[Federal Register Volume 62, Number 81 (Monday, April 28, 1997)]
[Notices]
[Pages 22968-22972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10781]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 95-26]
Leonel Tano, M.D.; Revocation of Registration
On March 7, 1995, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, (DEA), issued an
Order to Show Cause to Leonel Tano, M.D., (Respondent) of San Antonio,
Texas, notifying him of an opportunity to show cause as to why DEA
should not revoke his DEA Certificate of Registration, AT7513282, and
deny any pending applications for renewal of such registration as a
practitioner under 21 U.S.C. 823(f), for reason that his continued
registration would be inconsistent with the pubic interest pursuant to
21 U.S.C. 824(a)(4). The Order to Show Cause also asserted as a basis
for the proposed action pursuant to 21 USC 824(a)(1), Respondent's
material falsification of an application for registration.
By letter dated May 3, 1995, Respondent, through counsel, filed a
request for a hearing, and following prehearing procedures, a hearing
was held in Austin, Texas on December 12 and 13, 1995, before
Administrative Law Judge Mary Ellen Bittner. At the hearing, both
parties called witnesses to testify and introduced documentary
evidence. Ultimately, the alleged falsification was not pursued as an
independent basis for revocation and instead was considered as part of
the overall public interest issue. After the hearing, counsel for both
parties submitted proposed findings of fact, conclusions of law and
argument. On September 17, 1996, Judge Bittner issued her Opinion and
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision,
recommending that Respondent's DEA Certificate of Registration be
revoked. Neither party filed exceptions to her decision, and on October
18, 1996, Judge Bittner transmitted the record of these proceedings to
the Acting Deputy Administrator.
The Acting Deputy administrator has considered the record in its
entirety, and pursuant to 21 CFR 1316.67, hereby issues his final order
based upon findings of fact and conclusions of law as hereinafter set
forth. The Acting Deputy Administrator adopts, in full, the Findings of
Fact, Conclusions of Law, and Recommended Ruling of the Administrative
Law Judge, and his adoption is in no manner diminished by any
recitation of facts, issues and conclusions herein, or of any failure
to mention a matter of fact or law.
The Acting Deputy Administrator finds that Respondent is a
physician who has maintained a general practice in San Antonio, Texas
since 1978. Respondent testified that he practices in a low income
neighborhood and that ninety percent of his patients has been seeing
him for sixteen or seventeen years.
In 1987, DEA conducted a routine inspection of a local narcotic
treatment program. During that inspection, it was learned that some of
the clients in the program had tested positive for controlled
substances, other than methadone, including Valium, Darvon, Xanax, and
Phenephan with codeine, and that they admitted receiving the
prescriptions for those substances from Respondent.
Subsequently, in August 1990, the Texas State Board of Medical
Examiners (Board) entered an Order, which was agreed to by Respondent,
that found that Respondent prescribed controlled substances, including
Xanax, Halcion, Darvocet N-100, Restoril and Valium to two individuals
who were in a methadone treatment program. The Board found that as a
result, Respondent was subject to disciplinary action pursuant to Texas
Health & Safety Code Art. 4495b, section 3.08(4)(C) for ``writing
prescriptions for a dispensing to a person known to be a habitual user
of narcotic drugs, controlled substances, or dangerous drugs or to a
person who the physician should have known was a habitual user of the
narcotic drugs, controlled substances or dangerous drugs.'' It should
be noted that the statute also provides that the section ``does not
apply to those persons being treated by the physician for their
narcotic use after the physician notifies the board in writing of the
name and address of the person so treated.'' Respondent apparently did
not provide such notice to the Board. Therefore, the Board ordered,
among other things, that Respondent ``shall not prescribe or dispense
controlled substances to any known drug abuser, including methadone
patients.''
At the hearing in this matter, Respondent testified that his
problems with the Board began when ``somebody'' came to his office and
asked if he was treating any patients who were taking methadone.
According to Respondent, he told the person that for the last two or
three years he had been treating two patients he knew were on
methadone. Respondent testified that he did not believe that his
actions warranted restrictions being placed on his medical license by
the Board, but instead, he should have been reprimanded or advised
about the limitations on prescribing to methadone patients.
In September 1990, DEA conducted a routine inspection of a local
narcotic treatment program. During the course of the inspection, the
program's director noted that several of the program's patients had
tested positive for controlled substances other than methadone, and
that some of the
[[Page 22969]]
patients stated that they had received the prescriptions for the
controlled substances from Respondent.
Thereafter, in January 1992, DEA initiated an undercover
investigation of Respondent's controlled substance handling practices.
On January 9, 1992, a cooperating individual introduced an undercover
DEA task force officer to K.B. who had obtained controlled substances
from Respondent in the past. The officer's true identity was not
revealed to K.B. The officer and K.B. then went to Respondent's office.
K.B. filled out a form, telling the officer that she knew what to put
down on the form in order to get Xanax, however that form is not in
evidence in this proceeding. When he saw Respondent, the officer asked
for Xanax, but it is unclear from the officer's testimony what reason,
if any, was given for wanting the drug. Respondent asked the officer
whether he was an alcoholic or drug abuser, and whether he knew that
Xanax was addictive. Respondent performed a cursory physical
examination and then issued the officer a prescription for 30 dosage
units of Xanax. The Government does not contend that this prescription,
in and of itself, was improper.
The officer returned to Respondent's office on February 7, 1992,
this time accompanied by another undercover DEA task force officer. On
this occasion, the undercover officers represented that they were truck
drivers. The first officer asked Respondent for a prescription for 60
dosage units of Xanax, but Respondent gave him a prescription for forty
dosage units instead, saying that it would be too risky to prescribe a
larger quantity. After writing the prescription, Respondent then
performed a cursory physical examination, not asking the officer any
questions about his medical history or current problems.
A nurse took the second officer's weight and blood pressure. The
officer told Respondent that he was having trouble meeting his work
deadlines because he frequently had to stop to eat and rest, so he
asked for something that could keep him awake and something that could
bring him back down when he finished driving. The officer also told
Respondent that he was constantly hungry and needed to stop too
frequently to eat. He told Respondent that he had been buying drugs at
truck stops. At the hearing in this matter the second officer testified
that he always needed to lose weight, but that he and Respondent did
not discuss any weight problems. Respondent issued the officer
prescriptions for 30 dosage units of Zantryl (brand name for a product
containing phentermine) and 25 dosage units of Xanax, both Scheduled IV
controlled substances. Respondent testified at the hearing that he
prescribed the Zantryl to the officer because it is an appetite
suppressant and the officer had stated that he was a compulsive eater
and was overweight, and that he prescribed the Xanax to calm him down
at the end of the day.
On February 26, 1993, a third undercover DEA task force officer
went to Respondent's office. On the patient history form, the officer
listed her complaints as headache, back pain, and weight gain. She
indicated to Respondent that she was tired and that she had gained five
pounds. When Respondent asked her what was wrong with her, she replied,
``I am tired, bored, no energy to do anything. I was falling asleep
outside while waiting.'' At some point during the visit, the undercover
officer began crying. Respondent issued the officer a prescription for
a non-controlled antidepressant. As to her headaches, the officer told
Respondent that Tylenol did not help her. Respondent then issued a
prescription for Fiorinal, a Schedule III controlled substance. The
Government does not contend that these prescriptions were illegitimate.
The officer returned to Respondent's office on March 26, 1993.
During this visit she asked Respondent for phentermine, which
Respondent refused stating that she was not overweight. Respondent
issued the officer another prescription for the non-controlled
antidepressant, since according to Respondent, the officer appeared
``anxious or down.'' The officer next went to Respondent's office on
April 15, 1993. She told Respondent that the drugs that he had
previously prescribed for her were not strong enough. Respondent
advised the officer not to purchase drugs on the street, because she
would not know what she was buying. Respondent then prescribed the
officer a non-controlled substance and 20 dosage units of Xanax.
Respondent told the officer to take one Xanax per day and if that did
not help to take two, but to try not to take it at all. Respondent also
told the officer to take the Xanax only if she needed it to sleep, not
to relax.
The officer's fourth undercover visit was on April 28, 1993. The
day before, the officer, while acting in an undercover capacity,
attempted to purchase Xanax from an individual on the street. The
individual stated that he did not have any Xanax, but that he could get
some from Respondent. The officer and the individual went to
Respondent's office together on April 28, 1993. The officer saw
Respondent first. She asked Respondent for more Xanax, and Respondent
asked her if she wanted it to help her sleep. The officer responded
affirmatively, and then Respondent said he would give her ``something
else,'' because ``they don't want us to write Xanax.'' There was then
some discussion about giving the officer Valium or Restoril, both
Schedule IV controlled substances, but instead Respondent gave the
officer three sample packages each containing two tablets of Halcion,
also a Schedule IV controlled substance. Before leaving the examination
room, the officer asked Respondent if she could buy some Xanax from him
since she could not buy it on the streets. Respondent stated. ``I don't
know how much they charge,'' but refused to sell it to her. The
individual who had accompanied the officer then went into the
examination room. The officer stood outside the room listening to the
individual's conversation with Respondent. Respondent told the
individual that he could not write any prescriptions for Xanax because
he was being investigated. After some discussion, it was decided that
Respondent could issue the individual a prescription since Respondent
had not seen him in a while. The individual offered Respondent $25.00
and Respondent then wrote a prescription which turned out to be for 30
dosage units of diazepam 10 mg. (the generic form of Valium), not
Xanax. Respondent testified at the hearing in this matter that he
confronted the officer about not seeing a psychiatrist as he had
recommended and was confused by the officer's requests for different
drugs at different visits. Respondent did not offer any explanation for
the diazepam prescription issued for the individual on this occasion.
This officer made her final undercover visit on June 30, 1993. The
officer indicated that nothing was wrong with her, that she had not
gone to see a psychiatrist, and that she had finished the drugs he had
given her a long time ago. The officer offered to buy Xanax from
Respondent, but Respondent told her that he could not write a
prescription, and that she would have to see a psychiatrist.
Nonetheless, Respondent wrote the officer a prescription for 25 tablets
of Xanax.
Finally, a fourth undercover DEA task force officer made two visits
to Respondent's office. The officer testified that when he first went
to Respondent's office on October 15, 1993, the nurse would not let him
see Respondent unless he indicated that something was wrong with him,
so he put down on the medical history form that he had bad headaches.
However, when he saw Respondent, he indicated that he had
[[Page 22970]]
headaches a long time ago, but was now trying to get off Vicodin (a
Schedule III controlled substance containing hydrocodone). The officer
also told Respondent that he used to use marijuana, but not anymore.
Respondent testified that he was suspicious that the officer had
Medicaid coverage since ``he looked a healthy person to me.''
Respondent wrote a prescription for the officer for 20 dosage units of
hydrocodone with APAP, and told him ``don't take it if you don't need
it,'' and ``don't give this to anybody.'' Respondent testified at the
hearing in this matter that he prescribed the hydrocodone to the
officer in case he had headaches in the future, and that he did not
think that the officer was addicted to Vicodin. Respondent also
testified that ``I wouldn't call Vicodin a narcotic.''
The officer returned to Respondent's office on October 21, 1993.
During this visit, the officer indicated that was not having headaches,
but that he was going out of town and did not want to be ``short of
pills.'' Respondent continued to be suspicious of the officer's
Medicaid coverage. Respondent issued the officer a prescription for 25
tablets of Vicodin and told him to ``[t]ry not to take these things if
you don't need them.'' The officer then asked Respondent for some
Xanax. Respondent refused, offering to give him something else.
Respondent stated that, ``[t]here are a lot of problems with Xanax.''
The officer next offered to buy some Xanax from Respondent, but again
Respondent refused, saying, ``they check on everything.'' Respondent
testified at the hearing that the officer's insistence on obtaining
Xanax caused him to suspect that the officer was seeking the drug for
other than medical purposes.
In addition to the undercover visits, DEA's investigation of
Respondent included a review of the records of three local narcotic
treatment programs to determine whether Respondent had continued to
treat methadone patients with controlled substances after the Board's
1990 order precluding him from doing so. The records of one program
showed that Respondent issued a total of 29 controlled substance
prescriptions to 21 different patients between February 1991 and
January 1994. The records from the second program indicated that
Respondent prescribed controlled substances a total of 52 times to six
different patients between September 1990 and January 1994. Finally,
the third program's records showed that Respondent prescribed
controlled substances a total of 50 times to 18 patients between
January 1991 and February 1994. Except for five of these patients, it
is unclear whether Respondent knew that he was prescribing controlled
substances to individuals undergoing methadone treatment.
Respondent testified at the hearing that while he had never
received notification from the Board that the order restricting his
medical license had expired or been modified, he had received copies of
a form letter from the program director of one of the narcotic
treatment programs which he believed justified his prescribing of
controlled substances to individuals undergoing methadone treatment.
This letter, dated September 30, 1992, and addressed to ``Dear
Colleague'', was to be provided by a client of the program to a
physician who prescribed the client controlled substances, if the
client tested positive for drugs other than methadone. The letter
states that the bearer is in a methadone maintenance treatment program
and explains the effect of methadone maintenance treatment and
considerations in treating methadone patients with drugs for other
conditions.The letter advises the prescribing physician that state law
requires that methadone patients provide documentation to the narcotic
treatment program from the prescribing physician as to the necessity of
the prescription and that the prescribing physician is aware that the
patient is receiving methadone treatment. The letter specifically
states that, ``[t]he intention of the regulation is not to restrict
physicians in the exercise of their professional judgment in the
practice of medicine but to require [methadone maintenance] patients to
inform other physicians of this information which is vital to the
prescribing physician.''
Respondent testified that approximately 15 of his patients
presented him with a copy of this letter, and that he continued
treating four of them because they had been longtime patients.
Respondent admitted that he signed notes for these four patients saying
that he knew that they were on methadone. Respondent further testified
that he did not think that his prescribing of controlled substances to
the patients on methadone in any way violated the standard of care,
because he did not increase the dosages and some of the patients ``got
into trouble with the law.''
Notwithstanding the Board's order precluding Respondent's
prescribing of controlled substances to methadone patients, as
discussed above, Texas law precludes such prescribing unless the
physician notifies the Board in writing of the name and address of the
patient that the physician is treating for narcotic use. The Government
introduced into evidence an affidavit dated November 28, 1995, from the
Board's Assistant Custodian of Records stating that the Board had no
records indicating that Respondent had notified the Board of the name
and address of any person he was treating for his or her narcotic use.
Respondent testified at the hearing that he never knowingly
violated any standards of care with respect to prescribing for patients
who were in methadone treatment programs; that he has never caused a
patient to become addicted to any medication; that he was never a
``heavy writer'' of prescriptions, but that he has nonetheless become
more cautious; and that in the past five years, he has refused to treat
patients he thought were abusing drugs unless they agreed to a
urinalysis.
On November 30, 1994, Respondent executed an application for
renewal of his DEA Certificate of Registration. On this application, he
answered ``No'' to a question asking, among other things, if he ``ever
had a State professional license or controlled substance registration
revoked, suspended, denied, restricted or placed on probation?'' During
a discussion on March 22, 1995, a DEA investigator asked Respondent
whether his medical license had ever been suspended or had any other
action taken against it. Respondent answered that no such action had
been taken. At the hearing in this matter, Respondent did not offer any
explanation for the response on his 1994 renewal application or his
representations to the DEA investigator.
The Government contends that Respondent's registration should be
revoked based upon his prescribing of controlled substances to the
undercover officers; his violation of the Board's 1990 order not to
prescribe controlled substances to methadone treatment patients; and
his falsification of his 1994 renewal application for DEA registration.
Respondent contends that his registration should not be revoked because
he did not engage in any misconduct serious enough to warrant
restricting his authority to handle controlled substances; that
questions of medical judgment are not within the purview of this forum
and should be decided by the state medical board; and that he does the
best he can practicing in a ``war zone'' of drug activity.
Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy
Administrator may revoke a DEA Certificate of Registration and deny any
pending applications, if he determines that the continued registration
would be inconsistent with the public interest. Section 823(f)
[[Page 22971]]
requires that the following factors be considered:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to 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 or
safety. These factors are to be considered in the disjunctive; the
Deputy Administrator may rely on any one or a combination of factors
and may give each factor the weight he deems appropriate in determining
whether a registration should be revoked or an application for
registration be denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88-
42, 54 FR 16422 (1989).
Regarding factor one, in August 1990, the Board restricted
Respondent's license to practice medicine by prohibiting him from
prescribing or dispensing controlled substances to any known drug
abuser, including methadone patients. There is no evidence in the
record that the Board's order has been terminated or modified, and in
fact, Respondent testified that as far as he knew, it was still in
effect. The recommendation of the appropriate state licensing board is
just one of the factors to be considered and is not dispositive of
whether Respondent's continued registration is inconsistent with the
public interest. Therefore, the Acting Deputy Administrator rejects
Respondent's argument that consideration of the undercover visits
should be left to the state medical board.
As to Respondent's experience in dispensing controlled substances,
Judge Bittner concluded that, excluding the prescriptions issued on
January 9, 1992, February 26, 1993, and March 26, 1993, the
prescriptions that Respondent issued to the undercover officers were
not for a legitimate medical purpose. Respondent issued prescriptions
to the undercover officers with little, if any, discussion regarding
the medical need for the drug, and with little or no physical
examination. On one occasion the officer asked for 60 dosage units of
Xanax, however Respondent only prescribed 40 dosage units noting that
it would be ``too risky'' to prescribe more. On several occasions,
Respondent issued the prescriptions even after the officers indicated
that there was nothing wrong with them. Specifically, one officer,
while noting on the patient history form that he suffered from
headaches, told Respondent during his first visit that had suffered
from headaches in the past, but was now trying to get off Vicodin. On
his second visit, the officer stated that he was not having headaches.
The only reason given by the officer for wanting Vicodin was that he
was going out of town and he was ``short of pills.'' Nonetheless,
Respondent issued the officer a prescription for 20 hydrocodone with
APAP and six days later issued another prescription for 25 dosage
units.
Not only did Respondent issue prescriptions to the undercover
officers, but he also issued a prescription to another individual for
no legitimate medical reason. Of particular note regarding this
prescription is that Respondent at first refused to issue the
individual a prescription stating that he (Respondent) was under
investigation. Nevertheless, Respondent issued the individual a
prescription for Xanax after the individual pointed out that he had not
seen Respondent in a while.
Respondent asserts that he practices in a virtual ``war zone'' of
drug activity. The Acting Deputy Administrator concludes that in light
of this assertion, Respondent should have been all the more vigilant in
ensuring that controlled substances were prescribed only for legitimate
medical purposes. Instead, Respondent prescribed controlled substances
to the officers even though he admitted that he was confused by their
repeated requests for different drugs. Two of the officers asked to
purchase Xanax from Respondent after he refused to prescribe it for
them. Although Respondent refused to sell the officers Xanax, he
nonetheless issued them prescriptions for other controlled substances.
Respondent admitted during his testimony that he was suspicious of one
of the officer's Medicaid coverage, since the officer appeared healthy.
Respondent also admitted that he refused to issue this officer a
prescription for Xanax because he was suspicious of the officer's
request. Yet Respondent issued this officer prescriptions for
hydrocodone, in case the officer had headaches in the future, even
though the officer denied suffering from headaches. The Acting Deputy
Administrator concludes that these are not actions of a DEA registrant
who is trying to prevent controlled substances from being diverted.
Instead, Respondent's prescribing during the undercover investigation
demonstrates a disregard for his responsibilities as a DEA registrant.
Of equal concern to the Acting Deputy Administrator is Respondent's
continued prescribing of controlled substances to methadone patients
after the Board entered an order in 1990, specifically prohibiting such
prescribing. As Judge Bittner noted, it is undisputed that ``between
February 1991 and January 1994, Respondent prescribed controlled
substances a total of 131 times to a total of forty-five patients who
were clients of various methadone treatment programs.'' While Judge
Bittner found it unclear whether Respondent knew or should have known
that all of these individuals were in narcotic treatment, she did find
the evidence clear that ``Respondent was aware of five such patients. *
* *'' Respondent asserted that a form letter, presented to him by some
of his patients, that was addressed to ``Dear Colleague'' from the
program director of a local narcotic treatment program, constituted
permission for Respondent to issue prescriptions for controlled
substances to methadone treatment patients. Like Judge Bittner, the
Acting Deputy Administrator finds no merit to this assertion. This
letter was a form letter from a narcotic treatment program, not from
the Board that had restricted his medical license. There is no evidence
in the record that Respondent sought to ascertain from the Board
whether he was permitted to issue such prescriptions.
The Acting Deputy Administrator is extremely troubled by the number
of prescriptions that Respondent issued to narcotic treatment patients
after the Board issued its order prohibiting such prescribing. The
Acting Deputy Administrator agrees with Judge Bittner that the evidence
in the record shows that Respondent only actually knew that five of
these individuals were undergoing narcotic treatment. However, as Judge
Bittner stated in her opinion, ``one would expect that after the
Medical Board disciplined Respondent and restricted his medical license
for prescribing controlled substances to addicts and habitual users,
Respondent would have been especially careful to avoid engaging in that
conduct again.''
Regarding factors three and four, the Acting Deputy Administrator
finds that Respondent has no convictions under Federal or state law
relating to controlled substances. However, between 1987 and 1990,
Respondent violated the Texas Medical Practice Act by prescribing
controlled substances to patients who were in methadone maintenance
treatment. Respondent continued to prescribe controlled substances to
such patients after the Board prohibited him from doing so in 1990. In
addition, Respondent issued
[[Page 22972]]
prescriptions during the undercover investigation for no legitimate
medical purpose in violation of 21 CFR 1306.04.
Finally, as to factor five, the Acting Deputy Administrator finds
relevant Respondent's representation on his 1994 application for
renewal of his DEA registration that his state medical license had not
been restricted, when in fact the Board had restricted his license in
1990. As stated previously, ``[s]ince DEA must rely on the truthfulness
of information supplied by applicants in registering them to handle
controlled substances, falsification cannot be tolerated.'' Bobby
Watts, M.D. 58 FR 46995 (1993). In addition, the Acting Deputy
Administrator finds it significant that in 1995, when specifically
asked by a DEA investigator whether any action had been taken against
his state medical license, Respondent replied that no such action had
been taken. Respondent has not offered any explanation for these
misstatements.
Judge Bittner concluded that Respondent's continued registration
would be inconsistent with the public interest at this time in light of
his prescribing of controlled substances during the undercover
investigation for no legitimate medical purpose; his prescribing of
controlled substances to patients enrolled in methadone treatment
programs that resulted in the Board's 1990 order restricting his
medical license; his continued prescribing of controlled substances to
at least several patients he knew were in methadone treatment programs
after the Board prohibited such prescribing; and his false statements
on his renewal application and to the DEA investigator regarding the
Board's action against his medical license. Judge Bittner concluded
that ``Respondent is not fully capable and/or willing to accept and
carry out the responsibilities inherent in DEA registration. * * *''
The Acting Deputy Administrator concurs with Judge Bittner's findings
and conclusions.
Accordingly, the Acting Deputy Administrator of the Drug
Enforcement Administration, pursuant to the authority vested in him by
21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that
DEA Certificate of Registration AT7513282, issued to Leonel Tano, M.D.,
be, and it hereby is, revoked. The Acting Deputy Administrator further
orders that any pending applications for renewal of such registration,
be, and they hereby are, denied. This order is effective May 28, 1997.
Dated: April 16, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-10781 Filed 4-25-97; 8:45 am]
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