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

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]

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