Dale L. Taylor, M.D.; Revocation of Registration, 30855-30858 [E7-10622]
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Federal Register / Vol. 72, No. 106 / Monday, June 4, 2007 / Notices
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physicians on almost every other day it
was open for business.
As recognized in other cases, the
sheer volume of prescriptions thus
establishes that it more likely than not
that Respondent’s owner knew that the
prescriptions were illegitimate and
intentionally ignored this. See, e.g.,
Bertolino, 55 FR 4729, 4730. Beyond
that, the prescriptions were being sent
to persons in every part of the country.
Moreover, there is also some evidence
that the iPharmacy physicians
performed their reviews in rapid-fire
fashion. Yet none of this prompted
Respondent’s owner to question the
legality of the prescriptions. Contrary to
Mr. Enemchukwu’s assertion that
‘‘everything we are looking at now is
from hindsight,’’ Tr. 850, shortly into
the relationship with iPharmacy, Mr.
Enemchukwu was receiving abundant
evidence—on a nearly daily basis—to
know that iPharmacy (and its doctors)
were engaged in illegal activity.12
I thus conclude that Respondent is
responsible for the dispensing of more
than 43,000 illegal prescriptions and the
diversion of more than two million
dosage units of various controlled
substances. Not only is this a violation
of federal law, see 21 U.S.C. 841(a), and
appears to be a violation of Florida
law,13 see Fla. Stat. 465.016(s), it is
manifest that diversion on this scale
creates an extraordinary threat to the
public health and safety. Respondent’s
experience in dispensing controlled
substances and its record of compliance
with applicable laws thus provide
abundant reason to conclude that
Respondent committed acts which
rendered its registration ‘‘inconsistent
12 Respondent’s owner makes no claim that it was
reasonable for him to rely on the representations
made by Mr. Butler both orally and in the contract
regarding the legality of internet prescribing and
dispensing. This is rightly so for three reasons: (1)
Mr. Enemchukwu is a licensed professional and is
responsible for knowing the rules applicable to the
practice of his profession, (2) in April 2001, nearly
three years before he entered into the contract with
Mr. Butler, DEA published guidance which
explained the application of existing federal laws
and regulations to the proposed arrangement, and
(3) other bodies such as the AMA and Federation
of State Medical Boards had published information
regarding the invalidity of internet prescribing
under both ethical and legal standards. See Gov.
Exs. 3 & 4.
13 The Government also argues that Respondent
violated various state laws by dispensing to persons
in States where it was not licensed to do so. See
Gov. Br. at 48. In its brief, the Government did not,
however, cite to specific laws establishing the
licensure requirements of various States. Moreover,
the Government’s proof was largely confined to an
e-mail in which Respondent sought reimbursement
for the fees it paid to obtain the permits. The
Government’s evidence did not cite to specific
instances in which Respondent dispensed in
violation of a particular State’s law. See Tr. 361–
62.Therefore, I conclude that this allegation had not
been proved with substantial evidence.
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with the public interest’’ and thus
warranted the suspension of its
registration under section 304(a). 21
U.S.C. 824(a)(4).14
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824, as well as 28 CFR
0.100(b) & 0.104, the order of immediate
suspension of DEA Certificate of
Registration, BT2863668, issued to
Trinity Health Care Corporation, d/b/a/
Oviedo Discount Pharmacy, is hereby
affirmed.
Dated: May 21, 2007,
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7–10627 Filed 6–1–07; 8:45 am]
BILLING CODE 4410–09–P
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
14 Based on Mr. Enemchukwu’s insistence that he
did not know and had no reason to believe that the
iPharmacy prescriptions were unlawful, the ALJ
further concluded that he had failed to
acknowledge his wrongdoing and thus was not
‘‘willing to accept the responsibilities inherent in a
DEA registration.’’ ALJ at 31. While I agree with the
ALJ’s view of the evidence, there is neither an
existing registration to revoke nor a pending
application to deny. As this case is now limited to
a review of the validity of the suspension, there is
no need to considerer this finding and weigh it
against the slight mitigating evidence in the case.
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30855
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-ofstate 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
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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
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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
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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 hydrocodonecombination 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
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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.
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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
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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 doctorpatient 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
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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
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
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.
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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]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Office of the Secretary
Submission for OMB Emergency
Review; Comment Request
rwilkins on PROD1PC63 with NOTICES
May 29, 2007.
The Department of Labor has
submitted the following information
collection request (ICR), utilizing
emergency review procedures specified
in 5 CFR 1320.13, for the Office of
Management and Budget (OMB) review
and clearance in accordance with the
Paperwork Reduction Act of 1995 (Pub.
L. 104–13, 44 U.S.C. Chapter 35). OMB
approval has been requested by June 19,
2007. A copy of this ICR, with
applicable supporting documentation,
from RegInfo.gov at https://
www.reginfo.gov/public/do/PRAMain or
by contacting Darrin King on 202–693–
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20:34 Jun 01, 2007
Jkt 211001
4129 (this is not a toll-free number) / email: king.darrin@dol.gov.
Comments and questions about the
ICR listed below should be submitted to
the Office of Information and Regulatory
Affairs, Attn: OMB Desk Officer for the
Department of Labor, Office of
Management and Budget, Room 10235,
Washington, DC 20503 (202–395–7316)
(this is not a toll-free number), and
received 5 days prior to the requested
OMB approval date.
The Office of Management and Budget
is particularly interested in comments
which:
• Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
• Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
• Enhance the quality, utility, and
clarify of the information to be
collected; and
• Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
Agency: Office of the Assistant
Secretary for Administration and
Management.
Title: Contractor Data Collection
Form.
OMB Number: 1225–0NEW.
Frequency: On occasion.
Affected Public: Individuals.
Number of Respondents: 5,000.
Estimated Time per Respondent: 12
minutes.
Total Burden Hours: 1,000.
Total Burden Cost (capital/startup):
$0.
Total Burden Cost (operating/
maintaining): $0.
Description: Under Homeland
Security Presidential Directive 12
(HSPD–12), federal agencies are
required to comply with a standard for
identification issued to Federal
employees and contractors known as
FIPS–201 Personal Identity Verification
(PIV) of Federal Employees and
Contractors. In order to comply with the
directive and issue the new federal
credential to contractor personnel, the
DOL must collect certain data required
for the creation of an applicant record
in its Personal Identity Verification II
(PIV–II) system and for issuance of the
PIV–II badge.
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The information will be used to
determine suitability for the issuance of
DOL credentials. The information will
be used to identity proof and register
applicants as part of the Personal
Identity Verification process. Providing
this information is voluntary; however,
failure to submit this information may
result in denial of a DOL credential.
Without this form, DOL contractors are
not reviewed with the same rigor
applied to its Federal staff with respect
to HSPD–12/PIV–II credentialing
standards.
Edward C. Hugler,
Deputy Assistant Secretary for
Administration and Management.
[FR Doc. E7–10649 Filed 6–1–07; 8:45 am]
BILLING CODE 4510–23–P
DEPARTMENT OF LABOR
Employment and Training
Administration
Workforce Investment Act; Lower
Living Standard Income Level
Employment and Training
Administration, Labor.
ACTION: Notice of determination of lower
living standard income level.
AGENCY:
SUMMARY: Under Title I of the Workforce
Investment Act (WIA) of 1998 (Pub. L.
105–220), the Secretary of Labor
annually determines the Lower Living
Standard Income level (LLSIL) for uses
described in the law. WIA defines the
term ‘‘Low Income Individual’’ as one
who qualifies under various criteria,
including an individual who received
income for a six-month period that does
not exceed the higher level of the
poverty line or 70 percent of the LLSIL.
This issuance provides the Secretary’s
annual LLSIL for 2007 and references
the current 2007 Health and Human
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DATES: Effective Date: This notice is
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ADDRESSES: Send written comments to:
Mr. Evan Rosenberg, Department of
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FOR FURTHER INFORMATION CONTACT:
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telephone 202–693–3593; fax 202–693–
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E:\FR\FM\04JNN1.SGM
04JNN1
Agencies
[Federal Register Volume 72, Number 106 (Monday, June 4, 2007)]
[Notices]
[Pages 30855-30858]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10622]
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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]
BILLING CODE 4410-09-P