[Federal Register Volume 64, Number 199 (Friday, October 15, 1999)]
[Notices]
[Pages 55965-55968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27003]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 98-14]
Bernard C. Musselman, M.D.; Revocation of Registration
On February 10, 1998, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Bernard C. Musselman, M.D. of Ogdensburg, New
York, notifying him of an opportunity to show cause as to why DEA
should not revoke his DEA Certificate of Registration BM5006540,
pursuant to 21 U.S.C. 824(a)(1), and deny any pending applications for
renewal of such registration as a practitioner under 21 U.S.C. 823(f),
on the grounds that his continued registration would be inconsistent
with the public interest.
Respondent, through counsel, requested a hearing on the issues
raised by the Order to Show Cause, and the matter was docketed before
Administrative Law Judge Mary Ellen Bittner. During prehearing
procedures, the cited statutory authority for the proposed action was
changed from 21 U.S.C. 824(a)(1) to 21 U.S.C. 824(a)(4). Following
prehearing procedures, a hearing was held in Arlington, Virginia on
December 9, 1998. 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 16, 1999, Judge Bittner issued her Opinion and Recommended
Ruling, Findings of Fact, Conclusions of Law and Decision, recommending
that Respondent's DEA Certificate of Registration be revoked, and any
pending applications for registration be denied. Neither party filed
exceptions to Judge Bittner's opinion and recommended decision, and on
July 19, 1999, Judge Bittner transmitted the record of these
proceedings to the Deputy Administrator.
The 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
Deputy Administrator adopts, except as specifically noted below, the
Opinion and Recommended Ruling, findings of Fact, Conclusions of Law
and Decision 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 Deputy Administrator finds that Respondent entered the United
States Navy in 1958 during his senior year in medical school, graduated
from medical school in 1959, and then completed a one-year internship.
After leaving the Navy in 1963, he practiced general medicine in
Ogdensburg, New York for three years, and then completed a two-year
residency in pediatrics at the Mayo Clinic. Thereafter, Respondent
returned to Ogdensburg and practiced pediatric medicine until he
retired in 1990. While in practice in Ogdensburg, Respondent maintained
admitting privileges at a local hospital.
Respondent was issued a provisional registration to handle
controlled substances, AM3456680, effective May 1, 1971 through January
31, 1972. It is undisputed that Respondent prescribed controlled
substances throughout his medical career, but he was not registered
with DEA or its predecessor agencies to handle controlled substances
from February 1, 1972 until April 11, 1990. According to Respondent, it
was his understanding that a physician only needed a Federal narcotics
registration if he was dispensing controlled substances. Respondent
testified that he never obtained a DEA registration because he only
prescribed controlled substances in his pediatric practice, and did not
dispense them. Respondent further testified that he never received a
notice that he needed to renew his controlled substance registration.
According to Respondent, he even consulted with an attorney who was
also his Congressman who told Respondent that he only needed a Federal
controlled substance registration if he was dispensing controlled
substances. Yet it is also undisputed that during at least most of this
period Respondent's prescription pads were preprinted with DEA
registration number AM3456680.
In 1987, the local hospital was conducting a review of the medical
staff's credentials and discovered that it did not have a copy of
Respondent's DEA Certificate of Registration on file. In October 1987,
the hospital administrator wrote to Respondent requesting a copy of his
DEA registration. Respondent replied that he did not need a DEA
registration because he only prescribed controlled substances. The
hospital staff verified with DEA that Respondent did not have a DEA
registration, but through an oversight, no action was taken by the
hospital at that time.
In March 1990, the issue of Respondent's DEA registration was
raised again at the hospital. Once again, the hospital staff verified
with DEA that Respondent did not have a DEA Certificate of Registration
and also that AM3456680 was a non-existent DEA number.
At some point, the hospital administrator obtained a copy of a form
memorandum that was sent to Respondent by the hospital's director of
pharmacy in January 1989 or 1990 asking for Respondent's signature and
DEA registration number. Respondent signed the memorandum and listed
his DEA registration as AM3456680. Respondent testified that signing
the form was ``an error because I didn't know what I was doing. That's
my old BND (sic) number that had been on file there for years. I
thought that was the number they wanted.''
On March 26, 1990, the hospital administrator sent a memorandum to
the hospital's director of pharmacy, with copies to various other
hospital personnel including Respondent, advising that effective
immediately, Respondent was not able to write any controlled substance
prescriptions because he did not have a DEA registration. After
learning of the memorandum, Respondent had a discussion with the
hospital administrator. Respondent was told that he was not allowed to
write orders for controlled substances, and that if he needed to order
controlled substances
[[Page 55966]]
he would have to have a consulting physician write the order for him.
Respondent contacted the local DEA office in early April 1990 to
obtain an application for registration. he was issued DEA Certificate
of Registration BM2219673 on April 11, 1990.
On April 1 or 2, 1990, the hospital's medical director admitted a
patient to the hospital who had had a seizure and gave her
phenobarbital, a controlled substance. The medical director asked
Respondent to take over the patient's care. According to Respondent he
expressed concern over treating the patient since he could not write
controlled substance orders. On the morning of April 2, 1990,
Respondent met with the medical director, the floor nurse and the
patient's mother to discus the patient's care. According to Respondent,
the medical director agreed to countersign orders for phenobarbital for
the patient. Respondent believed that this meant that the medical
director would be taking responsibility for the order. Respondent
introduced into evidence at the hearing an affidavit from the patient's
mother who indicated that the medical director did agree to countersign
orders for phenobarbital for her daughter. However, the hospital
administrator testified that Respondent wrote the order for
phenobarbital that morning and that it was the hospital administrator
who asked the medical director to countersign the order.
As a result of this order for phenobarbital, the hospital's
executive committee summarily suspended Respondent's hospital
privileges because he did not comply with the hospital's directive to
not write orders for controlled substances. Respondent appealed the
suspension to a fair hearing committee which met on May 12, 1990. At
this hearing, the hospital administrator testified that on April 2,
1990, he received a telephone call from the medical director advising
that the pharmacist on duty had told the medical director that
Respondent had written an order for phenobarbital for a patient.
According to the hospital administrator, the medical director did not
indicate that he had agreed with Respondent to countersign such an
order.
Respondent testified before the fair hearing committee regarding
the meeting he had with the medical director and the patient's mother
on April 2, 1990 and regarding the medical director's agreement to
countersign any order for phenobarbital for the patient. Respondent
further testified before the fair hearing committee that he was
oblivious to the DEA number on his prescription pads and that ``the
reason we hire a CEO of a hospital is to keep abreast of the changes of
the rules and regulations of the health department. And when he
discovered the rules have changed, he ought to tell me. And when he
told me, I acted. * * *''
The fair hearing committee was troubled that no DEA representative
nor the hospital's medical director testified. The committee
recommended that Respondent's privileges be reinstated once he submits
a valid DEA Certificate of Registration to the hospital, he revises his
prescription pads to include a valid DEA registration number, and he
obtains continuing medical education credits on hospital credentialing
and the prescribing of controlled substances.
Notwithstanding the fair hearing committee's recommendation, the
hospital's Board of Directors said that Respondent's privileges would
not be reinstated at that time but that he could reapply the following
spring. Respondent felt that he could not practice medicine without
hospital privileges so he decided to retire.
After being advised by a state investigator that Respondent had
been issuing controlled substance prescriptions without a valid DEA
registration, DEA investigators went to three local pharmacies on April
26, 1990 and retrieved a total of 38 controlled substanced
prescriptions that Respondent had issued between 1986 and March 1990
with DEA number AM 3456680 on the prescriptions. No action was taken by
DEA at that time.
In March 1991, DEA learned that Respondent had retired from the
practice of medicine. In August 1991, two DEA investigators went to see
if Respondent would surrender his DEA registration since he was no
longer practicing medicine. Respondent signed the voluntary surrender
form, and checked the box on the form which stated that ``[i[n view of
my desire to terminate handling of controlled substances listed in
schedule(s) ____ (schedules 2, 2N, 3, 3N, 4, and 5 were handwritten); I
hereby voluntary surrender my Drug Enforcement Administration
Certificate of Registration. * * *'' According to both Respondent and
the investigator who testified at the hearing, this was a cordial
meeting.
In March 1992, the New York Bureau of Professional Medical Conduct
issued a statement of charges alleging 11 specifications of
professional misconduct. Respondent. filed an application to surrender
his license to practice medicine on grounds that he did not contest the
specifications, but also stating that nothing in his application was to
be construed as an admission of any act of misconduct. Respondent
agreed not to apply for restoration of his medical license for at least
one year. Respondent's application was granted effective March 25,
1992. On June 14, 1996, Respondent's medical license was restored.
On August 6, 1996, Respondent submitted a new application for DEA
registration. On this application, Respondent answered ``No'' to
question 4(c): ``Has the applicant ever surrendered or had a Federal
controlled substance registration revoked, suspended, restricted, or
denied?'' Respondent also answered ``No'' to question 4(d): ``Has the
applicant ever had a State professional license or controlled substance
registration revoked, suspended, denied, restricted or placed on
probation?'' These questions are hereinafter referred to as the
liability questions. On August 22, 1996, Respondent was issued DEA
Certificate of registration BM5006540.
When local DEA investigators learned of Respondent's registration,
they requested that Respondent surrender the registration on the basis
that he materially falsified his application by his answers to the
liability questions. Respondent refused to surrender his registration
because he did not believe that he materially falsified his 1996
application since in his opinion, he did not surrender his previous
registration in August 1991.
When asked at the hearing whether he considered his actions in
August 1991 a surrender of his previous DEA registration, Respondent
stated that,
No, I did not * * * You see, there's a matter of interpretation
here. Some people might interest surrender as a gift, you know. The
way I interpret surrender means that you're being forced to do it
and there is a confrontation when you surrender a license or
surrender anything. But if you just give somebody something without
a confrontation, that's a gift. I interpreted surrender in the sense
of, you know, this is a gift. They want to get it off the street.
I'm doing them a favor, and that was my interpretation.
Further according to Respondent he did not consider signing the
voluntary surrender form in 1991 a surrender because.
[W]hen you surrender a license, usually you do it because stress
is being put upon you. You're being threatened. Either you surrender
your license or we're going to bring criminal charges against you,
you see, and I asked these people, the DEA, ``Am I in any trouble
with you,'' and they said, ``No, you're in no trouble.''
Respondent also testified that he did not believe that he falsified
his 1996 application for registration by answering ``No'' to question
4(d) because he did not think that the question applied to him. He did
not feel that his state license had been restricted. According
[[Page 55967]]
to Respondent, ``I had an agreement that I would voluntarily surrender
my license for one year.''
On October 1, 1997, the New York Bureau of Professional Misconduct
issued a statement of charges alleging that Respondent practiced the
profession of medicine fraudulently and filed a false report by his
response to question 4(c) on his 1996 DEA application, and by answering
``No'' to the following question on his state application executed in
October 1990:
Since you last registered has any hospital or licensed facility
restricted or terminated your professional training, employment,
privileges or have you ever voluntarily or involuntarily resigned or
withdrawn from such association to avoid imposition of such action
due to professional misconduct, unprofessional conduct, incompetence
or negligence?
On March 2, 1998, a Hearing Committee of the Medical Board issued a
Determination and Order finding that the specifications in the state of
charges were not sustained, dismissing the charges in the statement of
charges, and directing that no action be taken against Respondent's
license to practice medicine in New York. The Committee found that the
factual allegations as to how Respondent answered the questions at
issue and that he had been suspended from the local hospital were
proven, but that it was not proven that he surrendered his DEA
registration in August 1991. The Committee also found that it was
reasonable for Respondent to answer the questions as he did because,
with respect to his hospital privileges, he reasonably interpreted that
his suspension was not based on any of the reasons stated in the
question, and he likewise did not consider that he surrendered his DEA
registration in 1991.
As of the date of the hearing, Respondent was ``pretty much
retired'' but every winter he goes to the Dominican Republic for a
month to work in a charity clinic. According to Respondent he wants his
DEA registration because he wants all of his credentials to be in order
when he works in the Dominican Republic. However, no evidence was
presented that a DEA registration is necessary for Respondent's charity
work.
When asked at the hearing whether it is incumbent upon an
individual who handles controlled substances to keep informed of
applicable laws and regulations, Respondent replied.
No. That's why you hire hospital administrators. I think it's
incumbent upon DEA to let doctors know when the law changes and it's
incumbent upon hospital administrators to bring doctors up to date.
When asked if he had taken any courses on the proper handling of
controlled substances, Respondent testified,
Doctors don't do that. There are no courses, you know. It's so
little to learn. All you need to know is you need a DEA number and
the law changes, and that's up to DEA and that's up to a hospital
administrator to let you know. You don't have to go take a course
for that.
The Deputy Administrator may revoke a DEA Certificate of
Registration and deny and pending application pursuant to 21 U.S.C.
823(f) and 824(a)(4), if he determines that the continuance or issuance
of such registration would be inconsistent with the public interest. In
determining the public interest, the Deputy Administrator is to
consider the following factors set forth in 21 U.S.C. 823(f).
(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 law
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
denied. See Henry J. Schwarz, Jr., M.D. 54 FR 16,422 (1989).
Regarding factor one, it is undisputed that Respondent is
authorized by the State of New York to practice medicine and handle
controlled substances. But, as Judge Bittner noted, ``inasmuch as State
licensure is a necessary but not sufficient condition for a DEA
registration, * * * this factor is not determinative.''
As to factor two, there is no allegation or evidence that
Respondent handled controlled substances for other than legitimate
medical purposes. However, it is undisputed that Respondent handled
controlled substances without being registered with DEA to do so. But
like Judge Bittner, the Deputy Administrator finds that this conduct is
more appropriately considered under factor four.
Regarding factor three, it is undisputed that Respondent has not
been convicted of violating any laws relating to the manufacture,
distribution, or dispensing of controlled substances.
As to factor four, Respondent prescribed controlled substances and
ordered them for hospital inpatients without being registered with DEA
to handle controlled substances from February 1, 1972 until April 11,
1990, which is prohibited by 21 U.S.C. 841(a)(1) and 843(a)(2).
Respondent knew or should have known that a DEA registration is
necessary to handle controlled substances and that he did not possess a
valid DEA registration. Particularly troubling to the Deputy
Administrator is that Respondent supplied a DEA registration number to
the hospital pharmacy when asked for one. It is inconceivable to the
Deputy Administrator that Respondent could fill out the form to the
hospital's director of pharmacy asking for Respondent's DEA
registration and not wonder why the hospital needed this number, if as
Respondent through a DEA registration is only needed if a physician
dispenses controlled substances. This conduct at the very last
demonstrates a careless disregard for the law relating to controlled
substances.
However unlike Judge Bittner, the Deputy Administrator does not
find that Respondent inappropriately ordered that phenobarbital be
given to a patient on April 2, 1990. There is some dispute as to what
was agreed to in advance by the medical director and Respondent
regarding the providing of phenobarbital for the patient. Given that
the medical director did not testify before Judge Bittner or at the
hospital's fair hearing committee, the Deputy Administrator is unable
to determine whether Respondent did anything improper.
As to factor five, the Government contends that Respondent
falsified his 1996 DEA application for registration and that this
conduct should be considered under this factor. In August 1991,
Respondent signed a form that was clearly entitled ``Voluntary
Surrender of Controlled Substances Privileges.'' He checked a box on
the form that clearly stated that he was voluntarily surrendering his
DEA Certificate of Registration in view of his desire to terminate his
handling of controlled substances. Respondent's failure to consider
this a surrender of his previous DEA registration and to note it as
such on his 1996 application for registration is at the very least
careless.
Judge Bittner concluded that Respondent's continued registration
would be inconsistent with the public interest and recommended that his
[[Page 55968]]
registration be revoked. The Deputy Administrator agrees. Respondent
handled controlled substances for over 18 years without a DEA
registration. He listed a non-existent DEA number on his prescription
pads and provided the number to the hospital pharmacy, but at the same
time contended that he did not have a DEA number and did not need one
because he did not dispense controlled substances. Further, he was at
the very least careless in answering the liability questions on his
application for registration. But even more troubling is Respondent's
failure to take responsibility for his actions. He blames others for
failing to keep him up-to-date on the requirements for handling
controlled substances. As Judge Bittner stated, ``[i]n these
circumstances, the inference is warranted * * * that Respondent is
unwilling or unable to accept the responsibilities inherent in a DEA
registration.''
According, 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 DEA
Certificate of Registration BM5006540, issued to Bernard C. Musselman,
M.D., be, and it hereby is, revoked. The Deputy Administrator further
orders that any pending applications for registration, be, and they
hereby are, denied. This order is effective November 15, 1999.
Dated: October 7, 1999.
Donnie R. Marshall,
Deputy Administrator,
[FR Doc. 99-27003 Filed 10-14-99; 8:45 am]
BILLING CODE 4410-09-M