[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33748-33773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13526]


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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. Sec.  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

[[Page 33749]]

prehearing statements.\1\ ALJX 6 (Prehearing Ruling) at 1-2.
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    \1\ The 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.
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    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).
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    \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 Post-Hearing Briefing Schedule); ALJX 20 (Order 
Granting Respondent's Motion for Extension of Time and Order 
Scheduling Telephonic Conference); ALJX 21 (Order Correcting the 
Transcript).
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    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.
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    \3\ The 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.
    \4\ Respondent'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).
    \5\ The 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.
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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

[[Page 33750]]

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.
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    \6\ See 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.).
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    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 doctor-patient 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.
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    \7\ The 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.
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    DI testified about her investigation-related 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.
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    \8\ I agree with the ALJ that DI was not qualified to opine on 
the requirements of a valid doctor-patient 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.
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    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

[[Page 33751]]

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.
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    \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.
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    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 co-prescribing, 
they just ``strongly recommend[] that docs not do it''). Additionally, 
I found that Dr. Lynch's testimony on the standard of care for co-
prescribing 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.

[[Page 33752]]

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.
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    \11\ For 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'').
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    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.
---------------------------------------------------------------------------

    \12\ S.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.
---------------------------------------------------------------------------

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

    \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.

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[[Page 33753]]

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

    \14\ Based 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).
    \15\ The parties stipulated that ``Halcion is a brand name for 
triazolam, a Schedule IV controlled substance.'' RD, at 27 
(Stipulation No. 11).
    \16\ H.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 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

[[Page 33754]]

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

    \17\ Respondent also testified that she felt under ``increasing 
duress'' during the Interview and was confused by some of the 
questions. Tr. 643.
---------------------------------------------------------------------------

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

    \18\ The parties stipulated that ``Valium is [sic] brand name 
for diazepam, a Schedule IV controlled substance.'' RD, at 27 
(Stipulation No. 8).
---------------------------------------------------------------------------

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

    \19\ See, 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'').
---------------------------------------------------------------------------

    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,

[[Page 33755]]

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

    \20\ The 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 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.
    \21\ The term ``benzos'' was used interchangeably with 
``benzodiazepines'' at the hearing. See, e.g., Tr. 170.
---------------------------------------------------------------------------

    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. Sec. Sec.  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.
---------------------------------------------------------------------------

    \22\ Respondent did not object to the admission of any of these 
exhibits.
---------------------------------------------------------------------------

    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. Sec.  32-1401(27)(ss) (2017).
---------------------------------------------------------------------------

    \23\ Physicians are excused from complying with this statute 
under certain circumstances, such as in an emergency medical 
situations. See Ariz. Rev. Stat. Ann. Sec.  32-1401(27)(ss)(i)-(ix). 
There is no evidence that any of these circumstances were present in 
this case.
---------------------------------------------------------------------------

    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

[[Page 33756]]

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 
doctor-patient 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.
---------------------------------------------------------------------------

    \24\ See 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.'')
---------------------------------------------------------------------------

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

    \25\ The 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 
doctor-patient 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. 
Sec.  32-1401(27)(h) (2014) (defining ``unprofessional conduct'' to 
include ``[p]rescribing or dispensing controlled substances to 
members of the physician's immediate family'').
    \26\ The 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.
---------------------------------------------------------------------------

    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. 
Sec.  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. Sec.  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,

[[Page 33757]]

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

    \27\ The 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 doctor-patient 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.
---------------------------------------------------------------------------

    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. Sec.  
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 X-rays? 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

[[Page 33758]]

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

    \28\ The 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.
---------------------------------------------------------------------------

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

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

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 ``co-prescribing.'' 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.
---------------------------------------------------------------------------

    \31\ Dr. Lynch testified that the biggest factor for predicting 
overdose and death is dose. Tr. 244.
---------------------------------------------------------------------------

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

    \32\ The parties stipulated that ``Xanax is a brand name for 
alprazolam, a Schedule IV controlled substance.'' RD, at 27 
(Stipulation No. 6).
---------------------------------------------------------------------------

    Dr. Lynch testified that ``for at least four years now, the State 
of Arizona has been urging physicians . . . not to have

[[Page 33759]]

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 co-
prescribing. 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.
---------------------------------------------------------------------------

    \33\ The parties stipulated that ``Soma is a brand name for 
carisoprodol, a Schedule IV controlled substance.'' RD, at 27 
(Stipulation No. 12).
---------------------------------------------------------------------------

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

    \34\ The 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.
---------------------------------------------------------------------------

    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. Sec.  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

[[Page 33760]]

patient's care at any point in the course of treatment.'' Ariz. Rev. 
Stat. Ann. Sec.  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.
---------------------------------------------------------------------------

    \35\ The 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.'').
    \36\ See 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.
---------------------------------------------------------------------------

    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

[[Page 33761]]

(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.
---------------------------------------------------------------------------

    \37\ The 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. 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.
    \38\ See 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'').
---------------------------------------------------------------------------

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

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

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

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

    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 doctor-patient 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.
---------------------------------------------------------------------------

    \41\ Respondent 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.
    \42\ M.D. testified that she did not provide past medical 
records to Respondent. See id. at 450, 452-53, 487-88, 491.
---------------------------------------------------------------------------

    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

[[Page 33762]]

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. Sec.  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.
---------------------------------------------------------------------------

    \43\ The 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.
    \44\ See 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.
---------------------------------------------------------------------------

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

    \45\ H.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.
---------------------------------------------------------------------------

    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 doctor-patient 
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.

[[Page 33763]]

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

    \46\ The 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.
---------------------------------------------------------------------------

    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. Sec.  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.
---------------------------------------------------------------------------

    \47\ The 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.
    \48\ See 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).
    \49\ According 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.
---------------------------------------------------------------------------

    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. Sec.  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

[[Page 33764]]

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

    \50\ S.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 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.
    \51\ The 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.
---------------------------------------------------------------------------

    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. [Sec.  ] 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.
---------------------------------------------------------------------------

    \52\ As 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.
---------------------------------------------------------------------------

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

[[Page 33765]]

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

    \53\ See 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).
    \54\ See 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).
---------------------------------------------------------------------------

    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. Sec.  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.
---------------------------------------------------------------------------

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

    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.

[[Page 33766]]

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

    \56\ Respondent'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.
    \57\ See 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 self-
reports of medication use are not always reliable and behavioral 
observations may detect some problems but not others.'').
---------------------------------------------------------------------------

    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 high-risk 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 co-prescribing 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.
---------------------------------------------------------------------------

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

    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

[[Page 33767]]

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

    \60\ As discussed above, I find that Dr. Lynch was sufficiently 
qualified to opine on M.D.'s substance abuse problems. See supra 
II.C.
---------------------------------------------------------------------------

    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. 
Sec. Sec.  32-1401(27)(e), (ss), (q)).\61\ I find that the Government 
has proven these allegations by substantial

[[Page 33768]]

evidence, at least with respect to certain prescriptions.
---------------------------------------------------------------------------

    \61\ This 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.
---------------------------------------------------------------------------

i. Respondent Violated Ariz. Rev. Stat. Ann. Sec.  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. Sec.  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. Sec.  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. Sec.  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. Sec.  
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. Sec.  32-
1401(27)(ss) (2017). I found above that in order to establish a valid 
doctor-patient 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.
---------------------------------------------------------------------------

    \62\ Although Respondent testified at the hearing that she 
believes that she established valid doctor-patient 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. Sec.  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. Sec.  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.
    \63\ There is no evidence that Respondent performed a mental 
status examination in lieu of a physical examination prior to 
prescribing.
---------------------------------------------------------------------------

    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. Sec.  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\
---------------------------------------------------------------------------

    \64\ See 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).

    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. Sec.  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 previously-established doctor-
patient relationship.\66\ Thus, any time

[[Page 33769]]

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

    \65\ See, 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.'')
    \66\ A 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. Sec.  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 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.
---------------------------------------------------------------------------

    Overall, I find that there is substantial evidence that Respondent 
violated Ariz. Rev. Stat. Ann. Sec.  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. Sec.  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. Sec.  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. Sec.  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. Sec.  
32-1401(27)(q) based on similar articulations of potential harm.\67\
---------------------------------------------------------------------------

    \67\ See, 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).
---------------------------------------------------------------------------

    For all these reasons, I find that the Government has proven by 
substantial evidence that Respondent violated Ariz. Rev. Stat. Ann. 
Sec.  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. 
Sec.  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.
---------------------------------------------------------------------------

    \68\ The 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. Sec.  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 doctor-patient 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. 
Sec.  32-1401(27)(q)'').
---------------------------------------------------------------------------

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

[[Page 33770]]

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 fact-dependent determination 
based on the circumstances presented by the individual respondent; 
therefore, the Agency looks at factors, such as the acceptance of 
responsibility and the credibility of that acceptance as it relates to 
the probability of repeat violations or behavior and the nature of the 
misconduct that forms the basis for sanction, while also considering 
the Agency's interest in deterring similar acts. See Arvinder Singh, 
M.D., 81 FR 8247, 8248 (2016).
    Here, 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

[[Page 33771]]

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

    \69\ Respondent 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).
    \70\ Respondent 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.
---------------------------------------------------------------------------

    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\
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    \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.
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    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 three-month 
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).
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    \72\ The 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.
    \73\ The 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.
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    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

[[Page 33772]]

``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.
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    \74\ See DEA FY 2020 Budget Request available at https://www.justice.gov/jmd/page/file/1142431/download.
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    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.
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    \75\ One 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 
long-term prescribing to someone with whom you are in a close 
personal relationship is a violation of the standard of care.
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    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

[[Page 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