[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
[[Page 45670]]
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.
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\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\
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\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\
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\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).
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(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.
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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).
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\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).
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\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.
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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)).
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\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.
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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.
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\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).
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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\
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\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\
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\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).
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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.
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\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.
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\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.
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\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).
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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.
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\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.'')
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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.).
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\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.'').
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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.
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\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.
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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).
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\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.
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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.
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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]
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