[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]
BILLING CODE 4410-09-M