Annicol Marrocco, M.D.; Decision and Order, 28695-28706 [2015-12035]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Pages 28695-28706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12035]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 13-34]


Annicol Marrocco, M.D.; Decision and Order

    On May 17, 2013, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Annicol Marrocco, M.D., (hereinafter, Respondent), of 
Mahwah, New Jersey. ALJ Ex. 1. The Show Cause Order proposed the 
revocation of Respondent's DEA Certificate of Registration BM8059102, 
which authorized her to dispense controlled substances in schedules II 
through V, at the registered address of Olean General Hospital, 515 
Main Street, Olean, New York 14760, on the ground that her ``continued 
registration is inconsistent with the public interest.'' Id. (citing 21 
U.S.C. 823(f) and 824(a)(4)).
    The Show Cause Order specifically alleged that between January 2008 
and August 2009, Respondent issued approximately twenty-one 
prescriptions to S.C. for oxycodone, a schedule II controlled 
substance, ``outside the usual course of professional practice and for 
other than a legitimate medical purpose.'' Id. (citing 21 U.S.C. 841(a) 
and 21 CFR 1306.04(a)). The Show Cause Order further alleged that 
Respondent failed to maintain medical records supporting the 
prescriptions, in violation of Florida law; that she was in a personal 
relationship with S.C.; and that she ``did not examine S.C. except to

[[Page 28696]]

listen to his heart and lungs.'' Id. at 1-2, 4-5 (citing Fla. Admin 
Rule 64B8-9.003 and 64B8-9.013).
    Next, the Show Cause Order alleged that Respondent had failed to 
both date and include S.C.'s address on multiple prescriptions, in 
violation of 21 CFR 1306.05(a). Id. at 2. The Show Cause Order then 
alleged that Respondent had violated DEA regulations that, while 
allowing a practitioner to issue multiple prescriptions for a schedule 
II controlled substance, limit the quantity of the prescriptions to a 
90-day supply, require that a prescription include the earliest date on 
which it can be filled, and require that each prescription be issued 
for a legitimate medical purpose. Id. at 2-4 (citing 21 CFR 
1306.12(b)(1)).
    Next, the Show Cause Order alleged that Respondent ``violated 
Federal law on at least forty-nine occasions'' by issuing controlled 
substance prescriptions while practicing as a contract emergency room 
physician at the Northern Navajo Medical Center in Shiprock, New 
Mexico, while being registered in New York. Id. at 5. The Government 
further alleged that ``[i]ssuing controlled substance prescriptions in 
one state under a DEA registration issued for another state is a 
violation of 21 U.S.C. 822(e) . . . which require[s] separate 
registrations for separate locations.'' Id. (also citing 21 CFR 
1301.12(a) & (b)(3)). The Government also alleged that Respondent 
knowingly and willfully violated these provisions, alleging that ``DEA 
personnel informed you and your attorney that to move your DEA 
registration to New Mexico you must first be properly licensed to 
practice medicine in New Mexico'' and that she ``ha[s] never held a New 
Mexico medical license.'' Id. Finally, the Show Cause Order alleged 
that Respondent ``no longer maintain[s] a medical practice at [her] 
registered address'' and that she violated DEA regulations by 
``[f]ail[ing] to keep [her] registered address current with the'' 
Agency. Id. (citing 21 CFR 1301.51).
    Respondent timely requested a hearing on the allegations; the 
matter was then placed on the docket of the Office of Administrative 
Law Judges and assigned to Administrative Law Judge Christopher B. 
McNeil (hereinafter, ALJ). ALJ Ex. 2. Following pre-hearing procedures, 
the ALJ conducted a hearing on August 21 and September 11, 2013, at 
which both parties called witnesses to testify and introduced 
documentary evidence. Following the hearing, both parties submitted 
briefs containing their proposed findings of fact and conclusions of 
law.
    On November 12, 2013, the ALJ issued his Recommended Decision. 
Therein, the ALJ found that the Government had established a prima 
facie case that Respondent's continued registration would be 
inconsistent with the public interest and that she had failed to rebut 
the Government's showing. R.D. at 75. The ALJ thus recommended that 
Respondent's registration be revoked. Id.
    With respect to factor one--the recommendation of the state 
licensing authority--the ALJ found that ``Respondent has a history of 
substantial and material disciplinary action taken by the medical 
licensing boards of three states'' and that the boards of Florida and 
New York have ``permanently limit[ed] [her] authority to prescribe 
controlled substances.'' Id. at 72. The ALJ thus concluded that 
``maintaining Respondent's unrestricted DEA registration would be 
inconsistent with the public interest.'' Id.
    With respect to factor two--Respondent's experience in dispensing 
controlled substances--the ALJ found ``that despite eighteen years of 
experience as an emergency medicine physician, Respondent lacked the 
experience necessary to identify and appropriately respond to drug-
seeking behavior.'' Id. The ALJ also found that Respondent ``lacked the 
experience necessary to appreciate the need to contact the DEA when 
questions arose regarding the need for in-state certification after she 
relocated her principal place of business or professional practice from 
New York to New Mexico.'' Id. The ALJ thus found that factor two 
supports a finding that Respondent's continued registration is 
``inconsistent with the public interest.'' Id.
    As for factor four--compliance with applicable laws related to 
controlled substances--the ALJ found that Respondent violated 21 CFR 
1306.04(a) by issuing multiple prescriptions for schedule II controlled 
substances, including OxyContin and oxycodone to S.C., while in a 
personal relationship with him, and that she acted outside the usual 
course of professional practice in issuing the prescriptions and lacked 
a legitimate medical purpose. R.D. 69-70. The ALJ further found that: 
(1) Respondent issued the prescriptions ``without maintaining medical 
records or justifying the prescriptions in violation of 21 CFR 
1306.04(a)''; (2) Respondent issued OxyContin prescriptions, which were 
undated, in violation of 21 CFR 1306.05(a); (3) Respondent issued 
OxyContin prescriptions, which ``lacked the patient's address, in 
violation of 21 CFR 1306.05(a)''; (4) Respondent issued multiple 
prescriptions for schedule II controlled substances which lacked ``the 
earlier date on which'' the prescription could be filled, in violation 
of 1306.12(b)(1); and (5) Respondent violated the State of Florida's 
``Standards for the Use of Controlled Substances for the Treatment of 
Pain,'' as well as the State's regulation regarding the adequacy of 
medical records. Id. at 73.
    The ALJ further concluded that ``[i]ssuing controlled substance 
prescriptions in one state under a DEA registration issued for practice 
in another state is a violation of 21 U.S.C. 822(e) and 21 CFR 
1301.12(a) and (b)(3).'' Id. at 74. While noting that an Agency 
regulation exempts an official of various federal agencies and the 
armed forces from these requirements, the ALJ found that because 
Respondent was a contract-physician she was not exempt under the 
regulation. Id. Based on his finding that ``[b]etween December 28, 2012 
and June 8, 2013, Respondent issued prescriptions for controlled 
substances from her principal place of business or professional 
practice in Shiprock, New Mexico,'' while ``using the DEA registration 
that was issued to her for her practice in New York,'' the ALJ 
concluded that Respondent violated these provisions. Id. The ALJ thus 
found that factor four supports a finding that Respondent's continued 
registration ``would be inconsistent with the public interest.'' Id.
    The ALJ further found that factor five--such other conduct which 
may threaten public health and safety--supports the conclusion that 
Respondent's continued registration ``would be inconsistent with the 
public interest.'' Id. at 74-75. As support for his conclusion, the ALJ 
found that Respondent lacked ``candor with the'' Agency, that she 
``willful[ly] fail[ed] to determine her obligations when relocating 
from New York to New Mexico,'' and that she ``refus[ed] to cooperate 
with the [Agency's] inquiry regarding liability issues in her renewal 
application.'' Id. at 75.
    Finally, the ALJ found that Respondent ``failed to affirmatively 
acknowledge specific acts of improper prescribing,'' as well as that 
she had ``failed to establish by credible and substantial evidence 
effective steps taken in remediation as would warrant a sanction other 
than revocation.'' Id. The ALJ thus found that ``the Government has 
established cause to revoke Respondent's . . . registration.'' Id.
    Both parties filed exceptions to the ALJ's Recommended Decision. 
Having

[[Page 28697]]

considered the record in its entirety, including the parties' 
exceptions, I conclude that the Government has established that 
granting Respondent's application would be inconsistent with the public 
interest and that Respondent has failed to rebut the Government's prima 
facie case. Accordingly, I will adopt the ALJ's recommendation that I 
deny any pending application for a new registration. I make the 
following factual findings.

Findings

Respondent's Licensure Status, the State Board Actions, and 
Registration Status

    Respondent is a board-certified physician in emergency medicine. 
See RX A, at 2. Respondent completed her residency in emergency 
medicine in 1998 and since then has worked at hospitals in New Jersey, 
Pennsylvania, New York, Florida, and New Mexico. Id. at 1-2. While 
Respondent holds an active license in New York, Florida, and 
Pennsylvania, she has been disciplined by the medical boards of each of 
these States, based on her prescribing of controlled substances to 
S.C., with whom she had a personal relationship while she was 
practicing in Florida. See GX 9, 11, 12, 13.
    In the Settlement Agreement she entered into with the Florida 
Board, ``Respondent neither admit[ted] nor denie[d] the allegations of 
fact contained in the [Board's] Administrative Complaint.'' GX 8, at 2. 
However, she did ``admit[] that the facts alleged in the Administrative 
Complaint, if proven,\1\ would constitute violations of Chapter 458, 
Florida Statutes, as alleged in the Administrative Complaint.'' Id.
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    \1\ These allegations largely track what the Government alleged 
and I find proved in this matter. See GX 7, at 1-7.
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    More specifically, the State alleged that ``Respondent failed to 
meet the prevailing standard of care in regard to Patient S.C. in one 
or more of the following ways.'' GX 7, at 9. The State alleged that 
Respondent ``fail[ed] to adequately assess and/or diagnose Patient S.C. 
with chronic pain,'' ``fail[ed] to appropriately treat . . . S.C.,'' 
``fail[ed] to use alternative treatment methods,'' ``prescrib[ed] S.C. 
an inappropriate and/or excessive quantity of [R]oxicodone, oxycodone, 
and/or OxyContin,'' ``fail[ed] to obtain laboratory results and/or 
diagnostic scans to collaborate [sic] or monitor S.C.'s condition,'' 
and ``fail[ed] to properly monitor and/or follow up on . . . S.C.'s 
condition.'' Id. at 9-10 (citing Fla. Stat. Sec.  458.331(1)(t)).
    The State further alleged that ``Respondent prescribed 
[R]oxycodone, oxycodone, and/or OxyContin to Patient S.C., in an 
inappropriate manner and/or in excessive quantities, which is outside 
the course of Respondent's professional practice.'' Id. at 11-12. The 
State thus alleged that Respondent violated Florida law ``by 
prescribing controlled substances other than in the course of her 
professional practice.'' Id. at 12 (citing Fla. Stat. Sec.  
458.331(1)(q)). Finally, the State alleged that Respondent violated 
Florida law by ``fail[ing] to maintain complete medical records that 
justify the course of treatment [that she] provided to . . . S.C.'' Id. 
at 10; see also id. at 11 (citing Fla. Stat. Sec.  458.331(1)(m)).
    Pursuant to the Settlement Agreement she entered into with Florida, 
Respondent received a letter of concern, was fined $5,000, and was 
required to reimburse the Florida Department of Health's costs of 
investigating and prosecuting the matter in an amount between $5,587.55 
and $6,587.55. GX 8, at 2-3. Respondent was also required to perform 25 
hours of community service, as well as to attend ten (10) hours of 
Continuing Medical Education (CME) in ``Appropriate Prescribing 
Practices'' and two (2) hours of CME in ``Proper Medical Record 
Keeping.'' Id. at 4-5. Finally, the Board prohibited Respondent from 
``prescrib[ing] controlled substances to persons with whom [she] is in 
a personal, familial or non-familial, relationship.'' GX 8, at 2-5.\2\
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    \2\ Based on the Florida Board's action, New York State Board 
for Professional Medical Conduct imposed a ``Censure and 
Reprimand,'' prohibited her from prescribing to persons with whom 
she is in a relationship, placed her on probation for three years, 
and fined her $1500. GX 11. Also, based on the actions of the 
Florida and New York Boards, the Pennsylvania State Board of 
Medicine imposed a $5000 civil penalty on her. GX 13.
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    As of the hearing, Respondent was working as a contract physician 
at the Northern Navajo Medical Center, a facility of the Indian Health 
Service (IHS), which is located in Shiprock, New Mexico; Respondent has 
worked at this hospital since August 2012. RX A, at 1; Tr. 163. 
Respondent is not licensed to practice medicine by the State of New 
Mexico. RX A, at 2.
    Respondent also held DEA Certificate Registration BM8059102, 
pursuant to which she was authorized to dispense controlled substances 
in schedules II through V, at the registered location of Olean General 
Hospital, 515 Main St., Olean, New York 14760. GX 20, at 1. This 
registration had an expiration date of January 31, 2015. Id.
    On December 31, 2014, Respondent applied for a renewal of this 
registration and sought to change her registered location to the 
Northern Navajo Medical Center, P.O. Box 160, Highway 491 North, 
Shiprock, New Mexico. See Government's Notice of Respondent's Filing of 
Renew Application and Change of Address Request, at 6-8. Thereafter, on 
January 23, 2015, Respondent submitted a letter seeking to change her 
registered location to Doctors Express Urgent Care, 1444 W. Passyunk 
Ave, Philadelphia, PA. Id. at 8.
    However, at the time Respondent submitted her renewal application, 
the Agency had issued the Order to Show Cause. A DEA regulation 
applicable to an applicant who has been served with an Order to Show 
Cause provides:

In the event that an applicant for reregistration (who is doing 
business under a registration previously granted and not revoked or 
suspended) has applied for reregistration at least 45 days before 
the date on which the existing registration is due to expire, the 
existing registration of the applicant shall automatically be 
extended and continue in effect until the date on which the 
Administrator so issues his/her order. The Administrator may extend 
any other existing registration under the circumstances contemplated 
in this section even though the registrant failed to apply for 
reregistration at least 45 days before expiration of the existing 
registration, with or without request by the registrant, if the 
Administrator finds that such extension is not inconsistent with the 
public health and safety.

21 CFR 1301.36(i).
    Respondent did not file her renewal application more than 45 days 
before her registration was due to expire and thus her registration was 
not automatically extended pending the issuance of this Decision and 
Final Order. Based on my review of the record in this matter, I further 
conclude that the extension of her registration would be ``inconsistent 
with the public health and safety.'' Id. Accordingly, I hold that her 
registration expired on January 31, 2015. See Ralph J. Chambers, 79 FR 
4962 (2014) (citing Paul H. Volkman, 73 FR 30630, 30641 (2008)). 
However, I conclude that her application remains pending before the 
Agency. See id.

The Allegations That Respondent Unlawfully Prescribed Controlled 
Substances to S.C.

    Between February 2007 and August 2009, Respondent worked as an ER 
physician at the Physicians Regional Medical Center in Naples, Florida. 
RX A, at 1. According to Respondent, in August 2007, she met S.C., a 
budding reality TV star, when he came to the ER

[[Page 28698]]

with a broken hand and she treated him by splinting his hand and 
prescribing Percocet to him.\3\ Tr. 207-08. A week or two later, 
Respondent was told by an x-ray technician that S.C. worked for Ticket 
Master and that he was hosting a fund-raising event at a local coffee 
shop. Id. at 211. Respondent went to the coffee shop to see if she 
could get tickets from S.C for an upcoming football game. Id. 
Thereafter, Respondent and S.C. entered into a personal relationship. 
Id.
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    \3\ Over the Government's objection, the ALJ allowed Respondent 
to testify by telephone from her lawyer's office, rather than in 
person or by appearing at a DEA facility which has Video-
Teleconferencing (VTC) capability. Gov. Exceptions, at 2-6. The 
Government took exception to this ruling.
     While the Government makes no claim that Respondent's counsels 
acted improperly at any time during her testimony, it is manifest 
that where a witness is allowed to testify by telephone, notes could 
be passed to the witness during the testimony without the ALJ or 
Government Counsel ever being aware of this. So too, the use of 
telephone testimony raises a greater risk that during breaks in the 
proceeding, the witness could discuss her testimony with others.
     I find the Government's exception to be well taken. This is not 
to say that every witness must testify either in person or by VTC. 
However, a respondent will invariably be a highly important, if not 
the most important witness in a proceeding, and thus, under no 
circumstance is it proper to allow a respondent to testify by 
telephone. As for other witnesses, with the exception of a witness 
who testifies only as to the authentication or foundation of 
proposed exhibits, the taking of testimony by telephone is 
disfavored and may be used only upon a showing that exceptional 
circumstances exist and that the failure to obtain a witness's 
testimony will result in a denial of due process.
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    Respondent did not prescribe any controlled substances to S.C. 
until January 18, 2008, when she wrote him a prescription for 90 
tablets of oxycodone 30mg. GX 1, at 1. Respondent did not recall 
exactly where she wrote the prescription (this having occurred at 
either her home or S.C.'s) but acknowledged that it was not at either 
of the hospitals (both of which were located in Fort Myers, Florida) 
which were listed on the prescription form she used. Tr. 213. When 
asked whether she performed a physical exam on this occasion, 
Respondent testified:

    I conducted a physical exam. I don't know if it was on that 
specific date, but prior to me issuing this prescription, I had 
gotten to know him very well, and I learned more about his chronic 
pain syndrome, and he was a smoker. So, I did, I had listened to his 
heart and lungs many times before.\4\
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    \4\ At several other points in her testimony, Respondent 
described the physical exam as listening to S.C.'s heart and lungs, 
and made no reference to any other tests she did. For example, when 
asked ``How often did you perform a physical examination of S.C. in 
the course of issuing prescriptions to him?,'' she answered:
     I can't say for certain, but I did listen--like I said, I mean, 
he was a smoker, so I did listen to his . . . heart and lungs, which 
is one of the main exams on a physical, on a regular basis, because 
I usually had my stethoscope with me, and you know, whenever I saw 
him, I just did a general, you know--was able to generally assess 
his overall health and well-being, just from interacting with him 
and speaking to his family.
    Tr. 244-45. Notably, only after Respondent was asked by the 
Government if she specifically examined S.C.'s back and neck did she 
assert that she palpated him ``along the spine and surrounding 
areas.'' Id. at 263.

Id. When then asked by the Government if subsequent to the August 2007 
ER visit, she ``had met with him in a clinical capacity prior to'' 
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issuing the January 18 prescription, Respondent answered:

    I don't understand what you mean, clinical capacity. We 
developed a friendship, and we . . . were involved in a 
relationship, at that time. So, you know, I had gotten to know him 
personally. I knew his family, and you know, we had discussed a lot 
of his medical conditions, I had discussed with him and his family.

Id.
    When then asked where she had conducted her physical examinations 
of S.C., Respondent stated ``[e]ither by my home or his home.'' Id. 
215. When asked how she had assessed his pain level, Respondent 
testified: ``Just by asking him and just seeing how his overall well-
being was.'' Id. at 215-16. Respondent then asserted that S.C. had told 
her that ``he was in excruciating pain. He couldn't function without 
being on his pain medicine.'' Id. at 216. Respondent admitted, however, 
that she did not create ``any formal records'' for the prescriptions. 
Id. Nor did she create a written treatment plan for S.C. Id. at 218. 
She further admitted that she did not order any additional tests, 
because she was ``work[ing] outside [the] emergency department'' and 
that ``that was already conducted by his pain management specialist.'' 
Id. at 232-33.
    When then asked what was the medical purpose of the prescription, 
Respondent testified that S.C. ``was in a pain management clinic, up 
until about November or December of 2007, and he was transitioning. He 
said he lost his medical insurance. He was trying to find a new 
treating physician for his chronic pain.'' Id. at 216. According to 
Respondent, S.C. told her that he had back fractures and neck injuries 
from doing acting stunts and motorcycle racing. Id. at 246.
    Respondent further explained that S.C. was ``starting to do a lot 
of traveling at that time'' as he was auditioning for various ``acting 
jobs,'' and that he asked her if she could help him out until he could 
get insurance and ``see another provider.'' Id. at 216-17; 234. 
According to Respondent, she looked at the labels of the prescriptions 
S.C. had received from the pain management specialist who had 
previously treated him and ``then copied the prescription off the 
bottles.'' Id. at 217. Respondent further denied having made a 
diagnosis of chronic pain, stating that ``that was established 
already'' by S.C.'s ``prior physician[].'' Id. at 229.
    While Respondent admitted that she ``was not familiar with treating 
chronic pain,'' she did not contact the pain management doctor who had 
previously treated S.C., explaining that S.C. had told her that ``he 
was no longer involved with his care, and he did not wish to . . . see 
that physician any longer.'' Id. at 218-19. Respondent explained that 
she relied on what S.C. and his family had told her, as well as some of 
his medical records, although she did not look through all of his 
records. Id.
    When then asked how she knew that his prior physician would have 
continued S.C. on controlled substances, Respondent answered that 
``[w]hen you're on controlled substances you just don't stop . . . you 
have to go through either a weaning process or--that's why it requires 
a specialist to . . . continue treating once you're up to a certain 
number of high dose pain medication.'' Id. at 234-35. She also claimed 
that his family told her that S.C. did not have a history of substance 
abuse. Id. at 232. Respondent acknowledged that it ``was [her] error'' 
to accept S.C.'s word instead of contacting his prior physician. Id. at 
219. She further maintained that she trusted S.C., that ``his family 
backed up his story,'' and that she had ``no reason to believe at the 
time'' that she ``was being deceived.'' Id. at 220. She also stated 
that she was in ``a very good friendship'' with S.C. and that over 
time, she ``lost the physician/patient relationship'' and ``was not 
objective.'' Id.
    On or about February 7, 2008, Respondent wrote S.C. three undated 
prescriptions for OxyContin 80mg.\5\ See GX 1, at 3, 5, and 7. The 
prescriptions, which authorized the dispensing of 100 dosage units 
q12h, 200 dosage units q8h, and 100 dosage units q8h, all lacked S.C.'s 
address. See id. Moreover, none of the prescriptions listed ``the 
earliest date on which'' it could be filled as required by 21 CFR 
1306.12(b)(1)(ii). See id. Based on Respondent's dosing

[[Page 28699]]

instructions, the prescriptions provided S.C. with 149 days' supply of 
the drug.
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    \5\ The prescriptions were written on the prescription forms of 
the Physicians Regional Medical Center and were sequentially 
numbered from 007424 through 007426. GX 1, at 3-7. While the 
prescriptions were undated, the evidence shows that prescription 
number 007425 for 200 OxyContin 80mg. was filled on February 7, 
2008. Id. at 4.
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    The evidence further shows that S.C. filled the prescription for 
200 tablets at a cost of $2,328.00. Id. at 4. Yet Respondent repeatedly 
claimed that she ``was trying to offer a short-term, fix for his 
situation'' because ``[h]e was short on money,'' Tr. 236, even though 
he was working at a local radio station. Id. at 238-39. Respondent 
further claimed that S.C. had told her that an office visit with a pain 
management specialist cost ``about $400 or $500'' not counting the cost 
of any prescriptions, and that she trusted what he told her. Id. at 
239. She also claimed that she was unfamiliar with the cost of various 
drugs. Id. at 237.
    Regarding the OxyContin 80mg prescriptions, Respondent stated that 
she had ``probably not'' physically examined S.C. ``because [she] had 
done it in the past.'' Tr. 231. Respondent then claimed that she had 
assessed S.C.'s pain level by ``his appearance and how he would tell me 
he was feeling.'' Id. Respondent did not create a record for the 
prescriptions. Id. at 231-32.
    Notwithstanding the quantity of drugs provided by these 
prescriptions, on or about March 10, 2008,\6\ Respondent issued S.C. 
three more prescriptions, each of which was for 450 oxycodone 30mg, 
with a dosing instruction to take up to 15 tablets per day ``as needed 
for pain.'' GX 1, at 9, 11, and 13. As before, the prescriptions were 
not dated, did not include S.C.'s address, and lacked the earliest date 
on which they could be filled.\7\ Id. The evidence further shows that 
S.C. filled each of the prescriptions on March 10, 2008, and paid 
$280.74 for each one. Id. at 10, 12, and 14.
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    \6\ Here again, the prescriptions were written on the forms of 
the Physicians Regional Medical Center and were numbered 009325, 
009326, and 009329. GX 1, at 9, 11, and 13.
    \7\ If the drugs were actually taken at fifteen tablets per day, 
the prescriptions would have provided an additional 90 days' supply.
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    Here again, Respondent could not state ``for certain'' that she 
performed a physical exam on S.C. when she issued these prescriptions. 
Tr. 244. However, Respondent testified that she issued the 
prescriptions at S.C.'s home because ``this was when he was getting 
ready to go to Los Angeles for his acting job.'' Id. at 245. She also 
testified that she assessed S.C.'s pain level by ``[j]ust interacting 
with him, asking how he was feeling,'' and by S.C. letting her know 
whether he ``was having a good day or a bad day.'' Id. at 245-46.
    As for why she did not date the prescriptions and include S.C.'s 
address, Respondent testified that:

I know I was very distracted when I would write the prescriptions, 
because it was either at his home or my home, and he had a three-
year-old child. It was usually--it was usually at his home.
    He had a three-year-old, or a four-year-old, at the time. There 
were two dogs, a monkey in the house. There was a loud . . . his 
father was hard of hearing, so . . . the TV was on very loud, and it 
was a very distracting environment. I don't . . . you know, I cannot 
explain exactly why the date wasn't on them, because I know that the 
date needs to be on them. So, I can just . . . go back in my mind 
and know that it was very distracting.

Tr. 222. Later in her testimony, Respondent explained that S.C. had two 
German Shepherds, and that there was also a mutt (which he apparently 
did not own) that was allowed to come into the house. Id. at 340. And 
then there was the monkey, which according to Respondent, was ``three 
or four feet'' tall and ``dangerous,'' but was nonetheless allowed to 
run free in the house. Id. at 340-41.
    As for why she had written the three oxycodone 30mg prescriptions 
which were filled on March 10, Respondent offered the following 
testimony:

    I'm just trying to recall, because also, on multiple times, I 
was told the prescriptions were either lost or destroyed by the 
animals in the house, by the monkey . . . the monkey was . . . he 
would take the pill bottle, open it, and throw it in the pool, or 
you know, various different times . . . I was told that they were 
lost or stolen or left behind at the different hotels he was staying 
at.
    I just can't--you know, it's unclear, which set of prescriptions 
it may have occurred with, but it happened on numerous occasions, 
which is why there is [sic] a number of prescriptions.

Id. at 240-41. Respondent further maintained that S.C.'s stories 
regarding the monkey were believable because he ``would try to rip up 
my clothes and my shoes and he would take anything and just try to 
shred it.'' Id. at 341.
    As a further reason for why she wrote the multiple prescriptions, 
Respondent explained that there were occasions in which S.C. would call 
and tell her that the pharmacy was either ``out of stock for a 
particular brand name or particular dosage.'' Id. at 241; see also id. 
at 245 (``this was around the time where he told me the prescriptions 
were being destroyed or lost or left at one pharmacy or another, 
because they weren't in stock'').
    At this point, S.C. apparently left the area and went off to pursue 
his acting career. Tr. 227. As for why she had issued the multiple 
OxyContin prescriptions, Respondent testified that S.C. had told her 
that he was going to be in Los Angeles for ``three to six months'' to 
film a show for MTV and ``he wanted to make sure he didn't run out of 
pain medication while he was there.'' Id. She also testified that she 
was unaware that she could write ``do not fill until a certain date'' 
on the prescriptions. Id.
    Following his appearance on the MTV show and his return to Florida 
(sometime around October 2008), S.C. was ``getting a lot of 
opportunities to travel, to do commercials, to do auditions,'' and 
contracts. Id. at 249. According to Respondent, S.C. asked her if she 
could continue to help him out ``because he was doing a lot of 
travelling'' and it was hard for him to find ``a physician in a 
different state.'' Id. Respondent agreed to do so and resumed 
prescribing to him. In her testimony, Respondent did not explain why 
given S.C.'s success, he could not afford health insurance and find a 
pain management specialist.
    On January 20, 2009, Respondent resumed prescribing to S.C., 
issuing him a prescription for 40 Roxicodone 30mg, with a dosing 
instruction of TID or one tablet, three times a day. GX 1, at 15. 
Between February 3 and March 6, 2009, Respondent issued S.C. the 
following prescriptions, all of which had a dosing instruction of TID, 
or one tablet three times a day:

------------------------------------------------------------------------
               Date                           Drug and quantity
------------------------------------------------------------------------
2/3/09............................  90 Roxicodone 30mg.
2/3/09............................  90 Roxicodone 30mg.
2/9/09............................  90 Roxicodone 30mg.
2/9/09............................  90 Roxicodone 30mg.
2/9/09............................  90 Roxicodone 30mg.
2/10/09...........................  90 Roxicodone 30mg.
2/10/09...........................  90 Roxicodone 30mg.
2/10/09...........................  90 Roxicodone 30mg.
2/20/09...........................  90 Roxicodone 30mg.
2/20/09...........................  90 Roxicodone 30mg.
3/6/09............................  90 Roxicodone 30mg.
3/6/09............................  280 Roxicodone 15mg.
------------------------------------------------------------------------

See GX 1, at 17-35.
    Based on Respondent's dosing instruction of TID, a single oxycodone 
30mg prescription would have provided S.C. with a thirty-day supply; 
thus, a single prescription issued on February 3rd, should have lasted 
him through March 5th.\8\ However, the prescriptions Respondent wrote 
S.C. between February 3 and March 6 authorized the dispensing of 990 
tablets of oxycodone 30mg, an eleven-month supply; the prescription for 
280 oxycodone 15mg

[[Page 28700]]

provided S.C. with more than another 1.5 month's supply of the drug.
---------------------------------------------------------------------------

    \8\ It is acknowledged that the pharmacy which filled one of the 
February 3, 2009 prescriptions dispensed only 54 tablets on that 
date. GX 1, at 17-18. However, even if S.C. was unable to obtain the 
remaining 46 tablets from the pharmacy within 72 hours as required 
by DEA's regulation, see 21 CFR 1306.13(a), Respondent did not 
explain why it was necessary to write S.C. a second prescription on 
that date for a full 90 tablets.
---------------------------------------------------------------------------

    As for why Respondent issued multiple prescriptions on February 3, 
2009, Respondent testified that ``that they were not in stock at the 
particular pharmacy that he initially went to,'' so S.C. ``called me or 
told me that he had left the prescription [and] needed a new one, so he 
could bring it to whatever other pharmacy he was using.'' Tr. 251. 
However, the evidence shows only that the pharmacy partially filled the 
prescription in the amount of 54 tablets. GX 1, at 17. Respondent then 
asserted that she ``never realized that [the prescriptions] were being 
filled'' and that she ``thought they were either being destroyed'' or 
``not being filled at all.'' Id. at 251-52. However, Respondent never 
called any of the pharmacies S.C. used and ``never got word from the 
pharmacist that they were being filled.'' Id. at 252; see also id. at 
241 (``I was never phoned by any of these pharmacists, telling me that 
these prescriptions were being filled. I had no idea, because I did not 
have any records of the number of prescriptions I wrote.'').
    Respondent then testified that she did not find S.C.'s claim 
suspicious because in the ER, ``there were multiple times where 
patients would'' complain that a pharmacy would not have a particular 
narcotic or dosage. Id. at 252. When asked why the pharmacies would not 
have just returned the prescriptions to S.C. if the drug was out of 
stock, Respondent testified that she thought ``that is how they 
operated down there'' and added that she ``was new to the State.'' Id. 
at 253. However, Respondent has been licensed in Florida since August 
2004 and had worked there since at least December 2004.\9\ RX A, at 1-
2. Respondent could not recall whether she had ever had another patient 
ask for a replacement prescription claiming that a pharmacist had said 
a drug was out of stock and yet kept the prescription. Id. at 254-55.
---------------------------------------------------------------------------

    \9\ Prior to working in Naples, Respondent worked at a hospital 
in Fort Myers. RX A, at 1-2.
---------------------------------------------------------------------------

    Regarding the February 3, 2009 prescriptions, Respondent again 
could not recall if she had done a physical examination. Id. at 255. 
While Respondent claimed that she had assessed S.C.'s pain level in the 
same manner as before, she admitted that she did not create a medical 
record or a written treatment plan. Id. at 255-56. Nor could she 
specifically recall if, on this occasion, she had discussed the risks 
and benefits of using controlled substances. Id. at 256.
    As for why she issued three prescriptions on February 9, 2009 
instead of a single prescription for 270 tablets, Respondent answered 
that ``[t]he particular pharmacy . . . didn't have that quantity in 
stock'' so she split the prescriptions. Id. at 260-61. Again, 
Respondent could not recall if she had conducted a physical exam on 
S.C. on this date, id. at 262, and acknowledged that she did not create 
a medical record for these prescriptions or a written treatment plan. 
Id. at 264. She claimed, however, that she had assessed his pain level 
in the same manner as before, and that she had discussed the risks and 
benefits of using controlled substances on this occasion. Id. at 265, 
273. Respondent further testified that she used the same approach in 
assessing S.C.'s need for oxycodone for all of the prescriptions (other 
than the one she wrote during his ER visit). Id. at 274.
    Moreover, when asked why she had issued these three prescriptions 
given that she had issued two similar prescriptions only six days 
earlier, Respondent testified that she believed that S.C. had begun 
having seizures and was becoming forgetful. Id. at 266. Continuing, 
Respondent testified that: ``I believe he was--he may have been having 
seizures, which I found out in May, when I went over [to] his house . . 
. and he was acting confused . . . and he was in a post-seizure state . 
. . and I . . . told [his] mom that he was having seizures.'' Id. at 
266-67. However, Respondent then testified that ``this was actually 
in--it was around May.'' Id. at 267.\10\ Still later in her testimony, 
Respondent explained that ``it was my understanding that he was being 
truthful and they were truly lost or misplaced or destroyed or left at 
the pharmacist and never filled. Id. at 274.
---------------------------------------------------------------------------

    \10\ The evidence shows that S.C. was hospitalized for seizures 
on two occasions, May 28, 2009, and July 3, 2009. See GX 15 & 16.
---------------------------------------------------------------------------

    The evidence shows that the two February 3 prescriptions were 
filled on February 3 and 5, and that three February 9 prescriptions 
were filled on February 9, 11, and 16. GX 1, at 18, 19, 21, 23, and 25. 
So too, the evidence shows that the three prescriptions Respondent 
wrote on February 10, were filled on February 13, 14, and 17; the two 
prescriptions she wrote on February 20, were filled on February 21 and 
25; and the two prescriptions she wrote on March 6, were filled on 
March 6 and 9. See id. at 26-35.
    On questioning by her counsel, Respondent testified that she did 
not become aware that S.C. had been arrested for doctor-shopping 
``until after the case was already over.'' Tr. 348-49. On further 
questioning by her counsel, and inconsistent with her earlier testimony 
that the last prescription she wrote for S.C. was in August 2009, id. 
at 267, Respondent denied having written S.C. any more prescriptions 
``after the last emergency room visit.'' Id. at 349. Yet the evidence 
shows that S.C.'s last ER visit was on July 3, 2009, see GX 15, and the 
evidence further shows that on July 31, 2009, Respondent issued S.C. a 
prescription for 30 Roxicodone 15mg. GX 1, at 36.
    The evidence further showed that Respondent and S.C. drove to a 
Publix pharmacy where the prescription was filled. Tr. 97-98. 
Respondent remained in the car while S.C. went in to the store to fill 
the prescription. Id. at 98. According to the pharmacist, ``S.C. was 
very chatty and used a lot of small talk'' about being on a reality TV 
show ``as if he was trying to distract'' her. Id. at 97, 105. After the 
pharmacist handed the filled prescription to S.C., he ``eagerly took 
the prescription . . . and quickly headed to the back of the store.'' 
Id. at 97. Finding S.C.'s behavior suspicious, the pharmacist called 
the hospital ER to verify the prescription and was told that Respondent 
was under investigation and was asked to fax the prescription to the ER 
and to call the sheriff. Id. at 101. The pharmacist then asked an 
assistant store manager to go into the bathroom and check on S.C. GX 6.
    While the pharmacist was still on the phone, S.C. reappeared at the 
pharmacy counter and asked if there was a problem with the 
prescription. Tr. 98. The pharmacist told S.C. that she ``need[ed] to 
clarify the prescription and'' asked him if she could have it back; 
S.C. complied. Id. The pharmacist then counted the tablets and found 
that two were missing. Id. S.C. then told the pharmacist that ``if 
there are any questions regarding this prescription the doctor is my 
girlfriend and she is out in the car.'' Id.
    The pharmacist then proceeded to the parking lot and found 
Respondent in a car; the pharmacist asked Respondent for her driver's 
license, and after determining that it was Respondent, asked if she had 
written the prescription. Id. Respondent ``said `yes.''' Id. The 
pharmacist then returned to the pharmacy and found that ``S.C. was 
still there''; S.C. ``was very anxious and ask[ed] if he was going to 
be arrested.'' Id. The pharmacist went back inside the pharmacy, called 
the ER again and verified that Respondent was still employed there. Id. 
at 98-99. After being told that she was, the pharmacist gave the 
prescription back to S.C. and called the sheriff. Id. at 99.

[[Page 28701]]

    Respondent testified that she still believes that the prescriptions 
she issued S.C. were within the usual course of professional practice 
and for a legitimate medical purpose. Id. at 277. However, Respondent 
then stated that ``[i]n hindsight . . . my judgment was impaired 
because of the relationship I had with the individual,'' the 
prescriptions ``were not within . . . the standards of my medical 
practice.'' Id. Yet Respondent later asserted that she ``was definitely 
manipulated and taken advantage of. I was victimized.'' Id. at 350.
    Respondent also testified that at the time she wrote the 
prescriptions she believed they were ``medically necessary'' because 
there was a ``prior diagnosis of chronic pain.'' Id. And when asked 
whether, ``[s]itting here today, knowing what you do today, do you 
still believe that they were medically necessary at the time?'' 
Respondent answered: ``[y]es.'' Id.
    Respondent did acknowledge that she violated Florida's regulations 
by failing to ``keep proper documentation of each visit.'' Id. at 351. 
She then maintained that through the continuing medical education 
course she was required to take under the Florida Board's Order, ``I 
realize that will never happen again.'' Id.\11\
---------------------------------------------------------------------------

    \11\ During its examination of Respondent, the Government asked 
her if her attorney had spoken ``with a DEA representative about 
whether [she] needed to obtain a DEA registration in New Mexico.'' 
Tr. 199. Respondent's counsel objected, asserting that this was a 
privileged communication and the ALJ sustained the objection. Id.; 
see also R.D. at 39 (``I sustained [Respondent's] objection to the 
question, finding that the response was likely to call for the 
disclosure of information protected by the attorney client 
privilege. I continue to believe the sought-after response would 
likely have called for [Respondent] to disclose what Mr. Leider [her 
attorney] did or did not tell her in the course of his 
representation of her.'').
     Notably, in his Recommended Decision, the ALJ did not cite a 
single case to support his ruling and I conclude that his ruling was 
erroneous. ``The privilege `protects only those disclosures 
necessary to obtain informed legal advice which might not have been 
made absent the privilege.' '' In re Walsh, 623 F.2d 489,494 (7th 
Cir. 1980) (quoting Fisher v. United States, 425 U.S. 391, 403 
(1976)). Moreover, ```when an attorney conveys to his client facts 
acquired from other persons or sources, those facts are not 
privileged.' '' See In re Sealed Case, 737 F.2d 94, 100 (D.C. Cir. 
1984)) (quoting Brinton v. Department of State, 636 F.2d 600, 604 
(D.C. Cir. 1980) (footnote omitted)). Because the question did not 
ask Respondent to disclose what facts she had communicated to her 
lawyer or the legal advice she received from her lawyer, the ALJ 
erred in barring the testimony. See United States v. DeFazio, 899 
F.2d 626, 635 (7th Cir. 1990) (holding that where attorney 
``testified only to what [an] IRS agent said to him, and that he 
later relayed those statements to [defendant,] [t]he content of this 
testimony is unprivileged because it did not reveal, either directly 
or implicitly, legal advice given [defendant] or any client 
confidences'').
---------------------------------------------------------------------------

Discussion

    Section 303(f) of the Controlled Substances Act (CSA) provides that 
an application for a practitioner's registration may be denied ``if the 
Attorney General determines that the issuance of such registration . . 
. would be inconsistent with the public interest.'' 21 U.S.C. 823(f). 
With respect to a practitioner, the Act requires the consideration of 
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 manufacture, 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.

Id. Sec.  823(f).
    ``These factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I 
``may rely on any one or a combination of factors[,] and may give each 
factor the weight [I] deem[] appropriate in determining whether a 
registration should be revoked. Id.; see also MacKay v. DEA, 664 F.3d 
808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 
2009); Hoxie v. DEA, 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 (quoting Hoxie, 419 F.3d at 482)).\12\
---------------------------------------------------------------------------

    \12\ ``In short, this is not a contest in which score is kept; 
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, 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.
---------------------------------------------------------------------------

    In this matter, I have considered all of the factors and conclude 
that the Government's evidence with respect to factors two 
(Respondent's experience in dispensing controlled substances), four 
(Respondent's compliance with applicable laws related to controlled 
substances), and five (such other conduct) establishes that she ``has 
committed such acts as would render [her] registration under section 
823 of this title inconsistent with the public interest.'' 21 U.S.C. 
824(a)(4). While I do not adopt the ALJ findings that Respondent 
violated federal law by issuing prescriptions while working as a 
contract physician at the Northern Navajo Medical Center without being 
registered in New Mexico, I find that Respondent acted outside the 
usual course of professional practice and lacked a legitimate medical 
purpose in issuing the prescriptions to S.C. Notwithstanding her claim 
that her conduct in prescribing to S.C. is an aberration, I find it to 
be egregious. And based on her insistence that even now, she still 
believes these prescriptions were legitimate, I conclude that 
Respondent has failed to produce sufficient evidence to demonstrate why 
she should be entrusted with a registration.\13\
---------------------------------------------------------------------------

    \13\ I acknowledge that Respondent remains licensed in various 
States, including Pennsylvania, the State where she seeks 
registration and therefore meets the CSA's prerequisite for holding 
a practitioner's registration in that State. See 21 U.S.C. 823(f) 
(``The Attorney General shall register practitioners . . . to 
dispense . . . controlled substances . . . if the applicant is 
authorized to dispense . . . controlled substances under the laws of 
the State in which he practices.'').
     However, the possession of state authority ```is not 
dispositive of the public interest inquiry.''' George Mathew, 75 FR 
66138, 66145 (2010), pet. for rev. denied Mathew v. DEA, No. 10-
73480, slip op. at 5 (9th Cir., Mar. 16, 2012); see also Patrick W. 
Stodola, 74 FR 20727, 20730 n.16 (2009). As the Agency has long 
held, ``the Controlled Substances Act requires that the 
Administrator . . . make an independent determination [from that 
made by state officials] as to whether the granting of controlled 
substance privileges would be in the public interest.'' Mortimer 
Levin, 57 FR 8680, 8681 (1992). Accordingly, this factor is not 
dispositive either for, or against, the granting of Respondent's 
applications. Paul Weir Battershell, 76 FR 44359, 44366 (2011) 
(citing Edmund Chein, 72 FR 6580, 6590 (2007), pet. for rev. denied 
Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008)).
     As for factor three, there is no evidence that Respondent has 
been convicted of an offense ``relating to the manufacture, 
distribution or dispensing of controlled substances.'' 21 U.S.C. 
823(f)(3). However, there are a number of reasons why even a person 
who has engaged in misconduct may never have been convicted of an 
offense under this factor, let alone prosecuted for one. Dewey C. 
MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied MacKay v. 
DEA, 664 F.3d 808 (10th Cir. 2011). The Agency has therefore held 
that ``the absence of such a conviction is of considerably less 
consequence in the public interest inquiry'' and is therefore not 
dispositive. Id.
---------------------------------------------------------------------------

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

    To effectuate the dual goals of conquering drug abuse and 
controlling both the legitimate and illegitimate traffic in controlled 
substances, ``Congress devised a closed regulatory system making it 
unlawful to manufacture, distribute, dispense, or possess any 
controlled substance except

[[Page 28702]]

in a manner authorized by the CSA.'' Gonzales v. Raich, 545 U.S. 1, 13 
(2005). Consistent with the maintenance of the closed regulatory 
system, a controlled substance may only be dispensed upon a lawful 
prescription issued by a practitioner. Carlos Gonzalez, M.D., 76 FR 
63118, 63141 (2011).
    Fundamental to the CSA's scheme is the Agency's longstanding 
regulation, which states that ``[a] prescription for a controlled 
substance [is not] effective [unless it 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). This 
regulation further provides that ``an order purporting to be a 
prescription issued not in the usual course of professional treatment . 
. . is not a prescription within the meaning and intent of [21 U.S.C. 
829] and . . . the person issuing it, shall be subject to the penalties 
provided for violations of the provisions of law relating to controlled 
substances.'' Id.
    As the Supreme Court has explained, ``the prescription requirement 
. . . ensures patients use controlled substances under the supervision 
of a doctor so as to prevent addiction and recreational abuse. As a 
corollary, [it] also bars doctors from peddling to patients who crave 
the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S. 
243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 
(1975)); United States v. Alerre, 430 F.3d 681, 691 (4th Cir. 2005), 
cert. denied, 574 U.S. 1113 (2006) (stating that the prescription 
requirement likewise stands as a proscription against doctors acting 
not ``as a healer[,] but as a seller of wares'').
    Under the CSA, it is fundamental that a practitioner must establish 
and maintain a legitimate doctor-patient relationship in order to act 
``in the usual course of . . . professional practice'' and to issue a 
prescription for a ``legitimate medical purpose.'' Paul H. Volkman, 73 
FR 30629, 30642 (2008), pet. for rev. denied, 567 F.3d 215, 223-24 (6th 
Cir. 2009); see also Moore, 423 U.S. at 142-43 (noting that evidence 
established that the physician exceeded the bounds of professional 
practice, when ``he gave inadequate physical examinations or none at 
all,'' ``ignored the results of the tests he did make,'' and ``took no 
precautions against . . . misuse and diversion''). The CSA, however, 
generally looks to state law to determine whether a doctor and patient 
have established a legitimate doctor-patient relationship. Volkman, 73 
FR at 30642.
    In Florida, a physician is barred from ``prescribing, dispensing, 
administering, mixing, or otherwise preparing . . . any controlled 
substance, other than in the course of the physician's professional 
practice.'' Fla. Stat. Sec.  458.331(q). The statute further explains 
that ``prescribing, dispensing . . . or otherwise preparing . . . 
controlled substances, inappropriately or in excessive or inappropriate 
quantities is not in the best interest of the patient and is not in the 
course of the physician's professional practice.'' Id.; see also Fla. 
Stat. Sec.  893.05(1) (``A practitioner, in good faith and in the 
course of his or her professional practice only, may prescribe . . . a 
controlled substance[.]'').
    As found above, while Respondent neither admitted nor denied the 
factual allegations of the Administrative Complaint which was filed 
against her by the Florida Board, she did admit that if those facts 
were proven, they would establish violations of the Florida Statutes as 
alleged in the Complaint, including not only that she failed to meet 
the prevailing standard of care, but also that she prescribed 
controlled substances other than in the course of her professional 
practice. See GX 8, at 2 (citing Fla. Stat. Chap. 458). In this 
proceeding, the material facts set forth in the Board's complaint have 
been proven.
    Moreover, under the Florida Board of Medicine's then-existing 
Standards for the Use of Controlled Substances for the Treatment of 
Pain:

    A complete medical history and physical examination must be 
conducted and documented in the medical record. The medical record 
should document the nature and intensity of the pain, current and 
past treatment for pain, underlying or coexisting disease or 
conditions, the effect of the pain on physical and psychological 
function, and history of substance abuse. The medical record also 
should document the presence of one or more recognized medical 
indications for the use of a controlled substance.

Fla. Admin R. 64B8-9.013(3)(a).\14\
---------------------------------------------------------------------------

    \14\ This version of the Standards was promulgated in 1999, 
amended in both 2002 and 2003, and remained in effect until a new 
version of the Standards was promulgated in 2010.
---------------------------------------------------------------------------

    The State's Standards also required a physician ``to keep accurate 
and complete records to include, but not be limited to: 1. [t]he 
medical history and physical examination, including history of drug 
abuse or dependence, as appropriate; 2. [d]iagnostic, therapeutic, and 
laboratory results; 3. [e]valuations and consultations; 4. [t]reatment 
objectives; 5. [d]iscussion of risks and benefits; 6.[t]reatments; 7. 
[m]edications (including date, type, dosage, and quantity prescribed); 
8. [i]nstructions and agreements; and 9. [p]eriodic reviews.'' Id. at 
64B8-9.013(f).
    While Respondent asserted that she did a physical examination and 
that she knew ``about [S.C.'s] chronic pain syndrome'' from talking to 
both him and his parents, Tr. 214, the fact remains that she failed to 
document and maintain any medical records to support the prescriptions. 
Indeed, she specifically denied having diagnosed S.C. as having chronic 
pain, asserting that the diagnosis ``was established already'' by 
S.C.'s ``prior physician,'' id. at 229, and that she wrote the 
prescriptions by ``cop[ying] the prescription off the bottles'' S.C. 
showed her. Id. at 217. Yet, notwithstanding that those prescriptions 
were legally required to contain the name of the prescribing physician, 
see 21 CFR 1306.14(a), and no claim is made that they did not, 
Respondent never called S.C.'s prior physician.\15\
---------------------------------------------------------------------------

    \15\ Respondent also testified that she looked at S.C.'s medical 
records. Thus, she clearly had available to her information as to 
Respondent's prior physician. While Respondent testified that S.C. 
was no longer seeing this physician because ``he lost his medical 
insurance,'' id. at 216, as well as that ``he did not wish to . . . 
see that physician any longer,'' id. at 219, because she never 
called the physician, she had no idea if S.C. had told her the truth 
or if his prior physician had discharged him.
---------------------------------------------------------------------------

    When then asked how she knew if Respondent's prior physician would 
have continued S.C. on narcotic controlled substances, Respondent 
replied that ``[w]hen you're on controlled substances you just don't 
stop . . . you have to go through either a weaning process--that's why 
it requires a specialist to . . . continue treating once you're up to a 
certain number of high dose pain medication.'' Tr. 234-35. Unexplained 
by Respondent is why she wrote S.C. prescriptions totaling 400 dosage 
units of OxyContin 80mg, given her testimony that a patient who is on a 
``high dose [of] pain medication,'' ``requires a specialist,'' id., 
which she is not, as well as her admission that she ``was not familiar 
with treating chronic pain.'' Id. at 218.
    Moreover, Respondent repeatedly provided S.C. with prescriptions 
which enabled him to obtain schedule II controlled substances including 
OxyContin 80mg and oxycodone 30mg, drugs which are among the most 
highly abused and diverted controlled substances, in quantities which 
greatly exceeded both her own dosing instructions and DEA regulations. 
As found above, on or about February 7, 2008, Respondent issued S.C. 
prescriptions for 400 dosage units of OxyContin 80mg. Putting aside 
that Respondent wrote two different dosing instructions on the three 
prescriptions

[[Page 28703]]

(one prescription calling for one tablet every 12 hours, the other two 
calling for one tablet every eight hours), these dosing instructions 
provided S.C. with more than a 149-day supply of the drug.\16\ However, 
under DEA regulations, Respondent could lawfully prescribe a maximum of 
a 90-day supply. See 21 CFR 1306.12(b)(1).
---------------------------------------------------------------------------

    \16\ This calculation was based on Respondent's actual dosing 
instructions for each prescription. These three prescriptions would 
have provided a 200-day supply of the drug had I calculated this 
figure using a dosing instruction of one tablet every twelve hours 
for all three prescriptions, which is consistent with the 
manufacturer's prescribing instructions. See Physician's Desk 
Reference 2707 (61st ed. 2007) (``It is most appropriate to increase 
the q12h dose, not the dosing frequency. There is no clinical 
information on dosing intervals shorter than q12h.''); see also id. 
(``The intent of the titration period is to establish a patient-
specific q12h dose that will maintain adequate analgesia with 
acceptable side effects for as long as pain relief is necessary.'').
---------------------------------------------------------------------------

    Notwithstanding that she had written the three OxyContin 
prescriptions only one month earlier and that if Respondent took the 
drugs in accordance with her dosing instructions, he would have had at 
least a four-month supply of the drug remaining, on or about March 10, 
2008, Respondent wrote S.C. three more prescriptions. Each of these 
prescriptions authorized the dispensing of 450 dosage units of 
oxycodone 30mg, and, with a dosing instruction of up to 15 tablets or 
450 milligrams per day, provided S.C. with an additional thirty-day 
supply. By comparison, the OxyContin prescriptions provided a daily 
dose of 160 or 240mg per day.
    Assuming S.C. took the full fifteen tablets per day, the three 
March 10, 2008 prescriptions provided S.C. with an additional 90-day 
supply of oxycodone. Thus, based on her own dosing instructions, the 
February and March 2008 prescriptions provided S.C. with nearly an 
eight-month supply of oxycodone.
    As for why she issued these six prescriptions, Respondent offered 
multiple explanations. First, regarding the OxyContin prescriptions, 
Respondent testified that S.C. had told her he was going to be in Los 
Angeles for three to six months filming a show for MTV and did not want 
to run out of medication. Tr. 227. Second, she asserted that S.C. told 
her that the monkey ``would take the pill bottle, open it, and throw it 
in the pool.'' Id. at 240-41. Third, she claimed that S.C required 
additional prescriptions because the pharmacy was either out of stock 
of the particular brand or dosage, or that he left the prescription at 
the pharmacy. Id. at 241 & 245.
    None of these explanations provides a persuasive justification that 
mitigates her misconduct. As for the first one, surely the Los Angeles 
area has an ample supply of pain management specialists who could have 
treated S.C. were he to run out of medication. Moreover, even if S.C. 
was a legitimate patient, given her testimony that patients on high 
doses of narcotics require a specialist to continue their treatment, 
Respondent's decision to provide S.C. with an eight-month supply of 
oxycodone when she had no ability to supervise his medication use--not 
that that ever appeared to be a concern to her--reflects a stunning 
disregard for her obligations as a prescriber of controlled substances. 
See Gonzales, 546 U.S. at 274 (``the prescription requirement . . . 
ensures patients use controlled substances under the supervision of a 
doctor so as to prevent addiction and recreational abuse'').
    As for the explanation that S.C. told her that he needed additional 
prescriptions because the pharmacies were out of either the branded 
medication (such as OxyContin) or the particular dosage strength, or 
that he left the prescription at the pharmacy, Respondent never called 
any of the pharmacies to verify S.C.'s claims. Tr. 241 & 252. Moreover, 
even if the pharmacies S.C. used were out of OxyContin, Respondent 
offered no explanation as to why, in a one-month period, she increased 
S.C.'s daily dose of oxycodone from either 160 or 240mgs per day 
(depending upon which prescription she wrote) to 450mgs per day.
    Then there is Respondent's testimony that she believed S.C. when he 
told her that his pet monkey was opening his pill bottles and throwing 
the drugs in the pool. While Respondent initially offered this far-
fetched story to explain why she had written the three undated 
oxycodone 30mg prescriptions, all of which were filled on the same date 
(March 10, 2008) and bore serial numbers suggesting they were all 
written in close temporal proximity, she offered no testimony to the 
effect that she had asked to see the pill bottles to determine if the 
prescriptions had actually been filled. Moreover, Respondent eventually 
backtracked on this testimony, explaining that it was ``unclear[] which 
set of prescriptions it may have occurred with.'' Tr. 241. Accordingly, 
I find this testimony incredible.
    Respondent further violated DEA regulations because she failed to 
date the three March 2008 prescriptions and include S.C.'s address on 
them. See 21 CFR 1306.05(a) (``All prescriptions for controlled 
substances shall be dated as of, and signed on, the day when issued and 
shall bear the full name and address of the patient . . . .''). As for 
why she did not date the prescriptions and include S.C.'s address on 
them, Respondent offered the ludicrous explanation that because of a 
young child, the dogs, the monkey, and S.C.'s hard-of-hearing father 
(who required that the volume on the TV be ``very loud''), ``it was a 
very distracting environment.'' Tr. 222. Yet somehow Respondent was 
able to include on the prescriptions the drug name, the dosage 
strength, the quantity, a dosing instruction, as well as her DEA 
number, printed name and signature. In short, I do not find her 
testimony credible as to why the prescriptions were undated.
    While Respondent apparently ceased her prescribing to S.C. while he 
was in Los Angeles, she resumed prescribing to him in January 2009, 
notwithstanding that with his opportunities and the ``contracts he was 
getting,'' S.C. presumably could have afforded to see a pain management 
specialist. Tr. 249. As found above, between February 3 and March 6, 
2009, Respondent issued S.C. eleven prescriptions for 90 Roxicodone 
(oxycodone) 30mg. Moreover, on several dates, Respondent issued S.C. 
two or more prescriptions.
    Based on her dosing instruction of one tablet, three times per day, 
the prescriptions authorized the dispensing of 990 tablets of oxycodone 
30mg, or an eleven-month supply of the drug. Moreover, on March 6, 
Respondent issued S.C. a prescription for 280 Roxicodone 15 mg (also 
with a dosing instruction of one tablet, three times per day). Thus, 
between February 3 and March 6, 2009, Respondent's prescriptions 
provided S.C. with more than a one-year supply of oxycodone if he 
actually took the drugs as directed.
    As for why she issued S.C. the two February 3 prescriptions, 
Respondent testified that S.C. had called her and told her that the 
pharmacy he initially went to was out of stock and that he left the 
prescription there. Once again, Respondent merely accepted S.C.'s 
story, which was only partially true, and did not call the pharmacy.
    While Respondent maintained that she did not find this suspicious 
because some of her ER patients had complained that a pharmacy would 
not have a particular drug, she could not recall if she had ever had 
another patient claim that he/she needed a new prescription because the 
pharmacist had kept it. When then asked why the pharmacist would not 
have simply returned the prescription to S.C., Respondent

[[Page 28704]]

asserted that was ``how they operated down there'' and that she ``was 
new to the State,'' even though she had worked in Florida for more than 
four years at that point. Yet the evidence shows that every single 
prescription she issued to S.C. in this period was filled, see GX 1, at 
17-35, and while the first February 3 prescription was only partially 
filled (with the pharmacy dispensing 54 tablets), even if the pharmacy 
could not fill the remaining portion of the prescription within 72 
hours, see 21 CFR 1306.13(a), there was no need for Respondent to issue 
him a second prescription for a full 90 tablets.
    As for why she then issued S.C. three more prescriptions just six 
days later (on Feb. 9), Respondent initially claimed that S.C. had 
begun having seizures and was becoming forgetful, but then acknowledged 
that this did not happen until three months later. Other than in her 
earlier ludicrous testimony that the monkey was throwing S.C.'s drugs 
in the pool or that Respondent was leaving the drugs in his hotel room, 
or the drugs had been stolen--none of which was documented in a medical 
record because she maintained none on S.C.--Respondent failed to 
address why she issued S.C. three more prescriptions the next day. So 
too, Respondent failed to address why she wrote the multiple 
prescriptions on February 20 and March 6.
    In her testimony, Respondent maintained ``that over time'' she 
``lost the physician/patient relationship.'' Tr. 220. To the contrary, 
the evidence suggests that the only time she prescribed to S.C. 
pursuant to a valid doctor-patient relationship was in August 2007, 
when she treated him for his broken hand in the ER. Her testimony as to 
whether she performed physical examinations of S.C. was exceedingly 
vague and changed, both as to the dates she performed these exams and 
the scope of the exams. Indeed, she explicitly denied having even made 
a diagnosis, id. at 229, claiming that S.C.'s prior physician had done 
that, and yet she proceeded to provide him with prescriptions for more 
than 1750 tablets of two of the most highly abused prescription 
narcotics (400 OxyContin 80mg and 1350 oxycodone 30mg) without even 
calling S.C.'s prior physician. She also offered no explanation for the 
inconsistency between the dosing instructions on the various OxyContin 
prescriptions or for increasing S.C.'s daily dose of oxycodone from 
240mgs (per the OxyContin prescriptions) to 450mgs per day (per the 
oxycodone 30 prescriptions) only one month later. Moreover, she 
provided the first set of prescriptions with full knowledge that S.C. 
was going off to California for several months and that she would have 
no ability to monitor him. And she failed to create any medical records 
and a written treatment plan.
    As for the 2009 prescriptions, notwithstanding that she had not 
``treated'' S.C. in nearly ten months, she could not recall if she had 
done a physical exam. Moreover, within a one- month period, she 
provided him with more than a one-year supply of oxycodone based on her 
own dosing instructions. As for her testimony that she believed the 
various excuses S.C. offered for why he needed additional 
prescriptions, and did so even when the excuse was patently absurd, the 
ALJ did not find this credible. Nor do I. And here again, she failed to 
create any medical records and a written treatment plan.
    I therefore conclude that with the exception of the Percocet 
prescription she wrote when she treated S.C. in the ER, Respondent 
repeatedly acted outside of the usual course of professional practice 
and lacked a legitimate medical purpose when she prescribed oxycodone 
(including OxyContin) to him. See 21 CFR 1306.04(a). While Respondent 
contends ``that her actions were not for personal gain,'' Resp. Post-
Hrng. Br. at 36, to sustain a violation, the Government was not 
required to prove that she provided the prescriptions in exchange for 
either money or to obtain S.C.'s affection. In sum, I conclude that 
Respondent knowingly diverted controlled substances when she prescribed 
to S.C.
    I also conclude that Respondent violated Agency regulations 
requiring that she: (1) Date the prescriptions as of the date of their 
issuance, 21 CFR 1306.05(a); (2) include S.C.'s address on the 
prescriptions, see id. ; (3) where issuing multiple prescriptions for 
schedule II drugs, not prescribe more than a 90-day supply, 21 CFR 
1306.12(b)(1); and (4) where issuing multiple prescriptions, 
``provide[] written instructions on each prescription . . . indicating 
the earliest date on which a pharmacy may fill each prescription. Id. 
1306.12(b)(ii). She also violated Florida law and regulations by 
failing to create medical records.
    Respondent nonetheless argues that she ``has had a long career in 
emergency medicine and has had no instances of malpractice or 
disciplinary action prior to the instant case.'' Resp. Exceptions, at 
11. She further contends that ``[t]he events surrounding her 
relationship with S.C. and her treatment of his purported medical 
conditions represent an aberrant set of circumstances that are unlikely 
to ever be repeated.'' Id.
    It is acknowledged that except for the matters at issue here, 
Respondent has practiced medicine as an ER physician for approximately 
sixteen years and dispensed controlled substances without incident. It 
also acknowledged that two of her co-workers wrote letters attesting to 
her ability as a clinician. See RX P & R.
    I nonetheless reject her contention that her misconduct is an 
aberration. As the evidence shows, Respondent engaged in two separate 
bouts of unlawful prescribing. Indeed, while her prescribings to S.C. 
in the February-March 2008 time period were egregious (providing him 
with 1750 tablets of highly abused schedule II narcotics), in January 
2009, she resumed prescribing to him, providing him with more than 
another 1,000 pills of this highly abused narcotic in a one-month 
period. Moreover, notwithstanding her admitted lack of familiarity with 
treating chronic pain, and that while S.C. was in LA, she had months to 
reflect on her prescribing practices with respect to him as well as to 
familiarize herself with Florida's standards for using controlled 
substances to treat pain, Respondent resumed prescribing to S.C. a 
highly abused narcotic in unlawful quantities, see 21 CFR 
1306.12(b)(1), that also greatly exceeded what was medically necessary 
according to her own dosing instructions.
    I therefore find that the Government's evidence with respect to 
factors two and four establishes that Respondent has committed such 
acts as to render her ``registration inconsistent with the public 
interest.'' \17\ I further find that

[[Page 28705]]

Respondent's misconduct was egregious and makes out a prima facie case 
for denying her application.
---------------------------------------------------------------------------

    \17\ While I have considered the allegation that Respondent 
violated the CSA by issuing prescriptions while working at the 
Northern Navajo Medical Center without being licensed by New Mexico 
and registered with DEA in that State, I decline to rule on the 
allegation because several material issues have not been adequately 
addressed. While the Government elicited testimony from a 
registration program specialist to the effect that in order for 
Respondent to obtain a registration in New Mexico, she was required 
to obtain a New Mexico medical license, it is unclear whether New 
Mexico has authority to require a federal contract physician to be 
licensed in the State if she works solely at an IHS facility. The 
limited case law suggests to the contrary. See Taylor v. United 
States, 821 F.2d 1428, 1431 (9th Cir. 1987) (noting that under the 
Supremacy Clause, a State ``lacks power to require licensing of 
federal health care providers and physicians'' and that ``[t]he 
United States has . . . essentially deemed [an] Army [h]ospital and 
its staff fit to provide health care services''); United States v. 
Composite State Bd. of Medical Examiners, 656 F.2d 131, 135 n.4 (5th 
Cir. 1981) (citing Sperry v. Florida ex rel. Florida Bar, 373 U.S. 
379 (1963)). Cf. 25 U.S.C. 1621t (``Licensed health professionals 
employed by a tribal health program shall be exempt, if licensed in 
any State, from the licensing requirements of the State in which the 
tribal health program performs the services described in the 
contract or compact of the tribal health program under the Indian 
Self-Determination and Education Assistance Act.''). However, this 
determination is not within the Agency's authority.
    Moreover, the Government does not address whether a physician is 
nonetheless required to obtain a registration specific to an IHS 
facility if the State lacks authority to require a physician to 
obtain a license in that State, or whether a physician who does not 
possess a license in the State where the facility is located and is 
not required to possess such a license, can nonetheless obtain a 
registration for that location.
    Because I find that the Government has otherwise proved that 
Respondent's continued registration is inconsistent with public 
interest and that she has failed to produce sufficient evidence to 
rebut this conclusion, I decline to remand the matter or issue a 
briefing order. On this record, I decline to adopt the ALJ's 
conclusions of law (# 8, 9, and 10) that Respondent violated federal 
law because she issued prescriptions while practicing at the 
Northern Navajo Medical Center without being registered in New 
Mexico and that she is not exempt from registration in that State. 
See R.D. 74. I also decline to adopt the ALJ's finding that 
Respondent's ``decision to rely exclusively on representations made 
to her by her future employers constitutes a willful and reckless 
disregard for her duty to inquire of the DEA regarding the need for 
re-registration and in-state licensure,'' R.D. at 64, and that this 
is actionable misconduct under factor five. Id.
---------------------------------------------------------------------------

Factor Five--Such Other Conduct Which May Threaten Public Health and 
Safety

    The ALJ also found that Respondent engaged in actionable misconduct 
under this factor. More specifically, the ALJ found, inter alia, that: 
(1) Respondent lacked candor in her testimony regarding her 
prescribings to S.C.; and (2) she failed to cooperate with DEA 
Investigators who were investigating her 2012 renewal application. R.D. 
at 63-66. Of these, I conclude that only the first finding is supported 
by substantial evidence.
    As for the second contention, the evidence showed that during the 
course of investigating her renewal application, Agency Investigators 
went to a hospital at which Respondent was then working and asked to 
speak to her about the ``yes'' answer she had provided to one of the 
liability questions on the application. Tr. 388. Respondent declined to 
answer any questions without an attorney being present. Id. While the 
Investigators then explained ``this was not a criminal investigation'' 
and that it ``was purely regulatory in scope'' as it involved the 
Florida Board matter, Respondent again refused ``to discuss the 
matter.'' Id. at 390. The DI then testified that he was never able to 
complete his interview of Respondent. Id. at 391; 398.
    Based on this evidence, the ALJ found that Respondent ``flatly 
refused to answer [the DI's] questions to resolve the liability issues 
she noted on her renewal application in the absence of an attorney, and 
made no attempt to arrange a subsequent meeting with [the DI], with or 
without counsel.'' R.D. at 65-66. The ALJ thus reasoned that 
``Respondent's failure to cooperate . . . suggests a substantial and 
willful disregard for her duty to comply with DEA directives as a 
regulated entity'' and ``[t]his conduct threatens public health and 
safety.'' Id. at 66.
    I find the ALJ's reasoning unpersuasive. Respondent was entitled to 
consult with her attorney before answering the DI's questions and had 
no obligation to agree to an interview without her attorney being 
present. Moreover, the DI offered no testimony to the effect that he 
made any further attempt to interview her, let alone that she rebuffed 
a further interview request or that she agreed to an interview and then 
failed to follow through. Accordingly, I reject the ALJ's finding and 
conclusion as unsupported by substantial evidence.
    However, I agree with the ALJ's legal conclusion that Respondent 
lacked candor in her testimony. More specifically, as ultimate 
factfinder, see 5 U.S.C. 557(b), I do not find credible her testimony 
that she did not know ``exactly why'' she did not include the date and 
S.C.'s address on the OxyContin 80mg and Oxycodone 30mg prescriptions 
other than that S.C.'s house was a ``very distracting'' environment. 
Tr. 222. As found above, notwithstanding her assertion, Respondent was 
not so distracted that she failed to include on the prescriptions such 
required information as the name of the drug, its dosage strength, the 
quantity, and her signature. Id.
    Nor do I find credible her testimony that she palpated S.C.'s back 
and neck as part of the physical exams she claimed to have performed. 
Id. at 263. As found above, at several earlier points in her testimony, 
Respondent described the physical exam she performed as listening to 
S.C.'s heart and lungs, making no mention of having palpated any part 
of S.C. See id. at 214 & 244-45. Indeed, she asserted that she palpated 
S.C.'s back and neck only after the Government specifically asked her 
if she did. Id. at 263.
    Finally, I do not find credible Respondent's testimony that she 
wrote the multiple oxycodone 30mg prescriptions because she actually 
believed S.C.'s claim that the monkey had taken the pill bottle, 
managed to open it, and then threw the medication in the pool. Id. at 
240-41, 341. Accordingly, I find that substantial evidence supports a 
finding that Respondent lacked candor when she testified in this 
proceeding. See Hoxie v. DEA, 419 F.3d 477, 483 (``Candor during DEA 
investigations properly is considered by the DEA to be an important 
factor when assessing whether a . . . registration is consistent with 
the public interest.''). Thus, I conclude that the record supports a 
finding that Respondent lacked candor when she testified in this 
proceeding and that she has committed such other conduct which may 
threaten public health and safety. 21 U.S.C. 823(f)(5).

Sanction

    Under Agency precedent, where, as here, ``the Government has proved 
that [an applicant] has committed acts inconsistent with the public 
interest, the [applicant] must `` `present sufficient mitigating 
evidence to assure the Administrator that [she] can be entrusted with 
the responsibility carried by such a registration.' ''' '' Medicine 
Shoppe-Jonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 
72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 
(1988))). ``Moreover, because `past performance is the best predictor 
of future performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th 
Cir. 1995), [DEA] has repeatedly held that where [an applicant] has 
committed acts inconsistent with the public interest, the [applicant] 
must accept responsibility for [her] actions and demonstrate that [she] 
will not engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; 
see also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 
(2006); Prince George Daniels, 60 FR 62884, 62887 (1995). See also 
Hoxie v. DEA, 419 F.3d at 483 (``admitting fault'' is ``properly 
consider[ed]'' by DEA to be an ``important factor[]'' in the public 
interest determination).
    So too, in making the public interest determination, ``this Agency 
places great weight on an [applicant's] candor, both during an 
investigation and in [a] subsequent proceeding.'' Robert F. Hunt, 75 FR 
49995, 50004 (2010) (citing The Lawsons, Inc., t/a The Medicine Shoppe 
Pharmacy, 72 FR 74334, 74338 (2007) (quoting Hoxie, 419 F.3d at 483 
(``Candor during DEA investigations properly is considered by the DEA 
to be an important factor when assessing whether a . . . registration 
is consistent with the public interest.''))).
    Moreover, while an applicant must accept responsibility and 
demonstrate that she will not engage in future misconduct in order to 
establish that her registration is consistent with the public

[[Page 28706]]

interest, DEA has repeatedly held these are not the only factors that 
are relevant in determining the appropriate sanction. See, e.g., Joseph 
Gaudio, 74 FR 10083, 10094 (2009); Southwood Pharmaceuticals, Inc., 72 
FR 36487, 36504 (2007). Obviously, the egregiousness and extent of an 
applicant's misconduct are significant factors in determining the 
appropriate sanction. See Jacobo Dreszer, 76 FR 19386, 19387-88 (2011) 
(explaining that a respondent can ``argue that even though the 
Government has made out a prima facie case, his conduct was not so 
egregious as to warrant revocation''); Paul H. Volkman, 73 FR 30630, 
30644 (2008); see also Gregory D. Owens, 74 FR 36751, 36757 n.22 
(2009).
    Moreover, as I have noted in several cases, `` `[n]either Jackson, 
nor any other agency decision, holds . . . that the Agency cannot 
consider the deterrent value of a sanction in deciding whether a 
registration should be revoked' '' or an application should be denied. 
Gaudio, 74 FR at 10094 (quoting Southwood, 72 FR at 36504 (2007)); see 
also Robert Raymond Reppy, 76 FR 61154, 61158 (2011); Michael S. Moore, 
76 FR 45867, 45868 (2011). This is so, both with respect to the 
respondent in a particular case and the community of registrants. See 
Gaudio, 74 FR at 10095 (quoting Southwood, 71 FR at 36504). Cf. 
McCarthy v. SEC, 406 F.3d 179, 188-89 (2d Cir. 2005) (upholding SEC's 
express adoptions of ``deterrence, both specific and general, as a 
component in analyzing the remedial efficacy of sanctions'').\18\
---------------------------------------------------------------------------

    \18\ Thus, in Gaudio, ``I explained that `even when a proceeding 
serves a remedial purpose, an administrative agency can properly 
consider the need to deter others from engaging in similar acts.' '' 
74 FR at 10094 (quoting Southwood, 72 FR at 36504) (citing Butz v. 
Glover Livestock Commission Co., Inc., 411 U.S. 182, 187-88 (1973)); 
cf. McCarthy, 406 F.3d at 189 (``Although general deterrence is not, 
by itself, sufficient justification for expulsion or suspension, we 
recognize that it may be considered as part of the overall remedial 
inquiry.''); Paz Securities, Inc., et al. v. SEC, 494 F.3d 1059, 
1066 (D.C. Cir. 2007) (agreeing with McCarthy). In Gaudio, I further 
noted that the ``[c]onsideration of the deterrent effect of a 
potential sanction is supported by the CSA's purpose of protecting 
the public interest, see 21 U.S.C. 801, and the broad grant of 
authority conveyed in the statutory text, which authorizes the 
[suspension or] revocation of a registration when a registrant `has 
committed such acts as would render [his] registration . . . 
inconsistent with the public interest,' id. Sec.  824(a)(4), and 
[which] specifically directs the Attorney General to consider [`such 
other conduct which may threaten public health and safety,' id. 
Sec.  823(f)].'' 74 FR at 10094 (quoting Southwood, 72 FR at 36504).
    Unlike factors two (``[t]he applicant's experience in 
dispensing'') and three (``[t]he applicant's conviction record''), 
neither factor four (``Compliance with applicable laws related to 
controlled substances'') nor factor five (``Such other conduct which 
may threaten public health and safety'') contain the limiting words 
of ``[t]he applicant.'' As the Supreme Court has held, ``[w]here 
Congress includes particular language in one section of a statute 
but omits it in another section of the same Act, it is generally 
presumed that Congress acts intentionally and purposely in the 
disparate inclusion or exclusion.'' Russello v. United States, 464 
U.S. 16, 23 (1983). Thus, the text of factors four and five suggest 
that these factors are not limited to assessing the specific 
practitioner's compliance with applicable laws and whether she has 
engaged in ``such other conduct'' (such as giving false testimony), 
but rather, authorizes the Agency to also consider the effect of a 
sanction on inducing compliance with federal law by other 
practitioners.
---------------------------------------------------------------------------

    In his decision, the ALJ acknowledged that Respondent produced some 
evidence of remedial measures she has undertaken. R.D. at 68. More 
specifically, the evidence shows that Respondent completed a four-day 
course in controlled substance management and a two-day course in 
medical record keeping. RXs F & I.
    However, based on Respondent's testimony, the ALJ also found that 
``it is far from clear that the courses have brought about changes in 
[her] that would support continued DEA registration.'' R.D. at 68. As 
the ALJ explained, ``[e]ven now, Respondent would attribute her action 
to being victimized by . . . SC's conduct, while averring that she 
believed, at the time, that her prescription practice was compliant 
with DEA regulations.'' Id. The ALJ thus concluded that ``Respondent 
has [not] admitted to the full extent of her . . . misconduct.'' Id.
    Respondent takes exception to the ALJ's conclusion that she has 
failed to accept responsibility for her misconduct, contending that 
this ``is contradicted by the facts in the record.'' Exceptions, at 2. 
Respondent argues that she ``readily admitted to losing the physician-
patient relationship when treating S.C.'' and that she ``also admitted 
that she violated Florida law and standards of practice when she 
treated S.C. without creating a medical record, [a] written treatment 
plan, etc.'' Id. at 3-4.
    It is acknowledged that at various points in her testimony, 
Respondent admitted to several professional failings. For example, she 
admitted that it was her error to accept S.C.'s word rather than call 
his prior physician. She also testified that she ``lost the physician/
patient relationship'' and ``was not objective.'' Still later, she 
testified that ``[i]n hindsight . . . my judgment was impaired because 
of the relationship I had with the individual'' and that the 
prescriptions ``were not within . . . the standards of my medical 
practice.'' And she also admitted that she violated Florida's 
regulations by failing to ``keep proper documentation.''
    While this testimony would have supported a finding that Respondent 
has accepted responsibility for her misconduct, at other points, she 
offered testimony that substantially undermines this conclusion. 
Notwithstanding her earlier admission that she lost the doctor/patient 
relationship (not that she ever had one outside of S.C.'s ER visit), 
she then testified that ``I was definitely manipulated and taken 
advantage of. I was victimized.'' Tr. 350. Respondent's statement is 
simply irreconcilable with the obligations imposed on a physician who 
is entrusted with the authority to prescribe controlled substances.
    So too, notwithstanding her testimony that the prescriptions ``were 
not within . . . the standards of my medical practice'' and her having 
taken a course in controlled substance management, Respondent testified 
that she still believes she issued the prescriptions for a legitimate 
medical purpose. Tr. 277. Still later in her testimony--and after 
maintaining that she was victimized by S.C.--she again testified that 
knowing what she knows today, she still believes that the prescriptions 
were medically necessary. Id. at 277-78.
    In short, this suggests that Respondent has learned nothing from 
the various state board proceedings, the course she took in controlled 
substance management, or this Proceeding. Accordingly, I have no 
confidence that she will refrain from similar acts were she to become 
love struck with a drug abuser or diverter in the future. Her equivocal 
testimony provides substantial evidence to support a finding that she 
does not accept responsibility for her misconduct.
    As explained above, notwithstanding her contention that her 
prescribing to S.C. is an aberration, I find that her misconduct was 
egregious. Moreover, as found above, Respondent lacked candor in her 
testimony. Accordingly, I conclude that denial of her application is 
necessary to protect the public interest.

Order

    Pursuant to the authority vested in me by 21 U.S. C. 823(f), as 
well as 28 CFR 0.100(b), I order that the application of Annicol 
Marrocco, M.D., for a DEA Certificate of Registration as a practitioner 
be, and it hereby is, denied. This Order is effective June 18, 2015.

    Dated: May 4, 2015.
Michele M. Leonhart,
Administrator.
[FR Doc. 2015-12035 Filed 5-18-15; 8:45 am]
 BILLING CODE 4410-09-P