Kaniz F. Khan-Jaffery, M.D.; Decision and Order, 45667-45691 [2020-16387]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 85, Number 146 (Wednesday, July 29, 2020)]
[Notices]
[Pages 45667-45691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16387]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 18-28]


Kaniz F. Khan-Jaffery, M.D.; Decision and Order

I. Procedural History

    On April 12, 2018, a former Acting Administrator of the Drug 
Enforcement Administration (hereinafter, DEA or Government), issued an 
Order to Show Cause and Immediate Suspension Order (hereinafter 
collectively, OSC) to Kaniz F. Khan-Jaffery, M.D. (hereinafter, 
Respondent), of Absecon, New Jersey. Administrative Law Judge 
(hereinafter, ALJ) Exhibit (hereinafter, ALJX) 1, (OSC) at 1. The OSC 
informed Respondent of the immediate suspension of her DEA Certificate 
of Registration No. BK9710939 pursuant to 21 U.S.C. 824(d) ``because . 
. . [her] continued registration constitute[d] an imminent danger to 
the public health and safety.'' Id. The OSC also proposed the 
revocation of Respondent's Registration pursuant to 21 U.S.C. 824(a)(4) 
and the denial of ``any pending applications for renewal or 
modification of such registration, because [her] continued registration 
is inconsistent with the public interest, as that term is defined in 21 
U.S.C. 823(f).'' Id.
    Specifically, the OSC alleged that Respondent issued prescriptions 
for controlled substances to six individuals outside the usual course 
of the professional practice and beneath the standard of care for the 
State of New Jersey in violation of 21 CFR 1306.04(a) and N.J. Stat. 
Sec. Sec.  24:21-15.2 and 45:9-22.19. OSC, at 2-5.
    On April 12, 2018, based on his preliminary finding that Respondent 
issued multiple prescriptions to one individual without a legitimate 
medical purpose, and to five individuals, while ignoring inconsistent 
urine screens that indicated abuse or diversion of controlled 
substances, the former Acting Administrator concluded that Respondent's 
``continued registration . . . [was] inconsistent with the public 
interest.'' OSC, at 5. Citing 21 U.S.C. Sec.  824(d), he also made the 
preliminary finding that Respondent's continued registration during the 
pendency of proceedings ``would constitute an imminent danger to the 
public health or safety because of the substantial likelihood that 
[Respondent] would continue to issue prescriptions for controlled 
substances, which would result in the abuse or diversion of controlled 
substances.'' Id.
    Pursuant to 21 U.S.C. 824(d) and 21 CFR 1301.36(e), the former 
Acting Administrator immediately suspended Respondent's Certificate of 
Registration and authorized the DEA Special Agents and Diversion 
Investigators serving the OSC on Respondent to place under seal or to 
remove for safekeeping all controlled substances Respondent possessed 
pursuant to the immediately suspended registration. Id. The former 
Acting Administrator also directed those DEA employees to take 
possession of Respondent's Certificate of Registration BK9710939. Id.
    The OSC notified Respondent of the right to request a hearing on 
the allegations or to submit a written statement, while waiving the 
right to a hearing, the procedures for electing each option, and the 
consequences for failing to elect either option. Id. (citing 21 CFR 
1301.43).
    By letter dated May 1, 2018, Respondent timely requested a hearing. 
ALJX 2 (Request for Hearing), at 1. The matter was placed on the docket 
of the

[[Page 45668]]

Office of Administrative Law Judges and assigned to Administrative Law 
Judge Charles W. Dorman (hereinafter, ALJ). On May 3, 2018, the ALJ 
established a schedule for the filing of prehearing statements. ALJX 3 
(Order for Prehearing Statements), at 1, 4. The Government filed its 
Prehearing Statement on May 15, 2018, and Respondent filed its 
Prehearing Statement on May 25, 2018. ALJX 4 (hereinafter, Govt 
Prehearing) and ALJX 5 (hereinafter, Resp Prehearing). On June 6, 2018, 
the ALJ issued his Prehearing Ruling that, among other things, set out 
twenty-two Stipulations already agreed upon and established schedules 
for the filing of additional joint stipulations and supplemental 
prehearing statements, which were filed by both the Respondent and the 
Government on August 8 and 15, 2018, respectively. ALJX 9 (Prehearing 
Ruling), at 1-9; ALJX 21 (hereinafter, Resp Supp Prehearing); ALJX 22 
(hereinafter, Govt Supp Prehearing). Additionally, on July 18, 2018, 
Respondent filed a Motion to Strike and for Recommendation for Interim 
Reinstatement, alleging among other things that the OSC mis-referenced 
N.J.S.A. 24:21-15.2, because the statute did not go into effect until 
May 16, 2017. ALJX 12 (Resp Motion to Strike), at 2-3. The Government 
filed an opposition on July 23, 2018. ALJX 15 (Govt Opposition). The 
ALJ denied Respondent's Motion to Strike, finding that Respondent's 
argument is fact-based and is ``best left for either resolution between 
the Parties or at the hearing.'' ALJX 17 (Motion to Strike Denial), at 
2.\1\ I have reviewed and agree with the procedural rulings of the ALJ 
during the administration of the hearing.
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    \1\ It is noted that on November 15, 2018, the ALJ sent notice 
to the parties that I had concluded that the DEA ALJs had not been 
properly appointed under Article II of the Constitution at the time 
of the hearing and the ALJ set a deadline to bring a challenge based 
on the Appointments Clause, which the ALJ then extended after the 
Respondent requested clarification regarding the implications of a 
challenge. ALJX 51 (Notice); ALJX 52 (Respondent Letter); ALJX 53 
(Response and Extension). Respondent then sent a letter to me 
requesting indemnification for the cost of the initial hearing so 
that she could request a new hearing and also moved for an 
adjournment of the proceedings until I responded to her request for 
indemnification. ALJX 55 (Respondent's Letter to the Acting 
Administrator). The ALJ denied the Adjournment, finding that he had 
extended the deadline already once and that Respondent had waived 
her opportunity to make an Appointments Clause challenge. ALJX 56 
(Order Denying Respondent's Request for Adjournment). I agree with 
the ALJ that Respondent's Appointments Clause challenge did not 
comply with the terms of the ALJ's notice authorizing such a 
challenge. Further, Respondent made no further argument about the 
Appointments Clause in either her Posthearing Brief or her 
Exceptions to the RD; therefore, I find that Respondent waived her 
right to challenge the ALJ's appointment.
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    The hearing in this matter spanned five days.\2\ The Recommended 
Rulings, Findings of Fact, Conclusions of Law and Decision of the 
Administrative Law Judge (hereafter, RD) is dated January 31, 2019. 
Both parties filed exceptions to the RD on March 13, 2019. ALJ 
Transmittal Letter, at 1. On March 20, 2019, the ALJ transmitted his 
RD, along with the certified record, to me. Id.
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    \2\ Hearings were held in New York, New York on September 17-21, 
2018.
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    Having considered this matter in the entirety, I find that 
Respondent issued twenty-three prescriptions beneath the applicable 
standard of care and outside of the usual course of the professional 
practice in New Jersey, in violation of federal law, and that 
Respondent also committed violations of state law.
    I issue this Decision and Order based on the entire record before 
me. 21 CFR 1301.43(e). I make the following findings of fact.

II. Findings of Fact

A. Respondent's DEA Registration

    Respondent is registered with the DEA as a practitioner in 
schedules II through V under DEA Certificate of Registration No. 
BK9710939, at the registered address of 1129 North New Road, Absecon, 
New Jersey, 08201. Government Exhibit (hereinafter, GX) 1 (Respondent's 
Certificate of Registration). This registration expires on December 31, 
2020. Id. This registration was suspended pursuant to the Immediate 
Suspension Order dated April 12, 2018. OSC, at 1.

B. The Government's Case

    The Government's documentary evidence consisted primarily of 
medical records for six individuals treated by Respondent between 
January 30, 2015, and October 18, 2017, which included the records for 
one undercover Special Agent. The Government called three witnesses; a 
DEA Special Agent, who posed undercover as patient A.D. on six 
occasions (hereinafter, the UC); a DEA Diversion Investigator 
(hereinafter, DI), who participated in the investigation of Respondent; 
and an expert witness, Dr. Andrew Kaufman. RD, at 7-10.
    The UC testified about her role in the investigation of Respondent 
and her role-related and investigatory experience. Tr. 36-38. On each 
of the six occasions in which the UC visited Respondent, she wore a 
recording device that provided audio and video recordings of each 
visit.\3\ Id. at 38. Those video recordings and transcripts of the 
recordings are provided in Government's exhibits.\4\ GX 6-11 (Video 
Files of the UC's visits with Respondent on October 17, 2016, November 
23, 2016, December 22, 2016, January 19, 2017, March 7, 2017, and April 
4, 2017, respectively); GX 12-17 (Transcripts of UC visits). The 
Government also provided copies of the UC's patient file for her six 
visits and the prescriptions issued to her by Respondent. GX 18, 19, 
21, 23, 25, 27, 29 (patient file and visit notes); GX 20, 22, 24, 26, 
28 (copies of prescriptions issued to the UC by Respondent). Having 
read and analyzed all of the record evidence, including the video 
recordings of the UC's visits, I agree with the ALJ's conclusion that 
the UC's relevant testimony was ``sufficiently objective, detailed, 
plausible, and internally consistent,'' and therefore, credible.\5\ RD, 
at 7-8.
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    \3\ The UC testified that during her final visit with 
Respondent, the recording device malfunctioned and provided only an 
audio recording of the visit. Tr. 38, 71; see also RD, at 7.
    \4\ The UC testified that the transcripts of the recordings were 
accurate depictions of the visits, with the exception of the 
transcript in GX 12 at page 8, where the UC testified that she told 
Respondent that she got her medicine in ``New York,'' rather than 
``Newark.'' Tr. 44, 50; RD, at 7.
    \5\ The ALJ noted that he found some irrelevant testimony of the 
UC confusing, but he also noted that the testimony does not detract 
from her overall credibility. RD, at 8 (citing tr. 81-88). I agree 
that the topic was irrelevant. Further, I determine that due to the 
Government's objections regarding law enforcement sensitivity during 
the hearing, it does not appear to me that the facts were fully 
explored on this topic, and therefore, I do not find the testimony 
confusing. I agree with the ALJ that this testimony does not detract 
from the UC's credibility.
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    The Government presented the testimony of a DI assigned to the DEA 
Camden Resident Office, who participated in the administrative 
investigation of Respondent. Tr. 125-26. The DI testified that she 
first became aware of Respondent while investigating a pharmacy. Id. at 
126; see also RD, at 8. She testified that one of the pharmacy's 
suppliers had ``seen that pharmacy had an unusually high volume of 
narcotic prescriptions being filled, and that [Respondent] was the No. 
1 prescriber for that pharmacy and for those controlled substances.'' 
Tr. 127. The DI testified that an administrative subpoena was issued to 
Respondent to obtain complete patient records for seventy-four named 
individuals, who were identified based on red flags for diversion, and 
another subpoena was issued for updates on thirty of those individuals 
named in the earlier subpoena. Tr. 128, 129; see GX 4 (first 
administrative subpoena issued November 3, 2017) and GX 5 (second 
administrative subpoena served April 13, 2018); see also RD, at 8. The

[[Page 45669]]

Government's evidence includes six patient files obtained through those 
subpoenas. GX 29, 84, 130, 175, 259, 344.
    I agree with the ALJ that the DI's testimony was ``sufficiently 
objective, detailed, plausible, and internally consistent.'' RD, at 8. 
Although the ALJ ultimately concluded that D.I.'s testimony was 
unnecessary, I credit her testimony regarding the Agency's initiation 
of an investigation into Respondent's practice and the results of the 
subpoenas to the extent that they provide the foundations of this 
administrative matter.
    The Government's expert witness, Professor Andrew Kaufman, M.D., is 
a professor of anesthesiology at Rutgers University, and testified that 
he has ``extensive clinical responsibilities, seeing patients in two 
offices'' in New Jersey. Tr. 155-57. He also teaches medical students 
and residents and serves as the Executive Director of the New Jersey 
Society of Interventional Pain Physicians. Id. at 157-58; GX 345 
(Curriculum Vitae of Dr. Kaufman); see also RD, at 8. The ALJ accepted 
Dr. Kaufman as ``an expert in the treatment of pain with controlled 
substances in the State of New Jersey.'' RD, at 8; tr. 168.\6\ The 
matters about which Dr. Kaufman testified included his review and 
standard-of-care analysis of medical records belonging to six of 
Respondent's patients, including the UC. Tr. 171-72. In forming his 
opinion, he also reviewed the video tapes and one audio tape of the UC 
visits with Respondent. Id. at 169.
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    \6\ I agree with the ALJ in overruling the objection of 
Respondent's counsel to Dr. Kaufman's expertise, which counsel 
appeared to be basing on the grounds that Dr. Kaufman only treats 
approximately ten percent of his patients with controlled 
substances, and that, given his preference for not prescribing 
controlled substances, his experience is not relevant to the case. 
RD, at 8; tr. 167-68. I find that the percentage of patients to whom 
controlled substances have been prescribed by Dr. Kaufman has no 
bearing on his expertise in the treatment of pain with controlled 
substances or the applicable standard of care in the State of New 
Jersey.
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    The ALJ found, and I agree, that Dr. Kaufman's testimony was 
``presented in a professional, candid, and straightforward manner'' and 
``was sufficiently objective, detailed, plausible, and internally 
consistent,'' and therefore credible.\7\ RD, at 10.
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    \7\ However, in comparing Dr. Kaufman's testimony with the 
testimony of Dr. Epstein, Respondent's expert witness, the ALJ 
frequently gave Dr. Epstein's testimony more weight, because ``Dr. 
Epstein supported his opinions with more well-reasoned analysis and 
explanation than did Dr. Kaufman.'' RD, at 17; 10 n1. I disagree 
with the ALJ's decision to give Dr. Epstein's testimony more weight 
as explained in the standard of care section below. See infra 
II(E)(1).
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C. The Respondent's Case

    Respondent presented the testimony of four witnesses at the 
hearing, including her own. The first witness, Dr. Lawrence J. Epstein, 
M.D., has treated pain patients for thirty years and is an Associate 
Professor of Anesthesiology and Neurology at the Icahn School of 
Medicine, Mt. Sinai Hospital, and has held professorial appointments 
and staff positions at multiple hospitals in New York. RD, at 11; see 
also tr. 687-97. Dr. Epstein is also the Chair of the New York State 
Board of Medicine, which is responsible for all medical licensure in 
that state and has input into all medical policy for the state. RD, at 
11; tr. 691-93. Dr. Epstein was involved in writing New York's law 
concerning its Prescription Monitoring Program. RD, at 11; tr. 696. Dr. 
Epstein testified that he is familiar with the standard of care for 
prescribing pain medicine and has published articles and spoken 
publicly about prescribing opioids, including the ``over-prescribing'' 
of opioids since about 2008 or 2009. RD, at 11 (citing tr. 699). Dr. 
Epstein submitted a written report on his assessment of the medical 
files of the patients at issue in this proceeding. ALJX 5, Attachment 
1.
    Dr. Epstein holds a license to practice medicine in New Jersey 
since ``somewhere between'' 1986-88, but has never practiced there, and 
his license is inactive. Tr. 703; RD, at 11.\8\ He testified that he 
has read some of the New Jersey statutes concerning pain management, 
but that the standard of care does not include the statutes, and it 
differs by region and the number of patients a doctor sees on a daily 
basis. RD, at 12; tr. 704, 708, 711. With respect to prescribing 
opioids, Dr. Epstein testified there is a nationwide standard of care, 
which he applied in evaluating this case. RD, at 12; tr. 722, 729.
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    \8\ The RD noted 1980, but in the transcript, Dr. Epstein 
hesitated and then said 86-88. Tr. 703.
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    The ALJ admitted Dr. Epstein as an expert in pain management 
practice in ``standard of care, on proper medical procedures with 
respect to pain management, and the appropriate use of controlled 
substances in medical practice.'' RD, at 12 (citing tr. 702, 730). The 
Government objected on the ground that he lacked experience and 
knowledge of the standard of care in New Jersey. RD, at 12; tr. 716-17, 
730. The ALJ found, and I agree, that Dr. Epstein's testimony regarding 
several aspects of the case was ``concerning.'' RD, at 14. In 
particular, the ALJ found that his testimony about Patient J.C.'s 
inconsistent urine screens did not withstand close scrutiny, because 
the patient records did not support his statements. Id. at 14-15 
(citing tr. 1583-84). Dr. Epstein also testified that the UC was an 
established patient by the time Respondent issued her a prescription 
for controlled substances on the second visit, which the ALJ believed 
was a ``bit of a stretch.'' RD, at 15 (citing tr. 1454). The ALJ also 
found that Dr. Epstein placed too much weight on the UC's previous 
medical records, about which even the Respondent ``expressed concern.'' 
RD, at 15 (citing GX 13, at 6-7; RX 7, at 2). Finally, the ALJ found 
that Dr. Epstein's testimony regarding Patient A.P.'s alcohol 
counseling was not based on the evidence. RD, at 15 (citing tr. 1542-
44; tr. 1640-41; GX 80). Despite these concerns, the ALJ found that 
``Dr. Epstein's testimony was compelling in several aspects.'' RD, at 
15. The ALJ credited Dr. Epstein's opinion about urine screens being 
positive for alcohol metabolites and documentation of counseling after 
inconsistent urine screens. Id. at 15-16. In all, the ALJ stated, 
``After having closely observed Dr. Epstein during his testimony, as 
well as having attentively listened to his testimony during the 
hearing, I have carefully reviewed the transcript of his testimony. I 
find that Dr. Epstein's testimony was sufficiently objective, detailed, 
plausible, and internally consistent to be considered credible in this 
Recommended Decision.'' Id. at 16. I defer to the ALJ's assessment of 
Dr. Epstein's overall credibility, and in particular, the ALJ's 
observations of his testimony. However, as further explained herein, I 
do not concur with the ALJ's finding that Dr. Epstein's testimony 
regarding the applicable standard of care in New Jersey was more 
credible than Dr. Kaufman's regarding prescribing after inconsistent 
urine screens. RD, at 16.
    Respondent testified on her own behalf. Tr. 775-1120. She testified 
that she earned her medical degree in Pakistan and completed a 
neurology residency and a fellowship in pain management at Louisiana 
State University. RD, at 17; tr. 784-87. In 2008, Respondent began 
practicing pain management in New Jersey, and worked for two years at a 
neurosurgeon's office, then she worked with her husband's practice, as 
well as consulted in pain management at AtlantiCare Regional Medical 
Center. Tr. 788-89, 793-94. Respondent testified as to her standard 
pain management practice with respect to the patients in question, 
including her use of monthly urine screens, her practice of obtaining 
MRIs before prescribing controlled substances, her use of an electronic 
recordkeeping

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program called eClinical (hereinafter, eClinical), and her counseling 
practice. Id. at 799-805, 827, 882, 991-92, 933-35, 1040; see also RD, 
at 18-19. She also testified specifically to her treatment of the six 
patients. RD, at 19-22. She testified that she sees fifty to fifty-five 
patients per day and bills about ten minutes per patient. Tr. at 985, 
988. Additionally, she testified to the controls that she has put in 
place in her practice. Specifically, she requires a referral from a 
physician to make an appointment. Id. at 815. She also requires all of 
her patients to take urine drug screens on a monthly basis, which she 
does at her own volition and expense, despite the burden it imposes. 
Id. at 799-800.
    The ALJ found, and I agree, that ``there were several aspects of 
[Respondent's] testimony that were problematic.'' RD, at 22. He found 
that her testimony regarding Patient L.M.'s urine screen showing 
Suboxone was not credible. Id. at 22-23. Respondent hypothetically 
discussed the possibility that the patient had received the Suboxone at 
a hospital or rehabilitation facility after running out of her 
medication, but ``two of the three times L.M. screened positive for 
Suboxone, she was also positive for oxycodone,'' and the other time the 
laboratory did not test for oxycodone. RD, at 22-23 (citing tr. 1095-
96, 1099, 1100; GX 175, at 139, 141, 144). If the patient had run out 
of oxycodone in order to receive the Suboxone for withdrawal, she would 
not have tested positive for it. The ALJ also found that Respondent's 
``explanation of why she did not conduct a physical examination of 
[UC's] shoulder to be unconvincing.'' RD, at 23. Specifically, 
Respondent testified at one point that a physical exam would be painful 
because of arthritis, but she also testified that she observed the UC's 
``range of motion to be `pretty good.' '' Id. at 23 (citing tr. 824, 
1065). He found that her testimony about L.M.'s urine screen that was 
positive for fentanyl was also inconsistent. RD, at 23. Finally, he 
found that her testimony regarding the UC's diagnosis of arthritis was 
``inconsistent with her own records.'' Id. at 23-24. The ALJ stated:

    While the five concerns discussed above detract from 
[Respondent's] overall credibility, I find that most of her 
testimony was sufficiently objective, detailed, plausible, and 
internally consistent. I do not find that [Respondent] was engaged 
in intentional fabrication . . . . Therefore, I merit her testimony 
to be credible in all non-contested matters in this Recommended 
Decision.

Id. at 24.

    Although I believe that the ALJ analyzed the Respondent's testimony 
thoroughly and honestly, and I defer to his determination of 
credibility as to Respondent's demeanor, I do not believe that there is 
practical value in meriting her testimony in non-contested matters for 
purposes of this proceeding, particularly because she did not offer 
much, if any, acceptance of responsibility, as further discussed in the 
sanctions section herein. See infra IV. The ALJ credited Respondent's 
testimony that she had counseled her patients for their urine screen 
results--a fact which is contested in this matter. See RD, at 43 
(citing tr. 853, 974-75, 981, 993-94, 1336, 1344-45, 1354). I found 
additional instances of inconsistencies in Respondent's testimony that 
undermine her credibility as well. For example, she testified that she 
relied on the UC's MRI in lieu of a physical exam to form her 
diagnosis, but the transcript demonstrates that Respondent was 
repeatedly confused about whether or not she had seen the MRI. See 
infra II(F)(1); GX 14, at 11, 13; GX 15, at 5; GX 16, at 9. Respondent 
also testified that when L.M. tested positive for Suboxone, she had 
called the lab and the lab had said to recheck the urine ``[a]nd I 
tested her again; she didn't come back positive the next time.'' Tr. 
857. This description of events is undermined by the evidence on the 
record that shows that L.M. testified positive three times in a row for 
Suboxone and by Respondent's own subsequent testimony. See infra 
II(F)(5); tr. 1092-95.
    Respondent also presented the testimony of Dr. Thomas Gutheil as an 
expert in medical documentation and medical records. RD, at 24-28; tr. 
1123-1325. Dr. Gutheil is a practicing psychiatrist and professor of 
psychiatry at Harvard Medical School and lectures on electronic medical 
recordkeeping, among other medical subjects. RD, at 24; tr. 1123-1124. 
He testified that as a hospital records committee chairperson reviewing 
medical records for quality assurance for many years, he developed his 
study of medical recordkeeping, and has published several peer review 
articles on medical documentation, and lectures on the subject 
worldwide. RD, at 24-25. He also provided a written report, which was 
submitted in Respondent's initial Prehearing statement. ALJX 5, 
Attachment 2. Dr. Gutheil testified that he is not licensed to practice 
medicine in New Jersey, but he follows the developments of medical 
documentation in New Jersey, and he reviewed some of the New Jersey 
regulations and laws about medical recordkeeping in preparation for the 
hearing. RD, at 28 (citing tr. 1135-36, 1136-38). He also testified 
that he was not familiar with Respondent's recordkeeping eClinical when 
he wrote his report, and that he did not know which version of 
eClinical Respondent used in her practice. RD, at 28; tr. 1155, 1281-
82.
    The ALJ accepted Dr. Gutheil as an expert in ``medical 
documentation and medical records.'' RD, at 28; tr. 1132. He also found 
Dr. Gutheil's testimony was presented in a professional, candid, 
straightforward manner, and it was ``helpful in understanding the 
standards of medical documentation and electronic medical 
recordkeeping.'' RD, at 28. He merited it as sufficiently objective, 
detailed, plausible and internally consistent to be fully credible. Id. 
Overall, I agree that Dr. Gutheil's testimony was credible, but I do 
not believe that the use of the word ``standards'' in the ALJ's 
assessment is appropriate, because Dr. Gutheil testified on numerous 
occasions that his testimony had nothing to do ``with issues of legal 
standards and so forth or even medical care. And that's not my 
subject.'' Tr. 1138.\9\ Additionally, the ALJ clarified to Respondent's 
attorney during the hearing that he was not accepting Dr. Gutheil as an 
expert in the standard of care. Id. at 1157-1161, 1216-1217 (ALJ 
stating that he was ``not going to allow the question, because it's 
going to a standard. I don't--what sort of standard?'' Respondent's 
attorney responded, ``Is there a standard for medical documentation?'' 
The ALJ then sustained the Government's objection that no standard was 
mentioned in Dr. Gutheil's report); accord tr. 1239, 1241, 1250, 1270, 
1291, 1294-97, 1308. To the extent that the ALJ permitted limited 
testimony differentiating a standard of recordkeeping from the standard 
of care, it seems largely irrelevant to the underlying charges of 
prescribing beneath the applicable standard of care in the State of New 
Jersey. See OSC, at 2-5. I agree with the ALJ that Dr. Gutheil's 
testimony supported the reasons why documentation is important ``to 
create a record for the continuity of care, including care provided by 
subsequent practitioners; create a permanent record about the patient's 
medical history; aid the practitioner in planning treatment; and to 
prevent liability.'' RD, at 116 (citing tr. 1214, 1272, 1280-81, 1287 
and ALJX

[[Page 45671]]

60 (Respondent's Posthearing Brief (hereinafter, Resp Posthearing), at 
16)). However, I find that overall, Dr. Gutheil's testimony is largely 
irrelevant to this proceeding, because he did not testify about the 
applicable standard of care.\10\ His testimony was presented to 
mitigate the Respondent's inadequate recordkeeping. See Resp 
Posthearing, at 17 (arguing that Dr. Gutheil's testimony established 
that ``there is always something more that a physician could write in a 
chart; if a physician spent all her time writing, there wouldn't be any 
time to see the patients.'' (citing tr. 1215)). This mitigating 
testimony may have been persuasive had Respondent accepted 
responsibility for her actions and demonstrated how she would prevent 
the recurrence of her violations of law as discussed in infra Section 
IV.
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    \9\ Respondent agreed that ``Dr. Gutheil was not qualified to, 
and could not, testify to the standard of care.'' Resp Exceptions, 
at 16 (citing Tr. 1158-1159).
    \10\ Respondent specifically highlighted this fact in stating, 
``The ALJ also ignored the fact that Dr. Gutheil was not qualified 
to, and could not, testify to the standard of care.'' Respondent's 
Exceptions, at 16 (citing tr. 1158-1159).
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    Finally, Respondent offered the testimony of Patient J.C., who was 
one of the six patients whose records were at issue in this proceeding. 
Tr. 1327-69; RD, 28-31. J.C. testified that Respondent had been 
treating him since 2016 for neuropathy in his feet and pain in his 
lower back due to a pinched nerve and degenerative disc disease in his 
lower back. RD, at 28; tr. 1328-29, 1330. He testified generally about 
Respondent's care, including her counseling on his inconsistent urine 
screens. RD, at 29-30. The ALJ found several ``discrepancies,'' which 
``detract from J.C.'s overall credibility.'' Id. at 30. The ALJ 
meticulously matched J.C.'s statements with his patient records and 
found that he inaccurately testified that Respondent had first 
prescribed tramadol to him after his inconsistent urine screen to help 
alleviate his pain, when the records demonstrated that she had 
prescribed tramadol on his second visit. Id. at 30 (citing tr. 1343-44, 
1354; ALJX 45, at 2). He also determined that J.C. had inaccurately 
testified that his second inconsistent urine screen occurred because of 
a cancelled appointment, whereas the record demonstrated that the 
inconsistent screen had occurred ``on June 20, 2017, and he had filled 
the previous prescription for 120 oxycodone tablets on May 22, 2017, 30 
days before he provided his urine sample.'' RD, at 30 (citing tr. 1355-
57, 1367; ALJX 45 (Spreadsheet of PMP Data), at 2). Despite the 
inconsistencies, the ALJ found that ``he testified in a professional, 
candid, and straightforward manner,'' and that his testimony ``[w]as 
sufficiently objective, detailed, plausible, and internally 
consistent.'' RD, at 30-31. Therefore, the ALJ merited the testimony as 
``fully credible concerning whether [Respondent] counseled him 
regarding his three inconsistent urine screens.'' Id. I defer to the 
ALJ's assessment of J.C.'s demeanor and his professionalism, but I 
struggle with accepting his finding that, despite the large 
inconsistencies that he, himself, found, J.C.'s testimony was 
``consistent.'' Id. However, because I am basing my findings regarding 
J.C. on Respondent's failure to document her counseling, as opposed to 
her failure to counsel, I find that his testimony regarding counseling 
does not affect my Decision and Order. See infra II(E)(3)(a).

D. The ALJ's Conclusions of Law Regarding New Jersey Statutes and 
Regulations

    The Government alleged that Respondent violated a New Jersey 
statute and two New Jersey regulations. See OSC, at 2; Govt Prehearing, 
at 4, 5. Overall, the ALJ did not sustain the Government's allegations 
of violations of the New Jersey statute and regulations, ``[b]ecause 
neither Dr. Kaufman nor Dr. Epstein testified that [Respondent] had 
violated any particular New Jersey statute or regulation in issuing any 
of the 17 prescriptions.'' RD, at 139. The Government filed Exceptions 
to the Recommended Rulings, Conclusions of Law, and Decision of the 
Administrative Law Judge, in which it argued that the ALJ's findings 
were in error, and that the error led the ALJ to credit Dr. Epstein's 
testimony over Dr. Kaufman's and to find ``Respondent's violations to 
be less numerous and egregious [than] they in fact were, and this 
finding contributed to his recommendation of a sanction less than 
revocation.'' Govt Exceptions, at 4. The Respondent also filed 
Exceptions to the Recommended Decision (hereinafter, Resp Exceptions), 
in which she specifically argued that the statutory language was 
essential to understanding that a physical exam under New Jersey law 
was only required ``as appropriate.'' Resp Exceptions, at 8-9. Although 
on close examination of the violations that the ALJ sustained, the 
effect of his finding regarding New Jersey law is potentially not as 
critical as the Government argued, I am addressing this issue at the 
outset because the law does lay a foundation for the applicable 
standard of care in New Jersey in this case.
1. New Jersey Administrative Code Sec.  13:35-7.1A
    New Jersey Administrative Code Sec.  13:35-7.1A requires in 
relevant part that practitioners shall not dispense drugs or issue 
prescriptions (not solely controlled substances) ``without first having 
conducted an examination, which shall be appropriately documented in 
the patient record.'' N.J. Admin. Code Sec.  13:35-7.1A (West 2020) 
(effective September 15, 2003).
    The ALJ noted that the first time that the Government cited to this 
section was in its Supplemental Prehearing Statement. RD, at 101 n.49, 
102 n.50 (citing ALJX 22, at 4). He determined that this regulation was 
never mentioned during the hearing, and ``[f]urthermore, the Government 
expert did not rely on N.J. Admin. Code Sec.  13:35.71A in reaching his 
conclusion that the Respondent's prescriptions to A.D. were issued 
beneath the standard of care in New Jersey.'' RD, at 101, n.49 (citing 
tr. 272, 674-77). He therefore concluded that Respondent ``was not put 
on notice that any of her prescriptions violated'' this provision. Id. 
The ALJ further noted that his recommended sanction would not have 
changed had he considered those provisions. RD, at 102 n.50. I disagree 
that N.J. Admin. Code Sec.  13:35.71A was not sufficiently noticed or 
litigated during the hearing.
    The Government's Supplemental Prehearing Statement used bold type 
to emphasize changes to the testimony of Dr. Kaufman, stating, ``Dr. 
Kaufman will also testify that the New Jersey standard of care is also 
governed by N.J. Stat. Section 13.35-7.1A and 13:35-7.6.'' Govt Supp 
Prehearing, at 4, 5. On August 20, 2018, Respondent filed a motion 
objecting to the Government's Supplemental Prehearing Statement, and 
made a correction to the Government's citation of the regulation, 
stating, ``Among other things, Dr. Kaufman's testimony has been changed 
to allege respondent's violation of New Jersey regulations--improperly 
identified as statutes--in the revised proposed testimony.'' 
Respondent's Pre-Trial Motions, at 9.
    During the hearing, the Government's attorney asked Dr. Kaufman if 
the requirement for a physical exam had recently changed in New Jersey 
and Dr. Kaufman said that it had not. Tr. 271-72. The Government's 
attorney then asked if, in 2015, someone would be required to do a 
physical exam to which the witness responded, ``[W]ithout

[[Page 45672]]

reviewing the statute \11\ again, I believe so.'' Id. The Government's 
attorney clarified by asking if the ``standard of care require[d] a 
physical exam, regardless of what the statute says,'' to which Dr. 
Kaufman answered, ``Yes.'' Id. Later, Dr. Kaufman testified that the 
regulation requires that a physical exam must be conducted, and in 
response, the Respondent's attorney specifically cited to this 
regulation to pose an argument that the regulation contained exceptions 
to the physical examination requirement and he presented copies of the 
regulation to the ALJ and Dr. Kaufman. Id. at 399-405.
---------------------------------------------------------------------------

    \11\ Dr. Kaufman used the word ``statute'' here, but he appears 
to be confusing the regulation and statute.
---------------------------------------------------------------------------

    Ultimately, the ALJ agreed with the Government's allegations 
regarding Respondent's failure to conduct a physical examination of the 
UC before prescribing controlled substances, because he found that 
Respondent's actions were beneath the applicable standard of care and 
outside the usual course of the professional practice in New Jersey. 
RD, at 38. Even though the ALJ recommended dismissing the allegations 
of a regulatory violation, he did not change his overall conclusion 
that the lack of a physical examination violated the applicable 
standard of care in New Jersey. I agree with the Government, and the 
Respondent, that the Government adequately noticed the regulatory and 
statutory violations, and at the very least, this regulation was 
clearly litigated by consent during the hearing, as exemplified by the 
Respondent's arguments during the hearing and in Respondent's 
Exceptions. See Farmacia Yani, 80 FR 29,053, 29,059 (2015). Therefore, 
I will consider the allegations regarding New Jersey Administrative 
Code Sec.  13:35-7.1A.
2. New Jersey Administrative Code Sec.  13:35-7.6
    The Government also cited to New Jersey Administrative Code Section 
13:35-7.6 in its Supplemental Prehearing Statement, which sets forth 
numerous requirements for practitioners prescribing controlled 
substances, including entering a pain management plan by the third 
visit and monitoring compliance. There are two affirmative obligations 
in this Section of the regulations that are applicable to this record--
``[w]hen controlled dangerous substances are continuously prescribed 
for management of chronic pain'' \12\ (defined as pain continuing for 
three months), the practitioner shall ``assess the patient prior to 
issuing each prescription to determine whether the patient is 
experiencing problems associated with physical and psychological 
dependence, and document the results of that assessment'' and ``monitor 
compliance with the pain management agreement . . . and discuss with 
the patient any breaches that reflect that the patient is not taking 
the drugs prescribed or is taking drugs, illicit or prescribed by other 
practitioners or prescribers, and document within the patient record 
the plan after that discussion.'' N.J. Admin. Code Sec. Sec.  13:35-
7.6(f)(2), (f)(5) (West 2020).\13\ Respondent testified that all of the 
patients whose treatments were the subject of this action signed a pain 
management agreement with her. Tr. 948; see, e.g., GX 29, at 4 (pain 
management agreement with the UC). She further testified that she would 
use her ``clinical judgment'' to determine whether a patient's conduct 
broke her agreement. Tr. 1007-08. One of the pain management agreements 
for J.C. stated, ``I will use my medicine at a rate no greater than the 
prescribed rate and that use of my medicine at a greater rate will 
result in my being without medication for a period of time.'' \14\ GX 
130, at 12. The plain language of the regulation requires that a 
practitioner discuss with the patient ``breaches that reflect that the 
patient is not taking the drugs as prescribed,'' which would include 
inconsistent urine screens that clearly demonstrate that the patient 
has not been following the prescription. N.J. Admin. Code Sec.  13:35-
7.6(f)(5) (West 2020); see infra Section III(A)(1)(b)(ii) for further 
discussion.
---------------------------------------------------------------------------

    \12\ `` `Chronic pain' means pain that persists for three or 
more consecutive months and after reasonable medical efforts have 
been made to relieve the pain or its cause, it continues, either 
continuously or episodically.'' N.J. Admin. Code 13:35-7.6(a) (West 
2020). Due to the fact that the patients in this case were 
prescribed opioids for more than three months prior to this 
regulation, I find that they fall under this definition.
    \13\ The requirement related to the assessing, monitoring and 
documenting of compliance in N.J. Admin. Code Sec.  13:35-7.6(f)(2) 
and (5) became effective on March 1, 2017, through an Emergency 
Rule. 2017 NJ REG TEXT 452254 (NS) (Emergency Rule). The regulation 
became permanent on June 5, 2017. 2017 NJ REG TEXT 452254 (NS) (Rule 
Adoptions).
    \14\ The record reflects that Respondent had two pain management 
agreements. The record contains one pain management agreement that 
makes no reference to taking the medicine as prescribed, but the 
other states that ``I will not attempt to obtain any controlled 
medicines, including opioid pain medicines, controlled stimulants, 
or anti-anxiety medications from any other doctor.'' GX 130, at 12; 
cf GX 130, at 2 (different pain management agreements with J.C.). To 
the extent that the pain management agreements do not address the 
required portions of the regulation, they appear to be inadequate. 
Regardless of the content of the actual pain management agreements, 
the regulation is clear about what would constitute a breach: not 
taking the medication as prescribed and taking drugs not prescribed 
or prescribed by other practitioners. I am basing my Decision and 
Order on the regulatory requirements as opposed to Respondent's 
agreements.
---------------------------------------------------------------------------

    The ALJ concluded that despite discussion of Respondent's pain 
agreements in the testimony,\15\ the Government had failed to 
adequately notice ``that the Respondent failed to enter into such 
agreements or conduct urine drug screens.'' \16\ RD, at 105 n.59. The 
Government argued not, as the ALJ contended, that she failed to enter 
into agreements, but that the regulation required Respondent to discuss 
breaches of the pain management agreement and document within the 
patient record the plan after the discussion, and alleged that 
Respondent issued eleven prescriptions for controlled substances in 
violation of this regulation. Government's Posthearing Brief 
(hereinafter, Govt Posthearing), at 17. The Respondent posed arguments 
both in her testimony and in her Posthearing Brief regarding her 
monitoring of the patients for dependence and her discussion of the 
inconsistent urine screens and how her documentation complied with the 
regulation. See, e.g., tr. 1024-1025; Resp Posthearing, at 18-20, 23. 
Respondent's arguments before the hearing,\17\ during the hearing, and 
after the hearing, demonstrate that she was on notice of the alleged 
violation of the New Jersey regulation; therefore, I disagree with the 
ALJ that this allegation was not adequately noticed, and I will 
consider the alleged violations of this regulation after its effective 
date of March 1, 2017.
---------------------------------------------------------------------------

    \15\ See, e.g., tr. 947-950.
    \16\ The ALJ seemed to be confused between this regulation and 
New Jersey Stat. Sec.  24:21-15.2, but substantively, as further 
explained herein in infra Section III(A)(1)(b)., the regulation 
implements the statute; therefore, they are very similar. See RD, at 
105 n.59. I also disagree that the Respondent was not on notice of 
the allegations regarding pain management agreements, because they 
are identical in scope to the requirement to document the resolution 
of evidence that the patient was not taking the medication as 
prescribed or was taking controlled substances that were not 
prescribed.
    \17\ See Respondent's Pre-Trial Motions, at 9 n.1.
---------------------------------------------------------------------------

    Further, at the very least, this regulation fully supports the 
testimony of Dr. Kaufman and discredits the testimony of Dr. Epstein 
regarding whether the applicable standard of care in New Jersey 
requires documentation of inconsistent urine screens as further 
explained below in Section II(E)(1) and (3).
3. New Jersey Statute 24:21-15.2
    The OSC alleged that Respondent did not ``comply with New Jersey 
Stat. [ ]Sec.  24:21-15.2 \18\ (requirements for

[[Page 45673]]

opioid and Schedule II controlled substances prescriptions).'' \19\ 
ALJX 1 (OSC) at 2. The OSC alleged that New Jersey Stat. Sec.  24:21-
15.2:
---------------------------------------------------------------------------

    \18\ It is noted that the OSC alleged a violation of this 
statute for the prescriptions written to the UC (all of which were 
issued prior to its effective date and which were the only 
allegations on the record regarding a lack of physical examination); 
therefore, the physical examination portions of the statute are not 
directly relevant to the findings herein.
    \19\ The OSC also alleged violations of N.J. Stat. Sec.  45:9-
22.19 (requirements for additional schedule II controlled substances 
prescriptions), but the Government did not offer further argument 
related to that provision--apparently abandoning it. Thus, I am not 
considering it.

requires, among other things, that a physical exam take place prior 
to the issuance of a Schedule II controlled substance prescription 
or opioid prescription; that a doctor prescribing opioids enters 
[sic] into a pain management agreement with patients; and that 
patients receiving opioids be monitored for compliance with the pain 
management agreement through various measures such as urine drug 
---------------------------------------------------------------------------
screens.

OSC at 2.

    During cross examination, Respondent's attorney asked Dr. Kaufman 
about the statutes to which he was testifying and Dr. Kaufman replied 
that he didn't know them by number, but he knew them in substance. Tr. 
297-298. He testified that the substance was:

that you must do a full history, in general, an appropriate physical 
exam. You must also check the prescription monitoring programs, and 
then issue a prescription. On subsequent visits, you need to make an 
assessment of the prescribed medicine. Is it working? Is it not 
working? You need to, again, do a physical exam, and then come up 
with a plan to then say do we continue the medication, or do we not 
continue it? That's the general substance of that.

Id. at 299-300.

    Later, on cross examination, the ALJ overruled Government's 
objection when Respondent's attorney required Dr. Kaufman to read a 
statute,\20\ holding ``[h]e has testified based on his understanding of 
the statutes. It's appropriate to allow Counsel to ask him, looking at 
the statutes, based on your reading of the statutes, do you think 
you've interpreted it correctly.'' Id. at 303.
---------------------------------------------------------------------------

    \20\ Although not explicit in the transcript, the contextual 
clues demonstrate that the ``statute'' was New Jersey Stat. Sec.  
24:21-15.2 (effective May 16, 2017). Tr. 302-303.
---------------------------------------------------------------------------

    The Government and Respondent both presented arguments about N.J. 
Stat. Sec.  24:21-15.2 in prehearing and posthearing filings, and 
therefore, I find that it was adequately noticed and will consider it 
below for prescriptions issued after its effective date. See, e.g., 
Govt Supp Prehearing, at 4; Resp Supp Prehearing, at 2.

E. The Applicable Standard of Care in New Jersey

1. Expert Testimony
    In accepting Dr. Epstein as an expert witness despite his lack of 
specific expertise in the New Jersey standard of care, the ALJ cited 
Jacobo Dreszer, M.D., in which my predecessor stated that, due to an 
``expert's academic and professional credentials, and the expert's 
testimony that he reviewed the state's regulations \21\ governing the 
standards of prescribing controlled substances, the expert was `clearly 
qualified to provide expert testimony.' '' RD, at 12 (citing Jacobo 
Dreszer, M.D., 76 FR 19 386, 19 387 (2011)). The ALJ opined that it was 
significant that Dr. Epstein testified that there is a nationwide 
standard of care with respect to prescribing opioids, which, he 
testified, ``establishes the floor.'' RD, at 13; tr. 722, 725. The ALJ 
noted that while Agency decisions exist to tailor analysis of medical 
practice to state standards, DEA ``has also accepted the propriety of 
analyzing the usual course of professional practice with reference to 
generally recognized and accepted medical practices that exist on a 
national level.'' RD, at 16 (citing Mirielle Lalanne, M.D., 78 FR 47 
750, 47 759 (2013)). He found, however, that in this case neither Dr. 
Kaufman nor Dr. Epstein based their opinions on New Jersey law or 
regulations, and that ``absent such controlling state laws or 
regulations . . . it is appropriate to focus upon whether the physician 
prescribes medicine in accordance with a standard of medical practice 
generally recognized and accepted in the United States.' '' RD, at 16 
n.2 (citations omitted). As noted in the previous section, Dr. Kaufman 
did acknowledge the substance of New Jersey law, and although he did 
not quote those authorities directly, they were part of his 
understanding of the applicable New Jersey standard of care and support 
the standard to which he testified. See, e.g., tr. 272.
---------------------------------------------------------------------------

    \21\ It is noted that although Dr. Epstein stated that he read 
recent statutes, he stated that the standard of care ``doesn't 
include the statute'' and he appeared to be unfamiliar with the New 
Jersey laws. Tr. 704, 708-709, 711.
---------------------------------------------------------------------------

    I do not disagree with the ALJ's determination regarding Dr. 
Epstein's general credibility or his admission as an expert; however, 
it is important to emphasize that the OSC alleges that Respondent 
prescribed ``outside the usual course of practice and beneath the 
standard of care in New Jersey.'' OSC, at 2-5; see RD, at 12; tr. 721-
722. The question in this case is, regardless of the rationality, 
credibility, and impressive credentials of an expert in a national 
standard of care, whether such an expert's view can outweigh expert 
testimony concerning the applicable New Jersey standard of care, which 
in several aspects has been codified in state law and regulation.
    Dr. Epstein testified that New Jersey laws and regulations ``can 
further limit the prescribing,'' and agreed with the Government 
attorney that ``Federal law \22\ sets maybe a floor but the community 
can have higher standards, but the community can't have lower 
standards.'' Tr. 725. Dr. Epstein then asserted that the standard of 
care is ``dictated by communities rather than by states,'' and that the 
New York metropolitan area is one community, including parts of New 
Jersey, and suburban practitioners have different standards of care 
than those in urban areas. RD, at 13; tr. 704, 711, 715. When asked if 
the standard of care in New York is different from New Jersey, he 
stated, ``[i]n my opinion, they are the same. The Board of Medicine in 
New Jersey may feel they're different.'' Tr. 713.
---------------------------------------------------------------------------

    \22\ In discussing federal law, Dr. Epstein seemed to be 
referring to the Center for Disease Control Guidelines that he 
referenced earlier in his testimony. Tr. 723-724. This demonstrates 
Dr. Epstein's general misunderstanding about the weight of 
applicable laws and guidance and the manner in which they affect the 
applicable standard of care in New Jersey.
---------------------------------------------------------------------------

    In this case, New Jersey has enacted laws and regulations, which, 
as Dr. Epstein predicted, have put in place ``higher standards'' than 
those upon which Dr. Epstein relies. Id. at 725. To the extent that Dr. 
Epstein discussed a baseline national standard of care, the laws and 
regulations of New Jersey and the direct testimony of a New Jersey 
practitioner directly contradict Dr. Epstein's depiction of the 
applicable standard of care. Although I recognize that some of the New 
Jersey laws and regulations in question were enacted after some of 
Respondent's alleged violations, because those authorities are 
consistent with the standard of care described by Dr. Kaufman, I give 
Dr. Kaufman's testimony more credibility than Dr. Epstein's.\23\
---------------------------------------------------------------------------

    \23\ Additionally, I note that it would defy logic to find Dr. 
Epstein more credible on matters of standard of care for the 
prescriptions that occurred after the effective date of these New 
Jersey laws, as the standard that he describes would be in direct 
violation of state law. See N.J. Admin. Code Sec.  13:35-7.6(f)(5) 
(West 2020) (requiring documentation of breaches of the pain 
management agreement that demonstrate that the patient is not taking 
the medication as prescribed); but see tr. 1629-41 (Dr. Epstein 
testifying that documentation is a best practice, not the standard 
of care in New Jersey).

---------------------------------------------------------------------------

[[Page 45674]]

2. Physical Examination
    The ALJ found, and I agree, that, before prescribing a controlled 
substance, the applicable standard of care in New Jersey ``requires a 
full medical history, a targeted physical examination based on the 
patient's complaint, review of relevant documents, and checking the 
PMP.'' RD, at 38 (citing tr. 174, 180, 271, 1442). Dr. Kaufman credibly 
testified that the applicable New Jersey standard of care requires a 
physical examination \24\ of a patient before prescribing a Schedule II 
controlled substance, including on return visits, and that observing a 
patient would not satisfy the applicable standard of care. RD, at 9 
(citing tr. 181, 398, 462). He also testified that a component of a 
physical exam is ``[c]ould you please move while I watch you and 
observe you and measure how much you can move it, that's part of a 
physical exam,'' but that undirected movement is an ``observation [ ] 
that's not a physical examination.'' Tr. 415, 430. He testified that 
``[e]ach time before prescribing a controlled substance, one needs to 
examine to see if the medication that you're giving is helping. Is it 
efficacious? Is the examination changed? Do you want to then continue 
therapy? '' Id. at 398.
---------------------------------------------------------------------------

    \24\ Respondent insinuated that Dr. Kaufman testified that 
``[i]f a physician knows the reasons for a patient's pain, there 
isn't necessarily a need to actually palpate the patient (Kaufman 
[304]).'' Resp Posthearing, at 11. The transcript does not support 
this statement. Dr. Kaufman testified, ``How could you never need a 
physical exam when someone's complaining of pain in a body part'' 
and explained that the only time the standard of care would not 
require a physical examination is if ``a patient's coming in to me 
with terminal cancer pain, I'm not going to subject them to what 
could be a very painful examination to know that they have cancer in 
bones or other organs, which we're now trying to alleviate their 
suffering.'' Tr. 304.
---------------------------------------------------------------------------

    Dr. Epstein stated that the standard of care requires a diagnosis 
obtained by ``a thorough history and then a physical that's directed, 
which can vary in scope \25\ and [ ] enough at least to get the right 
diagnosis, and to get a working diagnosis, and to do whatever 
diagnostic tests that you need to do if you need to do them, and to 
provide a diagnosis, provide a plan, discuss risks, and then implement 
the plan, and then to follow-up on the plan. . . .'' Tr. 1442. As 
further evidence of the applicable New Jersey standard of care, the 
Government cited to New Jersey Administrative Code Sec.  13:35-7.1A, 
which was in effect at the time of the prescriptions to the UC, and 
requires in relevant part that practitioners shall not dispense drugs 
or issue prescriptions ``without first having conducted an examination, 
which shall be appropriately documented in the patient record'' and 
part of that examination requires the practitioner to ``perform an 
appropriate history and physical examination.'' N.J. Admin. Code Sec.  
13:35-7.1A(a) and (a)(1) (West 2020).
---------------------------------------------------------------------------

    \25\ Respondent argued, among other things, that the variance in 
scope that Dr. Epstein describes supports her argument that a 
physical exam is only necessary as appropriate in the physician's 
sound medical opinion. Resp Exceptions, at 9. In making his initial 
assessment, Dr. Epstein relied on Respondent's records for the UC 
that had misleadingly indicated that a physical exam was performed, 
because Respondent's system auto-populated the template. Tr. 176; GX 
29; tr. 827, 904, 914. I note that Dr. Epstein did not state that a 
physical exam required palpation, but his statements about the 
requirements of a physical exam were minimal and did not elucidate 
the appropriate contents of a physical examination, because he had 
assumed that the physical exam had occurred. Further, Dr. Epstein's 
testimony undermines Repondent's argument that an MRI is adequate in 
lieu of a physical examination, because he sequences the physical 
examination first and differentiates between the physical and the 
``diagnostic tests that you need to do if you need to do them.'' Tr. 
1442. However, due to the limited nature of Dr. Epstein's testimony 
on this issue, Dr. Kaufman's testimony regarding what constitutes a 
physical examination is the only expert testimony on the record that 
addresses the contents of the physical examination, and I fully 
credit his testimony on this issue.
---------------------------------------------------------------------------

    As further explained below, I find that the applicable standard of 
care in New Jersey requires a physical examination, including a 
directed physical examination of the area of complaint, and that 
observation without directed movement, is not adequate under the 
applicable standard of care.\26\
---------------------------------------------------------------------------

    \26\ Respondent's arguments related to the extent of the 
physical exam are further discussed below. See infra Section 
II(F)(1) and III(A)(1)(b)(i).
---------------------------------------------------------------------------

3. Urine Screens Inconsistent With Prescribed Medication
    Dr. Kaufman testified that a urine screen \27\ that is negative for 
the controlled substance that the practitioner has prescribed is an 
inconsistent urine screen, and further that, when a patient's urine 
screen is inconsistent, the applicable standard of care in New Jersey 
requires a practitioner to ``have a discussion with the patient and to 
say, I gave you X amount of medication to last you from one visit to 
the other. And I'm not seeing anything, not the parent compound, which 
you would see if you had taken it that day, nor the breakdown products 
that you would see anywhere from three to four days later, why did you 
finish these sooner than how I prescribed them?'' Tr. 200. Further, he 
testified that the applicable standard of care requires the 
practitioner to document that conversation in the patient record ``for 
the record[] to show that you've had this discussion,'' because 
``within the State of New Jersey, each time the patient comes in, 
you're supposed to assess the patient, to make sure that, A, that 
they're taking it. B, that it is efficacious, are there any side 
effects? And then, make a justification as to continuation of 
therapy.'' Id. at 201-202.
---------------------------------------------------------------------------

    \27\ The ALJ found that ``[a] doctor's first assumption when 
reviewing an abnormal urine screen for a patient is that the test is 
wrong. Laboratories make mistakes all the time.'' RD, at 42 (citing 
tr. 1492). Respondent noted that the ALJ seemingly ignored this 
finding of fact when sustaining the allegations. Resp Exceptions, at 
27. I do not find this finding of fact to be inconsistent with Dr. 
Kaufman's testimony about the applicable New Jersey standard of 
care's requirement to document inconsistent urine screens as 
described herein. Without such documentation, for example, there is 
no way to know how an incorrect laboratory result was resolved or 
why a practitioner believed it to be incorrect.
---------------------------------------------------------------------------

    Dr. Epstein testified at several points that a urine screen that 
comes back negative for the controlled substance that was prescribed 
has two possible answers: ``the patient used the medication, finished 
the medication;'' or that ``they're diverting it, that they're not 
using it at all.'' Id. at 1501-02. He testified that the urine screens 
of diverters would be positive for opioids, because Respondent was 
conducting regular and predictable urine tests, so diverters would know 
to ``take the oxycodone for three or four days so that they develop a 
blood level and the metabolites'' to avoid detection, because 
``[t]hey're not stupid. They're making a lot of money at this.'' Id. at 
1502. Later, Dr. Epstein stated, ``There's zero way to defend against 
patients selling half or a third of their medication'' and that because 
of the low dose ``if it was positive on every urine tox, [he] would 
actually kind of wonder about that . . . how did they have enough to 
take this all the time.'' Id. at 1566. Dr. Epstein later testified that 
he had not ``thought about the one that [the Government] came up with, 
which is they're putting them--they're--they're hoarding which, 
honestly, I hadn't really thought of as a possibility.'' Id. at 
1584.\28\ He also

[[Page 45675]]

testified that the applicable standard of care on an inconsistent urine 
screen is based on ``being judicial'' and asking whether the patient 
has a ``good excuse.'' Id. at 1504. He testified later that the 
applicable standard of care for a patient who has doubled the 
medication is to say ``that's dangerous, you should not do that, why 
did you do that. Said my pain was completely out of control. You--you 
counsel them. You tell them not to do that . . . .'' Id. at 1575. His 
testimony does appear to agree with Dr. Kaufman that inconsistent 
screens require counseling. In contrast with Dr. Kaufman, Dr. Epstein 
testified that documenting the conversation after inconsistent urine 
screens is a ``best practice,'' as opposed to the standard of care, and 
that ``[i]t should be done, [b]ut it's not technically standard of 
care.'' Id. at 1629-41; id. at 1630-31.
---------------------------------------------------------------------------

    \28\ Reading the transcripts, I find it difficult to agree with 
the ALJ's assessment of Dr. Epstein's testimony when he stated that 
it was ``far more cogent and convincing than was Dr. Kaufman's'' on 
the issue of counseling and documentation. RD, at 116. The ALJ 
seemed concerned with ``why the standard of care required 
documentation of counseling about an inconsistent urine screen.'' 
Id. at n.64. The policy rationale for the requirements can be useful 
in understanding the applicable standard of care, but it should not 
be used to confuse the evaluation of what the applicable standard of 
care actually requires, particularly regarding bright line issues 
such as the documentation of counseling. Additionally, as shown 
here, Dr. Epstein's rationale about diverting patients who are 
purposefully taking the medication before the test to not raise 
suspicion at his own admission did not consider patients who might 
be hoarding or patients who are addicted and are taking too much of 
the medication at once. Tr. 1584. I did not find Dr. Epstein's 
testimony on this matter to be cogent or convincing.
---------------------------------------------------------------------------

    Much of Dr. Epstein's testimony was aimed at justifying why 
addressing an inconsistent urine screen is not, in his view, critical 
in preventing the diversion of opioids, but the issue in this case is 
whether the applicable standard of care in the State of New Jersey 
requires a practitioner to address an inconsistent urine screen, 
including with counseling, and whether and to what extent the 
practitioner must document an inconsistent urine screen.
    Support for the credibility of Dr. Kaufman's testimony is that, 
beginning on March 1, 2017, a New Jersey regulation required that a 
physician prescribing controlled substances for the treatment of 
chronic pain enter into a pain management agreement with the patient 
and monitor the patient's compliance with that agreement to include 
documentation of any breaches that indicated that the patient was not 
taking the medication as prescribed. See N.J. Admin. Code Sec.  13:35-
7.6(f)(5) (West 2020). I find that the existence of this regulation 
fully supports Dr. Kaufman's testimony that, after an inconsistent 
urine screen, the applicable standard of care in New Jersey requires 
the practitioner to counsel and document the resolution of the 
inconsistent screen, and after March 1, 2017, this practice was also 
required by law. Even though the regulation was not in effect for the 
entirety of the period of violations alleged in the OSC, its existence 
undermines Dr. Epstein's testimony regarding the applicable standard of 
care for inconsistent urine screens in this case, some of which 
occurred after the regulation became New Jersey law. This regulation 
had been in existence for a year and a half prior to Dr. Epstein's 
testimony and the language of the regulation clearly requires 
documentation not just as a ``best practice.'' Therefore, I credit Dr. 
Kaufman's testimony regarding inconsistent urine screens over Dr. 
Epstein's and find that documentation of the resolution of the 
inconsistent urine screens is required under the applicable standard of 
care in New Jersey.
(a) Whether Counseling Regarding the Inconsistent Urine Screens 
Occurred
    The Respondent dedicated substantial time in proffering that she 
always counseled her patients regarding negative urine screens through 
her own testimony and that of her patient J.C. See e.g., Tr. 805, 813, 
853, 935, 1343-45. The ALJ did ``not find that the Government met its 
burden of proving that [Respondent] did not counsel her patients, 
rather the weight of the evidence establishes that [Respondent] 
routinely counseled her patients about the results of their urine 
screens.'' RD, at 115. In coming to this conclusion, the ALJ credited 
the video recording and transcript of Respondent's fourth visit with 
the UC, in which she said, ``your urine last month did not show any 
medicine,'' and when the UC said that it wasn't ``lasting [her],'' 
Respondent asked how many she needed in one day and increased her 
dosage. GX 15, at 5; RD, at 115, 149. The Government argued that the 
ALJ erred in determining that this statement constituted counseling and 
that he ``improperly substituted his medical opinion for that of the 
medical experts,'' because the Government's expert provided testimony 
that the applicable standard of care requires more than just 
identifying an issue. Govt Exceptions, at 2-3.\29\ When asked about 
these statements that occurred during the UC's fourth visit, Dr. 
Kaufman credibly testified that Respondent ``rightly questioned why a 
urine screen that they did came back negative.'' Tr. at 185. However, 
Dr. Kaufman also testified that this interaction did not meet the 
applicable standard of care for counseling a patient with an 
inconsistent urine screen, because he stated, ``[I]f the patient is 
telling me, well, it's not lasting, and if the patient is saying that 
the pain is getting worse, I need to investigate why is the pain 
getting worse, not just say, well, here's another prescription, you 
need to make it last.'' Id. at 187-188.
---------------------------------------------------------------------------

    \29\ This particular interaction between Respondent and the UC 
was not included in the Government's allegations and therefore, it 
is only being considered as evidence to show whether Respondent 
regularly counseled her patients.
---------------------------------------------------------------------------

    Respondent testified that when a urine test comes back clean, she 
would state, ``Last month's urine was--didn't show any of your--any 
medication, why is that? And, when was the last time you took your 
medication? How often are you taking it? Are you taking it every--like 
I wrote it?'' Id. at 978. She further testified that she would ask, 
``How are you taking it? Like I'm prescribing it? Did you take more? Do 
you have any left? Did you go to the emergency room for any reason?'' 
Id. at 979. Additionally, she argued that she would tell her patients 
that if they continued to have inconsistent urines, she would stop 
prescribing them opiates. Resp Posthearing, at 35 (citing J.C.'s 
testimony at 1343, 1345). The interaction with the UC demonstrates that 
she asked one or two of the questions that she said she always asks, 
but none of the follow up questions or the potential consequences. Her 
videotaped questioning of the UC regarding her inconsistent urine did 
not even meet what she had described as her own practices after an 
inconsistent urine screen.
    In the case of patient records, it is impossible to know for 
certain one way or the other whether the counseling occurred if it was 
not documented. The evidence in the record shows that the UC was 
partially counseled once for her inconsistent urine screen, but the 
Government presented evidence that that counseling did not meet the 
applicable standard of care, nor was it documented. The ALJ found and I 
agree that the Respondent and her patient J.C. had dubious credibility, 
but the ALJ still deferred to them both that the counseling occurred. 
The windows through which we can clearly see what likely occurred are 
the recorded visits between Respondent and the UC, where the Government 
has demonstrated that the Respondent did not adequately counsel and 
that her recordkeeping was unreliable. See, e.g., GX 18, at 2 
(counseling not to smoke noted in the patient file but did not take 
place according to video recording and transcript of visit); GX 18, 19, 
21, 23, 25 (physical examination noted in the patient file did not take 
place according to the video recording and transcript of the visit). 
Therefore, the record shows that Respondent did not always counsel her 
patients as she repeatedly testified. See Tr. 805, 813, 853, 935. 
Despite the record's demonstration that Respondent did not counsel her 
patients as she claimed, this deficiency in Respondent's practice is 
not determinative, because even if appropriate counseling occurred,

[[Page 45676]]

Respondent did not document required counseling in most instances, the 
exceptions being a few alcohol-related instances.\30\
---------------------------------------------------------------------------

    \30\ Dr. Kaufman testified that if counseling is not documented, 
it did not happen. RD, at 115 (citing tr. 485-86, 632). The ALJ 
stated that ``that premise . . . does not exist in a vacuum.'' 
Although I do not disagree with the ALJ that the distinction can be 
meaningful, the effect of a finding that Respondent did counsel her 
patients for the majority of noticed instances only would mitigate 
the overall egregiousness of the prescriptions that violated the 
applicable standard of care and, as explained in infra Sections III 
and IV, I find that the violations solely based on the lack of 
required patient file documentation are egregious enough to call for 
revocation, particularly in light of the fact that the Respondent 
did not accept responsibility.
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(b) Timing of an Inconsistent Urine Screen
    Establishing that the applicable standard of care in New Jersey 
requires a practitioner to address and document an inconsistent urine 
screen, the Government put forward evidence attempting to establish a 
timeframe for when the patient's negative urine screen would be 
considered inconsistent and thus the lack of documentation of 
counseling would implicate a violation of prescribing beneath the 
applicable standard of care. Dr. Kaufman testified that a negative 
urine screen would be consistent if the patient came back thirty-five 
days after being issued a thirty-day prescription for oxycodone, 
because the oxycodone would likely no longer be in the patient's 
system. Tr. 206-07; 494. Dr. Kaufman further testified that if a 
prescription for thirty days was filled within thirty-three days of the 
negative urine screen, it would be inconsistent. Id. at 208; 497 (``I 
would still expect to see that . . . 33 days. 34 days, probably 
not.''); see also id. at 652 (confirming that at thirty-three days, Dr. 
Kaufman would expect to see metabolites for opioids). The ALJ found 
that Dr. Epstein testified that some individuals metabolize opioids in 
one-to-two days. RD, at 122 (citing tr. 1501-02). Dr. Epstein's 
testimony was more focused on the reasons to be concerned about the 
negative urine screen than on setting a specific timeframe, but he did 
state that ``if it's more than about 33 days since it was filled, then 
at that point, I'm not concerned.'' Id. at 1501. When pressed, Dr. 
Epstein testified that ``the appropriate measuring stick'' for negative 
urine was the date the prescription was filled but was ``not a black 
and white.'' Id. at 1530. Later, Dr. Epstein testified that he would 
not be surprised if a patient's urine was clean after a prescription 
for sixty pills, with a maximum of two per day on day thirty, because 
``patients are going to sometimes hurt and sometimes not'' and ``my 
patients will have a week or two that they don't use any meds.'' Id. at 
1552. He further said that ``a red flag is someone that never misses,'' 
but when asked by the ALJ if what he was stating was that a patient 
taking medication as prescribed would be concerning, Dr. Epstein said 
that was not his ``intent.'' Id. at 1552, 1553. He stated that he 
cannot write a prescription for ``p.r.n.'' six times a day and give 
sixty pills, because the pharmacy will flag it as not enough pills, but 
that he wants the pills to ``average out to no more than twice a day by 
the end of the month.'' Id. at 1554-55. Despite Dr. Epstein's testimony 
about what would ``concern'' \31\ him regarding negative urine screens, 
he generally testified that when there is ``an inconsistent UTOX, your 
first response is to reevaluate it and to--and to--combine that 
information with what else you know about the patient and with what 
their status is, why you're giving the drug, how they're responding to 
it, and--and--and whether everything else about them seems 
reasonable.'' Id. at 1590-91.
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    \31\ Throughout Dr. Epstein testified about when a red flag 
might be a ``concern,'' but it is unclear what the result of the 
concern would be. In some cases he appears to be discussing 
discharge of the patient and sometimes he says ``maybe I'm concerned 
and concerned enough to--to take a good look at it'' and ``we would 
not stop prescribing.'' Tr. 1559. It is difficult to distinguish in 
his testimony when a practitioner's concern would require 
counseling, and it is another reason why I find Dr. Kaufman more 
credible on this matter, because he was clearer about what the 
concern is and what the concern requires under the applicable 
standard of care.
---------------------------------------------------------------------------

    The ALJ found that the Government ``has the burden of proof to 
establish when a urine screen is inconsistent'' and that ``[t]he 
Government chose to meet its burden by offering evidence of an estimate 
of when the results of a urine screen would be inconsistent.'' RD, at 
122. I agree with the ALJ's statement, but I do not believe that the 
record supports his finding that the date that was established is ``up 
to and including 32 days prior to providing a urine sample.'' \32\ Id. 
Both Dr. Epstein and Dr. Kaufman testified that if it is more than 
about thirty-three days, they would not be concerned. Tr. 1501 
(Epstein); id. at 652 (Kaufman).\33\ Therefore, I find that the record 
in this case has established that a urine screen becomes inconsistent 
with a thirty-day prescription when it is negative for the prescribed 
controlled substances more than thirty-three days after the fill 
date.\34\
---------------------------------------------------------------------------

    \32\ Even if I did agree with the ALJ, only two prescriptions 
are affected by my finding (one to Patient J.C. and one to Patient 
A.P. (but which I still find was issued beneath the applicable 
standard of care due to lack of counseling on a positive alcohol 
test)) and if I were to reverse my finding on the one prescription 
to J.C., it would in no way affect my overall recommendation of 
sanction in this case.
    \33\ Respondent characterizes Dr. Epstein's testimony as a 
screen taken thity-three days after a thirty-day prescription was 
filled, but he actually stated that ``more than about 33 days,'' 
which is also consistent with his one-to-three day estimate. See 
Respondent's Posthearing, at 32.
    \34\ I find this fact reluctantly and emphasize that I find it 
only in the context of the evidence presented in this case, because 
the Government presented its evidence using a bright line rule 
regarding when to consider a urine screen as triggering the 
requirement for documentation. When a patient's urine is negative 
for opioids, even when the amount of the prescription should have 
reasonably been out of the patient's system, it would still make 
logical sense that a practitioner should address why the patient did 
not need the medication, did not go into withdrawal etc. Although 
bright line rules can be useful, Dr. Kaufman testified that the 
purpose of the monitoring and documentation requirement is to ensure 
that the patient is taking the medication as prescribed and is not 
diverting or abusing the medication, and to determine whether 
continuation of the prescribing is warranted and ``to make a 
justification as to continuation of therapy.'' Tr. 202.
---------------------------------------------------------------------------

(c) Level of Documentation Regarding Inconsistent Urine Screens
    The Respondent also posed arguments regarding the level of 
documentation that is required when there is an inconsistent screen. 
Respondent argued that the automatic counseling note that she included 
in combination with the maintenance of the results of the urine tests 
in the patient's record constitute adequate documentation of the 
counseling and the fact that the screen was addressed. Id. at 1026-
1027. She further argued that her documentation system, eClinical, 
would not permit her to type information into the plan section, but she 
admitted that she could have typed information into other sections. Id. 
at 914-15; RD, at 45. The regulations require that when there are any 
breaches of the pain management agreement that demonstrate that the 
patient is not taking the medication as prescribed, the practitioner 
must ``document within the patient record the plan after that 
discussion.'' N.J. Admin. Code Sec.  13:35-7.6(f)(5) (West 2020). It is 
clear from a plain reading of the regulation that the requirement for 
documentation is greater than just recording the urine results, and 
that there needs to be a documented plan as well. See infra 
III(A)(1)(b)(ii) or further discussion. The regulation further bolsters 
Dr. Kaufman's testimony that Respondent's counseling notes that she 
selected to autopopulate in eClinical were not adequate under the 
applicable standard of care. Specifically, he testified regarding the 
counseling notes that ``it was not counseled--I don't see a statement 
in here, which I've stated before, that there was the medication need 
to be taken as directed, that you need to not double up on the

[[Page 45677]]

medications, because that's going to put you at risk for other issues. 
I don't see that statement here.'' Tr. 612; see also id at 610. Dr. 
Kaufman clarified that the eClinical automatic entry that appeared in 
many of Respondent's records and stated ``take your medication 
regularly'' means only ``you take it on a regular basis.'' Id. at 612. 
These notations do not indicate any plan to address the failure of the 
patient to take the medication as prescribed, and therefore, I find 
that these notations are inadequate documentation under the applicable 
standard of care in New Jersey.\35\ I agree with the ALJ's ultimate 
finding that the applicable standard of care in New Jersey requires ``a 
practitioner to document the cause and resolution of inconsistent urine 
drug screens, as well as the practitioner's discussion with the patient 
about the urine drug screens.'' RD, at 117.
---------------------------------------------------------------------------

    \35\ In further support of Dr. Kaufman's testimony, the New 
Jersey Office of Administrative Law has specifically held that 
``summaries pieced together from memory long after the events sought 
to be recorded cannot substitute for timely record-keeping.'' In the 
Matter of the Suspension or Revocation of the License of Magdy 
Elamir, M.D., License No. 25MA41404, to Practice Medicine and 
Surgery in the State of New Jersey, OALK Dkt. No. BDS 01663-10 
(Decided August 26, 2014). Respondent testified that one could 
conclude from her records when the prescription was issued despite 
the inconsistent urine screen that she ``had a good, good reason to 
write the next script;'' however, she also testified that she could 
not remember the results of her discussions. Tr. 1027; 1090-95 
(Respondent testified that after L.M. tested positive for Suboxone 
three times in a row, she thought she had cut her dose, but she had 
not, and when asked for the reason, she stated, ``I don't remember, 
sir.'') Piecing together conclusions post hoc is not adequate 
recordkeeping to be able to understand the reason that she wrote the 
script or establish a plan moving forward. See infra Section 
III(A)(1)(b)(ii).
---------------------------------------------------------------------------

(d) Whether a Patient Must Be Dismissed for Inconsistent Urine
    In this case, I find that Dr. Kaufman and Dr. Epstein were 
generally in agreement that the matter of what a practitioner is 
required to do when the urine screen is inconsistent is not ``black or 
white,'' and where the toxicology screen is negative, the issue is not 
necessarily whether the practitioner stops prescribing the controlled 
substance. Id. at 1609. Dr. Epstein testified that ``[t]he standard of 
care is to counsel them. The standard of care is to reestablish the 
norm and to determine if you need to change the dosage, change the 
treatment, change the medication, do any of those things that you need 
to do to get them under control if they're not already.'' Id. at 1585. 
Dr. Kaufman testified that a patient who admitted that he or she 
``doubled up on a few days during the month'' would not disqualify the 
patient from getting another prescription, but would instead instigate 
questions from the practitioner to ``elucidate why this increase in 
pain occurred and treat it appropriately.'' Id. at 643. Overall, I find 
that the substantial evidence on the record demonstrates that the 
applicable standard of care in New Jersey, as verified by the 
regulation, requires that the inconsistent urine screen be addressed, 
counseled, and documented. See N.J. Admin. Code Sec.  13:35-7.6(f)(5) 
(West 2020).
(e) Positive Urine Screen for Non-Prescribed Controlled Substances
    Dr. Kaufman credibly testified that when the patient tests positive 
for a non-prescribed controlled substance, the applicable standard of 
care in New Jersey requires the practitioner to address the urine test 
with the patient and ``to document their conversation in the medical 
record.'' \36\ Tr. 241, 244 (he would expect to see specific discussion 
of the other controlled substance in the medical record on the 
subsequent visit). This concept is further supported by the New Jersey 
regulation requiring a practitioner to address breaches of pain 
management agreements and document the plan. See N.J. Admin. Code Sec.  
13:35-7.6(f)(5) (West 2020). Dr. Epstein testified that when the PMP 
shows prescriptions for opioids about which he was not aware, it would 
be a concern, but for certain types of opioids ``then that's okay as 
long as I know that's happening.'' Id. at 1594. Regarding fentanyl, he 
testified that upon a second test \37\ within a limited timeframe 
demonstrating a non-prescribed controlled substance, ``you would speak 
to the patient, you would try to figure out if there was a reason for 
it, you know, if there was some sort of--you know, they had had other 
tests. . . .'' Id. at 1604. Although Dr. Epstein did not explicitly 
testify that there needed to be a conversation with the patient about 
the screen, his testimony and findings imply that he would need to know 
what's ``happening.'' Id. at 1594. He also stated that ``[he has] to 
always explore'' what is going on. Tr. 1604. The primary difference 
between the two experts was that Dr. Kaufman testified that the 
applicable standard of care required the practitioner to document the 
resolution of the positive screen and Dr. Epstein did not. Dr. Epstein 
testified, ``There's actually no regulation anywhere that I know of in 
any state that says what needs to be, exactly says how the medical 
record, how much you have to put in.'' (Tr. 1630-1631). He also said 
that documentation is a ``best practice. It's really not standard of 
care. Because it's not care. Okay. It's not care. It's best practice. 
And it should be done, you know. It should be done.'' Tr. 1631. New 
Jersey's regulations contradict Dr. Epstein's testimony.\38\ The 
regulations require that practitioner shall ``assess the patient prior 
to issuing each prescription to determine whether the patient is 
experiencing problems associated with physical and psychological 
dependence, and document the results of that assessment'' and ``monitor 
compliance with the pain management agreement . . . and discuss with 
the patient any breaches that reflect that the patient is not taking 
the drugs prescribed or is taking drugs, illicit or prescribed by other 
practitioners or prescribers, and document within the patient record 
the plan after that discussion.'' N.J. Admin. Code Sec. Sec.  13:35-
7.6(f)(3), (f)(5). As already discussed, I find Dr. Kaufman to be more 
credible regarding documentation, and supported by New Jersey law.
---------------------------------------------------------------------------

    \36\ Respondent argued that sometimes the laboratories err in 
showing positive urine screens and the urine must be retested; 
however, I saw no evidence in the record of screens being retested 
shortly after showing positive results for non-prescribed 
substances. See Resp Posthearing, at 43. Additionally, the fact that 
a screen might be inaccurate does not change the applicable standard 
of care as Respondent implies, but instead seems to highlight the 
need for documenting the resolution of the screens to ensure that 
the patient records are accurate as to what has actually occurred. 
See Resp Posthearing, at 43. I also find this argument unavailing, 
because if the screens were so inaccurate that they would not help 
Respondent identify issues with her patients, I do not understand 
why she ordered them every month at her own expense.
    \37\ It was unclear from his testimony whether he believed the 
applicable standard of care would require a conversation with the 
patient after a first positive test for fentanyl. He seemed to imply 
that a practitioner could assume that fentanyl was from a surgical 
procedure upon the first positive test, but the question of whether 
the practitioner would be required to discuss with the patient was 
not answered due to a sustained objection. Tr. 1598, 1600.
    \38\ Additionally, I do not find Dr. Epstein's testimony about 
the difference between what should be done and what is care to be 
convincing, because he also testified that ``[i]t's about providing 
the best possible care for the most possible people. . . .'' Tr. 718 
(Dr. Epstein describing the standard of care).
---------------------------------------------------------------------------

(f) Effect on Prescriptions After an Inconsistent Urine Screen
    Although the Government originally alleged in the OSC that every 
prescription after the initial prescription demonstrating an 
inconsistent urine screen was outside the usual course of the 
professional practice and beneath the applicable standard of care, Dr. 
Kaufman contradicted that allegation, stating ``[a]ny subsequent ones, 
if

[[Page 45678]]

they're having positive urine screens, would be appropriate. The one 
that was issued directly right after this urine screen would not be 
because this was not addressed.'' Id. at 250. Therefore, like the ALJ, 
I am only considering the prescriptions issued directly after an 
inconsistent urine screen. See RD, at 145.
4. Documentation of Alcohol Counseling
    Dr. Kaufman testified that in order to meet the applicable standard 
of care in New Jersey a practitioner who was confronted with a urine 
screen that was positive for alcohol metabolites would need to 
``discuss it with the patient and discuss the risks of alcohol with the 
use of opioids, of opiates, and to tell him to stop drinking'' and 
would need to document that discussion in the record. Tr. 212. Dr. 
Epstein testified that mixing oxycodone and alcohol is a ``very, very 
bad thing,'' and a practitioner must counsel his patient, and ``the 
standard of care is that, you know, if you're going to have a drink you 
shouldn't be doing it at the same time you're taking this pill.'' Id. 
at 1636. The Respondent does not dispute the ALJ's finding that a 
doctor must counsel a patient who has been prescribed an opiate and 
also has alcohol metabolites \39\ in his urine about the dangers of 
concomitant alcohol and opioids. RD, at 120; Resp Exceptions, at 15 
(``Respondent does not disagree with this statement.'') Dr. Kaufman 
testified that a prescription on May 5, 2017, to Patient A.P. was not 
issued within the usual course of the professional practice in New 
Jersey, because the ``positive alcohol screen . . . was never 
addressed.'' Tr. 213. He testified that one time drinking alcohol might 
not be problematic, but that ``you have to explain the dangers of doing 
that. One drink combined with one opioid can cause an overdose, just 
once. You may not get a second chance. You can be dead.'' Id. at 482. 
He also testified numerous times that documentation of the alcohol 
counseling was essential. Id. at 485-86 (``If it's not in the record, 
it didn't exist, because then you can't substantiate that. That's very 
important in medicine. That's how we talk to one another.'') \40\ \41\
---------------------------------------------------------------------------

    \39\ Throughout the hearing, there was discussion about the 
difference between alcohol and alcohol metabolites on the urine 
screen and whether the presence of the metabolites indicated less of 
a concern than the presence of alcohol. See, e.g., tr. 1632. Dr. 
Epstein testified that an alcoholic's urine would show more than 
just metabolites, but his testimony seemed to be focused on 
alcoholics, because alcoholism was relevant to whether or not a 
practitioner be required under the standard of care to stop 
prescribing opioids ``because it's addictive behavior.'' Tr. 1634. 
More importantly, he testified that you have to counsel about the 
dangers of mixing alcohol and opioids even when the urine shows 
metabolites. Tr. 1636. I am setting aside the issue of metabolites, 
because I am only making findings on the counseling and 
documentation, not the dismissal of the patients, and furthermore, 
Respondent has conceded that a doctor must counsel when metabolites 
are present. Resp Exceptions, at 15.
    \40\ Dr. Kaufman's testimony was clear about the requirement 
under the applicable standard of care to counsel regarding alcohol 
and the requirement to document that counseling. See tr. 212. 
However, he also testified that a practitioner must cease 
prescribing opioids in the face of urine screens consistently 
demonstrating alcohol metabolites, and he stated that the standard 
of care required a practitioner to counsel twice regarding alcohol 
before terminating the medication. Id. at 471-473; RD, at 43. The 
ALJ found that this testimony ``undercuts his own testimony 
concerning several of the prescriptions to A.D. and SW'' RD, at 119. 
I agree with the ALJ that Dr. Kaufman's testimony regarding when to 
terminate a patient was confusing, and because of that confusion, I 
am not finding any violations on the basis that any of the patients' 
prescriptions should have been terminated for positive alcohol 
tests. However, I do not find that he undercut his previous 
testimony, because Dr. Kaufman was testifying about two different 
scenarios under the standard of care. In one scenario, he was 
testifying that a particular prescription ``was issued in light of 
positive urine screen for alcohol, which was not addressed at all.'' 
Tr. 251; 251-256; 257 (``in light of an aberrant urine screen, there 
was no counseling.'') In the other scenario, he was responding to 
Respondent's counsel's question ``assuming a person follows the 
standard of care and counsels against using alcohol or other drugs . 
. . they can then prescribe maybe another prescription for 
narcotics, is that right?'' Tr. 467.
    \41\ New Jersey's regulation (d) requires a discussion about 
risks that shall include ``the danger of taking opioid drugs with 
alcohol'' before the initial prescription and prior the third 
prescription and additionally states, ``The practitioner shall 
include a note in the patient record that the required discussion(s) 
took place.'' N.J. Admin. Code 13:35-76(d). Although this regulation 
does not specifically require that alcohol counseling must occur 
upon a positive urine screen, and is therefore not being alleged as 
a regulatory violation in this case, it does very specifically state 
that the counseling must be documented.
---------------------------------------------------------------------------

    Additionally, Respondent testified that when alcohol appears in a 
drug screen, her usual practice is to counsel the patients and insert 
the alcohol entry for counseling in e-Clinical. Id. at 1013. She 
admitted that she may sometimes fail to click on the alcohol entry, 
because she is ``not 100 percent.'' Id. at 1013-14. Respondent's own 
practices demonstrate that she knows that documentation of the alcohol 
counseling is important, and furthermore, her system includes a 
shortcut key that permits her to specify that the alcohol-specific 
counseling occurred. Id.
    Finding that counseling and its documentation is required when a 
urine screen shows alcohol metabolites, I also agree with the ALJ's 
finding that Respondent's selection of alcohol specific counseling is 
adequate to document the counseling. RD, at 124 n.68. Dr. Kaufman 
agreed that the ``counseling, alcohol and drugs . . . documented in the 
patient record . . . would [] be an appropriate way to deal with an 
alcohol screen.'' Tr. 214. This is further supported by the language in 
the state regulation regarding alcohol counseling that requires that 
the record ``note'' that the discussion took place and not the 
substance or the plan after that discussion. N.J. Admin. Code 13:35-
76(d). In sum, I find that when a urine screen tests positive for 
alcohol metabolites, the applicable standard of care in New Jersey 
requires that a practitioner counsel regarding the dangers of alcohol 
and opioid use and document that counseling, and further that noting 
that the alcohol-specific counseling occurred is adequate for purposes 
of this case.

F. Allegations of Issuing Prescriptions Outside of the Usual Course of 
the Professional Practice and Prescribing Below the Applicable Standard 
of Care in New Jersey

    Having read and analyzed all of the record evidence, I agree with 
the RD's conclusion and find that the substantial record evidence that 
Respondent prescribed controlled substances outside of the usual course 
of the professional practice and below the applicable standard of care 
in New Jersey. RD, at 139. The ALJ sustained the Government's 
allegations with regard to the five Vicodin prescriptions Respondent 
issued to the UC, and twelve of the twenty-one prescriptions that 
Respondent issued to patients A.P., J.C., L.M., M.W., and SW Id. In 
all, the ALJ found, and I agree, that ``between April 27, 2016, and 
March 8, 2018, [Respondent] issued a total of seventeen prescriptions 
on seventeen different occasions, to a total of six patients, which 
were issued outside the usual course of the professional practice and 
beneath the applicable standard of care in the State of New Jersey.'' 
Id. Although I agree with the ALJ's findings regarding these 
prescriptions, I make some additional findings as further explained 
below.
1. UC
    The ALJ sustained the Government's allegations that Respondent 
issued five prescriptions for hydrocodone-acetaminophen (Vicodin), a 
Schedule II controlled substance, to the UC between November 23, 2016 
and April 4, 2017, outside the usual course of the professional 
practice and beneath the applicable standard of care for the State of 
New Jersey in violation of 21 CFR 1306.04(a), because she failed to 
conduct a physical exam at each of the

[[Page 45679]]

UC's visits.\42\ RD, at 122-23; OSC, at 2. At each appointment, the UC 
complained of right shoulder pain or tightness. RD, at 46 (citing GX 
18, 19, 21, 23, 25, 27; Tr. 46, 51, 56-57, 62, 66, 75, 100). The ALJ 
found, and I agree, that the allegations were proven through the 
testimonies of Dr. Kaufman and Dr. Epstein,\43\ and to a lesser extent 
through Respondent and Dr. Gutheil based on the applicable standard of 
care in New Jersey. RD, at 122-23. Dr. Kaufman credibly testified that 
the applicable standard of care in New Jersey required a physical exam 
prior to prescribing controlled substances, and that Respondent should 
have ``examine[d] the shoulder where the primary complaint was, other 
than observing the patient.'' Tr. 391. He further explained that a 
minimal physical examination of the shoulder is ``certain maneuvers 
such as a Neer's test, a Hawkins' test, an Apley's test, an O'Brien's 
test, a reduction of the shoulder, intrinsic rotation of the shoulder, 
palpation of the AC joint, palpation of the bursa, palpation of the 
muscle; basic shoulder exam.'' \44\ Id. at 378.
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    \42\ The Respondent's treatment notes for each visit with the UC 
indicate that physical examinations were performed on each visit; 
however, the UC testified that they did not and the video recordings 
did not demonstrate palpation or otherwise adequate physical 
examination. Tr. 176; GX 29.
    \43\ As the ALJ noted, Dr. Epstein initially testified that 
prescriptions to the UC met the standard of care; however, in 
formulating his opinion, it was clear through his testimony that he 
had relied on the treatment record for UC, which had detailed a 
physical exam, which the Government proved through video evidence 
and testimony did not occur. See RD, at 122 (citing tr. 1435; tr. 
1614; GX-6). ``Dr. Epstein testified that his opinion would change . 
. . if [Respondent] had not conducted a physical examination.'' RD, 
at 123 (citing tr. 1527). See also supra II(E)(2).
    \44\ Respondent argued that ``Dr. Kaufman could not explain the 
minimum examination required for a shoulder complaint.'' Resp 
Exceptions, at 13. Respondent's argument taken in context of the 
transcript is not convincing. When pressed by Respondent's attorney 
to quantify how many of those nine tests would constitute and 
minimal shoulder examination, Dr. Kaufman stated, ``There is no 
strict number, whether you need to do two or three or four, but you 
need to do something'' and then stated, ``You need to do something 
to elucidate what the problem is.'' Tr. 379. Respondent's attorney 
then asked, ``Maybe one thing?'' Dr. Kaufman responded, ``One thing 
is not enough. If you do one thing, you're only checking one aspect 
of the shoulder.'' Id. Respondent's attorney continued to push to 
try to find out ``what [Respondent] needed to do to meet the 
threshold where you would say, No, this was okay.'' Id. at 380. Dr. 
Kaufman answered, ``She didn't do anything.'' Id. The facts 
demonstrate that Dr. Kaufman specifically testified to the 
components of a standard shoulder examination and he credibly 
testified that the number of tests that would need to be included in 
an examination of the shoulder to meet minimal standards is not 
essential in this instance, because Respondent did not conduct any 
of these tests on the UC. The argument that Respondent conducted 
part of a physical examination does not change Dr. Kaufman's 
credible testimony that any such examination was beneath the 
applicable standard of care in New Jersey.
---------------------------------------------------------------------------

    During the hearing, Respondent admitted that she did not palpate 
the UC's shoulder or touch the UC. RD, at 122 (citing tr. 878-79).\45\ 
Additionally, the UC credibly testified that Respondent did not give 
her a physical exam or touch her on any of the visits. Tr. 45, 51, 57, 
62, 66, 75. Respondent argued that observation of the patient, his or 
her presentation, speech, and carriage was part of the physical exam, 
which Dr. Kaufman conceded may be a ``small component,'' but is 
``woefully inadequate and below standards.'' Id. at 386, 390. Dr. 
Kaufman further testified that a physical exam is required each time 
controlled substances are issued based on the applicable standard of 
care and the regulation, which ``stipulates that an appropriate 
physical exam must be conducted.'' Id. at 399. When asked if a physical 
examination was still necessary if a physician had a recent MRI showing 
a problem, Dr. Kaufman testified that ``[i]t's still necessary.'' Id. 
at 397.
---------------------------------------------------------------------------

    \45\ Respondent's testimony directly contradicted a portion of 
the video that her attorney attempted to argue that she may have 
briefly touched the UC. Tr. 868. Later, it is noted that the 
attorney asked Respondent about her inconsistent statements with 
regard to whether she touched A.P. and she stated, ``I saw her in 
2016, so my memory is not that great.'' Id. at 1017. Upon reviewing 
the video, I agree with the ALJ's statement in the hearing that this 
movement is ``pretty insignificant given the fact that there was a 
desk between the two of them.'' Id.; GX 6, 0320.010, at 9:53-9:57.
---------------------------------------------------------------------------

    Respondent argued that she had required the UC to obtain a new MRI 
before prescribing controlled substances, and she testified that when 
she reviewed the second MRI, she was able to make a diagnosis that the 
UC had arthritis. Id. at 823-24; GX 29, at 24; Tr. 865 (Respondent 
testified that because pain is subjective, she relies on results of 
MRIs ``about 90 percent of the time''). However, Respondent did not 
include her alleged diagnosis of arthritis in the UC's treatment notes. 
RD, at 57 (citing GX 19 \46\). Instead, the assessment section lists 
``pain in right shoulder'' and ``chronic pain syndrome.'' GX 29, at 13; 
tr. 1057-58; RD, at 57. Further, Respondent's own recorded statements 
at the UC's third appointment undermine her testimony that she had made 
a diagnosis based on the second MRI.\47\ Tr. 824. In the recorded 
conversation, the UC reminded Respondent that she received a new 
(second) MRI, ``[c]ause I got--from the first time to the second time, 
I got a different--I got uh, updated MRI,'' and Respondent replied, 
``Right. And [it] still didn't show anything, sweetheart.'' GX 14, at 
11; see also RD, at 59.\48\ This statement clearly undermines 
Respondent's testimony that she had a clear diagnosis from the MRI to 
justify prescribing to the UC.\49\
---------------------------------------------------------------------------

    \46\ GX 19 is a one page extract of the UC's second visit. The 
same record is also found in GX 29, at 13.
    \47\ Despite this claim, Respondent responded affirmatively to 
the question, ``Couldn't you have learned more from a physical 
examination?'' Tr. 824-25.
    \48\ Further, in defending the lack of physical examination, 
Respondent stated, ``[I]n my clinical judgment, the way I observed 
[UC], even second time, third time, fourth time, [UC's] arm, the 
range of motion was good. And, I prescribed her the little amount 
that I thought was sufficient.'' Tr. 1067. It is unclear to me even 
from Respondent's testimony what her justification was for the 
prescriptions she issued to the UC. Additionally, this statement 
undermines her argument that she performed the physical examination 
by watching the UC, because the UC patient records list under 
Physical Examination, ``Right Shoulder Tenderness,'' which would 
imply that Respondent saw something indicating tenderness during her 
observation. See, e.g., GX 18, at 1.
    \49\ Respondent did mention arthritis in some of the UC 
transcripts, which she appeared to base on the MRI. See, e.g., GX 
13, at 7. However, on several subsequent visits, during which she 
prescribed controlled substances, she did not seem to have access to 
the MRI before she made any of the prescribing decisions. On 
December 22, 2016, she asked, ``[T]he reason we were giving you 
narcotic, we discussed that before, right? It was for what reason, 
sweetheart?'' And then, ``I mean, what was your diagnosis with the 
other doctor? I got me some records, right, before?'' GX 14, at 11. 
On the same visit, Respondent said she could not increase the dosage 
without x-rays showing something and she never seemed to find the 
MRI. Id. She stated, ``If it's just bursitis, I can't do it.'' Id. 
at 13. On January 19, 2017, she asked, ``[W]ere you able to give me 
the MRI of the ankle, right from the place?'' UC asked, ``Ankle? No, 
that wasn't me.'' Respondent said, ``Soft tissue injury, you had . . 
. sorry, not ankle, the shoulder.'' GX 15, at 5. Again, on March 7, 
2017, Respondent asked the UC, ``I didn't have any MRI's, nothing 
from you, right?'' GX 16, at 9. These statements further contradict 
Respondent's testimony that she relied on the UC's MRI in lieu of a 
physical examination as a basis for her prescriptions.
---------------------------------------------------------------------------

    After reviewing the record evidence, including the video and audio 
recordings of the UC's visits with Respondent, I agree with the ALJ's 
finding that, Respondent did not perform an adequate physical 
examination of the UC at any of the UC's appointments. RD, at 46.
    Based on the fact that Respondent did not perform an adequate 
physical examination, as required by the applicable standard of care in 
New Jersey, the ALJ found, and I agree, that the prescription for 
Vicodin issued to the UC at her second appointment on November 23, 
2016, was issued outside the usual course of the professional practice 
of medicine. RD, at 58 (citing Tr. 179-80, 878-79, 1442; GX 20). 
Additionally, I agree with the ALJ that the prescriptions Respondent 
issued to the UC for: Vicodin on December 22, 2016; Vicodin on January, 
19, 2017;

[[Page 45680]]

Vicodin \50\ on March 7, 2017; and Vicodin on April 4, 2017, did not 
meet the applicable standard of care in New Jersey and were issued 
outside the usual course of the professional practice of medicine, 
because Respondent never performed a competent physical examination of 
the UC. RD, at 62, 64, 68, 71 (citing GX 22, 24, 26, 28; tr. 191-93, 
195, 878-79, 1442).
---------------------------------------------------------------------------

    \50\ Although the ALJ found that on March 7, 2017, the 
Respondent's issuance of the prescription for tramadol (brand-name 
Ultram) did not meet the applicable standard of care in New Jersey, 
the ALJ ultimately did not sustain a violation related to tramadol, 
because the Government failed to allege the violation associated 
with this prescription in the OSC or either of its prehearing 
statements. RD, at 101 n.49. I agree with the ALJ that the 
Government did not mention the prescription for tramadol or Ultram 
in any of its prehearing documents, nor did it count this 
prescription in the number of violations related to UC. The 
Government argued that it raised the Ultram prescription 
specifically during the hearing, in which Dr. Kaufman testified that 
the prescription was issued below the applicable standard of care, 
and therefore it was litigated by consent. Govt. Exceptions, at 8, 
n.3 (citing Tr. 191-192); see also Govt Post Hearing, at 4. The 
analysis of litigation by consent is fact specific. See Farmacia 
Yani, 80 FR at 29,059. `` `An agency may not base its decision upon 
an issue the parties tried inadvertently. Implied consent is not 
established merely because one party introduced evidence relevant to 
an unpleaded issue and the opposing party failed to object to its 
introduction. It must appear that the parties understood the 
evidence to be aimed at the unpleaded issue.' '' Id. (quoting Yellow 
Freight System, Inc. v. Martin, 954 F.2d 353, 358 (6th Cir. 1992)). 
The Government had ample opportunity to include this prescription to 
its own undercover agent and, in this case, Respondent's counsel did 
not indicate any sort of consent other than failing to object, so I 
am not sustaining this allegation. See tr. 191-191.
---------------------------------------------------------------------------

    The ALJ did not sustain the alleged violation of the applicable 
standard of care that Respondent recorded the results of a complete 
physical in the UC's medical record, even though the exam did not 
occur. RD, at 139. He reasoned that he could not find a recordkeeping 
violation ``because it was not alleged as a separate violation in the 
OSC, and the Government did not detail in either of its prehearing 
statements how this false entry was a separate violation.'' Id. The 
Government did not take exception specifically to this finding, but 
urged that the false recordkeeping demonstrated that ``Respondent's 
medical records grossly overstate the care provided.'' Govt Exceptions, 
at 20. The Government laid out numerous inconsistencies in the records, 
related to when Respondent's records for the UC reflect that counseling 
occurred, when the transcripts demonstrate that it did not. Id. at 21-
22; e.g., tr. 52 (UC confirming no counseling occurred); GX 18, at 2 
(Respondent's medical record for UC noting that counseling about 
medication and smoking occurred). I agree with the ALJ that there was 
no specific violation alleged with regard to falsely documenting the 
physical examination, and therefore, I concur with the ALJ and sustain 
no violation on that account. I also agree with the Government that the 
fact that the UC's medical records reflect a detailed physical exam 
that was not, in fact, conducted, and counseling that never 
occurred,\51\ casts serious doubt upon the other records Respondent 
maintained and is relevant to the Respondent's overall credibility.
---------------------------------------------------------------------------

    \51\ See, e.g., GX 18, at 2 (smoking counseling noted that never 
occurred); GX 18, 19, 21, 23, 25 (physical examination never 
occurred).
---------------------------------------------------------------------------

2. Patient A.P. Alcohol Allegations
    The stipulated facts demonstrate that between and including June 6, 
2016, and April 5, 2018, Respondent issued prescriptions for controlled 
substances to A.P. on twenty-three occasions. See Stipulations 4(a)-
(v). In this time period, A.P. submitted a total of nineteen urine 
samples for screening. RD, at 73-74. The ALJ found, and I agree, that 
A.P.'s urine screens were positive for alcohol metabolites on May 5, 
2017; July 8, 2017; August 10, 2017; September 7, 2017; October 5, 
2017; and February 8, 2018. RD, at 75 (citing Stipulations 5(a), (c)-
(f), (h); GX 54, 60, 63, 69, 79). The ALJ found that on August 10, 
2017, (following the July 8, 2017 alcohol metabolite positive urine 
test) and September 7, 2017,\52\ (following the August 10, 2017 alcohol 
metabolite positive urine test), Respondent's patient records for A.P. 
indicate that she provided expanded and alcohol specific drug 
counseling. GX 61, 64. On direct examination at the hearing, Dr. 
Kaufman testified that A.P.'s patient notes for these visits 
demonstrate that specific discussions about alcohol counseling occurred 
on these two occasions. Tr. 214-15. Therefore, the ALJ found that the 
two prescriptions issued on these dates did not violate the applicable 
standard of care related to alcohol counseling. RD, at 75. I do not 
believe that Dr. Kaufman provided sufficient evidence to rebut the 
Respondent's arguments that this level of documentation with regard to 
alcohol screening was adequate under the applicable standard of care, 
and even though I have serious doubts regarding the credibility of 
Respondent's testimony and records in this case, I will concur with the 
ALJ and weigh alcohol-specific counseling documentation in her favor. 
However, the ALJ found, and I agree, that counseling occurred only when 
the patient records specifically indicated that alcohol counseling was 
provided. RD, at 124 n.68. Therefore, the prescriptions \53\ resulting 
from the visits on October 5, 2017, (following the September 7, 2017) 
and March 8, 2018,\54\ (following the February 8, 2018 alcohol positive 
urine screen) were not issued within the applicable standard of care 
for New Jersey, because there was no documentation of the alcohol 
counseling. RD, at 126-127; see also, tr. 219-20 (Dr. Kaufman testified 
that ``continued permissive alcohol use and continuance of opioids puts 
a patient in a dangerous situation. Therefore, it should not have been 
issued.'') The ALJ did not sustain the allegations related to the June 
8, 2017, prescription following the alcohol positive urine screen that 
occurred on May 5, 2017, despite the fact that Respondent did not 
document her alcohol counseling, because the ALJ did not believe it 
would be appropriate to terminate the prescriptions after the first 
screen demonstrating alcohol use. RD, at 124 (citing RD 117-20). I 
respectfully disagree with the ALJ's

[[Page 45681]]

determination regarding this prescription. Dr. Kaufman testified that 
this particular prescription was not issued within the usual course of 
the professional practice for New Jersey because, the ``positive 
alcohol screen . . . was never addressed.'' Tr. 213. As discussed 
previously, the ALJ had found the prescription on March 8, 2018, to be 
issued below the applicable standard of care in New Jersey, because 
Respondent ``did not document what she told him about consuming alcohol 
while also taking a prescription opiate,'' which would be the same 
rationale for the June 8, 2017 prescription. RD, at 127. I find that 
Government has proven by substantial evidence that a prescription 
issued after a positive urine screen for alcohol with no documentation 
of alcohol counseling does not meet the applicable standard of care in 
New Jersey, and therefore, I find that the prescription issued on June 
8, 2017, was also issued beneath the applicable standard of care. See 
infra Section II(E)(4).
---------------------------------------------------------------------------

    \52\ Dr. Kaufman testified that the discussion on September 7, 
2017, was appropriate for someone who had tested positive for 
alcohol two times in a row, but then testified that the prescription 
dated September 7, 2017, was not issued within the usual course of 
the professional practice, because Respondent ``in her notes, 
clearly stated to the patient twice, do not use alcohol with drugs, 
do not use alcohol with drugs.'' Tr. 216. Respondent had issued the 
second warning to the patient on the date of this prescription. See 
GX 64, 65. At this point, although A.P. had tested positive three 
times for alcohol (May 5, 2017, July 8, 2017, and August 10, 2017), 
Respondent had only documented counseling the patient twice (one of 
which was on the day of the prescription in question). The ALJ 
pointed out what he described as an inconsistency, that in 
accordance with Dr. Kaufman's later testimony, the applicable 
standard of care does not require a practitioner to terminate the 
controlled substances on the third visit following two inconsistent 
urine screens. RD, at 125-26 (citing Tr. 472). The ALJ is correct 
about the substance of Dr. Kaufman's testimony, but I do not believe 
that this part of his testimony was inconsistent. The confusing 
matter in this instance is that this was, in fact, the fourth visit, 
not the third and there had been three urine screens demonstrating 
alcohol, not two. The discussion related to the first positive urine 
screen had simply not been documented or had not occurred. I note 
this merely to clear up what the ALJ considered to be an 
inconsistency with the Government expert's testimony; however, as 
stated previously, I am only finding violations for alcohol where 
counseling was not documented, not on the basis of dismissal. See 
supra note 39; see also RD, at 120.
    \53\ Respondent pointed out that there was an additional 
unalleged positive test for alcohol on October 5, 2017, but the 
prescription issued on November 3, 2017, was not addressed by the 
Government. Resp Posthearing, at 26 n.15; GX 59. I agree that this 
was not appropriately alleged and will not include any findings on 
the November 3, 2017 prescription. The RD did not address this 
prescription either.
    \54\ Respondent alleged that the March 8, 2018 prescription was 
not alleged in the OSC; however, the prescription following the 
February 8, 2018 urine screen was noticed in the Government's 
Supplemental Prehearing statement. Resp Posthearing, at 26, n.15; 
Govt Supp Prehearing, at 5-6.
---------------------------------------------------------------------------

3. Patient A.P. Inconsistent Urine Screening
    The ALJ found, and I agree, that Patient A.P. tested negative for 
opioids \55\ on June 8, 2017, and January 8, 2018.\56\ RD, at 73-74; GX 
57, 73. The ALJ conducted a thorough evaluation of the New Jersey 
Prescription Monitoring Program (hereinafter, PMP) \57\ records to 
determine the number of days between the date that the PMP indicated 
that A.P. filled the prescription \58\ and the date that his urine 
tested negative for oxycodone. RD, at 73-74 (citing ALJX 45 (PMP), at 
6). The ALJ analyzed these dates in a chart with the amount of tablets 
in the prior prescription to determine whether it was reasonable for 
Respondent not to have documented the inconsistent urine screen.
---------------------------------------------------------------------------

    \55\ In the OSC, the Government ``incorrectly alleged that 
A.P.'s urine screen of May 5, 2017, tested negative for oxycodone.'' 
RD, at 124 (citing ALJX 1, at 2-3). The Government's Supplemental 
Prehearing Statement concedes that this was incorrect. G's 
Supplemental Prehearing, at 2. The OSC does allege that all 
prescriptions after November 3, 2016, were issued outside the usual 
course of the professional practice without giving a rationale for 
this finding, so it appears that the Government might have mixed up 
the May 5, 2017 date with November 3, 2016 (see infra note 55), but 
I am not including findings on November 3, 2016, either because it 
was not adequately noticed. ALJX 1, at 3.
    \56\ The ALJ also included in his chart two other dates where 
A.P. tested negative for opiates, November 3, 2016, and April 5, 
2018. RD, at 73-74 (citing GX 84, at 98 and 123). The Government did 
not allege any violations related to these two tests in the OSC, nor 
in either the Prehearing Statement or Supplemental Prehearing 
Statement or the Posthearing Brief. The ALJ does not address these 
two inconsistent urine screens in his final findings on the 
allegations, and I agree that this was appropriate, so I will not 
consider them.
    \57\ The Government introduced the PMP records in GX 2 and 3, 
and the ALJ presented an excerpt of the 6 patients' records to the 
parties for comment at the conclusion of the hearings, upon which he 
relied in his RD. Tr. 1646.
    \58\ It appears that on almost every negative urine screen in 
this case, the prescription was filled on the same date it was 
issued; therefore, I am only distinguishing the fill date where 
relevant, and I incorporate the RD's charts in this decision.
---------------------------------------------------------------------------

    Dr. Kaufman testified that a January 8, 2018 urine screen that 
tested negative for opiates following a prescription that was issued on 
December 7, 2017, thirty-three days prior to the drug screen, was 
inconsistent, and therefore the prescription issued on February 8, 
2018, following Respondent's knowledge of the results of that drug 
screen was issued outside the usual course of practice for the State of 
New Jersey. Tr. at 210. Dr. Kaufman reasoned that it was outside the 
usual course of the professional practice because ``[t]hat urine screen 
was never addressed, it's almost as if it didn't happen.'' Id. at 210-
11. The ALJ found that because this urine screen was within thirty-
three days of the fill date, there was no requirement for documentation 
of the screen, because he had found that the Government's evidence had 
only established the requirement at thirty-two days. RD, at 126. As 
explained above in supra Section II(E)(3)(b), I found that the 
Government established that the threshold for counseling and 
documentation of an inconsistent urine screen was more than thirty-
three days; and therefore, I sustain the allegation that this 
prescription was issued beneath the applicable standard of care, 
because the Respondent should have documented a discussion with the 
patient about the inconsistent results and the plan to address it.
    Dr. Kaufman testified that the urine screen on June 8, 2017, was 
inconsistent with the prescribed opioids; however, the ALJ found that 
the allegation regarding the prescription could not be sustained 
because it had been thirty-five days since A.P. had filled the 
prescription on May 5, 2017. RD, at 76. Due to the fact that the 
Government's expert testified that a negative urine screen would not be 
concerning thirty-three days after the prescription was filled, I agree 
with the ALJ that the Government has not proven that the prescription 
on July 6, 2017, after the results of the negative urine screen on June 
8, 2017, was issued outside of the usual course of the professional 
practice and below the applicable standard of care in New Jersey, based 
on the negative urine screen.\59\ RD, at 124-25.
---------------------------------------------------------------------------

    \59\ However, I find below that this prescription was issued 
beneath the applicable standard of care and outside the usual course 
of the professional practice because of the undocumented alcohol 
counseling.
---------------------------------------------------------------------------

    Overall, with respect to Patient A.P, I find that the prescriptions 
issued on October 5, 2017; June 8, 2017; March 8, 2018 were issued 
below the applicable standard of care in the State of New Jersey, 
because there was no documented alcohol counseling, and the 
prescription on February 8, 2018, was issued below the applicable 
standard of care in the State of New Jersey, because there was no 
documented discussion related to the inconsistent urine screens.
4. Patient J.C.
    The stipulated facts demonstrate that between and including August 
22, 2016, and April 10, 2018, Respondent issued prescriptions for 
controlled substances to J.C. on twenty-one occasions. See Stip. 6(a)-
(t); see also RD, at 77-78. In this time period, J.C. submitted a total 
of sixteen urine samples for screening. RD, at 78. The ALJ found, and I 
agree, that J.C.'s urine screens were negative for oxycodone on October 
19, 2016, June 20, 2017, July 25, 2017. RD, at 78-79 (citing GX 88; GX 
130, at 63; GX 130, at 53; GX 130, at 51; Stip. 7(a), 7(b) and 7(c)).
    The ALJ conducted a thorough evaluation of the PMP records to 
determine the number of days between the date that the PMP indicated 
that J.C. filled the prescription and the date that his urine tested 
negative for oxycodone. RD, at 78-79 (citing ALJX 45, at 2-3 (PMP)). 
The ALJ analyzed these dates in a chart with the amount of tablets in 
the prior prescription to determine whether it was reasonable for 
Respondent not to document the inconsistent urine screen. Id.
    Dr. Kaufman testified that a October 19, 2016, urine screen that 
tested negative for opiates following a prescription that was issued on 
September 21, 2016 (seventeen days prior to the drug screen) was 
inconsistent, and therefore the prescription issued on November 17, 
2016 following Respondent's knowledge of the results of that drug 
screen was issued outside the usual course of the professional practice 
in the State of New Jersey. Tr. 223. J.C. testified that Respondent 
always counseled him on the negative test results and asked him why he 
was not taking his medication and J.C. further testified that he told 
Respondent that his pain was too intense, so he used all of the 
medication. RD, at 80 (citing tr. 853,

[[Page 45682]]

935, 974-75, 978-79, 993-94, 1046, 1343-45, 1354). Although Respondent 
testified that she always counseled J.C. following the inconsistent 
urine screens, the patient notes for J.C. do not reflect additional 
counseling or what was discussed and what the plan was moving forward 
with treatment. Id.; see also, RD, at 80 (citing GX 92, 109, 112). Due 
to the Respondent's lack of documentation regarding the counseling that 
she asserts occurred, I agree with the ALJ that the prescription issued 
on November 17, 2016, was issued outside the usual course of the 
professional practice and below the applicable standard of care in the 
State of New Jersey. RD, at 128.
    On June 20, 2017, J.C. tested negative for opiates despite the fact 
that he had been prescribed thirty days of Roxicodone thirty days prior 
to the urine test on May 11, 2017. Dr. Kaufman testified that the 
prescription issued to J.C. on July 25, 2017, was ``not issued within 
the usual course of practice, because it `was issued after the negative 
urine screen, without counseling of the urine drug screen as to why it 
was negative . . .' for opiates.'' RD, at 81 (citing tr. 227, GX 109, 
110). Due to the Respondent's lack of documentation regarding the 
counseling that she asserts occurred, I agree with the ALJ that the 
prescription issued on July 25, 2017, was issued outside of the usual 
course of the professional practice and below the applicable standard 
of care in the State of New Jersey. RD, at 129.
    On July 25, 2017, J.C. tested negative for opiates despite the fact 
that he had been prescribed thirty days of Roxicodone thirty-four days 
prior to the urine test on June 20, 2017. The ALJ applied the measuring 
unit of thirty-two days to determine when the applicable standard of 
care would require counseling and found that the subsequent 
prescription on August 22, 2017, was issued within the usual course of 
the professional practice. RD, at 129. Although I believe the 
appropriate test is 33 days, I agree with the ALJ that the Government 
has not proven by substantial evidence that this prescription was 
beneath the applicable standard of care in New Jersey. RD, at 129.
    Overall, with respect to Patient J.C., I find that the 
prescriptions issued on November 17, 2016, and July 25, 2017, were 
issued below the applicable standard of care in the State of New 
Jersey, because there was no documented discussion related to the 
inconsistent urine screens.
5. Patient L.M.
    The stipulated facts demonstrate that between and including 
September 28, 2015, and May 24, 2017, Respondent issued prescriptions 
for controlled substances to L.M. on twenty-three occasions. See Stip. 
8(a)-(u); see also RD, at 82-83. In this time period, L.M. submitted a 
total of fourteen urine samples for screening. RD, at 84. The ALJ 
found, and I agree, that L.M.'s urine screens showed inconsistent 
results on May 17, 2016; \60\ June 13, 2016; July 12, 2016; \61\ 
January 31, 2017; and April 26, 2017. RD, at 84-85; GX 175, at 144; GX 
175, at 141; GX 175, at 139; GX 175, at 131; GX 175, at 123; Stip. 
9(a), 9(b) and 9(c)).
---------------------------------------------------------------------------

    \60\ Despite that the prescription on June 13, 2016, was issued 
after testing positive for Suboxone and fentanyl on May 17, 2016, 
the Government did not address this in any of its filings nor its 
testimony, so I am not including a violation for this date. GX 175, 
at 144.
    \61\ On July 12, 2016, for the third time in a row, the records 
demonstrate that Patient L.M. tested positive for Suboxone, but the 
Government did not reference this date in its OSC or prehearing 
statements or in the presentation of its case at the hearing. That 
being said, the Respondent raised the fact that L.M. had tested 
positive for Suboxone three times in a row. Tr. 1092-95. I will not 
include a specific finding regarding the prescription following this 
screen on August 18, 2016; however, I believe that the record 
adequately demonstrates that L.M. tested positive three times in a 
row for Suboxone--a fact which enhances the egregiousness of 
Respondent's overall prescribing to this patient. GX 147; Tr. 1092-
95; see also (Govt Posthearing, at 10 n.3 (admitting that the 
Government did not charge this prescription, but proposing that it 
demonstrates that the buprenorphine/Suboxone ``was not an isolated 
incident.'').
---------------------------------------------------------------------------

    Respondent testified that when L.M. tested positive for Suboxone, 
she had called the lab and the lab had said to recheck the urine 
``[a]nd I tested her again; she didn't come back positive the next 
time.'' Tr. 857. This description of the events is undermined by the 
evidence on the record that shows that L.M. tested positive three times 
in a row for Suboxone and Respondent's own later testimony. See infra 
note 60; tr. 1092-95. Dr. Kaufman testified that on June 13, 2016, 
L.M.'s urine screen tested positive for norbuphrenorpine or Suboxone, 
which is ``generally used for controlled substance withdrawal'' and in 
order to meet the minimum standard of care in New Jersey a practitioner 
would need to address why the patient tested positive for Suboxone. Tr. 
258-59. Dr. Kaufman testified that he would ``expect to see a note such 
as I discussed with the patient the positive urine screen for 
metabolite of Suboxone. I questioned the patient as to where they were 
getting this, why were they getting this? . . . . [a]nd could they be 
inadvertently hurting themselves because they're now taking two 
controlled substances?'' Tr. 260. Dr. Kaufman testified that he was 
particularly concerned that the PMP did not reflect that this 
medication was prescribed, which indicates that the patient could be 
receiving it illicitly and that the patient needed to know about safety 
issues of taking two controlled substances. Id. at 262-63. Respondent 
\62\ testified that she counseled L.M. about the Suboxone in her urine 
and she realized by the third visit when L.M. had tested positive three 
times in a row that the counseling was not successful, but she could 
not explain why she had not subsequently reduced the dose of Percocet 
for L.M. Tr. 1092-95. She believed that Suboxone was not ``a street 
drug'' and that the patient had likely received it from a hospital for 
withdrawal. Id. The fact that Respondent cannot remember why she 
continued to issue prescriptions for L.M. after she tested positive for 
Suboxone underscores the importance of maintaining adequate records 
resolving the inconsistent urine screen. The ALJ found, and I agree, 
that the prescriptions on the date following urine screen demonstrating 
Suboxone were not issued within the usual course of the professional 
practice in New Jersey ``because [Respondent]'s records for L.M. on 
July 12, 2016, following the June 13th urine test, did not document how 
she resolved the fact that L.M.'s urine screen was positive for 
Suboxone.'' RD, at 130 (citing his Finding of Facts (hereinafter, FF) 
34, 79, 189).
---------------------------------------------------------------------------

    \62\ The ALJ stated that Respondent credibly testified that she 
had counseled the patient here. See RD, at 130. However, earlier he 
had found Respondent's credibility regarding the Suboxone 
prescriptions to be problematic, because her explanation that the 
patient ran out of the oxycodone that she had prescribed and then 
went to a clinic or hospital to get Suboxone for withdrawal were not 
plausible. RD, at 23; see Tr. 1099-1101. On June 13, 2016, and July 
12, 2016, Patient L.M.'s urine testified positive for BOTH Suboxone 
and Oxycodone. GX 175, at 139; GX 175, at 131. If she had received 
Suboxone for withdrawal symptoms, then it does not make sense that 
she would still have tested positive for the oxycodone, unless she 
had received it illicitly. See also RD, at 23. I do not find 
Respondent to be credible that she counseled the patient about this 
test, because her explanation based on that counseling is 
implausible; however, as stated earlier, I am not resting my finding 
of a violation on the existence of counseling, but instead upon the 
non-existence of its documentation.
---------------------------------------------------------------------------

    On January 31, 2017, L.M.'s urine sample tested positive for 
fentanyl, which was not prescribed by Respondent. GX 175, at 129. 
Respondent stated that she ``called the primary care and [she] asked 
for their note'' and they ``told [her] over the phone that they ordered 
a

[[Page 45683]]

colonoscopy''; however, if such a call occurred, it was not documented 
in the patient record. Tr. 856. The ALJ determined, and I agree, that 
the prescription issued on February 28, 2017, following the January 
31st inconsistent test, ``was not issued within the usual course of 
practice of medicine in New Jersey because [Respondent] did not 
document that she resolved the `clearly aberrant urine screen . . . for 
[] [f]entanyl.'' RD, at 131 (citing tr. 265; FF 79, 192).
    On April 26, 2017, Patient L.M.'s urine sample tested positive for 
6-MAM, a heroin metabolite. RD, at 131; GX 175, at 126. On L.M.'s 
subsequent appointment with Respondent on May 24, 2017, L.M.'s patient 
records demonstrate that Respondent discharged the patient for heroin; 
however, she also issued L.M. a prescription for 90 Percocet 5/325 
milligrams. RD, at 131; see also tr. 550; GX 173 (``D/C UDS positive 
for heroin''); GX 174 (prescription). Dr. Kaufman testified that the 
only information in the patient record was that the patient was 
discharged for heroin. There was no additional explanation of 
counseling. Tr. 551. Dr. Kaufman testified that the applicable standard 
of care upon a urine screen positive for heroin would be ``to stop 
[prescribing opioids] and treat any withdrawal symptomology.'' Tr. 557. 
He testified that it would be within the applicable standard of care to 
prescribe a small amount of medication ``with a very specific weaning 
schedule for that patient.'' Id. at 562. Respondent did reduce \63\ the 
amount of her prescription to L.M., which she characterized as a 
``weaning script.'' Tr. 1061.
---------------------------------------------------------------------------

    \63\ During the two preceding visits on March 30, 2017, and 
April 26, 2017, Respondent had prescribed L.M. two prescriptions for 
Percocet. GX 175, at 64 (prescription for 90 tablets of Percocet 5/
325); RX 9, at 2 (prescription for 30 Percocet 10 miligrams).; Tr. 
560. The ALJ noted that the PMP confirmed the two prescriptions. RD, 
at 131 (citing ALJX 45, at 5).
---------------------------------------------------------------------------

    Dr. Kaufman testified that Respondent did address the positive 
heroin test, because ``she discharged [L.M.] from the practice.'' Tr. 
564; accord id. at 566. He also answered affirmatively to Respondent's 
counsel's question that it could be within the standard of care to 
issue a weaning dose upon the discharge. Tr. 565 (emphasis added). The 
ALJ concluded that on cross examination, Dr. Kaufman had testified that 
Respondent's reduction of the dose of L.M.'s prescription on her last 
visit was within the applicable standard of care. RD, at 132 (citing 
tr. 562-63). I agree that both the questions and the answers during 
this part of the hearing were confusing, but I do not agree with that 
conclusion. Dr. Kaufman answered, ``That's correct'' after a lengthy 
question containing a double negative and ending with ``it's your 
conclusion that this [presumably L.M.'s chart] doesn't indicate that 
this was outside the standard of care, is that right?'' Tr. 562-63. 
From my reading of the testimony, this response was not necessarily 
inconsistent, because Dr. Kaufman testified several times that the 
chart does not state anything about the reason for the prescription, so 
it does not make logical sense that a chart with no explanation could 
indicate whether or not the prescription was intended for weaning.\64\ 
In fact, the chart does not indicate one way or another that it was a 
weaning prescription, and that is the ultimate reason why I find that 
this prescription was issued beneath the applicable standard of 
care.\65\
---------------------------------------------------------------------------

    \64\ This response makes more sense when read along with 
Respondent Counsel's preceding question, ``So do you have any reason 
to believe that Doctor, from this chart, that [Respondent] didn't 
provide a weaning schedule?'' to which Dr. Kaufman responded, ``I 
don't.'' Tr. 562.
    \65\ It is noted that despite this characterization, 
Respondent's Pain Management Agreement with L.M. states that if she 
breaks the agreement, ``my doctor will taper off the medicine over a 
period of several days, as necessary to avoid withdrawal symptoms.'' 
See e.g., GX 175, at 2. Respondent's own Pain Management Agreement 
appears to dictate a much more specific and shorter period of 
prescription for discharged patients than what she prescribed for 
L.M. Although I am not sustaining an allegation regarding this 
prescription on whether the weaning prescription was appropriate, 
but instead on a lack of documentation, Respondent's Pain Management 
Agreement supports Dr. Kaufman's testimony that in order to meet the 
applicable standard of care, the prescription should have contained 
a weaning schedule or instructions to ``taper off the medicine.''
---------------------------------------------------------------------------

    Furthermore, when the Government followed up with Dr. Kaufman on 
this issue, he clarified that weaning a patient would require 
documentation in the record, and also would include directions 
``written on the prescription to give the patient the proper directions 
on how to do it''; therefore, the prescription was ``not necessarily'' 
a weaning prescription. Tr. 654-55. Dr. Kaurman also affirmed that the 
prescription was outside the applicable standard of care. Id. Even 
though Respondent had followed the applicable standard of care in 
discharging the patient after the heroin was discovered, I believe that 
the Government has established by substantial evidence that, the 
prescription issued on May 24, 2017, was issued outside the usual 
course of the professional practice and beneath the applicable standard 
of care in New Jersey, because Dr. Kaufman credibly testified that the 
applicable standard of care required that a weaning prescription be 
documented as such and provide weaning instructions to the patient. See 
id. Without adequate recordkeeping, there is no indication of the 
intent of the prescription or the fact that counseling occurred.\66\
---------------------------------------------------------------------------

    \66\ This finding is further supported by the regulation's 
mandate to ``document the plan'' after a breach of the pain 
management agreement, which was in effect at the time of this 
prescription. N.J. Admin. Code Sec.  13:35-7.6(f)(5) (West 2020). 
Even though Respondent documented the discharge, she did not explain 
the weaning prescription in any way and she provided no instructions 
to the patient. See GX 174 (prescription for 90 Percocet to L.M. on 
May 24, 2017).
---------------------------------------------------------------------------

6. Patient M.W.
    The stipulated facts demonstrate that between and including January 
30, 2015, and August 25, 2017, Respondent issued prescriptions for 
controlled substances to M.W. on thirty-two occasions. See Stip. 10(a)-
(ff); see also RD, at 87-89. In this time period, M.W. submitted a 
total of nineteen urine samples for screening. RD, at 89, 133. The ALJ 
found, and I agree, that M.W.'s urine screens showed inconsistent 
results for someone who has been prescribed opioids on May 3, 2016 
(thirty days since filled), July 8, 2016 (fifteen days since filled), 
and July 28, 2017 (thirty days since filled). RD, at 89-90; GX 207, 
242; Stip. 11(a), 11(b) and 11(d).\67\ There was no documented 
counseling that specifically addressed any of the inconsistent urine 
screens. RD, at 87-92; GX 259, at 60-61, 62-63, 92-93; Stip. 10(m), 
10(ee), 10(ff). Therefore, the ALJ found, and I agree, that the 
Government has proven by substantial evidence that the prescriptions 
issued on May 27, 2016, August 5, 2016, and August 25, 2017, following 
the inconsistent urine screens were issued beneath the applicable 
standard of care and outside of the usual course of the professional 
practice in New Jersey. See RD, at 91-92; GX 209, 216, 244.
---------------------------------------------------------------------------

    \67\ The OSC alleged a total of six inconsistent urine screens 
for M.W., but the Government did not present evidence about three of 
these dates through testimony and additionally did not include them 
in the Prehearing statement or in the Posthearing Brief; and 
therefore, the ALJ disregarded the inconsistent urine screens on 
June 1, 2015, November 3, 2015, and April 28, 2017. OSC, at 4; Govt 
Posthearing, at 11-12; RD, at 90; GX 235; GX 259, ar 116, 154, 158. 
Although I believe that the record evidence establishes that two of 
the screens were inconsistent and therefore required documented 
counseling that did not occur, I will not include them in my 
findings, because they appear to have been dropped by the Government 
and I do not find them necessary to my ultimate finding in this 
case.
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7. Patient S.W.
    The stipulated facts demonstrate that between and including March 
16, 2015, and April 6, 2018, Respondent issued prescriptions for 
controlled substances to S.W. on thirty-nine occasions. See

[[Page 45684]]

RD, at 92-94. In this time period, S.W. submitted a total of eighteen 
urine samples for screening. RD, at 94-96.
    Patient S.W.'s urine tested positive for alcohol metabolites on 
March 30, May 25, June 22, July 20, and August 23, 2016. RD, at 95-96 
(citing GX 288, 293, 296, 299, 302; Stip. 13(a), 13(b), 13(c), 13(d), 
13(e)). The patients' records for the prescriptions issued on the visit 
following the results of these urine screens did not document any 
specific counseling with regard alcohol.\68\ RD, at 93 (citing GX 289, 
291, 294, 297, 300, 303). Therefore, I find that the prescriptions for 
controlled substances issued on April 27, 2016; \69\ June 22, 2016; 
July 20, 2016;August 24, 2016; and September 21, 2016, were not issued 
within the usual course of practice of medicine and did not meet the 
applicable standard of care for New Jersey because there was no 
documented counseling regarding the patient's use of alcohol in her 
records, nor other explanation of the positive screens. RD, at 96-99, 
135-137.
---------------------------------------------------------------------------

    \68\ Respondent testified that she was told by a lab that a 
patient's diabetes could cause a urine screen to be positive for 
alcohol, and SW was diabetic. Tr. 851, 927. Dr. Kaufman agreed that 
diabetes may cause a positive alcohol screen, but ``she has to 
document that there's an average urine screen. It's shown that it's 
the metabolites of alcohol, and there's a comment that given the 
light of the patient's diabetes, one would expect a positive urine 
screen for alcohol[ ].'' Tr. 463. Therefore, despite the possible 
explanation of why alcohol might have been present, I find that 
these prescriptions were issued beneath the applicable standard of 
care, because Respondent did not document her counseling regarding 
the alcohol in the urine screens or her rationale for not 
counseling.
    \69\ The ALJ did not sustain the allegations related to the 
prescriptions on April 27, 2016, June 22, 2016, July 20, 2016, due 
to the fact that Dr. Kaufman had testified that the applicable 
standard of care required the practitioner to discharge a patient 
who has had alcohol counseling three times and continues to consume 
alcohol while taking opioids. RD, at 136. As explained herein, I 
agree with the ALJ that Dr. Kaufman's testimony was confusing on the 
issue of when to cease prescriptions in the face of an alcohol test; 
however, I find that Dr. Kaufman also credibly testified that the 
applicable standard of care in New Jersey required that the 
Respondent counsel the patient about the alcohol use on each 
occasion and document that counseling, and there is no such 
documentation; therefore, I disagree with the ALJ and sustain 
violations on these dates. See Tr. 212.
---------------------------------------------------------------------------

    On April 5, 2017, S.W.'s urine screen tested positive for fentanyl. 
Id. at 95 (citing GX 319; Stip. 13(f)). Dr. Kaufman testified that the 
prescription Respondent issued on May 3, 2017, after the positive 
fentanyl urine screen did not meet the applicable standard of care in 
New Jersey and was issued outside the usual course of the professional 
practice of medicine in New Jersey, because Respondent did not address 
the fentanyl with S.W. Tr. 249. Respondent testified that S.W. had a 
history of breast cancer \70\ and had told her that the fentanyl was 
the result of a port being inserted for chemotherapy. RD, at 99 (citing 
tr. 849). However, the patient records do not reflect this discussion, 
nor any counseling regarding the fentanyl. Id. (citing GX 320, 321). 
Therefore, the ALJ found, and I agree, that the prescription issued on 
May 3, 2017, did not meet the applicable standard of care and was 
issued outside the usual course of the professional practice in New 
Jersey. Id. at 138.
---------------------------------------------------------------------------

    \70\ Respondent argued that S.W.'s records reflect that she had 
a history of breast cancer and that she was actively being treated 
for breast cancer because they noted that she was receiving 
``Herceptin IV once a week.'' Tr. 630. Therefore, Respondent argued 
that it was reasonable given her history and ongoing treatment to 
continue prescribing after the fentanyl. Dr. Kaufman testified that 
he did not see any documentation in the record explaining the 
rationale for prescribing and stated, ``It all goes to the crux of 
the matter. If it's not written here, how can I assume all of that, 
what you just said, took place? I can't.'' Id. at 632. I agree with 
Dr. Kaufman that the applicable standard of care and State 
regulation in effect at this time in New Jersey required 
documentation. See infra III(A)(1)(b).
---------------------------------------------------------------------------

    In sum, I find that the record evidence demonstrates that 
Respondent issued twenty-three prescriptions for controlled substances 
beneath the applicable standard of care and outside the usual course of 
the professional practice in New Jersey (five occasions to UC, four 
occasions to A.P., two occasions to J.C., three occasions to L.M., 
three occasions to M.W., and six occasions to S.W.). Additionally, I 
find that the Government has presented substantial evidence that 
Respondent: failed to conduct a physical examination of the UC in 
violation of N.J. Admin. Code 13:35-7.1A, and failed to document the 
discussion of the plan and assess the risk of abuse, addiction or 
diversion after inconsistent urine screens in violation of N.J. Admin. 
Code Sec.  13:35-7.6(e) and (f), as further explained in infra 
III(A)(1)(b) for the following prescriptions issued after the 
regulation's effective date of March 1, 2017: July 25, 2017, to J.C.; 
February 8, 2018, to A.P.; May 24, 2017, to L.M.; August 25, 2017, to 
M.W.; and April 5, 2017, to S.W. Additionally, four of these 
prescriptions violated N.J. Stat. Ann. Sec.  24:21-15.2, which became 
effective May 16, 2017.

III. Discussion

A. Allegation That Respondent's Registration Is Inconsistent With the 
Public Interest

    Under Section 304 of the CSA, ``[a] registration . . . to . . . 
dispense a controlled substance . . . may be suspended or revoked by 
the Attorney General upon a finding that the registrant . . . has 
committed such acts as would render his registration under section 823 
of this title inconsistent with the public interest as determined by 
such section.'' 21 U.S.C. 824(a)(4). In the case of a ``practitioner,'' 
defined in 21 U.S.C. 802(21) to include a ``physician,'' Congress 
directed the Attorney General to consider the following factors in 
making the public interest determination:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing . . . controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the . . . distribution[ ] or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

21 U.S.C. 823(f). These factors are considered in the disjunctive. 
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (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.
    Under DEA's regulation, ``[a]t any hearing for the revocation . . . 
of a registration, the . . . [Government] shall have the burden of 
proving that the

[[Page 45685]]

requirements for such revocation . . . pursuant to . . . 21 U.S.C. 
[Sec. ] 824(a) . . . are satisfied.'' 21 CFR 1301.44(e). In this 
matter, while I have considered all of the factors, the Government's 
evidence in support of its prima facie case is confined to Factors Two 
and Four.\71\ I find that the Government's evidence with respect to Two 
and Four satisfies its 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.
---------------------------------------------------------------------------

    \71\ I agree with the ALJ that Factors One and Three do not 
weigh for or against revocation in this case, nor does Factor Five 
weigh in favor of revocation. RD, at 146. Without referencing Factor 
One, Respondent mentions that the State of New Jersey has not 
brought any action against her state license. Resp Posthearing, at 
1. However, Agency decisions have long found that in considering 
Factor One, a state entity's inactions does not weigh for or against 
revocation. See Ajay S. Ahuja, M.D., 84 FR 5479, 5490 (2019) 
(finding that ``where the record contains no evidence of a 
recommendation by a state licensing board that absence does not 
weigh for or against revocation.'')
---------------------------------------------------------------------------

1. Factors Two and/or 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 
prescription for controlled substances is one that is ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a). The 
Supreme Court has stated, in the context of the CSA's requirement that 
schedule II controlled substances may be dispensed only by written 
prescription, that ``the prescription requirement . . . ensures 
patients use controlled substances under the supervision of a doctor so 
as to prevent addiction and recreational abuse . . . [and] also bars 
doctors from peddling to patients who crave the drugs for those 
prohibited uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006).
    Respondent engaged a skillful attorney to defend herself against 
the allegations. I read and analyzed every aspect of Respondent's 
defense including all of the evidence she put in the record. 
Respondent's arguments regarding the allegations are not persuasive.
    I acknowledge the complexity of this case. The OSC/ISO contained 
errors, what appeared to be a very adversarial hearing led to confusion 
relating to testimony on both sides, and the ALJ's statements in the 
lengthy RD were at times inconsistent with each other.\72\ Because of 
the complexity of this case, I have parsed out only the allegations 
against that were clearly presented. The end result remains that 
Respondent issued numerous prescriptions beneath the applicable 
standard of care and outside of the usual course of the professional 
practice in New Jersey. DEA decisions have found that ``just because 
misconduct is unintentional, innocent, or devoid of improper motive, 
[it] does not preclude revocation or denial. Careless or negligent 
handling of controlled substances creates the opportunity for diversion 
and [can] justify the revocation of an existing registration . . .'' 
Bobby D. Reynolds, N.P., Tina L. Killebrew, N.P., & David R. Stout, 
N.P., 80 FR 28,643, 28662 (2015) (quoting Paul J. Caragine, Jr. 63 FR 
51,592, 51,601 (1998). In fact, in this case it seems that two out of 
the six patients presenting were successful in purposefully exploiting 
Respondent's carelessness (the UC and L.M.).
---------------------------------------------------------------------------

    \72\ See, e.g., RD, at 155 (stating that if Respondent had 
violated New Jersey law, her ``conduct would have been far more 
egregious than it actually was); but c.f., RD, at 101, n.49 (``even 
if N.J. Admin. Code Sec.  13.35-7.1A were considered, such 
consideration would not change my recommended sanction in this 
Recommended Decision.'').
---------------------------------------------------------------------------

    Respondent contended that the OSC alleged over 150 unlawful 
prescriptions and the Government only presented evidence about twenty-
six and highlights the ALJ's characterization of the OSC as ``error-
filled and overzealous.'' \73\ Resp Exceptions, at 1. She further 
alleged that ``[i]t effectively destroyed [r]espondent's practice built 
up over ten years.'' Id. The OSC alleged that Respondent continued to 
prescribe after she had not documented the resolutions of a multitude 
of red flags in violation of the applicable standard of care in, and 
state law of, New Jersey and therefore that every subsequent 
prescription issued after the first violation to each patient was 
issued beneath the applicable standard of care and outside the usual 
course of practice in New Jersey.\74\ Although the Government did not 
litigate the broader allegations that subsequent prescriptions were 
also in violation, in actuality the majority of the underlying facts 
alleged in the OSC were, in fact, sustained. I have sustained a few 
more violations than the ALJ based on the reasons stated herein, but it 
is truly not the mere number of violations that tip the public interest 
against Respondent.
---------------------------------------------------------------------------

    \73\ I disagree with this characterization of the OSC/ISO. Due 
to the ALJ's perceived errors in the OSC/ISO, the ALJ also made a 
statement that was misleading and incorrect. He stated, ``All of 
these allegations painted a picture of a practitioner whose actions 
were inconsistent with the public interest. All of those allegations 
were wrong!'' RD, at 155. In making this statement, the ALJ 
differentiated between the number of violations presented at hearing 
and a number that was not quantified in the OSC; incorrectly found 
that DEA did not prove violations of New Jersey law as alleged in 
the OSC; differentiated between alcohol and alcohol metabolites, 
which even Respondent admits is inconsequential to the requirement 
to counsel about alcohol risks; and highlighted one instance of an 
incorrect date in the OSC for a negative urine screen (however, the 
Government omitted two other negative urine screens for this patient 
that were never addressed and likely would have been found to be 
violations). RD, at 154-155; see supra notes 54, 55. The OSC did 
contain errors, as described throughout this decision, but several 
of the instances that the ALJ included here were incorrect and not 
as egregious as they seemed, and the errors that were made cannot 
justify a lesser sanction for someone who has not demonstrated that 
she can be entrusted with a DEA registration. See infra note 86.
    \74\ The ALJ characterized this as over one hundred and fifty 
prescriptions, but the OSC did not quantify how many prescriptions 
it was purporting to encompass.
---------------------------------------------------------------------------

    Respondent additionally contended that the number of alleged 
violations only represents a small subset of the 2,800 patient visits 
that DEA reviewed. See Resp Posthearing, at 2. Respondent argued that 
she has a very busy practice and that the Government presented 
allegations in only a subset of the prescriptions she wrote, but the 
violations I have found demonstrate that she repeatedly violated the 
applicable standard of care and state law and that her conduct was not 
an isolated occurrence, but occurred with multiple patients and in 
multiple contexts over a period of years. See Wesley Pope, M.D., 82 FR 
42,961, 42,986 (2017).
    The Respondent asserted that no one ``died or overdosed or diverted 
any medication.'' Resp Posthearing, at 1. She does not, however, cite 
legal authority for the proposition that I must find death, an overdose 
or controlled substance diversion before I may suspend or revoke a 
registration. I agree with the ALJ that a decision of revocation does 
not need to be based on specific evidence of death or overdose. See RD, 
at 141. As the ALJ noted, Agency decisions have found that ``diversion 
occurs whenever controlled substances leave `the closed system of 
distribution established by the CSA. . . .' '' Id. (citing Roy S. 
Schwartz, 79 FR 34,360, 34,363 (2014)). In this case, I have found that 
Respondent issued prescriptions without complying with her obligations 
under the CSA and New Jersey law. See George Mathew, M.D., 75 FR 
66,138, 66,148 (2010)).
    Respondent further argued that the UC failed in obtaining opiates 
without

[[Page 45686]]

any ailment, because the ``agent was only able to obtain a minimal 
prescription of a low-dose opiate after presenting an MRI report 
demonstrating disease.'' Resp Posthearing, at 2. Respondent did require 
that the UC obtain a clearer MRI before prescribing her controlled 
substances, she did recommend alternative therapies, she did conduct 
urine screens, but she also never conducted a physical examination of 
the UC required by law.\75\ Dr. Kaufman credibly testified that 
Respondent's opioid prescriptions to the UC were beneath the applicable 
standard of care and outside of the usual course of the professional 
practice in the State of New Jersey. As discussed below, the New Jersey 
regulations concur. It is possible that had Respondent required the new 
MRI and conducted a physical examination as required by law, in order 
to make her diagnosis, the investigation might have ceased. However, 
she did not conduct the requisite physical examination. Therefore, I 
cannot credit her efforts to characterize herself as a victim or 
attempts to compare this investigation to a ``second Katrina,'' when 
she was clearly responsible for an undocumented decision to not conduct 
the physical examination required by New Jersey. Resp Exceptions, at 1 
(quoting tr. 789).
---------------------------------------------------------------------------

    \75\ I note that this Agency has consistently relied on expert 
testimony stating that a component of an adequate physical 
examination is palpation. See, e.g., Garrett Howard Smith, M.D., 83 
FR 18,882 (2018); Randall L. Wolff, M.D., 77 FR 5106 (2012). N.J. 
Admin. Code Sec.  13:35-7.1A (West 2020); Govt Supp Prehearing, at 
4.
---------------------------------------------------------------------------

    I found Respondent's credibility to be dubious and her counseling 
on the record to be insufficient, but the record was clear that, 
whether or not Respondent actually counseled patients with inconsistent 
urine screens or alcohol metabolites, she did not adequately document 
that counseling to demonstrate that she was actively resolving the 
issues. The ALJ cited to numerous DEA cases that demonstrate that 
``requiring patients to take a drug test serves little purpose, if any, 
if the registrant ignores the test results.'' RD, at 112 (citing U.S. 
v. Moore, 423 U.S. 122, 142-143 (1975); see also Dreszer, M.D., 76 FR 
at 19,388.) \76\ Respondent argued that the ``caselaw cited by the ALJ 
in support of the documentation requirement seems to stand for the 
proposition that the documentation is needed to demonstrate that an act 
occurred, not that the documentation is a prerequisite for the proper 
practice of medicine.'' Resp Exceptions, at 24 (citing Gonzales v. 
Oregon, 546 U.S. 243, 270 (2006)). The cases to which the ALJ cited 
were decided based on expert testimony and state standards regarding 
the applicable standard of care and were not, as Respondent implies, 
medical judgments of the DEA. In this case, the applicable standard of 
care requiring documentation of the inconsistent urine screens was 
established by New Jersey laws that have explicitly addressed his issue 
and credible expert testimony. In fact, in exercising my authority 
under the CSA, I am instructed to consider ``the registrant's 
compliance with state and local drug laws.'' Gonzales v. Oregon, 546 
U.S. 243, at 270 (citing 21 U.S.C. 823(f)(4)). Furthermore, Agency 
decisions highlight the Agency's interpretation that ``[c]onscientious 
documentation is repeatedly emphasized as 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). 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.
---------------------------------------------------------------------------

    \76\ Agency decisions relying on expert testimony have found 
that documenting the results of inconsistent urine screens is part 
of the applicable standard of care. In Jacobo Dreszer, M.D., a case 
arising in Florida, inconsistent urine screens not only ``should 
have inspired additional diligence or inquiry on the part of the 
[r]espondent,'' but they should have also ``raised a sufficient 
suspicion of diversion to merit further inquiry by the registrant 
reflected in the patient file.'' 76 FR at 19,394; see also Cynthia 
Cadet, M.D., 76 FR 19,450, 19,457 (2011) (noting the patient's urine 
screen produced abnormal results and the respondent ``made no effort 
to resolve the conflict as best as can be divined from the patient 
file''). Even though these Agency decisions are not essential or 
controlling in determining the standard of care in New Jersey that 
applies to this case, the fact that other medical experts in other 
states have testified regarding the importance of documenting 
inconsistent urine screens to their applicable standard of care and 
that DEA has long highlighted the importance of this aspect of the 
standard of care in those states to maintaining registrations under 
the CSA lends further support to the findings herein.
---------------------------------------------------------------------------

    Respondent paints herself as an ``appropriate steward of her 
controlled-substance license.'' Resp Posthearing, at 2. Further, she 
argued that ``with her lack of venality and her cautious approach to 
her practice, it is submitted that [R]espondent is exactly the kind of 
practitioner who should be encouraged.'' Id. at 58. I disagree. 
Respondent's practice incorporated some safeguards to prevent the 
diversion of opioids, such as, monthly urine screens, diagnostic 
testing, and recommending alternative treatments, but the safeguards 
were not fully implemented in a meaningful way, because she never 
documented their resolution, if they were in fact resolved. In 
balancing the public interest, I weigh in Respondent's favor that the 
record evidence shows that she attempted to implement controls, such as 
monthly urine screens to prevent diversion. However, the record 
contains numerous instances where these controls fell short and lacked 
substance. When she continued to prescribe to Patient L.M. in the face 
of a multitude of inconsistent urine screens showing three tests for 
Suboxone in a row, fentanyl, and finally heroin, her justifications 
were inconsistent and not credible and they were not otherwise 
documented. See supra II(F)(5). When she prescribed to the UC, she 
claimed that she was basing the five prescriptions on the results of 
the MRI in lieu of a physical examination, but her diagnosis was 
inconsistent and the transcript of the recorded video, which shows that 
she could not appear to recall or find the MRI on some of the 
subsequent visits. See supra II(F)(1). Partially implementing 
safeguards against diversion is not the same as actually implementing 
them and is not an excuse for prescribing controlled substances beneath 
the applicable standard of care and outside the usual course of the 
professional practice. I therefore find that Factors Two and Four weigh 
in favor of revocation.
(b) Allegations of Violation of Federal and New Jersey Law
    I find that in issuing twenty-three prescriptions beneath the 
applicable standard of care and outside the usual course of the 
professional practice in New Jersey, Respondent violated 21 CFR 
1306.04(a).
i. New Jersey Administrative Code Sec.  13:35-7.1A
    I also find that the Government has proven by substantial evidence 
that Respondent's failure to conduct an adequate physical examination 
of the UC constitutes a violation of N.J. Admin. Code Sec.  13:35-7.1A 
(West 2020) (effective September 15, 2003) (practitioners shall not 
issue prescriptions ``without first having conducted an examination, 
which shall be appropriately documented in the patient record'' to 
include ``an appropriate history and physical examination.''). 
Respondent characterizes the regulation to require an ``appropriate 
physical examination,'' but in fact, the regulation requires ``an 
appropriate history'' and ``physical

[[Page 45687]]

examination.'' Resp Posthearing, at 10. She did not support a reading 
in New Jersey law that re-arranges the clear order of the regulation's 
provisions.\77\ Even if the word ``appropriate'' in the regulation were 
to apply only to the physical examination, any practitioner discretion 
\78\ would still be bound by the objective, applicable standard of care 
in New Jersey, which, as clearly established by Dr. Kaufman, 
Respondent's treatment of the UC fell below. Additionally, Respondent 
did not adequately document her justification for why a physical 
examination was inappropriate or unnecessary under the circumstances. I 
find that Respondent violated the New Jersey regulation when she 
prescribed a controlled substance to the UC without having performed an 
appropriate physical examination.
---------------------------------------------------------------------------

    \77\ Respondent argued that N.J.S.A. 24:21-15.2 requires a 
physical exam prior to an initial opioid prescription ``as 
appropriate.'' Resp Exceptions, at 8. Respondent noted that this 
provision was not in effect during the treatment in question, but 
that it ``does give insight into the State's standards.'' Id. at 
n.9. I agree with the Respondent that the New Jersey statutes and 
regulations give insight into the standard of care in New Jersey, 
which is one of the reasons why I am including them herein as 
evidence of the applicable standard of care as contradicting Dr. 
Epstein's testimony. Although not controlling law on this issue, 
this statute is not explicit about what the term ``appropriate'' 
means; however, its implementing regulation states that a 
practitioner must ``conduct a physical examination appropriate to 
the practitioner's specialty, including an assessment of physical 
and psychological function, and an evaluation of underlying or 
coexisting diseases or conditions.'' N.J. Admin. Code Sec.  13:35-
7.6(b)(2) (West 2020). From the regulation, it appears that the term 
``appropriate'' in the statute, as interpreted by the New Jersey 
Attorney General refers to the practitioner's specialty, which would 
correlate directly to the patient's medical condition, and not to 
the practitioner's discretion. Further, as noted, Dr. Kaufman 
credibly testified that Respondent's examination of the UC was not 
adequate under the standard of care in New Jersey.
    \78\ To further demonstrate this discretion, Respondent cites to 
the exceptions to the examination requirement in N.J. Admin. Code 
Sec.  13:35-7.1A(b) arguing that they list ``circumstances all 
relate[d] to, other than emergencies, those situations where a 
patient already has a diagnosis for their pain.'' Resp Posthearing, 
at 8 n.2. In fact, the provisions unrelated to emergencies are 
either because the physician is assuming the care of the patient for 
another practitioner who has performed a physical (b)(2) and (b)(5); 
or for ``an established patient who, based on sound medical 
practice, the physician believes does not require a new examination 
before issuing a new prescription.'' N.J. Admin. Code Sec.  13:35-
7.1A(b)(4) (West 2020). As the ALJ notes, there is no evidence on 
the record to support Dr. Epstein's claim that the UC was 
Respondent's ``established patient'' at the time of her second 
visit. RD, at 15. Additionally, even if she were considered an 
established patient, the term ``new'' examination necessarily 
implies that there was a previous examination, and there was not.
---------------------------------------------------------------------------

    Respondent further argued both that the patient's MRI gave her a 
diagnosis and that she had conducted enough of an examination by 
observing the patient ``to derive a proper etiology of a patient's 
subjective pain complaints and come up with a plan. . . .'' Id. at 10-
11. In interpreting the requirements of N.J. Admin. Code Sec.  13:35-
7.1A, the New Jersey Office of Administrative Law determined that a 
physician, who listened to the patient's breathing and ``visually 
observed her while she was in the examination room'' had ``failed to 
perform any competent physical examination of her back or spine,'' the 
place of the patient's complaint. In the Matter of the Suspension or 
Revocation of the License of John G. Costino, Jr., D.O. to Practice 
Medicine and Surgery in New Jersey, 2009 WL 1396180, at 5. (N.J. Adm.) 
(May 14, 2009). Respondent's observation of the UC was not a 
``competent physical examination'' of the place of the patient's 
complaint under New Jersey law, her ``diagnosis'' was undercut by her 
own recordkeeping and statements, and therefore, I find that her 
treatment of the UC violated this New Jersey regulation. See supra 
(II)(F)(1).
ii. New Jersey Administrative Code Sec.  13:35-7.6(f)(2), (5)
    I further find that Respondent violated N.J. Admin. Code Sec.  
13:35-7.6(f)(2) and (5) for five prescriptions issued after its 
effective date of March 1, 2017, where the patients' records 
demonstrate no documentation of the resolution or ``plan'' after 
breaches to the pain management agreement due to patients not taking 
controlled substances as prescribed and no documented assessment of 
their risk of dependence before issuing additional prescriptions.\79\
---------------------------------------------------------------------------

    \79\ I am considering Section 13:35-7.6(f)(2), because although 
there was limited specific discussion of this Section in the record, 
together Sections (f)(2) and (f)(5) demonstrate the requirement to 
document the rationale for continuing to prescribe after 
inconsistent urine screens--whether it is to develop a plan or 
assess the risk of the individual patient. The finding of violations 
of these sections individually has not been given any additional 
weight in my decision to revoke. Dr. Kaufman clearly testified that 
``within the State of New Jersey, each time the patient comes in, 
you're supposed to assess the patient, to make sure that, A, that 
they're taking it. B, that it is efficacious, are there any side 
effects? And then, make a justification as to continuation of 
therapy.'' Tr. 201-202.
---------------------------------------------------------------------------

    Respondent argued that she complied with the requirement to 
document a ``plan,'' because of what she described as her ``decision-
tree analysis'' based on Dr. Gutheil's testimony that the end result 
shows the judgment that goes before it. Resp Posthearing, at 20 (citing 
Tr. 1220). ``For [Respondent], whenever there was an inconsistent urine 
reported, but a prescription was issued, it indicated to her that 
appropriate counseling was done and all safety concerns were 
resolved.'' \80\ Id. (citing tr. 1024-1025, 1027). She further argued 
that the requirement to document the ``plan'' does not include the 
counseling or the discussion or the reasons for the breach. Id. at 18-
19. Respondent offered no New Jersey caselaw, valid regulatory 
interpretations, or expert testimony related to what constitutes a plan 
in the context of this regulation under the applicable standard of care 
and the usual course of the professional practice to support this 
reading, and legal analysis of the regulation's purpose and history do 
not support this limited reading.
---------------------------------------------------------------------------

    \80\ Dr. Gutheil testified at most that documentation of the 
result ``does minimally'' document what occurred in terms of the 
physician-patient interaction. Tr. 1220. However, in no way did Dr. 
Gutheil's testimony address the statutory requirement to discuss 
breaches and document the plan and how a decision tree analysis 
would meet that requirement.
---------------------------------------------------------------------------

    The plain meaning of the term ``plan'' cannot be, as Respondent 
suggests, merely identifying the breach and documenting the end result 
after a discussion. Respondent's own testimony demonstrates why it 
cannot. With regard to Patient L.M., who tested positive three times in 
a row for un-prescribed Suboxone, Respondent could not remember why she 
had not cut L.M.'s dosage even though she testified that after the 
third positive test, she realized that the ``counseling wasn't 
successful.'' Tr. 1092-95. The unchanged prescriptions following these 
visits could not be adequate documentation of a plan to address 
counseling about a breach of her pain management agreement that 
Respondent herself knew at that point was not being successful, because 
Respondent cannot remember why she issued the full prescription or why 
she resolved the unsuccessful counseling in that manner.\81\
---------------------------------------------------------------------------

    \81\ I am using this as an example to demonstrate why the 
prescription alone cannot demonstrate the ``plan.'' The regulation 
was not in effect until the prescription issued after Patient L.M. 
tested positive for heroin and was discharged in April of 2017.
---------------------------------------------------------------------------

    Furthermore, in other sections of the regulation, the State of New 
Jersey used very different terminology. For example, Section (d) 
states, ``The practitioner shall include a note in the patient record 
that the required discussion(s) took place.'' N.J. Admin. Code 13:35-
76(d). As discussed earlier, this provision requires that the 
practitioner note the fact that the discussions took place. The 
inclusion of the word ``plan'' in the Section at issue indicates that 
the regulations require more documentation than only a conclusory 
assertion.

[[Page 45688]]

    In interpreting the meaning of a regulation, ``agencies normally 
address problems in a detailed manner and can speak through a variety 
of means, including regulations, preambles, interpretive statements, 
and responses to comments. . . .'' Hillsborough County, Fla. v. 
Automated Medical Labs., Inc. 471 U.S. 707, 718 (1985). The New Jersey 
regulation requiring a ``plan'' was adopted through emergency 
amendments ``because of the imminent peril created by the epidemic of 
prescription opioid and heroin abuse in New Jersey.'' New Jersey 
Division of Consumer Affairs, Rule Proposal, Volume 49, Issue 6, (March 
20, 2017) available at: https://www.njconsumeraffairs.gov/proposals/pages/03202017-bme-proposal.aspx (hereinafter, the Preamble).\82\ 
Further, the Preamble to the regulation states that a statute was 
signed into law--Public Law 2017, c. 28, codified at N.J. Stat. Sec.  
24:21-15.2; however because it ``does not become effective until May 
16, 2017, the Attorney General has determined that this rulemaking is 
necessary because the state of New Jersey is confronting a staggering 
public health crisis brought about by prescription opioid and heroin 
abuse.'' Id. One reason for the public health emergency is ``the 
prevalence of opioid prescribing.'' Id.
---------------------------------------------------------------------------

    \82\ The online version of the Preamble does not contain 
pagination; therefore, the page references are based on a printed 
copy of the online document.
---------------------------------------------------------------------------

    There are two affirmative obligations in the regulation that are 
applicable to this record--``[w]hen controlled dangerous substances are 
continuously prescribed for management of chronic pain'' \83\ (defined 
as pain continuing for three months), the practitioner shall ``assess 
the patient prior to issuing each prescription to determine whether the 
patient is experiencing problems associated with physical and 
psychological dependence, and document the results of that assessment'' 
and ``monitor compliance with the pain management agreement . . . and 
discuss with the patient any breaches that reflect that the patient is 
not taking the drugs prescribed or is taking drugs, illicit or 
prescribed by other practitioners or prescribers, and document within 
the patient record the plan after that discussion.'' N.J. Admin. Code 
Sec. Sec.  13:35-7.6(f)(2), (f)(5). The preamble to the regulation 
states that (f)(2) ``contains an affirmative obligation to assess the 
patient prior to the issuance of each prescription for a controlled 
dangerous substance.'' The Preamble, at 7. ``Overall the amendments to 
this subsection are designed to increase practitioner involvement and 
vigilance when prescribing for the treatment of chronic pain, and to 
ensure that the patient record reflects active pain management 
procedures.'' Id.
---------------------------------------------------------------------------

    \83\ `` `Chronic pain' means pain that persists for three or 
more consecutive months and after reasonable medical efforts have 
been made to relieve the pain or its cause, it continues, either 
continuously or episodically.'' N.J. Admin. Code 13:35-7.6(a) (West 
2020). Due to the fact that the patients in this case were 
prescribed opioids for more than three months prior to this 
regulation, I believe that they fall under this definition.
---------------------------------------------------------------------------

    The Preamble is very clear that the State of New Jersey's purpose 
in enacting emergency controls on prescribing controlled dangerous 
substances for chronic pain is to ensure not only vigilance and 
involvement but that these ``active pain management procedures'' are 
also reflected in the patient record. Additionally, reading the two 
paragraphs together, it is apparent that the practitioner must assess 
the risks before every prescription and where there is a breach to the 
pain management agreement that demonstrates a potential risk of 
dependence, the plan and the assessment must be documented. Therefore, 
I find that five prescriptions with unresolved inconsistent urine 
screens issued after the effective date of March 1, 2017, violated N.J. 
Admin. Code Sec.  13:35-7.6(f)(2) and (5).
iii. New Jersey Statute Sec.  24:21-15.2 \84\
---------------------------------------------------------------------------

    \84\ Regarding N.J. Stat. Ann. Sec.  24:21-15.2, the ALJ found 
that the statute ``by its terms, applies to `initial prescriptions' 
and ``the Government presented no evidence to show that the 
prescription [Respondent] issued to [UC] was her first prescription 
for an opioid.'' RD, at 111 (citing N.J. Stat. Sec.  24:21-15.2(b)). 
The statute also was not in existence at the time that the alleged 
violations related to UC had occurred, as the relevant portions came 
into effect on May 16, 2017, and therefore I am disregarding his 
conclusions on that issue.
---------------------------------------------------------------------------

    In its Posthearing Brief and Exceptions, the Government alleged 
that ``when issuing prescriptions for opioids practitioners must 
determine `that the issuance of the subsequent prescription does not 
present an undue risk of abuse, addiction or diversion and [must] 
document[ ] that determination.' '' Govt Posthearing, at 15-16 (citing 
N.J. Stat. Ann. Sec.  24:21-15.2(c)(3)). The Section of the statute 
that the Government cited appears to apply only when issuing a 
subsequent prescription ``no less than four days after issuing the 
initial prescription.'' N.J. Stat. Ann. Sec.  24:21-15.2(c). It is not 
clear from the plain language of the subsection that the risk 
assessment would be required for every subsequent prescription, and the 
Government ignored the issue in its briefs. A reading of subsection (c) 
that applied to every subsequent prescription could also be in conflict 
with subsection (f)(2), which requires that after three months of 
prescribing a Schedule II controlled dangerous substance or any opioid 
drug for chronic pain the physician must ``assess the patient prior to 
every renewal to determine whether the patient is experiencing problems 
associated with physical and psychological dependence and document the 
results of that assessment.'' N.J. Stat. Ann. Sec.  24:21-15.2(f)(2). 
Despite the Government's error in citing to subsection (c) in its 
Posthearing filings, it did not so limit itself in its Supplemental 
Prehearing Statement or Posthearing Brief. The Supplemental Prehearing 
Statement stated that N.J. Stat. Ann. Sec.  24:21-15.2 requires ``that 
a doctor prescribing opioids enters into a pain management agreement 
with patients; and that patients receiving opioids are monitored for 
compliance with the pain management through various measures such as 
drug screens'' and further that a physician's compliance with the 
statute ``must be documented in a patient's medical records.'' Govt 
Supp Prehearing, at 4. Although not specifically noted, the Government 
was clearly implicating Sections N.J. Stat. Ann. Sec.  24:21-15.2 
Sections (e) and (f) pertaining to chronic pain, because the pain 
management agreement is not required under the subsequent prescription 
in Section (c) and Respondent and the Government presented arguments 
during the hearing implicating these sections; therefore, I find that, 
despite the Government's Posthearing briefings, Respondent was on 
adequate notice of the allegations of these violations and they are 
appropriately considered.
    Respondent argued that the statute does not specify the requirement 
to document noncompliance with the pain management agreement. See Resp 
Supp Prehearing, at 3. Respondent further argued that, because the 
statute was enacted after the regulation and the documentation was 
``intentionally absent'' in the statute, a narrow reading of the term 
``plan'' in the regulation is more appropriate, because if New Jersey 
had intended a broader interpretation, it would have required this by 
statute. Resp Posthearing, at 19. The history of the statute and the 
regulation refutes Respondent's contention. P.L. 2017, c. 28 was signed 
into law on February 15, 2017, prior to the emergency adoption of N.J. 
Admin. Code Sec.  13:35-7.6 on March 1, 2017. The stated purpose of the 
emergency regulation was because ``P.L. 2017, c.28, does not become 
effective until May 16, 2017.'' Preamble,

[[Page 45689]]

at 2. The Attorney General of New Jersey believed that the ``staggering 
public health crisis brought about by prescription opioid and heroin 
abuse'' could not wait for even another three months to become 
effective. Id. Further, because the ``standards set forth in this 
rulemaking will provide a basis to seek emergent action to suspend or 
limit licenses pending a plenary hearing, pursuant to N.J.S.A. 45:1-22, 
and/or for disciplinary sanctions pursuant to N.J.S.A. 45:1-21,'' I 
find that New Jersey intended that the regulatory violations found 
above also constitute statutory violations. Id.
    Therefore, I find sufficient evidence to sustain violations of N.J. 
Stat. Ann. Sec.  24:21-15.2 for the three prescriptions occurring after 
it was effective on May 16, 2017. I further find that these provisions 
support Dr. Kaufman's testimony regarding the importance under the New 
Jersey standard of care of documenting not only the fact that 
counseling occurred, but also the resolution of such counseling.
    The laws that New Jersey has implemented clearly demonstrate the 
extent to which the applicable standard of care in New Jersey relies 
on, not just checking for compliance with the pain management 
agreement, but that breaches, such as inconsistent urine screens are 
discussed and ``the plan after that discussion'' is documented in the 
patient record. N.J. Admin. Code Sec.  13:35-7.6(f)(5) (West 2020). 
These laws require more than lip service to safeguards, but actual 
rational, thoughtfulness on the part of the practitioner in making the 
decision to reissue a prescription to someone who is presenting red 
flags or danger AND the memorialization of that decision. To preserve 
the value of New Jersey law, I cannot agree with the ALJ here that this 
is ``not the sort of recordkeeping violation that would defeat the 
purpose of the Controlled Substances Act.'' RD, at 150.\85\ 
Documentation of a practitioner's decision-making is essential to the 
practitioner's accountability for that decision--it ensures that the 
practitioner is actually processing the information in front of her and 
applying it to her care of the patient and marking it with permanence.
---------------------------------------------------------------------------

    \85\ 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.'' 
Gonzales v. Oregon, 546 U.S. at 274.
---------------------------------------------------------------------------

(c) Summary of Factors Two and Four and Imminent Danger
    As found above, the Government's case establishes by substantial 
evidence that Respondent issued controlled substance prescriptions 
outside the usual course of the professional practice. I, therefore, 
conclude that Respondent engaged in misconduct which supports the 
revocation of her registration. See Wesley Pope, 82 FR 14,944, 14,985 
(2017).
    For purposes of the imminent danger inquiry, my findings also lead 
to the conclusion that Respondent has ``fail[ed] . . . to maintain 
effective controls against diversion or otherwise comply with the 
obligations of a registrant'' under the CSA. 21 U.S.C. 824(d)(2). The 
substantial evidence that Respondent issued controlled substance 
prescriptions outside the usual course of the professional practice 
establishes that there was ``a substantial likelihood of an immediate 
threat that death, serious bodily harm, or abuse of a controlled 
substance . . . [would] occur in the absence of the immediate 
suspension'' of Respondent's registrations. Id.; see, e.g., tr. 213, 
482 (the opinion of the Government's expert, Dr. Kaufman, that mixing 
alcohol and opioids could result in death); tr. 1494 (opinion of Dr. 
Epstein that ``people who use fentanyl as an abuse drug die.'').\86\ In 
particular, Respondent did not dismiss Patient L.M. after she had 
tested positive for fentanyl, Suboxone, and heroin, while still testing 
positive for prescribed oxycodone several times, and she did not 
document any explanation or discussions with Patient L.M. regarding 
breaches of her pain management agreement, which is particularly 
egregious in the face of the danger that her urine samples 
demonstrated. Although Respondent presented evidence to mitigate the 
egregiousness of her prescribing to patient SW, she was required to 
maintain adequate records describing the mitigating circumstances under 
the applicable standard of care in New Jersey and by New Jersey law; 
and therefore, the Government could not have known about these 
mitigations at the time of issuing the ISO. Although I agree that the 
OSC/ISO contained errors,\87\ I do not agree with the ALJ's statement 
that it was overzealous.\88\ See RD, at 154. At the time the Government 
issued the OSC/ISO, the Government had clear evidence of violations of 
law through an undercover who had been unlawfully prescribed controlled 
substances and records that appeared to demonstrate a practitioner who 
was prescribing with no explanation to individuals whose urine screens 
were demonstrating dangerous combinations of unprescribed controlled 
substances and alcohol or consistently showing no evidence of the 
controlled substances that she had prescribed.
---------------------------------------------------------------------------

    \86\ Although Dr. Epstein's testimony about fentanyl was aimed 
at concluding that L.M.'s multiple urine tests showing fentanyl must 
have been incorrect or a result of surgery, the evidence in the 
record demonstrates that L.M. was, in fact, also abusing heroin, so 
it seems likely that she was abusing fentanyl that was not 
legitimately prescribed, thus this danger that he is describing is 
applicable in this case.
    \87\ It is noted that although the OSC included some errors, 
such as that it alleged that on May 5, 2017, A.P.'s urine screen was 
negative for prescribed controlled substances, it also contained 
errors that omitted evidence which would have likely resulted in 
additional findings of violations, so the fact that the OSC included 
errors also benefitted Respondent. See, e.g., supra notes 49, 52, 
55, 59, 60, 66. Additionally, I would not have altered my decision 
on the Immediate Suspension Order due to these errors. There was 
enough evidence without them to justify the suspension of 
Respondent's registration.
    \88\ In making this statement, the ALJ highlighted the fact that 
the OSC argued that all prescriptions after the date of the first 
prescription were unlawful, which would have encompassed over 150 
unlawful prescriptions. RD, at 154. Although I agree with the ALJ on 
the legal matter that the Government did not prove this allegation, 
as stated previously, the OSC did not quantify how many 
prescriptions it was attempting to encompass; therefore, the impact 
of that number was not as strong as the ALJ implies.
---------------------------------------------------------------------------

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 due to her violations pertaining to controlled 
substance prescribing and non-compliance with federal and State law, 
the burden shifts to the Respondent to show why she can be entrusted 
with a new registration. Garrett Howard Smith, M.D., 83 FR 18,882, 
18,910 (2018) (collecting cases).
    The CSA authorizes the Attorney General to ``promulgate and enforce 
any rules, regulations, and procedures which he may deem necessary and 
appropriate for the efficient execution of his functions under this 
subchapter.'' 21 U.S.C. 871(b). This authority specifically relates 
``to `registration' and `control,' and `for the efficient execution of 
his functions' under the statute.'' Gonzales v. Oregon, 546 U.S. 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

[[Page 45690]]

argument Respondent submitted to determine whether or not she has 
presented ``sufficient mitigating evidence to assure the Administrator 
that [she] can be trusted with the responsibility carried by such a 
registration.'' Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 (2007) 
(quoting Leo R. Miller, M.D., 53 FR 21,931, 21,932 (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 23,853; John H. 
Kennnedy, M.D., 71 FR 35,705, 35,709 (2006); Prince George Daniels, 
D.D.S., 60 FR 62,884, 62,887 (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).
    In evaluating the degree of a respondent's acceptance of 
responsibility required to entrust her with a registration, in Mohammed 
Asgar, M.D., 83 FR 29,569, 29,572 (2018), the Agency looked for 
``unequivocal acceptance of responsibility when a respondent has 
committed knowing or intentional misconduct.'' Id. (citing Lon F. 
Alexander, M.D., 82 FR 49,704, 49,728 (2017)). The ALJ found, and I 
agree, that ``Respondent has not accepted responsibility, other than to 
concede that she `should have written more.' '' RD, at 152 (citing tr. 
1071). Respondent's assertion that she ``should have written more'' 
barely scrapes the surface of these issues, and seems to be an attempt 
to minimize the severity of her actions by so lightly characterizing a 
substantive documentation requirement. Tr. 1071; see Jeffrey Stein, 
M.D., 84 FR 46,968, 46,973 (2019) (finding that a registrant's 
minimization in describing his crime weighed against a finding of 
acceptance of responsibility). Respondent argued that she did accept 
responsibility for the prescriptions to the UC, when she stated that 
``yes, she wrote it, she wrote the scripts.'' Tr. 874; see Resp 
Exceptions, at 33. But when asked whether the prescriptions were issued 
outside the usual course of the professional practice, she answered no. 
Tr. 875. Accepting responsibility for writing the prescriptions does 
not equate to admitting fault. See Hoxie v. Drug Enf't Admin., 419 F.3d 
at 483 (``The DEA properly considers the candor of the physician'' and 
``admitting fault'' is an ``important factor[ ] in determining whether 
the physician's registration should be revoked''). Additionally, 
Respondent compared the DEA case to her ``second Katrina,'' which 
ultimately demonstrates that she takes no responsibility for her 
violations of law, but instead views herself entirely as a victim of 
forces beyond her control. Tr. 789.
    Respondent's mitigating evidence and the Government's mistakes have 
whittled down or softened some of the violations in this case; however, 
I see no evidence from Respondent that demonstrates that she will 
``prevent the re-occurrence of similar acts.'' Jeri Hassman, M.D. 75 FR 
8194, 8236 (2010). Acceptance of responsibility is an important part of 
that demonstration. Id. Although the evidence of her struggles with her 
software system is relatable at a basic level to every human being who 
has experienced technological frustrations, it again shows a passing of 
blame and an unwillingness to accept responsibility for a legal 
requirement and a requirement of the applicable standard of care and 
the usual course of the professional practice in her field to document 
her prescribing practices and decisions. Documentation of the 
discretion that Respondent had been implementing in her prescribing 
practices in the face of inconsistent urine screens is similar to 
accepting responsibility for her actions, because it memorializes her 
decisions with permanence. None of the recordkeeping in the 
Government's evidence demonstrates the rationale behind her prescribing 
decisions and she demonstrated through her testimony that her memory is 
not reliable to fill in the gaps.
    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 10,083, 10,095 (2009); Singh, 81 FR at 8248. 
With regard to specific and general deterrence, it is my responsibility 
under the CSA to encourage the good practices of preventing diversion 
that Respondent had implemented, including but not limited to, 
increasing urine screens to detect abnormalities, requiring an MRI to 
obtain more information about the source of pain, and encouraging 
alternative treatments; however, those additional measures are of no 
value to their stated purpose if the results of the urine screens are 
ignored. The cavalier attitude with which Respondent treated her 
documentation responsibilities and the fact that she did not undertake 
this responsibility with seriousness in any of these instances, weigh 
against my ability to entrust her with a registration. See 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.''). Therefore, I 
disagree with the ALJ that ``specific and general deterrence do not 
weigh in favor of revocation in this case.'' RD, at 153. The interests 
of general deterrence in discouraging practitioners from ignoring their 
legal obligations and not genuinely complying with important 
recordkeeping provisions, and the interests of specific deterrence in 
preventing Respondent from hiding behind rote diversion controls 
without legitimately attending to and documenting red flags weigh in 
favor of a sanction of revocation.
    Although the ALJ ultimately recommended a sanction short of 
revocation, I cannot agree, because there is insufficient evidence in 
the record to demonstrate that Respondent can be entrusted with a 
registration. See Leo R. Miller, M.D., 53 FR 21,931, 21,932 (1988) 
(describing revocation as a remedial measure ``based upon the public 
interest and the necessity to protect the public from individuals who 
have misused controlled substances or their DEA Certificate of 
Registration and who have not presented sufficient mitigating evidence 
to assure the Administrator that they can be trusted with the 
responsibility carried by such a registration.''). The ALJ's 
recommended mitigations might have helped Respondent understand better 
the legal requirements and might have permitted DEA to monitor her 
progress more easily, but they do not solve the underlying issue of 
trust.\89\ If I did not

[[Page 45691]]

appropriately consider whether Respondent had accepted responsibility 
such that I could entrust her with this responsibility, I would be 
minimizing Registrant's violations of state and federal law, 
undermining the public interest by not attempting to address those 
violations, and then placing the burden on the Agency whose trust she 
broke to monitor her compliance. Although such measures may be 
appropriate in some cases, here, Respondent has not given me a reason 
to extend them to her.
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    \89\ In fact, the ALJ does not address the issue of whether I 
can trust the Respondent at all in his Recommended Decision. Most of 
the statements in the RD do not demonstrate that I can trust her, 
such as his qualified finding of her credibility. RD, at 22-24. It 
seemed from the ALJ's diction and punctuation that it was his 
frustration with the Government's case that led him to recommend a 
sanction less than revocation. See id. at 155. However, I cannot 
exclude from a final determination on this case consideration of the 
issue of trust in the face of violations, even where there are fewer 
violations found than initially alleged.
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    Accordingly, I shall order the sanctions the Government requested, 
as contained in the Order below.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration 
BK9710939 issued to Kaniz F. Khan-Jaffery, 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 Kaniz F. Khan-Jaffery, M.D., to 
renew or modify this registration, as well as any other applications of 
Kaniz F. Khan-Jaffery, M.D. for additional registration in New Jersey. 
This Order is effective August 28, 2020.

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-16387 Filed 7-28-20; 8:45 am]
BILLING CODE 4410-09-P