[Federal Register Volume 84, Number 248 (Friday, December 27, 2019)]
[Notices]
[Pages 71465-71473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27945]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 17-23]


Lisa Hamilton, N.P.; Decision and Order

    On March 17, 2017, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, Government), 
issued an Order to Show Cause to Lisa Hamilton, N.P., (hereinafter, 
Respondent), of Taunton,\1\

[[Page 71466]]

Massachusetts. Administrative Law Judge Exhibit (hereinafter, ALJX) 1 
(Order to Show Cause (hereinafter, OSC)), at 1. The OSC proposed the 
revocation of and denial of any pending application to modify or renew 
Respondent's Certificate of Registration No. MH0525153 ``pursuant to 21 
U.S.C. 823(f) and 824(a)(4) for the reason that [her] continued 
registration is inconsistent with the public interest as that term is 
defined in 21 U.S.C. 823(f). Id.
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    \1\ According to DEA records, Respondent filed to change her 
registered address during the proceedings to 113 Washington Street, 
Number 1, Foxboro, Massachusetts 02035, but the initial Order to 
Show Cause was issued to her registered address at the time, which 
was 1 Washington Street, Suite 900, Taunton, Massachusetts 02780.
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    Specifically, the OSC alleged that Respondent issued prescriptions 
for controlled substances to eight individuals for other than a 
legitimate medical purpose and outside the usual course of professional 
practice, in violation of 21 CFR 1306.04(a), M.G.L. 94C Sec.  19(a), 
and 244 CMR Sec. Sec.  3.00, 4.00 et. seq., and 9.03(5),(6),(39) and 
(44). Id. at 2-3. Additionally, the OSC alleged that from June 14, 
2016, to February 3, 2017, Respondent's Massachusetts Controlled 
Substances Registration (hereinafter, MCSR) lapsed, yet Respondent 
continued to issue controlled substance prescriptions during that time 
period in violation of 21 CFR 1306.03(a), and M.G.L. 94C Sec. Sec.  
7(a) and 18(a). Id. at 4.
    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). The OSC also notified Respondent of the opportunity to submit 
a corrective action plan. Id. at 4-5 (citing 21 U.S.C. 824(c)(2)(C)).
    By letter dated April 10, 2017, Respondent timely requested a 
hearing. ALJX 2 (Request for a Hearing), at 1. The matter was placed on 
the docket of the Office of Administrative Law Judges and assigned to 
Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, 
Chief ALJ). On April 13, 2017, the Chief ALJ established a schedule for 
the filing of prehearing statements. ALJX 3 (Order for Prehearing 
Statements), at 1. The Government filed its Prehearing Statement on 
April 25, 2017, and its Supplemental Prehearing Statement on June 23, 
2017. ALJX 4 and ALJX 10, respectively. On May 8, 2017, the Chief ALJ 
issued a Notice to Show Cause, which noted that Respondent had not 
timely filed an adequate prehearing statement and required her to show 
good cause as to the reasons for the deficiency and to correct it by 
filing a prehearing statement by May 15, 2017. ALJX 5. By letter dated 
May 13, 2017, Respondent replied that she had not understood the 
additional requirements and filed a Prehearing Statement in compliance 
with the Chief ALJ's Order. ALJX 6. On May 16, 2017, the Chief ALJ 
issued an Order Regarding Late Compliance accepting Respondent's 
Prehearing Statement. ALJX 7. On May 24, 2017, the Chief ALJ issued a 
Prehearing Ruling that, among other things, set out the nine 
Stipulations already agreed upon and established schedules for the 
filing of additional joint stipulations and supplemental prehearing 
statements. ALJX 8 (Prehearing Ruling), at 1-2. Respondent filed her 
Supplemental Prehearing Statement on June 23, 2017. ALJX 11.
    The hearing in this matter spanned two days.\2\ The Recommended 
Rulings, Findings of Fact, Conclusions of Law and Decision of the 
Administrative Law Judge (hereafter, R.D.) is dated September 18, 2017. 
Neither party filed exceptions to the R.D.; however, Respondent filed a 
motion to reconsider the R.D.,\3\ which was denied by the Chief ALJ on 
October 24, 2017, because the motion ``raise[d] no newly discovered 
evidence and present[ed] no changed circumstances that would render the 
RD determination inappropriate.'' Transmittal Letter, at 1; ALJX 14 and 
15 (citing William H. Wyttenbach, M.D., 82 FR 18777 (2017)).
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    \2\ Hearings were held in Boston, Massachusetts on July 19 and 
20, 2017.
    \3\ Respondent's motion for reconsideration states that she has 
``in fact learned a lot from this case'' and indicates what she 
``should'' and ``will'' do in the future. ALX 14, at 2. I agree with 
the Chief ALJ's denial of the motion. ALJX 15. This Agency's 
adjudicative process notably does not permit reconsideration in this 
manner and I do not believe that I can consider Respondent's 
promises, because doing so would, among other things, deprive the 
Government of an opportunity to address Respondent's representations 
and prevent a full credibility assessment.
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    Having considered the record in its entirety, I agree with the R.D. 
that the record establishes, by substantial evidence, grounds for the 
revocation of Respondent's registration--that Respondent committed acts 
rendering her continued registration inconsistent with the public 
interest. R.D., at 56-59. I further agree with the R.D. that 
Respondent's acceptance of responsibility is insufficient, and that, 
even if it were sufficient, Respondent did not offer adequate remedial 
measures, and that overall the factors weigh in favor of sanction. Id.
    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.

Findings of Fact

Respondent's DEA Registration

    Respondent is the holder of DEA Certificate of Registration No. 
MH0525153 at the registered address of 113 Washington Street, Number 1, 
Foxboro, Massachusetts 02035.\4\ GX 1. Pursuant to this registration, 
Respondent is authorized to dispense controlled substances in schedules 
II through V as a practitioner. Id.
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    \4\ Since the issuance of the OSC, Respondent changed her 
address from 1 Washington St., Suite 900, Taunton, Massachusetts 
02780. See also n.1, supra.
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The Government's Case
    The Government's documentary evidence consists primarily of medical 
records for eight patients. The Government called two witnesses: a DEA 
Diversion Investigator (hereinafter, DI), and an expert, Marylou 
Gregory-Lee, MSN, ANP-BC (hereinafter, Nurse Practitioner Gregory-Lee).
    DI testified about her investigation-related actions, including her 
roles in interviewing Respondent's former employer and collecting 
evidence on Respondent's prescribing activities and on her lapse in 
MCSR. Tr. 29-130; see also R.D., at 7-9. DI testified that Respondent 
came to her attention during an inspection of a practitioner at 
Signature Health, who, in response to standard questions related to 
whether he had ``information regarding any prescribers of concern, DEA 
registrants of concern, or . . . illegal activity involving controlled 
substances,'' stated that ``there was a person in the practice that got 
[sic] terminated'' and that ``some of the prescriptions in panel 
patients . . . were not indicated.'' Tr. 40, 41; see also R.D., at 7. 
Two subsequent subpoenas to Signature Health to obtain the identity of 
the practitioner produced the identification of Respondent and her 
prescribing activities and charts. Tr. 40-47; see also R.D., at 8. The 
DI also testified about her investigation into the seven-month lapse in 
Respondent's MCSR, during which Respondent issued approximately five 
hundred controlled substance prescriptions, of which DI obtained a 
``representative sampling.'' Tr. 96-98; GX 18; see also R.D., at 8. 
Having read and analyzed all of the record evidence, I agree with the 
Chief ALJ that DI ``presented testimony that was plausible, detailed, 
consistent, and without any obvious motive to fabricate''; and, 
therefore, ``her testimony is afforded full credibility.'' R.D., at 9.
    The Government's expert, Nurse Practitioner Gregory-Lee, is a Nurse

[[Page 71467]]

Practitioner in Florida. She was a registered nurse practitioner in 
Massachusetts but has been inactive in that state since February of 
2016. GX 13, at 1 (Curriculum Vitae of Marylou Gregory-Lee, MSN, ANP-
BC). She holds a Master of Science in Nursing from the University of 
Rhode Island. Id.; R.D., at 9. She testified that she has been a nurse 
for forty-nine and a half years and had practiced in Massachusetts from 
1968 to approximately 2013, when she became a resident of Florida. Tr. 
135-37. She was registered with the DEA to handle controlled 
substances, which expired in 2016. Id. The Chief ALJ accepted Nurse 
Practitioner Gregory-Lee as an ``expert in the field of controlled 
substance prescribing by advanced practice nurse practitioners in the 
State of Massachusetts and in the scope of their practice in the State 
of Massachusetts.'' Id. at 161-162. The matters about which Nurse 
Practitioner Gregory-Lee testified included her review and standard-of-
care analysis of medical records belonging to eight of Respondent's 
patients, and she relied on her written reports analyzing the medical 
records for each patient. e.g., id. at 204-32, 233-62, 265-99, 300-14, 
315-26, 370-82, 383-94, 394-402; see also R.D., at 13-28; GX 14 (Expert 
Summary Report).

Patient E.B.

    The Government's records related to Patient E.B. show that the 
patient visited the Respondent on nine occasions and that controlled 
substances were prescribed on six. R.D., at 13; GX 5a and b; GX 14, at 
3-5. Nurse Practitioner Gregory-Lee testified that the Massachusetts 
prescribing standard requires a pain assessment prior to prescribing 
controlled substances. Tr. 208. However, for Patient E.B, Respondent 
did not document a pain assessment during the initial physical exam, 
and instead noted remarks that the patient was ``pleasant,'' and had 
``[n]o acute distress.'' Id.; GX 14, at 3; GX 5a, at 31. In a 
subsequent visit a month later, E.B. presented with a swollen wrist. GX 
5a, at 24. Again, she testified that on April 3, 2013, Respondent 
documented that the patient ``is currently on a chronic pain 
medication'' and ``doesn't need any meds''; nevertheless, Respondent 
ordered oxycodone for the patient. Tr. 217; see also GX 5a, at 26; GX 
5b, at 3 (demonstrating the prescription). Additionally, during this 
visit, Respondent did not document an assessment of pain related to the 
injury. Tr. 220. Nurse Practitioner Gregory-Lee also opined that it was 
generally inappropriate to issue prescriptions for post-hysterectomy 
abdominal pain from a 2006 operation, where the scarring tissue had 
been removed in 2007.\5\ Id. at 224-25.
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    \5\ On cross-examination, Respondent pointed out that EB's 
patient chart states, ``on chronic pain management went to Dr. 
Portnow for evaluation and he put her on oxycodone 15MG 3x daily as 
needed, she's doing well with this at this time.'' GX 5a, at 27; Tr. 
425.
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Patient D.C.

    The file for Patient D.C. that was presented by the Government 
shows that the patient visited the Respondent on six occasions, at each 
of which the Respondent prescribed oxycodone. R.D., at 16; GX 6a and b; 
GX 14, at 6-7. Nurse Practitioner Gregory-Lee testified that it was 
unclear from the record what the patient's complaint was about--knee 
injury, lumbar disc, or coughing. Tr. 235-37; GX 6a, at 33-34. She 
determined that there was no physical evaluation and no pain 
assessment, and therefore, the oxycodone prescribed was not for a 
legitimate medical purpose. Tr. 238. On March 15, 2013, the record 
demonstrated that the purpose of Patient D.C.'s visit was an annual 
physical exam, but there was no physical exam documented. Tr. 243. 
Nurse Practitioner Gregory-Lee testified that a pain scale was 
mentioned but no results were recorded and oxycodone was prescribed. 
Id; see also GX 6a, at 30. On April 4, 2013, the physical exam stated, 
``pleasant. No acute distress.'' GX 6a, at 28; Tr. 243. Nurse 
Practitioner Gregory-Lee testified that ``[t]here's a physical exam 
that's completely normal, and there's no pain assessment. Based on that 
information, why would you order oxycodone? So it's inappropriate.'' 
Tr. 245. Likewise, there were no pain assessments on further visits, 
but Respondent prescribed controlled substances. Id. at 247. After 
Respondent was terminated, a new nurse practitioner saw D.C. on June 
24, 2013. Id. at 256; GX 6a, at 14-16. Unlike Respondent, she conducted 
a full physical examination, did not refill the oxycodone, referred 
D.C. for a toxicity screen, and had the patient follow up for a pain 
management visit.\6\ Id.
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    \6\ It should be noted that another Physician did subsequently 
prescribe the patient with Oxycodone, but shortly thereafter, the 
patient was terminated from care by Signature Health for a violation 
of her Controlled Substances Agreement. GX 6a, at 3, 12.
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Patient T.D.

    The Government introduced records for Patient T.D. demonstrating 
ten visits to Respondent, which resulted in ten prescriptions for 
oxycodone and fentanyl. R.D., at 18; GX 7a and 7b; GX 14, at 8-10. 
Nurse Practitioner Gregory-Lee testified that the chart describes 
Patient T.D. as a binge drinker, and so the Respondent should have 
documented a conversation about the dangers of mixing alcohol and 
controlled substances and also should have done a urinalysis to check 
for alcohol. Tr. 266-69. She testified that, on February 14, 2013, the 
patient was documented as having ``tremors,'' but there was no physical 
evaluation, no pain assessment, and fentanyl and oxycodone were 
prescribed. GX 7b, at 8; Tr. 270. Further, she opined that on 
subsequent visits, there was no pain assessment, no documentation of 
pain or of the effectiveness of controlled substance medication, and no 
discussion with the patient, so the prescriptions for fentanyl and 
oxycodone were not issued for a legitimate medical purpose under 
Massachusetts standards. GX 7b, at 3, 8; Tr. 277-82. Additionally, she 
testified that on April 8, 2013, there was no office visit attached to 
Respondent's issuance of a controlled substance prescription and that 
the standard in Massachusetts requires an office visit for controlled 
substance prescriptions. Tr. 282-83; GX 7b, at 3. Finally, Nurse 
Practitioner Gregory-Lee testified that the records demonstrate that 
the patient requested that Respondent decrease his medication, but she 
prescribed him the full amount without further explanation in the 
charts. Tr. 287; GX 7b, at 4.

Patient M.J.

    The Government's evidence related to Patient M.J. demonstrates four 
visits, each of which resulted in prescriptions for oxycodone, which 
Nurse Practitioner Gregory-Lee testified that, in her opinion, ``were 
not issued for a legitimate medical purpose because there was no pain 
assessment at any of the visits.'' R.D., at 22 (citing Tr. 301-14). 
Specifically, she testified that, on February 7, 2013, there was an 
initial visit with a physical exam, but there was no pain management or 
assessment. Tr. 299-300. On March 14, 2013, the records mentioned a 
``Wong-Baker'' pain assessment, but the resulting number was not 
recorded. Nurse Practitioner Gregory-Lee stated, ``Exam was there. It 
was pleasant, no acute distress, gait was normal. Everything was--he 
did have some exam, and what he had was completely normal. There was no 
pain assessment, but she ordered oxycodone.'' Id. at 303; GX 8a, at 12; 
GX 8b, at 2. Again, regarding Patient M.J.'s visit on April 11, 2013, 
Nurse Practitioner Gregory-Lee testified that there was ``no pain 
assessment'' and ``[Respondent] did a physical exam that was completely 
normal.'' Tr. 306-7, GX

[[Page 71468]]

8b,\7\ at 3. GX 8a, at 8-10. Further, Nurse Practitioner Gregory-Lee 
noted that Signature Health terminated M.J.'s patient care on August 9, 
2013, based on his violation of his controlled substances agreement. 
Tr. 311; GX 8a, at 3.
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    \7\ Tr. 307 cites to GX8a, at 3, but the prescription issued on 
April 11, 2013, is in GX8b, at 3.
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Patient E.L.

    The Government's records on Patient E.L. encompass eight visits, 
during which Respondent prescribed him hydrocodone/acetaminophen and 
oxycodone/acetaminophen. R.D., at 23 (citing GX 9a and 9b and GX 14, at 
13-15). Nurse Practitioner Gregory-Lee testified that Patient E.L. 
first visited Respondent on January 29, 2013, but there was no physical 
exam or pain assessment, and the patient was just documented as not 
feeling well. Tr. 315-17; GX 9a, at 22; GX 9b, at 1-2 (Percocet and 
Vicodin prescriptions). She testified further that on March 18, 2013, 
Respondent wrote a prescription with no corresponding patient visit, 
which does not meet the Massachusetts standard, because there was no 
pain assessment or physical evaluation. Tr. 322-23; GX 9b, at 6. On 
later visits, the patient presented with elbow pain, but there was no 
pain assessment and Nurse Practitioner Gregory-Lee opined that, in her 
expert opinion, the prescriptions were therefore not legitimate. Tr. 
324-25; GX 9a, at 14. GX 9b, at 8-11. Nurse Practitioner Gregory Lee 
once again clarified that ``[a]ny time pain medication is ordered, you 
have to have a pain assessment.'' Tr. 366. Further, on May 10, 2013, 
Respondent increased the dosage without a pain assessment or physical 
exam, and Nurse Practitioner Gregory-Lee testified that an increase of 
dosage in particular requires a justification to comply with the 
standard in Massachusetts. Tr. 367-68; GX 9a, at 9.

Patient K.M.

    The patient records presented by the Government regarding Patient 
K.M. reflect six visits to the Respondent, during four of which 
Respondent prescribed oxycodone, and none of which were prescribed for 
a legitimate medical purpose in the opinion of Nurse Practitioner 
Gregory-Lee, because there was no pain assessment. R.D., at 25 (citing 
GX 10a and b; and GX 14, at 16-17). Specifically, Nurse Practitioner 
Gregory-Lee testified that on March 4, 2013, Patient K.M. presented 
with a bruised elbow after a fall down the stairs, but Respondent did 
not order an x-ray, nor conduct a pain assessment. Tr. 374; GX 10a, at 
17-19; GX 10b, at 1. On March 28, 2013, Patient K.M. returned claiming 
another fall down the stairs, but Respondent did not conduct a pain 
assessment and increased the dosage without documenting the reason. Tr. 
376; GX 10b, at 1-2; GX 10a, at 14-16. Nurse Practitioner Gregory-Lee 
testified that further visits also resulted in the issuance of 
controlled substance prescriptions for other than a legitimate medical 
purpose under the applicable standard based on the lack of pain 
assessment--noting in one that ``[t]he pain was on physical exam, but 
there was no actual notation, assessment, of the severity, and no 
notation of the results of the x-rays, if they were even done, or 
reports, but the medication was ordered inappropriately as a result of 
that.'' Tr. 380; GX 10b, at 4a.

Patient G.R.

    The Government's evidence for Patient G.R. demonstrates five visits 
to Respondent, at each of which the Respondent prescribed oxycodone. 
R.D., at 26; GX 11a and b; GX 14, at 18-19. Nurse Practitioner Gregory-
Lee testified that Respondent did not conduct a pain assessment 
regarding the patient's shoulder pain on the first visit of this 
patient, and therefore, the prescription for oxycodone that Respondent 
issued was not legitimate. Tr. 386-88. On a subsequent visit, 
Respondent obtained an x-ray of the shoulder. Nurse Practitioner 
Gregory-Lee testified that there was a ``mention of a pain assessment, 
but there's no documentation of what it was. The findings on the x-ray 
that she now has show that there's no fracture, no dislocation, the 
joint is normal, there's no bone lesion, there's nothing wrong with 
that joint, but she orders oxycodone 10mg.'' Tr. 388-89; GX 11a, at 15; 
GX 11b, at 2.

Patient S.V.

    The file for Patient S.V. demonstrates that the patient visited 
Respondent four times, three of which resulted in prescriptions for 
oxycodone. R.D., at 27; GX 12a and b; GX 14, at 20-21. In particular, 
Nurse Practitioner Gregory-Lee testified that Patient S.V. visited 
Respondent on April 18, 2013, and that, even though the chart mentions 
arthritis, it was unclear from the charts what the medication was 
prescribed to address. Tr. 395. She opined that the prescriptions for 
controlled substances were not legitimate under the standard ``for the 
first time you see a patient who comes in . . . to your practice and 
says, I have an ear infection, with a normal exam, and I have chronic 
pain, and I need oxycodone,'' and additionally, there was no documented 
pain assessment for this patient on any of the visits. Tr. 395-96. GX 
12a, at 12-14.
    Having read and analyzed all of the record evidence, I agree with 
the Chief ALJ that Nurse Practitioner Gregory-Lee is ``certainly a 
well-credentialed Advanced Practice Nurse Practitioner, and although 
she was not the most focused of witnesses, taken overall, her testimony 
was generally authoritative, consistent, objective and persuasive.'' 
R.D., at 29. I also agree that the Respondent's case did not adequately 
refute her representation of the Massachusetts standard of care; 
therefore, I agree and find that ``her opinions regarding the standard 
of care prevalent in Massachusetts . . . [should] be credited.'' Id.

Respondent's Case

    Respondent's documentary evidence consists of emails related to the 
renewal of her Massachusetts controlled substance license and an 
advertisement for Signature Healthcare featuring herself. RX 2A-K and 
1A. Respondent testified and called one witness, a pharmaceutical 
representative who knew Respondent for over ten years (hereinafter, 
D.W.). Tr. 471, 473.
    Respondent initially demonstrated intent to have D.W. represent her 
at the hearing, but the Chief ALJ determined that D.W. was not eligible 
to represent her based on 21 CFR Sec.  1316.50, which provides in 
relevant part that ``any person entitled to appear in a hearing may 
appear in person or by a representative in any proceeding or hearing . 
. . A representative must either be an employee of the person or an 
attorney at law who is a member of the bar, in good standing.'' Id.; 
R.D., at 4-6. The Chief ALJ found that, although D.W. had reportedly 
studied law and the Respondent ``pa[id] him hourly'' to give ``advice 
with law and licenses,'' he was not a barred attorney. Tr. 20; R.D., at 
2. The Chief ALJ also found that he was not eligible to represent 
Respondent on the basis of an employee relationship, because he was not 
the Respondent's employee. Id. at 4. In making this determination, he 
relied on Community for Creative Non-Violence v. Reid, in which, in 
absence of a clear statutory definition of ``employee'' from Congress, 
the Supreme Court looked to the common law of agency and the 
Restatement of Agency for guidance. 490 U.S. 730, 751-52 (1989). Using 
the factors in the Restatement, the Chief ALJ analyzed the overall 
relationship between D.W. and the Respondent based on their testimony 
demonstrating that: payment was sporadic; D.W. was in a distinct 
occupation; the nature of

[[Page 71469]]

the work was not part of Respondent's regular business; and there was 
no demonstrated intent to form an employee relationship in the form of 
a contract or set wages. R.D., at 4-6 (citing to Restatement (Second) 
of Agency Sec.  220).
    The language in 21 CFR 1316.50 is not based on statutory mandate, 
other than the requirement that the Agency conduct its hearings in 
accordance with the procedures in subchapter II of chapter 5 of Title 
5, which makes no mention of representation. 21 U.S.C. Sec.  875(b). 
Further, the application of 21 CFR 1316.50 is necessarily fact-based. 
In this case, the ALJ repeatedly encouraged the Respondent to retain 
barred counsel. Tr. 24-25. Here, I find that the Chief ALJ's 
interpretation of the ambiguous term ``employee'' in the Agency's 
regulations is consistent with the purposes of the Controlled 
Substances Act (hereinafter, CSA) and is based on his ``fair and 
considered judgment,'' and I therefore, uphold the determination that 
D.W. was not an employee for purposes of representation under 21 CFR 
1316.50. Auer v. Robbins, 519 U.S. 452, 462 (1997).
    Called as a witness, D.W. testified to the Respondent's good 
reputation and that, in particular, she had a ``great representation'' 
with one of the physicians at Signature Health. Tr. 479; Tr. 476-79; 
R.D., at 37. He further testified that he knew about ``internal 
personnel records and decisions'' at Signature Health, and that he was 
present for ``a little bit heated of a discussion'' between Respondent 
and Human Resources, which he believed to be about vacation days. Tr. 
480, 482-85; R.D., at 37. He also said that he spoke with one of the 
physicians, and he said Respondent's separation was about 
``inappropriate something in the office, but it had to do with the 
argument.'' Tr. at 487; see also R.D., at 38.
    I agree with the Chief ALJ that D.W.'s ``credibility was 
problematic.'' R.D., at 38. In particular, I find, as the Chief ALJ 
concluded, that ``his answers to whether and to what extent he has had 
a compensated business relationship with the Respondent were ambiguous, 
implausible, vague and confusing.'' Id. He testified that he was not 
providing the Respondent with legal advice,\8\ but Respondent testified 
that he had provided legal advice. Tr. 505; Tr. 21, 23; see also R.D., 
at 38. Additionally, I find that his testimony related to his personal 
knowledge of the personnel decisions at Signature Health ``is likewise 
implausible.'' R.D., at 38.
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    \8\ Respondent testified that D.W. had ``studied law,'' but was 
not an attorney. Tr. At 19.
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    Respondent testified regarding the allegations that her MCSR had 
lapsed. Tr. 523, 555-69; see also RX 2. She testified that she had been 
a nurse practitioner since 1999 and further described her education and 
experience. Id. at 528-47. She presented testimony about the 
circumstances of her termination from Signature Health. Id. at 548-51. 
She testified about the patients whose records the Government had 
presented. Id. at 570-74. Additionally, she testified about her 
standard practice in documenting patient visits. Id. at 583-622.
    Regarding the allegations of the lapse in her MCSR, Respondent 
testified that renewal was due on June 14, 2016, and she provided 
paperwork to renew her license to the owner of Medi-Weightloss in 
Plainville, where she was employed on June 2, 2016, and he took the fee 
for the renewal out of her paycheck. Id. at 524-26; see also R.D., at 
31. Respondent presented email evidence demonstrating that she had 
signed the form required to renew on June 2, 2016, prior to its 
expiration. Tr. 559-60; see also RX 2-H, Page 8 \9\; RX 2-I, Page 9 
(back of form). She testified that, perhaps in August, she ``had called 
the office a couple of times to see if it had come in the mail, because 
it comes to the place where you work, but it's in your name.'' Tr. 527. 
When her current practice manager requested a copy of her license, she 
emailed her Medi-Weightloss employer to obtain it. Id. She provided 
email documentation between herself and her former employer requesting 
a copy of her renewal and demonstrating that she had thought it had 
been renewed. RX 2-A, Page 1. On October 12, 2016, she sent an email to 
her former employer that stated, ``[i]t has come to my attention that 
my MCSR renewal was not renewed by your facility. DPH \10\ claims that 
they never received forms from your company for my renewal.'' Id. In 
approximately December or January, Respondent testified that she spoke 
to the Massachusetts Department of Health and Human Services and that 
they had no record of the check or her renewal, so she filed a new 
application ``right away.'' Tr. 568-69.
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    \9\ Respondent used both numbers and letters and page numbers on 
her exhibits. I am citing to both to avoid confusion.
    \10\ DPH is the acronym commonly used by the Massachusetts 
Department of Public Health. See e.g., https://www.mass.gov/orgs/department-of-public-health. Respondent uses this acronym in 
reference to the Massachusetts Department of Public Health in her 
testimony. Tr. 599 ([H]er practice manager ``said she had called DPH 
because we had put in for the addendum.'') If Respondent was 
referring to the Massachusetts DPH in this email, it would directly 
contradict her testimony that the first time she knew that DPH had 
not received the renewal was in December or January and she 
``renewed it within less than a week'' of confirming that it had not 
been filed. Tr. 599-601.
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    Regarding the circumstances of her termination at Signature Health, 
Respondent testified that she has never been fired from another job, 
but admitted that approximately two years ago, she left another job 
before she would be terminated for a personality conflict. Id. at 547-
48. She testified that her termination from Signature Health was 
regarding a disagreement about vacation days that had not been paid and 
that the reason she was given was ``inappropriate conduct in a patient 
care setting.'' Id. at 549-51. She introduced an exhibit showing that 
Signature used her in an advertisement in May 2013, to demonstrate that 
there were no issues with her prescribing, because they were using her 
specifically to promote their business. RX 1; Tr. 586-88. She also 
testified that she was never approached for improper prescribing and 
that she had regular meetings with the collaborating physician, during 
which no one ever mentioned her prescribing practices. Tr. 586-87, 590; 
see also R.D., at 30.
    Respondent testified that patients G.R., K.M., E.L., DC and E.B. 
had followed her through two practices to Signature Health. Tr. 570-71. 
She had treated G.R., K.M. and E.B. for approximately ten years and DC 
for approximately six years. Id. at 572. T.D., M.J. and S.V. had 
followed her from her previous employment, so she had been treating 
them for approximately a year previously, with the exception of M.J., 
whom she had been treating for ``[m]aybe less than a year.'' Id. at 
573-74; see also R.D., at 33. She testified that she was merely 
continuing the care of these patients whom she knew well for chronic 
pain management. Tr. 580-81; see also R.D., at 35.
    Respondent testified that several of the charts in the Government 
exhibits do not have her electronic signature on them. \11\ Tr. 574-75; 
see also R.D., at 33. But when pressed, she said that the patients had 
still been prescribed the controlled substances. Tr. 576. She said that 
there may be notes on what she called ``scutsheets'' that she planned 
on entering in later, because she saw 18-28

[[Page 71470]]

patients a day and did not always have time to complete the charts. Id. 
at 577-80.
---------------------------------------------------------------------------

    \11\ A review of the approximately fifty-two of patient records, 
where Respondent was the listed ``Document Author'' in the 
Government's exhibits demonstrates that seven of the records do not 
contain Respondent's electronic signature. GX5a, at 6, 9; GX6a, at 
34; GX9a, at 6; GX9a, at 8; GX9a, at 10; GX12a, at 8. Due to the low 
percentage of records without signature, I find that Respondent's 
allegations do not hold weight.
---------------------------------------------------------------------------

    In response to Nurse Practitioner Gregory-Lee's testimony, 
Respondent stated that ``everybody does things different. It doesn't 
mean that it's a lower standard of care.'' Id. at 583. She additionally 
testified that she disagreed with Nurse Practitioner Gregory-Lee about 
the standard of care and that she does not ``believe that [she] 
unlawfully prescribed anything.'' Id. at. 584, 592, 605; see also R.D., 
at 35. On cross-examination, when pushed about whether her notes would 
be complete prior to seeing the patient again or prior to prescribing 
controlled substances, she said, ``I don't understand some of the 
notes. That's not my typical pattern.'' Tr. 612-16. She further alleged 
that the charts might have been tampered with, because they ``are not 
[her] typical charting.'' Id. at 627. When asked about writing a 
prescription without a patient visit, Respondent said, ``It wouldn't be 
what I usually do,'' but added that ``it's done all the time.'' Id. at 
622. Respondent also raised concerns throughout her testimony that the 
DIs revised Nurse Practitioner Gregory-Lee's report and took such a 
long time to bring the charges against her. Id. at 593-94, 596; see 
also R.D., at 36. Additionally, Respondent specifically questioned the 
amount of time that it took for Nurse Practitioner Gregory-Lee to 
perform this audit, when she had testified that she had conducted 
``over 100 chart audits.'' Tr. 409.
    Having reviewed all the evidence, including and Respondent's 
testimony, I agree with the Chief ALJ that ``credibility for this 
witness is something of a mixed bag.'' R.D., at 36.

    When called upon to explain the level of documentation 
supporting her controlled substance prescribing, the Respondent 
alternatively offered: (1) The documentation obtained from Signature 
omits handwritten ``scutnotes'' (described in no detail) that she 
obviously had not yet transferred to the EMR; (2) the documentation 
obtained from Signature is deficient because the Government did not 
(as she did not) subpoena medical records from other medical 
practices where she had treated the same Eight Patients; and, (3) 
some unknown person (possibly a medical assistant who had complained 
about the Respondent in the past) for unknown reasons has tampered 
with her [electronic medical record] entries pertaining to the Eight 
Patients to render them incomplete and unreliable
. . . . Each theory arose independently at various times during the 
Respondent's testimony and struck more of convenience than an honest 
assessment of the lacking condition of the chart notes she prepared 
in support of her controlled substance prescribing.

Id. at 36-37.

Allegation That Respondent Prescribed Controlled Substances During the 
Lapse of Her MCSR

    I find that the Government proved that Respondent's MCSR expired on 
June 14, 2016, and was not renewed until February 3, 2017. GX15 
(Original Controlled Substances Registration); GX 16 (New Controlled 
Substances Registration). I find that Respondent proved that she had 
provided the paperwork to her employer and that she had no reason to 
believe that her MSCR had not been renewed until approximately October 
of 2016. Tr. 559-60; see also RX2-H, Page 8, RX2-1, page 9. However, I 
find that ``Respondent's own documentary evidence makes it virtually 
uncontroverted that she suspected that her MCSR had lapsed as of 
October 12, 2016, and yet she continued to issue controlled substance 
prescriptions in the state.'' R.D., at 45. In fact, according to her 
own email evidence, I find that she may have known of the renewal 
failure from the Massachusetts Department of Public Health as early as 
October. See n.6, supra. Respondent admits, as the DI testified, that 
she had written controlled substance prescriptions during the lapse 
period. Tr. 96 (DI's testimony), 598 (Respondent's admission). 
Additionally, I find that the Government's evidence confirms that she 
wrote controlled substance prescriptions after October 12, 2016, when 
she knew or should have known that her MCSR had lapsed. See, e.g., GX 
18c, at 40 (prescription for oxycodone dated November 3, 2016). In sum, 
I find that Respondent prescribed controlled substances without state 
authority to do so.

Allegation That Respondent's Controlled Substance Prescriptions Did Not 
Comply With DEA Regulations

    The Government's Prehearing Statement additionally alleged that the 
Respondent's controlled substance prescriptions during the period of 
the lapse of her MCSR did not comply with DEA regulations, because they 
did not include a full address of the patient on the face of the 
prescriptions in violation of 21 CFR 1306.05(a). ALJX 4 (Government's 
Prehearing Statement), at 5. See, e.g., GX 18b, at 4, 5; GX 18c, at 2, 
3, 5, 8, 10, 11, 14, 16, 18, 20, 22, 24-26, 28, 30. Respondent argued 
that the address was unnecessary because the patients lived in a long-
term care facility, and therefore, the pharmacist knew where the 
patients lived; however, the DI confirmed that failure to include a 
patient's address on the face of the prescription is a regulatory 
violation, regardless of the patient's residence in a long-term care 
facility. Tr. 122-25, 128. I find that Respondent prescribed controlled 
substances in violation of 21 CFR Sec.  1306.05(a).

Allegation That Respondent Issued Prescriptions for Controlled 
Substances Below the Applicable Standard of Care

    Paragraph (2) of the OSC alleges that Respondent ``issued 
prescriptions for controlled substances to several individuals . . . 
for other than a legitimate medical purpose and outside the usual 
course of professional practice.'' \12\ OSC, at 2. The Government's 
expert, Nurse Practitioner Gregory-Lee, credibly testified that the 
Massachusetts prescribing standard requires a pain assessment prior to 
prescribing controlled substances. Tr. 208. I agree with the Chief ALJ 
and find that Respondent's prescribing of: oxycodone on six occasions 
to Patient DC; oxycodone on four occasions to Patient M.J.; oxycodone 
on seven occasions and hydrocodone \13\ on six occasions to Patient 
E.L.\14\; oxycodone on four occasions to Patient K.M; oxycodone on five 
occasions to Patient G.R.; and oxycodone on three occasions to Patient 
S.V. were below the applicable standard for prescribing because 
Respondent did not conduct a pain assessment prior to issuing those 
prescriptions. Id. at 48-51.
---------------------------------------------------------------------------

    \12\ I agree with the Chief ALJ's recommendation that I not 
sustain a few of the Government's allegations based on its failure 
to adequately provide notice to the Respondent in the prehearing 
statements and OSC of the matters of fact and law asserted. For 
example, I agree that the OSC and prehearing statements did not 
adequately notice Respondent's alleged failure to document any pain 
assessment concerning Patient E.B., despite adequate testimony and 
evidence presented by the Government's expert and the OSC's focus on 
the lack of drug screens. R.D., at 47-48.
    \13\ There were additionally five refills (ten total 
prescriptions) of hydrocodone (Vicodin) during the alleged period. 
R.D., at n. 126.
    \14\ The Chief ALJ also sustained the allegation in the OSC and 
the Government's 1st Prehearing Statement that the charting for 
Patient E.L. did not document a physical examination and, as such, 
justified a finding of prescribing below the standard of care in 
Massachusetts. R.D., at 50. I agree and find a violation related to 
the lack of physical examination for Patient E.L.
---------------------------------------------------------------------------

    Further, I agree with the Chief ALJ and find that, as Nurse 
Practitioner Gregory-Lee opined, Respondent's prescribing of oxycodone 
on seven occasions and fentanyl on four occasions to Patient T.D. 
``fell below the requisite standard based on documented evidence of 
alcohol abuse indications that contraindicate controlled medication 
use, as well as a general lack of documentation, including abnormal 
physical examination findings or pain assessments.'' Id. at 48-49.

[[Page 71471]]

    In addition, I agree with, and appreciate the substantial work 
involved in, the Chief ALJ's careful analysis of the Government's 
allegations that Respondent's prescriptions were unlawful because they 
were issued before the previous prescriptions should have been 
exhausted, if the pills had been ingested as prescribed. Id. at 52; 
OSC, at 2-3. I agree with the Chief ALJ and find that Respondent 
credibly rebutted the Government expert's premise that the 
prescriptions were filled too early, based on the fact that they were 
ordered for a thirty day supply, because the Respondent asserted that 
the electronic system automatically ``pops out by computer'' thirty 
days for each prescription. Tr. 636; R.D., at 52. However, I concur 
with the Chief ALJ's detailed analysis and I sustain the specific 
allegations, where the prescriptions taken at the rate of their dosages 
could not have been exhausted prior to when Respondent issued the next 
prescription. R.D., at 53-55.
    In particular, the Chief ALJ concluded, and I agree, that 
prescriptions to Patient DC, dated February 13, 2013, but instructed 
not to be filled before February 16th, could not, at the rate of sixty 
tablets taken one every six hours,\15\ have been exhausted before 
Respondent issued the next prescription on February 27th. Id. at 53 
(citing GX 6b, at 2-3). Similarly, I find that the prescription issued 
on February 27, 2013, could not be exhausted at a rate of 120 tablets 
taken one every four hours before Respondent issued the next 
prescription on March 15, 2013. R.D., at 53 (citing GX 6b, at 3-4). The 
Chief ALJ further recommended that I sustain, and I do sustain, the 
early prescribing allegations related to four of the oxycodone 
prescriptions and the fentanyl prescription to Patient T.D. R.D., at 54 
(citing GX 7a, at 32; GX 7b, at 3-5, 8). Additionally, the Chief ALJ 
recommended that I sustain, and I do sustain, the early prescribing 
allegations for: Patient K.M. of oxycodone on two occasions (R.D., at 
54 (citing GX 10b, at 1-3)); Patient G.R. for one prescription (R.D., 
at 55 (citing GX 11b, at 1-2)); and Patient S.V. for two prescriptions 
(R.D., at 55 (citing GX 12b, at 1-3)).
---------------------------------------------------------------------------

    \15\ For example, there being twenty four hours in a day and one 
tablet prescribed every six hours, the prescription would have 
permitted four tablets per day. Sixty tablets at a rate of four a 
day should have lasted fifteen days, which should not have been 
exhausted prior to the end of March 2nd, possibly March 3rd, 
depending on the time of the day that it was filled.
---------------------------------------------------------------------------

    In sum, I find that Respondent issued multiple controlled substance 
prescriptions outside of the usual course of the professional practice 
for advanced practice nurse practitioners in Massachusetts. R.D., at 
47, 55-56.

Discussion

Allegation That Respondent's Registration Is Inconsistent With the 
Public Interest
    Under Section 304 of the CSA, ``[a] registration . . . to . . . 
distribute[ ] or dispense a controlled substance . . . may be suspended 
or revoked by the Attorney General upon a finding that the registrant . 
. . has committed such acts as would render his registration under 
section 823 of this title inconsistent with the public interest as 
determined by such section.'' 21 U.S.C. Sec.  824(a)(4). In the case of 
a ``practitioner,'' which is defined in 21 U.S.C. 802(21) and includes 
a nurse practitioner, 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 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, I agree 
with the Chief ALJ that the Government's evidence in support of its 
prima facie case is confined to Factors Two and Four. R.D., at 42 
(citing 21 U.S.C. 823(f)(2), (4)). I find that the Government's 
evidence with respect to Factors 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. 823(f). I further 
find that Respondent failed to produce sufficient evidence to rebut the 
Government's prima facie case.

Factors Two and/or Four--The Respondent's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances

    Respondent has demonstrated substantial experience both as a nurse 
practitioner, since 1999, and as a DEA registrant, since approximately 
2000. R.D., at 42 (citing Tr. 528, 537). Her treatment of the patients 
as alleged in the OSC demonstrates that her prescribing practices fell 
short of the applicable standard of care. Even though the Agency 
considers the evidence related to her prescribing as presented in the 
OSC, and assumes that other than those allegations that the Government 
has substantially evidenced, the registrant has prescribed legally, 
Respondent herself testified that these individuals had followed her 
from other practices. Tr. 570-72; see Wesley Pope, M.D., 82 FR 14944, 
14982-84 (2017). It is difficult to believe that she had not prescribed 
below the standard previously to these patients; however, it is also 
unnecessary to explore, because Respondent did not formulate an 
adequate defense that the prescriptions listed in the OSC are isolated 
and that her history of prescribing was otherwise flawless. She 
mentioned that her documentation was ``not [her] usual charting,'' but 
in defense she alleged that the records had been tampered

[[Page 71472]]

with, and she defended against the Government's evidence entirely by 
stating, ``[E]verybody does things different. It doesn't mean that it's 
a lower standard of care.'' Tr. 627; id. at 583.
    Factor four is demonstrated by evidence that a registrant has not 
complied with laws related to controlled substances, including 
violations of the CSA, DEA regulations, or other state or local laws 
regulating the prescribing of controlled substances.

Allegation That Respondent Prescribed Controlled Substances During the 
Lapse of Her MCSR

    In Massachusetts, the state in which Respondent practices, a 
prescription for a controlled substance may be issued ``only by a 
practitioner who is: (1) authorized to prescribe controlled substances; 
and (2) registered pursuant to the provisions of this chapter.'' Mass. 
Gen. Laws Ann. ch. 94C, Sec.  18(a) (West 2019); see also id. at Sec.  
7(a) (``[E]very person who manufactures, distributes or dispenses, or 
possesses with intent to manufacture, distribute or dispense any 
controlled substance within the commonwealth shall . . . register with 
the commissioner of public health.''); R.D., at 45. Additionally, as 
the Chief ALJ highlighted, the text of the Massachusetts Controlled 
Substances Act does not appear to include an excuse for compliance with 
the state registration requirement, regardless of intent. Id. Further, 
DEA's regulations provide that only an individual practitioner who is 
authorized to prescribe controlled substances by the jurisdiction in 
which he or she is licensed to practice his or her profession may issue 
a controlled substance prescription. 21 CFR 1306.03(a)(1). For all of 
these reasons, I find that Respondent violated federal and 
Massachusetts law by prescribing controlled substances without the 
authorization required in Massachusetts to do so.

Allegation That Controlled Substance Prescriptions Respondent Issued 
Did Not Comply With DEA Regulations

    DEA regulations require that all prescriptions for controlled 
substance ``shall bear the full . . . address of the patient.'' 21 CFR 
1306.05(a). As already discussed, I found that, during the time of the 
lapse in her MCSR, Respondent did not include the full address of the 
patients to whom they were issued. I find that this failure is a 
violation of 21 CFR 1306.05(a). See also R.D., at 46; ALJX 4, at 5.

Allegation That Respondent Issued Prescriptions for Controlled 
Substances Below the Applicable Standard of Care

    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). 
Massachusetts state law also requires that controlled substance 
prescriptions ``shall be issued for a legitimate medical purpose by a 
practitioner acting in the usual course of his professional practice.'' 
Mass. Gen. Laws Ann. ch. 94C, Sec.  19(a) (West 2019); see also R.D., 
at 45.
    The Government also alleged several Massachusetts regulatory 
violations in the OSC. OSC, at 2. Section 3 covers the general 
responsibility of nurses licensed in Massachusetts and Section 4 covers 
the responsibilities and accountability of Advanced Practice Registered 
Nurses. 244 Mass. Code Regs. sec. nos. 3 and 4 (2019); see, e.g., id. 
at 4.06. Among the standards of conduct in Massachusetts, Section 9.03 
sets forth that nurses licensed by the Board of Registration in Nursing 
shall: practice in accordance with the accepted standards of practice; 
comply with other federal and state laws and regulations; and 
administer controlled substances in accordance with, and make complete 
accurate, and legible entries in all records required by, ``all federal 
and state laws and regulations and in a manner consistent with accepted 
standards of nursing practice.'' Id. at 9.03(5), (6), (39) and (44) 
(2019).
    As already discussed, I find credible the testimony of the 
Government's expert witness that Respondent issued multiple controlled 
substance prescriptions below the Massachusetts standard of care, and I 
find that those violations and the other federal and state law and 
regulatory violations establish violations of the Massachusetts state 
regulations as described above.
    I agree with the Chief ALJ and find that the record in this case 
establishes by substantial evidence that Respondent issued multiple 
controlled substance prescriptions below the applicable standard of 
care and, therefore, violated 21 CFR 1306.04(a) and Massachusetts 
statutory and regulatory provisions.
    In sum, I find that, although the Government did not notice all of 
the evidence and not all of the evidence supported all of the 
Government's allegations, there remains substantial evidence on the 
record that Respondent: prescribed controlled substances without a 
valid MCSR in violation of state law; prescribed controlled substances 
without fulfilling the DEA regulation's requirement to include the 
patient's full address; and recurrently prescribed controlled 
substances below the usual standard of the professional practice in 
Massachusetts; and repeatedly issued prescriptions for controlled 
substances prior to the exhaustion of the patient's supply.

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 of the state standard of care 
for controlled substance prescribing, as well as due to her non-
compliance with 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, 546 U.S. at 259. In 
efficiently executing the revocation and suspension authority delegated 
to me under the CSA for the aforementioned purposes, I review the 
evidence and 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. Drug Enf't Admin., 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

[[Page 71473]]

accept responsibility for [the registrant's] actions and demonstrate 
that [registrant] will not engage in future misconduct.''' Jayam 
Krishna-Iyer, 74 FR at 463 (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).
    Regarding all of these matters, I agree with the analyses and 
conclusions contained in the R.D.'s Recommendation. R.D., at 56-59.
    Here, the Respondent has accepted absolutely no responsibility for 
her actions. Regarding the allegations of her lapsed MCSR, she 
testified and presented evidence that she had relied to her detriment 
on a previous employer to file on her behalf; however, she also 
demonstrated that she had knowledge, and, possibly even contrary to her 
testimony, that she knew directly from the state, that her MCSR had not 
been renewed in October; and yet, she still continued prescribing 
controlled substances without obtaining a new MCSR until February. Tr. 
524-69; RX 2; see also R.D., at 56-57 (``[H]er testimony and her 
reliance on the email correspondence with [her employer] leave no doubt 
that she continues to adhere to her position that the former bears all 
the blame, and she bears none.'')
    Additionally, Respondent took no responsibility for the allegations 
related to her prescribing practices. Instead, she provided vague 
theories about evidence tampering, unfinished charts and testified that 
the Government's exhibits were ``not [her] typical notes.'' Tr. 574-75, 
610, 616; see also R.D., at 57. She offered no intention of instituting 
remedial measures. ``There was no indication from the Respondent that 
she planned to, or already had, improved her recordkeeping practices 
when issuing prescriptions for powerful controlled substance 
medications.'' R.D., at 57.
    In sum, I find that the record supports the imposition of a 
sanction because the Respondent did not unequivocally accept 
responsibility.
    In sanction determinations, the Agency has also historically 
considered its interest in deterring similar acts, both with respect to 
the respondent in a particular case and the community of registrants as 
a whole. See Joseph Gaudio, M.D., 74 FR 10,083, 10,095 (2009); Singh, 
81 FR at 8248. Here, the interests of specific and general deterrence 
``militate in favor of revocation.'' R.D., at 58. Respondent has 
evidenced no understanding that her controlled substance prescribing 
fell short of legal requirements.

    To the extent that her progress notes fail to establish an 
adequate basis for prescribing powerful controlled drugs, she chalks 
that up to the risks attendant upon the practice of a busy 
prescriber, and she fails to recognize any significance of 
prescriptions issued before the patient's previous medication supply 
would have been exhausted.

R.D., at 58-59. As such, it is not reasonable to believe that 
Respondent's future prescribing will comply with legal requirements. 
Further, given the number of Respondent's violations, a sanction less 
than revocation would send a message to the regulated community that 
``so long as there is another person available to blame for failing to 
file required paperwork, and a busy . . . practice to blame for 
inadequate documentation,'' compliance with the law is not a condition 
precedent to maintaining a registration. Id. at 59.
    In evaluating the egregiousness of Respondent's conduct, I agree 
with the Chief ALJ that although ``the record did not paint the picture 
of a pill mill operator, this Respondent failed to exercise the level 
of care in prescribing and documenting her prescribing decisions that 
would allow a meaningful evaluation by those charged with regulating 
controlled substances.'' Id. Throughout the hearing, she vehemently 
protested against any acceptance of responsibility, consistently 
pinning blame on everyone and anyone else, even when entirely 
implausible, and unsupported by the evidence, and she demonstrated a 
general disdain for the charges against her and the situation in which 
she had found herself. Id.
    Accordingly, I find that the factors weigh in favor of sanction and 
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. 823(f) and 824(a), I hereby revoke DEA Certificate of 
Registration No. MH0525153 issued to Lisa Hamilton, N.P. I further 
hereby deny any pending application of Lisa Hamilton, N.P. to renew or 
modify this registration, as well as any other pending application of 
Lisa Hamilton, N.P. for registration in Massachusetts. This Order is 
effective January 27, 2020. ins

    Dated: December 4, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-27945 Filed 12-26-19; 8:45 am]
 BILLING CODE 4410-09-P