[Federal Register Volume 76, Number 153 (Tuesday, August 9, 2011)]
[Notices]
[Pages 48884-48887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20046]


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 DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Stacey J. Webb, M.D.; Denial of Application

    On February 24, 2010, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order To 
Show Cause to Stacey J. Webb, M.D. (Respondent), of Chesapeake, 
Virginia. The Show Cause Order proposed the denial of Respondent's 
pending application for a DEA Certificate of Registration as a 
practitioner, on the ground that she had committed acts which render 
her registration ``inconsistent with the public interest.'' Order at 1 
(citing 21 U.S.C. 823(f)).
    The Show Cause Order specifically alleged that Respondent, while 
holding a DEA registration (which expired by its terms on May 31, 
2009), had ``prescribed controlled substances to individuals in 
Virginia and Alabama via the Internet based on online questionnaires, 
submissions of unverified medical records, and/or telephone 
consultations without a medical examination.'' Id. The Order further 
alleged that ``[t]he prescriptions * * * were issued for other than a 
legitimate medical purpose or outside the usual course of professional 
practice.'' Id. (citing 21 CFR 1306.04(a)). Specifically, the Order 
alleged that Respondent ``failed to establish a valid physician-patient 
relationship'' as required by the laws of Virginia and Alabama. Id.; 
see Va. Code Ann. Sec. Sec.  54.1-3303, 54.1-2915; Ala. Code Sec.  34-
24-360; Ala. Admin. Code 540-X-9-.11. Finally, the Show Cause Order 
alleged that Respondent holds a medical license in Virginia, but 
prescribed controlled substances via the internet to individuals in 
Alabama without possessing a controlled substance certificate as 
required by state law. Id.

[[Page 48885]]

at 1-2; see Ala. Code Sec.  20-2-51; Ala. Admin. Code 540-X-.01.
    Following service of the Show Cause Order, Respondent initially 
requested a hearing on the allegations and the matter was placed on the 
docket of the Agency's Administrative Law Judges. However, the day 
before the hearing was to convene, Respondent withdrew her request for 
a hearing and submitted a letter in lieu of a hearing. Order 
Terminating Proceedings, at 1; Ltr. of Respondent to Hearing Clerk (May 
24, 2010) (hereinafter, Resp.'s Ltr.) Respondent did, however, respond 
to the allegations of the Show Cause Order. See id. Thereafter, the 
Investigative Record was forwarded to me for Final Agency Action.
    Based on Respondent's letter, I find that she has waived her right 
to a hearing. See 21 CFR 1301.43(c). However, in accordance with 21 CFR 
1301.43(c), Respondent's letter has been made a part of the record and 
will ``be considered in light of the lack of opportunity for cross-
examination in determining the weight to be attached to matters of fact 
asserted therein.'' Id. Having considered the entire record, I issue 
this Decision and Final Order. I make the following findings.

Findings

    On July 14, 2009, Respondent \1\ applied for a DEA Certificate of 
Registration as a practitioner, which, if granted, would authorize her 
to prescribe controlled substances in schedules II through V; 
Respondent listed an address in Chesapeake, Virginia as her registered 
location. GX 1. Respondent previously held a practitioner's 
registration, DEA number BJ4518114, which expired by its terms on May 
31, 2009. Order Terminating Proceedings, at 1 n.1.
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    \1\ Respondent is referred to throughout investigative file by 
the names Stacey Johnson Webb, Stacey J. Webb, and Stacey Johnson. 
When using any of the three names, Respondent consistently listed 
Virginia Board of Medicine license number 0101-240458. Accordingly, 
I find that all three names refer to the same person.
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    On August 1, 2006, the Virginia Board of Medicine issued Respondent 
a license (number 0101-240458) to practice medicine and surgery in the 
Commonwealth of Virginia. In re Stacey Johnson Webb, M.D., Consent 
Order, at 1 (Va. Bd. Med., Sept. 2, 2009) (hereinafter, Va. Consent 
Order). Respondent did not hold a registration as required by Alabama 
law to prescribe controlled substances in that State. Alabama State 
Board of Medical Examiners, Physician/PA Search; see also Ikner Decl., 
at 9.
    From approximately January 2007 through August 2008, Respondent was 
employed by one or more Internet pharmacy ventures known as Telemed 
Ventures and/or Secure Telemedicine (hereinafter, Telemed). Va. Consent 
Order, at 1-2.; Ikner Decl. at 2; see also Resp.'s Ltr.\2\ While 
working for Telemed, Respondent issued prescriptions for controlled 
substances to customers who placed orders through the company's Web 
site. Ikner Decl. at 2.
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    \2\ Respondent's own letter uses the names--Telemed Ventures and 
Secure Telemedicine--interchangeably, suggesting that they are one 
and the same.
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    During interviews conducted by Drug Enforcement Administration 
(DEA) Special Agents and Diversion Investigators with Telemed 
customers, Respondent's customers described learning about Telemed 
through an internet source. Fitzgerald Decl. at 11, Aug. 17, 2010. Once 
connected with the Telemed Web site, customers completed an online 
questionnaire, which included general health questions and Telemed 
disclaimer questions. Id.; Terpening Decl. at 14, Aug. 2, 2010. After 
completing the online questionnaire and paying the consultation fee, a 
doctor assigned to the customer by Telemed contacted the customer. 
Fitzgerald Decl. at 11. The customers then submitted their medical 
records by fax or e-mail and the doctor would call the customer again 
for a telephone consultation. Id.; see also Ikner Decl. at 2.
    Following the telephone consultation with the customer, in most 
instances, an order for a controlled substance was issued and forwarded 
to a pharmacy to dispense the drugs to the customer. Ikner Decl. at 2. 
Respondent's customers ``could choose the type of drug and dosage 
desired.'' Fitzgerald Decl. at 11. One customer reported that he was 
``able to receive the drug he selected every time he visited the 
[Telemed web]site.'' Terpening Decl. at 15.
    During an interview with a DEA Investigator, Respondent admitted 
that she never physically examined the Telemed customers before 
authorizing a prescription, but stated that she spoke with them by 
telephone every other month. Tribble Decl. at 12, Aug. 2, 2010. 
Respondent also admitted that she did not have any medical records for 
the customers, but only ``prescription originals.'' Id. She also had 
not previously treated the Telemed customers. Ikner Decl. at 8. 
According to those customers who were interviewed, while they may have 
had a primary physician, they sought prescriptions from Telemed for 
pain medications, such as hydrocodone, because their treating 
physicians would no longer prescribe the drug to them. Fitzgerald Decl. 
at 11. Moreover, the customers' primary physicians did not refer them 
to Telemed. Id.
    Each of the customers who were interviewed provided a description 
of their interaction with Telemed, and all of them stated that they 
received prescriptions from Respondent; their prescriptions are 
contained in the investigative file. Id.; Terpening Decl., at 14-15. 
For example, in just over two months, Respondent authorized four 
prescriptions for 90 hydrocodone/apap (acetaminophen) (10/325 mg) 
tablets \3\ to Customer T.F., who lived approximately 145 miles from 
Respondent's practice. See GX 3 (Rxs dated Sept. 6 and 26, Oct. 22, and 
Nov. 14, 2007). In addition, in less than a year's time, Respondent 
authorized ten prescriptions for 90 hydrocodone/apap (10/500 mg) 
tablets to Customer D.H., who resided approximately 180 miles from 
Respondent's practice. See GX 9 (Rxs dated Oct. 15, Nov. 16, Dec. 10, 
2007, Jan. 7 and 31, April 18, May 16, June 11, July 18, and Sept. 9, 
2008). The record also contains prescriptions for hydrocodone and 
Ambien \4\ which Respondent authorized for six additional customers who 
were interviewed by the Investigators; none of the customers lived 
closer than 140 miles from Respondent's practice.\5\
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    \3\ This formulation of hydrocodone is a schedule III controlled 
substance. 21 CFR 1308.13(e)(iv).
    \4\ Ambien (zolpidem) is a schedule IV controlled substance. 21 
CFR 1308.14(c)(51).
    \5\ See GX 4 (Rxs issued to L.D. for hydrocodone/apap 10/325 mg 
on Oct. 10 and Nov. 2, 2007); GX 5 (Rxs issued to R.M. for 
hydrocodone/apap 10/325 mg on Aug. 13, Oct. 29, Dec. 31, 2007, and 
Jan. 30, 2008); GX 6 (Rxs issued to N.N. for hydrocodone/apap 10/325 
mg on July 30, Aug. 21, Sept. 24, Oct. 29, Dec. 24, 2007, and Jan. 
17, 2008); GX 7 (Rxs issued to R.D. for zolpidem on Dec. 19, 2007, 
Jan. 18, Feb. 12, Mar. 10, and April 7, 2008); GX 8 (Rxs issued to 
N.C. for hydrocodone/apap 10/325 mg on Jan. 18 and Feb. 13, 2008); 
GX 10 (Rxs issued to K.H. for hydrocodone/apap 10/500 mg on Oct. 2 
and 29, Dec. 13, 2007, Jan. 7, Feb. 4, Mar. 3, April 24, May 20, 
June 20, July 11, and Sept. 4, 2008).
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    While she was employed by Telemed, Respondent based her practice in 
and around Norfolk, Virginia. See e.g., id. During this time, 
Respondent stated that she wrote prescriptions for patients in Virginia 
and Georgia.\6\ Tribble Decl. at 12. The record further contains 
spreadsheets purporting to indicate that she authorized prescriptions 
to patients in Alabama.\7\ Ikner Decl. at 8.
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    \6\ The Order To Show Cause did not, however, allege that 
Respondent issued prescriptions to customers in Georgia.
    \7\ The only evidence of Respondent's having issued 
prescriptions to customers in Alabama is a spreadsheet, which 
purports to list prescriptions Respondent issued to customers in 
Alabama. However, the Investigative Record does not explain how and 
when this document was obtained. In the absence of a foundation for 
this evidence, I conclude that the record lacks substantial evidence 
proving the allegation that Respondent issued prescriptions to 
customers in Alabama.

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[[Page 48886]]

    On September 2, 2009, the Virginia Board of Medicine found that 
Respondent violated Va. Code Sec. Sec.  54.1-2915.A(13), (17) and 54.1-
3303(A), by prescribing controlled substances over the Internet. 
Consent Order, at 1. More specifically, the Board found that from July 
2007 through October 2008, Respondent prescribed controlled substances, 
including opioids (schedule III hydrocodone), outside of a bona fide 
practitioner-patient relationship to numerous persons who ``sought 
medical services'' on the Web site TopLineRx.com; the patients were 
assigned to Respondent by her employer, Secure Telemedicine, LLC, which 
also owned the Web site. Id. at (1) The Board concluded that Respondent 
issued prescriptions to these individuals without having contact beyond 
a telephone conversation, seeing the individuals in person, or 
performing a physical examination of them (either in person or through 
the use of instrumentation and diagnostic equipment). Id. at 1-2.

Discussion

    Section 303(f) of the Controlled Substances Act (CSA) 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 in the case of a practitioner, 
Congress directed that the following factors be considered:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The Respondent's experience in dispensing * * * controlled 
substances.
    (3) The Respondent'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.
    ``[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 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) (citing 
Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005)).
    With respect to a practitioner's registration, the Government bears 
the burden of proving by a preponderance of the evidence that granting 
the application would be inconsistent with the public interest. 21 CFR 
1301.44(d). However, where the Government has made out a prima facie 
case, the burden shifts to the applicant to ``present[] sufficient 
mitigating evidence'' to show why she can be entrusted with a new 
registration. Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008) 
(quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. 
Miller, 53 FR 21931, 21932 (1988))), aff'd, Medicine Shoppe-
Jonesborough v. DEA, 2008 WL 4899525 (6th Cir. 2008).
    ``Moreover, because `past performance is the best predictor of 
future performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th 
Cir.1995), [DEA] has repeatedly held that where a registrant has 
committed acts inconsistent with the public interest, the registrant 
must accept responsibility for [his] actions and demonstrate that [he] 
will not engage in future misconduct.'' Medicine Shoppe, 73 FR at 387. 
See also Jayam Krishna-Iyer, 74 FR 459, 464 (2009) (``[E]ven where the 
Agency's proof establishes that a practitioner has committed only a few 
acts of diversion, this Agency will not grant or continue a 
practitioner's registration unless he accepts responsibility for his 
misconduct.''); Hoxie, 419 F.3d at 483 (``admitting fault'' is 
``properly consider[ed]'' by DEA to be an ``important factor'' in the 
public interest determination); Cuong Trong Tran, 63 FR 64280, 62483 
(1998); Prince George Daniels, 60 FR 62884, 62887 (1995).
    In this matter, while I have considered all of the factors, I 
conclude that it is not necessary to make findings with respect to 
factors one (the recommendation of the state licensing board), three 
(Respondent's conviction record), and five (such other conduct which 
may threaten public health and safety). I find that the Government's 
evidence with respect to Respondent's experience in dispensing 
controlled substances (factor two) and her compliance with applicable 
Federal and State laws related to the distribution and dispensing of 
controlled substances (factor four) makes out a prima facie case that 
Respondent has committed acts which render her registration 
``inconsistent with the public interest.'' 21 U.S.C. 823(f), 824(a)(4). 
I further find that Respondent has not rebutted the Government's prima 
facie case and will therefore deny her application.

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

    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 [her] 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 related to controlled 
substances.'' Id.; see also Va. Code Ann. Sec.  54.1-3303 (``A 
prescription not issued in the usual course of treatment * * * is not a 
valid prescription.'').
    As the U.S. Supreme Court has explained, ``the [CSA's] 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 Kamir 
Garces-Mejias, 72 FR 54931, 54935 (2007); United Prescription Services, 
Inc., 72 FR 50397, 50407 (2007); but see 21 U.S.C. 829(e)(2)(B) 
(providing federal standard for prescribing over the Internet as of 
October 15, 2008).

[[Page 48887]]

    Under Virginia law, a ``prescription * * * 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 statute 
defines the term ``bona fide practitioner-patient-pharmacist 
relationship'' as ``one in which a practitioner prescribes, and a 
pharmacist dispenses, controlled substances in good faith to his 
patient for a medicinal or therapeutic purpose within the course of his 
professional practice.'' Id. To establish a ``bona fide practitioner-
patient relationship,'' the ``practitioner shall'' meet the following 
criteria:
    (i) [E]nsure that a medical or drug history is obtained;
    (ii) [P]rovide information to the patient about the benefits and 
risks of the drug being prescribed;
    (iii) [P]erform 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; except for medical emergencies, the 
examination of the patient shall have been performed by the 
practitioner himself, within the group in which he practices, or by a 
consulting practitioner prior to issuing a prescription; and
    (iv) [I]nitiate additional interventions and follow-up care, if 
necessary, especially if a prescribed drug may have serious side 
effects. Id.
    Respondent violated the CSA's prescription requirement because she 
did not establish a bona fide doctor-patient relationship with the 
Telemed customers. While Respondent was a resident of Virginia, her 
practice was located a substantial distance from the majority of the 
Virginia residents she prescribed to through Telemed. Most 
significantly, Respondent admitted to Investigators that she prescribed 
on the basis of telephonic consultations and did not conduct a physical 
examination of the customers; she also admitted that she did not 
maintain medical records for them.
    In her letter responding to the allegations, Respondent maintained 
that her ``actions met [Virginia's] definition of a practitioner-
patient relationship.'' Resp.'s Ltr. at 1. First, Respondent maintained 
that patients submitted their medical records, that Telemed scrutinized 
the documents for legitimacy, and that she reviewed records and called 
the customer's primary care physician and/or consultant. Id. Second, 
Respondent stated that she provided information to her customers 
regarding the risks and benefits of each medication and that this 
information was documented in the Telemed medical record. Id. Third, 
Respondent maintained that she only continued a treatment plan 
initiated by the primary care provider or specialist, and that she did 
not ``make a new diagnosis or initiate a new medication.'' Id. Finally, 
Respondent wrote that the Telemed customers were ``required to see 
their primary care physician or consultant at least every three months 
to update their condition, diagnosis and/or treatment plan.'' Id.
    In her letter, Respondent maintained that based on her ``literal 
reading of the Virginia code,'' her actions met the definition of a 
practitioner-patient relationship. Id. Respondent also argued that 
under ``case law and other sources,'' a physician patient 
``relationship is established when a patient seeks medical care and/or 
advice from a practitioner, and the practitioner knowingly provides 
medical care and/or advice to the patient.'' Id. at 2.
    That may be as a matter of tort liability, but that does not mean 
that the relationship complies with accepted standards of medical 
practice necessary to properly diagnose a patient and issue treatment 
recommendations, including prescribing a controlled substance. Indeed, 
the Virginia Board found Respondent's position unavailing, concluding 
that she ``issu[ed] prescriptions to [customers of the website] despite 
the fact that her contact with the individuals was solely by telephone 
and despite the fact that she never saw these individuals in person, 
and did not perform any examination of them either physically or by the 
use of instrumentation and diagnostic equipment.'' Consent Order at 1-
2. The Board further concluded that Respondent ``prescribed controlled 
substances including opioids * * * to numerous individuals outside of a 
bona fide practitioner-patient relationship.'' Id. at 1.
    In numerous other cases involving practitioners who prescribed 
controlled substances over the internet and telephone to persons they 
had never physically examined and with whom they did not establish a 
bona-fide doctor-patient relationship, DEA has denied pending 
applications and revoked registrations pursuant to its authority under 
21 U.S.C. 824(a)(4). See Ladapo O. Shyngle, M.D., 74 FR 6056 (2009) 
(denying application for DEA registration after Respondent issued 
prescriptions outside bona fide doctor-patient relationship with 
customers of a website); see also Ronald Lynch, M.D., 75 FR 78745 
(2010); George Mathew, M.D., 75 FR 66138 (2010); Patrick W. Stodola, 
M.D., 74 FR 20727 (2009); Dale L. Taylor, M.D., 72 FR 30855 (2007); 
Andre DeSonia, M.D., 72 FR 54293 (2007). Likewise, several Federal 
courts have held that such prescribing constitutes a criminal violation 
of the CSA. United States v. Nelson, 383 F.3d 1227, 1231-32 (10th Cir. 
2004); cf. United States v. Smith, 573 F.3d 639, 657-58 (8th Cir. 
2009); United States v. Fuchs, 467 F.3d 889 (5th Cir. 2006).
    I therefore conclude that because Respondent failed to establish a 
legitimate physician-patient relationship with various persons found 
above, she lacked a legitimate medical purpose and acted outside of the 
usual course of professional practice in prescribing controlled 
substances to them and thus violated Federal law. See 21 CFR 
1306.04(a); 21 U.S.C. Sec.  841(a)(1). I further conclude that 
Respondent's experience in dispensing controlled substances (factor 
two) and record of compliance with applicable laws related to 
controlled substances (factor four) establishes that granting 
Respondent's application for a new registration ``would be inconsistent 
with the public interest.'' 21 U.S.C. 823(f). Finally, based on 
Respondent's letter, I find that Respondent has failed to accept 
responsibility for her misconduct and has therefore not rebutted the 
Government's prima facie case. See, e.g., Krishna-Iyer, 74 FR at 464; 
see also Hoxie, 419 F.3d at 483. Accordingly, Respondent's application 
will be denied.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 
CFR 0.100(b), I order that the application of Stacey J. Webb, M.D., for 
a DEA Certificate of Registration as a practitioner be, and it hereby 
is, denied. This order is effective September 8, 2011.

    Dated: August 2, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-20046 Filed 8-8-11; 8:45 am]
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