[Federal Register Volume 63, Number 160 (Wednesday, August 19, 1998)]
[Notices]
[Pages 44471-44475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22223]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 97-8]
Leonard E. Reaves, III, M.D., Revocation of Registration
On January 29, 1997, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Leonard E. Reaves, III, M.D., (Respondent) of
Windsor, North Carolina, notifying him of an opportunity to show cause
as to why DEA should not revoke his DEA Certificate of Registration,
AR2127377, 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 public
interest pursuant to 21 U.S.C. 824(a)(4).
By letter dated March 28, 1997, Respondent, through counsel, filed
a request for a hearing, and following prehearing procedures, a hearing
was held in Raleigh, North Carolina on September 10 and 11, 1997,
before Administrative Law Judge Gail A. Randall. At the hearing, both
parties called witnesses to testify and the Government introduced
documentary evidence. After the hearing, counsel for both parties
submitted proposed findings of fact, conclusions of law and argument.
On March 11, 1998, Judge Randall issued her Opinion and Recommended
Ruling, recommending that Respondent's DEA Certificate of Registration
be revoked. Neither party filed exceptions to her decision, and on
April 13, 1998, Judge Randall 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, with noted exceptions,
the Opinion and Recommended Ruling of the Administrative Law Judge, and
his adoption is in no manner diminished by any recitation of facts,
issues and conclusions therein, or of any failure to mention a matter
of fact or law.
The Acting Deputy Administrator finds that Respondent graduated
from medical school in 1961 and became licensed to practice medicine in
North Carolina. He has continuously maintained his North Carolina
medical license since that time. In the 1960's, Respondent received
some advanced
[[Page 44472]]
training in internal medicine in Florida. Initially, Respondent was
issued a temporary Florida medical license, but subsequently took the
state licensure examination and was issued a Florida medical license.
Beyond his training, Respondent never practiced medicine in Florida,
yet he retained his Florida medical license. Respondent entered into
private practice in North Carolina in 1967.
In 1975, Respondent was suspended from participating in the North
Carolina Medicaid Assistance Program, following a determination that he
had received an overpayment of over $76,000.00 due to his over-
utilization of extended office visit codes; over-utilization of x-rays;
alteration of service dates to coincide with medicail eligibility, and
over-utilization of in-patient hospital admissions for short-term
stays.
On or about June 20, 1986, the South Carolina Board of Medical
Examiners (South Carolina Board) received Respondent's application for
licensure in that state. Respondent failed to disclose his suspension
from the North Carolina Medicaid Program on his application. The South
Carolina Board asked Respondent for a detailed written explanation of
the findings that led to his suspension. During a hearing on the
proposed denial of his application, Respondent stated that he had not
been suspended from the North Carolina Medicaid Program. In October
1986, the South Carolina Board ordered the denial of Respondent's
application for medical licensure in that state based upon his ``total
lack truthful, accurate and complete answers on his written application
for licensure''; his ``lack of candor when he was given the opportunity
to be heard before this Board''; and his ``failure to provide, as
required in this Boards's letter of September 2, 1986, a detailed
explanation regarding the finding of the North Carolina Medicaid
audit.'' The South Carolina Board found that the explanation that was
given by Respondent was ``grossly inadequate and unacceptable * * *.''
As a result of the South Carolina Board's denial, on April 12,
1988, the Florida Board of Medicine (Florida Board) revoked
Respondent's Florida medical license.
Also in 1988, Respondent's privileges were revoked at a
Fayetteville, North Carolina hospital because he treated a patient in
the intensive care unit in violation of an agreement that he had with
the hospital.
In 1991, Respondent began practicing medicine at his own clinic in
Windsor, North Carolina. After several yeas, he joined a medical center
in Bertie, North Carolina, where he was still practicing as of the date
of the hearing. This medical center serves a poor rural community.
In August 1991, Respondent contacted the medical director of the
North Carolina Physicians Health Program, and was encouraged to seek
treatment for codependency, a problem where a person is addicted to
approval from others. Respondent attended a 28-day inpatient treatment
facility.
On March 24, 1992, Respondent submitted an application for the
renewal of his DEA Certificate of Registration in North Carolina. On
the application, Respondent answered ``No'' to a question (hereinafter
referred to as the liability question) which asks in relevant part
whether the applicant has ``ever had a State professional license * * *
revoked, suspended, denied, restricted or placed on probation.''
Respondent provided this response despite the 1986 denial of his
application for licensure in South Carolina and the 1988 revocation of
his Florida medical license. Also on this application, Respondent did
not request registration with DEA in Schedules IIN, III, and IIIN.
Consequently on April 2, 1992, Respondent's DEA Certificate of
Registration was renewed in Schedules II, IV and V only.
When Respondent next applied to renew his DEA Certificate of
Registration on April 15, 1995, he answered ``Yes'' to the liability
question, and explained, ``In 1990 or 1991, I made application to the
Board of Medical Examiners of the State of South Carolina for a medical
license. Because of the way I presented a dispute with NC Medicaid, the
license was denied to me. By electronic mail, an earned license in
Florida was revoked as I did not know how to appeal. A license to
practice in NC [is] in effect and has never been revoked, suspended, et
al. I have never had a DEA license revoked, suspended et al.'' On this
application, Respondent requested registration in Schedules II, III, IV
and V, but not IIN and IIIN.
In light of Respondent's affirmative answer to the liability
question on his 1995 renewal application, DEA initiated an
investigation of Respondent. A review of Respondent's prior renewal
applications revealed that in 1988 and 1989, Respondent applied for
registration in Schedules II, IIN, III, IIIN and IV, but not V. This
review also revealed the negative answer to the liability question on
the 1992 renewal application, as well as the fact that Respondent only
applied for registration in Schedules II, IV and V.
On August 2, 1995, a DEA investigator contacted three local
pharmacies and discovered that Respondent had been prescribing
controlled substances in schedules that were outside the authority
granted to him by his DEA Certificate of Registration. The DEA
investigator then contacted Respondent and advised him that he was
issuing prescriptions for controlled substances that were in schedules
for which he was not registered. The investigator testified that
Respondent ``expressed confusion to me about the drug schedules * * *
he didn't seem to understand the difference in, for instance * * * a
Schedule III narcotic versus * * * a Schedule II nonnarcotic * * *.''
As a result of this conversation with the investigator, Respondent
asked local pharmacists to assist him in ensuring that he only issued
prescriptions for controlled substances that he was authorized to
handle. However, there is no evidence in the record to indicate that
Respondent took any affirmative steps on his own, such as attending a
continuing medical education course in the proper handling of
controlled substances, to learn the difference between the schedules
and what drugs fall within each schedule.
Subsequently, in October 1995, the investigator obtained printouts
from the three local pharmacies of Respondent's controlled substance
prescribing between January 1, 1994 and October 19, 1995. The printouts
revealed that the pharmacies filled over 450 Schedule III
prescriptions, including refills, issued by Respondent. In addition,
one pharmacy's records revealed that Respondent issued a prescription
for a Schedule IIN controlled substance and one for a Schedule IIIN
controlled substance after being advised on August 2, 1995, that he was
only authorized to handle controlled substances in Schedules II, IV and
V.
In October 1995, the DEA investigator contacted Respondent again
and advised him of the discovery of the two unauthorized prescriptions
and reminded Respondent that he was only authorized to handle
controlled substances in Schedules II, IV and V. At the hearing, the
investigator testified that following this second conversation, he had
not found any unauthorized controlled substance prescriptions issued by
Respondent.
At the hearing in this matter, Respondent and the medical director
of the North Carolina Physicians Health Program testified that
Respondent's codependency problem resulted in difficulty with
authority, as well as difficulty in accepting responsibility for his
actions. The medical director
[[Page 44473]]
testified that Respondent had undergone some treatment for his
codependency problem and was better about taking responsibility for his
actions. However, he felt that Respondent would benefit from further
treatment, but he did not believe that Respondent was still seeking
treatment at the time of the hearing. Respondent testified that he
``got the appropriate treatment'' and is ``doing fine now.'' He
indicated that he was currently seeing a local psychiatrist, ``[a]nd I
feel good about myself and my practice and my emotional well-being.''
At the hearing, Respondent did acknowledge that he falsely answered
the liability question on his 1992 renewal application. When asked why
he gave a false answer, Respondent replied, ``[p]erhaps the emotional
pain of trying to put down, yes. That was an error, and that was false.
And I'm sorry about that. I made mistakes. Something made me do that. I
don't know. That was not correct.''
However, it appears that Respondent still has difficulty accepting
responsibility for his actions. With respect to the Medicaid
suspension, Respondent testified that he did not think there had been
an alteration of service dates. Regarding his failure to request
registration in all schedules on his DEA renewal applications,
Respondent testified that filling out a renewal application is ``one of
those things that physicians just really hate to do * * *. And they do
it in a haphazard way. And they give it to their secretary and say,
copy this the way it was last year * * *. He doesn't really spend any
time on it.'' Finally, as to his prescribing outside his authorization,
Respondent blamed DEA for not sending him documentation regarding what
controlled substances he was not authorized to handle.
There was testimony at the hearing by Respondent, the Chief of
Staff at the hospital where Respondent has privileges, and two
physician assistants who work with Respondent that Respondent is
precise in his writing of medical records, in his caring for patients,
and in his prescribing of controlled substances. There has never been
any indication that Respondent has a substance abuse problem.
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) 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 16,422
(1989).
Regarding factor one, it is undisputed that the South Carolina
Board denied Respondent's application for medical licensure in that
state in 1986, and that his Florida medical license was revoked in
1988. However, it is also undisputed that North Carolina has not taken
any action against Respondent's North Carolina medical license.
Factors two and four, Respondent's experience in dispensing
controlled substances and his compliance with applicable laws related
to the handling of controlled substances, clearly are relevant in
determining the public interest in this case. Pursuant to 21 U.S.C.
822(b), ``[p]ersons registered by the Attorney General under this
subchapter to * * * dispense controlled substances * * * are authorized
to possess * * * or dispense such substances * * * to the extent
authorized by their registration and in conformity with the other
provisions of this subchapter.'' In 1992, Respondent applied for
renewal of his DEA registration in Schedules II, IV and V. Thereafter,
between 1994 and 1995, Respondent issued over 450 Schedule III and IIIN
prescriptions. The Acting Deputy Administrator finds that the
Respondent issued these prescriptions without being authorized by his
registration to do so.
The Acting Deputy Administrator further finds that even after being
advised of the extent of his authorization, Respondent issued two
prescriptions for substances that he was not registered to handle.
Judge Randall found that only one of the prescriptions was outside of
Respondent's authorization. This prescription was for testosterone, a
Schedule III controlled substance, and Respondent was not authorized to
handle any Schedule III controlled substance. Judge Randall found
however, that the other prescription for Dexedrine, a Schedule IIN
controlled substance did not exceed Respondent's authority, stating
that there is ``no scheduling distinction between Schedule II and
Schedule IIN substances * * *. Consequently, a registrant authorized to
handle Schedule II substances would seem to be authorized to handle
both narcotic and non-nartotic Schedule II substances, as both are
designated as `Schedule II' in the Controlled Substances Act and the
regulations.''
The Acting Deputy Administrator disagrees with Judge Randall's
conclusion. While it is true that Schedule II substances, whether
narcotic or non-narcotic substances, are all considered Schedule II
substances for recordkeeping and penalty purposes under the Controlled
Substances Act, DEA has historically differentiated between narcotic
and non-narcotic substances for registration purposes.\1\ Not all
registrants wish to be registered to handle narcotic substances, and
are therefore given the opportunity to apply only those substances that
they wish to handle. In addition, there are occasions where a
practitioner is not authorized by the state in which he/she practices
to handle narcotic substances, and as a result cannot be issued a DEA
registration to handle those substances. Therefore, the Acting Deputy
Administrator finds that it is appropriate, as well as prudent, to
differentiate between narcotic and non-narcotic substances for
registration purposes. Registrants are on notice as to which substances
fall within these categories. The term ``narcotic drug'' is defined in
the Controlled Substances Abuse Act and it is clear in looking at the
regulations which substances meet this definition. See 21 U.S.C.
802(17); 21 CFR 1308.12(b) and (c) and 1308.13(e).
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\1\ The same applies for Schedule III controlled substances.
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Consequently, the Acting Deputy Administrator finds that Repondent
issued a prescription for testosterone, and one for Dexedrine, without
being authorized by his registration to do so. The Acting Deputy
Administrator recognizes that after being advised of the extent of his
authorization to handle controlled substances, Respondent substantially
complied with the law. However, the fact that he issued two
unauthorized prescriptions indicates that Respondent is still not aware
of what schedule certain drugs fall within,
[[Page 44474]]
and that he is not diligent in verifying a substance's schedule.
Like Judge Randall, the Acting Deputy Administrator finds it
commendable that Respondent sought the assistance of local pharmacists
to ensure that he did not inadvertently issue prescriptions outside of
his DEA granted authorization. However, as Judge Randall notes, ``the
record lacks evidence that the Respondent took any actions to enhance
his own knowledge about scheduled substances, so that he could be
responsible for his prescribing conduct.'' The responsibility for the
proper prescribing of controlled substances is on the practitioner and
he should not rely on others to ensure his compliance.
Under 21 U.S.C. 843(a)(4)(A), it is ``unlawful for any person
knowingly or intentionally--to furnish false or fraudulent material
information in, or omit any material information from, any application,
report, record, or other document required to be made, kept, or filed
under this subchapter or subchapter II of this chapter.'' Answers to
the renewal application's liability question are material, since DEA
relies upon such answers to determine whether an investigation is
needed prior to granting the application. See Ezzat E. Majd Pour, M.D.,
55 FR 47,547 (1990).
Here, it is undisputed that Respondent materially falsified his
1992 renewal application by answering ``No'' to the question which asks
in relevant part whether the applicant has ``ever had a State
professional license * * * revoked, suspended, denied, restricted or
placed on probation,'' despite the fact that his application for a
South Carolina medical license was denied in 1986 and his Florida
medical license was revoked in 1988. What makes this falsification all
the more troubling is that a major reason for the denial of his
application for a medical licenses in South Carolina was that he failed
to disclose his prior suspension from the North Carolina Medicaid
Program. If anything, Respondent should have been especially diligent
in truthfully answering the questions on the DEA application, since his
failure to disclose information on his South Carolina application
resulted in his loss of licensure in two states.
The Acting Deputy Administrator agrees with Judge Randall that
``[a]lthough the Respondent acted to correct this error in his 1995
application, the reasons he provided for the adverse state actions are
disconcerting.'' Respondent indicated that he lost his Florida medical
license because he ``did not know how to appeal.'' As Judge Randall
notes, ``[t]his half-hearted attempt at disclosing adverse information
raises concerns about the Respondent's continuing problem with taking
responsibility for his own actions, a trait vital in a person
authorized to handle controlled substances.''
Regarding factor three, it is undisputed that Respondent has not
been convicted of any offense relating to the manufacture, distribution
or dispensing of controlled substances.
In considering factor five, other conduct threatening to the public
safety, the Acting Deputy Administrator is concerned by Respondent's
lack of familiarity with the schedules of drugs. While Respondent
contends that his problems stem from his codependency, the Medical
Director of the North Carolina Physicians Health Program testified that
Respondent's lack of knowledge regarding the scheduling of drugs was
not a symptom of his codependency. There is no evidence in the record
that Respondent has made any attempt to educate himself regarding the
scheduling of drugs. In addition, Respondent's lack of familiarity with
the concept of controlled substances is further evidenced by his
response to a question at the hearing about whether he had ever written
an article regarding the handling of controlled substances. Respondent
indicated that he had written one such article and ``it had to do with
alcoholism, concepts of alcoholism.''
The Acting Deputy Administrator is also troubled by Respondent's
lack of attention to detail. Respondent indicates that his failure to
request registration in all schedules on his 1992 application was
merely an ``oversight.'' However, the Acting Deputy Administrator finds
this explanation hard to believe, since Respondent had to skip over
boxes in filling out the application. In addition, Respondent has
exhibited a pattern of not requesting registration in all schedules on
his renewal applications. In 1988 and 1989, Respondent sought
registration in schedules II, IIN, III, IIIN, and IV, but not V. In
1992, he failed to request registration in Schedules IIN, III and IIIN,
and in 1995, he checked the boxes for registration in Schedules II,
III, IV and V, but not IIN or IIIN. The Acting Deputy Administrator
concludes that at the very least Respondent has a problem with
attention to detail.
Further, Respondent's less than candid responses to governmental
agencies is of concern to the Acting Deputy Administrator. Not only did
he fail to disclose certain information on his 1992 DEA renewal
appliction, but the South Carolina Board specifically found that
Respondent's ``total lack of truthful, accurate and complete answers on
his written application for licensure`` provided the basis for denial
of the application.
Finally, the Acting Deputy Administrator is concerned by
Respondent`s failure to accept responsibility for his actions.
Respondent attributes his actions to his codependency problem for which
he has received treatment. However, the Medical Director of the North
Carolina Physicians Health Program testified that Respondent ``still
had some work to do'' in recovering from his codependency problem. Even
Respondent acknowledged that he was ``still in a state of recovery.''
Yet, there is no evidence of Respondent's continuing treatment for his
codependency problem.
In determining whether revocation is warranted in this case, Judge
Randall stated that ``[a]lthough * * * this is a close case, especially
in light of the time that has elapsed since the 1992 falsification of
the Respondent's DEA application, the adverse state actions in the
1980's, and the instances of mishandling of controlled substances in
1994 and 1995, * * * the totality of the circumstances does justify
revoking the Respondent's Certificate of Registration.'' Judge Randall
reached this conclusion in light of Respondent's less than truthful
dealings with governmental agencies; his lack of ongoing treatment and
efforts to continue his recovery from his codependency problems; his
continued lack of knowledge about the scheduling of controlled
substances; and his failure to take affirmative action to increase his
knowledge regarding controlled substances.
Judge Randall noted that ``the record contains ample evidence that
the Respondent's prescribing practices are otherwise appropriate, that
his treatment of his patients is well within the community standard,
and that he is serving an important interest in his rural community.''
However, Judge Randall concluded ``that until the Respondent (1)
submits a complete application to the DEA for a Certificate of
Registration that accurately discloses his professional licensing
history and requests authority to handle the scheduled substances he
needs to effectively treat his patient population, (2) includes with
that application evidence of his completion of continued medical
education containing instruction on scheduled drugs, and (3) provides
the DEA with information concerning his ongoing treatment for his
codependency problem and a medical problem and a medical prognosis as
to
[[Page 44475]]
the impact of his condition upon his ability to accept the
responsibilities inherent in a DEA registrant, it is in the public
interest to revoke his DEA Certificate of Registration.''
The Acting Deputy Administrator agrees with Judge Randall that this
is a close case. Respondent's lack of attention to detail, knowledge
regarding the scheduling of controlled substances, and evidence of
ongoing treatment for his codependency problems all justify revocation
of his DEA Certificate of Registration as inconsistent with the public
interest. However, the Acting Deputy Administrator also recognizes that
Respondent practices in a poor rural community, that he is conservative
in his prescribing of controlled substances and that he correctly
answered the liability question on his 1995 renewal application. As a
result, the Acting Deputy Administrator concludes that the public
interest would be served by giving Respondent an opportunity to become
educated regarding controlled substances and to receive continued
treatment for his codependency problems while still being permitted to
handle controlled substances.
Therefore, the Acting Deputy Administrator will stay the revocation
for six months, during which time Respondent must present evidence to
the Acting Deputy Administrator of his completion of a training course
regarding controlled substances, and of his ongoing treatment for his
codependency problems. In addition, Respondent must request
modification, if necessary, of his 1995 renewal application to
accurately reflect what schedules he wishes to be registered in to
effectively treat his patient population. If Respondent does not submit
this information within six months of the effective date of this order,
a subsequent order will be issued lifting the stay and Respondent's DEA
Certificate of Registration will be revoked. If Respondent does submit
the information in a timely manner, the Acting Deputy Administrator
will issue a subsequent order indicating that the conditions have been
met, that the DEA Certificate of Registration is reinstated and renewed
without limitations, and that Respondent shall acknowledge the
revocation in response to the liability question on any future
applications.
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 AR2127377, issued to Leonard E. Reaves,
III, M.D., be, and it hereby is, revoked, and any pending applications
for renewal of such registration, be, and they hereby are, denied. It
is further ordered that this order will be stayed for a period of six
months from its effective date. If during the six month period,
Respondent fails to provide the Acting Deputy Administrator with
evidence of the completion of a course regarding controlled substances
or of his ongoing treatment for his codependency problems, the stay
will be removed and Respondent's DEA Certificate of Registration will
be revoked and any pending application for renewal will be denied. This
order is effective September 18, 1998.
Dated: August 13, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-22223 Filed 8-18-98; 8:45 am]
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