[Federal Register Volume 62, Number 94 (Thursday, May 15, 1997)]
[Notices]
[Pages 26818-26821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12802]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[Docket No. 96-28]


Robert G. Hallermeier, M.D. Continuation of Registration With 
Restrictions

    On March 27, 1996, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Robert G. Hallermeier, M.D., (Respondent) of 
Boothwyn, Pennsylvania, notifying him of an opportunity to show cause 
as to why DEA should not revoke his DEA Certification of Registration, 
AH6871049, and deny any pending applications for registration as a 
practitioner under 21 U.S.C. 823(f), for reason that pursuant to 21 
U.S.C. 824(a)(4), his continued registration would be inconsistent with 
the public interest.
    By letter dated April 29, 1996, Respondent, through counsel, filed 
a timely request for a hearing, and following prehearing procedures, a 
hearing was held in Philadelphia, Pennsylvania on October 23 and 24, 
1996, before Administrative Law Judge Gail A. Randall. At the hearing, 
both parties called witnesses to testify and introduced documentary 
evidence. After the hearing, counsel for both parties submitted 
proposed findings of fact, conclusions of law and argument. On February 
27, 1997, Judge Randall issued her Opinion and Recommended Ruling, 
recommending that Respondent's registration be continued subject to 
several temporary conditions. No exceptions were filed to her Opinion 
and Recommended Ruling, and on March 27, 1997, 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, in full, the opinion of 
the Administrative Law Judge, and adopts, with several modifications, 
the recommended ruling of the Administrative Law Judge. 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 received his 
medical degree from Temple University. While in medical school, 
Respondent observed a physician assistant write orders and 
prescriptions for medications without direct supervision of a 
physician. In 1977, Respondent joined an internal medicine group where 
there was a nurse practitioner who saw patients, and wrote orders and 
prescriptions for medication also without direct supervision of a 
physician.
    In October 1988, Respondent began working, on a trial basis, for 
Joseph Kurtz, a physician assistant who operated three medical 
facilities, and in January 1989, Respondent was hired by Mr. Kurtz as 
an independent contracting physician. There was a written agreement 
between the Respondent and Mr. Kurtz, stating that one of Respondent's 
responsibilities was to act as a supervisor for the physician 
assistant, however there were no details provided as to the nature and 
extent of the supervision, and the agreement was not submitted for 
approval to the State Board of Medicine, Commonwealth of Pennsylvania 
as required by state law. In addition, Respondent was not registered 
with the Pennsylvania Board of Medicine to use the services of a 
physician assistant as required by state law.
    When he first began working for Mr. Kurtz, Respondent was concerned 
about the number of controlled substance prescriptions that were issued 
at the facilities and that a number of the patients appeared to be drug 
seekers. Respondent began reducing the number of controlled substance 
prescriptions issued and patients indicated that they felt safer coming 
to the facilities. After he was hired in 1989 and pursuant to Mr. 
Kurtz' request, Respondent provided three copies of his signature for 
the purpose of making a rubber stamp of his signature to be used for 
billing purposes and for writing prescriptions. Respondent and Mr. 
Kurtz had very little contact since they alternated working at the 
various facilities and would never work at the same facility at the 
same time. Respondent was told by another physician who had worked for 
Mr. Kurtz that the level of physician supervision used with Mr. Kurtz, 
including Mr. Kurtz working at a different facility, was permitted. 
Respondent testified at the hearing in this matter that pursuant to his 
agreement with Mr. Kurtz, Mr. Kurtz could only issue prescriptions for 
refills of earlier prescriptions and could not issue any new 
prescriptions. However, during previous interviews, Respondent did not 
mention this restriction on Mr. Kurtz' prescribing.
    In 1990, the Pennsylvania Office of the Attorney General, Medicaid 
Fraud Section initiated an investigation of Respondent. As a result of 
this investigation, it was determined that Mr. Kurtz had been billing 
the medical assistance program using the provider identification number 
of Respondent, who was an approved provider under the program. Pursuant 
to the medical assistance program regulations, services by a physician 
assistant are permissible, providing that there is direct supervision 
of the physician assistant by the supervising physician and that the 
supervising physician is registered as such with the Board. Since the 
prescriptions discovered during the investigation were written by Mr. 
Kurtz, and not Respondent, they were not legitimately billed to the 
medical assistance program. As a result, criminal charges were filed 
against Mr. Kurtz and Maureen Clark, his wife, who owned Clark Family 
Pharmacy where the prescriptions were filled, which is located adjacent 
to one of the medical

[[Page 26819]]

facilities. Both Mr. Kurtz and his wife were each convicted in 1994 of 
three counts of Medicaid fraud.
    In January 1992, after Respondent had testified before the grand 
jury in the state criminal proceedings against Mr. Kurtz and Ms. Clark, 
he became concerned and asked Mr. Kurtz to return his signature stamps. 
Mr. Kurtz provided Respondent with several photocopied pages from the 
Federal Register and the Pennsylvania Medical Board rules with portions 
highlighted by Mr. Kurtz and represented by Mr. Kurtz to be the law 
regarding the supervision of physician assistants. Respondent testified 
that he was afraid to confront Mr. Kurtz for fear of losing his job, 
and therefore, without further inquiry, Respondent continued to permit 
Mr. Kurtz to use his signature stamp and DEA registration number. 
According to Respondent, he did however begin going to the pharmacy on 
a weekly basis to review and initial the prescriptions issued by Mr. 
Kurtz to be certain they were not for ``outrageous'' amounts. However, 
this review was conducted after the controlled substances had already 
been dispensed. Respondent admitted at the hearing in this matter that 
he had not reviewed Mr. Kurtz' patient charts to see if the prescribed 
controlled substances were medically appropriate.
    In May 1992, DEA initiated its investigation of Clark Family 
Pharmacy after receiving reports that the pharmacy was purchasing 
excessive quantities of controlled substances. Previously, while at the 
pharmacy to witness the destruction of drugs, a DEA investigator had 
noticed prescriptions that appeared to have rubber stamped signatures, 
and was told by the pharmacist that the prescriptions were written by 
Mr. Kurtz using the rubber stamp signature of Respondent. Pursuant to 
an administrative inspection warrant, DEA obtained controlled substance 
records from the pharmacy. A DEA investigator then entered into a 
database all of the prescriptions with Respondent's rubber stamped 
signature obtained from the pharmacy by DEA pursuant to the 
administrative inspection warrant, and by the Pennsylvania Attorney 
General's Office during its earlier investigation. It was determined 
that Respondent's signature was rubber stamped on a total of 2,545 
prescriptions for controlled substances in Schedules III and IV between 
November 1990 and November 1992, for a total of 92,281 dosage units. 
These prescriptions were issued by Mr. Kurtz and were original 
prescriptions, and not refills.
    During the course of DEA's investigation, on April 23, 1993, an 
investigator interviewed the pharmacist at Clark Family Pharmacy who 
indicated that when he began working at the pharmacy in April 1989, he 
was told by Ms. Clark that Mr. Kurtz would hand carry patient files 
over to the pharmacy. The pharmacist was instructed to reduce the notes 
from these files to writing on Clark Family Pharmacy prescription pads 
and to sign Respondent's name to the prescriptions. In 1990, the 
pharmacy was visited by a state inspector who advised the pharmacist to 
cease the practice of reducing the information from patient files to 
writing on the pharmacy's prescription pads because that was the 
procedure for call-in prescriptions. The inspector advised the 
pharmacist that instead, the prescriptions should be generated by the 
medical facility on its own prescription pads and then filled at the 
pharmacy. Consequently, the medical facility and the pharmacy began a 
new procedure whereby Mr. Kurtz would write the prescription on the 
facility's prescription pad and rubber stamp it with Respondent's 
signature. The prescription would then be hand carried to the pharmacy 
by either Mr. Kurtz or one of the facility's employees. The patient 
would pick up the medication from the pharmacy without ever seeing the 
actual prescription. The pharmacist related that 90 percent of the 
pharmacy's business came from Mr. Kurtz' clinic.
    Respondent was aware that Mr. Kurtz was not a licensed physician, 
that he was not registered with DEA, and that he treated patients and 
wrote controlled substance prescriptions without physician supervision. 
Respondent knowingly permitted Mr. Kurtz to use his DEA registration 
number to authorize controlled substance prescriptions. A letter from 
Respondent to DEA dated March 11, 1993, indicated that Mr. Kurtz told 
Respondent that he had destroyed the signature stamps in January of 
1993. Respondent stopped working for Mr. Kurtz in August 1993. The last 
stamped prescription in evidence in this proceeding is dated November 
of 1992.
    According to Respondent, one cause of his failure to adequately 
supervise Mr. Kurtz and to allow him to use Respondent's DEA 
registration number was his ignorance of the responsibilities of a 
supervising physician of a physician assistant. Respondent testified 
that based upon representations made by Mr. Kurtz and his previous 
experience with physician assistants and nurse practitioners, he did 
not know that allowing Mr. Kurtz to independently practice medicine was 
not permissible. Respondent acknowledged that he made no further 
inquiries regarding the acceptable scope of practice for a physician 
assistant nor did he attempt to verify whether the prescriptions issued 
by Mr. Kurtz were refills of earlier prescriptions or new 
prescriptions.
    In addition, Respondent testified that his actions were also caused 
by his abuse of alcohol. Respondent has a family history of alcoholism 
and started abusing alcohol in 1979. Following his first attempt to 
commit suicide in 1988, Respondent was admitted to the hospital for 
several weeks, where he was treated for depression, rather than 
alcoholism. In July 1988, he voluntarily signed up with the Physician's 
Health Program (PHP), an arm of the State Medical Society. Pursuant to 
this program, among other things, Respondent underwent urine screens, 
attended professional support group meetings and met with his 
psychiatrist. Respondent followed the program for approximately six 
months, when he began drinking again, and ultimately attempted suicide 
a second time in 1992.
    Following his second suicide attempt, Respondent was hospitalized 
for two weeks and then was transferred to the Strecker Institute in 
November 1992 where for four weeks he received group and individual 
counseling from a psychiatrist specializing in addiction counseling, 
and attended alcoholics anonymous and narcotics anonymous meetings. 
Upon his release from inpatient treatment, Respondent participated in 
extensive aftercare for two years including regular attendance at AA 
meetings, random drug and alcohol screening, continued therapy with his 
psychiatrist and regular contact with the PHP. When his contract with 
the PHP expired in December 1995, Respondent voluntarily sighed up for 
an additional five years of monitoring by the PHP, which he was still 
participating in at the date of the hearing in this matter. The 
Assistant Medical Director at the PHP testified that he had seen 
Respondent two to three times per month for the few years prior to the 
hearing; that Respondent met all of the requirements of his contract 
with the PHP; that Respondent's urine screens were negative for alcohol 
and controlled substances; and that Respondent's prognosis for 
continued recovery and sobriety is excellent.
    In describing Respondent's behavior in 1992, Respondent's 
psychiatrist noted in a treatment summary dated July 26, 1996, that 
``He stated that he never looked into the regulations of working as a 
physician's assistant, and

[[Page 26820]]

in retrospect it is clear that he was mentally obtunded and not 
thinking clearly and coherently due to his active alcoholism.'' 
Respondent's psychiatrist further noted that ``[t]he recommendation is 
that if Dr. Hallermeier continues to do as he currently is doing and 
follow [sic] his current regime which is that of attending many AA 
meetings every week and working his program as he is doing the 
prognosis for continuing successful outcome is quite optimistic.''
    Respondent's wife testified at the hearing in this matter that the 
family was supportive of Respondent's treatment efforts. She also 
stated that they have ``an abstinence based home,'' in which no 
alcoholic beverages are kept or consumed.
    Also testifying at the hearing were the administrators of three 
medical facilities where Respondent had been employed for the two to 
three years prior to the hearing. Each administrator stated that 
Respondent had refused a request for a signature stamp, and instead 
personally signs all comments requiring his signature. There are no 
physician assistants employed at any of these facilities. The 
administrators testified that Respondent is a professional and caring 
physician.
    Respondent testified that he has progressively become more 
``stingy'' in his handling of controlled substances. He further 
testified that although he has not frequently needed to prescribe 
controlled substances recently, he believed that such prescribing might 
be necessary in the future. He also stated that he has become a better 
doctor as a result of his recovery and that there is no question that 
the situation that occurred with Mr. Kuntz would never happen again.
    The Government contends that Respondent's continued registration 
would be inconsistent with the public interest in light of the fact 
that he allowed Mr. Kurtz to use his DEA registration to issue over 
2,000 controlled substance prescriptions, and in so doing, violated 
numerous provisions of both state and Federal laws and regulations. The 
Government also argues that Respondent's conduct is all the more 
egregious since he felt that a number of the patients of the facility 
were drug seekers; he was concerned over the number of controlled 
substance prescriptions being issued at the facility; and he was called 
to testify before a grand jury regarding the prescribing and billing 
practices of the facility. The Government questions Respondent's 
credibility, his lack of remorse, and his explanation that alcoholism 
was the cause of his problems.
    The Respondent contends that the Government has not met its burden 
of proof and that his continued registration is not inconsistent with 
the public interest. Respondent argues that the Government's case 
focused entirely on Respondent's past misconduct and that Respondent 
does not deny this misconduct. However, Respondent contends that there 
was uncontroverted evidence presented at the hearing that his continued 
registration is in the public interest in light his recovery from 
alcohol addiction, his current responsible use of his DEA registration, 
his refusal to give new employers a signature stamp, his responsible 
practices regarding the prescribing of controlled substances, and the 
testimony of his present employers who think highly of his medical 
judgment and professionalism. Respondent further argues that the causes 
of his past misconduct, ignorance of the laws regarding physician 
assistants and his alcoholism, have now been remedied.
    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 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. Schwarz, Jr., M.D., Docket No. 88-
42, 54 Federal Register 16,422 (1989).
    Regarding factor one, there is no evidence that any action has been 
taken against Respondent's license to practice medicine or handle 
controlled substances by any State licensing board or disciplinary 
authority.
    As to factors two and four, it is undisputed that Respondent 
allowed an unsupervised physician assistant to prescribe large 
quantities of controlled substances. This is extremely troubling given 
that Respondent admitted that he did not trust Mr. Kurtz; that he 
thought that too many controlled substance prescriptions were being 
issued by Mr. Kurtz' medical facility; that he thought that some of the 
people receiving these prescriptions were drug seekers; and that he was 
subpoenaed to testify before the grand jury regarding Mr. Kurtz' 
prescribing and billing practices. Any one of these circumstances 
should have caused Respondent to be more vigilant in his supervision of 
Mr. Kurtz. Instead, Respondent continued to allow Mr. Kurtz to use his 
DEA registration number and the rubber stamp of his signature, thereby 
causing the unauthorized dispensing of over 92,000 dosage units of 
controlled substances over a two year period. Respondent's actions 
permitted the prescribing of controlled substances by an unauthorized 
individual in violation of numerous provisions of Federal and state 
laws and regulations, including 21 U.S.C. 829(b) and 841 and 21 C.F.R. 
1306.03 and 1306.04(a), as well as, 63 P.S. 422.13 and 49 Pa. Code 
18.144, 18.152, and 18.153 (1988-1992 version).
    As Judge Randall noted, ``[s]uch violations clearly raise questions 
as to the Respondent's fitness to possess a DEA Certificate of 
Registration.'' The Acting Deputy Administrator finds that Respondent's 
lack of control and supervision over the dispensing of controlled 
substances through the use of his DEA registration from 1989 to 1992 is 
reprehensible. However, like Judge Randall, the Acting Deputy 
Administrator notes that Respondent offered evidence that his behavior 
was caused by his alcoholism, and that he has taken numerous steps 
towards recovery and has remained alcohol-free since October 1992. The 
Acting Deputy Administrator also finds significant that there is no 
evidence that Respondent has improperly dispensed controlled substances 
or allowed the improper dispensing of controlled substances since 
November 1992.
    As Judge Randall noted regarding factor three, ``[t]he record 
contains no evidence that the Respondent has been convicted of any 
Federal or State laws relating to the manufacture, distribution or 
dispensing of controlled substances.''
    The Acting Deputy Administrator concurs with Judge Randall that 
``[t]he Respondent's lack of responsibility in dealing with Mr. Kurtz 
bears on factor five.'' While Respondent testified that he has never 
frequently prescribed controlled substances, he exhibited an extremely 
cavalier attitude towards the potentially dangerous nature of these

[[Page 26821]]

drugs by allowing an unsupervised and unauthorized physician assistant 
to prescribe these substances at will. As a DEA registrant, Respondent 
was entrusted with the responsibility to ensure that controlled 
substances are only dispensed for a legitimate medical purpose. While 
working for Mr. Kurtz, Respondent miserably failed to carry out his 
responsibilities as a DEA registrant.
    Nevertheless, as Judge Randall notes, ``the record contains no 
evidence that the Respondent has engaged in similar conduct since 
beginning treatment for his alcohol addiction.'' In addition, 
``Respondent has maintained his DEA registration [since 1992] and acted 
without incident.'' The Acting Deputy Administrator finds that while 
passage of time alone is not dispositive, it is a consideration in 
assessing whether Respondent's continued registration is inconsistent 
with the public interest. See Norman Alpert, M.D., 58 F.R. 67,420 
(1993).
    Judge Randall found, and the Acting Deputy Administrator concurs 
that ``[t]he Government has proven by a preponderance of the evidence 
that the Respondent's past conduct would justify revocation of his DEA 
Certificate of Registration. Further, the Respondent has taken no 
remedial courses to enhance his knowledge of the proper prescribing 
practices related to controlled substances.'' However, Respondent has 
admitted and accepted responsibility for his past misconduct, and there 
is no evidence of any wrongdoing since November 1992, when he began 
extensive treatment for his alcoholism. Following the expiration of his 
treatment contract with the PHP, Respondent voluntarily signed up for 
an additional monitoring program. In addition, it is the opinion of the 
Assistant Medical Director at the PHP and Respondent's psychiatrist 
that Respondent's prognosis is excellent for continued recovery and 
sobriety provided that he continues to actively participate in his 
treatment program. Respondent's family is extremely supportive of his 
recovery efforts. Further, Judge Randall found Respondent's testimony 
credible that he has been sober since October 1992. Respondent's 
assertion is supported by the reports in evidence of Respondent's 
negative urine screens for the presence of alcohol or drugs. Finally, 
it appears that Respondent has learned from his past mistakes as 
evidenced by the fact that he has refused the requests of his 
subsequent employers to provide a signature stamp and considers it 
highly unlikely that he will ever work with physician assistants again.
    Judge Randall concluded that ``based upon the Respondent's hearing 
testimony and demeanor, and the fact that he has practiced medicine 
with his DEA registration for over four years without incident, I find 
it highly unlikely that he will engage in this type of misconduct 
again.'' However, she further concluded that ``Respondent's misconduct 
warrants future monitoring of his prescribing practices and some 
remedial training.'' Judge Randall recommended that Respondent's 
continued registration subject to the following conditions would be in 
the public interest:
    (1) For two years after the date of the final order, Respondent 
shall be required quarterly to submit a controlled substance 
prescription log to the local DEA office, with the type of log entries 
to be determined by the Special Agent in Charge or a designated 
representative. However, at a minimum the log should record the name of 
the patient, the date the prescription was issued, and the name, dosage 
and quantity of the controlled substance prescribed.
    (2) By not later than two years after the date of the final order, 
Respondent shall submit to the local DEA office evidence of successful 
completion, after October of 1992, of formal training in the proper 
prescribing of controlled substances.
    (3) If Respondent's current PHP contract requires urine screens, 
then Respondent shall keep these urine screen results on file in his 
office for two years, and shall allow DEA to review them upon 
reasonable request.
    The Acting Deputy Administrator agrees with Judge Randall that in 
light of Respondent's rehabilitative efforts, his acceptance of 
responsibility for his past misconduct, his current employment 
situation, and the lack of any wrongdoing since November 1992, 
revocation of Respondent's DEA Certificate of Registration is not 
appropriate, but that some monitoring of his controlled substance 
handling and remedial training is appropriate to protect the public 
health and safety. The Acting Deputy Administrator agrees with Judge 
Randall that Respondent should receive some remedial training within 
two years of this final order. However, given the nature and extent of 
Respondent's previous misconduct, the Acting Deputy Administrator finds 
it appropriate to impose several additional restrictions than those 
recommended by the Administrative Law Judge and to require that these 
restrictions remain on Respondent's registration for three years, the 
period of one full registration cycle.
    Therefore, the Acting Deputy Administrator finds that Respondent's 
DEA Certificate of Registration should be continued subject to the 
following restrictions:
    (1) For the years after the effective date of this final order, 
Respondent shall submit at the end of every calendar quarter, a log of 
all controlled substances he has prescribed, administered or dispensed 
during the previous quarter to the Special Agent in Charge of the 
nearest DEA office or his designee. The log shall include the name of 
the patient, the date that the controlled substance was prescribed, 
administered or dispensed, and the name, dosage and quantity of the 
controlled substance prescribed, administered or dispensed. If no 
controlled substances are prescribed, administered or dispensed during 
a given quarter, Respondent shall indicate that fact in writing in lieu 
of submission of the log.
    (2) For three years after the effective date of this final order, 
Respondent shall notify in writing the Special Agent in Charge of the 
nearest DEA office of his designee, if he assumes responsibility for 
the supervision of a physician assistant or any other mid-level 
practitioner.
    (3) For three years after the effective date of this final order, 
Respondent is to continue his association with the PHP, and if for any 
reason, the PHP no longer requires random urine screens, Respondent 
shall continue these screens at his own expense. Respondent shall 
provide copies of the reports of the results of the screens upon 
reasonable request by DEA personnel.
    (4) Within two years after the effective date of this final order, 
Respondent shall submit to the local DEA office evidence of successful 
completion, after October of 1992, of formal training in the proper 
handling of controlled substances.
    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 C.F.R. 0.100(b) and 0.104, hereby orders 
that DEA Certificate of Registration AH6871049, issued to Robert G. 
Hallermeier, M.D., be continued, and any pending applications be 
granted, subject to the above described restrictions. This order is 
effective June 16, 1997.

    Dated: May 8, 1997.
[FR Doc. 97-12802 Filed 5-14-97; 8:45 am]
BILLING CODE 4410-09-M