[Federal Register Volume 79, Number 222 (Tuesday, November 18, 2014)]
[Notices]
[Pages 68701-68710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27206]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Richard D. Vitalis, D.O.; Decision and Order

    On August 12, 2013, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Richard D. Vitalis, D.O. (Applicant), of Debary, Florida. 
GX 1. The Show Cause Order proposed the denial of Applicant's 
application for a DEA Certificate of Registration on the ground that 
his continued ``registration would be inconsistent with the public 
interest.'' Id. at 2 (citing 21 U.S.C. 823(f)).
    The Show Cause Order made numerous allegations against Applicant. 
First, it stated that on October 1, 2008, the Florida Department of 
Health (DOH) entered an emergency suspension of Applicant's medical 
license on the basis of his history of alcohol dependency and his 
failure to comply with DOH orders requiring the monitoring of his 
medical practice. Id. The Order then specifically alleged that after 
reinstatement of his Florida medical license on March 26, 2009, 
Applicant materially falsified three applications for a DEA 
registration when he falsely answered ``no'' on each application to the 
liability question which asks: ``Has the applicant ever surrendered 
(for cause) or had a state professional license or controlled 
substances registration revoked, suspended, denied, restricted or place 
on probation?'' Id. at 2-3 (citing 21 U.S.C. 843(a)(4)(A)). The Order 
alleged that Applicant submitted these applications on October 5, 2009; 
May 22, 2012; and January 7, 2013. Id.
    The Show Cause Order also alleged that on October 6, 2009, 
Applicant became registered as a practitioner to handle schedule II 
controlled substances under DEA registration number FV1682269, at the 
registered address of 230 Caddie Court, Debary, Florida. The Order then 
alleged that between July 2010 and June 3, 2011, Applicant ``issued 
and/or authorized prescriptions for controlled substances in Schedules 
2N, 3, 3N, 4 and 5, for which [he] did not have the authority to 
handle, in violation of 21 U.S.C. 822(b).'' Id. at 3. The Show Cause 
Order also alleged that on June 3, 2011, Applicant's registration was 
modified to add all schedules. Id.
    Next, the Show Cause Order alleged that between July 7, 2011 and 
March 22, 2012, three law enforcement officers made six undercover 
visits to Applicant at All Family Medical (hereinafter, AFM), a state-
registered pain management clinic. Id. The Order then alleged that at 
the conclusion of each visit, Applicant prescribed Schedule II and IV 
controlled substances, including oxycodone and Xanax, to the undercover 
officers, for other than a legitimate medical purpose and outside the 
usual course of professional practice in violation of applicable 
federal, state and local law. Id. at 3-4 (citing 21 CFR 1306.04(a)).
    The Show Cause Order further alleged that a medical expert reviewed 
the undercover visits and determined that Applicant prescribed 
unnecessary and excessive doses of controlled substances to the 
undercover officers, in deviation from the standard of care in pain 
medicine. Id. at 4-5. The Order alleged that the Expert further found 
that Applicant failed to comply with Florida's standards for the use of 
controlled substances for the treatment of pain, and that the 
prescriptions were issued for other than a legitimate medical purpose 
and outside the usual scope of professional practice. Id. at 5 (citing 
Fla. Stat. Sec.  456.44; Fla. Admin. Code r.64B15-14.005; 21 CFR 
1306.04(a)).
    Finally, the Show Cause Order alleged that on January 1, 2012, 
D.V., a 34-year old male died as a result of an accidental overdose of 
controlled substances. Id. The Order then alleged that on December 27, 
2011, Applicant issued prescriptions to D.V. for 180 tablets of 
oxycodone 30mg, 120 tablets of oxycodone 15mg, 40 tablets Percocet 10/
325 mg, 60 tablets of alprazolam 2mg, and 90 tablets of Motrin 800mg, 
and that the prescriptions ``were for other than a legitimate medical 
purpose and outside the usual scope of professional practice.'' Id. 
(citing 21 CFR 1306.04(a)).
    The Show Cause Order, which also notified Applicant of his right to 
request a hearing on the allegations or to submit a written statement 
in lieu of a hearing, the procedure for electing either option, and the 
consequence of failing to elect

[[Page 68702]]

either option, was served on Applicant by certified mail addressed to 
him at his proposed registered address. As evidenced by the signed 
return-receipt card, service was accomplished on August 27, 2013.
    Since that date, more than thirty days have now passed and neither 
Applicant, nor anyone purporting to represent him, has requested a 
hearing or submitted a written statement in lieu of a hearing. 
Accordingly, I find that Applicant has waived his right to a hearing or 
to submit a written statement on the allegations of the Show Cause 
Order. 21 CFR 1301.43(c) & (d). I therefore issue this Decision and 
Order based on the investigative record submitted by the Government and 
make the following findings of fact.

 Findings

Applicant's Licensure and Registration Status

    Applicant is an osteopathic physician licensed by the Florida DOH. 
On October 1, 2008, the DOH ordered the emergency suspension of his 
medical license, on the ground that Applicant had been diagnosed with 
alcohol dependency and that absent monitoring by the Professional 
Resource Network, his continued practice of osteopathic medicine 
constituted an immediate and serious danger to the health, safety and 
welfare of the public. GX 10, at 9-10. However, on March 26, 2009, the 
DOH reinstated his Florida medical license. Government Request for 
Final Agency Action (Gov. Request), at 2.
    During this period, Applicant held a DEA practitioner's 
registration, pursuant to which he was authorized to dispense 
controlled substances in schedules II though V. GX 4. However, on May 
31, 2009, Applicant allowed his registration to expire and the number 
was subsequently retired by the Agency. Id. at 2.
    On October 5, 2009, Applicant applied for a new DEA practitioner's 
registration at an address in Debary, Florida. On the application, 
Applicant sought authority to dispense schedule II narcotics and no 
other controlled substances. GX 4, at 7. Applicant was also required to 
answer four questions, including Question Three which asked: ``Has the 
applicant ever surrendered (for cause) or had a state professional 
license or controlled substances registration revoked, suspended, 
denied, restricted, or placed on probation, or is any such action 
pending?'' GX 4, at 11. Applicant answered ``no.'' Id. The following 
day, DEA issued Applicant a new registration which was limited to 
schedule II. Id. at 7. Applicant did not submit a request to add the 
additional drug schedules until June 6, 2011. GX 8, at 3.
    On December 2, 2010, Applicant requested a change in his registered 
address to ``The Center for Wellness and Weight Loss D/B/A All Family 
Medical,'' a pain management clinic located in North Lauderdale, 
Florida. GX 4, at 7; GX 8, at 2 (DI Declaration). Applicant's request 
was approved. GX 4, at 7; GX 8, at 2.
    On May 22, 2012, Applicant submitted a renewal application for his 
registration. Id. at 3. Once again, he provided a ``no'' answer to 
Question Three. GX 4, at 8; see also GX 8, at 3. The next day, DEA 
Agents and Task Force Officers (who had previously conducted undercover 
operations), along with members of the Broward County Sheriff's Office, 
executed a federal search warrant at AFM. GX 8, at 3.
    On July 27, 2012, an Order to Show Cause and Immediate Suspension 
Order was personally served on Applicant. Id. While Applicant filed a 
timely hearing request, prior to the hearing date, Applicant's counsel 
advised the Government that he would submit a voluntary surrender in 
lieu of a hearing. Id. at 4. On December 20, 2012, the Miami Field 
Office received a letter which voluntarily surrendered Applicant's 
registration and his registration was subsequently retired from the DEA 
registration system. Id.; see also GX 4, at 7.
    On January 4, 2013, Applicant again applied for a registration as a 
practitioner in Schedules II-V, at the address of 230 Caddie Court, 
Debary, Florida, 32713. GX 4, at 1. Question Two asked: ``Has the 
applicant ever surrendered (for cause) or had a federal controlled 
substance registration revoked, suspended, restricted or denied, or is 
any such action pending?'' Id. at 4. Applicant answered ``Yes.'' Id. 
However, in response to Question Three, Applicant again answered 
``No.'' Id.

The DEA Investigation

    Between July 7, 2011 and March 22, 2012, three law enforcement 
officers, acting in an undercover capacity, made a total of six visits 
to AFM.\1\ GX 11, GX 24, GX 30. The Officers were able to see Applicant 
five times and were successful at obtaining controlled substance 
prescriptions at each of these visits.
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    \1\ This location is also known by an alternate address, 995 
Rock Island Rd, North Lauderdale, FL 33068 as referenced by the UCs 
in their declarations. See GXs 11, 24, 30.
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    DEA Task Force Officer M.C., using an undercover name with the same 
initials, visited AFM on July 7, 2011; August 11, 2011; and September 
8, 2011. Declaration of M.C., at 2.
    On each visit, he was equipped with a device which recorded his 
interactions with Applicant. The evidence includes the audio 
recordings, as well as a transcribed record of the portion of the visit 
during which M.C. met with Applicant. GX 12, 13, 15, 16, 18, 19.
    During his first visit, M.C. filled out a pain management 
questionnaire and rated his average pain at a 5 on a scale from 1 to 
10, with 10 being ``pain as bad as you can imagine.'' GX 5, at 43. He 
underwent a urine screening, which showed that he had no controlled 
substances in him. GX 11, at 2. At some point unspecified in the 
record, his weight, blood pressure and pulse were recorded on an 
``Intake Form''; this form also stated that his CC (chief complaint) 
was ``chronic LBP'' and ``shoulder pain.'' GX 5, at 38. Handwritten 
notes under the Examination and Symptoms Findings are largely 
undecipherable. Id.
    The patient record also includes a form, which is appropriately 
mistitled as: ``Medical Justifiction (sic) Form for Prescribing More 
Than a 72 Hour Dose of Controlled Substance for the Treatment of Non-
Malignant Pain'' \2\; this form was signed by Applicant and dated July 
7, 2011. On the form, Applicant checked the box next to the section 
which reads:
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    \2\ This form states that: ``Pursuant to Florida Code Section 
458.32654(2)(c) a physician who prescribes more than a 72 hour dose 
of a controlled substance must document in the patient's record the 
reason for prescribing that quantity. If it is found by the 
applicable regulatory agencies that this clinic qualifies as a pain 
clinic under such Florida Statute, I hereby document the following 
medical justification for prescribing the amounts prescribed to this 
patient.'' GX 5, at 19.

    I have performed an adequate physical examination of this 
patient this same day utilizing the standard of practice required by 
the Florida Board of Medicine for physicians practicing in a pain 
management clinic, and I find that his/her medical condition 
justifies the use of this medication to treat such condition.\3\
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    \3\ An identical form is found in the medical file for each 
visit made by the undercovers, each indicating that ``an adequate 
physical exam had been performed utilizing the standards of practice 
required by the Florida Board of Medicine.'' Each form contains 
brief, illegible handwritten notes.

GX 5, at 19. Directly below this statement is a place for comments, 
which appear to be in Applicant's handwriting, but which are illegible. 
Id.
    M.C.'s file also includes a form, entitled ``Pain Management 
Treatment Plan Medical Record'' (Treatment Plan), which appears to 
track the various

[[Page 68703]]

components of the guidelines \4\ adopted by the Florida Board of 
Osteopathic Medicine as part of its regulations entitled ``Standards 
for the Use of Controlled Substances for Treatment of Pain.'' See Fla. 
Admin. R.64B15-14.005. Several of the form's sections list various line 
items with either a place to check ``yes'' or ``no'' or to check 
applicable boxes; in addition, several sections have a place for the 
physician to write notes. See GX 5, at 15-18.
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    \4\ The form contains sections with such headings as ``Patient 
Evaluation/Assessment,'' ``Medical Diagnosis,'' ``Objectives of 
Treatment Used to Determine Treatment Success,'' ``Recommended Non-
Medication Treatment Modalities,'' ``Risks and Benefits,'' 
``Periodic Review,'' ``Patient Drug Testing Completed'' and 
``Compliance With Controlled Substance Laws.''
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    With respect to the first section of this form, which pertains to 
the patient evaluation, the form indicates that a pain survey was 
completed. Id. at 15. While this portion of the form contains places to 
indicate whether therapeutic goals were discussed, whether a functional 
assessment was performed, whether social and drug use histories were 
taken, whether a medication use assessment was done and whether prior 
records were reviewed, Applicant checked neither the yes nor the no 
line and the corresponding notes section contains two indecipherable 
words. Id. So too, the medical diagnosis section appears to simply 
state ``as above.'' Id.
    As for the treatment objectives, check marks are placed next to 
entries for ``improvement of pain without complete resolution,'' 
``ability to return to some sort of employment,'' and ``return to 
certain level of physical activity,'' but no further notes were made. 
Id. at 16. As for non-medication treatments, which lists ten different 
modalities, the word ``cold'' is circled but none of the boxes are 
checked. Id. Applicant checked ``yes'' to indicate that he had 
discussed the risks and benefits of controlled substances with M.C. Id. 
at 17. He also indicated that drug testing had been completed, but left 
blank the results. Id at 18. Yet other evidence in M.C.'s record shows 
that his urine drug screen was negative.\5\ Id. at 40.
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    \5\ Applicant also checked ``no,'' indicating that he did not 
recommend that M.C. consult with a specialist or undergo additional 
evaluations or tests. Yet he made another indecipherable note in the 
section for listing additional evaluations and tests.
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    The audio recording of the initial office visit reveals Applicant 
greeted M.C. and stated, ``I understand you've been having some low 
back pain,'' to which M.C. replied: ``yeah low back pain and, like, my 
shoulder's bugging me too.'' GX 12; GX 13, at 1. M.C. told Applicant he 
did not have an MRI of his shoulder because it was an additional charge 
to the MRI for his back. GX 13, at 1.
    M.C. told Applicant that he controlled his pain by taking 
oxycodone, and that ``it's really the only thing that's helped. I've 
done . . . Advil and Tylenol, but it doesn't really help me.'' Id. 
Applicant stated ``so it's partially controlled with those, but you get 
much better pain relief when you take Roxicodone.'' Id. He then asked 
if M.C. had ``taken anything else, like hydrocodone,'' to which M.C. 
replied: ``No. Just the blue thirties (30's).'' Id.
    Applicant then asked M.C. what was wrong with his shoulder. M.C. 
replied: ``it's just more sore. Cause right after I play it will be 
sore for a couple days and . . . it kinda goes away.'' Id. Next, 
Applicant asked M.C. whether he had undergone surgeries; whether he 
used tobacco, alcohol and either illegal or illicit drugs; and if there 
was a family history of various diseases. Id. Applicant then listened 
to M.C.'s breathing with a stethoscope.
    After asking about M.C.'s work, Applicant stated he had ordered 
Roxicodone and Ibuprofen to help control his pain. Id. at 3. He then 
asked M.C., ``what, other than pain medication, seems to help with your 
pain; heat, cold or relaxation?'' Id. M.C. replied ``a little cold.'' 
Id. Applicant then repeated that he was going to prescribe Motrin and 
Roxicodone and told M.C. he wanted to see him back in about one month. 
Id. The visit ended, with M.C. receiving a prescription for 90 Motrin 
800mg and 150 Roxicodone 30mg. GX 14; see also GX 11, at 3.
    On August 11, 2011, M.C. returned to AFM. Upon meeting, Applicant 
asked M.C. ``[h]ow are you doing?'' to which M.C. replied ``[g]ood.'' 
GX 16, at 1. Applicant then asked M.C. if he was ``getting pain relief 
with [his] current medications'' and if he was ``tolerating [his] 
medications well''; M.C. replied ``yes'' to both questions. Id.; see 
also GX 15. After a silence which lasted approximately 3 minutes, GX 
15, Applicant stated, ``Alright Michael . . . I re-ordered your Motrin 
and Roxicodone for you . . . and see you back in about one (1) month.'' 
GX 16, at 1.
    Following another brief silence, M.C. asked: ``Do you want me to 
stand up?'' Applicant replied, ``[y]ou're fine. Take some deep 
breaths.'' Id. Applicant then told M.C., ``[s]ee you in about one (1) 
month,'' and the visit ended. Id. at 2. The total length of the visit 
was approximately 5 minutes, GX 15, and Applicant issued M.C. 
prescriptions for 150 Roxicodone 30mg and 90 Motrin 800mg. GX 17. A 
note for the visit lists M.C.'s weight, blood pressure, and pulse 
(although it is unclear if these were ever taken), and also includes 
Applicant's notes, which are largely indecipherable, but state that 
``pt states good pain relief with current meds'' and ``tolerates meds 
well.'' GX 5, at 35. Id.
    On September 8, 2011, M.C. made a third visit to AFM. GX 19; GX 5, 
at 32. M.C. filled out a Daily Pain Summary Form, on which he stated 
that he had pain on that day, that it was on average a three out of 
ten, and that he had ``experienced unrelieved breakthrough pain'' on 
three occasions on that date. GX 5, at 8.
    During this appointment, Applicant asked M.C. if he was ``getting 
good relief with [his] current medications?'' GX 18; GX 19, at 1. M.C. 
answered ``[y]es,'' but added: ``I'm having a little trouble sleeping 
some nights . . . I didn't know if I can get any Xanax . . . Just a 
couple Xanax . . . I've taken it before and it helped.'' GX 19, at 1. 
Applicant replied, ``[s]o you're having some insomnia''; M.C. stated, 
``[y]eah, not too bad, but sometimes.'' Id.
    After placing his stethoscope on M.C.'s back and listening to him 
breathe, Applicant told M.C. that he had ``renewed'' both his 
Roxicodone and Motrin and added that he wanted to see M.C. ``back in 
about one (1) month.'' Id. The visit then concluded. Id. at 2. While 
the visit lasted approximately nine minutes, the recordings establish 
that M.C. and Applicant exchanged very little dialog other than that 
which is quoted above. In fact, after Applicant said to M.C., ``breathe 
normal'' and ``sounds good'' (apparently while listening with his 
stethoscope), approximately four and one-half minutes passed without 
further dialogue until Applicant told M.C. that he had ``renewed [his] 
Roxicodone.'' Id., see also GX 18 (audio recording.) Applicant again 
issued M.C. prescriptions for 150 Roxicodone 30mg and 90 Motrin 800mg. 
GX 20.
    On October 11, 2011, M.C. made a fourth visit to AFM. GX 5, at 3. 
After Applicant greeted M.C. and made an unintelligible comment, M.C. 
stated: ``[y]eah, I asked you for them last time . . . I don't know if 
you forgot, but, you said you would, but I didn't get the script for 
them,'' apparently referring to the Xanax he had sought at his previous 
visit.\6\ GX 22, at 1.
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    \6\ The patient record includes an undated, unsigned handwritten 
note stating: ``pt said you were going to write some Xanax but 
forgot.'' GX 5, at 1.
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    The following exchange then ensued:


[[Page 68704]]


    Applicant: ``I think I said I wanted you to try and go without 
them.'' \7\
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    \7\ There is, however, no evidence that Applicant ever made this 
Statement to M.C. during his September 8, 2011 visit. See GX 19, at 
1-2; see also GX 18.
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    M.C.: ``Oh, OK.''
    Applicant: ``I will go ahead and prescribe them for you this 
time.''
    M.C.: ``OK.''
    Applicant: ``Did you do ok when you didn't have them?''
    M.C.: ``Um, I had taken them before and I did better with them 
when I was taking them. . . . And also, I work in a warehouse, and I 
know the holidays are coming up. So, it's a lot of heavy lifting. I 
didn't know if I could get a couple more of the Oxy's . . . You gave 
me one hundred and fifty (150) last time . . . I didn't know if you 
could bump it up to, like, one hundred eighty (180) maybe, if that's 
possible.''
    Applicant: ``I'll see what I can do.''

Id.

    Next, Applicant asked M.C. if he was ``doing well,'' with M.C. 
answering ``yes.'' Id. at 2. M.C. then asked if Applicant wanted him 
``to stand up.'' Id. Applicant said ``you're fine,'' asked M.C. to 
``take some deep breaths,'' and said ``sounds good.'' Id. Approximately 
four minutes of silence followed (see GX 21), after which Applicant 
told M.C. that he had ``renewed [his] scripts,'' as well as given him 
``Xanax for the sleep'' and needed to see him ``back in about a 
month.'' GX 22, at 2. The total length of the visit was approximately 
eight minutes and Applicant issued M.C. prescriptions for 160 
Roxicodone 15mg, 150 Roxicodone 30mg, 60 Xanax 2mg, and Motrin. GX 5, 
at 28.
    On July 7, 2011, a second Special Agent (B.O.), made an undercover 
visit to AFM. GX 24, at 2; GX 26, at 1 (transcript). B.O. provided 
paperwork and an MRI to the clerk as a walk-in patient, and returned to 
AFM later in the day for his appointment. GX 26, at 1-3. He provided a 
urine sample, which tested negative for controlled substances. GX 24, 
at 2. He also completed a Pain Survey on which he reported that in the 
last 24 hours, his pain (on a zero to ten scale) was a five (5) at its 
worst, a two (2) at its least, and averaged a three (3). GX 6, at 35.
    The form also asked the patient to rate the extent to which the 
pain interfered with various things, such as general activities, work, 
and sleep, with zero being no interference and ten being complete 
interference. B.O. circled three (3) for both his general activity and 
work, and five (5) for sleep. Id. at 36. He also wrote that he had 
taken non-prescription Motrin which had no effect on his pain. Id. at 
37. Another form included in the patient file, signed by B.O. on July 
7, 2011, included an oath that he ``had not been prescribed narcotic 
pain medication within the last 30 days, or from another physician, 
since my last visit to this clinic.'' Id. at 15.
    Thereafter, B.O. was seen by Applicant, but the recording device 
malfunctioned and depicts only about two minutes of their interaction, 
during which Applicant was sitting at his desk and asked B.O. what type 
of work he did and how many hours a week he worked before ending. GX 
26, at 5-6; GX 25. However, the Special Agent submitted a sworn 
declaration stating that he told Applicant he was experiencing back 
problems due to work, and that he had taken oxycodone from a friend 
which relieved the pain. GX 24, at 2. The Special Agent further stated 
that following this, Applicant ``placed a stethoscope on my back and 
printed prescriptions for 180 tablets of oxycodone 30mg and 90 tablets 
of Motrin 800mg.'' Id.; see also GX 27.
    B.O.'s patient file includes an intake form which purports to 
document his chief complaint, his symptoms, and exam findings. GX 6, at 
27. Again, most of the handwritten notes for the exam findings are 
illegible. The Pain Management Treatment Plan form notes a diagnosis of 
``chronic lbp''; it also includes the words ``work out, stretching, 
chiropractic'' in the notes section under objectives of treatment. Id. 
at 6-7. In addition, the ``yes'' box is checked indicating that a pain 
survey was done, that the risks and benefits were discussed, that a 
follow-up appointment was scheduled and that a drug test was done; the 
``no'' box is checked indicating that specialist consultations or 
additional tests were not being scheduled. Id. at 6-9. However, the 
rest of the form is blank. Id.
    On August 4, 2011, B.O. returned to AFM. GX 29; see also GX 24, at 
2. During the visit he was required to submit a urine sample, which 
registered negative for controlled substances. GX 29, at 2. He was then 
informed by the office clerk that he was dismissed from the practice. 
Id. at 3; see also GX 6, at 1-2.
    On March 22, 2012, a local sheriff's deputy, using an alias with 
the initials T.B., went to AFM. GX 30, at 1. T.B. was initially told by 
the office staff that his MRI was too old because it was over two years 
old; he then obtained a new MRI for his neck and returned to AFM that 
same day. Id.; see also GX 31 (audiovisual recording).
    T.B. completed two forms regarding his pain, a Daily Pain Summary 
and a Pain Management Questionnaire. On the former, he placed an x on 
his upper back to indicate the area where he had pain. GX 7, at 2. On 
the latter, he noted that in the last twenty-four hours, his pain was a 
four (4) at its worst, a three (3) at its least, and on average a three 
(3). GX 7, at 20. He also wrote that the onset of his pain was in 2005, 
and that ``oxycodone--helps.'' Id. at 22.
    While the audio-video recording of T.B.'s visit depicts his 
interactions with the office staff regarding his MRI and his urine 
sample (which was negative for controlled substances), the recording in 
the evidentiary record ends before T.B. actually met with Applicant.\8\ 
See generally GX 31. However, the undercover officer submitted a 
declaration summarizing his visit with Applicant. Therein, the Officer 
stated that Applicant said to him, `` `I understand you are having some 
chronic low back pain,' despite the MRI I provided of my neck.'' GX 30, 
at 2. The Officer further stated that Applicant then asked if he ``had 
any success with pain relief in the past''; the Officer ``told 
[Applicant] that [he had] taken oxycodone, and that worked.'' Id. 
According to the Officer, Applicant ``then placed a stethoscope on 
[his] chest and back,'' after which Applicant wrote him prescriptions 
for 120 Roxicodone 15mg, 180 Roxicodone 30mg, as well as Motrin. Id., 
see also GX 33.
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    \8\ The record also contains an exhibit which purports to be a 
transcript of the meeting between TB and Applicant. The record, 
however, contains no statement establishing that the transcript is 
reliable and accurate.
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    T.B.'s patient file includes both an intake form and a pain 
management treatment plan. While the first form includes entries for 
T.B.'s chief complaint and ``examination and symptom findings,'' here 
again, most of the entries are illegible. GX 7, at 15. As for the 
second form, it contains a ``yes'' checkmark next to the entries 
indicating that a pain survey was taken, that non-medication treatment 
of heat/cold was recommended, that risks and benefits were discussed, 
that a patient drug test was completed, and a ``no'' checkmark 
indicating that neither specialist consultations nor additional 
evaluations or tests were recommended; there are also two two-word long 
handwritten notes under the medical diagnosis and dates of appointment 
which are illegible. Id. at 3-6. However, nearly every other line and 
entry is blank. Id.
    The record also includes the medical file of D.V., a thirty-four 
year old male, who was under Applicant's care for approximately 
thirteen months. On January 1, 2012, D.V., who had received several 
controlled substance prescriptions from Applicant only days

[[Page 68705]]

before, died of ``acute combined drug toxicity.'' See generally GX 37 
(Patient File), GX 38 (Medical Examiner's Cause of Death Report), GX 39 
(Autopsy).
    D.V.'s patient file included medical records from his initial visit 
in June 2010 to AFM (then called the ``Center for Wellness and Weight 
Loss'') through his final visit on December 27, 2012. GX 37. D.V. was 
initially seen by a different physician who recorded ``low back pain 
and left lower extremity radiculopathy'' as D.V.'s chief complaint. GX 
37, at 113. His patient file included two MRI reports from March 2006, 
and a prescription record from Holiday CVS dated January 2010 through 
June 14, 2010. Id. at 115-121.
    D.V. first saw Applicant on November 9, 2010. Id. at 102. According 
to the records for this date, Applicant issued D.V. prescriptions for 
210 Roxicodone 30mg, 90 Roxicodone 15mg, and 30 Xanax 2mg.\9\ Id. at 
103. While most of the notes on the intake form for the visit are 
illegible, the notes state that D.V.'s ``CC'' (chief complaint) was 
``chronic LBP'' (chronic lower back pain). Under ``Examination and 
Symptom Findings,'' the notes list D.V.'s weight as ``265 lbs'' and 
blood pressure as ``162/90.'' The findings further state: ``he also 
notes good pain relief with current meds . . . overall feels well.'' 
Id. at 102.
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    \9\ The record does not include copies of DV's actual 
prescriptions, but does contain Discharge Summaries which correspond 
to office visit records and list medications prescribed by 
Applicant.
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    On December 8, 2010, D.V. again saw Applicant as a follow-up for 
``chronic LBP.'' Id. at 99. The Intake Form notes which are legible 
read: ``overall feels well . . . tolerating pain meds'' and ``Back full 
ROM [symbol] tenderness. . . .'' Id. Applicant wrote that the treatment 
plan was to ``continue meds,'' which were listed as 210 Roxicodone 
30mg, 80 Roxicodone 15mg and 80 Xanax 2mg. GX 37, at 100. However, the 
file does not contain copies of the prescriptions or a discharge 
summary for this visit. Id.
    On December 28, 2010, D.V. again saw Applicant, who documented a 
diagnosis of chronic LBP and anxiety. GX 37, at 98. The physician's 
handwritten notes state: ``Overall feels well . . . good pain relief 
with current meds . . . does report running out of 15mg Roxicodone.'' 
Id. The notes also list D.V.'s weight at ``278 lbs'' and blood pressure 
as ``180/116.'' Id. The Discharge Summary lists the prescriptions 
issued that date as 210 Roxicodone 30mg, 120 Roxicodone 15mg, 90 Xanax 
2mg, and Motrin. Id. at 97.
    D.V. returned to AFM on a monthly basis for his ``chronic LBP'' 
throughout 2011. Id. at 49-96. Throughout this period, Applicant 
repeatedly issued D.V. prescriptions on a monthly basis providing 210 
Roxicodone 30mg, 90 or 120 Roxicodone 15mg, and 60 or 90 Xanax 2mg. 
Also, on multiple dates, Applicant provided additional prescriptions or 
early refills.
    For example, on August 30, 2011, Applicant issued D.V. 
prescriptions for 210 Roxicodone 30mg, 120 Roxicodone 15mg, and 60 
Xanax 2mg. Id. at 69. Yet on September 6, Applicant wrote D.V. a script 
for an additional 180 Roxicodone 30mg, followed by a script on 
September 13 for 180 Percocet 10/325, a schedule II drug combining 
oxycodone and acetaminophen. Id. at 67-68. Yet only three days later, 
Applicant issued D.V. a further script for 180 Roxicodone 30mg. Id. at 
66.
    Indeed, during the 63-day period between D.V.'s August 30, 2011 
visit and his next appointment on November 1, 2011, the record shows 
that Applicant issued D.V. prescriptions totaling 738 tablets of 
Roxicodone 30mg, 390 tablets of Roxicodone 15mg, 300 Percocet 10/325 
mg, and 180 Xanax 2mg. Id. at 62-69. Per Applicant's dosing instruction 
of one Roxicodone 30mg tablet every 4-6 hours, even if D.V. took one 
tablet every 4 hours, he still would have used only 378 tablets in that 
63 day period, leaving 360 tablets unaccounted for. As for the Xanax, 
based on the dosing instruction of one tablet every twelve hours, D.V. 
would have had 60 tablets remaining. Yet, at D.V.'s November 1st visit, 
Applicant provided him with prescriptions for 180 Roxicodone 30mg, 120 
Roxicodone 15mg, 60 Percocet 10/325, and 60 Xanax. Id. at 59.
    Regarding Applicant's prescribing to D.V. during this period, the 
Government's Expert found that ``[t]here is no documentation in the 
history as to why the additional prescriptions had been provided to the 
patient between that visit of 11/01/2011 and the previous visit of 8/
30/2011.'' GX 35, at 12. There is, however, a Sheriff's Office Event 
Report which establishes that on September 30th, D.V. was a passenger 
in a car which was followed by the Sheriff's Office as it left 
Applicant's clinic and was stopped after its driver ran a stop sign. GX 
37, at 9. During the traffic stop, the Officers learned that D.V. was 
on probation; D.V. consented to a search of his person, during which 
the Officers found a clear orange pill bottle which contained twenty-
seven tablets of oxycodone 30mg; the vial's label was partially torn 
off and the remaining information ``was unreadable.'' Id. The Officers 
also seized D.V.'s prescriptions for oxycodone 15mg, alprazolam 2mg, 
and Motrin. Id. D.V. ``was released and given a case number for the 
pills and prescriptions.'' Id.
    There is also a one-page document in the file, which is titled: 
``[D.V.] Medication Report.'' Id. at 6. The document lists the dates of 
the various oxycodone prescriptions Applicant wrote between August 2 
and October 6 and contains various notations as to why several of the 
prescriptions were issued. Id. For example, the document states that 
D.V. could not fill the August 30 prescription for 210 oxycodone 30mg 
and that he turned in the prescription, thus suggesting the reason why 
Applicant issued him a prescription for 180 oxycodone 30mg on September 
6. Id. Yet the document also includes a notation that the reason 
Applicant issued D.V. a prescription for 120 oxycodone 15mg on 
September 29 was because the police had taken D.V.'s prescription 
(dated September 27) for 138 oxycodone 30mg. Id. The reliable evidence 
shows, however, that the police did not take this prescription but 
rather the September 29 prescription for 120 oxycodone 15mg. Id. 
Moreover, the handwriting is markedly more legible than that on the 
various intake forms, thus suggesting that Applicant did not create the 
document.
    On November 29, D.V. again saw Applicant, who noted on the Intake 
Form: ``pt reports good pain relief with current meds . . . tolerates 
meds well overall feels well . . . Back full ROM.'' Id. at 57. 
According to a Discharge Summary, which was printed at 12:16 p.m., 
Applicant prescribed 180 Roxicodone 30mg, 120 Roxicodone 15mg, 60 Xanax 
2mg, and Motrin.\10\ GX 37, at 56.
---------------------------------------------------------------------------

    \10\ The file contain a second discharge summary for the same 
date which was printed at 3:08:57 p.m., and which documents that 
Applicant issued DV prescriptions for 180 Roxicodone 30mg, 120 
Percocet 10/325mg, 60 Xanax 2mg, and Motrin. It is unclear, however, 
whether these were additional prescriptions beyond those listed in 
the first discharge summary. GX 37, at 54.
---------------------------------------------------------------------------

    On December 9, 2011, Applicant issued D.V. a prescription for 100 
tablets of Roxicodone 15mg. Id. at 55. There are, however, no notes in 
D.V.'s file bearing this date.\11\
---------------------------------------------------------------------------

    \11\ An undated, unsigned handwritten note in the file states 
``trade in 50 30's and get 100 15s.'' Id. at 53.
---------------------------------------------------------------------------

    On December 27, D.V. made his next and last visit. On the Intake 
Form, Applicant wrote: ``pt states good pain relief with current meds . 
. . tolerates meds well . . . overall feels well.'' Id. at 51. An 
unsigned, undated, handwritten note in the file states ``Due for 
urine.'' Id. at 50. Applicant issued D.V. prescriptions for 180 
Roxicodone 30mg, 120 Roxicodone 15mg, 40

[[Page 68706]]

Percocet 10/325mg, 60 Xanax 2mg, and Motrin. Id. at 49.
    As found above, on January 1, 2012, D.V. ``died as a result of 
acute combined drug toxicity.'' GX 39, at 1. The medical examiner's 
toxicology report found that D.V.'s blood was positive for alprazolam, 
cocaine, diazepam, methadone, and oxycodone. Id. at 5. The Medical 
Examiner's Cause of Death Report states that D.V.'s family reported 
that he was ``currently taking Xanax and Oxycodone . . . and had been 
addicted to pain medications for a number of years for treatment of 
back pain and a shoulder injury, but all incidents were remote and full 
recovery was reached.'' GX 38, at 1. On the date of his death, D.V. 
``was drinking alcohol throughout the day while continuing to take his 
daily Xanax and Oxycodone regimen [that] he was prescribed.'' Id. at 2.

The Expert's Report

    The medical files of the three undercover officers and patient D.V. 
were reviewed by the Government's Expert, Mark Rubenstein, M.D. Dr. 
Rubenstein, who is licensed in Florida, Maryland, and Virginia, is a 
diplomate of the American Board of Physical Medicine and Rehabilitation 
with a subspecialty certificate in Pain Medicine; a Fellow of the 
American Academy of Physical Medicine and Rehabilitation; a diplomate 
of the American Academy of Pain Management; and has held positions with 
several pain and rehabilitation clinics. GX 34. He has also held 
various appointments, including that of clinical professor at several 
medical schools, and has made numerous presentations on the treatment 
of injuries and chronic pain. Id.
    Using the Florida Standards for the Use of Controlled Substances 
for [the] Treatment of Pain, see Fla. Admin. Code r. 64B15-14.005, Dr. 
Rubenstein reviewed the patient files of the undercover officers and 
D.V. and evaluated Applicant's controlled substance prescribing 
practices. He then provided a report with his conclusions. See GX 35, 
at 1.
    Regarding T.B., Dr. Rubenstein found that the patient file ``showed 
no objective abnormality for the chief complaint of low back pain.'' 
Id. He noted that ``the only objective abnormality contained within the 
file was a cervical MRI scan, but the patient's complaints as per the 
physician were chronic low back pain.'' Id. Yet there was ``no 
documentation of any musculoskeletal or neurologic examination germane 
to the neck or back region.'' Id. at 4.
    Dr. Rubenstein further found that Applicant failed to do a ``a 
complete history and physical examination'' and ``therefore, there was 
no justification for the use of high doses of opioids, specifically 
high quantities of Roxicodone 15 and 30mg, with no other treatment 
alternatives afforded to the patient other than Motrin 800 mg.'' Id. 
Dr. Rubenstein also observed that:

[T.B.]'s initial drug screen was negative, indicating he was either 
opioid na[iuml]ve or clearly not using any opioid medications 
demonstrating any tolerance at the initial visit, therefore it would 
be considered inappropriate to initiate a dose of Roxicodone 30 mg 
every four to six hours for a patient who is not using same . . . 
this dose would be aggressive, excessive and place the patient at 
risk for drug toxicity or overdose including respiratory depression.

Id.

    Dr. Rubenstein thus concluded that Applicant's treatment 
``represents a deviation from the standard of care in pain medicine.'' 
Id. He also observed that the physician's handwriting and medical 
records were not legible, which would ``be a deviation from the Florida 
statutes for the standards of adequacy of medical records, as well as a 
deviation from the standards for the use of controlled substances for 
the treatment of pain.'' Id.
    With regard to M.C., Dr. Rubenstein found that the only objective 
pathology was an MRI of the lumbar spine showing only some disc 
bulging. Id. at 6. Yet, ``[t]here was no documented detailed neurologic 
or musculoskeletal exam, and the only follow-up visits were [sic] a 
neurologic exam is even referenced indicated that the neurologic exam 
was ``intact.'' '' Id. According Dr. Rubenstein, ``[t]he medical 
records are lacking legibility, and clearly a detailed history and 
physical was not performed or documented by the physician.'' Id.
    Dr. Rubenstein observed Applicant ``offered the patient only 
medications with no other treatment alternatives for a complaint of 
chronic low back pain.'' Id. at 6. He further observed that while 
M.C.'s ``initial urine drug screen was completely negative'' and 
``there was no documented history of using medications from other 
providers and no records of same,'' Applicant prescribed M.C. 
``Roxicodone 30mg to take every four to six hours.'' Id.
    Dr. Rubenstein explained that ``[t]his would be an inappropriate 
dose for an opioid na[iuml]ve patient'' and ``would be considered 
excessive for a young male who had no significant pathology documented 
from an objective perspective.'' Id. He then noted that ``[t]here were 
no follow-up [sic] urine screens to ensure compliance with the 
medication regimen.'' Id.
    Dr. Rubenstein further observed that there were no treatment 
alternatives afforded to the patient for his back pain, such as 
physical therapy, injection therapy, activity modification and non-
opioid alternatives other than Motrin. Id. He also noted that on 
October 11, 2011, Applicant added Roxicodone 15mg to M.C.'s 
medications, and that M.C. ``may have been taking up to six Roxicodone 
30mg tablets and six 15mg tablets for a total of 270mg of oxycodone 
daily if the full dose was utilized.'' Id. Yet there was no 
documentation ``as to why the Roxicodone 15mg was being added, and 
especially why an additional 160 of these tablets were recommended.'' 
Id. at 5.
    As for the Xanax 2mg prescription which Applicant provided on 
M.C.'s last visit, Dr. Rubenstein observed that this would be excessive 
for an initial starting dose. Id. at 6. He further noted that ``[t]here 
was no mental health consultation or other documented abnormal mental 
status exam to have even warranted such a dose.'' Id.
    Next, Dr. Rubenstein noted that Applicant violated the standards 
for the adequacy of medical records by not keeping legible medical 
records. Id. Finally, he concluded that Applicant violated the Florida 
standards for the use of controlled substances in treating pain, 
because he did not perform a detailed history and physical, use 
appropriate consultations for treatment objectives, keep accurate and 
complete medical records, or individualize treatment. Id. As such, this 
represented a deviation from the standard of care in pain medicine. Id.
    As for B.O., Dr. Rubinstein found that he presented with low level 
back pain and an MRI showing only some disc bulging and facet 
hypertrophy. Id. at 8. Yet Applicant did not perform a ``detailed 
physical examination'' to include a musculoskeletal or neurologic exam. 
Id.
    Dr. Rubinstein also found that Applicant did not take a detailed 
history of B.O.'s pain. Id. While Dr. Rubenstein acknowledged that the 
file included a completed pain questionnaire, ``it was not even 
specific to low back pain.'' Id. Moreover, while the MRI listed a 
referring physician of Robert Green, there were no records in the chart 
from prior physicians and there was ``no information in the chart'' 
that Applicant ``attempt[ed] to discern what had been done by [Dr. 
Green] or any other providers in the past.'' Id. According to Dr. 
Rubenstein, ``[t]here was not nearly enough documentation on physical 
exam to support any diagnosis other

[[Page 68707]]

than `chronic low back pain,' which is a generic diagnosis and not 
specific for a neurologic or musculoskeletal abnormality.'' Id. There 
was also no documentation that Applicant had considered alternative 
treatments ``such as physical therapy, referral to a spine specialist, 
non-opioid alternatives such as medications or other agents, injection 
therapy, [or] exercise specifically for lumbar stabilization.'' Id.
    Dr. Rubenstein further noted that B.O.'s initial urine drug screen 
was negative and thus ``there was clearly no basis to initiate a dose 
of Roxicodone 30mg every four to six hours.'' Id. Dr. Rubenstein then 
observed that ``[t]his dose would be considered excessive, aggressive, 
and placed the patient at risk for drug overdose or drug toxicity.'' 
Id. Based on his conclusion that Applicant had failed to perform an 
adequate history and physical examination, Dr. Rubenstein concluded 
that Applicant breached the standard of care for pain medicine and 
violated Florida rule 64B8-9.013 when he prescribed Roxicodone 30mg at 
B.O.'s first visit. Id. at 9.
    Dr. Rubenstein also noted that Applicant's physical exam notes were 
illegible and lacked ``sufficient detail to document why the course of 
treatment was undertaken.'' Id. Thus, he concluded that Applicant 
violated Florida's regulation governing the ``Standards of Adequacy of 
Medical Records.'' Id.
    Dr. Rubenstein reviewed D.V.'s patient file and the medical 
examiner's report. He described D.V.'s file as ``[d]isconcerting.'' Id. 
at 15. He found that the only imaging study was a 2006 MRI and there 
was ``no attempt to obtain previous medical records for his pain 
management.'' Id. at 16. He then noted that

    The young male with a history of chronic low back pain and no 
focal neurologic abnormality [was] given high doses of Roxicodone, 
oxycodone, and alprazolam. There was never any documented mental 
status examination, referral for treatment of anxiety, specialist 
referral for evaluation of back pain, etc. There were no consults 
with other specialists, no consideration of treating drug dependence 
or addiction, and no treatment alternatives [were] afforded to the 
patient. There was no documentation as to any history of shoulder 
pain or evaluation of same despite the . . . medical examiner's 
report indicating presence of same that initiated [D.V.'s] drug 
dependence and drug addiction. There was no attempt to recognize 
[D.V.'s] drug addiction . . . and no serial drug monitoring to 
ensure the prescriptions were being utilized appropriately. No 
attempts were made . . . to reliably reduce the risk of drug 
diversion, such as urine drug screens to ensure compliance. . . . 
Had drug screens been performed . . . then a proper treatment 
protocol may have been afforded to the individual.

Id. at 15-16.

    Dr. Rubinstein further observed that while Applicant documented on 
the ``Pain Management Treatment Plan'' form that drug testing had been 
completed at several of D.V.'s visits, there were no drug test results 
in the file. Id. at 13-14. Dr. Rubinstein thus explained that 
Applicant's documenting that monitoring had been performed when there 
were no test results in D.V.'s file ``represents improprieties in the 
medical records themselves.'' Id. at 16.
    Dr. Rubinstein also observed that D.V.'s weight rendered him obese 
and yet Applicant never addressed this issue or his intermittent 
hypertension with him. Id. Moreover, D.V. ``was clearly either drug 
dependent, drug addicted, or drug diverting and no attempts were made 
to address those issues'' with him. Id.
    Dr. Rubenstein thus concluded that Applicant did not meet ``the 
standard of care for pain medicine in prescribing such high doses of 
medications with the frequency performed to this individual.'' Id. He 
further found that Applicant deviated ``from the Standards for the Use 
of Controlled Substances for the Treatment of Pain by failing to 
perform periodic reviews, ensure compliance, obtain consultations for 
the evaluation of ongoing back pain, and by fail[ing] to provide any 
treatment alternatives to opioid medications and high-dose 
benzodiazepines.'' Id.
    Dr. Rubinstein thus found that Applicant deviated from the standard 
of care in pain medicine with respect to each of the undercover 
officers and D.V. He further concluded that the prescriptions Applicant 
issued ``for these individuals were issued for other than a legitimate 
medical purpose and would be considered outside the usual course of 
professional practice.'' GX 35, at 1.

Other Evidence

    In preparation for the previous Order to Show Cause proceeding, 
Investigators reviewed prescription data from the Florida Prescription 
Monitoring Program (PDMP), as well as pharmacy records from various 
states, including Florida. GX 8, at 3-4 (Declaration of Diversion 
Investigator). They also obtained from several pharmacies some of the 
prescriptions which Applicant had authorized between July 2010 and June 
3, 2011. Id. at 3. As found above, when Applicant applied for a new 
registration in October 2009, he sought authority to dispense only 
schedule II narcotics. Accordingly, the Agency issued him a 
registration which authorized him to dispense schedule II narcotics but 
no other controlled substances. Thus, Applicant did not have authority 
to dispense non-narcotic schedule II controlled substances or any 
controlled substances in schedules III, IV, and V.
    According to the declaration of an Agency Investigator, various 
records show that during this period, Applicant issued approximately 
1,116 prescriptions, which authorized the dispensing of approximately 
85,432 dosage units of controlled substances in drug schedules 2N (non-
narcotic), 3, 4, and 5. Id. at 3-4.
    Included in the evidentiary record are fifteen prescriptions for 
Xanax, a schedule IV controlled substance, five prescriptions for 
Adderall, a schedule 2N controlled substance, and two prescriptions for 
Valium, a schedule IV controlled substance, which Applicant issued 
between November 30, 2010 and May 24, 2011. GX 9.
    The record also includes a computer-generated sixteen (16) page 
document, which lists various prescriptions for drugs such as 
alprazolam, diazepam, phentermine, zolpidem, and amphetamine salts 
issued by Applicant between July 2, 2010 and June 3, 2011, along with 
the names of the patients (and their city of residence) and the 
dispensing pharmacy (and city where located). See GX 40. While in the 
record's Table of Contents, the Government refers to this document as 
``Chart and PDMP Report for Respondent's Prescribing Outside 
Registration (19 pages),'' GX Table of Contents, the document bears no 
label identifying it as such. Moreover, while an Investigator stated 
that she had had reviewed Florida PDMP records, her affidavit does not 
identify this document as being part of the PDMP records she reviewed. 
See generally GX 8.

Discussion

    Section 303(f) of the Controlled Substances Act provides that an 
application for a practitioner's registration may be denied upon a 
determination ``that the issuance of such registration would be 
inconsistent with the public interest.'' 21 U.S.C. 823(f). In making 
the public interest determination, the CSA requires the consideration 
of the following factors:

    (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

[[Page 68708]]

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.

    ``These factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or 
a combination of factors, and may give each factor the weight [I] 
deem[] appropriate in determining whether . . . an application for 
registration [should be] denied.'' Id. Moreover, it is well established 
that I am ``not required to make findings as to all of the factors.'' 
Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Kevin Dennis, 
M.D., 78 FR 52787, 52974 (2013); MacKay v. DEA, 664 F.3d 808, 816 (10th 
Cir. 2011).
    Furthermore, under Section 304(a)(1), a registration may be revoked 
or suspended ``upon a finding that the registrant . . . has materially 
falsified any application filed pursuant to or required by this 
subchapter.'' 21 U.S.C. 824(a)(1). DEA has long held that the various 
grounds for revocation or suspension of an existing registration that 
Congress enumerated in section 304(a), 21 U.S.C. 824(a), are also 
properly considered in deciding whether to grant or deny an application 
under section 303. See Anthony D. Funches, 64 FR 14267, 14268 (1999); 
Alan R. Schankman, 63 FR 45260 (1998); Kuen H. Chen, 58 FR 65401, 65402 
(1993). Thus, the allegation that Respondent materially falsified his 
application is properly considered in this proceeding. See Samuel S. 
Jackson, 72 FR 23848, 23852 (2007). The Government bears the burden of 
proof in showing that the issuance of a registration is inconsistent 
with the public interest. 21 CFR 1301.44(d).

The Material Falsification Allegation

    As found above, on October 1, 2008, the Florida Department of 
Health entered an emergency suspension of Applicant's Florida medical 
license, on the basis of his history of alcohol dependency and his 
failure to comply with the DOH's orders which required the monitoring 
of his medical practice. GX 10, at 10. In March 2009, the DOH re-
instated his medical license. Applicant, however, allowed his DEA 
registration to expire on May 31, 2009.
    On October 5, 2009, Applicant applied for a new DEA registration 
and provided a ``no'' answer to the third liability question, which 
asked whether he had previously had a state professional license 
revoked or suspended. GX 4, at 10. Applicant's answer was clearly 
false, and knowingly so, as the DOH had suspended his medical license 
on October 1, 2008 and Applicant's license was not reinstated until 
March 26, 2009. Moreover, Applicant also provided a ``no'' answer to 
question three on the applications he filed on May 22, 2012 and January 
4, 2013. Thus, Applicant has submitted three applications in which he 
provided a false answer to question three.
    Congress did not, however, grant the Agency authority to revoke an 
existing registration or deny an application based on any 
falsification, but rather, only those which are material. See 21 U.S.C. 
824(a)(1). As the Supreme Court has explained, ``[t]he most common 
formulation'' of the concept of materiality ``is that a concealment or 
misrepresentation is material if it `has a natural tendency to 
influence, or was capable of influencing, the decision of' the 
decisionmaking body to which it was addressed.'' Kungys v. United 
States, 485 U.S. 759, 770 (1988) (quoting Weinstock v. United States, 
231 F.2d 699, 701 (D.C. Cir. 1956)) (other citation omitted); see also 
United States v. Wells, 519 U.S. 482, 489 (1997) (quoting Kungys, 485 
U.S. at 770). The Supreme Court has further explained that ``[i]t has 
never been the test of materiality that the misrepresentation or 
concealment would more likely than not have produced an erroneous 
decision, or even that it would more likely than not have triggered an 
investigation.'' Kungys, 485 U.S. at 771 (emphasis added). Rather, the 
test is ``whether the misrepresentation or concealment was predictably 
capable of affecting, i.e., had a natural tendency to affect, the 
official decision.'' Id. `` `[T]he ultimate finding of materiality 
turns on an interpretation of substantive law,' '' id. at 772 (int. 
quotations and other citation omitted), and must be met ``by evidence 
that is clear, unequivocal, and convincing.'' \12\ Id.
---------------------------------------------------------------------------

    \12\ While Kungys involved a denaturalization proceeding, in 
other civil proceedings, courts have required that a party establish 
that a falsification is material by ``clear, unequivocal, and 
convincing evidence'' and not simply by a ``preponderance of the 
evidence.'' Driscoll v. Cebalo, 731 F.2d 878, 884 (Fed. Cir. 1984). 
In any event, the Government has produced no evidence as to why the 
statement is material.
---------------------------------------------------------------------------

    As the above makes clear, the relevant decision for assessing 
whether a false statement is material is the Agency's decision as to 
whether an applicant is entitled to be registered (or in the case of a 
current registrant, remain registered). Thus, because possessing 
authority to dispense controlled substances under the laws of the State 
in which a physician practices medicine is a requirement for holding a 
DEA registration, see 21 U.S.C. 802(21) & 823(f), a false answer to 
question three is material where an applicant no longer holds authority 
to practice medicine (regardless of the reason for the State's action) 
or authority to dispense controlled substances, as well as where the 
State has placed restrictions on a practitioner's authority to 
prescribe controlled substances. So too, because in determining whether 
an application should be granted, Congress directed the Agency to 
consider the five public interest factors, even where an applicant 
currently holds unrestricted state authority to dispense controlled 
substances, the failure to disclose state action against his medical 
license may be material if the action was based on conduct (or on the 
status arising from such conduct, i.e., a conviction for a controlled 
substance offense or mandatory exclusion from federal health care 
programs) which is actionable under either the public interest factors 
or the grounds for denial, suspension, and revocation set forth in 
section 824. See Scott C. Bickman, 76 FR 17694, 17701 (2011) (holding 
that failure to disclose state probation was not material where 
probation was based on an act of medical malpractice and did not 
involve controlled substances).
    Here, citing Bickman, the Government contends that Applicant's 
falsification is material because the Florida DOH concluded that as a 
result of his dependency on alcohol, ``his `continued practice as an 
osteopathic physician constitute[d] an immediate serious danger to the 
health, safety, and welfare of the public' '' and that `` `[n]othing 
short of suspending [his] license will adequately protect the public.' 
'' Req. for Final Agency Action, at 14. Had Applicant's state license 
been suspended at the time he filed any of his DEA applications, his 
answer to question three would have been materially false because he 
would have lacked authority to dispense controlled substances and would 
not have been entitled to be registered.\13\ But it wasn't.
---------------------------------------------------------------------------

    \13\ Citing Bickman, the Government argues that ``[a] 
falsification is material if the state medical board `concluded that 
Respondent's conduct posed such a risk to patients as to warrant the 
suspension or revocation of his medical license (and authority to 
prescribe controlled substances under [s]tate law).'' Gov. Req. for 
Final Agency Action, at 14. The quoted language, however, does not 
support the Government's contention as it served only to distinguish 
Bickman's circumstance of having been placed on probation by his 
state board from that which would have existed had his state license 
been suspended or revoked at the time he submitted his application. 
As explained above, because possessing state authority is a 
requirement for obtaining a DEA registration, failing to disclose a 
continuing state suspension (or a revocation order which remains in 
effect) is always material. See 21 U.S.C. 802(21) & 823(f)). By 
contrast, whether the failure to disclose a suspension which has 
since terminated is material depends upon the basis of the State's 
action.

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

[[Page 68709]]

    Moreover, the Government makes no argument that had Applicant 
truthfully disclosed the State's suspension, it would have uncovered 
information that he had committed actionable misconduct under the 
public interest standard or the other grounds provided in 21 U.S.C. 
824(a). Indeed, the State's suspension order made no allegation that 
Applicant engaged in misconduct actionable under the public interest 
standard (whether resulting in a criminal conviction or not) or that he 
was convicted of an offense subjecting him to mandatory exclusion from 
federal health care programs. See id. Rather, the DOH's Order was based 
on its conclusion that Applicant is an alcoholic. Notably, the DOH made 
no allegation that Applicant was also a drug abuser and the Government 
cites no decision in which this Agency has denied the application of a 
physician, who was then duly authorized by the State in which he/she 
practiced to dispense controlled substances, on the sole ground that 
the physician was an alcoholic. Accordingly, I reject the allegation. 
Hoi Y Kam, 78 FR 62694, at 62696 (2013); see also Scott C. Bickman, 76 
FR 17694, 17701 (2011).

The Public Interest Allegations

    The Government alleges that granting Applicant's registration would 
be inconsistent with the public interest based on his conduct which is 
relevant in assessing his experience as a dispenser of controlled 
substances (Factor Two) and his compliance with applicable laws related 
to controlled substances (Factor Four).\14\ More specifically, the 
Government contends that Applicant violated the CSA in two respects. 
First, he issued prescriptions to three undercover officers and D.V. 
which lacked a legitimate medical purpose in violation of the CSA's 
prescription regulation. Second, he issued controlled substances 
prescriptions for drugs he was not authorized to prescribe under his 
registration. I agree.
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    \14\ As for factor one--the recommendation of the state 
licensing board--it is undisputed that Applicant holds a current 
license as an osteopathic physician in the State of Florida and 
possesses state authority to dispense controlled substances. While 
Respondent therefore meets an essential prerequisite for obtaining a 
registration under the CSA, 21 U.S.C. 823(f), DEA has held 
repeatedly that a practitioner's possession of State authority is 
not dispositive of the public interest determination. DEA maintains 
a separate oversight responsibility with respect to the handling of 
controlled substances and has a statutory obligation to make its 
independent determination as to whether the granting of such 
privileges would be in the public interest. Mortimer Levin, 57 FR 
8680, 8681 (1992). Thus, neither a State's failure to take action 
against a registrant's medical license, nor a State's restoration of 
a practitioner's prescribing authority, is dispositive in 
determining whether or not an application should be granted. See 
Jayam Krishna-Iyer, 74 FR 459, 461 (2009); 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.
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Factors Two and Four

    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 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 provides 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.'' Ralph J. Chambers, 
79 FR 4962 at 4970 (2014) (citing Paul H. Volkman, 73 FR 30629, 30642 
(2008), pet. for rev. denied Volkman v. DEA, 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 30642.
    Pursuant to Florida Stat. Sec.  456.44(3)(a), a ``complete medical 
history and a physical examination must be conducted before beginning 
any treatment and must be documented in the medical record.'' Moreover, 
``the medical record must, at a minimum, document the nature and 
intensity of the pain, current and past treatments for pain, underlying 
or coexisting diseases or conditions, the effect of the pain on 
physical and psychological function, and a review of previous medical 
records, previous diagnostic studies, and history of alcohol and 
substance abuse.'' Id. This section also requires a physician to 
develop a written plan for assessing ``each patient's risk for of 
aberrant drug-related behavior, and monitor that risk on an ongoing 
basis in accordance with the plan.'' Id.; see also Fla. Admin. Code r. 
64B15-14.005(3)(a).
    The Government also cites to the Florida Standards for the Use of 
Controlled Substances for Treatment of Pain. One of the Standards 
states that ``osteopathic physicians should be diligent in preventing 
the diversion of drugs for illegitimate purposes,'' and that ``all such 
prescribing must be based on clear documentation of unrelieved pain and 
in compliance with applicable state or federal law.'' Fla. Admin. Code 
r. 64B15-14.005(1)(d) & (e).

[[Page 68710]]

    As found above, upon reviewing the patient files of the undercover 
officers as well as D.V., the Government's Expert found that Applicant 
issued controlled substances for other than a legitimate medical 
purpose and outside the usual course of professional practice. As 
support for his conclusion, the Expert observed that Applicant failed 
to perform detailed histories and adequate physical examinations, 
failed to develop any treatment plan other than to prescribe controlled 
substances, prescribed large and excessive doses of controlled 
substances, failed to properly monitor patients, and failed to keep 
legible and complete medical records. I agree with the Expert's 
analysis and conclude that Applicant knowingly diverted controlled 
substances including oxycodone (schedule II) and alprazolam (schedule 
IV) to the undercover officers and D.V. and thus violated federal law. 
21 U.S.C. 841(a)(1); 21 CFR 1306.04(a). I further find that Applicant's 
misconduct was egregious. This finding provides reason alone to deny 
Applicant's application.
    However, the record also supports the conclusion that Applicant 
exceeded the authority of his registration by prescribing controlled 
substances in schedules which were outside the scope of his 
registration. Pursuant to 21 U.S.C. 822(b), ``[p]ersons registered by 
the Attorney General . . . to . . . dispense controlled substances . . 
. are authorized to possess . . . or dispense such substances . . . to 
the extent authorized by their registration.'' (emphasis added).
    As found above, on October 5, 2009, Applicant applied for a new 
registration as a practitioner. Notwithstanding that the application 
form clearly instructed him to check all drug schedules for which he 
sought authority, Applicant checked the box for only schedule II 
narcotics. Accordingly, the Agency granted him a registration which was 
limited to schedule II narcotics. Applicant did not seek authority to 
dispense controlled substances in the additional schedules until June 
6, 2011.
    Thus, between October 6, 2009 (the date the application was 
granted) and June 6, 2011, Applicant could not lawfully prescribe any 
controlled substances outside of those narcotics in schedule II. The 
record, however, contains fifteen prescriptions for Xanax (alprazolam) 
and two prescriptions for Valium (diazepam), both of which are schedule 
IV controlled substances, as well as five prescriptions for Adderall 
(amphetamine), a schedule II non-narcotic, which Applicant issued 
without authority to do so. Even though Applicant eventually obtained a 
registration for the remaining drug schedules, Applicant was 
responsible for ensuring that he had obtained the necessary authority 
for each schedule of controlled substances he intended to dispense. I 
thus conclude that Applicant violated federal law by dispensing 
controlled substances for which he lacked authorization. 21 U.S.C. 
822(b) & 841(a)(1).
    Accordingly, I find that the Government's evidence with respect to 
factor two and four establishes a prima facie case that granting 
Applicant's application ``would be inconsistent with the public 
interest.'' Id. Sec.  823(f). Because Applicant failed to respond to 
the Show Cause Order, whether by requesting a hearing or submitting a 
written statement, and thus has failed to offer any evidence to the 
contrary, I will order that his application be denied.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well 
as 28 CFR 0.100(b) and 0.104, I order that the application of Richard 
D. Vitalis, D.O., for a DEA Certificate of Registration as a 
practitioner, be, and it hereby is, denied. This Order is effective 
immediately.

    Dated: November 10, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-27206 Filed 11-17-14; 8:45 am]
BILLING CODE 4410-09-P