[Federal Register Volume 63, Number 246 (Wednesday, December 23, 1998)]
[Notices]
[Pages 71157-71159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33890]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 97-25]
Mary M. Miller, M.D.; Grant of Restricted Registration
On July 8, 1997, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Mary Margaret Miller, M.D. (Respondent) of
Louisville, Kentucky, notifying her of an opportunity to show cause as
to why DEA should not deny her application for registration as a
practitioner pursuant to 21 U.S.C. 823(f) and 824(a)(2).
By letter dated July 16, 1997, Respondent requested a hearing on
the issues raised by the Order to Show Cause. Following prehearing
procedures, a hearing was held in Frankfurt, Kentucky on December 10,
1997, before Administrative Law Judge Gail A. Randall. At the hearing,
both parties called witnesses to testify and introduced documentary
evidence. After the hearing, both parties submitted proposed findings
of fact, conclusions of law and argument. On June 25, 1998, Judge
Randall issued her Opinion and Recommended Ruling, recommending that
Respondent be granted a DEA Certificate of Registration subject to
several conditions. Neither party filed exceptions to the Opinion and
Recommended Ruling of the Administrative Law Judge and on July 28,
1998, Judge Randall transmitted the record of these proceedings to the
then-Acting Deputy Administrator.
The Deputy Administrator has considered the record in its entirety,
and pursuant to 21 CFR 1316.67, hereby issues her final order based
upon findings of fact and conclusions of law as hereinafter set forth.
The Deputy Administrator adopts the Opinion and Recommended Ruling of
the Administrative Law Judge, but includes an additional condition on
Respondent's registration. 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 of law.
The Deputy Administrator finds that Respondent graduated from
medical school in 1962 and obtained her first DEA registration in
approximately 1963 while practicing in Colorado. In 1981, Respondent
also became licensed to practice medicine in Kentucky.
In 1983, DEA noted that pharmacies in the Fort Collins, Colorado
area were ordering large quantities of Schedule II controlled
substances. Further investigation revealed that Respondent's name
repeatedly came up as a large prescriber of Schedule II substances. As
a result, DEA initiated an investigation of Respondent. An undercover
DEA agent went to Respondent's office on five occasions to attempt to
obtain controlled substance prescriptions for no legitimate medical
purposes.
The first undercover operation was conducted on August 16, 1983,
during which the undercover agent received prescriptions for
Biphetamine and Seconal, both Schedule II controlled substances, from
Respondent. Initially, the undercover agent told Respondent that she
needed to lose weight, but later stated that she was a prostitute and
that she needed Biphetamine to stay up all night and Seconal to allow
her to sleep during the day. Respondent did not perform any physical
examination and told the undercover agent not to fill the prescriptions
in the Fort Collins area. Neither Biphetamine nor Seconal were
acceptable for weight loss treatment in Colorado in 1983. Respondent
later said that the prescribed substances were for narcolepsy and
narcolepsy was noted on the prescriptions. However, there was no
discussion regarding narcolepsy during this visit.
The undercover agent returned to Respondent's office on August 23,
1983, however she was unable to see Respondent on that day. The third
undercover operation was conducted on September 15, 1983, during which
the undercover agent obtained prescriptions from Respondent for
Biphetamine, Seconal and Valium, a Schedule IV controlled substance.
The undercover agent received the prescription for Valium after telling
Respondent that she needed something to ``smooth her out'' between the
Biphetamine and the Seconal. The undercover agent did not assert any
medical complaints during this visit.
The undercover agent returned to Respondent's office on October 4,
1983. She obtained prescriptions for Biphetamine, Seconal and Valium
from Respondent even though she did not give any medical reasons for
needing the drugs. Respondent told the undercover agent to fill the
prescriptions at different pharmacies and not to fill them at
pharmacies in Fort Collins.
The final visit occurred on November 1, 1983, during which the
undercover agent again obtained prescriptions for Biphetamine, Seconal
and Valium from Respondent without giving any medical reason.
Respondent again told the undercover agent not to have the
prescriptions filled in Fort Collins. On this occasion the undercover
agent asked for a prescription for another amphetamine and also asked
for a prescription for a friend. Respondent refused both of these
requests.
As a result of this investigation, Respondent was ultimately
convicted on October 22, 1984, in the United States District Court of
Colorado of 15 counts of distribution of controlled substances and
prescriptions not issued for a letigimate medical purpose in violation
of 21 U.S.C. 841(a)(1) and 21 CFR 1306.04(a). Respondent was sentenced
to 30 months imprisonment followed by 5 years probation and fined
$75,000. She served 10 months in prison during which time she
inactivated her Kentucky medical license.
As a result of her conviction, in October 1984 the Colorado Board
of Medical Licensure (Colorado Board) suspended her medical license.
Her license was reinstated in 1986.
According to Respondent, she abused alcohol during her criminal
trial and again after her release from prison. After being confronted
by her family about her alcohol abuse she entered an in-patient
treatment facility for three months. Respondent testified that she has
not consumed any alcohol since January 29, 1990. While in treatment,
the Colorado Board suspended her medical license and on September 28,
1990, Respondent's Colorado medical license was revoked based upon her
``habitual intemperance'', referring to her abuse of alcohol.
Thereafter, Respondent applied for reinstatement of her Kentucky
medical license which was denied by the Kentucky Board of Medical
Licensure (Kentucky Board) in November 1992. The Kentucky Board
recommended that Respondent get involved with the Kentucky Impaired
Physicians Program (Kentucky Program). Respondent became involved with
the Kentucky Program in 1993 and was required to attend four to six
Alcoholics Anonymous (AA) meetings per week.
In December 1992, Respondent also became involved with an
outpatient facility that treats alcohol and drug addiction. Respondent
participated in the physicians' therapy group for approximately two
years and agreed to
[[Page 71158]]
undergo random urine screens. Respondent still has monthly individual
sessions with the executive director of the facility. The executive
director testified at the hearing in this matter that he does not have
any concern about Respondent relapsing, as long as she continues to
attend to herself as a recovering alcoholic.
In March 1994, Respondent applied for and received Kentucky
institutional medical license so she could work as a resident in family
practice at the University of Louisville. Beginning on April 1, 1994,
she worked in the residency clinic for six months and then spent six
months on assigned rotations. During her residency training, Respondent
continued to participate in the Kentucky Program.
In March 1995, the Kentucky Board granted Respondent a full
Kentucky license with conditions. Respondent was placed on probation
for five years, was required to maintain her contractual relationship
with the Kentucky Program, and was required to have all controlled
substance prescriptions co-signed by another physician.
On May 1, 1995, Respondent submitted the application that is the
subject of these proceedings for registration in Schedules III
narcotic, III non-narcotic, IV and V. On the application, Respondent
fully disclosed her prior conviction, sentencing and rehabilitation
information.
Thereafter, on September 22, 1997, the Kentucky Board entered an
Amended Order of Probation striking the co-signature requirement and
replacing it with a requirement that Respondent maintain a log of her
controlled substance prescriptions. The log must include the date,
patient name, patient complaint, medication prescribed, date it was
last prescribed and the amount last prescribed.
In the meantime, Respondent applied for recertification by the
American Board of Family Practice, since such certification is a
requirement for hospital privileges. Respondent was advised that she
was not eligible for recertification due to the revocation of her
Colorado medical license. Consequently, Respondent applied for
reinstatement of her Colorado medical license. On February 15, 1996,
the Colorado Board reinstated Respondent's medical license with the
condition that she never practice medicine in Colorado. The Colorado
Board's action was taken solely to enable Respondent to sit for
recertification with the American Board of Family Practice. At the time
of the hearing, Respondent was still attempting to be recertified.
Since August 1996, Respondent has been working at a family heath
care clinic with two locations in Kentucky. Respondent is one of three
physicians affiliated with the clinics. One of the clinics is the only
medical provider in the city and is approximately a thirty minute drive
from the nearest hospital. Four out of five days a week, Respondent is
the only physician at this location. The head and senior partner of the
clinics testified at the hearing that he reviews the charts of the
other physicians. He further testified that Respondent is very
professional, responsible, ethical, hard-working and has a good medical
judgment.
A physician and professor in the Family Practice Residency at the
University of Louisville provided an affidavit stating that Respondent
demonstrated good medical judgment and good ethical standards during
her residency, and that she did not exhibit any signs of substance
abuse. He recommended that Respondent be granted a DEA registration
provided that she ``be followed by an appropriate organization who can
monitor her continued recovery from alcoholism.''
Respondent testified that she takes full responsibility for her
actions that led to her conviction and that she does not attribute her
prior misconduct to her alcoholism. However, since 1990, Respondent's
urine screens have never tested positive for alcohol or any other
substance of abuse. At the time of the hearing, she was still enrolled
in the Kentucky program, participating in monthly sessions with the
executive director of the outpatient facility, attending AA meetings on
a regular basis, and participating in health care professional
meetings.
The medical director of the Kentucky Program testified that
nationally, physicians involved in impaired physicians programs have a
90-95% recovery rate. He further testified that he does not believe
that Respondent will relapase as long as she remains involved with her
recovery efforts, and in his opinion, Respondent can handle the
responsibilities of a DEA registrant.
Respondent testified that she needs a DEA registration to be able
to treat acute trauma patients and patients with chronic pain with
controlled substances. She also wants her registration because she has
been denied privileges at area hospitals and her current employer has
been denied participation in various insurance plans due to her lack of
a registration.
Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny an
application for a DEA Certificate of Registration if he determines that
such registration would be inconsistent with the public interest. In
determining the public interest, the following factors are considered:
(1) The recommendation of 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 and
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. Schwartz, Jr., M.D., 54 FR 16,422
(1989).
Regarding factor one, it is undisputed that Respondent is currently
licensed to practice medicine in Colorado and Kentucky. However, when
Colorado granted Respondent a license in January 1996, it did so with
the stipulation that Respondent never practice medicine in the state.
In addition, Respondent's Kentucky medical license is currently on
probation and she is required to maintain a log of her controlled
substance prescribing.
As to factors two and four, Respondent's experience in dispensing
controlled substances and her compliance with applicable laws relating
to the handling of controlled substances, Respondent does not dispute
that she issued controlled substance prescriptions to the undercover
agent for no legitimate medical purpose in violation of 21 U.S.C.
841(a)(1) and 21 CFR 1306.04(a). In addition, as Judge Randall noted,
``her instructions to [the undercover agent] not to fill all of the
prescriptions at the same pharmacy demonstrate an understanding that
she was acting improperly, as well as an effort to avoid detection.''
This egregious conduct by Respondent raises serious concerns about her
ability to responsibly handle controlled substances.
However, the Deputy Administrator notes that Respondent's
misconduct occurred 15 years ago, and there is no evidence of any
wrongdoing since that time. In fact, during the ensuing years,
Respondent has attempted to rehabilitate her career by participating in
the family practice residency at the
[[Page 71159]]
University of Louisville and by working at the family health care
clinics since 1996. However, as Judge Randall noted, ``since she has
not been registered by the DEA to handle controlled substances for the
past fifteen years she has lacked the opportunity to demonstrate that
she can responsibly handle controlled substances.''
Regarding factor three, it is undisputed that in 1984, Respondent
was convicted in the United States District Court for the District of
Colorado of 15 counts of distributing controlled substances and issuing
prescriptions for other than a legitimate medical purpose in violation
of 21 U.S.C. 841(a)(1) and 21 CFR 1306.04.
As to factor five, the Deputy Administrator is concerned with
Respondent's history of alcohol abuse. However, Respondent's sobriety
date is Janaury 29, 1990. In addition, she has taken tremendous steps
toward rehabilitating herself, and there was credible evidence
presented at the hearing that Respondent is unlikely to relapse if she
continues to attend to her recovery.
The Deputy Administrator concludes that Respondent's actions in
1983 were clearly contrary to the public interest and raise serious
concerns regarding her fitness to be registered with DEA. However, the
Deputy Administrator finds that there is evidence in the record that
supports granting Respondent's application. Respondent's criminal
conduct occurred 15 years ago. As has been previously determined,
``[t]he paramount issue is not how much time has elapsed since
[Respondent's] unlawful conduct, but rather, whether during that time
Respondent has learned from past mistakes and has demonstrated that
[she] would handle controlled substances properly if entrusted with DEA
registration.'' Leonardo V. Lopez, M.D., 54 FR 36,915 (1989). Here, the
Deputy Administrator finds it significant that Respondent has accepted
responsibility for her past misconduct and fully disclosed her history
on her application for registration. In addition, she has recently
participated in a family practice residency program and has continued
to practice medicine at the family health care clinics in Kentucky.
Also, if granted a DEA registration, Respondent's controlled substance
prescribing will be monitored by the Kentucky Board.
Concerning her alcoholism the Deputy Administrator agrees with
Judge Randall's finding ``that the significant steps the Respondent has
taken to rehabilitate herself demonstrate her commitment to her
continuing recovery and to her profession.'' The Deputy Administrator
also finds it noteworthy that according to the medical director of the
Kentucky Impaired Physicians Program, the chance of Respondent
relapsing is 90-95% if she continues with her recovery efforts.
Therefore, the Deputy Administrator agrees with Judge Randall's
conclusion that Respondent should be given the opportunity to
demonstrate that she can responsibly handle controlled substances. But
in order to protect the public health and safety, some controls are
warranted given her illegal prescribing of controlled substances, her
conviction and her alcohol abuse. Imposing controls upon Respondent's
registration ``will allow the Respondent to demonstrate that [she] can
responsibly handle controlled substances in [her] medical practice, yet
simultaneously protect the public by providing a mechanism for rapid
detection of any improper activity related to controlled substances.''
Steven M. Gardner, M.D., 51 FR 12,576 (1986), as cited in Michael J.
Septer, D.O., 61 FR 53,762 (1996).
Judge Randall recommended that Respondent's application be granted,
provided that for three years Respondent must provide the local DEA
office with a log of her controlled substance handling; she must
maintain her contractual relationship with the Kentucky Impaired
Physicians Program; and she must inform DEA of any action taken by any
state upon her license or authorization to practice medicine or handle
controlled substances. The Deputy Administrator agrees with Judge
Randall's recommended restrictions, but concludes that Respondent
should also be required to consent to periodic inspections by DEA
without requiring an Administrative Inspection Warrant.
Therefore, the Deputy Administrator concludes that Respondent's
application for registration in Schedules III, IIIN, IV and V should be
granted subject to the following restrictions for three years from the
date of issuance of the DEA Certificate of Registration:
1. On a quarterly basis, Respondent must provide the DEA Louisville
Resident Office with a log, which at a minimum, should indicate: (1)
the date that the controlled substance prescription was written, or
such substance was administered or dispensed; (2) the name of the
patient for whom the prescription was written, or to whom the substance
was dispensed or administered; (3) the patient's complaint; (4) the
name, dosage, and quantity of the substance prescribed, dispensed or
administered; and (5) the date that the medication was last prescribed,
dispensed or administered to that patient, as well as the amount last
provided to that patient.
2. Respondent must maintain her contractual relationship with the
Kentucky Impaired Physicians Program and abide by their
recommendations.
3. Within 30 days, Respondent must inform the DEA Louisville
Resident Office of any action taken by any state upon her medical
license or upon her authorization to handle controlled substances.
4. Respondent shall consent to periodic inspections by DEA
personnel based on a Notice of Inspection rather than an Administrative
Inspection Warrant.
Accordingly, the 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 the May
1, 1995 application for registration in Schedules III, IIIN, IV and V
submitted by Mary M. Miller, M.D., be, and it hereby is, granted
subject to the above described restrictions. This order is effective no
later than January 21, 1999.
Dated: December 16, 1998.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 98-33890 Filed 12-22-98; 8:45 am]
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