 2, at 10. He 

has been board certified in 

anesthesiology for twelve years and in 

pain management for eleven years. Tr. 

168–69. He is licensed to practice 

medicine in Arizona, Nevada, 

California, Oregon, Colorado, Texas, and 

Florida, and he has treated patients for 

pain since he became a physician in 

2002. Id. at 167, 169. Dr. Lynch is the 

Chief Medical Officer at Pain Doctor, 

Inc., a pain management practice in 

Scottsdale, Arizona. Id. at 166–67. For 

the last ten years, he owned a practice 

called Arizona Pain Specialists, which 

has pain clinics throughout Arizona and 

provides consulting services. Id. at 166. 

Dr. Lynch has managed pain 

management practices in about 15 

states. Tr. 167. He has also served as an 

assistant professor of anesthesiology and 

pain management at the Mayo Clinic. Id. 

Dr. Lynch is a member of the American 

Society of Interventional Pain 

Physicians, the American Society of 

Anesthesiology, and the Spinal Injection 

Society. Id. at 334–35. 

Dr. Lynch was qualified as an expert 

medical witness in Arizona, with an 

emphasis in pain management. Id. at 

171. Respondent’s counsel did not 

object to Dr. Lynch being recognized as 

an expert. Id. Dr. Lynch’s 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. See 

infra II.E, II.F; Tr. 171–383; RD, at 

10–17, 27–42. 

With regard to credibility, the ALJ 

found that ‘‘[a]lthough Dr. Lynch’s 

education, training, and work 

experience qualify him as an expert,’’ he 

did not find all of Dr. Lynch’s testimony 

to be ‘‘straightforward and internally 

consistent.’’ RD, at 13. The ALJ 

identified five portions of Dr. Lynch’s 

testimony that he believed were 

‘‘confusing or inconsistent.’’ RD, at 

13–14. First, the ALJ found that Dr. 

Lynch’s testimony that a physician must 

document a patient’s treatment in order 

to establish a valid doctor-patient 

relationship was based on Dr. Lynch’s 

‘‘inference,’’ not the standard of care. 

RD, at 14 (referencing Tr. 232, 354, 379, 

381). The ALJ determined that ‘‘as far as 

[he could] tell from Dr. Lynch’s 

testimony, neither the Arizona medical 

community nor Arizona authorities 

have reached a settled definition of a 

doctor/patient relationship.’’ Id. (citing 

Tr. 233–35). Therefore, the ALJ 

concluded that ‘‘the Government has 

not proved that to establish a legitimate 

doctor/patient relationship in Arizona, a 

doctor must have medical 

documentation of the treatment 

provided to the patient.’’ Id. As 

discussed below, see infra II.E.1, I find 

that Dr. Lynch’s testimony about the 

requirements for establishing a valid 

doctor-patient relationship is consistent 

with the Arizona standard of care and 

is supported by Arizona courts’ 

interpretation of Arizona state law. 

Therefore, I do not find that Dr. Lynch’s 

testimony on this issue detracted from 

his credibility as a witness. 

Second, the ALJ found that ‘‘Dr. 

Lynch had a difficult time explaining 

the terminology of substance use, 

substance abuse, substance misuse, and 

alcoholism.’’ RD, at 14. The ALJ 

identified several instances where he 

felt that Dr. Lynch’s testimony was 

inconsistent or confusing. For example, 

Dr. Lynch testified that ‘‘substance use 

disorder’’ and ‘‘substance abuse 

disorder’’ are ‘‘pretty much the same 

thing,’’ and then he proceeded to offer 

distinct definitions of ‘‘use’’ and 

‘‘abuse.’’ Tr. 257–59; RD, at 14–15. The 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33751 

9 Dr. Lynch testified that the Arizona DHS says it 

is an absolute contraindication to give controlled 

substances to a patient with an active substance 

abuse issue. Tr. 181. The RD finds that Dr. Lynch’s 

testimony ‘‘slightly mischaracterizes the Arizona 

Health Department’s guidance on this issue,’’ 

because it ‘‘ma[kes] it appear that the Arizona 

Health Department has issued a blanket prohibition 

against prescribing any controlled substance to any 

patient with active substance abuse problems 

regardless of whether the patient is receiving 

treatment.’’ RD, at 15 (citing Tr. 181, 261, 307). The 

RD finds that ‘‘[t]he Arizona Health Department’s 

recommendation is narrower than portrayed by Dr. 

Lynch’’ because it states that it is an absolute 

contraindication to prescribe chronic opioid 

therapy to an individual with a ‘‘[d]iagnosed 

substance use disorder (SUD) not in remission and/ 

or active treatment.’’ RD, at 15 (citing GX 16, at 12). 

I agree with the RD’s interpretation of Dr. Lynch’s 

testimony. 

10 Dr. Lynch testified that the Arizona Medical 

Board has not issued guidance on prescribing to 

patients with active substance abuse problems. Tr. 

181. This is incorrect. The Arizona Medical Board 

Guidelines provide that ‘‘[p]atients who have an 

active substance use disorder should not receive 

opioid therapy until they are established in a 

treatment/recovery program or alternatives are 

established such as co-management with an 

addiction professional.’’ GX 14, at 7. 

ALJ also found that Dr. Lynch’s 

characterizations of different abuse 

patterns were confusing; for example, 

that a binge drinker is not necessarily an 

alcoholic, that a patient who abuses a 

drug does not necessarily have a 

substance use disorder, and that there 

are different definitions of an alcoholic. 

RD, at 15 (citing Tr. 306, 329–30). The 

ALJ also found that Dr. Lynch misstated 

the Arizona Department of Health 

Services’ (hereinafter, Arizona DHS) and 

the Arizona Medical Board’s positions 

on prescribing opioids to individuals 

with substance abuse disorders. RD, at 

15–16. Finally, the ALJ noted that Dr. 

Lynch is not an addiction psychiatrist. 

RD, at 10 (citing Tr. 329–30). 

I agree with the ALJ that Dr. Lynch 

over-stated the Arizona DHS’s 9 and the 

Arizona Medial Board’s 10 guidance on 

prescribing to individuals with 

substance use disorders. Therefore, to 

the extent that Dr. Lynch’s testimony 

conflicts with the guidelines, I will 

reference the guidelines directly and 

disregard Dr. Lynch’s testimony about 

them. But aside from Dr. Lynch’s 

testimony on the guidelines, I found his 

testimony about substance abuse 

disorders to be helpful, internally 

consistent, credible, and supported by 

other record evidence. For example, Dr. 

Lynch’s testimony that M.D. ‘‘has a clear 

history of alcoholism, [and] potentially 

other substance abuse disorders as well’’ 

was supported by Respondent’s 

statements to Investigators in 2017 that 

Respondent had ‘‘tried to get M.D. to go 

to rehab,’’ because she had an alcohol 

‘‘addiction.’’ Tr. 198 (Dr. Lynch’s 

testimony); GX 4, at 5, 7, 21 

(Respondent’s statements to 

Investigators); see also Tr. 293, 306–07, 

327–32, 357. Although the ALJ found 

that Dr. Lynch’s characterization of 

various abuse patterns was confusing, 

Dr. Lynch explained that the language 

in addiction medicine is nuanced. Tr. 

258–59. Therefore, I have no reason to 

discredit that testimony. 

I also decline to discredit Dr. Lynch’s 

views on substance abuse issues simply 

because he is not an addiction 

specialist. Tr. 329–30. Dr. Lynch was 

qualified as ‘‘an expert medical witness 

in the State of Arizona, with an 

emphasis in Pain Management,’’ see id. 

at 171, and pain management 

physicians must be vigilant about 

monitoring for substance abuse 

disorders. The Arizona DHS Guidelines 

provide that ‘‘before initiating opioid 

treatment,’’ a physician should conduct 

‘‘a comprehensive medical and pain 

related evaluation that includes 

assessing for substance use’’ and the 

physician should ‘‘assess for risk of 

misuse, addiction, or adverse effects.’’ 

GX 16, at 8. Similarly, the Arizona 

Medical Board Guidelines provide that 

an ‘‘initial evaluation’’ should include 

‘‘[a]ssessment of the patient’s personal 

and family history of alcohol or drug 

abuse.’’ GX 14, at 7. Additionally, Dr. 

Lynch testified that he has studied 

alcoholism. Tr. 332. 

Third, the ALJ found that Dr. Lynch’s 

testimony that it was ‘‘below the 

standard of care’’ to ‘‘prescrib[e] opioids 

to someone with whom the prescriber 

has a personal relationship over a long 

period of time’’ conflicted with ‘‘the 

bulk of Dr. Lynch’s testimony’’ that 

prescribing to friends and family 

members was an ethical issue, not a 

standard of care issue. RD, at 16 

(comparing Tr. 355 with Tr. 185–86, 

204, 285, 351–53). I agree with the ALJ’s 

assessment of Dr. Lynch’s testimony. 

Therefore, I do not give any weight in 

my public interest analysis to Dr. 

Lynch’s testimony that long-term 

prescribing to someone with whom you 

are in a close personal relationship is a 

violation of the standard of care. 

Fourth, the ALJ disagreed with Dr. 

Lynch’s testimony during cross 

examination about whether Respondent 

was prescribing low or moderate-dose 

therapy. See RD, at 16–17. I find that 

this testimony is irrelevant to Dr. 

Lynch’s overall opinions because Dr. 

Lynch testified that he does not believe 

that Respondent prescribed narcotics in 

excessive quantities, Tr. 254, and he 

agreed that the low doses of controlled 

substances that Respondent prescribed 

to M.D. were a mitigating factor. Id. at 

294. I do not find that this testimony 

detracts from Dr. Lynch’s credibility as 

a witness. 

Fifth, the ALJ found that Dr. Lynch’s 

testimony that it was a violation of the 

standard of care in Arizona to prescribe 

opioids and benzodiazepines 

concurrently conflicted with his later 

testimony that ‘‘it’s hard to say it’s 

below the standard of care’’ because it 

‘‘still continues to happen.’’ RD, at 17 

(comparing Tr. 275 with Tr. 371). The 

ALJ found that this inconsistency 

‘‘undermine[d] Dr. Lynch’s credibility 

on the issue of co-prescribing.’’ Id. I 

agree with the ALJ that this testimony 

was inconsistent, but I do not find that 

this inconsistency detracted from Dr. 

Lynch’s credibility on co-prescribing 

because he later clarified. Tr. 370–71; 

see also id. at 244–45 (agreeing that the 

Arizona DHS Guidelines do not ban coprescribing, they just ‘‘strongly 

recommend[] that docs not do it’’). 

Additionally, I found that Dr. Lynch’s 

testimony on the standard of care for coprescribing benzodiazepines was 

consistent with other record evidence, 

including guidelines from the Arizona 

DHS, the Arizona Medical Board, and 

the Centers for Disease Control and 

Prevention (hereinafter, CDC). See infra 

II.E.4. 

The ALJ concluded that ‘‘[d]espite 

these concerns, in general [he] found Dr. 

Lynch to be a highly qualified expert in 

the area of pain management who 

testified in a professional, candid, and 

objective manner.’’ RD, at 17. The ALJ 

also concluded that Dr. Lynch’s 

testimony was ‘‘detailed, plausible, and, 

with a few exceptions, internally 

consistent.’’ Id. Finally, the ALJ noted 

that Dr. Lynch’s testimony was 

unrebutted. Id. Therefore, the ALJ 

concluded that he would ‘‘merit most of 

Dr. Lynch’s testimony as credible in this 

Recommended Decision.’’ Having read 

and analyzed all of the record evidence, 

I agree with the ALJ’s conclusions 

regarding credibility and I merit Dr. 

Lynch’s testimony as credible in this 

Decision. 

D. Respondent’s Case 

Respondent’s documentary evidence 

consisted of Curriculum Vitae for 

Respondent, H.D., M.D., and S.P.; 

Arizona PMP data for M.D. and S.P.; a 

prescription that Respondent obtained 

from S.P.; and an affidavit of John M. 

Reid, the Medical Director at Carondolet 

Holy Cross Hospital, where Respondent 

worked since 2014. See Respondent’s 

Exhibits (hereinafter, RX) 1–5, 8, 11, 13. 

Respondent testified and called three 

witnesses: H.D., M.D., and S.P. 

H.D. testified about his background as 

an internal medicine and emergency 

room physician. Tr. 385–86. Although 

H.D. is a doctor, he was not offered as 

a medical expert. Id. at 387. H.D. 


lotter on DSK11XQN23PROD with NOTICES1
33752 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

11For example, H.D. testified that he did not have 

any concerns about the medical examination that 

Respondent performed or the medical history that 

she took. Tr. 396. He also testified that he felt that 

he had established a valid doctor-patient 

relationship with Respondent. Id. at 419. Finally, he 

testified that he did not feel that Respondent had 

harmed him or put his life at risk with her 

treatment. Id. at 419–20. H.D.’s concerns and 

feelings about Respondent’s prescribing do not have 

any bearing on whether Respondent’s prescribing 

was consistent with the applicable standard of care 

in Arizona. Additionally, even if H.D.’s lay 

opinions had been couched in terms of the standard 

of care, they would not be given any weight where 

they conflict with Dr. Lynch’s expert testimony. See 

Zvi H. Perper, M.D., 77 FR 64131, 64140 (2012) 

(citing Ross v. Gardner, 365 F.2d 554 (6th Cir. 

1966)) (‘‘When an administrative tribunal elects to 

disregard the uncontradicted opinion of an expert, 

it runs the risk of improperly declaring itself as an 

interpreter of medical knowledge.’’); Cf. Jacobo 

Dreszer, M.D., 76 FR 19,386 (2011) (finding that 

respondent’s counsel’s posthearing argument that 

respondent’s medical records were ‘‘satisfactory’’ 

constituted a ‘‘lay evaluation of standards 

applicable to the nuanced and sophisticated science 

that is the practice of medicine,’’ and it could not 

‘‘supplant the unrefuted view of an accepted expert 

witness’’). 

12S.P. initially testified that she did not 

remember which documents she gave to 

Respondent in 2018. Tr. 605–06. S.P. then testified 

that she provided Respondent with ‘‘everything that 

[she] had of [Respondent’s] care of her’’ in 2018. Id. 

at 611–12. S.P. later testified that she gave 

Respondent copies of the records that she ‘‘had 

immediately available’’ in 2018. Id. at 612. Finally, 

S.P. testified that she is unsure whether she has 

more records related to Respondent’s care of her 

that she did not provide. Id. 

13 In addition to the two minor concerns 

identified by the ALJ, I found that S.P.’s frequent 

use of the word ‘‘extensively’’ when discussing the 

conversations that she had with Respondent about 

her treatment made her testimony seem less neutral. 

See, e.g., Tr. 543 (testifying that she and 

Respondent ‘‘discussed side effects extensively’’ 

and Respondent ‘‘talked to her extensively about 

other options’’); see also id. at 547–48, 561, 573– 

74. I also found that S.P.’s testimony that that she 

‘‘always saw [Respondent] writing’’ when they met 

was not supported by other record evidence, which 

showed that Respondent did not maintain 

contemporaneous medical records for S.P. Tr. 599. 

testified about his friendship with 

Respondent, id. at 389; his first 

encounter with Respondent near the 

end of 2012, including the examination 

that she performed on him, id. at 390– 

94, 424–428, 440–43; and offered lay 

opinions about the quality of care that 

Respondent provided, id. at 393, 396, 

419–20. See also RD, at 18–19, 42–49. 

The ALJ concluded that H.D. ‘‘presented 

his testimony in a professional, candid, 

and straightforward manner.’’ RD, at 19. 

The ALJ noted that ‘‘[a]lthough H.D.’s 

answers seemed vague and general 

when responding to some questions, 

especially questions about the physical 

examinations [Respondent] performed, 

he provided more detail when pressed 

by counsel, and overall his testimony 

was sufficiently objective, plausible, 

and internally consistent.’’ Id. 

Therefore, the ALJ concluded that H.D.’s 

testimony was credible. Id. 

Having read and analyzed all of the 

record evidence, I agree with the ALJ’s 

conclusions about H.D.’s testimony. 

However, I find that H.D.’s testimony 

has limited probative value because it 

was based on his memory of 

examinations and encounters that 

happened many years before, and his 

testimony was often vague. I also find 

that his testimony has limited probative 

value because he has a strong incentive 

to provide testimony that supports that 

Respondent’s prescribing to him was 

lawful and legitimate. This is especially 

true because he is a medical 

professional operating in a regulated 

profession. Additionally, H.D.’s lay 

opinions about the quality of care that 

Respondent provided him were not 

grounded in the Arizona standard of 

care.11 Dr. Lynch observed H.D.’s 

testimony and testified that it did not 

change any of his opinions about 

Respondent’s compliance with the 

standard of care. Tr. 739. Thus, I give 

H.D.’s testimony limited weight in this 

Decision. 

M.D. testified about her background 

as an emergency room nurse, her 

intimate relationship with Respondent, 

her patient encounters with 

Respondent, and her discussions with 

Respondent about her medical 

conditions and alcohol problems. Id. at 

446–527; see also RD, at 19–21, 49–57. 

M.D. also testified that she accepted a 

loan from Respondent in order to pay 

for her own attorney in connection with 

this proceeding. Tr. 487. 

Regarding M.D.’s credibility, the ALJ 

concluded that ‘‘M.D.’s testimony about 

physical examinations seemed vague 

and general, but she provided more 

detail when pressed by counsel.’’ RD, at 

21. The ALJ found it ‘‘noteworthy, 

however, that M.D. was unable to recall 

certain information, such as when she 

testified that she could not recall 

whether [Respondent] ever asked her for 

medical records from past providers, 

and that she did not pay attention to 

whether [Respondent] took notes during 

her examinations.’’ Id. (citing Tr. 468, 

488, 489–93, 502). The ALJ found that 

‘‘[t]hose answers did not seem entirely 

forthcoming’’ and ‘‘they detract slightly 

from M.D.’s credibility.’’ Id. The ALJ did 

not believe that the loan that M.D. 

received ‘‘discredit[ed] her testimony 

because there [was] no evidence before 

[him] that receiving the loan was 

contingent on her testifying in a certain 

way.’’ Id. at 21. Overall, the ALJ found 

that M.D.’s testimony was ‘‘objective, 

plausible, and internally consistent, and 

she presented her testimony in a 

professional, straightforward, and 

candid manner in all other respects.’’ Id. 

Therefore, he merited M.D.’s testimony 

as credible. 

Having read and analyzed all of the 

record evidence, I agree with the ALJ’s 

conclusions about M.D.’s testimony. 

However, I find that M.D.’s testimony 

has limited probative value for the same 

reasons discussed with H.D. Dr. Lynch 

observed M.D.’s testimony and testified 

that it did not change any of his 

opinions about Respondent’s 

compliance with the standard of care. 

Tr. 738. Thus, I give M.D.’s testimony 

limited weight in this Decision. 

S.P. testified that she is a full-time 

neurosurgery nurse practitioner at 

Banner University Medical Center. Id. at 

529. S.P. testified about her intimate 

relationship with Respondent and about 

the medical treatment that they 

provided to each other. Id. at 531–612; 

see also RD, at 21–24, 57–62. S.P. also 

testified about medical records that she 

provided to Respondent in 2018 and 

throughout the course of Respondent’s 

treatment of her. Tr. 604–06, 609–11. 

The ALJ identified two minor 

concerns with S.P.’s testimony. RD, at 

23–24. First, the ALJ was confused by 

S.P.’s testimony about the medical 

records that she provided to Respondent 

in 2018, after DEA had begun its 

investigation.12 Id. Second, the ALJ 

found that S.P. became defensive when 

she was questioned about controlled 

substances that she received from 

providers other than Respondent. RD, at 

23. When Respondent’s counsel asked 

S.P. if she could recall ‘‘off the top of 

[her] head’’ which providers on her 

PMP were delegates of her primary care 

physician, S.P. replied that it would be 

‘‘completely inaccurate in every way’’ to 

say that she has multiple doctors or is 

doctor shopping. Id. (citing Tr. 534–36). 

The ALJ found that this testimony came 

across as ‘‘advocacy rather than an 

objective, unbiased testimony,’’ because 

nobody had accused S.P. of doctor 

shopping. Id. at 24. However, ‘‘[d]espite 

those minor issues,’’ the ALJ concluded 

that S.P. ‘‘presented her testimony in a 

professional and straightforward 

manner,’’ and that her testimony was 

‘‘sufficiently objective, plausible, and 

internally consistent.’’ Id. Therefore, the 

ALJ merited S.P.’s testimony as credible. 

Having read and analyzed all of the 

record evidence, I agree with the ALJ’s 

conclusions about S.P.’s testimony.13

However, I find that S.P.’s testimony has 

limited probative value for the same 

reasons discussed with H.D. and M.D. 

Dr. Lynch observed S.P.’s testimony and 

testified that it did not change any of his 

opinions about Respondent’s 

compliance with the standard of care. 

Tr. 739. Thus, I give M.D.’s testimony 

limited weight in this Decision. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33753 

14Based on a review of Respondent’s Prehearing 

Statement, I believe that Respondent intended to 

testify in greater detail about her treatment of S.P. 

than she did at the hearing. See Resp Prehearing, 

at 8–10. After Respondent testified extensively 

about her treatment of M.D., see Tr. 653–92, 

Respondent’s counsel began questioning 

Respondent about S.P. Id. at 692. However, this line 

of questioning was interrupted, and Respondent’s 

counsel shifted his questioning to H.D. Id. at 691– 

94. At that point, Respondent had offered very little 

testimony about her treatment of S.P., other than 

testifying about their personal relationship and the 

triazolam prescriptions that she issued to S.P. for 

shift work disorder. See Id. at 55–57, 629, 636, 643, 

646–47. While it is unfortunate that Respondent did 

not complete her testimony, I am confident that my 

conclusions about the legality of Respondent’s 

prescribing to S.P. would not be impacted by any 

additional testimony that Respondent might have 

provided. As found herein, Respondent committed 

numerous violations of the Arizona standard of care 

and Arizona state law in her treatment of S.P. and 

she did not maintain any medical records justifying 

her prescribing decisions. See infra II.F.3. 

Additionally, I find that revocation would be 

warranted based solely on the unlawful 

prescriptions that Respondent issued to M.D. and 

H.D. See infra II.F.1, II.F.2 (concluding that 

Respondent issued one hundred and eighty-five 

prescriptions to M.D. and H.D. outside the usual 

course of professional practice and beneath the 

standard of care in Arizona). The Government can 

meet its prima facie burden for revocation by 

proving ‘‘only a few instances of illegal 

prescribing.’’ Jayam Krishna-Iyer, M.D., 74 FR 459, 

464 (2009). 15The parties stipulated that ‘‘Halcion is a brand 

name for triazolam, a Schedule IV controlled 

substance.’’ RD, at 27 (Stipulation No. 11). 

16H.D. testified at the hearing that Respondent 

prescribed triazolam to him for shift work disorder. 

Tr. 398. However, the letter that H.D. prepared 

before the hearing did not mention shift work 

disorder as one of the conditions that Respondent 

treated. GX 7, at 2. It mentioned diabetes, 

hypertension, and chronic pain. Id. 

Respondent testified that she is 

currently employed as an independent 

contractor for an emergency department 

group, Sound Physicians. Id. at 30, 635. 

Respondent began practicing emergency 

medicine in 1998 and she currently 

practices internal medicine and 

emergency medicine. Id. Respondent 

testified about her education, training, 

and background, and the 2017 

Interview. Id. at 30–31, 58, 61, 622–36. 

Respondent testified about her 

relationships with M.D., H.D., and S.P. 

Id. at 47–51, 57, 629. Respondent was 

intimately involved with M.D. from 

approximately late 2012 or early 2013 

until approximately the end of 2015. Id. 

at 47–48. Respondent testified that they 

lived together from approximately 2014 

to 2016. Id. at 48. Respondent has 

known H.D. since 2008 or 2009. Id. at 

50. Respondent stated that they are 

friends, but they rarely socialize. Id. at 

51. Respondent testified that she and 

S.P. are currently friends, but they were 

intimately involved from approximately 

1998 to 2005. Id. at 57, 629. Respondent 

testified about her treatment of H.D., 

M.D., and S.P. See Id. at 636, 643–44, 

653–91, 709–14, 729 (M.D.); id. at 628– 

29, 636, 642–43, 646–47, 691–92, 694, 

696, 705–06, 718, 722 (S.P.); id. at 636, 

646–47, 695, 717–18 (H.D.); see also RD, 

at 24–26, 49–67. Respondent testified 

that she believes that she entered into a 

valid doctor-patient relationship with 

each individual. Id. at 639. Finally, 

Respondent testified about the contents 

of her medical records for M.D., H.D., 

and S.P. Id. at 33–54. 

With regard to credibility, the RD 

concludes that Respondent 

‘‘demonstrated a commanding grasp of 

the medical issues of H.D., M.D., and 

S.P.’’ ‘‘[e]ven without the benefit of 

having medical records to review,’’ and 

that ‘‘[Respondent’s] understanding of 

M.D.’s medical issues was especially 

strong.’’ RD, at 25–26. The RD finds that 

Respondent ‘‘gave detailed, thorough, 

and objective testimony of the medical 

care she provided to H.D., M.D., and 

S.P.’’ and ‘‘[s]he also candidly 

acknowledged the deficiencies in her 

medical records.’’ Id. at 8, 26. The RD 

concludes that Respondent ‘‘testified in 

a professional, candid, and 

straightforward manner,’’ and ‘‘her 

testimony was sufficiently objective, 

detailed, plausible, and internally 

consistent.’’ Id. Therefore, the RD 

‘‘merit[s] Respondent’s testimony as 

credible in [the] Recommended 

Decision.’’ Id. 

Having read and analyzed all of the 

record evidence, I cannot agree with all 

of the RD’s characterizations of 

Respondent’s testimony. For example, I 

cannot agree that Respondent 

demonstrated a commanding grasp of 

the medical issues of S.P. or H.D., 

because Respondent offered very little 

testimony about her treatment of 

them.14 Additionally, Respondent’s 

testimony about H.D. was not always 

supported by other record evidence. For 

example, Respondent testified that she 

began treating H.D. in ‘‘approximately 

2013,’’ but the narcotics log that she 

generated after the 2017 Interview 

showed that she had prescribed opioids 

to H.D. at least as early as January 2011. 

Compare Tr. 636 with GX 7, at 5 

(showing that Respondent issued at 

least 11 controlled substance 

prescriptions to H.D. prior to 2013) and 

GX 7, at 1 (H.D.’s letter confirming that 

Respondent began treating him in 2011). 

Additionally, Respondent testified that 

she prescribed triazolam 15 to H.D. for 

shift work disorder, but there is no 

mention of shift work disorder in H.D.’s 

medical record.16 GX 7. 

Respondent testified in greater detail 

about her treatment of M.D. Although I 

agree with the ALJ that Respondent had 

a strong grasp on M.D.’s medical issues, 

I found that Respondent was 

occasionally limited in her ability to 

recall details of her treatment of M.D., 

because she did not have 

contemporaneous medical records to 

reference. For example, when 

Respondent was asked about a 

particular laboratory result in M.D.’s 

medical file, she did not recall with 

certainty who had generated the record 

or why M.D. had gone to that provider. 

Tr. 683–85 (discussing GX 6, at 16). 

Respondent initially testified that M.D. 

went to the clinic ‘‘[i]n an attempt to 

establish primary care,’’ and then 

clarified that ‘‘[s]he may have also gone 

there in addition to that if she had a 

different intercurring [sic] clinical 

experience that [Respondent] didn’t feel 

was consistent with her current stable 

chronic medical problems.’’ Id. at 683– 

84. Additionally, Respondent testified 

that when M.D. returned sick from 

Africa, she referred M.D. to another 

provider, because she was concerned 

that she might have an infection. Tr. 

686. Respondent was vague in 

answering whether she had modified 

her treatment of M.D. based on the 

hydrocodone that M.D. had received 

from the other provider. Tr. 687. She 

testified that ‘‘it would depend on 

whether she received a significant 

quantity of that medication or what her 

symptoms were.’’ Id. 

I defer to the RD’s assessment that 

Respondent ‘‘testified in a professional, 

candid, and straightforward manner’’ 

and I agree that Respondent’s hearing 

testimony was ‘‘plausible[ ] and 

internally consistent.’’ RD, at 8, 26. 

However, I identified several 

inconsistencies between Respondent’s 

hearing testimony and her statements to 

Investigators during the investigation. 

First, when Investigators asked 

Respondent in December 2017 whether 

the people that she treated out of her 

home were ‘‘patients of [her] practice 

location,’’ Respondent replied, ‘‘More 

friends, I guess.’’ GX 4, at 11. 

Investigators also asked Respondent 

whether M.D. was a ‘‘patient at 

[Respondent’s] practice’’ or ‘‘kind of an 

on the side thing,’’ and Respondent 

replied, ‘‘I would call it more on the 

side.’’ Id. at 5. However, Respondent 

testified at the hearing that she entered 

into valid doctor-patient relationships 

with H.D., M.D., and S.P. Tr. 639. 

Second, Respondent told Investigators 

during the 2017 Interview that she did 

not maintain medical records for the 

patients that she treated out of her 

home. See GX 4, at 8, 13, 15. However, 

after the Interview, Respondent 

produced medical records for M.D. and 

S.P. that contained documents that she 

testified were in her possession at the 

time of the Interview. See Tr. 34–40, 53; 

GX 6, 8. When Government counsel 


lotter on DSK11XQN23PROD with NOTICES1
33754 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

17Respondent also testified that she felt under 

‘‘increasing duress’’ during the Interview and was 

confused by some of the questions. Tr. 643. 

18The parties stipulated that ‘‘Valium is [sic] 

brand name for diazepam, a Schedule IV controlled 

substance.’’ RD, at 27 (Stipulation No. 8). 

19See, e.g., GX 4, at 4 (‘‘maybe a dozen [patients], 

if that’’); Id. at 14 (‘‘a handful, maybe’’); Id. at 28 

(‘‘less than 5, probably’’). 

20The RD took official notice that tramadol is an 

opioid. See RD, at 102 n.61 (citing Diversion 

Control Division, Drug & Chemical Evaluation 

Section, Tramadol, https://

www.deadiversion.usdoj.gov/drug_chem_info/ 

tramadol.pdf (October 2018) (‘‘Tramadol is an 

opioid analgesic and opioid activity is the 

overriding contributor to its pharmacological 

effects.’’)). Under the Administrative Procedure Act 

(APA), an agency ‘‘may take official notice of facts 

at any stage in a proceeding.’’ U.S. Dept. of Justice, 

Attorney General’s Manual on the Administrative 

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

Inc., Reprint 1979). In accordance with the APA 

asked Respondent why she initially told 

Investigators that she did not have 

medical records, she testified that she 

misspoke and thought they were 

referring to electronic medical records, 

because ‘‘the current climate in 

healthcare is exclusively focused on 

electronic health records.’’ Id. at 58, 62, 

648. However, Investigators did not 

mention electronic medical records 

during the Interview and their questions 

were general enough to cover any type 

of medical records that Respondent 

might have maintained. GX 4; see also 

Tr. 61, 92–93, 707. For example, 

Investigators asked Respondent whether 

she ‘‘ha[d] a medical file at all for 

M.D.,’’ whether she had file for M.D. 

‘‘that shows . . . like the diagnostic 

exam . . . and all that,’’ and whether 

she had a ‘‘current medical record . . . 

like vital signs taken or . . . any of 

that.’’ GX 4, at 13, 15–16. Respondent 

confirmed that she did not. Id. 

Despite the inconsistency, I credit 

Respondent’s testimony that the 

medical records that she produced to 

Investigators after the Interview were in 

her possession at the time of the 

Interview. Respondent did not have 

advance notice of the topics that would 

be discussed during the Interview and 

some of the records pertained to 

treatment that had happened years 

before. See Resp Posthearing, at 4. Thus, 

Respondent may not have remembered 

that she possessed records related to 

these patients’ treatment.17

Additionally, because the records that 

Respondent subsequently produced 

were primarily generated by other 

physicians, not Respondent, 

Respondent may have thought that these 

records were not encompassed by the 

Investigators’ questions. 

Third, Respondent told investigators 

in December 2017 that triazolam is a 

detox drug that is used for alcohol 

withdrawal. GX 4, at 21–22; Tr. 73. At 

the hearing, however, Respondent 

testified that she ‘‘would never use 

triazolam for alcohol withdrawal, nor 

does anyone else that [she’s] aware of.’’ 

Tr. 723; see also id. at 643–44 (testifying 

that she prescribed triazolam for sleep, 

not for alcohol withdrawal). 

Government counsel asked Respondent 

what she had told Investigators in 

December 2017 about the purpose of 

triazolam. Id. at 723. Respondent 

testified that there had been a lot of 

‘‘cross-talk and people talking over each 

other,’’ and that investigators ‘‘show[ed] 

[her] a piece of paper with other 

prescriptions on it,’’ including 

diazepam,18 at the same time they were 

asking her about triazolam. Id. at 723. 

Respondent testified that she was 

referring to diazepam when she said the 

drug was for alcohol withdrawal. Id. 

However, the transcript and audio 

recording from the Interview clearly 

capture DI’s question, ‘‘Triazolam, I 

don’t see that a whole lot; is that also 

sort of like an antianxiety?’’ GX 3, at 

24:00–24:25; GX 4, at 21. Respondent 

replied, ‘‘It’s, uh, no; yes, it’s a, it’s a, 

uh alcohol withdrawal.’’ Id. DI asked, 

‘‘[d]o they use it a lot like they would 

with valium?’’ GX 4, at 22. Amidst the 

cross talk, Respondent confirmed, ‘‘it’s 

more like . . . it’s a . . . detox drug.’’ 

Id. DI testified that she understood that 

Respondent was referring to triazolam 

when she spoke about a detox drug. Tr. 

141 (‘‘I mean, the words are speaking for 

themselves. She’s saying that it’s a detox 

drug.’’). 

Fourth, Respondent testified at the 

hearing that she ‘‘didn’t have any 

significant reason to utilize [the PMP] 

because [she] knew each time [the 

patients] were receiving [controlled 

substances] from somebody else.’’ Tr. 

733. However, when Respondent was 

interviewed by Investigators in 

December 2017, she did not seem to be 

aware that M.D. frequently receives 

controlled substances from other 

providers. See GX 4, at 20–21. At the 

Interview, Investigators asked 

Respondent whether she knew if M.D. 

was receiving treatment from any other 

providers, and Respondent said she had 

‘‘look[ed] her up one time, [ ] because 

with the endometriosis and stuff . . . 

she did get some narcotics . . . from 

that person . . . who did the surgery.’’ 

Id. at 20. Respondent said that she had 

not checked the PMP in a while, but she 

thought that ‘‘those [prescriptions] 

kinda went away.’’ Id. Respondent 

continued, ‘‘[S]he got some from her 

gynecologist . . . or something, and 

then they kinda disappeared. So, I . . . 

don’t think that she’s getting em’ from 

anybody else.’’ Id. at 20. Respondent 

also said that she did not get the sense 

that M.D. was being treated by another 

doctor for these issues. Id. at 20–21. 

However, Arizona PMP data shows 

that M.D. received controlled substances 

from four different practitioners other 

than Respondent in the 12 months 

before the interview. GX 18, at 2–3. 

These practitioners included: (1) D.B., 

an emergency room physician who 

treated M.D. for acute alcohol 

intoxication, Tr. 516–17, 525; (2) A.B., 

a nurse practitioner at Tucson Family 

Medicine who treated M.D. for an ulcer 

and H. pylori, id. at 516; (3) K.T., 

another provider at Tucson Family 

Medicine who diagnosed M.D. with 

pyelonephritis, id. at 523; and (4) C.L., 

an oral surgeon, id. at 521. GX 18, at 2– 

3. M.D. received controlled substances 

from twelve additional practitioners on 

seventeen separate occasions from 

January 2013 to December 2017. GX 18, 

at 1–8. 

Fifth, Investigators asked Respondent 

in the 2017 Interview how many 

individuals she was prescribing to from 

her home. Although Respondent offered 

various estimates throughout the 

interview,19 she ultimately confirmed 

that she was only prescribing controlled 

substances for two patients: H.D. and 

M.D. GX 4, at 15, 30. Respondent did 

not tell Investigators that she had 

prescribed controlled substances to S.P., 

even though S.P. was discussed during 

the Interview. See id. at 34–35. 

According to the Arizona PMP, 

Respondent issued twenty-four 

controlled substances prescriptions to 

S.P. from January 2013 to July 2017. GX 

18, at 16–20. Although Respondent’s 

most recent prescription to S.P. was 

issued approximately five months 

before the Interview—meaning that 

Respondent was not actively prescribing 

to S.P. at the time of the Interview— 

Respondent had regularly prescribed 

controlled substances to S.P. for at least 

the last four years and she testified that 

she had been involved in S.P.’s care for 

approximately fifteen years. Tr. 636 

(testifying that she had treated S.P. from 

the ‘‘early 2000s, [ ] until the end of 

2017’’). 

At the hearing, Respondent testified 

that she had not told Investigators about 

S.P. because ‘‘she thought . . . they 

were referring to opiate therapy,’’ and 

she had not prescribed opioids to S.P. 

since 2013. Id. at 642–43; see also id. at 

699 (‘‘I thought they were referring to 

more active patients in terms of 

opiates.’’). This testimony was not 

supported by the record. First, 

Respondent had prescribed tramadol, an 

opioid,20 to S.P. in March 2015, 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33755 

and DEA’s regulations, Registrant is ‘‘entitled on 

timely request to an opportunity to show to the 

contrary.’’ 5 U.S.C. 556(e); see also 21 CFR 

1316.59(e). The RD notified the parties of this right, 

and advised them that they ‘‘may address whether 

tramadol is not an opioid in any exceptions they 

may file to this Recommended Decision.’’ Id. 

Neither party filed exceptions addressing this issue, 

so I adopt the RD’s finding. 

21The term ‘‘benzos’’ was used interchangeably 

with ‘‘benzodiazepines’’ at the hearing. See, e.g., Tr. 

170. 

22Respondent did not object to the admission of 

any of these exhibits. 

23Physicians are excused from complying with 

this statute under certain circumstances, such as in 

an emergency medical situations. See Ariz. Rev. 

Stat. Ann. § 32–1401(27)(ss)(i)–(ix). There is no 

evidence that any of these circumstances were 

present in this case. 

according to the Arizona PMP. See GX 

18, at 18. Second, Investigators were 

clear with Respondent that they were 

not only concerned with opioids. So 

clear, in fact, that Respondent told 

Investigators that she may have 

prescribed antibiotics for ‘‘somebody’s 

kid.’’ GX 4, at 15. Investigators 

explained that they did not have 

‘‘jurisdiction over antibiotics,’’ and 

asked whether she had prescribed 

‘‘benzos 21 or . . . pain meds . . . or 

anything . . . ’’ for any other 

individuals from home. Id. Respondent 

replied, ‘‘I really don’t think so,’’ ‘‘no.’’ 

Id. Investigators asked, ‘‘So, you think 

just probably [H.D.] and [M.D.] for the 

controlleds written out of your house?’’ 

Id. Respondent replied, ‘‘Mm hm.’’ GX 

3, at 16:23–16:37; GX 4, at 15. 

Investigators asked Respondent again, 

approximately 15 minutes later, 

whether there was anybody else that she 

was ‘‘writing controlleds for.’’ GX 4, at 

30; GX, at 36:20–35. Respondent said, ‘‘I 

mean, there might be . . . an occasional 

antibiotic for someone,’’ but she 

confirmed that ‘‘[t]here’s nobody else’’ 

that she was writing controlled 

substances prescriptions for other than 

M.D. and H.D. Id. 

Respondent argues that her failure to 

tell Investigators that she had prescribed 

to S.P. was not ‘‘an affirmative attempt 

to mislead the investigators,’’ but rather 

was ‘‘a failure to volunteer information 

regarding a subject not discussed in an 

interview.’’ Resp Posthearing, at 6. I 

disagree with Respondent’s contention 

that this topic was not discussed during 

the Interview. The primary topic of 

discussion during the Interview was 

Respondent’s treatment of patients from 

her home, and Investigators asked 

Respondent several times how many 

patients she treated from home. See, 

e.g., GX 4, at 4, 14, 28. And although 

Investigators did not specifically ask 

Respondent whether she had ever 

prescribed controlled substances to S.P., 

S.P. was a topic of discussion during the 

interview. See id. at 34–35. 

However, I agree with Respondent 

that the record does not support a 

finding that she affirmatively attempted 

to mislead Investigators. I found that 

Respondent was sincere and cooperative 

during the Interview, and I found 

Respondent’s hearing testimony to be 

thorough and credible, despite the 

inconsistencies outlined above. 

Therefore, I generally merit 

Respondent’s testimony as credible in 

this Decision, except as noted herein, 

and except where her testimony 

conflicts with Dr. Lynch’s credible 

expert testimony. 

E. The Applicable Standard of Care in 

Arizona 

According to the Controlled 

Substances Act (hereinafter, CSA), 

‘‘[e]xcept as authorized by this 

subchapter, it shall be unlawful for any 

person knowingly or intentionally . . . 

to . . . distribute, . . . dispense, or 

possess with intent to . . . distribute[ ] 

or dispense, a controlled substance.’’ 21 

U.S.C. 841(a)(1). The CSA’s 

implementing regulations state, among 

other things, that a lawful controlled 

substance order or prescription is one 

that is ‘‘issued for a legitimate medical 

purpose by an individual practitioner 

acting in the usual course of his 

professional practice.’’ 21 CFR 

1306.04(a). 

Respondent is licensed as a physician 

in the State of Arizona. Tr. 624. Dr. 

Lynch, the Government’s medical 

expert, presented unrebutted expert 

testimony about the applicable standard 

of care in Arizona for prescribing 

controlled substances. Dr. Lynch 

testified that he considered the 

following materials in forming his 

opinions: (1) Ariz. Rev. Stat. Ann. 

§§ 32–1401(2) and 32–1401(27)(e), 

defining adequate medical records; (2) 

The Arizona Medical Board’s Reference 

for Physicians on the Use of Opioid 

Analgesics in the Treatment of Chronic 

Pain, in the Office Setting (GX 14; 

hereinafter, the Arizona Medical Board 

Guidelines); (3) The CDC’s Guideline for 

Prescribing Opioids for Chronic Pain— 

United States, 2016 (GX 15; hereinafter, 

the CDC Guidelines); and (4) The 

Arizona DHS’s November 2014 Arizona 

Opioid Prescribing Guidelines, (GX 16; 

hereinafter, the Arizona DHS 

Guidelines). Tr. 216–20; 366–68.22 Dr. 

Lynch testified that the guidelines are 

meant to influence the standard of care, 

but ‘‘there’s an art to medicine beyond 

guidelines,’’ and the ‘‘Arizona standard 

of care trumps all these documents.’’ Id. 

at 217; 265–67. Dr. Lynch testified that 

the ‘‘ultimate guide’’ for the standard of 

care is ‘‘what [ ] physicians are doing in 

the marketplace’’ and what Arizona 

physicians ‘‘believe . . . is right.’’ Id. at 

267; see also id. at 217 (explaining that 

the standard of care is determined by 

‘‘what the community does based on all 

the doctors and how they work 

together’’). Dr. Lynch testified that all of 

his opinions at the hearing were based 

on the minimum standard of care in 

Arizona ‘‘and the documented 

regulations from the Arizona Medical 

Board and the Department of Health.’’ 

Id. at 216. 

There was significant disagreement at 

the hearing and in the parties’ 

posthearing briefs on a number of 

issues: (1) Whether a physician must 

maintain medical records in order to 

establish a valid doctor-patient 

relationship, (2) whether the Arizona 

standard of care requires physicians to 

conduct urine drug screens and query 

the Arizona PMP while prescribing 

controlled substances, and (3) whether 

it is a violation of the standard of care 

to prescribe benzodiazepines and 

opioids concurrently. In accordance 

with Dr. Lynch’s uncontroverted expert 

testimony and the record as a whole, I 

make the following findings regarding 

the applicable standard of care in 

Arizona. 

1. The Record Evidence Supports a 

Finding That the Applicable Standard of 

Care in Arizona Requires Physicians To 

Perform a Physical Examination or 

Otherwise Establish a Valid, 

Documented Doctor-Patient 

Relationship Prior to Prescribing 

Controlled Substances 

Dr. Lynch testified that the applicable 

standard of care in Arizona requires a 

physician to conduct a physical 

examination before prescribing 

controlled substances. Tr. 176–77. Dr. 

Lynch’s opinion is supported by 

Arizona statute, which states that it is 

‘‘unprofessional conduct’’ to 

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

prescription medication . . . 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.’’ 23 Ariz. Rev. Stat. Ann. 

§ 32–1401(27)(ss) (2017). 

Dr. Lynch testified that the Arizona 

Medical Board and the Arizona DHS 

typically recommend that physicians do 

‘‘a complete physical exam as part of 

prescribing opioids, but [a physician] 

can do more limited exams.’’ Tr. 177, 

196–97. A physical examination can 

include ‘‘anything from a focused exam 

on a painful area to a complete exam 

. . . [of] all the systems, including 


lotter on DSK11XQN23PROD with NOTICES1
33756 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

24See also Tr. 233 (testifying that the Arizona 

legislature and the Arizona Medical Board mandate 

that physicians document, so by not documenting, 

there is no valid doctor-patient relationship); id. at 

379 (testifying that it is possible to treat a patient 

without documentation, but ‘‘the fact that 

[Respondent is] not documenting it makes it not 

. . . an adequate doctor-patient relationship); id. at 

381 (‘‘My opinion is medical documentation is an 

important aspect of a doctor-patient relationship 

and if you don’t have that it’s hard for me to believe 

it is appropriate medical doctor-patient 

relationship.’’) 

25The ALJ also found that Dr. Lynch’s opinion on 

doctor-patient relationships conflicted with a 

previous Agency Decision. RD, at 14. The ALJ asked 

Dr. Lynch whether a physician who prescribed 

controlled substances to ‘‘his or her minor child 

. . . over a continued period of time’’ without 

evidence that he had performed a physical 

examination or a medical history had formed a 

doctor-patient relationship with the child. Tr. 359– 

60. Dr. Lynch testified that the physician had not 

formed a doctor-patient relationship and it was 

‘‘completely outside the standard of care to treat 

your own children with [controlled substances].’’ 

Tr. 359. The ALJ found that this testimony was 

‘‘contrary to the Administrator’s finding in Belinda 

R. Mori, N.P., 78 FR 36582, 36587–88 (2013).’’ RD, 

at 14. However, Belinda involved a New Mexico 

practitioner and explored the confines of a valid 

doctor-patient relationship under New Mexico law. 

Belinda R. Mori, 78 FR at 36588 (‘‘As for whether 

her failure to create a patient record is, by itself 

sufficient to establish that she prescribed without 

a valid practitioner-patient relationship under New 

Mexico law, I conclude that that was a matter for 

state authorities.’’). ‘‘The CSA . . . generally looks 

to state law and standards of practice to determine 

whether a doctor and patient have established a 

legitimate doctor-patient relationship.’’ Bobby D. 

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

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

citation omitted). Thus, I need not assess whether 

Dr. Lynch’s opinion is consistent with the Agency’s 

decision in Belinda. I need only assess whether Dr. 

Lynch’s opinion is consistent with Arizona law. As 

discussed below, I find that Dr. Lynch’s testimony 

that the physician did not form a valid doctorpatient relationship in the ALJ’s hypothetical is 

consistent with my finding that Arizona law 

requires physicians to maintain contemporaneous 

medical records to establish a valid doctor-patient 

relationship. I also find that Dr. Lynch’s testimony 

that it is outside the standard of care for a physician 

to prescribe controlled substances to his minor 

child is consistent with Arizona law, which 

prohibits prescribing to family members. See Ariz. 

Rev. Stat. Ann. § 32–1401(27)(h) (2014) (defining 

‘‘unprofessional conduct’’ to include ‘‘[p]rescribing 

or dispensing controlled substances to members of 

the physician’s immediate family’’). 

26The RD states: ‘‘Dr. Lynch agreed that a doctor 

and patient establish a legitimate doctor/patient 

relationship when (1) the ‘doctor and patient agree 

that the patient wishes the doctor to examine them’; 

(2) the patient and doctor agree that ‘the doctor 

should diagnose what [the patient’s] medical 

problems are’; and (3) the ‘doctor agrees to treat a 

patient and the patient agrees to be treated.’ ’’ RD, 

at 118 (citing Tr. 233–235). I disagree with the ALJ’s 

assessment of Dr. Lynch’s testimony. Dr. Lynch 

agreed that these elements are indicative of, and 

consistent with, a valid doctor-patient relationship, 

but he did not testify that a valid doctor-patient is 

established if these three elements are met. Tr. 233– 

235. Dr. Lynch agreed that a doctor-patient 

relationship ‘‘is a gray area to try to define,’’ but he 

reiterated his position that he has always inferred 

that documentation and a doctor-patient 

relationship are ‘‘very similar things’’ because the 

‘‘medical Board goes to great lengths to define how 

[doctors] should document.’’ Id. at 235. Neither 

Respondent nor the ALJ provided support for the 

ALJ’s definition of a doctor-patient relationship in 

Arizona law or the Arizona standard of care. The 

ALJ argues that this definition aligns with DEA’s 

understanding of a doctor-patient relationship, as 

articulated in Patrick W. Stodola, MD., 74 FR 20727, 

20729 (2009). However, Stodola is not applicable 

because it involves an Illinois practitioner and does 

not address Arizona law. 

neurologic, cardiac, pulmonary, et 

cetera.’’ Id. at 177. Dr. Lynch’s 

testimony is consistent with the Arizona 

Medical Board’s and the Arizona DHS’s 

Guidelines on prescribing opioids for 

chronic pain. The Arizona DHS 

provides that a practitioner should 

complete ‘‘a comprehensive medical 

and pain related evaluation’’ that 

includes a ‘‘pain focused physical 

exam.’’ GX 16, at 11. The Arizona 

Medical Board provides that a 

practitioner should complete an ‘‘initial 

work-up’’ of every patient that includes 

‘‘a systems review and relevant physical 

examination.’’ GX 14, at 7. Dr. Lynch 

testified that the results of the physical 

examination should be recorded in the 

patient’s medical record. Tr. 196–97 

(referencing GX 12). 

Dr. Lynch testified about the 

requirements for establishing a valid 

doctor-patient relationship. Dr. Lynch 

testified that a valid doctor-patient 

relationship is not established unless 

the physician documents the treatment 

of the patient. Id. at 233, 379, 381. Dr. 

Lynch testified that the Arizona Medical 

Board does not define a doctor-patient 

relationship, but it ‘‘goes to great lengths 

to define how [doctors] should 

document.’’ Id. at 235. Therefore, he has 

‘‘always inferred’’ that documentation 

and the doctor-patient relationship are 

‘‘very similar things.’’ Id.24 Dr. Lynch 

identified additional aspects of a doctorpatient relationship—that the treatment 

is ‘‘done in an office setting’’ and ‘‘in 

the normal course of medical practice 

that occurs [ ] in Arizona every day.’’ Tr. 

232–35. 

There was disagreement at the hearing 

about the requirements for forming a 

valid doctor-patient relationship. The 

ALJ discredited Dr. Lynch’s testimony 

that documentation is required for a 

valid doctor-patient relationship, 

because he found that this testimony 

was based on Dr. Lynch’s ‘‘inference,’’ 

not the standard of care.25 RD, at 14 

(referencing Tr. 232, 235, 354, 379, 381). 

The ALJ determined that ‘‘as far as [he 

could] tell from Dr. Lynch’s testimony, 

neither the Arizona medical community 

nor Arizona authorities have reached a 

settled definition of a doctor/patient 

relationship.’’ Id. (citing Tr. 235). 

Therefore, the ALJ concluded that ‘‘the 

Government has not proved that to 

establish a legitimate doctor/patient 

relationship in Arizona, a doctor must 

have medical documentation of the 

treatment provided to the patient.’’ 26 Id. 

I disagree with the ALJ’s conclusions 

on this issue. I find that Dr. Lynch’s 

testimony on this issue is consistent 

with Arizona’s interpretation of the 

requirements for establishing a valid 

doctor-patient relationship. In Golob v. 

Arizona Med. Bd., 217 Ariz. 505 (2008), 

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. 

Although Dr. Golob conceded that she 

had not performed physical 

examinations, she argued that she 

fulfilled the requirements of Ariz. Rev. 

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

created ‘‘a previously established . . . 

doctor-patient relationship’’ with each 

individual by accepting a consultation 

fee, reviewing responses to a 

questionnaire, and occasionally 

directing an operator to ask the 

individuals additional questions. Id. at 

510. The court wholly rejected Dr. 

Golob’s 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 

physician-patient 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, which states that in order to 

establish a ‘‘valid patient-physician 

relationship,’’ a physician ‘‘shall’’ do 

the following: (i) Obtain a reliable 

history and perform a physical 

examination, (ii) have a sufficient 

dialogue with the patient about the risks 

and benefits of treatment, (iii) follow up 

with the patient to assess therapeutic 

outcomes, as appropriate, (iv) maintain 

a contemporaneous medical record, and 

(v) include a copy of the electronic 

prescription in the record. Id. at 511 

(citing American Medical Association’s 

Guidance for Physicians on Internet 

Prescribing, H–120.949 (June 2003)). 

The Arizona Court of Appeals rejected 

Dr. Golob’s argument that the phrase 

‘‘previously established doctor-patient 

relationship’’ was impermissibly vague, 

noting that the phrase pertains to 

‘‘trained professionals’’ who are 

‘‘expected to be knowledgeable about 

their profession and the context of the 

rule.’’ Id. at 513–14 (citing Brighton 

Pharmacy, Inc. v. Colorado State 

Pharmacy Board, 160 P.3d 412, 419–20 

(Colo. App. 2007)) (internal quotations 

omitted); see also Low Cost Pharmacy, 

Inc. v. Arizona State Bd. of Pharmacy, 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33757 

27The ALJ found that the Government ‘‘place[d] 

too much weight on Golob’s lone reference to ‘a 

contemporaneous medical record’ ’’ in a ‘‘lengthy 

block quote of the AMA’s policy.’’ RD, at 120. He 

found that the holding in Golob is much narrower 

than the Government asserts—it is merely that a 

physician may not ‘‘prescrib[e] medication via the 

internet . . . based exclusively on the results of an 

internet questionnaire.’’ Id. I find that Golob has 

more weight than the ALJ concludes. Although the 

block quote in Golob may be lengthy, the length of 

the quote does not minimize the importance of the 

five critical components of medical treatment that 

it highlights. Each component is identified by the 

Arizona Medical Board and the Arizona DHS as 

critical to safe prescribing. See generally GX 14, 16. 

The ALJ also finds that ‘‘the Government’s reliance 

on Golob conflicts with the testimony of its own 

expert witness that there’s nowhere you can find 

the definition of a valid doctor/patient 

relationship.’’ RD, at 121. I disagree. Consistent 

with Dr. Lynch’s testimony, the court in Golob 

acknowledges that the Arizona legislature does not 

define the phrase ‘‘previously established doctorpatient relationship.’’ See Golob, 217 Ariz. at 513. 

Finally, the ALJ concludes that the Agency’s 

decision in Patrick W. Stodola, M.D., 74 FR 20727, 

20734–45 (2009)—which assessed the 

establishment of a doctor-patient relationship 

according to ‘‘many state authorities’’—is more on 

point than Golob. RD, at 119–20. However, as stated 

above, I do not find that Stodola informs my 

decision in this case because it involves an Illinois 

practitioner and it does not address Arizona law. 

No. 1 CA–CV 07–0547, 2008 WL 

2154793, at *6 (Ariz. Ct. App. May 20, 

2008) (‘‘[A] previously established 

doctor-patient relationship is one that a 

licensed physician, who is expected to 

be knowledgeable about his or her 

profession in the context of the rule, 

should reasonably understand.’’). 

Although Golob dealt with internet 

prescribing, the court stated that 

physicians who prescribe over the 

internet are held to the ‘‘very same 

standard of care that is required of all 

physicians.’’ Id. at 514. Thus, I find that 

Golob is consistent with my finding, 

based on Dr. Lynch’s unrebutted and 

credible expert testimony, that 

physicians must maintain 

contemporaneous medical records in 

order to establish a valid doctor-patient 

relationship in Arizona.27

After Golob was decided, the Arizona 

Medical Board published a Substantive 

Policy Statement providing physicians 

with additional guidance on Internet 

prescribing. See Arizona Medical Board 

Substantive Policy Statement # 12 on 

Internet Prescribing, Adopted Dec. 6, 

2006, available at https://

www.azmd.gov/Files/LawsRules/SPS_

12_PolicyStmt.pdf (herinafter, the 

Statement). The Statement references 

the legislature’s requirement that a 

physician conduct a physical 

examination or have previously 

established a physician-patient 

relationship prior to prescribing 

medications. Id. at 2 (citing Ariz. Rev. 

Stat. Ann. § 32–1401(27)(ss)). The Board 

notes that the nature of the examination 

will ‘‘depend on the patient and 

condition being treated,’’ but 

emphasizes that a documented patient 

evaluation is required: ‘‘Prior to 

providing treatment, including issuing 

prescriptions, . . . a physician must 

document a patient evaluation, 

including taking a history and 

conducting a physical examination 

adequate to establish the diagnoses and 

identify underlying conditions and/or 

contraindications to the treatment 

recommended or provided.’’ Id. 

Although the Statement is ‘‘advisory 

only,’’ and ‘‘does not impose additional 

requirements or penalties on regulated 

parties,’’ it provides further support for 

my finding that documentation is 

required in Arizona to establish a valid 

doctor-patient relationship. Id. at 1. 

Therefore, based on Dr. Lynch’s 

unrebutted and credible expert 

testimony, as supported by evidence in 

Arizona law and policy, I conclude that 

in Arizona, a physician must perform a 

physical examination or otherwise 

establish a valid doctor-patient 

relationship prior to prescribing a 

prescription medication. I also conclude 

that a valid doctor-patient relationship 

is not formed unless a physician 

maintains contemporaneous medical 

records documenting the treatment of 

the patient. 

2. The Record Evidence Supports a 

Finding That the Applicable Standard of 

Care in Arizona Requires Physicians To 

Take a Medical History and Conduct a 

Review of Past Relevant Medical 

Records Prior to Prescribing Controlled 

Substances 

Dr. Lynch testified that the applicable 

standard of care in Arizona requires that 

a physician take a medical history 

before prescribing controlled 

substances. Tr. 176, 239–40. The 

purpose of the medical history is to 

‘‘define the disease state.’’ Id. at 176, 

239–40. Dr. Lynch testified that a 

medical history should explore ‘‘when 

the condition started, what’s happened 

since, what makes it better, what makes 

it worse, what’s been tried, what’s 

failed, [and] what works.’’ Id. at 176. Dr. 

Lynch’s testimony is supported by the 

Arizona DHS Guidelines, which state 

that physicians should complete an 

evaluation that includes ‘‘a medical, 

pain-related, and social history.’’ GX 16, 

at 11. The medical history should be 

documented in the patient’s medical 

records. GX 14, at 12. 

Dr. Lynch testified that a physician 

also must conduct a ‘‘full review of 

prior records’’ in order to ‘‘understand 

the condition’’ and evaluate the 

effectiveness of past treatments. Tr. 

183–84. For example, if a patient is 

being treated for shoulder pain, a 

physician should review past medical 

records in order to understand the 

following: ‘‘Has there been an MRI or Xrays? Have they seen a surgeon? What 

was the documentation? What is the 

diagnosis? Have they been to physical 

therapy? If so, did it work? If not, you 

know, what else have they tried?’’ Id. at 

183–84. Dr. Lynch testified that it would 

not be sufficient for the physician to 

simply review an MRI or laboratory 

results. Id. at 184. Dr. Lynch’s testimony 

that past medical records must be 

reviewed is supported by guidance from 

the Arizona Medical Board and the 

Arizona DHS. The Arizona Medical 

Board provides that ‘‘[r]eports of 

previous evaluations and treatments 

should be confirmed by obtaining 

records from other providers, if 

possible.’’ GX 14, at 7. The Arizona DHS 

provides that ‘‘[c]linicians treating 

patients with opioids for chronic pain 

should obtain and review past medical 

records when possible.’’ GX 16, at 8. Dr. 

Lynch testified that the minimum 

standard of care in Arizona requires that 

the review of past medical records be 

documented in the medical record. Tr. 

196–97 (referencing GX 14). Therefore, 

based on the unrebutted and credible 

expert testimony of Dr. Lynch, as 

supported by Arizona guidance, I find 

that the standard of care in Arizona 

requires physicians to take a medical 

history and document that medical 

history in the patient’s medical record 

before prescribing controlled 

substances. I also find that a physician 

must conduct a review of the patient’s 

past relevant medical records prior to 

prescribing. 

3. The Record Evidence Supports a 

Finding That the Applicable Standard of 

Care in Arizona Requires Physicians To 

Perform Periodic Urine Drug Screens 

and Regularly Query the Arizona PMP, 

and Document Those Results in the 

Medical Record 

Dr. Lynch testified that the applicable 

standard of care in Arizona requires that 

a physician query the Arizona PMP on 

a regular basis and document the results 

in the medical record. Tr. 181–82. He 

testified that regular PMP monitoring 

became ‘‘strong standard in care’’ in 

2014 when the Arizona DHS Guidelines 

were published. Id. at 181. Dr. Lynch’s 

testimony is supported by the Arizona 

DHS Guidelines, which provide that 

‘‘[a]ppropriate monitoring for [chronic 

opioid therapy] includes, at a minimum, 

. . . periodic query of the [Arizona 

PMP].’’ GX 16, at 8. Dr. Lynch’s 

testimony is also supported by the 

Arizona Medical Board Guidelines, 

which recommend that physicians 


lotter on DSK11XQN23PROD with NOTICES1
33758 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

28The Arizona Medical Board also provides 

guidance on the frequency of drug screening. The 

Board advises that ‘‘clinical judgment trumps 

recommendations for frequency of testing’’ for 

patients being treated for pain, but for patients 

being treated for addiction, testing should occur ‘‘as 

frequently as necessary to ensure therapeutic 

adherence.’’ GX 14, at 10. 

29 I also decline to discredit Dr. Lynch’s testimony 

about the standard of care for treating individuals 

with substance abuse problems simply because he 

relied on Arizona prescribing guidelines to 

formulate his opinions. See RD, at 86–87. 

30 ‘‘When an administrative tribunal elects to 

disregard the uncontradicted opinion of an expert, 

it runs the risk of improperly declaring itself as an 

interpreter of medical knowledge.’’ Zvi H. Perper, 

M.D., 77 FR 64,131, 64,140 (2012) (citing Ross v. 

Gardner, 365 F.2d 554 (6th Cir. 1966)). 

31 Dr. Lynch testified that the biggest factor for 

predicting overdose and death is dose. Tr. 244. 

32The parties stipulated that ‘‘Xanax is a brand 

name for alprazolam, a Schedule IV controlled 

substance.’’ RD, at 27 (Stipulation No. 6). 

query the PMP and document the 

results in the record. GX 14, at 8. 

According to the Arizona DHS 

Guidelines, the frequency with which a 

practitioner checks the PMP should be 

based on the patient’s risk of misuse. GX 

16, at 13–14. The PMP should be 

checked ‘‘yearly or more often as 

indicated’’ for low-risk patients, ‘‘every 

[six] months or more often as indicated’’ 

for moderate-risk patients, and ‘‘every 

[three] months or more often as 

indicated’’ for high-risk patients. GX 16, 

at 13–14, 16; see also Tr. 277–80.28 Risk 

factors include a ‘‘personal or family 

history of addiction’’ and ‘‘[a]berrant 

drug-related behaviors,’’ such as 

‘‘obtaining opioids from multiple 

sources.’’ GX 16, at 13. 

The Arizona Medical Board states that 

it will consider the failure to ‘‘mak[e] 

use of available tools for risk 

mitigation,’’ such as the PMP, as 

‘‘inappropriate management of pain’’ 

and a ‘‘departure from best clinical 

practices.’’ GX 14, at 3–4. The Board 

also states that ‘‘[t]o be within the usual 

course of professional practice, . . . the 

prescribing or administration of 

medications should be . . . 

accompanied by careful follow-up 

monitoring of the patient’s response to 

treatment as well as his or her safe use 

of the prescribed medication.’’ Id. at 5. 

Dr. Lynch testified that physicians 

should also perform ‘‘periodic urine 

drug screening’’ on patients receiving 

chronic opioid therapy to ‘‘make sure 

that [the patients are] compliant with 

therapy.’’ Tr. 182–83, 238–39, 262–63, 

271–72. He testified that this 

requirement is based on guidance from 

the Arizona DHS and the Arizona 

Medical Board. Id. at 182–83, 238. The 

Arizona DHS Guidelines provide that 

‘‘[a]ppropriate monitoring for [chronic 

opioid therapy] includes, at a minimum, 

. . . periodic completion of [urine drug 

screens].’’ GX 16, at 8. The Arizona 

Medical Board Guidelines state that 

‘‘[p]eriodic drug testing may be useful in 

monitoring adherence to the treatment 

plan, as well as in detecting the use of 

non-prescribed drugs.’’ GX 14, at 10. Dr. 

Lynch testified that ‘‘there’s 

disagreement on how often’’ urine drug 

screens should be performed,’’ but they 

should be performed ‘‘at some interval.’’ 

Tr. 198. Dr. Lynch testified that the 

frequency of drug testing is based on the 

risk score of the patient. Id. at 238. The 

Arizona DHS recommends that drug 

testing be conducted with the same 

frequency as PMP checks, as determined 

by the patient’s risk factors. GX 16, at 

13. 

Dr. Lynch testified that if a doctor 

learns that a patient is receiving 

controlled substances from other 

providers, the doctor must discuss it 

with the patient to understand why the 

patient is receiving controlled 

substances from other providers and 

make sure that the doctor is ‘‘okay with 

it.’’ Tr. 281, 323. The doctor must 

document those discussions in the 

record, as well as the patient’s reason 

for receiving controlled substances from 

multiple providers. Id. 

Notwithstanding this testimony, the 

ALJ concluded that neither PMP checks 

nor urine drug screens were required by 

the minimum standard of care in 

Arizona. See, e.g., RD, at 88. The ALJ 

reached this conclusion primarily 

because he found that the documents 

that Dr. Lynch referenced as requiring 

urine drug screens—the Arizona DHS 

Guidelines and the Arizona Medical 

Board Guidelines—do not establish the 

standard of care. RD, at 27–28, 35–36, 

88. The ALJ quotes disclaimers that the 

guidelines ‘‘do[ ] not replace or 

constrain the Arizona Medical Board’s 

determination of standard of care in 

individual cases’’ and ‘‘should not be 

used to establish any standard of care.’’ 

RD, at 27–28 (citing GX 14, at 1; GX 16, 

at 2). The ALJ also references Dr. 

Lynch’s testimony that the guidelines 

influence the standard of care, but they 

do not establish it. Id. (citing Tr. 217, 

265, 267). 

Although I agree with the ALJ’s 

assessment of Dr. Lynch’s testimony 

that the guidelines do not 

independently establish the standard of 

care, I decline to discredit Dr. Lynch’s 

testimony merely because he referenced 

the guidelines in formulating his 

opinions.29 Dr. Lynch testified that all of 

his opinions at the hearing were based 

on the minimum standard of care in 

Arizona. Tr. 216. He testified that the 

‘‘ultimate guide’’ for the standard of care 

is ‘‘what [ ] physicians are doing in the 

marketplace,’’ id. at 267, and physicians 

began conducting urine drug screens in 

2011 when ‘‘the CDC started releasing 

data showing that 19 to 40 percent of 

patients were abusing or misusing’’ the 

drugs that they were prescribed. Id. at 

271. Dr. Lynch testified repeatedly that 

urine drug screens are part of the 

minimum standard of care in Arizona. 

Id. at 182–83, 238–39, 262–63, 271–72. 

Dr. Lynch also testified that regular PMP 

monitoring became ‘‘strong standard in 

care’’ in 2014. Id. at 181. Therefore, 

based on the uncontroverted testimony 

of the expert witness as supported by 

state guidance, I conclude that the 

minimum standard of care in Arizona 

requires that physicians prescribing 

opioids regularly query the PMP and 

periodically conduct urine drug 

screens.30

4. The Record Evidence Supports a 

Finding That the Applicable Standard of 

Care in Arizona Requires Physicians to 

Document Their Justification for 

Prescribing Opioids and 

Benzodiazepines Concurrently, and to 

Avoid Prescribing This Combination If 

Possible 

Dr. Lynch testified about the 

applicable standard of care in Arizona 

for prescribing opioids and 

benzodiazepines concurrently. Tr. 178– 

80, 244–45, 275, 299, 300–02, 370–72. 

He referred to this practice as ‘‘coprescribing.’’ Id. at 245. Dr. Lynch 

testified that ‘‘about 1 in 500 patients 

who take a pain pill will overdose and 

die every year, which is a very high 

death rate.’’ Id. at 182. When opioids 

and benzodiazepines are combined, the 

death rate increases by nine times. Id. at 

180, 302. Dr. Lynch testified that the 

‘‘second biggest predictor’’ of overdose 

and death is ‘‘concomitant 

benzodiazepine use.’’ 31 Id. at 244. In 

2014, the Arizona DHS reported that 

benzodiazepines were involved in thirty 

to sixty percent of opioid overdose 

deaths. Id.; GX 16, at 19. 

Dr. Lynch testified that 

benzodiazepines are like ‘‘alcohol in a 

pill form,’’ because they ‘‘hit the same 

receptors in the brain’’ as alcohol. Tr. 

176. He stated, ‘‘[They] will make you 

a little bit tired, a little bit less anxious, 

[and] more relaxed.’’ Id. Dr. Lynch 

testified that Xanax,32 a benzodiazepine, 

is ‘‘one of the most addictive drugs in 

the U.S. today.’’ Id. at 304. Dr. Lynch 

concluded that Xanax is ‘‘highly sought 

after,’’ ‘‘has a very high street value,’’ 

and ‘‘generally shouldn’t be used very 

much.’’ Id. 

Dr. Lynch testified that ‘‘for at least 

four years now, the State of Arizona has 

been urging physicians . . . not to have 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33759 

33The parties stipulated that ‘‘Soma is a brand 

name for carisoprodol, a Schedule IV controlled 

substance.’’ RD, at 27 (Stipulation No. 12). 

34The Arizona DHS defines substance use 

disorder as ‘‘cluster of cognitive, behavioral, and 

physiological symptoms indicating that the 

individual continues using the substance despite 

significant substance-related problems.’’ GX 16, at 

5; see also Tr. 305–06, 328. 

patients on both [opioids and 

benzodiazepines].’’ Id. at 180. He further 

stated that if a physician is going to 

prescribe both, he should ‘‘go to great 

lengths to document the reasons’’ and to 

document the discussions with the 

patient about the risks and benefits. Id. 

Dr. Lynch discussed the Arizona DHS’s 

and the CDC’s recommendations on coprescribing. Id. at 179. The Arizona DHS 

recommends that ‘‘[c]ombined use of 

opioids and benzodiazepines should be 

avoided if possible. If this combination 

is used, it should be with great caution 

and informed consent should be 

obtained.’’ GX 16, at 8. The CDC 

likewise cautions that ‘‘[c]linicians 

should avoid prescribing opioid pain 

medication and benzodiazepines 

concurrently wherever possible.’’ GX 

15, at 18. Dr. Lynch testified that the 

Arizona DHS and the CDC also advise 

physicians not to prescribe opioids 

along with carisoprodol,33 which he 

described as ‘‘a highly diverted and 

addictive muscle relaxant.’’ Tr. 200; see 

also GX 16, at 8, 19 (stating that 

carisoprodol ‘‘should be avoided’’ and 

‘‘[p]articular caution should [ ] be 

exercised when opioids are used with 

other sedatives/hypnotics’’). Dr. Lynch 

declared that carisoprodol is ‘‘one of the 

top 10 most diverted drugs in the 

United States, and it’s only FDA 

approved for two or three weeks of use 

. . . because patients tend to get 

addicted to it.’’ Id. Therefore, I conclude 

that Dr. Lynch credibly testified that the 

standard of care in Arizona requires 

physicians to document their 

justification for prescribing an opioid 

and a benzodiazepine (or carisoprodol) 

concurrently, and to avoid prescribing 

this combination if possible. 

5. The Record Evidence Supports a 

Finding That the Applicable Standard of 

Care in Arizona Requires Physicians to 

Take Extra Precautions When 

Prescribing to Individuals With Active 

Substance Use Disorders or a History of 

Substance Abuse 

Dr. Lynch further testified about the 

applicable standard of care in Arizona 

for prescribing controlled substances to 

patients with active substance abuse 

disorders or a history of substance 

abuse. Prescribing an opioid or a 

benzodiazepine to a patient with a 

substance abuse disorder increases the 

patient’s risk of ‘‘abuse, misuse, 

overdose, and death.’’ Tr. 198. Dr. 

Lynch testified that the Arizona Medical 

Board and the Arizona DHS advise that 

physicians should ‘‘tread very, very 

lightly if someone is an alcoholic.’’ Id. 

at 259. He stated that a physician 

‘‘should always get an assessment first 

by an addiction specialist to . . . set the 

baseline’’ and figure out ‘‘[w]hat exactly 

is going on? How bad was this? Is it 

alcohol? Is it poly-substance abuse?’’ Id. 

at 259; see also id. at 261 (testifying that 

physicians should ‘‘document the 

baseline from an addiction specialist’’ 

before prescribing to an alcoholic), 357. 

Dr. Lynch testified that then, the 

physician should ‘‘balance[e] the risk[s] 

and benefits of [the] treatment’’ with the 

patient. Id. at 259. He concluded that in 

general, it is very difficult to 

‘‘[b]alanc[e] the risk of opioids . . . 

because there’s a lot of downside to it,’’ 

but if the patient has a ‘‘history of 

alcoholism, it’s going to be almost 

impossible . . . to balance those 

scales.’’ Id. at 259–60. Dr. Lynch stated 

that if a patient is abusing a drug, but 

does not have a ‘‘full-on addiction,’’ 

‘‘there should still be extra caution 

when prescribing opioids or benzos for 

that person.’’ Id. at 329–30. Dr. Lynch 

also testified that under the ‘‘local 

standard of care,’’ ‘‘someone who is 

abusing any medication or alcohol 

should not be getting benzos and 

opioids at the same time.’’ Id. at 330–31. 

Dr. Lynch’s testimony is supported by 

guidance from the Arizona DHS and the 

Arizona Medical Board. The Arizona 

DHS provides that it is an ‘‘absolute 

contraindication[ ]’’ to use chronic 

opioid therapy on a patient with a 

‘‘[d]iagnosed substance use disorder 

(SUD) 34 not in remission and/or active 

treatment.’’ GX 16, at 12. Dr. Lynch 

testified that in the context of the 

Arizona DHS Guidelines, an ‘‘absolute 

contraindication’’ means ‘‘don’t do it for 

any reason at all.’’ Tr. 261. The 

guidelines state that ‘‘[c]linicians should 

consider consultation, when available, 

for patients with . . . a history or 

evidence of current drug addiction or 

abuse.’’ GX 16, at 8. 

The Arizona Medical Board also 

distinguishes between patients with an 

active substance abuse disorder and a 

history of substance abuse. The Board 

advises that ‘‘[p]atients who have an 

active substance use disorder should not 

receive opioid therapy until they are 

established in a treatment/recovery 

program or alternatives are established 

such as co-management with an 

addiction professional.’’ GX 14, at 7. 

The Board advises that a physician 

treating a patient with a history of 

substance abuse ‘‘should, if possible, [ ] 

consult[ ] with an addiction specialist 

before opioid therapy is initiated (and 

follow-up as needed).’’ Id.; see also Tr. 

181 (‘‘The Arizona Medical Board . . . 

mandate[s] that you should have a 

referral to addiction specialist.’’). The 

Board emphasizes that ‘‘[p]atients who 

have a history of substance use disorder 

(including alcohol) are at elevated risk 

for failure of opioid analgesic therapy to 

achieve the goals of improved comfort 

and function, and also are at high risk 

for experiencing harm from this therapy, 

since exposure to addictive substances 

often is a powerful trigger of relapse.’’ 

GX 14, at 7. 

Therefore, I conclude that based on 

the uncontroverted and credible 

testimony of Dr. Lynch, as supported by 

Arizona guidance, the applicable 

standard of care in Arizona requires 

that: Physicians must get an assessment 

by an addiction specialist before 

prescribing opioids to a patient with a 

history of substance abuse, and they 

must document the patient’s baseline; 

physicians should not prescribe opioids 

to individuals who have active 

substance abuse disorders unless those 

patients are in active treatment; and, 

physicians should not prescribe opioids 

and benzodiazepines concurrently to 

anyone who is abusing any medication 

or alcohol. 

6. The Record Evidence Supports a 

Finding That the Applicable Standard of 

Care in Arizona Requires Physicians To 

Maintain Contemporaneous Medical 

Records Documenting the Patient’s 

Treatment 

Finally, Dr. Lynch testified that the 

standard of care in Arizona requires that 

physicians maintain medical records 

documenting a patient’s treatment. Tr. 

233, 247–48, 301, 354. He further 

testified that the documentation must be 

contemporaneous with the treatment, 

and that it is not consistent with the 

standard of care for a physician to create 

medical records years after treatment 

was provided based on memory. Id. at 

190–91, 346. Dr. Lynch’s opinion is 

supported by Arizona statute, which 

states that it is ‘‘unprofessional 

conduct’’ to ‘‘fail[ ] or refus[e] to 

maintain adequate records on a 

patient.’’ Ariz. Rev. Stat. Ann. § 32– 

1401(27)(e). Under Arizona law, 

‘‘adequate records’’ must contain, at a 

minimum, ‘‘sufficient information to 

identify the patient, support the 

diagnosis, justify the treatment, 

accurately document the results, 

indicate advice and cautionary warnings 

provided to the patient and provide 

sufficient information for another 

practitioner to assume continuity of the 


lotter on DSK11XQN23PROD with NOTICES1
33760 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

35The OSC alleged that Respondent issued 

twenty-eight prescriptions to M.D. in violation of 

federal and state law, but the Government admitted 

evidence at the hearing that Respondent issued one 

hundred and seventeen prescriptions to M.D. 

Compare OSC, at 3–4 with GX 5; GX 18, at 2–7; see 

also RD, at 85, 110. I find that the Government 

provided Respondent with adequate notice of these 

additional prescriptions. The Government included 

photocopies of some of these prescriptions in 

Government Exhibit 5, and the remaining 

prescriptions were listed in Government Exhibit 18 

(Arizona PMP report). The Prehearing Statement 

notified Respondent that Dr. Lynch was expected to 

testify about all of these prescriptions. See Govt 

Prehearing, at 7–10, 13. Respondent did not argue 

that the Government failed to provide adequate 

notice of these additional prescriptions, nor did she 

dispute that she had issued them. See RD, at 110. 

Previous Agency Decisions have stated that ‘‘[t]he 

primary function of notice is to afford [a] 

respondent an opportunity to prepare a defense by 

investigating the basis of the complaint and 

fashioning an explanation that refutes the charge of 

unlawful behavior.’’ Wesley Pope, M.D., 82 FR 

14,944, 14,947 (2017) (internal citation omitted). 

‘‘The parameters of the hearing are determined by 

the prehearing statements,’’ and even when an issue 

is not raised in the OSC or the prehearing 

statement, ‘‘an issue can be litigated if the 

Government otherwise timely notifies a 

[r]espondent of its intent to litigate the issue.’’ Id. 

(internal quotations and citations omitted). 

Although I am including all of the prescriptions 

alleged, the difference in the number of violations 

alleged in the OSC and that I have found proven 

at the hearing does not ultimately affect the 

sanction I have ordered in this case. See, e.g., Kaniz 

Khan-Jaffery M.D., 85 FR 45,667, 45,685 (2020) 

(finding that ‘‘it is truly not the mere number of 

violations that tip the public interest against 

Respondent.’’). 

36See GX 5, at 1–2, 16–21, 24–25, 32–36, 43–48, 

51–56, 65–67, 76–78, 81–82, 88–99, 104–116, 119– 

20, 123–25, 130–36, 139–44; GX 18, at 2–7; see also 

RD, at 55–57, 85. The parties stipulated that all of 

these drugs are controlled substances. See RD, at 

26–27 (Stipulation Nos. 4–6, 8–11). The parties also 

stipulated that ‘‘Norco is a brand name for 

hydrocodone’’ (Stipulation No. 5), ‘‘Librium is a 

brand name for chlordiazepoxide’’ (Stipulation No. 

9), ‘‘Tylenol # 4 is a brand name for acetaminophen 

with codeine’’ (Stipulation No. 10, Tr. 199), and 

‘‘Percocet is a brand name for oxycodone’’ 

(Stipulation No. 4). RD, at 26–27. 

37The RD notes that Dr. Lynch ‘‘failed to mention 

that during the almost seven years covered by 

M.D.’s PMP there was only one time where the 

prescriptions of [Respondent] overlapped the 

prescriptions of another doctor.’’ RD, at 39–40, n.19. 

Contrary to the RD’s assertion, I find that Dr. Lynch 

directly addressed this issue. The ALJ told Dr. 

Lynch that he had observed that Respondent’s 

prescriptions typically did not overlap with the 

other providers’ prescriptions, meaning that the 

patients had already completed the course of 

medication from the other providers when 

Respondent prescribed to them. Tr. 363. Dr. Lynch 

testified that it does not matter whether the patient 

has run out of medication from the other provider. 

Id. at 364. He testified that it is a violation of the 

standard of care if a patient is receiving the same 

drug from multiple providers during the year. Id. 

Dr. Lynch testified that it is a very high-risk 

behavior to ‘‘jump[ ] around from doc to doc.’’ Id. 

patient’s care at any point in the course 

of treatment.’’ Ariz. Rev. Stat. Ann. 

§ 32–1401(2). 

The Arizona DHS and the Arizona 

Medical Board provide additional 

guidance about what information 

should be contained in a physician’s 

medical records. The Arizona DHS 

Guidelines state that ‘‘[o]ngoing medical 

records should document the patient 

evaluation, a treatment plan with clearly 

defined goals, discussion of risks and 

benefits, informed consent, treatments 

prescribed, results of treatment, and any 

aberrant drug-related behavior 

observed.’’ GX 16, at 8, 16. The Arizona 

Medical Board Guidelines provide that 

‘‘[t]he medical record should document 

the presence of one or more recognized 

medical indications for prescribing an 

opioid analgesic and reflect an 

appropriately detailed patient 

evaluation.’’ GX 14, at 6. They further 

state that: 

Every physician who treats patients 

for chronic pain must maintain accurate 

and complete medical records’’ that 

include the following information: 

• Copies of the signed informed 

consent and treatment agreement. 

• The patient’s medical history. 

• Results of the physical examination 

and all laboratory tests. 

• Results of the risk assessment, 

including results of any screening 

instruments used. 

• A description of the treatments 

provided, including all medications 

prescribed or administered (including 

the date, type, dose and quantity). 

• Instructions to the patient, 

including discussions of risks and 

benefits with the patient and any 

significant others. 

• Results of ongoing monitoring of 

patient progress (or lack of progress) in 

terms of pain management and 

functional improvement. 

• Notes on evaluations by and 

consultations with specialists. 

• Any other information used to 

support the initiation, continuation, 

revision, or termination of treatment 

and the steps taken in response to any 

aberrant medication use behaviors. 

These may include actual copies of, or 

references to, medical records of past 

hospitalizations or treatments by other 

providers. 

• Authorization for release of 

information to other treatment 

providers. 

Id. (internal citations removed). Further, 

the Arizona Medical Board’s ‘‘10 

essential steps of universal precautions’’ 

in assessing and reducing risk include 

maintaining ‘‘careful and complete 

records of the initial evaluation and 

each follow-up visit.’’ Id. at 16. Based 

on the uncontroverted and credible 

testimony of Dr. Lynch, as supported by 

Arizona guidance, I find that the 

applicable standard of care in Arizona 

requires that physicians maintain 

contemporaneous medical records 

documenting the patient’s treatment. 

Having read and analyzed all of the 

record evidence, I find that Dr. Lynch’s 

credible and uncontroverted testimony 

is accurately supported by the Arizona 

guidelines and Arizona law. As such, I 

afford Dr. Lynch’s standard of care 

testimony controlling weight in this 

proceeding. 

F. Allegation That Respondent Issued 

Prescriptions for Controlled Substances 

Outside the Usual Course of 

Professional Practice 

I find that Respondent issued two 

hundred and nine prescriptions to three 

patients without complying with the 

minimum requirements of the 

applicable standard of care in Arizona. 

Respondent’s treatment of each patient 

was below the applicable standard of 

care and outside the usual course of the 

professional practice for numerous 

reasons outlined below, including that 

she failed to (1) maintain adequate 

medical records, (2) perform a physical 

examination or otherwise establish a 

valid doctor-patient relationship prior to 

prescribing, (3) conduct an adequate 

review of past medical records prior to 

initiating opioid therapy, (4) query the 

Arizona PMP and document the results, 

(5) conduct urine drug screens and 

document the results, and (6) document 

a medical justification for co-prescribing 

opioids and benzodiazepines. 

Ultimately, I find that there is 

substantial evidence that Respondent 

issued two hundred and nine 

prescriptions outside the usual course of 

professional practice, and beneath the 

applicable standard of care in Arizona. 

1. Patient M.D. 

Respondent issued one hundred and 

seventeen 35 prescriptions to M.D. from 

November 23, 2012, to November 19, 

2017, for hydrocodone, oxycodone, 

alprazolam, triazolam, diazepam, 

acetaminophen with codeine, and 

chlordiazepoxide.36 Dr. Lynch testified 

that the controlled substances 

prescriptions that Respondent issued to 

M.D. were not issued in the usual 

course of professional practice. Tr. 199. 

Dr. Lynch testified that ‘‘there were 

multiple indications that [M.D.] had a 

possible substance use disorder.’’ Id. at 

191–92; see also id. at 198, 293, 306–07, 

327–32, 357. He stated that these 

indications included Respondent’s 

statements to Investigators about M.D.’s 

alcohol problems and Arizona PMP data 

showing that Respondent received 

controlled substances from other 

providers on at least eighteen different 

occasions while under Respondent’s 

care, from 2012 to 2017.37 Id. at 191–93 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33761 

at 363. He testified that if a doctor learns that a 

patient is receiving controlled substances from 

other providers, the doctor must discuss it with the 

patient to understand why the patient is receiving 

controlled substances from other providers and 

make sure that the doctor is ‘‘okay with it.’’ Id. at 

281, 323. The doctor must document those 

discussions in the record, as well as the patient’s 

reason for receiving controlled substances from 

multiple providers. Id. 

38See also id. at 307 (‘‘[T]he standard of care on 

how to treat an alcoholic or someone who has 

substance use disorder to alcohol is not to put them 

on opioids and benzos.’’), 329–30 (explaining that 

even if M.D. did not qualify as an alcoholic, she was 

abusing alcohol, ‘‘and there should still be extra 

caution when prescribing opioids or benzos’’). 

39 Dr. Lynch testified that it is ‘‘not a very good 

justification’’ to say that you told the patient not to 

take opioids and benzodiazepines together because 

‘‘these drugs build up in your system and will stay 

around for days.’’ Id. at 245. 

40 Dr. Lynch also testified that Respondent 

violated the standard of care by prescribing 

controlled substances to an active substance abuser. 

Tr. 198, 357. I found above based on Dr. Lynch’s 

uncontroverted expert testimony that it is an 

‘‘absolute contraindication[ ]’’ in Arizona to use 

chronic opioid therapy on a patient with a 

‘‘[d]iagnosed substance use disorder (SUD) not in 

remission and/or active treatment.’’ See II.C. n. 9, 

II.E.5. (citing GX 16, at 12). I find that the record 

establishes that M.D. had a ‘‘diagnosed substance 

use disorder’’ at some point during the time period 

alleged in the OSC, see, e.g., Tr. 471, 729, but the 

record is less clear on whether M.D. was receiving 

active treatment. Dr. Lynch’s explanation for why 

he believed that M.D. had an active substance use 

disorder appears to contemplate that M.D. may have 

been in treatment: ‘‘I would see someone that’s 

going to treatment rehab is having active substance 

abuse.’’ Id. at 357. Although I am unable to 

conclude that it was an ‘‘absolute contraindication’’ 

for Respondent to prescribe controlled substances 

to M.D., I find that the record contains substantial 

evidence that Respondent violated the standard of 

care by (1) failing to document a baseline from an 

addiction specialist before prescribing to M.D., and 

(2) prescribing opioids and benzodiazepines to M.D. 

41Respondent testified that she thinks she 

checked the PMP for M.D. once in approximately 

2014. Id. at 722. However, she did not document 

the results in M.D.’s medical record, as Dr. Lynch 

testified was required by the standard of care. Id. 

at 181–82. 

42M.D. testified that she did not provide past 

medical records to Respondent. See id. at 450, 452– 

53, 487–88, 491. 

(referencing GX 18). Dr. Lynch testified 

that Respondent violated the standard of 

care by prescribing controlled 

substances to M.D. without ‘‘get[ting] a 

referral first and document[ing] the 

baseline from an addiction specialist.’’ 

Tr. 261; see also id. at 307 (‘‘[Y]ou 

should . . . send them to an addiction 

specialist to figure out how to treat their 

alcoholism.’’); id. at 357. Dr. Lynch also 

testified that Respondent prescribed 

opioids and benzodiazepines to M.D. at 

the same time on a number of occasions. 

Id. at 177–78; see also GX 18, at 2–7; RX 

3, at 2–7. Dr. Lynch testified that under 

the Arizona standard of care, a 

physician should not prescribe opioids 

and benzodiazepines to ‘‘someone who 

is abusing any medication or alcohol,’’ 

including someone who is a binge 

drinker. Tr. 331.38 Dr. Lynch testified 

that it is an egregious violation of the 

standard of care to co-prescribe opioids 

and benzodiazepines without 

documentation. Id. at 275. 

Respondent and M.D. confirmed at 

the hearing that M.D. had a substance 

abuse disorder, but they characterized it 

as ‘‘mild.’’ Tr. 471, 729. M.D. testified 

that she told Respondent ‘‘during [their] 

initial exams and conversations’’ that 

she ‘‘had issues with alcohol in the 

past.’’ Id. at 471. M.D. testified that she 

was ‘‘managing her alcohol problems 

very well’’ when ‘‘Respondent first 

started caring for her,’’ and she did not 

have ‘‘a binge drinking episode until 

2014.’’ Id. at 474–75. M.D. testified that 

she discussed the episode with 

Respondent and Respondent ‘‘referred 

[her] to a treatment facility in Florida.’’ 

Tr. 471–73. M.D. estimated that she got 

treatment in April 2015. Id. at 474. 

Respondent testified that she recognized 

that prescribing opioids and 

benzodiazepines to M.D. was ‘‘not 

ideal,’’ but she ‘‘sp[oke] to [M.D.] about 

not using these agents together in any 

capacity’’ and she ‘‘[did not] feel that 

[M.D.] suffered any negative 

consequences from it.’’ 39 Id. at 729. 

Despite Respondent’s and M.D.’s 

efforts to minimize M.D.’s alcohol 

problems, it was evident from 

Respondent’s previous statements to 

Investigators that M.D.’s alcohol 

problems were significant and active 

during the timeframe alleged in the 

OSC, and they were known to 

Respondent. Respondent told 

investigators in December 2017 that 

M.D. ‘‘was removed from [Respondent’s] 

property one time . . . because she was 

drunk.’’ GX 4, at 3. She also told 

Investigators, ‘‘I can’t tell you what this 

couple years has been like with this 

addiction, this alcohol issue.’’ Id. at 7. 

Thus, I credit Dr. Lynch’s expert 

testimony that Respondent violated the 

standard of care by prescribing 

controlled substances to M.D. without 

getting a referral first and documenting 

the baseline from an addiction 

specialist, and I also credit Dr. Lynch’s 

testimony that Respondent violated the 

standard of care by prescribing opioids 

and benzodiazepines to an individual 

with substance abuse problems.40

Dr. Lynch also testified that 

Respondent failed to establish a valid 

doctor-patient relationship with M.D. 

Id. at 199. Respondent disagreed. 

Although Respondent initially told 

Investigators that the individuals that 

she treated at home were ‘‘more friends’’ 

than patients, and that M.D. was ‘‘more 

on the side’’ than a patient of her 

practice, GX 4, at 5, 1, Respondent 

testified at the hearing that she believes 

that she established a valid doctorpatient relationship with M.D. Tr. 639. 

I found above based on the credible 

testimony of Dr. Lynch, as supported by 

Arizona law, that a physician must 

document a patient’s treatment in order 

to establish a valid doctor-patient 

relationship in Arizona. See supra 

II.E.1. Therefore, I credit Dr. Lynch’s 

credible expert testimony that 

Respondent failed to establish a valid 

doctor-patient relationship with M.D. 

Dr. Lynch testified that Respondent’s 

treatment of M.D. fell beneath the 

standard of care because her medical 

records do not contain any of the 

following: (1) Documentation of a 

sufficient medical history, Tr. 189–90; 

(2) documentation of a sufficient 

physical examination, Id. at 191; (3) 

documentation of informed consent, id. 

at 196; (4) documentation justifying the 

co-prescribing of opioids and 

benzodiazepines, id. at 180; (5) evidence 

that Respondent properly addressed the 

co-prescribing of opioids and 

benzodiazepines, id. at 191; (6) 

documentation justifying the long-term 

prescribing of alprazolam, id. at 196; (7) 

evidence that Respondent identified and 

addressed the controlled substances that 

M.D. received from other providers, id. 

at 194; (8) evidence that Respondent 

addressed M.D.’s substance abuse 

problems, id. at 192; (9) evidence that 

Respondent conducted urine drug 

screens, id. at 194; (10) evidence that 

Respondent checked the Arizona 

PMP,41 id. at 279, 358; and (11) evidence 

that Respondent obtained M.D.’s past 

medical records and put those records 

in the context of the patient’s treatment 

plan,42 id. at 194–95. 

Despite her failure to document her 

treatment of M.D., Respondent testified 

that she conducted a physical 

examination and took a medical history 

during her first encounter with M.D. Id. 

at 653–60. Respondent and M.D. 

testified in detail about the 

examinations that Respondent 

performed and the conversations they 

had about M.D.’s treatment. See, e.g., id. 

at 447–526 (M.D.’s testimony); 653–92 

(Respondent’s testimony). However, 

none of those examinations or 

discussions was documented. Dr. Lynch 

testified ‘‘it’s possible’’ to conduct 

adequate physical examinations and 

medical histories without documenting 

them, but the fact that Respondent is not 

documenting them ‘‘makes it not 

appropriate, not an adequate doctor/ 

patient relationship.’’ Id. at 379. 

Dr. Lynch testified that Respondent’s 

medical records for M.D. do not comply 


lotter on DSK11XQN23PROD with NOTICES1
33762 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

43The OSC alleged that Respondent issued 

seventeen prescriptions to H.D. in violation of 

federal and state law, but the Government admitted 

evidence at the hearing that Respondent issued 

sixty-eight prescriptions to H.D. Compare OSC, at 

3 with GX 5 (prescriptions), GX 18, at 10–15 (PMP 

data); RD, at 91. I find that the Government 

provided Respondent with adequate notice of these 

additional prescriptions in its prehearing statement. 

See Govt Prehearing, at 12–13. Respondent did not 

argue that the Government failed to provide 

adequate notice of these additional prescriptions, 

nor did she dispute that she had issued them. See 

RD, at 110. Ultimately, the difference in the number 

of the violations alleged in the OSC and those 

demonstrated at hearing does not affect my findings 

on the public interest in this case. See supra n.35. 

44See GX 5, at 3–6, 10–15, 22–23, 28–31, 37–42, 

49–50, 57–64, 72–75, 79–80, 83–84, 87, 100–03, 

117–18, 126–29, 137–38, 145–46; GX 18, at 10–15; 

see also RD, at 47–49, 91. 

45H.D. testified that he showed Respondent blood 

pressure readings, results of an A1C test, and an 

MRI report, but none of those records were 

produced at the hearing. Id. at 392. Dr. Lynch 

testified that a full review of medical records is 

required by the standard of care, and it is not 

sufficient for the physician to simply review an MRI 

or laboratory results. Id. at 183–84. 

with the minimum requirements of the 

Arizona standard of care. Id. at 196–97. 

Dr. Lynch testified that the Arizona 

Medical Board has a ‘‘very good 

document on giving physicians 

guidance on how to prescribe opioids, 

and they go into great detail of what 

must be documented, including 

informed consent, . . . a sign[ed] [ ] 

contract understanding the risks and 

benefits of the opioids, . . . a thorough 

review of systems, a thorough physical 

exam[,] . . . periodic urine drug testing, 

. . . [and a] review [of] prior records.’’ 

Id. at 196–97. Dr. Lynch testified that he 

‘‘[did not] see any of that provided 

here.’’ Id. at 197. Additionally, Dr. 

Lynch was asked whether Respondent’s 

medical records for M.D. ‘‘sufficiently 

identify the patient, support the 

diagnosis, justify the prescribing of 

controlled substances, accurately 

document the results, indicate advice 

and cautionary warnings provided to 

the patient, and provide sufficient 

information for another practitioner to 

assume continuity of the patient’s care 

at any point in the course of treatment,’’ 

and he confirmed that they do not. Id. 

These elements that Dr. Lynch testified 

are missing from M.D.’s medical records 

mirror Arizona law’s requirements for 

‘‘adequate’’ medical records. See Ariz. 

Rev. Stat. Ann. § 32–1401(2). 

Dr. Lynch testified that Respondent’s 

efforts after the December 2017 

Interview to memorialize past treatment 

of M.D. were not sufficient to show that 

a medical history or physical 

examination were performed, because 

‘‘memories change over time, and a 

medical history should be done 

contemporaneous to doing the medical 

exam.’’ Id. at 190–91, 195–96. Dr. Lynch 

testified that ‘‘creat[ing] a document to 

show retrospectively what happened 

during the year’’ is ‘‘definitely outside 

the standard of care, not the intent of 

the Arizona Medical Board, the Arizona 

Department of Health, or even the 

Arizona legislature in their direction on 

how to deal with medical records.’’ Id. 

at 190. 

Dr. Lynch testified that Respondent 

may have ‘‘put [M.D.’s] life at risk’’ by 

failing to comply with the standard of 

care because of M.D.’s ‘‘clear history of 

alcoholism, [and] potentially other 

substance abuse disorders as well,’’ 

which ‘‘puts [her] at risk of abuse, 

misuse, overdose, and death.’’ Id. at 

197–98. Dr. Lynch acknowledged that 

Respondent prescribed low doses of 

controlled substances to M.D., which is 

‘‘a mitigating factor,’’ but he stated that 

he believed that Respondent ‘‘put [M.D.] 

at undue risk by the way she managed 

[M.D.]’’ because of ‘‘the history of 

alcoholism, plus opioids, plus benzos, 

plus multiple providers.’’ Id. at 294. 

Based on the credible, uncontroverted 

testimony of Dr. Lynch and the 

substantial evidence on the record that 

M.D. had a history of substance abuse 

with alcohol, I find that Respondent 

issued one hundred and seventeen 

prescriptions to M.D. outside the usual 

course of professional practice, and 

beneath the applicable standard of care 

in Arizona. 

2. Patient H.D. 

Respondent issued sixty-eight 43

prescriptions to H.D. from February 8, 

2013, to December 6, 2017, for 

hydrocodone, oxycodone, carisoprodol, 

triazolam, and acetaminophen with 

codeine.44 Dr. Lynch testified that the 

controlled substances prescriptions that 

Respondent issued to H.D. were not 

issued in the usual course of 

professional practice. Tr. 209–10. 

Dr. Lynch testified that Respondent’s 

medical record for H.D. does not contain 

sufficient evidence that Respondent 

took an adequate medical history or 

performed an adequate physical 

examination prior to prescribing 

controlled substances. Id. at 204–05. Dr. 

Lynch also testified that there is no 

evidence in Respondent’s medical 

record that Respondent conducted urine 

drug screens or obtained prior medical 

records, as required by the standard of 

care. Id. at 205–06. Respondent 

admitted that she did not check the 

PMP for H.D. while she was prescribing 

to H.D. Id. at 722. 

H.D. testified that Respondent 

prescribed him opioids for neck and 

back pain and triazolam for sleep 

problems related to shift work. Id. at 

398, 433–34. Respondent also testified 

that she prescribed triazolam to H.D. for 

shift work disorder, although there is no 

mention of shift work disorder in H.D.’s 

medical file or in the letter that H.D. 

prepared discussing Respondent’s 

treatment of him. Compare id. at 646– 

47 with GX 7. H.D. testified that 

Respondent conducted a physical 

examination, took a medical history, 

and reviewed past medical records on 

his computer prior to prescribing 

controlled substances.45 See, e.g., id. at 

389–98. H.D. testified that the physical 

examination of his back and neck 

occurred ‘‘probably [ ] sometime in 

2012,’’ and Respondent did not examine 

his back and neck again because ‘‘it was 

the same continuing problem.’’ Id. at 

443. I found above based on Dr. Lynch’s 

credible expert testimony that the 

Arizona standard of care requires 

physicians to document the physical 

examination and medical history. See 

supra II.E.1, 2. Therefore, I find that 

Respondent violated the standard of 

care by failing to document a medical 

history and physical examination, even 

if she performed them. 

Dr. Lynch testified that Respondent 

failed to establish a valid doctor-patient 

relationship with H.D. Tr. 209–10. 

Respondent testified that she believes 

that she established a valid doctorpatient relationship with H.D., id. at 

639, and H.D. testified that he felt that 

he had a valid doctor-patient 

relationship with Respondent. Id. at 

419. However, I found above that a 

physician must document a patient’s 

treatment in order to establish a valid 

doctor-patient relationship in Arizona. 

See supra II.E.1. Therefore, I credit Dr. 

Lynch’s credible expert testimony that 

Respondent failed to establish a valid 

doctor-patient relationship with H.D. 

Dr. Lynch further identified several 

instances where Respondent prescribed 

H.D. an opioid concurrently with 

carisoprodol or a benzodiazepine, and 

he testified that this prescribing pattern 

occurs throughout the entire file. Id. at 

199–203. Dr. Lynch testified that there 

is no documentation in H.D.’s medical 

record explaining why these two 

substances were prescribed together. Id. 

at 205. Dr. Lynch testified that with 

‘‘72,000 deaths per year in the United 

States due to overdoses, with 1 in 500 

patients overdosing and dying[,] [t]here 

should be great vigilance when a [sic] 

opioid or benzodiazepines or 

[carisoprodol] is given to a patient.’’ Id. 

at 209. Dr. Lynch testified that 

Respondent could have done harm to 

H.D. by prescribing this drug 

combination. Id. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33763 

46The RD notes that ‘‘Dr. Lynch failed to mention 

that during the almost seven years covered by 

H.D.’s PMP none of these four instances of 

obtaining a controlled substance from a provider 

other than [Respondent] resulted in a situation 

where the prescriptions of [Respondent] overlapped 

the prescriptions of another doctor.’’ RD, at 39 n.18 

(citing GX 18, at 10–14). As noted above, see supra 

n.37, I find that Dr. Lynch addressed the fact that 

the prescriptions did not overlap. Generally, I find 

that the question of whether or not Respondent’s 

prescriptions overlapped with the other providers’ 

prescriptions was not relevant to Dr. Lynch’s 

opinion. The violation of the standard of care, 

according to Dr. Lynch, is that Respondent failed 

to document that H.D. was receiving controlled 

substances from other providers while she was 

prescribing to him. See Tr. 206–07, 281, 323. 

47The OSC alleged that Respondent issued seven 

prescriptions to S.P. in violation of federal and state 

law, but the Government admitted evidence at the 

hearing that Respondent issued twenty-four 

prescriptions. Compare OSC, at 3 with GX 5 

(prescriptions), GX 18, at 16–20 (PMP data); see also 

RD, at 95. I find that the Government provided 

Respondent with adequate notice of these 

additional prescriptions in its prehearing statement. 

See Govt Prehearing, at 11–13. Respondent did not 

argue that the Government failed to provide 

adequate notice of these additional prescriptions, 

nor did she dispute that she had issued them. See 

RD, at 110. 

48See RX 5, at 4; GX 5, at 7, 9, 26–27, 68–69, 70– 

71, 85–86, 121–122; GX 18, at 16–20; see also RD, 

at 61–62, 95. The parties stipulated that ‘‘Klonopin 

is a brand name for clonazepam, a Schedule IV 

controlled substance.’’ RD, at 27 (Stipulation No. 

14). 

49According to the Arizona PMP, S.P. issued 

thirty prescriptions to Respondent for at least four 

different controlled substances: Alprazolam, 

hydrocodone/acetaminophen, triazolam, and 

testosterone. GX 18, at 1–3. 

50S.P. testified that three providers on the PMP— 

Dr. Mortazavi, Dr. Nicoletti, and Dr. Wristen—were 

colleagues of her primary care provider, Dr. 

Bessette. Tr. 568–70. These three providers wrote 

prescriptions for S.P. on Dr. Bessette’s behalf, but 

S.P. testified that she never saw these providers. Id. 

Dr. Lynch acknowledged that four of the providers 

on S.P.’s PMP shared the same address. Id. at 349. 

Dr. Lynch testified that his concerns would be 

‘‘slightly mitigated’’ if those doctors worked for the 

same practice, but he testified that there were still 

Continued 

Dr. Lynch also testified that the 

Arizona PMP shows that H.D. received 

controlled substances from providers 

other than Respondent while he was 

under Respondent’s care. Id. at 206–07; 

GX 18, at 10–15. Dr. Lynch identified 

four instances where H.D. obtained 

prescriptions from other providers for 

hydrocodone, acetaminophen with 

codeine, or carisoprodol—the same 

controlled substances that Respondent 

was prescribing. Tr. 206–07; GX 18, at 

12–13. Dr. Lynch stated that H.D.’s 

medical record does not address these 

prescriptions, as required by the 

standard of care.46 Id. at 207. 

Finally, Dr. Lynch testified that 

Respondent’s medical records for H.D. 

do not comply with the minimum 

standard of care because ‘‘there’s no 

contemporaneous documentation of any 

of the scripts.’’ Id. at 208. Additionally, 

Dr. Lynch was asked whether 

Respondent’s medical records for H.D. 

‘‘sufficiently identify the patient, 

support the diagnosis, justify the 

prescribing of controlled substances, 

accurately document the results, 

indicate advice and cautionary warnings 

provided to the patient, and provide 

sufficient information for another 

practitioner to assume continuity of the 

patient’s care at any point in the course 

of treatment,’’ and he confirmed that 

they do not. Id. at 209. These elements 

that Dr. Lynch testified are missing from 

H.D.’s medical records mirror Arizona 

law’s requirements for ‘‘adequate’’ 

medical records. See Ariz. Rev. Stat. 

Ann. § 32–1401(2). 

Based on the credible, uncontroverted 

testimony of Dr. Lynch and the 

substantial evidence on the record, I 

find that Respondent issued sixty-eight 

prescriptions to H.D. outside the usual 

course of professional practice and 

beneath the applicable standard of care 

in Arizona. 

3. Patient S.P. 

Respondent issued twenty-four 47

prescriptions to S.P. from January 3, 

2013, to July 16, 2017, for hydrocodone, 

triazolam, diazepam, tramadol, and 

clonazepam.48 During that same 

timeframe, S.P. was also prescribing 

controlled substances to Respondent.49

GX 19, at 1–3. Dr. Lynch testified that 

the controlled substances prescriptions 

that Respondent issued to S.P. were not 

issued in the usual course of 

professional practice. Tr. 216. 

Dr. Lynch testified that Respondent 

failed to establish a valid doctor-patient 

relationship with S.P. Id. Respondent 

disagreed. Respondent testified that she 

believes that she established a valid 

doctor-patient relationship with S.P. Id. 

at 639. Respondent testified that she 

treated S.P. from the early 2000s to the 

end of 2017 ‘‘for a myriad primary care 

issues.’’ Id. at 636, 691. S.P. and 

Respondent testified that Respondent 

performed physical examinations on 

S.P. before prescribing controlled 

substances. Id. at 540, 598, 608, 692. 

S.P. testified that the examinations 

usually took place in her home. Id. at 

598. S.P. testified that Respondent 

examined her on more than ten 

occasions but she could not recall 

precisely how many times. Id. at 598– 

99. S.P. testified that Respondent 

prescribed Xanax and triazolam for shift 

work sleep disorder. Id. at 546, 646. S.P. 

also testified that Respondent 

prescribed controlled substances to her 

for a shoulder and knee injury. Id. at 

537–38, 541, 592–93. In her lay opinion, 

S.P. believed that Respondent 

prescribed controlled substances to her 

for a legitimate medical purpose. Id. at 

549–50. 

Despite S.P.’s and Respondent’s 

efforts to describe the treatment that 

Respondent provided to S.P. over a 

number of years, I found above based on 

Dr. Lynch’s credible expert testimony 

that the Arizona standard of care 

requires physicians to document the 

physical examination and medical 

history. See supra II.E.1.2. I also found 

above that a physician must document 

a patient’s treatment in order to 

establish a valid doctor-patient 

relationship in Arizona. See supra 

II.E.1. Therefore, I credit Dr. Lynch’s 

credible expert testimony that 

Respondent failed to establish a valid 

doctor-patient relationship with S.P. 

Dr. Lynch testified that Respondent’s 

medical records for S.P. do not comply 

with the minimum standard of care. Id. 

at 214. He reasoned that there is no 

documentation of a sufficient medical 

history or a proper physical 

examination and there is no explanation 

of why triazolam and hydrocodone were 

prescribed. Id. at 213. Dr. Lynch 

testified that Respondent obtained some 

‘‘other records’’ for S.P. from other 

physicians, but these records were 

insufficient to meet the minimal 

Arizona standard of care because 

Respondent failed to document ‘‘when 

they were received, what they mean, 

[and] any kind of follow-up on it.’’ Id. 

at 214–15. ‘‘[T]here’s nothing here that 

anyone could use to treat [S.P.] going 

forward.’’ Id. Additionally, Dr. Lynch 

was asked whether Respondent’s 

medical records for S.P. ‘‘sufficiently 

identify the patient, support the 

diagnosis, justify the prescribing of 

controlled substances, accurately 

document the results, indicate advice 

and cautionary warnings provided to 

the patient, and provide sufficient 

information for another practitioner to 

assume continuity of the patient’s care 

at any point in the course of treatment,’’ 

and he confirmed that they do not. Id. 

at 215. These elements that Dr. Lynch 

testified are missing from S.P.’s medical 

records mirror Arizona law’s 

requirements for ‘‘adequate’’ medical 

records. See Ariz. Rev. Stat. Ann. § 32– 

1401(2). 

Dr. Lynch testified that S.P.’s PMP 

shows that she received nine different 

controlled substances from nine 

different providers from January 1, 

2013, to September 4, 2018. Id. at 211– 

12, 343–44; GX 18, at 16–20. Dr. Lynch 

testified that getting controlled 

substances from nine different providers 

is ‘‘a big red flag’’ and ‘‘a high-risk 

behavior,’’ even if the patient has an 

excuse.50 Tr. 272–73. Dr. Lynch testified 


lotter on DSK11XQN23PROD with NOTICES1
33764 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

a lot of red flags in the chart. Id. at 297. Dr. Lynch 

also acknowledged that one of the nine providers 

did not prescribe to S.P. until 2018, and 

Respondent stopped prescribing to S.P. in 2017. Id. 

at 360–61. Dr. Lynch testified that this fact did not 

change his opinion. Id. at 361. 

51The RD notes that ‘‘Dr. Lynch failed to mention 

that during the almost six years covered by S.P.’s 

PMP none of these instances of obtaining a 

controlled substance from a provider other than 

[Respondent] resulted in a situation where 

prescriptions of [Respondent] overlapped the 

prescriptions of another doctor.’’ RD, at 41 n.20. As 

noted above, see supra n.37, I find that Dr. Lynch 

addressed the fact that the prescriptions did not 

overlap. Generally, I find that the question of 

whether or not Respondent’s prescriptions 

overlapped with the other providers’ prescriptions 

was not relevant to Dr. Lynch’s opinion. The 

violation of the standard of care, according to Dr. 

Lynch, is that Respondent failed to document that 

S.P. was receiving controlled substances from other 

physicians while she was prescribing to him. See 

Tr. 213–14, 323. 

52As to Factor One, the evidence in the record 

is that Respondent has an Arizona medical license, 

Tr. 624, 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. 

As to Factor Five, the Government alleged that 

Respondent made several false statements to 

Investigators that should be considered under 

Factor Five. See Govt Prehearing, at 6; Govt 

Posthearing, at 5–13, 45–48. In this case, I found it 

more appropriate to address these statements in my 

assessment of Respondent’s credibility as a witness, 

rather than under Factor Five. See supra II.D. 

that there is no documentation in S.P.’s 

medical file addressing this behavior, as 

required by the Arizona standard of 

care. Id. at 213–14, 323. Dr. Lynch also 

testified that it was outside the standard 

of care for Respondent to prescribe 

opioids and benzodiazepines to a 

patient who was getting these drugs 

from other doctors, even if Respondent’s 

prescriptions did not overlap with the 

other doctors’ prescriptions.51 Id. at 274, 

323, 364–65. He testified that this is 

especially true because there was no 

documentation. Id. at 274–75; 323. 

Dr. Lynch testified that there were red 

flags that S.P. may have been struggling 

with ‘‘opioid use disorder’’ or ‘‘benzo 

use disorder,’’ including that S.P. 

received multiple controlled substances 

from multiple doctors, and that S.P. was 

prescribing controlled substances to 

Respondent at the same time that 

Respondent was prescribing to her. Id. 

at 213–15, 294–95, 297, 307. Dr. Lynch 

testified that by failing to address these 

red flags, Respondent ‘‘could have done 

harm to [S.P.] by her treatment.’’ Id. at 

215, 294–95. Dr. Lynch testified that he 

would have ‘‘do[ne] a urine drug test,’’ 

‘‘sen[t] for an assessment,’’ and ‘‘ha[d] a 

conversation about what’s going on.’’ Id. 

at 295. There is no evidence that 

Respondent conducted urine drug 

screens, id. at 213, and Respondent 

admitted that she did not check the 

PMP for S.P. while she was prescribing 

to S.P., id. at 722. 

Based on the credible, uncontroverted 

testimony of Dr. Lynch and the 

substantial evidence on the record, I 

find that Respondent issued twenty-four 

prescriptions to S.P. 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 . . . distribute[ ] or 

dispense a controlled substance . . . 

may be suspended or revoked by the 

Attorney General upon a finding that 

the registrant . . . has committed such 

acts as would render his registration 

under section 823 of this title 

inconsistent with the public interest as 

determined by such section.’’ 21 U.S.C. 

824(a)(4). In the case of a ‘‘practitioner,’’ 

which is defined in 21 U.S.C. 802(21) to 

include a ‘‘physician,’’ Congress 

directed the Attorney General to 

consider the following factors in making 

the public interest determination: 

(1) The recommendation of the appropriate 

State licensing board or professional 

disciplinary authority. 

(2) The applicant’s experience in 

dispensing . . . controlled substances. 

(3) The applicant’s conviction record under 

Federal or State laws relating to the . . . 

distribution[ ] or dispensing of controlled 

substances. 

(4) Compliance with applicable State, 

Federal, or local laws relating to controlled 

substances. 

(5) Such other conduct which may threaten 

the public health and safety. 

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

considered in the disjunctive. Robert A. 

Leslie, M.D., 68 FR 15227, 15230 (2003). 

According to Agency Decisions, I 

‘‘may rely on any one or a combination 

of factors and may give each factor the 

weight [I] deem[ ] appropriate in 

determining whether’’ to revoke a 

registration. Id.; see also Jones Total 

Health Care Pharmacy, LLC v. Drug 

Enf’t Admin., 881 F.3d 823, 830 (11th 

Cir. 2018) (citing Akhtar-Zaidi v. Drug 

Enf’t Admin., 841 F.3d 707, 711 (6th Cir. 

2016); MacKay v. Drug Enf’t Admin., 

664 F.3d 808, 816 (10th Cir. 2011); 

Volkman v. U.S. Drug Enf’t Admin., 567 

F.3d 215, 222 (6th Cir. 2009); Hoxie v. 

Drug Enf’t Admin., 419 F.3d 477, 482 

(6th Cir. 2005). Moreover, while I am 

required to consider each of the factors, 

I ‘‘need not make explicit findings as to 

each one.’’ MacKay, 664 F.3d at 816 

(quoting Volkman, 567 F.3d at 222); see 

also Hoxie, 419 F.3d at 482. ‘‘In short, 

. . . the Agency is not required to 

mechanically count up the factors and 

determine how many favor the 

Government and how many favor the 

registrant. Rather, it is an inquiry which 

focuses on protecting the public 

interest; what matters is the seriousness 

of the registrant’s misconduct.’’ Jayam 

Krishna-Iyer, M.D., 74 FR 459, 462 

(2009). Accordingly, as the Tenth 

Circuit has recognized, findings under a 

single factor can support the revocation 

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

821. 

DEA regulations state, ‘‘[a]t any 

hearing for the revocation . . . of a 

registration, the . . . [Government] shall 

have the burden of proving that the 

requirements for such revocation . . . 

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

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

In this matter, while I have considered 

all of the factors,52 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 CSA’s implementing 

regulations, a lawful controlled 

substance order or prescription is one 

that is ‘‘issued for a legitimate medical 

purpose by an individual practitioner 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33765 

53See also GX 13 (Respondent’s August 22, 2018 

letter to Investigators stating that Respondent’s 

‘‘standard practice has always been to prioritize 

patient care and safety,’’ and emphasizing that 

Respondent established valid doctor-patient 

relationships with H.D., M.D., and S.P. and treated 

them for legitimate medical conditions). 

54See also Tr. 730 (testifying that ‘‘[o]ne of the 

benefits of having medical providers as patients is 

they are very cognitively aware of the situation 

they’re entering into,’’ but noting that it ‘‘doesn’t 

negate [her] responsibility’’ to them). 

55 I also noted above that the witness accounts 

have limited probative value because the witnesses 

have a strong incentive to provide testimony that 

supports that Respondent’s prescribing to them was 

lawful and legitimate. See supra II.D. 

acting in the usual course of his 

professional practice.’’ 21 CFR 

1306.04(a). The Supreme Court has 

stated, in the context of the CSA’s 

requirement that schedule II controlled 

substances may be dispensed only by 

written prescription, that ‘‘the 

prescription requirement . . . ensures 

patients use controlled substances 

under the supervision of a doctor so as 

to prevent addiction and recreational 

abuse . . . [and] also bars doctors from 

peddling to patients who crave the 

drugs for those prohibited uses.’’ 

Gonzales v. Oregon, 546 U.S. 243, 274 

(2006). 

Based on Dr. Lynch’s credible and 

unrebutted expert testimony and the 

substantial evidence on the record, I 

found above that Respondent issued two 

hundred and nine prescriptions for 

controlled substances beneath the 

applicable standard of care in Arizona 

and outside of the usual course of 

professional practice. See supra II.F. 

Therefore, I find that Respondent 

violated 21 CFR 1306.04(a). 

Respondent admits that she 

committed unprofessional conduct by 

failing to maintain adequate medical 

records. Resp Posthearing, at 8, 12; Tr. 

719. However, aside from that failure, 

Respondent maintains that her 

treatment of H.D., M.D., and S.P. was 

appropriate. See Resp Posthearing, at 15 

(stating that ‘‘[t]he only acknowledged 

and established deficiency was the 

maintenance of medical records’’).53

Respondent argues that the 

Government’s ‘‘assumption that the 

absence of a written record implies the 

absence of a sufficient medical history 

or medical examination of each patient’’ 

was ‘‘rebutted by the credible, sworn 

testimony of M.D., H.D., S.P., and [ ] the 

Respondent.’’ Id. at 10. Respondent 

argues that she conducted ‘‘[t]horough 

medical histories’’ and ‘‘thorough 

focused physical exams,’’ she reviewed 

relevant diagnostic tests, she devised a 

treatment plan, she ‘‘periodically 

assessed’’ ‘‘the effectiveness of 

controlled substance treatment,’’ and 

she made ‘‘referrals . . . to appropriate 

specialists.’’ Id. at 15. Respondent 

emphasizes that H.D., M.D., and S.P. 

were ‘‘experienced health care 

professionals’’ who ‘‘had a 

comprehensive grasp of their medical 

treatment.’’ Id. at 9.54 Finally, 

Respondent argues that the Government 

failed to prove that she committed 

additional violations of the standard of 

care beyond her failure to maintain 

adequate medical records. See Resp 

Posthearing, at 7–10, 15. 

I am not persuaded by Respondent’s 

arguments. First, I cannot agree with 

Respondent that she performed 

adequate physical examinations, 

conducted adequate medical histories, 

and otherwise appropriately treated her 

patients when there is no 

documentation of that treatment. The 

Agency has repeatedly emphasized that 

‘‘[c]onscientious documentation is . . . 

not just a ministerial act, but a key 

treatment tool and vital indicator to 

evaluate whether the physician’s 

prescribing practices are within the 

usual course of professional practice.’’ 

Cynthia M. Cadet, M.D., 76 FR 19,450, 

19,464 (2011) (internal citation and 

quotation omitted); see also Kaniz F. 

Khan-Jaffery, M.D., 85 FR 45667, 45686 

(2020) (‘‘DEA’s ability to assess whether 

controlled substances registrations are 

consistent with the public interest is 

predicated upon the ability to consider 

the evidence and rationale of the 

practitioner at the time that she 

prescribed a controlled substance— 

adequate documentation is critical to 

that assessment.’’). 

The Arizona Medical Board echoes 

this sentiment, emphasizing that 

adequate documentation is critical in 

assessing a physician’s compliance with 

the standard of care. The Guidelines 

state: ‘‘The Board will consider the use 

of opioids for pain management to be for 

a legitimate medical purpose if it is 

based on sound clinical judgment and 

current best clinical practices, is 

appropriately documented, and is of 

demonstrable benefit to the patient.’’ GX 

14, at 5 (emphasis added). The 

Guidelines further state that ‘‘[t]he 

Board will judge the validity of the 

physician’s treatment of a patient on the 

basis of available documentation, rather 

than solely on the quantity and duration 

of medication administered.’’ Id. at 6 

(emphasis added). Finally, the 

Guidelines state that ‘‘[t]he Board will 

not take disciplinary action against a 

physician for deviating from this 

Reference when contemporaneous 

medical records show reasonable cause 

for such deviation.’’ GX 14, at 6 

(emphasis added). The Arizona 

legislature, the Arizona Medical Board, 

and the Arizona DHS provide detailed 

guidance on what must be documented, 

including a medical history, a physical 

examination, and sufficient information 

to support the diagnosis and justify the 

treatment. See supra II.E.6 (citing GX 

14, GX 16, and Ariz. Rev. Stat. Ann. 

§ 32–1401(2)). Dr. Lynch testified that 

the medical record is also known as the 

‘‘medical/legal record,’’ because ‘‘it’s 

accepted that when we go through [the] 

process’’ of ‘‘document[ing] exactly 

what we talked about, what we did, . . . 

then it actually happened, and we did 

it.’’ Tr. 301; see also id. at 354. He has 

‘‘always been taught if you didn’t 

document it, you didn’t do it.’’ Id. at 

301. 

Without documentation, there is no 

way to adequately assess Respondent’s 

treatment of her patients. Witness 

accounts of treatment that happened 

years before are not reliable.55

Respondent’s witnesses occasionally 

acknowledged that their recollection 

was limited. For example, M.D. and S.P. 

could not reliably estimate how many 

times Respondent had physically 

examined them. M.D. testified, ‘‘that’s a 

lot of years. I don’t recall.’’ Id. at 502. 

S.P. testified that she ‘‘[did not] recall 

that number’’ and she could not ‘‘give 

[ ] an estimate.’’ Id. at 598. When 

pressed, S.P. testified that she was 

examined ‘‘several times’’ and agreed 

that it was more than ten. Id. at 599. S.P. 

also could not recall what condition 

Respondent first treated her for, or when 

Respondent first prescribed her 

controlled substances. Id. at 536–37. 

This lack of precision is insufficient to 

assess Respondent’s compliance with 

the standard of care. 

I am also not persuaded by 

Respondent’s argument that her only 

violation of the standard of care was her 

failure to maintain adequate medical 

records. I found above that the 

Government’s expert credibly testified 

that Respondent committed numerous 

violations of the Arizona standard of 

care in her treatment of H.D., M.D., and 

S.P. See supra II.F. For example, I found 

that Respondent failed to document 

adequate medical histories and physical 

examinations, failed to conduct urine 

drug screens, failed to check the 

Arizona PMP, failed to document a 

justification for co-prescribing opioids 

and benzodiazepines, and failed to 

adequately review past medical 

records—all required by the Arizona 

standard of care. I also found that 

Respondent violated the standard of 

care by prescribing opioids and 

benzodiazepines to an individual with 

known substance abuse problems. 


lotter on DSK11XQN23PROD with NOTICES1
33766 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

56Respondent’s counsel asked Dr. Lynch whether 

PMP checks and urine drug screens were 

‘‘required’’ in Arizona, and Dr. Lynch testified that 

they were not. Id. at 270–71, 280. Dr. Lynch 

clarified that urine drug screens are part of the 

minimum standard of care in Arizona, even though 

they are not required by state law: ‘‘[Y]ou keep 

using words like requirements or standard of care 

or law. There are a lot of bodies that spend a lot 

of time trying to influence the standard of care, and 

they’ll come out in the form of requirements—or 

not requirements but recommendations. And then 

the doctors typically will get in line, but they don’t 

always adopt all of it. But it certainly has been the 

standard of care to urine drug test in the State of 

Arizona for the last seven or eight years.’’ Id. at 271. 

57See also Tr. 183 (‘‘between 19 and 40 percent 

of patients will be abusing or misusing the opioid 

that you’re writing . . . so urine drug screening is 

one objective way that we know that they’re taking 

the medication’’), id. at 237–38 (physicians should 

‘‘trust’’ what their patients are telling them, ‘‘but 

verify’’ their reports using tools such as urine drug 

screens and PMP reports); GX 14, at 10 (‘‘Drug 

testing is an important monitoring tool because selfreports of medication use are not always reliable 

and behavioral observations may detect some 

problems but not others.’’). 

58 Dr. Lynch agreed with Respondent’s counsel 

that a physician is ‘‘always supposed to use clinical 

judgment’’ and that ‘‘clinical judgment trumps the 

recommendations.’’ Tr. 262. Dr. Lynch also agreed 

that a ‘‘doctor’s clinical judgment could cause her 

to prescribe treatment for somebody or not use drug 

testing, even though the guidelines recommend it, 

if, in her clinical judgment, it wasn’t necessary.’’ Id. 

at 262–63. However, Dr. Lynch also testified that 

the Arizona DHS and the Arizona Medical Board 

‘‘each give eight to 10 things that you should do,’’ 

and while physicians may ‘‘have a right to kind of 

say, well, I’m not going to do that or I’m not going 

to do this,’’ they should generally follow the 

guidance. Id. at 263. Dr. Lynch continued, ‘‘[I]t 

doesn’t seem like any of the recommendations are 

followed, and that’s my concern.’’ Id. Thus, it may 

have been permissible for Respondent to exercise 

her clinical judgment not to follow a specific 

recommendation, but Dr. Lynch testified that she 

violated the standard of care by ignoring the 

‘‘totality of’’ the Arizona DHS’s and the Arizona 

Medical Board’s recommendations. Id. Respondent 

also violated the standard of care by failing to 

document why her ‘‘clinical judgment’’ caused her 

to disregard recommendations of the Arizona DHS 

and the Arizona Medical Board. 

59 I found above that Respondent violated the 

standard of care by co-prescribing to M.D based on 

Dr. Lynch’s expert testimony that it is a violation 

of the standard of care to co-prescribe to individuals 

with substance abuse problems. See supra II.F. 

(citing Tr. 331). 

Respondent argues that she did not 

violate the standard of care by failing to 

conduct periodic urine drug screens and 

regular PMP checks, because neither 

tool was required by state law. Resp 

Posthearing, at 9. Respondent also 

argues that the patients informed her 

about all of the controlled substances 

that they received from other 

physicians, so she ‘‘had sufficient 

knowledge of all the medical treatment 

and prescriptions’’ to enable her to 

‘‘exercise properly her clinical judgment 

as to each patient.’’ Id.; see also Tr. 733 

(testifying that she had no ‘‘significant 

reason to utilize those [tools] because 

[she] knew each time they were 

receiving something from somebody 

else’’ and she ‘‘believed what [they] 

were telling [her]’’). 

I disagree with Respondent that PMP 

checks and urine drug screens were not 

required by the standard of care. See 

supra II.E.3. Although Dr. Lynch 

acknowledged that neither tool was 

mandated by the Arizona legislature,56 I 

found above that Dr. Lynch credibly 

testified that both are part of the 

minimum standard of care in Arizona. 

Id. This expert testimony was 

unrebutted and it was supported by the 

Arizona DHS Guidelines and the 

Arizona Medical Board Guidelines. Id. I 

also disagree with Respondent that it 

was appropriate for her to rely on her 

patients’ accounts of the prescriptions 

that they received from other 

physicians. Dr. Lynch testified that it is 

important to use objective tools, such as 

urine drug screens and the PMP, to 

monitor patient compliance because ‘‘1 

in 500 patients [is] dying from opioids 

and 33 percent . . . [are] abusing or 

misusing’’ opioids. Tr. 198.57

Additionally, I found based on Dr. 

Lynch’s unrebutted expert testimony 

that if Respondent knew that her 

patients were receiving controlled 

substances prescriptions from other 

physicians, the standard of care 

required her to at the very least, 

document that fact in the patient 

records, as well as her discussions with 

the patients resolving the red flag. See 

id. at 281, 293, 323. 

Respondent implies that her patients 

required less monitoring because they 

are experienced health care 

professionals who ‘‘had a 

comprehensive grasp of their medical 

treatment including their controlled 

substance prescriptions from other 

medical providers.’’ Resp Posthearing, 

at 9. However, Respondent did not offer 

any evidence that medical providers are 

less susceptible to drug abuse and 

diversion than other patients. And in 

fact, the evidence showed that H.D., 

M.D., and S.P. were all receiving 

controlled substances from other 

providers, while under Respondent’s 

care, which is considered an ‘‘[a]berrant 

drug-related behavior[ ]’’ that requires 

more frequent monitoring, according to 

the Arizona DHS. See supra II.E.3 

(citing GX 16, at 13). 

Respondent’s failure to utilize 

objective monitoring tools was 

particularly egregious with M.D., due to 

her known substance abuse problems. 

Dr. Lynch testified that M.D. is a highrisk patient because she is an alcoholic. 

Tr. 272. According to the Arizona DHS, 

high-risk patients should be screened 

every three months or more often, as 

indicated. Id. at 277–80; GX 16, at 13– 

14. Objective testing was also important 

with M.D. because the evidence suggests 

that Respondent lacked objectivity with 

M.D. because of their close personal 

relationship. Respondent told 

Investigators in 2017 that she had been 

‘‘duped’’ by M.D. before and that she 

can ‘‘be a little too trusting sometimes, 

especially if it’s someone . . . [she] 

care[s] about.’’ GX 4, at 7. 

Respondent also argues that she did 

not violate the Arizona standard of care 

by prescribing opioids and 

benzodiazepines concurrently because 

‘‘the use of [these drugs] is allowable 

and is a matter of medical judgment.’’ 

Resp Posthearing, at 7 (citing GX 16; Tr. 

262, 299). Respondent references Dr. 

Lynch’s testimony that co-prescribing is 

not a violation of the standard of care 

and his testimony that a physician’s 

clinical judgment trumps the guidelines. 

Tr. 280. I find that Respondent’s 

reliance on Dr. Lynch’s testimony about 

clinical judgment is misplaced,58 but I 

agree with Respondent that Arizona 

does not ban co-prescribing in 

individuals who do not have substance 

abuse problems.59 See supra II.E.4. 

However, I found above that the Arizona 

standard of care requires physicians to 

document their justification for coprescribing and their discussions with 

the patient about the risks and benefits 

of co-prescribing. Id. Because 

Respondent did not document either, I 

have found that she violated the 

standard of care. See supra II.F. 

In addressing her failure to obtain 

past medical records, Respondent 

argues that she was ‘‘well acquainted’’ 

with each patient and ‘‘openly 

discussed all past medical care’’ before 

initiating treatment. Resp Posthearing, 

at 9. Respondent references M.D.’s 

testimony that they discussed all of 

M.D.’s past experiences, medications, 

and providers before Respondent 

prescribed any medication. Id. (citing 

Tr. 450). Respondent also cites H.D.’s 

testimony that Respondent took a 

complete medical history and reviewed 

his laboratory and MRI results on his 

computer before prescribing. Id. (citing 

391–92, 394, 396). 

I disagree with Respondent that these 

efforts excused her from complying with 

the requirement of obtaining past 

medical records. Dr. Lynch testified that 

physicians should conduct a full review 

of relevant prior records in order to 

‘‘understand the condition’’ and 

evaluate the effectiveness of past 

treatments. See supra II.E.2. The 

Arizona Medical Board emphasizes that 

it is important to verify patients’ reports 

of past treatment by obtaining past 

medical records: ‘‘Information provided 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33767 

60As discussed above, I find that Dr. Lynch was 

sufficiently qualified to opine on M.D.’s substance 

abuse problems. See supra II.C. 

61This statute has been updated approximately 

yearly over the last decade. Throughout my 

Decision, I will refer to the version of the statute 

that became effective on August 9, 2017, consistent 

with how to statute is referenced in the OSC. See 

OSC, at 2. Although there have been substantive 

changes to the statute during the time period at 

issue, none of them impact my Decision. In 

September 2013, the statute was modified to clarify 

that a ‘‘mental health status examination’’ may be 

performed in lieu of a physical examination. 

Additionally, various revisions clarified that 

examinations may be performed virtually through 

telemedicine encounters. Because there is no 

evidence that Respondent performed a mental 

status examination in lieu of a physical 

examination, or performed examinations virtually, 

I find that these changes do not impact my 

Decision. 

The lettering of the statute’s various provisions 

has also changed. On April 26, 2018, subsection (q) 

was changed to subsection (r) and subsection (ss) 

was changed to subsection (tt). Throughout my 

Decision, I will refer to these provisions by their 

original lettering, consistent with how they were 

cited in the OSC. See OSC, at 2. 

by the patient is a necessary but 

insufficient part of the evaluation 

process. Reports of previous evaluations 

and treatments should be confirmed by 

obtaining records from other providers, 

if possible.’’ GX 14, at 7. It is critical that 

physicians take steps to prevent the 

abuse and diversion of controlled 

substances by using objective tools to 

verify the veracity of patients’ 

statements and their compliance with 

their treatment plan. See Roy S. 

Schwartz, 79 FR 34,360, 34,363 (2014) 

(‘‘[D]iversion occurs whenever 

controlled substances leave ‘the closed 

system of distribution established by the 

CSA . . . .’ ’’). 

Respondent also defends her decision 

to prescribe controlled substances to 

M.D. despite M.D.’s substance abuse 

problems. Respondent states that she 

had ‘‘first-hand knowledge’’ of M.D.’s 

alcohol problems because she discussed 

them with M.D. ‘‘during [their] initial 

conversations and medical 

examinations.’’ Resp Posthearing, at 8 

(citing 471, 479, 655). Respondent 

argues that M.D. was ‘‘managing her 

alcohol problems very well’’ when 

‘‘Respondent first started caring for 

her,’’ and that M.D. did not have ‘‘a 

binge drinking episode until 2014.’’ Id. 

(citing Tr. 474–75). Respondent 

discussed the episode with M.D. and 

‘‘referred [her] to a treatment facility in 

Florida.’’ Id. (citing Tr. 471–73). Thus, 

Respondent argues that the 

Government’s ‘‘claim that [her] 

treatment of M.D. fell below the 

standard of care because she allegedly [ ] 

failed to refer M.D. to an Addiction 

Specialist . . . is simply not true.’’ Id. 

I appreciate that Respondent 

discussed M.D.’s substance abuse 

problems with her and referred her to a 

treatment facility. However, Respondent 

did not document any of those efforts. 

Dr. Lynch testified that physicians 

should ‘‘define’’ and ‘‘document the 

baseline from an addiction specialist’’ 

before prescribing to an alcoholic 

because ‘‘addiction docs do a really 

good job of doing a history.’’ See supra 

II.E.5, II.F.1 (citing Tr. 261, 357). Dr. 

Lynch also testified that prescribing 

opioids and benzodiazepines to anyone 

who is abusing alcohol is a violation of 

the standard of care, and that 

prescribing these drugs with no 

documentation is an ‘‘egregious’’ 

violation. See supra II.E.5, II.F.1 (citing 

Tr. 275, 331). There is no evidence that 

Respondent ever performed a urine drug 

screen on M.D., despite M.D.’s 

alcoholism and her high risk behavior of 

receiving controlled substances from 

different providers on eighteen 

occasions. Id. (citing Tr. 191–93). And 

Respondent only checked the PMP once 

in at least five years of prescribing 

controlled substances to M.D. Tr. 722. 

Thus, Respondent’s standard of care 

violations with M.D. go beyond her 

alleged failure to refer M.D. to a 

treatment facility. 

Respondent also argues that Dr. Lynch 

is not an expert in treating substance 

abuse disorders 60 and that he ‘‘admitted 

he did not even have enough medical 

records to render an expert opinion on 

M.D.’s alcohol consumption.’’ Resp 

Posthearing, at 8. Although Dr. Lynch 

testified that he did not have enough 

documentation to definitively diagnose 

M.D. with a substance abuse disorder, 

he testified that it is ‘‘more than likely’’ 

that she had a substance abuse disorder. 

Tr. 338–39; see also II.F.1. (citing Tr. 

191–92, 198, 293, 306–07, 327–32, 357). 

There is substantial evidence on the 

record to support Dr. Lynch’s testimony 

that M.D. had substance abuse 

problems, including Respondent’s 

statements to Investigators in 2017 that 

M.D. was an alcoholic and M.D.’s 

testimony that she was diagnosed with 

a ‘‘mild’’ substance abuse disorder. See 

supra II.F.1. Moreover, it is not 

necessary to definitively diagnose M.D. 

with a substance abuse disorder because 

Dr. Lynch testified that even if M.D. did 

not have a ‘‘full-on addiction,’’ she was 

‘‘still [] abusing [alcohol],’’ and it is a 

violation of the standard of care to 

prescribe opioids and benzodiazepines 

to ‘‘someone who is abusing any 

medication or alcohol.’’ Tr. 329–31. Dr. 

Lynch testified that prescribing opioids 

or benzodiazepines to an individual 

with a substance abuse disorder ‘‘puts 

the person at risk of abuse, misuse, 

overdose, and death,’’ and Respondent 

may have put M.D.’s life at risk because 

of her clear history of alcoholism. Id. at 

197–98. 

Finally, Respondent asserts that ‘‘[t]he 

government did not produce any 

evidence of diversion in three days of 

testimony,’’ nor did the government 

‘‘produce any evidence of harm to the 

public health of a patient of the 

Respondent.’’ Resp Posthearing, at 11. 

However, Respondent does not cite legal 

authority for the proposition that I must 

find evidence of diversion or harm 

before I may suspend or revoke a 

registration. Agency Decisions have 

found that DEA has the authority to 

revoke a DEA registration in the absence 

of evidence of diversion if the 

registrant’s ‘‘prescribing practices . . . 

create a substantial risk of diversion’’ or 

even the ‘‘opportunity for diversion.’’ 

See, e.g., Garrett Howard Smith, M.D., 

83 FR 18882, 18905 n.32 (2018) (citing 

Dewey C. Mackay, M.D., 75 FR 49,956, 

49,974 n.35 (2010) (‘‘Accordingly, under 

the public interest standard, DEA has 

authority to consider those prescribing 

practices of a physician, which, while 

not rising to the level of intentional or 

knowing misconduct, nonetheless create 

a substantial risk of diversion.’’); Paul J. 

Caragine, Jr., 63 FR 51592, 51601 

(‘‘Careless or negligent handling of 

controlled substances creates the 

opportunity for diversion and could 

justify revocation or denial.’’)). I found 

that Respondent issued numerous 

prescriptions beneath the applicable 

standard of care and outside of the usual 

course of professional practice in 

Arizona. I also found that Respondent 

failed to adequately respond to red flags 

that her patients may have been abusing 

or diverting the controlled substances 

that she prescribed, which constitutes 

‘‘acts inconsistent with the public 

interest.’’ See supra II.F; Wesley Pope, 

M.D., 82 FR 14944, 14966 (2017) 

(internal quotations and citations 

omitted). 

(b) Violation of State Law 

In addition to alleging that 

Respondent violated 21 CFR 1306.04(a), 

the OSC alleged that Respondent 

violated Arizona law by prescribing 

controlled substances (1) without 

maintaining adequate patient records, 

(2) without conducting a physical 

examination or previously establishing a 

valid doctor-patient relationship, and 

(3) while engaging in conduct that was 

or might have been harmful or 

dangerous to the health of the patient. 

See OSC, at 3 (citing Ariz. Rev. Stat. 

Ann. §§ 32–1401(27)(e), (ss), (q)).61 I 

find that the Government has proven 

these allegations by substantial 


lotter on DSK11XQN23PROD with NOTICES1
33768 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

62Although Respondent testified at the hearing 

that she believes that she established valid doctorpatient relationships with H.D., M.D. and S.P., see 

Tr. 639, I find that my conclusion that Respondent 

failed to establish valid doctor-patient relationships 

is consistent with Respondent’s initial statements to 

Investigators that the individuals that she treated at 

home were ‘‘more friends’’ than patients, and that 

M.D. was ‘‘more on the side’’ than a patient of her 

practice. GX 4, at 5, 11. The Arizona Medical Board 

has initiated disciplinary actions alleging violations 

of Ariz. Rev. Stat. Ann. § 32–1401(27)(ss) based on 

similar facts. See, e.g. In the Matter of Warren 

Moody, M.D., No. MD–07–0874A, 2007 WL 3375035 

(Oct. 16, 2007) (summarily suspending physician’s 

license for various forms of misconduct, including 

prescribing controlled substances to friends without 

maintaining medical records); In the Matter of Brian 

R. Briggs, M.D., No. MD–15–0164A, 2017 WL 

554258 (Feb. 2, 2017) (issuing a Letter of Reprimand 

and placing respondent on probation for prescribing 

controlled substances to a live-in girlfriend—who 

was also receiving opioids from other providers— 

without maintaining medical records and without 

‘‘perform[ing] and document[ing] an appropriate 

physical and mental examination’’); In the Matter 

of David Landau, M.D., No. MD–17–0777A, 2018 

WL 2192279 (Apr. 16, 2018) (issuing a Letter of 

Reprimand against a physician for various forms of 

misconduct, including prescribing controlled 

substances to a friend without maintaining 

adequate medical records); see also In the Matter of 

Joshua D. Holland, M.D., No. MD–08–1020A, 2009 

WL 2461330 (Aug. 6, 2009) (entering a Consent 

Agreement with the respondent for various forms of 

misconduct, including failing to maintain adequate 

medical records required by Ariz. Rev. Stat. Ann. 

§ 32–1401(27)(e), because the respondent prescribed 

controlled substances to two close personal friends 

without a ‘‘documented physician-patient 

relationship’’ and without documenting a rationale 

for the prescriptions). Although I do not rely on 

these Board decisions as espousing any particular 

interpretation of Arizona’s laws, I find that they 

provide support for Dr. Lynch’s testimony and for 

my ultimate conclusions about Arizona law. 

63There is no evidence that Respondent 

performed a mental status examination in lieu of a 

physical examination prior to prescribing. 

64See also In the Matter of Thomas J. Petrone, 

M.D., No. MD–08–0059A, 2009 WL 349716 (Ariz. 

Med. Bd. Feb. 5, 2009) (finding that respondent’s 

records were inadequate because ‘‘he did not 

document a physical examination or include past 

medical records in the patient’s charts and he 

prescribed medications and escalated doses of 

opioids without therapeutic indications’’); In the 

Matter of Mark D. Goldberg, M.D., No. MD–07– 

0128A, 2009 WL 981092 (Ariz. Med. Bd. Apr. 2, 

2009) (finding that respondent’s medical records 

were inadequate because there was no 

documentation of a history, a physical examination, 

or the medication administered). 

65See, e.g., Tr. 441–44 (H.D.’s testimony that not 

all of the prescriptions that Respondent issued were 

based on in-person encounters and Respondent 

only performed a targeted examination of his back 

once), Tr. 502 (M.D.’s testimony that Respondent 

performed focused physical examinations ‘‘when 

things changed or [she] had different symptoms’’); 

GX 13, at 2 (Respondent’s letter dated August 22, 

2018, stating that ‘‘[p]hysical exams and in person 

discussions are not utilized each and every time a 

prescription is called in to a pharmacy.’’) 

66A plain language reading of the statute supports 

this interpretation. The statute prohibits 

‘‘prescribing, dispensing, or furnishing a 

prescription medication . . . unless the licensee 

first conducts a physical or mental health status 

examination of that person or has previously 

established a doctor-patient relationship.’’ There is 

no language limiting the application of the statute 

to initial prescriptions. The phrase ‘‘initial 

prescription’’ is used elsewhere in the Arizona 

code. See Ariz. Rev. Stat. Ann. § 32–3248 (2018) 

(placing restrictions on ‘‘initial prescriptions’’ for 

Schedule II controlled substances). Additionally, 

the fact that the statute excuses a physician from 

performing a physical examination if there is a 

‘‘previously established a doctor-patient 

relationship’’ implies that that statute will be 

evidence, at least with respect to certain 

prescriptions. 

i. Respondent Violated Ariz. Rev. Stat. 

Ann. § 32–1401(27)(e) by Failing To 

Maintain Adequate Medical Records 

I find that the substantial evidence on 

the record supports a finding that 

Respondent violated Arizona law by 

issuing two hundred and nine 

prescriptions without ‘‘maintain[ing] 

adequate records.’’ Ariz. Rev. Stat. Ann. 

§ 32–1401(27)(e). Arizona law provides 

that ‘‘adequate records’’ must contain, at 

a minimum, ‘‘sufficient information to 

identify the patient, support the 

diagnosis, justify the treatment, 

accurately document the results, 

indicate advice and cautionary warnings 

provided to the patient and provide 

sufficient information for another 

practitioner to assume continuity of the 

patient’s care at any point in the course 

of treatment.’’ Ariz. Rev. Stat. Ann. 

§ 32–1401(2). Respondent did not 

maintain contemporaneous medical 

records for any patient that satisfied the 

requirements of the statute. See supra 

II.F; see also Tr. 197, 209, 215 (Dr. 

Lynch’s testimony confirming that 

Respondent’s medical records failed to 

meet the above criteria); id. at 719 

(Respondent’s testimony acknowledging 

that she committed unprofessional 

conduct by failing to maintain adequate 

medical records). 

ii. Respondent Violated Ariz. Rev. Stat. 

Ann. § 32–1401(27)(ss) by Failing to 

Physically Examine or Otherwise 

Establish a Doctor-Patient Relationship 

Prior To Prescribing Controlled 

Substances 

Additionally, I find that the 

substantial evidence on the record 

supports a finding that Respondent 

violated Ariz. Rev. Stat. Ann. § 32– 

1401(27)(ss) in issuing some, or all, of 

the prescriptions at issue by failing to 

physically examine or otherwise 

establish a doctor-patient relationship 

prior to prescribing controlled 

substances. Arizona law states that it is 

‘‘unprofessional conduct’’ to 

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

prescription medication . . . 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) (2017). I found above 

that in order to establish a valid doctorpatient relationship in Arizona, a 

physician must maintain medical 

records documenting the patient’s 

treatment, see supra II.E.1, and I 

concluded that Respondent failed to 

establish valid doctor-patient 

relationships with H.D., M.D., and 

S.P.62 See supra II.F. I also found above 

that Respondent failed to document 

sufficient physical examinations for 

each patient.63 Id. 

Respondent argues that she conducted 

thorough, focused physical 

examinations, despite her failure to 

document them. See Resp Posthearing, 

at 10, 15. However, I found above based 

on Dr. Lynch’s credible and 

uncontroverted testimony that the 

Arizona standard of care requires 

physicians to document physical 

examinations. See supra II.E.1. (citing 

Tr. 196–97; GX 12, at 28). Consistent 

with Dr. Lynch’s testimony, the Arizona 

Medical Board has deemed physicians’ 

records to be inadequate under Ariz. 

Rev. Stat. Ann. § 32–1401(27)(e) based 

on a failure to document physical 

examinations. For example, the Board 

found that a physician violated section 

(e) when he issued eleven controlled 

substances prescriptions to a friend 

without maintaining medical records. In 

the Matter of Steven M. Rayle, M.D., 

2017 WL 3461215, at *1–2 (Aug. 3, 

2017). In support of its conclusion that 

the physician’s records were 

inadequate, the Board stated that a 

physical examination must be 

documented: 

The standard of care requires a physician 

to document a patient evaluation, including 

history and physical examination adequate to 

establish a diagnosis, identify underlying 

conditions, and monitor for effectiveness, 

side effects, and adverse effects of the 

medication. Respondent deviated from the 

standard of care by repeatedly prescribing 

medications to Patient 1 without 

documenting a history and/or physical exam, 

and without monitoring for efficacy, side 

effects or adverse outcomes. 

Id. at *1.64

Even if I were to conclude that 

Respondent had performed adequate 

physical examinations, despite her 

failure to document them, the 

substantial record evidence would still 

support a finding that Respondent 

violated section Ariz. Rev. Stat. Ann. 

§ 32–1401(27)(ss), at least with respect 

to certain prescriptions. The record 

evidence demonstrates that Respondent 

did not perform a physical examination 

every time she prescribed a controlled 

substance,65 which the statute requires 

in the absence of a previouslyestablished doctor-patient 

relationship.66 Thus, any time 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33769 

applied to every prescription that a physician 

issues, because it suggests that a physician who has 

established a doctor-patient relationship has 

discretion over when to perform a physical 

examination. 

67See, e.g., In the Matter of Thomas J. Petrone, 

M.D., No. MD–08–0059A, 2009 WL 349716, at *3 

(Ariz. Med. Bd. Feb. 5, 2009) (finding that there was 

‘‘potential harm of misuse, addiction, overdose, and 

death’’ when ‘‘[r]espondent dispensed opioids to 

[three individuals] in the absence of any 

documented therapeutic indications’’); In the 

Matter of Leonard A. Jasinski, M.D., MD–09–0625A, 

2009 WL 6038216, at *1 (Ariz. Med. Bd. Feb. 11, 

2009) (finding that there was potential for harm 

from respondent’s prescribing to his stepson, who 

had a prior history of opiate dependence, because 

the prescribing ‘‘may have exacerbated [his 

stepson’s dependence] and may have prevented 

him from obtaining appropriate medical treatment 

and intervention’’); In the Matter of Mark R. 

Austein, M.D., Nos. MD–14–0230A, MD–14–1060A, 

MD–15–1027B, 2017 WL 554260, at *3 (Ariz. Med. 

Bd. Feb. 2, 2017) (finding that ‘‘abuse, addiction, 

and/or diversion’’ could have resulted from 

respondent’s failure to monitor his buprenorphine 

patients for treatment compliance); Osborne v. 

Arizona Medical Board, No. 1 CA–CV 16–0250, 

2017 WL 2544508, at *3–5 (Ariz. Ct. App. June 13, 

2017) (affirming the superior court’s order 

upholding the Arizona Medical Board’s conclusion 

that respondent caused the ‘‘potential for overdose 

and death’’ by prescribing excessive dosages of 

opioids, failing to document a clear rationale for 

dosage escalations, failing to account for co-morbid 

conditions, and failing to recognize clear signs of 

opioid misuse and diversion). 68The RD found that Respondent issued two 

hundred and nine prescriptions to H.D., M.D., and 

S.P. outside the usual course of professional 

practice and not for a legitimate medical purpose, 

in violation of federal law. See, e.g., RD, at 90, 94, 

99. Although the RD implied that the Government 

had failed to meet its burden of proving certain 

state law violations, the RD ultimately sustained all 

of the Government’s state law allegations. Compare 

Id. (stating that ‘‘the Government’s allegation that 

[Respondent] issued prescriptions outside the usual 

course of professional practice and without a 

legitimate medical purpose, in violation of 21 

U.S.C. 841(a)(1), 21 CFR 1306.04(a) and Ariz. Rev. 

Stat. Ann. § 32–1401(27)(e), (q), and (ss), is 

SUSTAINED’’) with RD, at 88–90, 92–93, 97, 118– 

21 (disagreeing with the Government’s conclusion 

that a physician must maintain medical records in 

order to establish a valid doctor-patient 

relationship, and concluding that Respondent 

physically examined and formed valid doctorpatient relationships with H.D., M.D., and S.P.), id. 

at 83 (stating that the ‘‘Arizona Revised Statute, 

which the Government cited to in the OSC, does not 

share ‘a substantial relationship to the CSA’s 

purpose of preventing substance abuse and 

diversion’ ’’), id. at 84 (noting that section (q) is 

‘‘undeniably broad’’); see also Govt Posthearing, at 

15 (taking exception to the RD’s ‘‘fail[ure] to 

evaluate any of the testimony and exhibits against 

the backdrop of Ariz. Rev. Stat. Ann. § 32– 

1401(27)(q)’’). 

Respondent prescribed a controlled 

substance without performing a 

physical examination, Respondent 

violated section (ss). I cannot conclude 

with certainty how many times 

Respondent violated this statute because 

Respondent did not maintain any 

documentation, or offer sufficient 

evidence of when she performed 

physical examinations. 

Overall, I find that there is substantial 

evidence that Respondent violated Ariz. 

Rev. Stat. Ann. § 32–1401(27)(ss), based 

on Dr. Lynch’s credible expert 

testimony that Respondent failed to 

establish valid doctor-patient 

relationships and document adequate 

physical examinations. Any such 

violation weighs against Respondent’s 

continued registration under Factors 

Two and Four. 

iii. Respondent Violated Ariz. Rev. Stat. 

Ann. § 32–1401(27)(q) By Committing 

Conduct That Might Have Been Harmful 

or Dangerous to the Health of Her 

Patients 

I also find that the substantial 

evidence on the record supports a 

finding that Respondent violated 

Arizona law by issuing two hundred 

and nine prescriptions while 

‘‘[c]ommitting any conduct or practice 

that is or might be harmful or dangerous 

to the health of the patient or the 

public.’’ Ariz. Rev. Stat. Ann. § 32– 

1401(27)(q). The Arizona Court of 

Appeals has acknowledged that this 

statute is ‘‘potentially overly inclusive,’’ 

because it is broad enough to encompass 

‘‘many appropriate forms of medical 

treatment [that] entail potential harm,’’ 

such as radiation, chemotherapy, and 

most prescription drugs. Webb v. Ariz. 

Bd. of Med. Exam’rs, 48 P.3d 505, 511 

(Ariz. Ct. App. 2002) (rejecting 

appellant’s argument that Ariz. Rev. 

Stat. Ann. § 32–1401(27)(r) was 

unconstitutionally vague). The court 

concluded that the Arizona legislature 

could not have intended to proscribe 

‘‘any form of treatment that entails 

potential danger or harm,’’ but rather 

must have intended to ‘‘proscribe only 

those forms of treatment whose 

potential or actual harm is unreasonable 

under the circumstances, given the 

applicable standard of care.’’ Id. There 

is no requirement that the state board 

‘‘make an express finding that potential 

or actual harm is ‘unreasonable under 

the circumstances.’’’ Osborne v. Arizona 

Medical Board, No. 1 CA–CV 16–0250, 

2017 WL 2544508, at *4 (Ariz. Ct. App. 

June 13, 2017) (internal citation 

omitted). 

I find that the substantial evidence on 

the record supports a finding that 

Respondent’s prescribing to H.D., M.D., 

and S.P. might have been harmful or 

dangerous to their health. Dr. Lynch 

testified that patients who are taking 

pain pills have a one in five hundred 

chance of overdosing and dying, ‘‘which 

is a very high death rate.’’ Tr. 182–83. 

He stated that when opioids and 

benzodiazepines are combined, the 

death rate increases by nine times. Id. at 

302. Respondent could have caused 

harm by prescribing this dangerous 

combination of controlled substances 

without maintaining medical records; 

without documenting any justification 

for the prescriptions; without obtaining 

past medical records to confirm the 

patients’ past treatment; without 

utilizing monitoring tools, such as the 

PMP and urine drug screens; without 

adequately addressing red flags of abuse 

and diversion, such as doctor shopping; 

and without adequately addressing 

M.D.’s substance abuse problems. See 

supra II.F; see also Tr. 197–98 (Dr. 

Lynch’s testimony that Respondent’s 

prescribing may have ‘‘put [M.D.’s] life 

at risk’’ because of M.D.’s clear history 

of alcoholism); id. at 205, 209 (Dr. 

Lynch’s testimony that Respondent 

could have harmed H.D. by prescribing 

opioids and benzodiazepines without 

any documented justification); id. at 

213–15, 294–95, 297, 307 (Dr. Lynch’s 

testimony that Respondent could have 

harmed S.P. by failing to address red 

flags of opiate use disorder or 

benzodiazepine use disorder). Further, 

the Arizona Medical Board has initiated 

disciplinary actions alleging violations 

of Ariz. Rev. Stat. Ann. § 32–1401(27)(q) 

based on similar articulations of 

potential harm.67

For all these reasons, I find that the 

Government has proven by substantial 

evidence that Respondent violated Ariz. 

Rev. Stat. Ann. § 32–1401(27)(q). 

In conclusion, I find that the 

Government has proven by substantial 

evidence that Respondent issued two 

hundred and nine controlled substance 

prescriptions 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)(e), (q), and (ss).68 As 

Respondent issued these prescriptions 

without complying with her obligations 

under the CSA and Arizona law, I find 

that Factors Two and Four weigh in 

favor of revocation. See George Mathew, 

M.D., 75 FR 66138, 66148 (2010)). 

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 she can be entrusted with a 

registration. Garrett Howard Smith, 

M.D., 83 FR at 18910 (collecting cases). 

Respondent has not ensured me that she 

can be trusted with a registration. 

The CSA authorizes the Attorney 

General to ‘‘promulgate and enforce any 


lotter on DSK11XQN23PROD with NOTICES1
33770 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

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, supra, 546 U.S. at 

259. 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 

she has presented ‘‘sufficient mitigating 

evidence to assure the Administrator 

that [s]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, Respondent has presented no 

evidence on the record that I could 

consider as accepting responsibility. 

Respondent maintained throughout 

these proceedings that she believes that 

her prescribing to the three individuals 

in question was proper and she made 

statements throughout the proceeding 

that minimized her misconduct. See 

Resp Posthearing, at 15; supra III.A.1.a. 

For example, Respondent testified that 

she was ‘‘not the least bit concerned that 

any of [the prescriptions that she issued] 

were given away, diverted, or used 

inappropriately.’’ Tr. 729. Respondent 

also minimized the potential dangers of 

prescribing controlled substances to 

M.D., despite M.D.’s substance abuse 

problems. Respondent testified that she 

‘‘hope[d] . . . [M.D.] was able to clarify 

that she has a mild alcohol use 

disorder,’’ and while she recognized 

that prescribing opioids and 

benzodiazepines to M.D. was ‘‘not 

ideal,’’ she testified that she ‘‘sp[oke] to 

[M.D.] about not using these agents 

together in any capacity’’ and ‘‘[did not] 

feel that [M.D] suffered any negative 

consequences from it.’’ Id. (emphasis 

added). Although Respondent and M.D. 

downplayed M.D.’s struggles with 

alcohol at the hearing, it was evident 

from Respondent’s previous statements 

to Investigators that M.D.’s alcohol 

problems were significant and 

disruptive. Respondent told 

investigators in December 2017 that 

M.D. ‘‘was removed from [Respondent’s] 

property one time . . . because she was 

drunk.’’ GX 4, at 3. She also told 

Investigators, ‘‘I can’t tell you what this 

couple years has been like with this 

addiction, this alcohol issue.’’ Id. at 7. 

Dr. Lynch testified that Respondent put 

M.D.’s life at risk with her prescribing 

because of M.D.’s history of alcoholism 

and her history of receiving controlled 

substances from multiple providers. Tr. 

197–98, 294. I am concerned by 

Respondent’s unwillingness to 

acknowledge the dangers of prescribing 

dangerous combinations of controlled 

substances to an intimate partner who 

has substance abuse problems, without 

utilizing any monitoring tools or 

maintaining medical records. 

Respondent did admit that she failed 

to maintain adequate medical records. 

See, e.g., id. at 719; Resp Posthearing, at 

8, 12. However, Respondent 

occasionally minimized the importance 

of diligent recordkeeping in her 

testimony. She testified that she 

‘‘probably took some notes’’ when she 

was providing treatment to H.D., but she 

‘‘probably threw them away.’’ Tr. 694– 

95, 717–18. When asked why she would 

throw away records pertaining to a 

patient, Respondent said it was 

‘‘[b]ecause [she] felt like [she] had the 

information [she] needed to treat him.’’ 

Id. at 718. When asked again why she 

destroyed the records, she replied: 

‘‘Because I knew what it was. For 

example, if a patient is being managed 

for hypertension, it’s a trend 

phenomenon. If you’re managing two 

patients for hypertension, it’s usually 

fairly easy to remember the trends for 

two people.’’ Id. Respondent’s 

implication that she could have safely 

treated H.D. without maintaining 

medical records is contrary to Arizona’s 

emphasis on the importance of 

maintaining contemporaneous medical 

records. See supra II.E., III.A.1.a. 

Regardless, Respondent’s admission 

that she failed to maintain adequate 

medical records was not a sufficient 

acceptance of responsibility, because I 

found above that Respondent’s standard 

of care violations went beyond her 

failure to maintain adequate medical 

records. See supra II.F, III.A.1. 

Respondent did not accept 

responsibility for any of those 

additional violations. In all, Respondent 

failed to explain why, in spite of her 

misconduct, she 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 [s]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 46968, 49973 (2019); see also Singh, 

M.D., 81 FR at 8248 (‘‘until . . . [a] 

Respondent can convincingly show he 

[or she] accepts the authority of the law 

and those bodies charged with enforcing 

it and regulating his [or her] activities, 

granting [ ] a DEA registration will 

gravely endanger the public.’’). 

Even if Respondent’s acceptance of 

responsibility for her wrongdoing had 

been sufficient such that I would reach 

the matter of remedial measures, 

Respondent has not offered adequate 

remedial measures to assure me that I 

can entrust her with a registration. 

Respondent testified that she has closed 

her private practice and indicated that 

she does not intend to resume it in the 

future. Tr. 637, 731–33; Resp 

Posthearing, at 8, 12–13. Respondent 

also testified that her documentation 

will be better in the future because she 

will only use her registration in the 

emergency room ‘‘where there are 

electronic medical records that [she] 

fill[s] out on every single patient.’’ Tr. 

732. Respondent testified that she 

thinks she is a better documenter in the 

emergency room than in her private 

practice because the company that she 

works for has told her that her 

documentation is adequate enough for 

billing. Id. at 691. 

These remedial measures primarily 

address Respondent’s documentation 

failures. They do not address my 

additional concerns about Respondent’s 

prescribing, such as prescribing 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33771 

69Respondent states in her posthearing brief that 

she completed courses in ‘‘Safe and Effective 

Opioid Prescribing While Managing Acute and 

Chronic Pain’’ and ‘‘Introduction to Prescribing 

Opioids for Pain Management.’’ Resp Posthearing, 

at 13. I agree with the RD that these courses should 

not be considered as remedial evidence because no 

testimony was offered about them and they are not 

mentioned in Respondent’s curriculum vitae. See 

RD, at 80 n.45 (referencing RX 1). 

70Respondent admitted into evidence an affidavit 

from the Emergency Department Medical Director at 

the hospital where she has been working since 

2014. RX 11. The affidavit states that ‘‘[Respondent] 

is an outstanding Emergency Room physician, is 

dedicated to delivering high quality, compassionate 

patient care and she succeeds at same.’’ Id. at 1. The 

affidavit also states that ‘‘[Respondent] is an 

exceptional asset to Holy Cross and the vastly 

underserved population that is treated there,’’ and 

‘‘if [Respondent] were to lose her DEA registration 

she would be unable to work at Holy Cross 

Hospital, which would be devastating to the 

community.’’ Id. While I appreciate that 

Respondent is a highly-qualified and hardworking 

physician, and that she has made substantial 

contributions to her community, community impact 

evidence is considered to be irrelevant to DEA 

revocation proceedings. See, e.g., Frank Joseph 

Stirlacci, M.D., 85 FR 45229, 45239 (2020) 

(declining to consider Respondent’s argument that 

his revocation ‘‘would deprive the low-income and 

homeless patients . . . of his medical services’’); 

Mark De La Lama, P.A., 76 FR 20011, 20020 n.20 

(2011) (declining to consider a registrant’s service 

to underserved and underinsured persons). 

Although this affidavit could be relevant to my 

determination of whether I can entrust Respondent 

with a DEA registration, I find that this affidavit has 

little weight because the affiant was not subject to 

cross examination at the hearing. 

71 I agree with the RD that Terese is not relevant 

to my sanction determination because it is a 

pharmacy case that involves three recordkeeping 

violations of a different nature than those involved 

in this case. RD, at 126–27. 

72The RD proposes that registration number 

BH3877733—which Respondent testified that she 

uses to prescribe controlled substances in her 

private clinical practice and in the emergency room, 

Tr. 631—be suspended for three months. RD, at 127. 

Following the suspension period, the RD proposes 

that Respondent may resume using that registration 

in the emergency room, but she must provide DEA 

with a signed writing that she will cease private 

practice. Id. It further proposes that Respondent 

may seek permission from DEA to resume private 

practice two years after the Agency’s final order, but 

she must provide evidence that she has attended 

trainings on medical recordkeeping and prescribing 

controlled substances. Id. 

Respondent has five additional DEA registrations 

that are connected with five air medical bases in 

Southern Arizona that she supervises: FH2922169, 

FH2922157, FH2922133, FH2922121, and 

FH2922119. Id. at 630–31. Respondent testified that 

these registrations are ‘‘used exclusively to obtain 

medications for flight crews’’ and she does not use 

them to prescribe controlled substances to patients. 

Id. at 630–31633. The RD recommends that these 

five registrations remain active during the 

suspension period, but only ‘‘to order, purchase, or 

obtain controlled substances for the air bases that 

[Respondent] supervises for Air Methods.’’ RD, at 

128. I reject the RD’s (and Respondent’s) contention 

that Respondent’s various DEA registrations should 

be subjected to different sanctions based on the 

manner in which Respondent uses them. See RD, 

at 122 (stating that the Government ‘‘ha[d] 

advanced no evidence whatsoever concerning 

[Respondent’s] prescribing of controlled substances 

in the emergency room or how she has handled 

controlled substances as director of Air Methods’’); 

Resp Posthearing, at 2, 10 (arguing that ‘‘the 

evidence presented by Government [sic] at the 

Order to Show Cause hearing related solely to 

conduct that involved Respondent’s DEA 

Registration BH 3877733’’ and there is ‘‘no evidence 

justifying any adverse action against Respondent’s 

FH DEA Registrations’’). My finding that 

Respondent’s continued registration is inconsistent 

with the public interest applies equally to all of 

Respondent’s DEA registrations, regardless of how 

she uses those registrations. In cases involving 

pharmacies with multiple DEA registrations, DEA 

has held that it may revoke the pharmacy’s second 

registration where misconduct has been proven 

with respect to ‘‘owners, officers, or key 

employees’’ of the first pharmacy who ‘‘have 

influence over the management or control of the 

second pharmacy.’’ See Superior Pharmacy I and 

Superior Pharmacy II, 81 FR 31310, 31341 n.71 

(2016) (citing Lawsons & Sons Pharmacy and 

Fenwick Pharmacy, 48 FR 16140, 16141 (1983); 

Orlando Wholesale, L.LC., 71 FR 71,555, 71,557 

(2006)). This rule has also been applied to 

practitioners who hold multiple registrations. See 

Roberto Zayas, MD, 82 FR 21410, 21430 (revoking 

physician’s Florida registration based on allegations 

concerning his Texas registration and where there 

was no evidence that the Florida registration was 

being used). In fact, when the Agency orders 

revocation, as a matter of course it orders revocation 

of pending applications in the same jurisdiction. 

See e.g., Leslie Pompy, M.D., 84 FR 57749, 57762 

(2019); Kaniz F. Khan-Jaffery, M.D., 85 FR at 45686. 

In this case, all of the registrations at issue are based 

in Arizona and I have found that Respondent 

violated the applicable standard of care in Arizona 

and state law; therefore, I find that her registrations 

in Arizona are inconsistent with the public interest 

and I apply my sanction to all of her Arizona 

registrations. 

73The ALJ found that the Agency’s Decision in 

Joseph Gaudio, M.D., 74 FR 10083 (2009) was 

instructive in crafting a remedy. RD, at 124–26. 

However, Dr. Gaudio’s violations were of a different 

nature than Respondent’s. While Gaudio involved 

a physician who prescribed controlled substances 

for a short period of time to individuals over the 

internet, the case before me involves a physician 

who prescribed controlled substances to close 

friends over a long period of time without 

maintaining any medical records. See Tr. 636. 

Moreover, the sanction imposed in Gaudio was 

more substantial than the remedy proposed by the 

ALJ in this case. In Gaudio, the Agency suspended 

the respondent’s registration for one year and 

ordered that the registrant provide a sworn 

statement accepting responsibility for his violations 

of the CSA in order to get his registration back. Id. 

at 10,095. By contrast, in this case, the ALJ proposes 

that only one of Respondent’s registrations be 

suspended for three months, while her other 

registrations remain active for certain purposes. RD, 

at 127–28. 

potentially dangerous combinations of 

controlled substances, failing to utilize 

monitoring tools, and prescribing 

controlled substances to an individual 

with a substance abuse disorder.69 The 

fact that Respondent has closed her 

private practice is not a sufficient 

remedial measure. If Respondent retains 

her registrations, she will continue to 

prescribe controlled substances in the 

emergency room. Respondent has not 

taken any steps to assure me that she 

will prescribe controlled substances in a 

lawful manner in any setting, including 

the emergency room.70

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). 

Respondent argues that her misconduct 

was not egregious enough to warrant 

revocation because it involved the 

treatment of ‘‘three fellow health care 

professionals in a small private 

practice,’’ ‘‘[i]t was not a fee-generating 

business,’’ ‘‘none of [the individuals] 

suffered any adverse effects from the 

care[,] and there was no harm to the 

public health.’’ Resp Posthearing, at 12. 

Respondent characterizes this case as a 

recordkeeping case involving three 

recordkeeping failures, and she 

references an Agency Decision in which 

the Agency declined to revoke a 

pharmacy’s registration after the 

pharmacy accepted responsibility for 

three recordkeeping violations. Id. 

(citing Terese Inc., 76 FR 46843 

(2011)).71

The ALJ agreed with Respondent that 

revocation was not warranted. Although 

he acknowledged that Respondent had 

not fully accepted responsibility as 

previous Agency Decisions have 

required, he found that Respondent 

‘‘candidly acknowledged’’ that she 

failed to maintain adequate medical 

records, which was the ‘‘main reason 

her prescriptions violated DEA 

regulations.’’ RD, at 114. The ALJ found 

that the Government had not proven 

that Respondent’s violations were 

‘‘egregious enough or severe enough to 

warrant outright revocation,’’ because 

all three patients were healthcare 

professionals who testified at the 

hearing, Respondent established a 

doctor-patient relationship with each 

individual and demonstrated a 

commanding grasp of their medical 

issues, and Respondent closed her 

private practice. Id. at 115–23. 

Additionally, the ALJ found that Dr. 

Lynch’s opinions were primarily based 

on Respondent’s failure to maintain 

adequate medical records. Thus, the ALJ 

concluded that ‘‘this is a factually 

unique case’’ that warrants a ‘‘unique 

sanction,’’ and recommended a threemonth suspension of one of 

Respondent’s six DEA registrations,72

followed by various restrictions on 

Respondent’s registrations.73 Id. at 123, 

127 (internal quotations and citations 

omitted). 

I appreciate the ALJ’s careful analysis 

and hard work on this case. I also 

appreciate the hard work and dedication 

of Respondent’s attorney. However, I 

cannot agree with Respondent that this 

is a recordkeeping case that deserves a 

remedy short of revocation, nor can I 

agree with the ALJ’s conclusion that this 

is a ‘‘unique case’’ that warrants a 


lotter on DSK11XQN23PROD with NOTICES1
33772 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

74See DEA FY 2020 Budget Request available at 

https://www.justice.gov/jmd/page/file/1142431/ 

download. 

75One of the eight violations that Dr. Lynch 

summarized was prescribing controlled substances 

to close personal friends. Tr. 355. As discussed 

above, see II.C., I found that Dr. Lynch’s testimony 

on prescribing to close friends was primarily 

framed as an ethical violation, not a standard of 

care violation. Therefore, I do not give any weight 

in my Decision to Dr. Lynch’s testimony that longterm prescribing to someone with whom you are in 

a close personal relationship is a violation of the 

standard of care. 

‘‘unique remedy.’’ Rather, I find that 

revocation is the appropriate remedy 

based on the egregiousness of 

Respondent’s conduct, her failure to 

accept responsibility, and her failure to 

ensure that I can entrust her with a 

registration in the future. 

I do not find that Respondent’s 

misconduct was mitigated by the fact 

that she prescribed to health care 

professionals. There was no testimony 

or evidence at the hearing that the 

standard of care for treating healthcare 

professionals is different from the 

standard of care for treating individuals 

who are not healthcare professionals. 

Nor was there any evidence that 

healthcare professionals are any less 

susceptible to drug abuse or diversion. 

In fact, there were red flags that 

indicated that these individuals may 

have been abusing or diverting 

controlled substances. See supra II.F, 

III.A.1.a. And while I appreciate that 

H.D., M.D., and S.P. all presented as 

credible witnesses with impressive 

credentials who believed that 

Respondent treated them for legitimate 

medical conditions, and that 

Respondent was knowledgeable about 

their medical conditions, there is not 

sufficient documentary proof to assure 

me that Respondent was not merely 

handing out controlled substances to 

her friends. I found above that a 

physician must maintain medical 

records in order to establish a valid 

doctor-patient relationship in Arizona, 

and I also found that documentation is 

critical to effective enforcement of the 

CSA. See supra II.E., III.A.1.a. With a 

regulated community of nearly two 

million registrants,74 DEA must be able 

to rely on physicians to maintain 

complete and accurate medical records 

justifying their prescribing decisions. 

In finding that revocation was not 

warranted, the ALJ concluded that 

recordkeeping was Respondent’s 

‘‘primary fault.’’ RD, at 116. He found 

that Dr. Lynch’s opinions in the case 

were primarily based on Respondent’s 

failure to maintain adequate medical 

records. Id. at 115–16 (citing Tr. 354, 

379, 381, 741–42). The ALJ placed much 

emphasis on Dr. Lynch’s testimony that 

‘‘we wouldn’t be here today if it was 

[sic] for the lack of documentation.’’ Id. 

(citing Tr. 741). He also referenced Dr. 

Lynch’s testimony that ‘‘it’s possible’’ to 

conduct adequate physical 

examinations and medical histories 

without documenting them, but ‘‘the 

fact [Respondent is] not documenting it 

makes it not appropriate, not an 

adequate doctor/patient relationship.’’ 

Id. at 115 (citing Tr. 378–79). The ALJ 

interpreted Dr. Lynch’s testimony as 

meaning that ‘‘Respondent’s DEA 

registrations would not be subject to 

revocation had she only documented 

what she had done.’’ Id. at 116. 

However, given the extensive testimony 

of Dr. Lynch regarding Respondent’s 

multiple violations of the standard of 

care, I interpret Dr. Lynch’s statement to 

refer to the fact that without 

documentation, it is not possible to 

adequately assess the appropriateness of 

Respondent’s actions. 

Additionally, Dr. Lynch testified that 

Respondent’s standard of care violations 

went beyond her failure to document. 

Specifically, Dr. Lynch testified that 

Respondent committed ‘‘eight standard 

of care violations’’ that ‘‘add up to 

pretty substandard care.’’ 75 Tr. 355; see 

also id. at 742 (testifying that ‘‘most of 

it is the medical record,’’ but ‘‘there are 

a lot of deficiencies, eight that I pointed 

out in my report’’). Dr. Lynch testified 

that some of these violations were 

‘‘egregious’’ and dangerous and 

Respondent could have done harm with 

her prescribing. See II.F. Overall, I do 

not minimize Dr. Lynch’s testimony 

about Respondent’s many standard of 

care violations simply because he 

testified that his decision was primarily 

based on Respondent’s failure to 

document. 

I decline to adopt the ALJ’s proposed 

remedy because it imposes 

administrative burdens on DEA to 

monitor Respondent’s registrations and 

it does not adequately protect the 

public. Respondent has not given me 

any assurances that she will prescribe 

controlled substances appropriately in 

the future nor has she accepted 

responsibility for any of her violations 

of the CSA. In the midst of an opioid 

epidemic where Arizona ranked sixth 

highest in the nation for drug overdose 

deaths in 2010, see GX 16, at 4, I find 

that revocation is the appropriate 

remedy given the egregiousness of 

Respondent’s conduct and her failure to 

accept responsibility. I found above that 

Respondent could have done harm to 

her patients by prescribing dangerous 

combinations of controlled substances 

without maintaining medical records; 

without documenting any justification 

for the prescriptions; without obtaining 

past medical records to confirm the 

patients’ past treatment; without 

utilizing monitoring tools, such as the 

PMP and urine drug screens; without 

adequately addressing red flags of abuse 

and diversion, such as doctor shopping; 

and without adequately addressing 

M.D.’s substance abuse problems. See 

III.A.1.b.iii. For those same reasons, I 

find that Respondent’s conduct was 

egregious. Respondent acknowledged at 

the hearing that combining opioids and 

benzodiazepines might increase the risk 

of respiratory depression or sedation, 

Tr. 665–66, yet she prescribed this 

combination to M.D., even though M.D. 

had known substance abuse problems. 

See supra II.F.1. Dr. Lynch testified that 

opioids have a ‘‘very high death rate,’’ 

and the death rate increases by nine 

times when opioids are combined with 

benzodiazepines. Tr. 180, 182, 302. It 

was dangerous for Respondent to 

prescribe these controlled substances to 

M.D., especially without utilizing any 

monitoring tools to ensure that M.D. 

was not abusing or diverting the drugs. 

These tools would have provided the 

objectivity that Respondent was lacking 

with regard to M.D., as Respondent 

stated in the Interview that she had been 

‘‘duped’’ by M.D. before and that she 

can ‘‘be a little too trusting sometimes, 

especially if it’s someone . . . [she] 

care[s] about.’’ GX 4, at 7. It was also 

egregious for Respondent to prescribe 

controlled substances to S.P.—a former 

intimate partner who was also 

prescribing controlled substances to 

Respondent—without maintaining any 

medical records documenting that 

treatment. Dr. Lynch testified that such 

an arrangement is ‘‘way outside the 

standard of care’’ and he would ‘‘have 

a real concern’’ with it because ‘‘it’s 

akin to treating yourself.’’ Tr. 187. 

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. A 

sanction short of revocation would send 

a message to the regulated community 

that a practitioner can prescribe 

controlled substances to individuals 

over long periods of time without 

maintaining even basic medical records, 

without performing or documenting 

objective assessments of whether they 

were abusing or diverting controlled 

substances in violation of state and 

federal law, even in the face of red flags 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33773 

indicating such abuse and diversion, 

and continue to maintain a controlled 

substances registration in spite of the 

violations and without accepting 

responsibility. Further, there is simply 

no evidence that Respondent’s egregious 

behavior is not likely to recur in the 

future such that I can entrust her with 

a DEA registration; In other words, the 

factors weigh in favor of revocation as 

a sanction. 

I will therefore order that 

Respondent’s registrations 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 Nos. BH3877733, 

FH2922119, FH2922121, FH2922133, 

FH2922157, and FH2922169 issued to 

Carol Hippenmeyer, 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 Carol Hippenmeyer, M.D. 

to renew or modify these registrations, 

as well as any other application of Carol 

Hippenmeyer, M.D., for additional 

registrations in Arizona. This Order is 

effective July 26, 2021. 

D. Christopher Evans, 

Acting Administrator. 

[FR Doc. 2021–13526 Filed 6–24–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Mine Safety and Health Administration 

Petitions for Modification of 

Application of Existing Mandatory 

Safety Standards 

AGENCY: Mine Safety and Health 

Administration, Labor. 

ACTION: Notice. 

SUMMARY: This notice includes the 

summaries of three petitions for 

modification submitted to the Mine 

Safety and Health Administration 

(MSHA) by the party listed below. 

DATES: All comments on the petitions 

must be received by MSHA’s Office of 

Standards, Regulations, and Variances 

on or before July 26, 2021. 

ADDRESSES: You may submit your 

comments including the docket number 

of the petition by any of the following 

methods: 

1. Electronic Mail: zzMSHAcomments@dol.gov. Include the docket 

number of the petition in the subject 

line of the message. 

2. Facsimile: 202–693–9441. 

3. Regular Mail or Hand Delivery: 

MSHA, Office of Standards, 

Regulations, and Variances, 201 12th 

Street South, Suite 4E401, Arlington, 

Virginia 22202–5452, Attention: Jessica 

Senk, Director, Office of Standards, 

Regulations, and Variances. Persons 

delivering documents are required to 

check in at the receptionist’s desk in 

Suite 4E401. Individuals may inspect 

copies of the petition and comments 

during normal business hours at the 

address listed above. 

MSHA will consider only comments 

postmarked by the U.S. Postal Service or 

proof of delivery from another delivery 

service such as UPS or Federal Express 

on or before the deadline for comments. 

FOR FURTHER INFORMATION CONTACT: 

Jessica D. Senk, Office of Standards, 

Regulations, and Variances at 202–693– 

9440 (voice), Senk.Jessica@dol.gov 

(email), or 202–693–9441 (facsimile). 

[These are not toll-free numbers.] 

SUPPLEMENTARY INFORMATION: Section 

101(c) of the Federal Mine Safety and 

Health Act of 1977 and Title 30 of the 

Code of Federal Regulations (CFR) part 

44 govern the application, processing, 

and disposition of petitions for 

modification. 

I. Background 

Section 101(c) of the Federal Mine 

Safety and Health Act of 1977 (Mine 

Act) allows the mine operator or 

representative of miners to file a 

petition to modify the application of any 

mandatory safety standard to a coal or 

other mine if the Secretary of Labor 

determines that: 

1. An alternative method of achieving 

the result of such standard exists which 

will at all times guarantee no less than 

the same measure of protection afforded 

the miners of such mine by such 

standard; or 

2. The application of such standard to 

such mine will result in a diminution of 

safety to the miners in such mine. 

In addition, sections 44.10 and 44.11 

of 30 CFR establish the requirements for 

filing petitions for modification. 

II. Petitions for Modification 

Docket Number: M–2021–016–C. 

Petitioner: Consol Pennsylvania Coal 

Company LLC, 1000 Consol Energy 

Drive, Canonsburg, Pennsylvania (ZIP 

15317). 

Mine: Itmann No. 5 Mine, MSHA ID 

No. 46–09569, located in Wyoming 

County, West Virginia. 

Regulation Affected: 30 CFR 75.507– 

1(a) (Electric equipment other than 

power-connection points; outby the last 

open crosscut; return air; permissibility 

requirements). 

Modification Request: The petitioner 

requests a modification of the existing 

standard, 30 CFR 75.507–1(a), as it 

relates to the use of an alternative 

method of respirable dust protection for 

miners at the Itmann No. 5 Mine in 

West Virginia. Specifically, the 

petitioner is applying to use the 3MTM

VersafloTM TR–800 Intrinsically Safe 

Powered Air Purifying Respirator 

(PAPR) and the CleanSpace EX in return 

air outby the last open crosscut. 

The petitioner states that: 

(a) Currently the petitioner uses the 

3MTM AirstreamTM helmet to provide 

additional protection for its miners 

against exposure to respirable coal mine 

dust. There are clear long-term health 

benefits from using such technology. 

(b) 3M elected to discontinue the 

3MTM AirstreamTM helmet, replacing it 

with a 3MTM VersafloTM TR–800 which 

benefits from additional features and 

reduced weight. Because of its reduced 

weight, it provides significant 

ergonomic benefits. 

(c) For more than 40 years the 3MTM

AirstreamTM Headgear-Mounted PAPR 

System has been used by many mine 

operators to help protect their workers. 

During those years there have been 

technological advancements in products 

and services for industrial applications. 

3M indicated that they had faced 

multiple key component supply 

disruptions for the AirstreamTM product 

line that created issues with providing 

acceptable supply service levels. 

Because of those issues, 3M 

discontinued the AirstreamTM in June 

2020, and this discontinuation is global. 

(d) 3M announced that February 2020 

was the final time to place an order for 

systems and components and that June 

2020 was the final date to purchase 

AirstreamTM components. 

(e) Currently there are no replacement 

3M PAPRs that meet applicable MSHA 

standards for permissibility. Electronic 

equipment used in underground mines 

in potentially explosive atmospheres is 

required to be approved by MSHA in 

accordance with 30 CFR. 3M and other 

manufacturers offer alternative products 

for many other environments and 

applications. 

(f) Following the discontinuation, 

mines that currently use the 

AirstreamTM do not have an MSHAapproved alternative PAPR to provide to 

miners. One of the benefits of PAPRs is 

that they provide a constant flow of air 

inside the headtop or helmet. This 

constant airflow helps to provide both 

respiratory protection and comfort in 

hot working environments. 

(g) Application of the standard results 

in a diminution of safety at the mine. 


lotter on DSK11XQN23PROD with NOTICES1