[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Notices]
[Pages 20036-20039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8545]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Clifton D. Burt, M.D.; Revocation of Registration

    On April 6, 2010, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Clifton D. Burt (Registrant) of Richmond, Virginia and 
Union, New Jersey. The Show Cause Order proposed the revocation of 
Registrant's DEA Certificates of Registration, FB0575499 and FB1499587, 
on the ground that his ``continued registrations are inconsistent with 
the public interest as that term is defined in 21 U.S.C. 823(f).'' Show 
Cause Order, at 1.
    The Show Cause Order alleged that from ``May 2008 to October 
2008,'' Registrant ``prescribed controlled substances to individuals 
via the Internet based on online questionnaires, submissions of 
unverifiable medical records, and telephone consultations'' such that 
the prescriptions ``were for other than a legitimate medical purpose or 
outside the usual course of professional practice in contravention of 
21 CFR 1306.04(a).'' Id. at 2. The Order further alleged that 
Registrant ``failed to establish a valid physician-patient relationship 
as required by the laws of Virginia.'' Id. (citing, inter alia, Va. 
Code Ann. Sec. Sec.  54.1-2915.A(3), (13), (16) & (17)). The Order next 
alleged that ``[f]rom October 2008 to March 2009,'' Registrant 
``directly dispensed control substances to patients in Schedules IV and 
V without possessing a controlled substance certificate in violation of 
the laws of the Commonwealth of Virginia.'' Id. (citing, inter alia, 
Va. Code Ann. Sec. Sec.  54.1-2914.A., 54.1-2915.A(17) & (18), 54-1-
111.A(4),\1\ and 54.1-3303(A)). The Order also informed Registrant of 
his right to request a hearing or to submit a written statement in lieu 
of a hearing, the applicable procedures for doing so, and the 
consequence if he failed to do either. Id. at 2-3.
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    \1\ The correct citation is Va. Code Ann. Sec.  54.1-111.A(4).
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    On April 9, 2010, the Show Cause Order was served on Registrant by 
registered mail addressed to him at both of his registered locations. 
Since that time, thirty days have now passed, and neither Registrant, 
nor anyone purporting to representing him, has either requested a 
hearing or submitted a written statement. I therefore find that 
Registrant has waived his rights under 21 CFR 1301.43(b) and (c) and 
therefore

[[Page 20037]]

issue this Decision and Final Order based on relevant evidence 
contained in the record submitted by the Government. 21 CFR 1301.43(e).

Findings

    Registrant is the holder of two DEA registrations, both of which 
authorize him to dispense controlled substances in schedules II through 
V as a practitioner: (1) Certificate of Registration FB1499587, issued 
for the registered location of 1505 Stuyvesant Avenue, Union, New 
Jersey, and which expires on July 31, 2012; and (2) Certificate of 
Registration FB0575499, issued for the registered location of 9211 
Burge Avenue, Richmond, Virginia, which expires on July 31, 2010. The 
record, however, contains no evidence as to whether Respondent has 
filed an application to renew the latter registration.
    On September 17, 2008 a DEA Diversion Investigator (DI) and a DEA 
Special Agent (SA) interviewed patient T.M. at the Richmond District 
Office. T.M. indicated that since 2006, he had obtained hydrocodone 
through the Web site Fortune Telemed on ten to fifteen occasions. T.M. 
stated that he acquired the drugs by visiting the Web site, filling out 
an online questionnaire, and requesting the drug; T.M. also faxed his 
medical records to the Web site. Thereafter, T.M. spoke on the phone 
with individuals who identified themselves as physicians and who, after 
a brief consultation, wrote prescriptions for him for hydrocodone/
acetaminophen(apap) (10/325 mgs.), the drug he had requested. T.M. was 
never physically examined by, let alone met, any of the physicians who 
issued the prescriptions he obtained through Fortune Telemed.
    During his interview, T.M. did not recall the names of the Fortune 
Telemed physicians. However, the record contains copies of two 
controlled substance prescriptions (dated June 7 and July 20, 2008) 
issued by Registrant for T.M., both of which were for 45 tablets of 
hydrocodone/apap (10/325 mgs.), a schedule III controlled substance. 
See 21 CFR 1308.13(e).
    On September 18, 2008, two DIs interviewed patient N.N. N.N. stated 
that he had received hydrocodone/apap (10/325 mgs.) ten to fifteen 
times in the last year and a half from the Web site Topline.com. N.N. 
stated that to acquire the drugs, he had completed an online 
questionnaire, requested the drug and faxed his medical records to 
Topline; thereafter, N.N. was called by individuals who identified 
themselves as physicians and who wrote the prescriptions after 
consultations which typically lasted less than five minutes. N.N. was 
never physically examined by, nor saw, any of these physicians.
    N.N. did not remember the names of any of the Topline physicians. 
The record, however, contains a copy of a prescription written by 
Registrant for N.N. on June 10, 2008 for 90 tablets of hydrocodone/apap 
(10/325 mgs.).
    On September 24, 2008, a DI and SA interviewed patient R.D. in 
Alexandria, Virginia. R.D. stated that during the previous two and a 
half to three years, he had obtained hydrocodone/apap (10/500 mgs.) 
approximately 30 times from the Web site Telemed. R.D. stated that he 
had filled out an online questionnaire, requested the drug, and faxed 
his medical records to Telemed. Thereafter, R.D. was called by 
individuals who identified themselves as doctors from Telemed, who then 
did a two to three minute-long consultation with him. R.D. stated that 
he never was physically examined by the Telemed doctors and never saw 
them.
    Although R.D. stated that he had obtained hydrocodone 10 mg. from 
Telemed, the only prescriptions written by Registrant for him which are 
in the record were for 30 tablets of Ambien (zolpidem), a schedule IV 
controlled substance.\2\ See 21 CFR 1308.14(c). The prescriptions were 
dated July 1, October 14, November 26, and December 26, 2008.
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    \2\ Ambien is the name brand of generic zolpidem.
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    On September 26, 2008, a DI and an SA interviewed patient K.H. at 
his residence in Manassas, Virginia. K.H. indicated that he first 
visited the Topline Web site to obtain drugs in ``[e]arly 2008.'' He 
completed an online questionnaire and faxed his medical records to the 
site. He was then contacted by individuals identifying themselves as 
physicians who, after ``[n]o more than five (5) minutes'' of 
conversation, wrote prescriptions for hydrocodone/apap (10/500 mgs.). 
The Topline doctors issued the prescriptions without ever physically 
examining or meeting him.
    The investigative file contains three controlled substance 
prescriptions written by Registrant for K.H. All were for 90 tablets of 
hydrocodone/apap (10/500 mgs.) and are dated October 30, November 28, 
and December 23, 2008.
    On Wednesday, March 4, 2009, an Intelligence Research Specialist 
(IRS), a DI, and an Investigator from the Virginia Department of Health 
Professionals interviewed Registrant at his place of employment, 
Concentra Medical Center (``Concentra'') in Richmond, Virginia. 
Registrant stated that he first learned about Telemed Ventures, L.L.C. 
(``Telemed'') through advertising in May 2008 and that he contacted the 
company on his own initiative. After speaking with a woman named Ana 
Goris and providing his curriculum vitae and licensing information, he 
then spoke with the Medical Director, Dr. John Maye.
    During the interview, Registrant stated that he was still working 
for Telemed. In the interview, he indicated that he would review any 
medical records submitted by the customer and talk with him, discuss 
the side effects of the drug being sought, and then authorize the 
prescription, which he would fax to Telemed Ventures, L.L.C. He further 
claimed that he could deny the prescription if he chose to.
    According to Registrant, customers were required to submit updated 
records approximately every four to six months, but he did not state 
what records were required. Registrant stated that he never ordered any 
medical tests for any of Telemed's customers and that he never 
independently verified customer records. He further asserted that he 
would speak with approximately three to nine customers per week and 
admitted that he never saw the customers in person or evaluated them 
face-to-face. He also stated that he was paid $25.00 for new patients 
and $20.00 for returning patients and that he received a check every 
Friday in payment for the consultations he had done the previous week. 
Finally, he stated that the majority of the Telemed customers requested 
hydrocodone.
    On November 7, 2009, Registrant entered into a Consent Order with 
the Virginia Board of Medicine (``the Board''). In its Findings of 
Fact, the Board determined that Registrant ``violated Sections 54.1-
2915.A(3),\3\ (13),\4\ (16) \5\ and (17),\6\ and Section 54.1-

[[Page 20038]]

3303.A \7\ of the Code, in that from May 2008 to October 2008, he 
prescribed controlled substances, including hydrocodone * * * and 
zolpidem * * * to individuals outside of a bona fide practitioner-
patient relationship.'' Consent Order, at 1. According to the Consent 
Order, ``during that time period [Registrant] was employed by Secure 
Telemedicine, LLC (``Telemed''), a company offering medical services 
and prescriptions to patients via its Web site, TopLineRx.com.'' Id. 
The Consent Order further indicated that Registrant ``stated that he 
would review medical records and speak with patients by phone prior to 
issuing a prescription'' and that he ``prescribed controlled substances 
to these individuals without seeing these patients in person and 
without performing any physical examinations on these patients.'' Id. 
at 1-2.
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    \3\ Under Virginia law, the Board may discipline a physician, 
suspend his license or revoke his license for the ``unprofessional 
conduct'' of ``[i]ntentional or negligent conduct in the practice of 
any branch of the healing arts that causes or is likely to cause 
injury to a patient or patients.'' Va. Code Ann. Sec.  54.1-
2915.A(3).
    \4\ This paragraph makes it unprofessional conduct for a 
physician to ``[c]onduct[] his practice in a manner as to be a 
danger to the health and welfare of his patients or to the public.'' 
Va. Code Ann. Sec.  54.1-2915.A(13).
    \5\ This paragraph makes it unprofessional conduct for a 
physician to ``[p]erform[] any act likely to deceive, defraud, or 
harm the public.'' Va. Code Ann. Sec.  54.1-2915.A(16).
    \6\ This paragraph makes it unprofessional conduct for a 
physician to ``[v]iolat[e] any provision of statute or regulation, 
state or federal, relating to the manufacture, distribution, 
dispensing, or administration of drugs.'' Va. Code Ann. Sec.  54.1-
2915.A(17).
    \7\ Similar to the CSA, Virginia law provides that a 
``prescription for a controlled substance may be issued only by a 
practitioner of medicine * * * who is authorized to prescribe 
controlled substances'' and that the ``prescription shall be issued 
for a medicinal or therapeutic purpose and may be issued only to 
persons * * * with whom the practitioner has a bona fide 
practitioner-patient relationship.'' Va. Code Ann. Sec.  54.1-
3303.A. The section also provides, in pertinent part, that ``a bona 
fide practitioner-patient relationship means that the practitioner 
shall * * * (iii) perform or have performed an appropriate 
examination of the patient, either physically or by means of 
instrumentation and diagnostic equipment through which images and 
medical records may be transmitted electronically.'' Id.
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    In its findings, the Board also determined that Registrant 
``violated Sections 54.1-2915.A(17) and (18),\8\ and Section 54.1-
111.A(4) \9\ of the Code, in that, from approximately October 2008 to 
March 4, 2009, he dispensed controlled substances in Schedules IV, V, 
and VI to patients without being licensed by the Board of Pharmacy, as 
required by Section 54.1-3302 of the Code.'' Id. at 2. The Board 
further found that ``since October 1, 2008, [Registrant] has been 
employed by Concentra Medical Center * * * in Richmond, Virginia, 
providing medical care to workers' compensation patients,'' that he 
``admits that he has dispensed controlled substances during the course 
of his employment with Concentra, and states that he was unaware that 
he was required to have an additional license to do so.'' \10\ Id. By 
the terms of the Consent Order, Registrant received a reprimand, was 
fined fifteen hundred dollars ($1,500.00), and was required to complete 
``at least twelve (12) hours of continuing medical education * * * in 
the subject of proper prescribing.'' Id.
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    \8\ This paragraph makes it unprofessional conduct to 
``[v]iolat[e] or cooperat[e] with others in violating any of the 
provisions of Chapters 1, 24, and this chapter or regulations of the 
Board.'' Va. Code Ann. Sec.  54.1-2915.A(18).
    \9\ This section makes illegal ``[p]erforming any act of 
function which is restricted by statute or regulation to persons 
holding a professional or occupational license or certification, 
without being duly certified or licensed.'' Va. Code Ann. Sec.  
54.1-111.A(4).
    \10\ In the Consent Order, Registrant ``neither admit[ted] nor 
den[ied] the truth of the * * * Findings of Fact, but agree[d] not 
to contest them in any future proceedings before'' the Board. Id. at 
3. This, however, does not foreclose the Agency from giving weight 
to these findings.
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Discussion

    Section 304(a) of the Controlled Substances Act (``CSA'') provides 
that a ``registration pursuant to section 823 of this title 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 make 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). In the case of a practitioner, 
Congress directed that the following factors be considered 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. 21 U.S.C. 823(f).

    ``[T]hese factors are * * * considered in the disjunctive.'' Robert 
A. Leslie, 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 to revoke an existing registration 
or to deny an application. Id. Moreover, 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 Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 
2005).
    While I have considered all five factors, I conclude that it is not 
necessary to make findings as to factors one, three, and five. As 
explained below, I conclude that the evidence relevant to Registrant's 
experience in dispensing controlled substances (factor two) and his 
compliance with applicable laws related to controlled substance (factor 
four) establishes that he has committed acts which render his 
registration ``inconsistent with the public interest.'' 21 U.S.C. 
824(a)(4). I will therefore order that his registration be revoked and 
that any pending application be denied.

Factors Two and Four: Registrant's Experience in Dispensing Controlled 
Substances and Record of Compliance With Applicable Controlled 
Substance Laws

    Under a longstanding DEA regulation, 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. See also 21 U.S.C. 802(10) (Defining 
the term ``dispense'' as meaning ``to deliver a controlled substance to 
an ultimate user * * * by, or pursuant to the lawful order of, a 
practitioner, including the prescribing and administering of a 
controlled substance.'')
    As the Supreme Court recently 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)).
    Under the CSA it is fundamental that a practitioner must establish 
and maintain a bona fide doctor-patient relationship in order to act 
``in the usual course of * * * professional practice'' and to issue a 
prescription for a ``legitimate medical purpose.'' Laurence T. 
McKinney, 73 FR 43260, 43265 n.22 (2008); 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.''). At the time of the events at issue here, the CSA 
generally looked to state law to determine whether a doctor and patient 
have established a bona fide doctor-patient relationship. See 
Christopher Henry Lister, 75 FR 28068,

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28069 (2010); Kamir Garces-Mejia, 72 FR 54931, 54935 (2007); United 
Prescription Services, Inc., 72 FR 50397, 50407 (2007).
    Under Virginia law, a controlled substance prescription ``shall be 
issued for a medicinal or therapeutic purpose and may be issued only to 
persons * * * with whom the practitioner has a bona fide practitioner-
patient relationship.'' Va. Code Ann. Sec.  54.1-3303.A. Furthermore, 
under the statute, ``a bona fide practitioner-patient relationship 
means that the practitioner shall * * * (iii) perform or have performed 
an appropriate examination of the patient, either physically or by the 
use of instrumentation and diagnostic equipment through which images 
and medical records may be transmitted electronically.'' Id.
    As found above, Registrant admitted in an interview with agency 
Investigators that he prescribed controlled substances for Telemed 
without conducting physical examinations of its customers. Moreover, 
the record shows that each of the four persons who were interviewed by 
DEA Investigators, obtained controlled substances from Telemed through 
prescriptions issued by him, without being physically examined by him, 
let alone seeing him. The Virginia Board's findings corroborate the 
various admissions Registrant made in his interview as well as the 
statements made by T.M., N.N., R.D., and K.H. in their respective 
interviews. I therefore find that Registrant issued controlled 
substances to internet patients without physically examining them and 
that he failed to establish a bona fide doctor-patient relationship 
with the Telemed customers. I further hold that in prescribing 
controlled substances to these persons, Respondent lacked a legitimate 
medical purpose and acted outside of the usual course of professional 
practice. 21 CFR 1306.04(a). Respondent thus violated both the CSA and 
Virginia law.
    I further find--as did the Virginia Board--that Registrant violated 
Virginia Code Sec. Sec.  54.1-2915.A(17) & (18) in that between October 
2008 and March 2009, he prescribed controlled substances in Virginia's 
schedules IV through VI in the State of Virginia without possessing the 
required license. Consent Order, at 2; see also Christopher Henry 
Lister, 75 FR 28068, 28069 (2010) (citing University of Tennessee v. 
Elliot, 478 U.S. 788, 797-98 (1986)). This conduct also violated a DEA 
regulation. See 21 CFR 1306.03(a)(1). I therefore find that Registrant 
violated both DEA regulation and Virginia law in this regard as 
well.\11\
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    \11\ Under Federal law, because Respondent did not hold a 
Virginia license to dispense controlled substances, he was not even 
entitled to hold a DEA registration in the State because he did not 
meet a statutory prerequisite for obtaining a registration. See 21 
U.S.C. 802(21) (defining ``[t]he term `practitioner' [as] a 
physician * * * licensed, registered, or otherwise permitted, by the 
United States or the jurisdiction in which he practices * * * to 
dispense * * * a controlled substance in the course of professional 
practice''); id.Sec.  823(f) (``The Attorney General shall register 
practitioners * * * to dispense * * * controlled substances * * * if 
the applicant is authorized to dispense * * * controlled substances 
under the laws of the State in which he practices.''). See also 
Jovencio L. Raneses, 75 FR 11563, 11564 (2010); Nasim F. Khan, 73 FR 
4630, 4632 (2008).
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    In sum, the evidence shows that Registrant has repeatedly violated 
both Federal and State laws related to the dispensing of controlled 
substances and has therefore committed acts which render his 
registration ``inconsistent with the public interest.'' 21 U.S.C. 
824(a)(4). Accordingly, Respondent's registrations will be revoked and 
any pending application to renew or modify either registration will be 
denied.

Order

    Pursuant to the authority vested in me by 21 U.S.C. Sec. Sec.  
823(f) & 824(a)(4), as well as 28 CFR 0.100(b) & 0.104, I order that 
DEA Certificate of Registration FB1499587, issued to Clifton D. Burt, 
M.D., be, and it hereby is, revoked. I also order the Office of 
Diversion Control to determine whether Clifton D. Burt, M.D., filed a 
timely renewal application for DEA Certificate of Registration 
FB0575499, and if so, order that this registration be, and it hereby 
is, revoked. I further order that any pending application of Clifton D. 
Burt, M.D., to renew or modify his registrations, be, and it hereby is, 
denied. This Order is effective May 11, 2011.

    Dated: April 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-8545 Filed 4-8-11; 8:45 am]
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