[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3624-3630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01221]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Jose Raul S. Villavicencio, M.D.; Decision and Order

    On June 24, 2013, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Jose Raul S. Villavicencio, M.D. (hereinafter, 
Registrant), of Parkersburg, West Virginia. GX 1. The Show Cause Order 
proposed the revocation of Registrant's DEA Certificate of Registration 
and denial of any applications for renewal or modification of the 
registration, and any applications for any other DEA registration, on 
the ground that his continued ``registration would be inconsistent with 
the public interest.'' Id. at 1 (citing 21 U.S.C. 823(f)) and 
824(a)(4)).
    The Show Cause Order alleged that Registrant is registered as a 
practitioner in Schedules II through V, pursuant to DEA registration 
number BV3249643, at the location of 1909 Dudley Avenue, Parkersburg, 
West Virginia, and that his registration does not expire until May 31, 
2016. Id. The Show Cause Order alleged that Registrant had previously 
been registered at 1761 High Street, Columbus, Ohio, and that on 
September 27, 2012, the Agency had approved his request for a change 
from his previous registered address. Id. The Show Cause Order also 
alleged that Registrant's DEA registration authorizes him to dispense 
schedule III drugs to patients for maintenance or detoxification 
treatment, and that since July 12, 2007, Registrant has been authorized 
to treat up to one hundred patients, pursuant to 21 U.S.C. 823(g)(2)(A) 
and (2)(b)(iii). Id.
    The Show Cause Order then alleged that on September 12, 2012, the 
State Medical Board of Ohio permanently revoked Registrant's medical 
license following a hearing. Id. The Show Cause Order alleged that the 
Ohio Board's Order was based on his failure to comply with applicable 
state law pertaining to the prescribing of schedule II through IV 
controlled substances for chronic pain, and that upon its review of 
sixteen (16) patient files, the Board found that he ```failed to 
maintain minimal standards applicable to the administration or 
selection of drugs''' for fourteen (14) of the patients, and that his 
``care of all [sixteen (16)] patients was `a departure from, or the 
failure to conform to, minimal standards of care of similar 
practitioners,' in violation'' of Ohio Revised Code Sections 
4731.22(B)(2) and 4731.22(B)(6). Id. at 1-2. The Show Cause Order then 
alleged that the Ohio Board's findings with respect to the sixteen 
patients establish that Registrant prescribed controlled substances 
without a legitimate medical purpose and outside of the usual course of 
professional practice in violation of 21 CFR 1306.04(a). Id. at 2.
    Next, the Show Cause Order alleged that a review of data obtained 
from the Ohio Automated Rx Reporting System (OARRS), the state database 
to which all Ohio pharmacies are required to report their dispensings 
of controlled substances, showed that on at least five separate 
occasions between September 1, 2010 and March 1, 2012, Registrant was 
treating over 100 patients with Suboxone or Subutex prescriptions at a 
time. Id. The Show Cause Order thus alleged that Registrant violated 21 
U.S.C. 823(g)(2)(B)(iii) and 21 CFR 1301.28(f). Id.
    The Show Cause Order further alleged that on March 9, 2013, DEA 
served an administrative inspection warrant at Registrant's registered 
location seeking to inspect all of his controlled substance records 
pertaining to his prescribing of Subutex and Suboxone for maintenance 
or detoxification treatment. Id. The Show Cause Order alleged that 
Investigators found that Registrant committed numerous violations of 
two DEA regulations, 21 CFR 1304.03(c) and 1306.05(a), including that: 
(1) On 116 occasions, he ``failed to record dosage units prescribed''; 
(2) on five occasions, he ``failed to record the date on which the 
prescriptions were signed''; (3) on three occasions, he ``failed to 
record the drug name''; and (4) on sixteen occasions, he ``failed to 
record any prescription information.'' Id. (citing 21 CFR 1304.03(c) 
and 1306.05(a)). The Order also alleged that Registrant issued eleven 
Subutex or Suboxone prescriptions to patients from a location at which 
he was not registered. Id. (citing 21 U.S.C. 822(e)). Id. at 2.
    Finally, the Show Cause Order also alleged that Registrant had not 
been candid in providing material information in violation of 21 U.S.C. 
823(f)(5). Specifically, the Order alleged that: (1) The Ohio Board 
found that he ``provided questionable, self-serving testimony during 
the hearing'' in three respects; (2) that on an application to a drug 
distributor, he had falsely stated that his medical license or 
registration had never been subject to ``sanction or disciplinary 
action''; (3) and that during an inspection by an Investigator for the 
West Virginia Board of Medicine, Registrant had stated that he had not 
ordered any drugs for dispensing when he had done so two days earlier.

[[Page 3625]]

    Finally, the Show Cause Order notified Registrant of his right to 
request a hearing on the allegations or to submit a written statement 
in lieu of a hearing, the procedure for doing either, and the 
consequence for failing to do either. Id. at 3-4 (citing 21 CFR 
1301.43).
    On July 8, 2013, a Diversion Investigator (DI) served the Show 
Cause Order on Registrant by electronic mail to the email address he 
had provided to the Agency on his registration application. GX 4, at 1 
(Declaration of Diversion Investigator). The DI received an electronic 
response stating that the email had been delivered on the same date. 
Id. Also, the DI faxed a copy of the Order to Show Cause to the 
facsimile number provided by Registrant on his registration 
application. Id. The DI then called the telephone number listed on 
Registrant's application and confirmed that Registrant had received the 
Order. Id. at 1-2. The DI also informed Registrant that a hearing 
request form had been included in both transmissions and that he had 
thirty days in which to request a hearing. Id. at 2. According to the 
DI, ``Registrant responded that he understood.'' Id.
    Since the date of service of the Show Cause Order, more than thirty 
days have now passed and neither Registrant, nor anyone purporting to 
represent him, has requested a hearing or submitted a written statement 
in lieu of a hearing. I therefore find that Registrant has waived his 
right to a hearing or to submit a written statement in lieu of hearing, 
and issue this Decision and Final Order based on relevant evidence 
contained in the record submitted by the Government. 21 CFR 1301.43(d) 
& (e). I make the following findings of fact.

Findings

    Registrant is registered as a practitioner in Schedules II through 
V pursuant to DEA registration number BV3249643, at the registered 
address of 1909 Dudley Avenue, Parkersburg, West Virginia. GX 2. 
Registrant is also authorized to dispense Schedule III drugs, as a 
DATA-waived practitioner, to up to 100 patients for maintenance or 
detoxification treatment pursuant to 21 U.S.C. 823(g)(2)(A) and 
(2)(b)(iii). Id. Registrant's previous registered address was 1761 High 
Street, Columbus, Ohio. Id. at 3.
    However, by letter dated September 26, 2012, Registrant requested 
that his registered location be changed from his Ohio office to a 
location at 1900 Dudley Ave., Parkersburg, West Virginia. GX 7. In the 
letter, Registrant explained that his West Virginia medical license was 
active and that ``I lost my Ohio license recently over alleged improper 
prescribing in 2005.'' Id. Nonetheless, the following day, Registrant's 
request was approved. GX 2, at 3. On May 30, 2013, Registrant submitted 
a timely renewal application; his registration is not due to expire 
until May 31, 2016. GX 2, at 1.
    As noted above, Registrant previously held an Ohio Medical License. 
However, on April 13, 2011, the Ohio Board notified Registrant that it 
was proposing to take action against his license. GX 5, at 1. On May 
10, 2011, Registrant requested a hearing, and on January 17-18 and 23-
27, 2012, a state Hearing Examiner conducted a hearing at which both 
the Board and Registrant were represented by counsel.
    Following the hearing, the Hearing Examiner issued a 164-page 
Report and Recommendation. GX 5. Therein, the Hearing Examiner found 
that between 2005 and 2008, Registrant ``provided care and treatment 
for'' sixteen patients and that he had ``inappropriately treated and/or 
failed to appropriately treat and/or failed to appropriately document 
his treatment of these patients.'' Id. at 142. With respect to these 
patients, the Hearing Examiner further found that Registrant:

    (1) ``repeatedly and/or continually treated patients by 
excessively and/or inappropriately prescribing medications'' and 
``continued to prescribe controlled substances without appropriately 
pursuing or documenting the pursuit of alternative non-narcotic 
therapies'';
    (2) ``failed to record in the patients' medical records the 
reason(s) he prescribed medication and/or the need . . . for 
prescribing multiple medications'';
    (3) ``repeatedly and/or continually treated patients without 
performing and/or documenting appropriate physical examinations or 
evaluations, and/or without utilizing and/or documenting appropriate 
diagnostic testing or other methods of evaluating the patients' 
health conditions, and/or without devising and/or documenting 
treatment plans, and/or without periodically reassessing or 
documenting the reassessment of the effectiveness of treatment for 
illnesses'';
    (4) ``failed to adequately and/or appropriately diagnose and/or 
document an adequate or appropriate diagnosis of the patients' 
medical conditions'';
    (5) ``failed to document in the patient record adequate findings 
to support his diagnoses'';
    (6) ``repeatedly and/or continually treated patients without 
making appropriate and/or timely referrals to specialists''; and
    (7) ``failed to keep and maintain adequate records reflecting 
his care and treatment of the patients[,]'' because ``[t]he entries 
in the medical records frequently appeared verbatim from one office 
visit to the next and from one patient to another, with few or no 
changes.''

Id. The Hearing Examiner then set forth specific examples of each 
finding with respect to the sixteen patients, including the testimony 
and opinion of the Board's expert witness with regard to each of the 
patients. Id. at 143-160.

    The Hearing Examiner thus concluded, inter alia, that Registrant's 
acts, conduct and/or omissions constituted: (1) The ``failure to 
maintain minimal standards applicable to the selection or 
administration of drugs, or failure to employ acceptable scientific 
methods in the selection of drugs or other modalities for treatment of 
disease,'' as set forth in Ohio Rev. Code 4731.22(B)(2); and (2) a 
``departure from or the failure to conform to, minimal standards of 
care of similar practitioners under the same or similar circumstances, 
whether or not actual injury to a patient is established,'' as set 
forth in Ohio Rev. Code 4731.22(B)(6). GX 5, at 160-161.
    The Hearing Examiner further concluded that Registrant ``provided 
questionable, self-serving testimony during the hearing'' and 
specifically found that ``he provided conflicting testimony'' as to 
whether he had terminated one patient from his practice. Id. at 163. 
She also found ``disingenuous'' his ``attempt to explain away his 
notation that [another patient] was `caught selling cocaine.' '' Id. 
While the Hearing Examiner noted that Registrant had presented some 
``mitigating evidence,'' she concluded that ``[t]he evidence 
overwhelmingly establishes that [his] treatment of these patients 
place[d] them in serious danger.'' Id. at 163-64. She therefore 
recommended that Registrant's Ohio medical license be permanently 
revoked. Id. at 164.
    On September 12, 2012, the Ohio Board adopted the Hearing 
Examiner's Report and Recommendation and ordered that Registrant's 
medical license be permanently revoked. GX 6, at 1. The Board further 
ordered that the revocation be effective immediately upon the mailing 
of its Order. Id. Registrant appealed the decision to the Ohio Court of 
Common Pleas, which affirmed the Board's revocation order on July 29, 
2013. GX 18, at 21.
    As found above, on September 26, 2012, Registrant wrote to a 
Diversion Investigator in the Charleston, West Virginia office 
requesting that he ``expedite the transfer'' of his DEA registration 
from Ohio to West Virginia. GX 7. The next day, Registrant's request 
was approved. GX 2, at 3.
    On March 9, 2013, a DEA DI (along with other DEA personnel), 
accompanied by a West Virginia

[[Page 3626]]

Medical Board Investigator, went to Registrant's Parkersburg office 
where the DI served him with an Administrative Inspection Warrant. GX 
8; see also GX 3, at 1. Pursuant to the warrant, the DI seized 149 
patient files and miscellaneous photocopies of prescriptions, as well 
as related notes and claim forms. GX 3, at 3. Registrant told the DI 
that all records of the controlled substances he prescribed in the 
course of providing treatment for addiction since September 2012 were 
in the medical charts, but that his Suboxone records for the period 
prior to September 2012 were stored electronically on an off-site 
computer server. Id. However, when asked by the DI to access those 
records, Registrant was unable to do so, and as of the date of the DI's 
affidavit (July 14, 2014), he had not submitted any such records to the 
DI. Id.
    The evidence submitted by the Government includes excerpts from 78 
patient files which include Subutex and Suboxone prescriptions issued 
by Registrant between September 29, 2012 and March 9, 2013. See GXs 11-
15. The evidence includes 55 patient file excerpts, which the DI stated 
show that for 118 prescriptions issued during this period, Registrant 
failed to record the quantity of the Suboxone or Subutex prescribed.\1\ 
See GX 11. The evidence also includes undated visit notes for seven 
patients, which document that Registrant prescribed Suboxone or 
Subutex, see GX 12, as well visit notes for two patients on which 
Registrant failed to record the name of the drug prescribed (Suboxone 
or Subutex). GX 13.
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    \1\ Pages 1-3 of the exhibit consist of an itemized list 
prepared by the DI specifying each patient (by a number assigned by 
the DI), the date of the prescription, the drug (Subutex or 
Suboxone) and the specific violation (generally that he ``did not 
record dosage units''). See GX 11. However, the list contains a 
patient file (#59) whose file is not included in the exhibit. 
According to the itemized list, Patient 59's prescription for 
buprenorphine on January 21, 2013 did not include a recorded dosage 
unit. Id. at 3.
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    The evidence also includes patient file excerpts for five 
individuals, along with printouts obtained from the Ohio Automated Rx 
Reporting System (OARRS) and the West Virginia Controlled Substance 
Monitoring Program (WVCSMP). See GX 14. This evidence shows that on 
twenty-nine occasions, Registrant failed to record in the patients' 
files any information regarding the Suboxone or Subutex prescriptions 
he issued. Id. In one instance, the OARRS printout shows that 
Registrant issued twelve prescriptions for Suboxone or buprenorphine to 
a patient between June 8, 2012 and January 12, 2013. Id. at 1 & 9. Yet 
none of the prescriptions are documented in the patient's file. Id. at 
1, 6-9.
    The Government also submitted evidence tending to show that 
notwithstanding that his Ohio license had been revoked and that 
Registrant had changed the address of his DEA registration to 
Parkersburg, West Virginia, he continued to issue prescriptions from 
his prior DEA-registered location at the South German Village Medical 
Center, Columbus, Ohio. GX 15. More specifically, the evidence shows 
that between November 28, 2012 and March 5, 2013, Registrant issued ten 
prescriptions for Suboxone or Subutex which he faxed from the South 
German Village Medical Center. See also GX 3, at 5. Facsimile records 
for two additional Suboxone prescriptions purportedly issued to one 
individual show that they were faxed within Ohio on February 2, 2013. 
Id., see also GX 15, at 12.
    The evidence also includes a list of patients to whom Registrant 
prescribed buprenorphine, along with the dates of the first and last 
such prescription. GX 16. According to the DI, this list was compiled 
based on data obtained from the prescription monitoring programs of 
Ohio and West Virginia, and shows that ``on five specific dates,'' 
Registrant exceeded the 100-patient limit on the number of patients to 
whom he could prescribe Suboxone and Subutex as a DATA-Waived 
physician. GX 3, at 5-6; see also 21 U.S.C. 823(g)((2)(B)(iii). More 
specifically, the DI asserted that on September 1, 2010, Registrant 
``was treating 148 buprenorphine patients.'' GX 3, at 6.\2\ Consistent 
with the DI's findings, Registrant testified before the Ohio Medical 
Board that: ``[w]e also currently have 150 patients in our Suboxone 
program. This program has actually allowed us to return to function a 
fair number of nurses, businessmen, teachers, computer programmers, and 
homemakers.'' GX 5, at 137 (citation omitted).
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    \2\ According to the exhibit, as of January 1, 2011, Registrant 
was treating 158 buprenorphine patients; as of June 1, 2011, he was 
treating 143 buprenorphine patients; as of January 1, 2012, he was 
treating 118 buprenorphine patients; and as of March 1, 2012, he was 
treating 110 such patients. GX 16, at 7.
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    As found above, an Investigator from the West Virginia Board of 
Medicine was also present during the execution of the Administrative 
Inspection Warrant at Registrant's Parkersburg office on March 9, 2013. 
GX 10, at 1. When the Investigator advised Registrant that she would be 
conducting an on-site dispensing inspection, he stated that he was not 
ready to dispense and that he did not have any dispensing equipment. 
Id. at 1. The Investigator's report states that Registrant had applied 
for a Dispensing Registration from the West Virginia Board of Medicine 
on February 25, 2013, and had telephoned the Board again on March 6, 
2013 requesting that the registration be faxed as soon as possible. Id. 
According to the report, Registrant told the Investigator that he had 
not ordered any pharmaceuticals because the ``packagers Dr. Dispense 
and Advantage RX need a copy of my dispensing license before they will 
process the pharmaceuticals and provide me with the scanner, label 
maker, everything I need to dispense.'' Id. at 1-2.
    The evidence also includes a copy of a customer application 
Registrant submitted on February 20, 2013, to Smith Medical Partners, a 
distributor of controlled substances. GX 9, at 5-6. On the application, 
Registrant wrote that his business was an ``addiction clinic'' and that 
it ``dispenses only schedule III drugs, Suboxone & Subutex.'' Id. at 5.
    On the application, Registrant was also required to answer the 
following question: ``[h]as any sanction or disciplinary action been 
taken regarding any license, permit, or registration issued to the 
applicant, officer, owner member, partner, [or] physician . . . 
involving the operations or ownership of a clinic?'' Id. at 6. 
Notwithstanding that the Ohio Medical Board had revoked his medical 
license five months earlier, Registrant answered ``No.'' Id.
    Registrant was approved as a customer, and on or about March 7, 
2013, ordered both buprenorphine and Suboxone from Smith, which shipped 
the drugs by UPS to his Parkersburg office. Id. at 4. The drugs, 
however, were returned to Smith by UPS after Registrant failed to pick 
up them up at UPS per an arrangement he had made with it. Id. at 3. 
During a phone call with a Smith employee, Registrant told her that 
because his Parkersburg office was open only `` `on Saturdays . . . he 
need[ed] to pick up his product from a UPS location.' '' Id.
    Finally, the evidence includes a copy of a Final Order issued by 
the West Virginia Board of Medicine and a copy of the Hearing 
Examiner's Proposed Findings of Fact, Conclusions of Law, and 
Recommendation. GX 17. These documents establish that on or about June 
8, 2013, the West Virginia Medical Board issued a Complaint and Notice 
of Hearing to Registrant, which sought to revoke his medical license, 
and that following a hearing, the Hearing Examiner concluded that the 
evidence ``clearly and convincingly established

[[Page 3627]]

that [Registrant]'s practice of medicine in West Virginia renders him 
unqualified for continued licensure based upon his violations'' of 
state law and that his license should be revoked. Id. at 50. The 
evidence further shows that on November 18, 2013, the Board adopted the 
Hearing Examiner's report (albeit with one minor modification to a 
single finding of fact) and concluded that Registrant ``is unfit to 
practice medicine and surgery in the state of West Virginia.'' Id. at 
2. The Board thus revoked Registrant's medical license effective on 
entry of its order. Id.

Discussion

The Public Interest Analysis

    Section 304(a) of the Controlled Substances Act (CSA) provides that 
a registration to ``dispense a controlled substance . . . may be 
suspended or revoked by the Attorney General upon a finding that the 
registrant . . . has committed such acts as would render his 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). 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). 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 Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 
2009). While I must consider each factor, I am ``not required to make 
findings as to all of the factors.'' Volkman, 567 F.3d at 222; see also 
Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); Morall v. DEA, 412 
F.3d 165, 173-74 (D.C. Cir. 2005).
    However, even where a Registrant fails to request a hearing on the 
allegations, the Government has the burden of proving, by substantial 
evidence, that the requirements for revocation or suspension pursuant 
to 21 U.S.C. 824(a) are met. 21 CFR 1301.44(e).\3\ Having considered 
the Government's evidence, I find that the Government has established 
that Registrant ``has committed such acts'' as to render his 
registration ``inconsistent with the public interest.'' \4\ 21 U.S.C. 
824(a)(4).
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    \3\ Where the Government seeks to deny an application for a 
practitioner's registration, it also has ``the burden of proving 
that the requirements for such registration . . . are not 
satisfied.'' 21 CFR 1301.44(d).
    \4\ Regarding factor three, there is no evidence that Respondent 
has been convicted of an offense related to the manufacture, 
distribution or dispensing of controlled substances. However, as 
there are a number of reasons why a person may never be convicted of 
an offense falling under this factor, let alone be prosecuted for 
one, ``the absence of such a conviction is of considerably less 
consequence in the public interest inquiry'' and thus, it is not 
dispositive. David A. Ruben, 78 FR 38363, 38379 n. 35 (2013) (citing 
Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied 
MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011)).
     As for factor one, while there is no recommendation in the 
record from the West Virginia Medical Board, it is noted that the 
State has revoked his medical license. The consequence of the 
Board's action is discussed more fully later in this Decision.
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Factors II and IV--The Applicant's Experience in Dispensing Controlled 
Substances and Compliance With Applicable Laws Related to Controlled 
Substances

    Relevant to these factors, the Government has alleged that 
Registrant violated federal law by: (1) Issuing controlled substance 
prescriptions which lacked a legitimate medical purpose, (2) exceeding 
the 100-patient limit on his authority to treat narcotic dependent 
patients under the Drug Addiction Treatment Act of 2000, and (3) 
failing to maintain required records when he prescribed Subutex and 
Suboxone for maintenance and detoxification purposes. GX 1, at 1-2. As 
discussed below, each of these allegations is supported by substantial 
evidence.

The Violations of 21 CFR 1306.04(a)

    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 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) (the prescription requirement 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 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.
    As support for this allegation, the Government submitted the 
decisions and orders of the Ohio and West Virginia medical boards.\5\ 
Under the

[[Page 3628]]

doctrine of collateral estoppel, the Ohio Board's findings of fact and 
conclusions of law are entitled to preclusive effect in this proceeding 
if Registrant had an adequate opportunity to litigate the issues in the 
state proceeding. See Thomas Neuschatz, 78 FR 76322, 76325 (2013) 
(citing Robert L. Dougherty, M.D., 76 FR 16823, 16830 (2011)); Univ. of 
Tenn. v. Elliot, 478 U.S. 788, 797-98 (1986) (``When an administrative 
agency is acting in a judicial capacity and resolves disputed issues of 
fact properly before it which the parties have had an adequate 
opportunity to litigate, the courts have not hesitated to apply res 
judicata[.]'') (internal quotations and citations omitted).
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    \5\ Noting that the West Virginia Board's Order was not issued 
until after the OTSC was issued, the Government asks that I take 
official notice of its various factual findings related to 
Registrant's prescribing of Suboxone. Req. for Final Agency Action, 
at 16. I take official notice of the Order only to the extent it 
establishes that Registrant is no longer authorized to practice 
medicine in West Virginia, the State in which he is registered. 
Pursuant to 5 U.S.C. 556(e) Registrant is entitled to show to the 
contrary by filing a properly supported motion for reconsideration 
within fifteen (15) days of the date of service of this Order which 
shall begin on the date of mailing.
    I otherwise decline to take official notice of the findings of 
fact and conclusions of law set forth in the West Virginia Board's 
Order. While it is true that the Order was not issued until after 
the Show Cause Order was issued, the West Virginia Board issued its 
complaint two weeks before the Show Cause Order was issued. 
Moreover, the Board issued its Final Order eight months before the 
Government filed its Request for Final Agency Action. Yet, at no 
point did the Government provide notice to Registrant that it was 
also alleging that his prescribing to the nine patients who were at 
issue in the West Virginia proceeding would also be at issue here. 
While it is true that even if he had notice, the doctrine of 
collateral estoppel would likely foreclose any challenge to those 
findings in this proceeding, I nonetheless conclude that he was 
entitled to notice that the Government also intended to rely on 
these additional allegations. Cf. Fed. R. Civ. P. r 5(a)(2) (``No 
service is required on a party who is in default for failing to 
appear. But a pleading that asserts a new claim for relief against 
such a party must be served on that party . . .'').
     By contrast, because possessing state authority is an essential 
condition for maintaining a practitioner's DEA registration, and the 
Agency has long held that it lacks authority to continue a 
practitioner's registration where a practitioner no longer holds 
state authority to dispense controlled substances, the Agency has 
consistently taken official notice of state board decisions 
suspending or revoking a practitioner's state authority 
notwithstanding that the state did not take action until after the 
issuance of a Show Cause Order. In such cases, adequate notice is 
provided either by the Government's filing of a Motion for Summary 
Disposition (in a case where a hearing was requested) or by taking 
official notice and providing the applicant/registrant with the 
opportunity to refute the finding (when no hearing request was 
filed).
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    Here, having reviewed the Ohio Board's decision, I conclude that 
Registrant had an adequate opportunity to litigate (and did litigate) 
the issues raised in that proceeding. Accordingly, I give preclusive 
effect to the Board's findings of fact and conclusions of law. See 
Neuschatz, 78 FR at 76325; Dougherty, 76 FR at 16830.
    As found above, the Ohio Board adopted its Hearing Examiner's 
findings of fact that with respect to sixteen patients, Registrant:

    (1) ``repeatedly and/or continually treated patients by 
excessively and/or inappropriately prescribing medications'' and 
``continued to prescribe controlled substances without appropriately 
pursuing or documenting the pursuit of alternative non-narcotic 
therapies'';
    (2) ``failed to record in the patients' medical records the 
reason(s) he prescribed medication and/or the need . . . for 
prescribing multiple medications'';
    (3) ``repeatedly and/or continually treated patients without 
performing and/or documenting appropriate physical examinations or 
evaluations, and/or without utilizing and/or documenting appropriate 
diagnostic testing or other methods of evaluating the patients' 
health conditions, and/or without devising and/or documenting 
treatment plans, and/or without periodically reassessing or 
documenting the reassessment of the effectiveness of treatment for 
illnesses'';
    (4) ``failed to adequately and/or appropriately diagnose and/or 
document an adequate or appropriate diagnosis of the patients' 
medical conditions'';
    (5) ``failed to document in the patient record adequate findings 
to support his diagnoses'';
    (6) ``repeatedly and/or continually treated patients without 
making appropriate and/or timely referrals to specialists''; and
    (7) ``failed to keep and maintain adequate records reflecting 
his care and treatment of the patients[,]'' because ``[t]he entries 
in the medical records frequently appeared verbatim from one office 
visit to the next and from one patient to another, with few or no 
changes.''

GX 5, at 142.

    The Ohio Board thus found that Registrant, in treating the sixteen 
patients, violated Ohio law in that he failed to ``maintain minimal 
standards applicable to the selection or administration of drugs, or . 
. . to employ acceptable scientific methods in the selection of drugs 
or other modalities for treatment of disease.'' Id. at 160 (citing Ohio 
Rev. Code Sec.  4731.22(B)(2)). And the Ohio Board also found that 
Registrant's acts, conduct and/or omissions constituted a ``departure 
from or the failure to conform to, minimal standards of care of similar 
practitioners under the same or similar circumstances.'' Id. at 161 
(citing Ohio Rev. Code 4731.22(B)(6)).
    It is acknowledged that the State Board did not charge, and the 
Board did not find, that Registrant violated the provision of the Ohio 
Code which most closely tracks the standard of the CSA's prescription 
requirement. See Ohio Rev. Code 4731.22(b)(3) (authorizing sanction of 
medical license holder for ``[s]elling, giving away, personally 
furnishing, prescribing, or administering drugs for other than legal 
and therapeutic purposes''). Cf. Kenneth Harold Bull, 78 FR 62666, 
62674 n.9 (2013) (dictum). However, while the State Board's legal 
conclusion sounds in malpractice, I nonetheless conclude that the 
Board's factual findings support the conclusion that Respondent's 
prescribing went well ``beyond the bounds of any legitimate medical 
practice, including that which would constitute civil negligence'' and 
thus establish that he acted outside of the usual course of 
professional practice and lacked a legitimate medical purpose in 
prescribing controlled substances to the sixteen patients. Laurence T. 
McKinney, 73 FR 43260, 43266 (2008) (quoting United States v. McIver, 
470 F.3d 550, 559 (4th Cir. 2006)); see also United States v. Feingold, 
454 F.3d 1001, 1010 (9th Cir. 2006) (``[T]he Moore Court based its 
decision not merely on the fact that the doctor had committed 
malpractice, or even intentional malpractice, but rather on the fact 
that his actions completely betrayed any semblance of legitimate 
medical treatment.'').
    Numerous decision of the courts (including the Supreme Court in 
Moore) and this Agency have recognized that the prescribing of a 
controlled substance (and the continued prescribing of a controlled 
substance) under the following circumstances establishes that a 
physician lacked a legitimate medical purpose and acted outside of the 
usual course of professional practice and therefore violated the CSA:
    <bullet> Without performing an appropriate physical examination,
    <bullet> without utilizing appropriate diagnostic testing,
    <bullet> failing to devise and document a written treatment plan,
    <bullet> failing to periodically reassess the effectiveness of the 
treatment,
    <bullet> continuing to prescribe controlled substances without 
pursuing alternative therapies,
    <bullet> repeatedly and continually prescribing without referring 
the patient to appropriate specialists, and
    <bullet> failing to keep and maintain records which contain 
adequate findings to support a diagnosis and the need to prescribe one 
or more medications.

See, e.g.; Paul H. Volkman, 73 FR 30630 (2008), pet. for rev. denied, 
567 F.3d. 215 (6th Cir. 2009); see also David A. Ruben, 78 FR 38363 
(2013); Henri Wetselaar, 77 FR 57126 (2012); Jack A. Danton, 76 FR 
60900 (2011); George C. Aycock, 74 FR 17529, 17544 (2009).
    Accordingly, I hold that the Ohio Board's findings support the 
Government's allegation that Respondent violated 21 CFR 1306.04(a)

[[Page 3629]]

when he prescribed to the sixteen patients discussed in the Board's 
Order.

Other CSA Violations

    As found above, DEA's investigation of Registrant established that 
he has committed numerous additional violations of the CSA related to 
his prescribing as a DATA-Waived practitioner. First, the evidence 
shows that notwithstanding that Registrant was only authorized to 
provide maintenance or detoxification treatment to 100 patients at a 
time, he was in violation of this limit on multiple dates. Indeed, in 
the Ohio Board proceeding, Respondent admitted that he ``currently 
ha[d] 150 patients in our Suboxone program.'' GX 5, at 137. Thus, 
Respondent violated the conditions imposed by federal law on the 
prescribing of Suboxone and Subutex for maintenance or detoxification 
treatment. See 21 U.S.C. 823(g)(2) (A) & (B)(iii); 21 CFR 
1301.28(b)(iii).
    The DI also found evidence that Registrant committed numerous 
violations of the recordkeeping requirement applicable to the 
prescribing of Suboxone and Subutex in the course of maintenance or 
detoxification treatment. See 21 U.S.C. 827(c)(1)(a) Records and 
Reports of Registrants); see also 21 CFR 1304.03(c) (requiring 
registered practitioners to keep records of controlled substances that 
are prescribed in the course of maintenance or detoxification 
treatment).
    The DI's review of OARRS and WVCSMP records found that on twenty-
nine (29) occasions, Registrant failed to record any information in his 
patient files for prescriptions issued for Suboxone and Subutex, in 
violation of 21 U.S.C. 827(a)(3) & (c)(1)(a) and 21 CFR 1304.03(a) & 
(c). Also, the DI's review of the patient files found that between 
September 9, 2012 and March 9, 2013, Registration issued 118 
prescriptions for Suboxone and Subutex, without recording the quantity 
prescribed in the patient's file. See 21 U.S.C. 827(a)(3) (requiring 
the maintenance of a complete and accurate record of each controlled 
substance delivered by him); 21 CFR 1304.22(c) (requiring dispenser's 
records to include ``[t]he name of the substance,'' the ``finished 
form,'' ``the number of units or volumes of such finished form 
dispensed, . . . the name and address of the person to whom it was 
dispensed, the date of the dispensing, [and] the number of units or 
volume dispensed''). Cf. 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, the 
drug name, strength, dosage form, quantity prescribed, directions for 
use, and the name, address and registration number of the 
practitioner.'').
    In addition, the DI found that in seven instances, Registrant had 
issued Suboxone or Subutex prescriptions but had not documented the 
date of the prescription (whether in a log, on the progress note, or by 
making a copy of the prescription and keeping it in the patient's 
file), as well as that in three instances, Registrant failed to 
document whether he had prescribed Suboxone or Subutex.
    The evidence also showed that subsequent to September 26, 2012, 
Registrant issued ten prescriptions for Subutex and/or Suboxone to 
patients, which were faxed from his office at the South German Village 
Medical Center in Columbus, Ohio. Notably, this was after the Ohio 
Board had revoked his medical license and after Registrant had changed 
his DEA registered address to his office in Parkersburg, West Virginia. 
In doing so, Registrant violated the separate registration requirement 
of 21 U.S.C. 822(e), which provides that ``[a] separate registration 
shall be required at each principal place of business or professional 
practice where the [registrant] distributes or dispenses controlled 
substances.'' See also 21 CFR 1301.12(a).
    The evidence also shows that when Registrant applied for an account 
with Smith Medical Partners so that he could purchase controlled 
substances, he provided a false answer to the application's question 
which asked whether ``any sanction or disciplinary action [had] been 
taken regarding any license, permit, or registration issued to'' him. 
Thereafter, Registrant was approved as a customer and ordered both 
buprenorphine and Suboxone from Smith. However, the drugs were returned 
to Smith after Registrant failed to pick them up.
    Pursuant to 21 U.S.C. 843(a)(3), it is ``unlawful for any person 
knowingly or intentionally . . . to acquire or obtain possession of a 
controlled substance by misrepresentation, fraud, forgery, deceptions 
or subterfuge.'' Here, while Registrant never actually obtained 
possession of the drugs, the CSA also provides that ``[a]ny person who 
attempts . . . to commit any offense defined in this subchapter shall 
be subject to the same penalties as those prescribed for the offense, 
the commission of which was the object of the attempt.'' 21 U.S.C. 846.
    At the time Registrant submitted his application to Smith, he 
clearly knew that the Ohio Board had revoked his medical license. See 
GX 7 (Registrant's letter of Sept. 26, 2012 to DI stating that ``I lost 
my Ohio license recently over alleged improper prescribing in 2005''). 
And by falsifying the application, and then proceeding to order the 
controlled substances, Registrant clearly attempted to obtain the drugs 
by ``misrepresentation, fraud, . . . deception, or subterfuge.'' Given 
that the question was clearly part of Smith's process for screening its 
potential new customers, I further conclude that the falsification was 
capable of influencing Smith's decision to approve him as a customer 
and was therefore material. I therefore find that Registrant violated 
federal law when he attempted to procure controlled substances by 
falsifying his application to become a customer of Smith Medical 
Partners.
    As the forgoing demonstrates, Registrant's experience in dispensing 
controlled substances is characterized by his violations of multiple 
provisions of federal law. These include: 1) his violations of the 
prescription requirement, see 21 CFR 1306.04(a); 2) his violations of 
the 100-patient limit on his authority to prescribe as a DATA-Waived 
practitioner, see 21 U.S.C. 823(g)(2)(B)(iii); 3) his violations of the 
separate registration requirement, see 21 U.S.C. 822(e); 4) his 
numerous violations of recordkeeping requirements applicable to the 
prescribing Suboxone and Subutex for the purpose of providing 
maintenance and detoxification treatment, see 21 U.S.C. 827(a)(3) & 21 
CFR 1304.22(c); and 5) his attempt to procure controlled substances by 
misrepresentation and fraud. 21 U.S.C. 843(a)(3) & 846.
    I therefore conclude that the Government's evidence with respect to 
factors two and four establishes that he has committed such acts as 
would render his registration ``inconsistent with the public 
interest.'' Id. Sec.  824(a)(4). I further conclude that the proven 
misconduct is egregious and supports the revocation of Registrant's 
registration.\6\
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    \6\ The Government also alleged that Registrant has not ``been 
candid in providing material information in violation of 21 U.S.C. 
823(f)(5) based on: 1) the application he submitted to Smith Medical 
Partners, 2) testimony he gave on several issues before the Ohio 
Board, and 3) a false statement he made to the West Virginia Board 
Investigator. GX 1, at 2-3. Putting aside that section 823(f)(5) is 
simply a public interest factor and creates no substantive rule of 
conduct, I have concluded that Registrant's submission of his false 
customer application to Smith Medical Partners is properly 
considered under factor four.
    As also found above, the Ohio Board's Hearing Examiner did find 
Registrant's testimony on several issues to be disingenuous. This 
provides some additional support under factor five (not that it is 
needed) for the conclusion that Registrant has committed such acts 
as to render his registration ``inconsistent with the public 
interest.'' 21 U.S.C. 824(a)(4).
    As for the allegation that on March 9, 2013, Registrant made a 
false statement to a West Virginia Board Investigator, the Board 
itself apparently did not pursue the allegation, and given the 
extensive evidence of Registrant's misconduct, I deem it unnecessary 
to address it.

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[[Page 3630]]

Loss of State Authority Grounds

    The Government also seeks the revocation of Registrant's 
registration on the separate and independent ground that he no longer 
holds a valid medical license in West Virginia, and thus lacks 
authority to dispense controlled substances in the State in which he is 
registered with DEA. Pursuant to 21 U.S.C. 824(a)(3), the Attorney 
General is authorized to revoke or suspend a registration ``upon a 
finding that the registrant . . . has had his State license or 
registration suspended, revoked, or denied by competent State authority 
and is no longer authorized by State law to engage in the . . . 
distribution or dispensing of controlled substances.'' With respect to 
a practitioner, ``DEA has repeatedly held that the possession of 
authority to dispense controlled substances under the laws of the State 
in which a practitioner engages in professional practice is a 
fundamental condition for obtaining and maintaining a practitioner's 
registration.'' James L. Hooper, 76 FR 71371, 71371 (2011) (citing 
Leonard F. Faymore, 48 FR 32886, 32887 (1983)), pet. for rev. denied, 
Hooper v. Holder, 481 Fed. Appx. 826, 828 (4th Cir. June 6, 2012) 
(unpublished).
    This rule derives from the text of two provisions of the CSA. 
First, Congress defined ``the term `practitioner' [to] mean [ ] a 
physician . . . or other person licensed, registered or otherwise 
permitted, by . . . the jurisdiction in which he practices . . . to 
distribute, dispense, [or] administer . . . a controlled substance in 
the course of professional practice.'' 21 U.S.C. 802(21). Second, in 
setting the requirements for obtaining a practitioner's registration, 
Congress directed that ``[t]he Attorney General shall register 
practitioners . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f) (emphasis added).
    Because Congress has clearly mandated that a practitioner possess 
state authority in order to be deemed a practitioner under the Act, DEA 
has held repeatedly that revocation of a practitioner's registration is 
the appropriate sanction if the practitioner is no longer authorized to 
dispense controlled substances under the laws of the State in which he 
practices medicine. See, e.g., Calvin Ramsey, 76 FR 20034, 20036 
(2011); Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick 
A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 
(1988).
    Here, I have taken official notice of the West Virginia Medical 
Board's Final Order which revoked Registrant's medical license 
effective with the entry of the Order. Accordingly, I conclude that 
Registrant is without authority under West Virginia law to handle 
controlled substances in the State in which he holds his registration. 
Because Registrant no longer meets the CSA's requirement that he be 
currently authorized to dispense controlled substances in the State in 
which he holds his registration, I will order that his registration be 
revoked for this reason as well. See Craig Bammer, 73 FR 34327, 34329 
(2008); Richard Carino, M.D., 72 FR 71955, 71956 (2007) (citing cases).

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a)(3) & (4), as well as 28 CFR 0.100(b) and 0.104, I order that DEA 
Certificate of Registration BV3249643, issued to Jose Raul S. 
Villavicencio, M.D., be, and it hereby is, revoked. I further order 
that any application of Jose Raul S. Villavicencio, M.D., to renew or 
modify his registration, be, and it hereby is, denied. This Order is 
effectively immediately.\7\
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    \7\ Based on the extensive and egregious nature of the 
misconduct proved by the Government, I conclude that the public 
interest necessitates that this Order be effectively immediately. 21 
CFR 1316.67.

    Dated: December 30, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2015-01221 Filed 1-22-15; 8:45 am]
BILLING CODE 4410-09-P