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Dale L. Taylor, M.D.; Revocation of Registration
FR Doc E7-10622 [Federal Register: June 4, 2007 (Volume 72, Number
106)] [Notices] [Page 30855-30858] From the Federal Register Online via
GPO Access [wais.access.gpo.gov] [DOCID:fr04jn07-87]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Dale L. Taylor, M.D.; Revocation of Registration
On February 2, 2007, I, the Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Immediate
Suspension of Registration to Dale L. Taylor (Respondent) of Winter
Haven, Florida. The Order immediately suspended Respondent's Certificate
of Registration, BT8732631, as a practitioner, based on my preliminary
finding that Respondent was diverting large quantities of controlled
substances through an internet-prescribing scheme. Show Cause Order at
2. I therefore concluded that Respondent's "continued registration
during the pendency of these proceedings would constitute an imminent
danger to the public health and safety because of the substantial
likelihood that [he would] continue to divert controlled substances to
drug abusers.'' Id. at 3.
The Show Cause Order also alleged that Respondent's "continued
registration is inconsistent with the public interest.'' Id. at 1. More
specifically, the Show Cause Order alleged that beginning in May 2004,
Respondent had been issuing prescriptions for controlled substances over
the Internet "without the benefit of a legitimate doctor-patient
relationship and outside the course of professional practice.'' Id. The
Show Cause Order alleged that Respondent had admitted to DEA
investigators that he had done such prescribing for three different
internet entities including Pacific MD, Norco Worldwide, and
BestRxCare.com. Id. at 1-2.
The Show Cause Order further alleged that Respondent had admitted
that he would log onto a Web site and view a list of customers, review
their medical records, and then contact each person by telephone. Id. at
2. The Show Cause Order alleged that Respondent had admitted that his "role
was simply to make sure that the type of medication, strength and
quantity were consistent with the online customers' alleged medical
need,'' and he had "never called patients after authorizing their drug
orders to provide aftercare.'' Id. Relatedly, the Show Cause Order
alleged that Respondent told investigators that he took "the on-line
patient's word when determining their need for hydrocodone.'' Id.
The Show Cause Order alleged that BestRxCare.com's orders were filled
by CRJ Pharmacy and that the pharmacy's records for the period from July
3, 2006, to January 22, 2007, showed that it had dispensed "approximately
6,000 [i]nternet drug orders that [Respondent] authorized.'' Id. The
Show Cause Order alleged that "approximately 85% of these [i]nternet
drug orders were for hydrocodone combination products.'' Id.
Finally, the Show Cause Order alleged that Respondent had admitted to
investigators that he had "authorized controlled substance
[prescriptions] for online customers throughout the United States'' even
though he acknowledged that he was "only licensed to practice medicine
in'' Florida. Id. The Show Cause Order thus alleged that Respondent had
violated various state laws that prohibit "unlicensed, out-of-state
physicians issuing controlled substance prescriptions to state
residents.'' Id.
On February 6, 2007, DEA Investigators served the Show Cause Order
and Immediate Suspension, which notified Respondent of his right to a
hearing, by leaving it at his residence with his wife. Cf. F.R.C.P.
4(e). Since that time, neither Respondent, nor anyone purporting to
represent him, has responded. Because (1) more than thirty days have
passed since service of the Show Cause Order, and (2) no request for a
hearing has been received, I conclude that Respondent has waived his
right to a hearing. See 21
[[Page 30856]]
CFR
1301.43(d). I therefore enter this final order without a hearing
based on relevant material in the investigative file and make the
following findings.
Findings
Respondent is the holder of DEA Certificate of Registration,
BT8732631, as a practitioner, with an expiration date of November 30,
2006. On October 11, 2006, Respondent, however, applied for a renewal of
his registration via the Internet. Therefore, in accordance with the
Administrative Procedure Act, Respondent's registration remains in
existence pending the issuance of a final order in this matter. See 5
U.S.C. 558(c).
According to the investigative file, on January 26, 2007, DEA
investigators interviewed Respondent regarding his participation in
various schemes involving the dispensing of controlled substance over
the Internet. Respondent told the investigators that in early to mid
2004, he answered an advertisement placed by an entity known as Pacific
MD in a Gainesville, Florida newspaper which sought physicians to
perform internet consultations. In May 2004, Pacific MD engaged
Respondent to review patient records and if the records were not more
than two years old, contact the "patient'' and authorize a prescription
which was typically for either combination products containing
hydrocodone, a schedule III controlled substance, see 21
CFR 1308.13(e), or Xanax (alprazolam), a schedule IV controlled
substance. See 21 CFR 1308.14(c).
Respondent related that in June 2005, he quit working for Pacific MD
because it owed him money.
At some date not specified in the investigative file, Respondent
submitted his credentials to a temporary employment service that
specialized in medical staffing. Thereafter, Respondent was contacted by
another entity, Norco Worldwide, and began working for it. Norco gave
Respondent a password which enabled him to review medical records
submitted by Norco's customers. According to Respondent, a physician's
assistant would contact and talk to the patients and authorize a
prescription for a controlled substance using his DEA registration.
Respondent further admitted that he wrote prescriptions on a computer
program, which were then submitted electronically to a pharmacy which
filled them. Respondent stated that he worked for Norco from October
2004 through December 2004 and authorized approximately forty
prescriptions per day. Respondent further told investigators that he
quit Norco because he wasn't comfortable with the fact that a
physician's assistant was authorizing controlled substance prescriptions
using his DEA registration.
Shortly thereafter, Respondent was contacted by one Chris Larson.
Larson had also formerly worked for Norco and had started two Web sites,
BestRx.com, and your painmanagement.com, which allowed persons to order
controlled substances over the Internet by completing a questionnaire
and submitting their "medical records.'' Larson also owned several
pharmacies that filled prescriptions for his Web sites.
Respondent told investigators that he would log onto the BestRx.com
Web site and obtain a list of "patients'' with "appointments.''
Respondent would then review the "patient's'' medical records before
telephoning the person. Respondent asserted that he required the records
to be on the previous physician's letterhead and be signed. Respondent
further maintained that he reviewed the records to determine whether the
drug sought was consistent with the customer's medical condition.
When asked by investigators whether he had ever contacted any of the
customer's prior physicians, Respondent claimed that he had but could
not recall their names. Respondent further admitted that he was not
authorized to require that a customer undergo additional testing and
that the customer had to go to their original physician to obtain such
tests.
Respondent admitted that he simply trusted that the records submitted
by the website's customers were not fraudulent and took the customer's
word during the phone consultation. Based on the medical records and the
phone conversation, Respondent would prescribe controlled substances.
Respondent further admitted that he never called a customer to follow
up. Respondent also admitted that on numerous occasions, customers would
call him seeking more drugs.
One of the investigators then asked Respondent if he maintained any
patient files. Respondent claimed that he kept meticulous record for all
of his "patients'' at his residence in a plastic storage bin located in
his office. Respondent's wife, however, told investigators that the bin
did not contain any medical records but merely the names and addresses
of persons Respondent had spoken with.
Respondent admitted that he had authorized controlled substances
prescriptions for persons located throughout the United States even
though he held only a Florida medical license. Respondent further
admitted that he authorized as many as twenty to twenty-five
prescriptions a day while working for BestRxCare.com.
The investigators asked Respondent to voluntarily surrender his DEA
registration. Respondent refused and stated that he intended to continue
authorizing prescriptions through the Internet because on-line medicine
is the wave of the future. Respondent acknowledged that absent use of a
webcam, it was not possible to verify the validity of a "patient'' and
his or her medical needs. Respondent stated that until then, he would
continue to take online patients at their word and accept their records
as authentic.
On January 22, 2007, DEA personnel executed an Administrative
Inspection Warrant at CRJ Pharmacy and YPM Total Care Pharmacy, two of
the businesses owned by Chris Larson. During the search, DEA obtained
each pharmacy's dispensing records; the records were then reviewed by a
DEA intelligence analyst. According to the records of CRJ Pharmacy,
between July 2006 and January 2007, Respondent authorized 6,069
prescriptions for 1,098 persons who resided in forty-six States and the
District of Columbia. Of the prescriptions, 5,156 were for hydrocodone-
combination products, and 526 were for alprazolam.
The records for YPM showed that from November 27, 2006, through
January 17, 2007, Respondent authorized prescriptions for another 171
patients who resided in thirty-six States. More specifically, Respondent
authorized 367 orders for hydrocodone-combination products and
thirty-three orders for alprazolam. The records also showed that on a
single day, Respondent had written as many as fifty-six orders which
were filled by YPM.
Discussion
Section 304(a) of the Controlled Substances Act 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). In making the public interest determination, the
Act requires the consideration of the following factors:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State laws
relating to the
[[Page 30857]]
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.
"[T]hese 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. 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 (D.C. Cir. 2005).
Finally, section 304(d) provides that "[t]he Attorney General may, in
his discretion, suspend any registration simultaneously with the
institution of proceedings under this section, in cases where he finds
that there is an imminent danger to the public health or safety.'' 21
U.S.C. 824(d). In this case I conclude that Factors Two and Four
establish that allowing Respondent to continue to dispense controlled
substances would be inconsistent with the public interest and therefore
will order the revocation of Respondent's registration and the denial of
his pending application for renewal.
Factors Two and Four--Respondent's Experience in Dispensing
Controlled Substances and Respondent's Compliance With Applicable Laws
The central issue in this case is whether the prescriptions
Respondent issued pursuant to his employment with the Web sites
BestRx.com and yourpainmanagement.com complied with Federal law. As
explained below, the evidence conclusively demonstrates that Respondent
used his prescribing authority to act as a drug pusher; the only
difference between him and a street dealer was that he did not
physically distribute the drugs to the customers of the aforementioned
websites.
Under DEA regulations, 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 related to
controlled substances.'' Id. 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, 126 S.Ct. 904, 925 (2006) (citing Moore, 423 U.S.
122, 135 (1975)).
It is fundamental that a practitioner must establish a bonafide
doctor-patient relationship in order to be acting "in the usual course
of * * * professional practice'' and to issue a prescription for a "legitimate
medical purpose.'' Under the State of Florida's regulations, a physician
"shall not provide treatment recommendations, including issuing a
prescription, via electronic or other means, unless the following
elements have been met:
(a) A documented patient evaluation, including history and physical
examination to establish the diagnosis for which any legend drug is
prescribed.
(b) Discussion between the physician * * * and the patient
regarding treatment options and the risks and benefits of treatment.
(c) Maintenance of contemporaneous medical records meeting the
requirements of [Florida regulations].
Fla. Admin. Code R. 64B8-9.014.
Relatedly, the American Medical Association's Guidance for Physicians
on Internet Prescribing has explained that to establish a bonafide
doctor-patient relationship, a "physician shall'':
i. Obtain a reliable medical history and perform a physical
examination of the patient, adequate to establish the diagnosis for
which the drug is being prescribed and to identify underlying conditions
and/or contraindications to the treatment recommended/ provided; ii.
have sufficient dialogue with the patient regarding treatment options
and the risks and benefits of treatment(s); iii. as appropriate, follow
up with the patient to assess the therapeutic outcome; iv. maintain a
contemporaneous medical record that is readily available to the patient
and * * * to his * * * other health care professionals; and v. include
the electronic prescription information as part of the patient medical
record.
(quoted in William R. Lockridge, 71 FR 77791,77798 (2006)).
To similar effect are the guidelines issued by the Federation of
State Medical Boards of the United States, Inc. See Model Guidelines for
the Appropriate Use of the Internet in Medical Practice. According to
the Guidelines, "[t]reatment and consultation recommendations made in an
online setting, including issuing a prescription via electronic means,
will be held to the same standards of appropriate practice as those in
traditional (face-to-face) settings. Treatment, including issuing a
prescription, based solely on an online questionnaire or consultation
does not constitute an acceptable standard of care.'' Id. at 4 (emphasis
added). Cf. DEA, Dispensing and Purchasing Controlled Substances over
the Internet, 66 FR 21181, 21183 (2001) (guidance document) ("Completing
a questionnaire that is then reviewed by a doctor hired by the Internet
pharmacy could not be considered the basis for a doctor/patient
relationship.'').\1\
---------------------------------------------------------------------------
\1\ The guidance document reflects this Agency's
understanding of what constitutes a bonafide doctor-patient
relationship under state laws and existing professional standards. 66
FR 21182-83.
---------------------------------------------------------------------------
Under the Florida rule and standards of the medical profession, it is
clear that Respondent did not prescribe controlled substances pursuant
to a bonafide doctor-patient relationship and thus did not comply with
federal law. Respondent did not physically examine the "patients.'' Nor
did he ever act in a consultative capacity "with another physician who
ha[d] an ongoing relationship with the patient, and who ha[d] agreed to
supervise the patient's treatment, including the use of any prescribed
medications.'' Fla. Admin. Code R. 64B8- 9.014(4).
Moreover, Respondent admitted that he was not authorized by his
employer to order that a customer undergo additional testing. Respondent
also admitted that he never called a "patient'' to follow- up on whether
the treatment was successful. Finally, notwithstanding his statement to
investigators that he kept meticulous records, the evidence establishes
that Respondent did not maintain medical records on his purported
patients. Thus, it is clear that under Florida law as well as existing
professional standards, Respondent did not establish a bonafide
doctor-patient relationship with the persons he prescribed controlled
substances for. See, e.g., Fla. Admin. Code R. 64B8-9.014.
Moreover, the investigative file establishes that Respondent issued
thousands of prescriptions for controlled substances and did so
notwithstanding the potential for fraud that was inherent in the scheme
and his admission that on numerous occasions, customers called him
requesting more controlled substances. As recognized in Lockridge and
other agency orders, "'[le]gally there is absolutely no
[[Page 30858]]
difference between the sale of an illicit drug on the street and the
illicit dispensing of a licit drug by means of a physician's
prescription.''' 71 FR at 77800 (quoting Mario Avello, M.D., 70 FR
11695, 11697 (2005)). See also Floyd A. Santner, M.D., 55 FR 37581
(1990). In short, Respondent was not engaged in the legitimate practice
of medicine, but rather, was dealing drugs.
Accordingly, Respondent's experience in dispensing controlled
substances and his record of compliance with applicable laws makes plain
that his continued registration would "be inconsistent with the public
interest.'' 21 U.S.C. 824(a)(4). Moreover, for the same reasons which
led me to find that Respondent posed "an imminent danger to the public
health or safety,'' id. section 824(d), I conclude that the public
interest requires that his registration be revoked effective immediately
and his pending application for renewal be denied. See 21
CFR 1316.67.
Order
Pursuant to the authority vested in me by 21
U.S.C. 823(f) & 824(a),
as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA
Certificate Registration, BT8732631, issued to Dale L. Taylor, M.D., be,
and it hereby is, revoked. I further order that Respondent's pending
application for renewal of his registration be, and it hereby is,
denied. This order is effective immediately.
Dated: May 21, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-10622 Filed 6-1-07; 8:45 am]
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