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Mario Alberto Diaz, M.D.--Denial of Application
FR Doc E6-20630 [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]
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\
\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.
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.
\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.
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.
\3\ The investigative file does not establish the precise date that
Respondent issued these prescriptions.
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\
\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.
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.''
\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.
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.
\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.
[[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.
\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.
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
NOTICE: This is an
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