[Federal Register: December 6, 2006 (Volume 71, Number 234)]
[Notices]
[Page 70788-70793]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06de06-93]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Mario Alberto Diaz, M.D.--Denial of Application
On June 27, 2005, the Deputy Assistant Administrator, Office of
[[Page 70789]]
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Mario Alberto Diaz, M.D. (Respondent) of Miami, Florida.
The Show Cause Order proposed to deny Respondent's pending application
for a DEA Certificate of Registration as a practitioner, on the ground
that granting Respondent a registration would be inconsistent with the
public interest. See Show Cause Order at 1; see also 21 U.S.C.
824(a)(4), id. Sec. 823(f).
More specifically, the Show Cause Order alleged that in May 2003,
Respondent, who had previously been registered as a practitioner,
entered into a contract with Pharmacom, an Internet pharmacy, under
which he agreed to issue prescriptions online. Show Cause Order at 5.
The Show Cause Order alleged that Respondent issued approximately 100
prescriptions per day, and that Respondent admitted having issued
approximately twenty to twenty-five thousand prescriptions during the
period of his employment with Pharmacom. See id.
The Show Cause Order further alleged that Respondent issued
prescriptions for controlled substances based on questionnaires
submitted by customers over the Internet. See id. The Show Cause Order
alleged that the questionnaire solicited from the customer information
regarding the drugs the customer wished to purchase and obtained the
customer's payment information and was then electronically transmitted
to Respondent. See id. The Show Cause Order alleged that based on the
questionnaire, Respondent would issue a prescription for a controlled
substance and that the principal drugs he prescribed were hydrocodone,
a Schedule III controlled substance, and Valium, a Schedule IV
controlled substance. See id.
The Show Cause Order also alleged that Respondent never saw the
customers and did not perform a physical exam on them, that he did not
have a pre-existing doctor-patient relationship with them, and that he
did not create or maintain patient records for them. See id. The Show
Cause Order further alleged that Respondent never consulted with the
customers' primary care physicians or obtained from them the customers'
medical records, and that the only information he reviewed was the
questionnaires submitted by the customers. See id. at 5-6.
The Show Cause Order additionally alleged that many of the
prescriptions written by Respondent were for minors. See id. at 6. The
Show Cause Order also alleged that during its investigation of
Pharmacom, the Iowa Board of Pharmacy contacted approximately 20
customers who had received prescriptions for controlled substances that
were issued by Respondent. See id. The Show Cause Order alleged that
each of these customers told investigators that before receiving
controlled substances, they had had no contact with Respondent other
than by e-mail. Id. The Show Cause Order thus concluded by alleging
that Respondent was ``responsible for the diversion of large quantities
of controlled substances,'' and that he had ``indiscriminately
dispensed large volumes of controlled substances to persons'' he had
never seen or physically examined. Id.
On July 15, 2005, the Show Cause Order was served on Respondent by
certified mail as evidenced by the Return Receipt Card. Thereafter, on
July 23, 2005, Respondent submitted a letter to me in which he waived
his right to a hearing and submitted a written statement setting forth
his position on the matters of fact and law involved. See 21 CFR
1301.43(c). The investigative file was then forwarded to me for final
agency action.
Based on Respondent's letter to me, I conclude that Respondent has
waived his right to a hearing. Moreover, having considered the record
as a whole including Respondent's statement, I conclude that granting
Respondent's application for a new registration would be inconsistent
with the public interest and make the following findings.
Findings
Respondent, a medical doctor with a specialty in anesthesiology,
formerly held a DEA certificate of registration as a practitioner under
which he was authorized to prescribe Schedule II through Schedule V
controlled substances. On May 20, 2004, Respondent surrendered his
registration during the execution of a search warrant at his residence/
registered location, which was located in Miami, Florida.
On September 12, 2003, two DEA Diversion Investigators from the Des
Moines, Iowa office, DEA Task Force Officers, and investigators from
the Iowa Board of Pharmacy Examiners executed a federal search warrant
at the Union Family Pharmacy, 2541 Central Avenue, Dubuque, Iowa. The
search was initiated based on information that the Union Family
Pharmacy was engaged in filling purported prescriptions that it
downloaded from an Internet site and that it distributed the drugs to
persons nationwide.
During the search, investigators seized approximately twenty
thousand prescriptions that the pharmacy had filled and dispensed from
March 2003 through September 12, 2003, the date the warrant was
executed. Of these twenty thousand prescriptions, approximately five
thousand of them had been filled and dispensed on behalf of Pharmacom.
All of the Pharmacom prescriptions were filled between August 18, 2003,
and September 12, 2003.
The investigation determined that Pharmacom was located in Miami,
Florida, and that it owned the domain name Buymeds.com and operated the
Web site http://www.buymeds.com. Approximately 1,240 of the controlled
substance prescriptions downloaded by Union Family Pharmacy from the
Pharmacom web site and filled by the pharmacy were issued by
Respondent.
Because of unusual banking activity, Pharmacom had previously come
to the attention of the Internal Revenue Service (IRS) and, on
September 2, 2003, two IRS special agents interviewed Mr. Orlando
Birbragher, Pharmacom's President and CEO. During the interview, the
IRS special agents determined that Pharmacom operated multiple on-line
pharmacy Web sites including Buymeds.com. The interview determined that
Pharmacom's customers submitted on-line questionnaires to purchase
Schedule III and IV controlled substances, and that Pharmacom's doctors
evaluated the questionnaires to determine whether to approve or reject
the order. Pharmacom's doctors did not, however, conduct a physical
exam of the customer. Instead, the questionnaires required the patient
to indicate whether they had been examined by a physician within the
past year. Mr. Birbragher further maintained that Pharmacom's doctors
contacted the customers and their physicians when evaluating the
questionnaires. Those prescriptions which were approved were then sent
to a pharmacy, which filled the prescriptions and shipped them to the
customers. Pharmacom paid both the doctor who issued the prescription
and the pharmacy which filled it.
Mr. Birbragher told the IRS agents that Respondent had started
working for Pharmacom in March 2003. Respondent's duties involved
reviewing the questionnaires and determining whether a prescription
should be issued. Pharmacom initially paid Respondent $20 for
evaluating a request for a new prescription and $10 for evaluating a
request for a refill. Because of the volume of business it attracted,
Pharmacom subsequently cut its payment rates in half. Even at this
reduced payment rate, Pharmacom paid Respondent $218,586 between April
and August 2003. Mr. Birbragher further
[[Page 70790]]
told the IRS agents that Respondent used physician assistants (PA's) to
assist him in evaluating the patient questionnaires. Mr. Birbragher did
not know, however, whether Respondent or the PA's actually reviewed the
questionnaires.
Thereafter, one of the DIs reviewed prescription data obtained
during the search of the Union Family Pharmacy. More specifically, the
DI reviewed the prescription data that the pharmacy downloaded from the
buymeds.com website and filled on September 7, 2003. On that date, the
pharmacy filled 583 Buymeds' prescriptions. Of the 583 prescriptions,
only 29 (4.9%) were for non-controlled substances. The remaining
prescriptions were for controlled substances such as hydrocodone,
codeine, propoxyphene, and Ambien (zolpidem). Respondent issued 146 of
the 583 prescriptions that were filled that day. While the
investigative file does not indicate how many of these prescriptions
were for controlled substances, even if Respondent issued all of the
non-controlled substance prescriptions, he still would have issued 117
controlled substance prescriptions that were filled on that day.\1\
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\1\ A further analysis of the computer data seized during the
search of the Union Family Pharmacy found that Respondent issued
1,240 prescriptions for controlled substances during the period
August 18, 2003, through September 12, 2003.
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On May 20, 2004, investigators executed a search warrant at
Respondent's residence in Miami. While Respondent was not home when the
search commenced, his son contacted him by cell phone. Respondent spoke
with a DEA Special Agent and agreed to return to his residence. Upon
his return, a DI and IRS special agent interviewed him.
Respondent told the investigators that he began working for
Pharmacom in April 2003 and quit in November 2003. Respondent stated
that another physician had told him about Pharmacom's business and had
recommended him to Marshall Kanner, one of the owners. Thereafter,
Respondent interviewed with Kanner for a position with Pharmacom.
Kanner told him that the position would involve authorizing medication
over the Internet to patients who were seeing or had seen a doctor in
the past year. Respondent claimed that he expressed to Kanner his
concerns regarding prescribing medicine in this manner, but Kanner told
him it was legal. According to Respondent, Kanner also told him he
could authorize prescriptions for customers throughout the United
States.
Respondent told the investigators that customers would contact
Pharmacom through the Internet and fill out a questionnaire provided by
it. Pharmacom then assigned a list of patients to Respondent.
Respondent's job was to review the questionnaires and then interview
the customers either by telephone or e-mail to determine whether the
customers were eligible to receive the drug they requested.
Respondent stated to the investigators that he told Pharmacom that
he was only willing to review 100 customers a day and that he did not
issue prescriptions to ten to twenty-five percent of the customers.
Respondent also told the investigators that he reviewed approximately
40 to 50 refill prescriptions a day and that he made as much as $14,000
a week.
Respondent further told the investigators that he never saw any of
the customers and that he never developed a doctor/patient relationship
with any of them as everything was done either via the Internet or by
telephone. According to the DI's report, Respondent admitted that the
information provided by the customers was never verified and that when
he interviewed customers by telephone, he could not verify whom he was
talking to.
When the DI asked Respondent whether he knew it violated the law to
issue a prescription for a controlled substance without having a
legitimate doctor/patient relationship, Respondent did not give a
specific answer. Instead, Respondent asserted that whenever he
questioned the legality of the practice, Kanner or Birbragher assured
him that it was legal. When the DI reminded Respondent that he was the
doctor, Respondent stated, ``Yes, I know that.''
Respondent also told the investigators that he quit Pharmacom
because sometime in September or October 2003, Birbragher told him that
all customers would have to receive a physical exam and that he did not
agree with this policy. When questioned as to the basis of his
disagreement, Respondent became vague and evasive and would not
specifically answer the question. Towards the end of the interview,
Respondent was also advised by the DI that having surrendered his DEA
registration, he was not authorized to handle controlled substances in
any manner and could not possess, dispense, administer or prescribe
them.
Subsequently, on September 14, 2004, Respondent agreed to undergo a
proffer interview at the DEA Miami field office. During the interview,
at which he was represented by counsel, Respondent stated that he was
currently employed at a cosmetic surgery center where he provided
anesthesia services even though he had previously surrendered his DEA
registration.
During this interview, Respondent asserted that he had researched
the DEA w Web site and could not find any statute indicating that
prescribing over the Internet ``could not be done.'' Respondent further
stated that he thought the practice was similar to that in an emergency
room where the patients are ``unknown'' to the physician. Respondent
again maintained that he had contacted Kanner to determine whether the
practice was legal and had been told by Kanner that Pharmacom's
attorneys had ``stated that it was legal.'' Respondent further stated
that when he met with Kanner and Birbragher, they told him ``they were
licensed in all states and [that] he could make a huge amount of
money.''
Respondent further admitted that while he limited himself to 100
``patients'' per day, a general practitioner would normally see thirty
to forty patients per day. Respondent asserted that the only difference
between his activities and that of a general practitioner was that a
``general practitioner sees the patient.'' Respondent added that he
would review the medical history provided by the customer and such
other information as the customer's location, age, weight, height, and
previous and current medications. Later in this interview, Respondent
admitted that he ``felt uncomfortable with the number of patients'' he
was assigned, and that when he telephoned patients, ``some appeared to
be druggies.'' Respondent also stated that as time went on, he ``felt
people were ordering medications for habits or entertainment,'' and
that the ``types of people ordering were getting worse and worse.''
Respondent admitted that the customers submitted requests for
specific drugs, but that he would ``never ask a patient what drug they
wanted'' because doing so would be contrary to ``good medical
practice.'' He further stated that the ``best professional care would
be face to face.'' He also claimed that he had quit because the
physical examinations that Pharmacom had started providing were
incomplete.
Respondent admitted that some customers requested multiple drugs
such as hydrocodone and alprazolam. Respondent also stated that he
approved between twenty and twenty-five thousand prescriptions during
the period of his association with Pharmacom and that the highest
number of prescriptions he authorized in a day
[[Page 70791]]
was about 200. In response to a question regarding the danger of
prescribing medication without establishing a doctor/patient
relationship, Respondent stated that the ``potential for killing people
can happen in a hospital,'' but that ``a bigger potential [exists] over
the Internet.''
In his written statement responding to the Show Cause Order,
Respondent asserted that he ``attempted to perform my medical functions
in a professional and ethical manner.'' Respondent further stated that
he ``did call the patient to evaluate them for their prescriptions,''
and that he ``denied a high percentage of the prescriptions
requested.''
Respondent asserted that he searched the websites of both DEA and
the Florida Department of Health to see if there were ``any laws that
made this business illegal.'' Respondent also stated that Pharmacom's
owners had ``fooled [him] into thinking that their business was legal''
and that he ``would never knowingly violate any laws.'' Respondent
further asserted that he was unaware of the statements of DEA, the
American Medical Association, the Federation of State Medical Boards,
the Food and Drug Administration, and the National Association of
Boards of Pharmacy (all of which were recited in the Show Cause Order)
and all of which discuss the illegality and/or impropriety of
prescribing over the Internet without establishing a bona-fide doctor-
patient relationship.
Respondent contended that as an anesthesiologist he had rarely
written prescriptions and that while he ``knew that a patient-doctor
relationship had to be established,'' he ``honestly believed that
having a patient fill out a questionnaire about their health and
another dedicated section related to the medication they were
requesting would fulfill this criteria.'' Respondent also maintained
that he ``would question the patient about any previous prescriptions
for the medication they were then requesting,'' and that ``[a] very
large percentage of them had already been prescribed the medication by
their family physician.'' Respondent further stated that he ``did call
a few of their physicians in cases I suspected of problems.''
In his written statement, Respondent added that he resigned when he
became aware ``that a physical examination was needed to write a
prescription.'' Respondent also stated that he ``will never work for
any endeavor of this type ever again.'' Respondent concluded by stating
that he ``accept[ed] that the selling of medications over the Internet
is not correct and that a prescription should not be written without a
physical examination.''
I further take official notice of the fact that on May 17, 2006,
the Florida Department of Health issued an order imposing an emergency
suspension of Respondent's state medical license. That order remains in
effect.
Discussion
Section 303(f) of the Controlled Substances Act 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, 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 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, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or
combination of factors, and may give each factor the weight [I] deem[]
appropriate in determining whether * * * an application for
registration [should be] denied.'' Id. Moreover, case law establishes
that I am ``not required to make findings as to all of the factors.''
Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005); see also Morall v.
DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).
In this matter, I conclude that multiple grounds support the denial
of Respondent's application. Specifically, Respondent currently lacks
authority under Florida law to practice medicine and therefore is not
entitled to a DEA registration. Moreover, even if the State of Florida
were to rescind its order of emergency suspension, my analysis of
several other factors also demonstrates that granting his application
would be inconsistent with the public interest.
Factor One--The Recommendation of the State Licensing Board
It has long been recognized that ``[a]gencies may take official
notice of facts at any stage in a proceeding--even in the final
decision.'' U.S. Dept. of Justice, Attorney General's Manual on the
Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc.,
Reprint 1979). Therefore, pursuant to 5 U.S.C. 556(e) and 21 CFR Sec.
1316.59(e), I hereby take official notice of the fact that on May 17,
2006, the Florida Department of Health issued an order imposing an
emergency suspension of Respondent's state medical license.\2\
Respondent is therefore without authority under state law to handle
controlled substances in the state in which he intends to practice
medicine.
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\2\ In accordance with the Administrative Procedure Act and
DEA's regulations, Respondent is ``entitled on timely request, to an
opportunity to show to the contrary.'' 5 U.S.C. 556(e). See also 21
CFR 1316.59(e). DEA's regulations contain no provision for
requesting reconsideration of a final order. See Robert A. Leslie,
M.D., 60 FR 14004, 14005 (1995). To allow Respondent the opportunity
to refute the facts of which I am taking official notice,
publication of this final order shall be withheld for a fifteen-day
period, which shall begin on the date of service by placing this
order in the mail.
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Our precedents have repeatedly construed the Controlled Substances
Act (CSA) as precluding DEA from issuing a registration to an applicant
who lacks authority to handle controlled substances in the state where
the applicant practices medicine. See 21 U.S.C. 802(21) & 823(f); see
also George Thomas, 64 FR 15811, 15812 (1999); Robert E. Hales, 52 FR
17646 (1987). Moreover, denial of an application is appropriate even
``when a State license has been suspended, but [there is] a possibility
of future reactivitation.'' Alton E. Ingram, Jr., 69 FR 22562 (2004).
Therefore, I conclude that Respondent's lack of state authority is
reason alone to deny his application for a registration. But because
the Florida Department of Health's order is not a final decision and
may be rescinded, an analysis of Respondent's conduct as charged in the
Show Cause Order and his defenses is warranted.
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and His Record of Compliance With Applicable Laws
The CSA's implementing regulations state that for ``[a]
prescription for a controlled substance to be effective [it] must be
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 ``[a]n 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
[[Page 70792]]
violations of the provisions of law relating to controlled
substances.'' Id.
As the Supreme Court has recognized, the CSA reflects Congress's
``intent to limit a registered physician's dispensing authority to the
course of his professional practice.'' United States v. Moore, 423 U.S.
122, 140 (1975). The Court has further explained that the CSA
``reflect[s] the intent of Congress to confine authorized medical
practice within accepted limits.'' Id. at 141-42. Thus, in Moore, the
Court upheld a criminal conviction of a physician for knowingly or
intentionally distributing controlled substances in violation of the
CSA, explaining that the physician's ``conduct exceeded the bounds of
professional practice'' when the physician prescribed controlled
substances and ``gave inadequate physical examinations or none at
all.'' Id. at 142-43.
The evidence in this case establishes that Respondent repeatedly
acted outside the course of professional practice and violated the CSA.
Respondent, while contracted to Pharmacom, issued between twenty and
twenty-five thousand prescriptions to persons with whom he had no
bonafide doctor-patient relationship. While the investigative file does
not establish the exact number of controlled substance prescriptions
issued by Respondent, the analysis of the 583 Buymeds.com prescriptions
filled by Union Family Pharmacy on September 7, 2003, establishes that
at least 117 (out of a total of 143) prescriptions issued by Respondent
and filled on that date were for a controlled substance.\3\
Furthermore, the analysis of the prescriptions filled by the Union
Family Pharmacy for Pharmacom between August 18, 2003, and September
12, 2003, shows that Respondent issued 1240 controlled substance
prescriptions. Given that this represents only a small portion of the
period during which Respondent was engaged with Pharmacom, it is
reasonable to infer that Respondent issued many more prescriptions for
controlled substances.
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\3\ The investigative file does not establish the precise date
that Respondent issued these prescriptions.
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Respondent issued the prescriptions notwithstanding that he did not
perform a physical exam and had no face-to-face interaction with
Pharmacom's customers. While Respondent maintained that he called or
contacted via e-mail the customers ``on a regular basis'' to discuss
their questionnaires and denied some percentage of the requests,
Respondent admitted in the interviews that there was generally no way
to verify the information provided by the customers.\4\
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\4\ I note, however, that Respondent does not contend that he
actually contacted every patient. Moreover, the assembly line nature
of his activity begs the question of what Respondent did when a
customer did not answer the phone or failed to timely call him back
or respond to his e-mail.
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Furthermore, while Respondent asserts that he asked Pharmacom's
owners about the legality of issuing Internet prescriptions (who
assured him that the practice was lawful), there were numerous reasons
to question its legality. For example, customers were not required to
submit any documentation (other than the questionnaire) regarding a
medical condition that would demonstrate the need for a drug.\5\
Moreover, Respondent did not review the customer's questionnaires and
choose a drug to prescribe based on his ``diagnosis'' of the customer's
medical condition. Rather, it was the customer who requested a specific
drug. Respondent admitted, however, that he would ``never ask a patient
what drug they wanted'' because doing so would be contrary to ``good
medical practice.''
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\5\ This is not to suggest that Respondent would have acted
lawfully if he had issued prescriptions on the basis of medical
reports submitted directly to him by customers.
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Finally, Respondent should have questioned why Pharmacom's
customers did not submit prescriptions issued by their own doctors but
rather required that prescriptions be issued by him and the other
Pharmacom doctors. Indeed, Respondent admitted that when he telephoned
patients, ``some appeared to be druggies,'' and that as time went on he
``felt people were ordering medications for habits or entertainment.''
In short, Respondent had numerous indications that issuing
prescriptions in this manner ``exceeded the bounds of professional
practice,'' Moore, 423 U.S. at 142, and violated federal law
notwithstanding the comments of Pharmacom's owners.
Respondent maintains that he visited the DEA and Florida Department
of Health Web sites but could find no information that the practice of
Internet prescribing was illegal. As for his effort to find information
on the issue at the DEA Web site, Respondent must not have looked very
hard. On April 27, 2001, DEA published a Notice in the Federal Register
entitled ``Dispensing and Purchasing Controlled Substances over the
Internet.'' See 66 FR 21181. To the extent DEA was required to give
notice of this policy statement, publication in the Federal Register is
all that was necessary to comply with the Administrative Procedure Act.
See 5 U.S.C. 552(a)(1)(D). DEA, however, took the further step of
posting this policy statement on the Office of Diversion Control's Web
page and the document is easily found by using the Web page's search
engine.
The purpose of the Notice was ``to provide guidance to prescribers
* * * and the public concerning the application of current laws and
regulations as they relate to the use of the Internet for dispensing
[and] purchasing * * * controlled substances.'' Id. The Notice further
explained that ``[w]ith the advent of Internet pharmacies, DEA
registrants and the public have asked how these Internet pharmacies fit
into the requirements that currently exist for the prescribing and
dispensing of controlled substances.'' Thus, DEA issued this policy
statement, which was based on the application of existing law to the
new circumstances that arose with the emergence of the Internet as a
mechanism to engage in commerce.
The Notice expressly addressed the potential illegality under
existing law of prescribing a controlled substance based on an on-line
questionnaire. After noting the regulation pertaining to the purpose of
a prescription, see 21 CFR 1306.04, the Notice explained that ``[u]nder
Federal and state law, for a doctor to be acting in the usual course of
professional practice, there must be a bona fide doctor/patient
relationship.'' 66 FR at 21182. The Notice further observed that:
many state authorities, with the endorsement of medical societies,
consider the existence of the following four elements as an
indication that a legitimate doctor/patient relationship has been
established:
A patient has a medical complaint
A medical history has been taken
A physical examination has been performed; and
Some logical connection exists between the medical
complaint, the medical history, the physical examination, and the
drug prescribed.
Id. at 21182-83.
The Notice thus concluded that ``[c]ompleting 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. * * * It is
illegal to receive a prescription for a controlled substance without
the establishment of a legitimate doctor/patient relationship, and it
is unlikely for such a relationship to be formed through Internet
correspondence alone.'' \6\ Id. at 21183.
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\6\ As the Notice explained, ``[a] consumer can more easily
provide false information in a questionnaire than in a face-to-face
meeting with a doctor.'' Id. at 21183.
The Notice also discussed some Internet sites which ``ask[ed]
patients to waive the requirement for a physical and to agree to
have a physical before taking a drug they purchase via the
Internet.'' Id. In this regard, the Notice stated: ``[a]n after-the-
fact physical does not take the place of establishing a doctor/
patient relationship. The physical exam should take place before the
prescription is written.'' Id.
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[[Page 70793]]
The Notice further stated that doctors who issued prescriptions
without establishing a legitimate doctor/patient relationship could be
subjected ``to criminal, civil, or administrative actions,'' and that
``[f]or DEA registrants administrative action may include the loss of
their DEA registration.'' Id. Thus, contrary to Respondent's suggestion
that no information was publicly available regarding the potential
illegality of the practice, DEA had given fair warning that prescribing
a controlled substance based on an on-line questionnaire and without
conducting a physical exam could be deemed a violation of the CSA's
longstanding requirement that a prescription must be issued for a
legitimate medical purpose. DEA also warned that issuing a prescription
without such a purpose could subject a physician to criminal, civil and
administrative proceedings.
Moreover, in April 2002, the Federation of State Medical Boards
adopted its model guidelines for the use of the Internet in medical
practice. Section Five of this document states that ``[a] documented
patient evaluation, including history and physical evaluation adequate
to establish diagnoses and identify underlying conditions and/or
contra-indications to the treatment recommended/provided, must be
obtained prior to providing treatment, including issuing prescriptions,
electronically or otherwise.'' Federation of State Medical Boards of
the U.S., Inc., Model Guidelines for the Appropriate Use of the
Internet in Medical Practice 5 (2002) (emphasis added).
The guidelines further state that ``[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.'' Id. Finally, the guidelines state that ``[t]reatment,
including issuing a prescription, based solely on an online
questionnaire or consultation, does not constitute an acceptable
standard of care.'' Id.
Thus, while Respondent may have lacked actual knowledge of DEA's
interpretation of the CSA and the position of other entities involved
in the regulation of his profession, I conclude that such information
was readily available at the time Respondent commenced his contract
with Pharmacon and therefore will not excuse his misconduct.\7\
Moreover, I find that Respondent's experience in dispensing controlled
substances and his record of compliance with applicable laws involve
numerous violations of the CSA in that Respondent issued prescriptions
without a legitimate medical purpose and that these factors demonstrate
that granting Respondent's application (in the event the State were to
rescind its order) would be inconsistent with the public interest.
Having found so, it is unnecessary to address the remaining factors.
See, e.g., Hoxie, 419 F.3d at 483; Morall, 412 F.3d at 165.
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\7\ I do not rely on the fact that Respondent worked as an
anesthesiologist after he surrendered his DEA registration. While
the administration of anesthesia invariably requires the use of
controlled substances and it seems highly probable that Respondent
further violated the CSA by administering controlled substances
without a registration, this conduct was not alleged in the Show
Cause Order.
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Order
Accordingly, pursuant to the authority vested in me by 21 U.S.C.
823(f), and 28 CFR 0.100(b) and 0.104, I hereby order that the
application of Mario Alberto Diaz for a DEA Certificate of Registration
as a Practitioner be, and it hereby is, denied. This order is effective
January 5, 2007.
Dated: November 3, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-20630 Filed 12-5-06; 8:45 am]
BILLING CODE 4410-09-P