[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
