[Federal Register Volume 63, Number 159 (Tuesday, August 18, 1998)]
[Notices]
[Pages 44278-44283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22098]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 96-23]
Merritt Matthews, M.D.; Continuation of Registration With
Restrictions
On February 22, 1996, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Merritt Matthews, M.D., (Respondent) of San
Diego, California, notifying him of an opportunity to show cause as to
why DEA should not revoke his DEA Certificate of Registration,
AM0006571, and deny any pending applications for renewal of such
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 March 15, 1996, Respondent, through counsel, filed
a timely request for a hearing, and following prehearing procedures, a
hearing was held in San Diego, California on January 15-16, 1997, and
April 22-24, 1997, 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 December 3, 1997, Judge Randall issued her Opinion and Recommended
Ruling, recommending that Respondent's registration be continued
subject to two conditions. On January 23, 1998, the Government filed
Exceptions to the Opinion and Recommended Ruling of the Administrative
Law Judge, and on February 12, 1998, Respondent submitted a response to
the Government's exceptions. On March 9, 1998, 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 issued 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 one modification, 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 in 1965 from Howard University. In 1970 Respondent moved
to San Diego, California and ultimately joined the Western Medical
Group, a multi-specialty practice in a low income area of San Diego. In
1994, Respondent left the Western Medical Group and went to work for a
large health maintenance organization (HMO). Respondent is board
certified by the American Board of Family Physicians and is a member of
the American Academy of Family Physicians. To maintain his
certification, Respondent must complete an oral and a written
examination every seven years, which covers at least four different
areas concerning pharmaceuticals. According to Respondent, the
examination process includes a peer review of his patient charts.
Respondent was last recertified in 1995.
In 1991, the California Bureau of Narcotic Enforcement and the
Bureau of MediCal Fraud initiated an investigation of Respondent after
an inmate at a local detention facility indicated that anyone with
$100.00 cash could get a controlled substance prescription for Valium
or Doriden from Respondent for no legitimate medical reason. As a
result of this information, undercover operatives went to Respondent's
office to attempt to obtain controlled substance prescriptions for no
legitimate medical purpose. Each of the undercover operatives wore a
concealed transmitting device. The visits were monitored and recorded
by agents located in Respondent's office parking lot.
The first undercover visit occurred on May 7, 1991. The transcript
of the visit reveals that the undercover agent told Respondent that she
``was here to get a prescription,'' specifically asking for Valium, a
Schedule IV controlled substance. Respondent told the undercover agent
that he would give her ``some Valium this time, but no more. And don't
come back here for no more Valium.'' The undercover agent indicated
that she was not nervous and that nothing was wrong with her, but she
needed something to ``help (her) out once and awhile.'' The undercover
agent asked for 50 dosage units of Valium, yet Respondent nonetheless
wrote her a
[[Page 44279]]
prescription for 100 dosage units. Respondent asked the agent a series
of medical history questions, and performed a physical examination.
Notations in the patient chart for the undercover agent indicate that
the agent was there for a check up, and that there were to be ``no more
refills.''
An expert, called as a witness by the Government, testified that he
evaluated all of the undercover visits conducted during this
investigation. In arriving at his conclusions, he reviewed the reports
written by the undercover agents, the tape recordings and transcripts
of the visits and the patient charts. It was his opinion that this
Valium prescription was not issued for a legitimate medical purpose.
Respondent testified that he had diagnosed the undercover agent
with anxiety neurosis, however this diagnosis was not noted in the
patient chart. Respondent testified that he felt that he had enough
information to make the diagnosis and to prescribe a one month supply
of Valium. However, Respondent further testified that he told the
undercover agent to see someone else because he did not think that he
had good rapport with her.
A second undercover agent went to Respondent's office on June 24,
1991, claiming to be new to the area and indicating that she was
looking for a doctor in San Diego. Respondent asked a series of medical
history questions and performed a physical examination. The undercover
agent asked for a refill of a Tylenol with codeine prescription stating
that she ``had a doctor (in the Bay area) who, uh, I could get it from,
uh, I don't take street drugs or anything like that. I'm in good
health, uh, I just take it every once in awhile * * * just to kinda get
met through.'' Respondent issued the undercover agent a prescription
for 35 dosage units of Tylenol with codeine, a Schedule III controlled
substance.
This undercover agent made another visit to Respondent's office on
July 9, 1991, however she was refused a refill of the prescription
because it had not been a month since her last visit. On August 5,
1991, the undercover agent did receive a prescription from Respondent
for 45 Tylenol with codeine. The patient chart for this visit indicated
that the agent suffered from menses pain and back pain. The transcript
of the visit did not reflect any conversation between Respondent and
the undercover agent regarding pain. However, the undercover agent did
have a conversation with Respondent's nurse which was not transcribed
verbatim. The expert concluded that both of these prescriptions were
not issued for a legitimate medical purpose.
On September 27, 1991, a third undercover agent went to
Respondent's office claiming to have a doctor in another city and
requesting a refill on a Vicodin prescription. Respondent refused to
issue this agent a prescription and inquired about any payment made by
her to ensure that she had not paid for services he had not provided.
A fourth undercover agent went to Respondent's office on November
21, 1991, claiming to be looking for a new doctor since she was from
Cleveland, Ohio. Respondent asked the agent a series of medical history
questions and performed a physical examination. The undercover agent
specifically asked for a prescription for Vicodin, a Schedule III
controlled substance, which she used to get ``back home.'' Respondent
informed the agent that MediCal would not cover Vicodin, but that
Tylenol with codeine or aspirin with codeine would be covered. The
undercover agent indicated that she wanted Tylenol with codeine and
Respondent issued her a prescription for 30 dosage units. The expert
witness indicated that it was his opinion that there was no legitimate
medical reason for the issuance of this prescription.
Respondent testified at the hearing in this matter that he
prescribed to this undercover agent based upon a continuity of care
determination, and that he did not believe that she was a drug abuser.
Physicians testified at the hearing that continuity of care means
either a physician taking continuous care of a patient, or a physician
continuing a new patient on the care provided by a prior physician.
However, Respondent did not identify or contact the undercover agent's
previous doctor. Respondent admitted at the hearing that his patient
chart for this agent was incomplete since it did not reflect the
prescription issued nor the results of the physical examination.
Respondent testified that he did not know why he gave the agent a
prescription for Tylenol with codeine since there was no indication of
pain, however, it may have been for continuity of care and because he
believed her.
On December 30, 1991, a fifth undercover agent went to Respondent's
office claiming to have moved from Cleveland, Ohio and stating that his
girlfriend wanted him to get a check up. Respondent asked the agent a
series of medical history questions during which the agent told
Respondent that he smoked ``marijuana, now and then, a little bit.''
Respondent testified that it was not uncommon in his practice for
patients to admit to smoking marijuana. Respondent performed a physical
examination and referred the agent to the laboratory for an
electrocardiogram and chest x-ray. The agent asked for and received a
prescription for Tylenol, however, he did not receive a prescription
for any controlled substance. The undercover agent subsequently
telephoned Respondent's office and attempted to obtain a prescription
for Tylenol with codeine, but this request was refused.
A sixth undercover agent went to Respondent's office on March 19,
1992. The agent told Respondent that she was feeling tired because she
was working and attending school full-time. Respondent asked the agent
a series of medical history questions, and performed a physical
examination noting that the agent's thyroid was large and the inside of
her eyelids were pale. The undercover agent asked Respondent for some
``Prelude'' stating that she had been prescribed it by a doctor ``back
east.'' The Respondent indicated that Preludin is a diet pill, but that
one of its side effects ``is that it peps you up.'' After giving the
agent extensive warnings regarding the addictive nature of the drug,
Respondent issued her a prescription for 30 dosage units of Preludin, a
Schedule II controlled substance. On March 20, 1992, the agent returned
to Respondent's office and told him that Preludin had been
discontinued. Respondent had her read excerpts from the Physicians'
Desk Reference regarding diet pills. He then issued the agent a
prescription for 30 dosage units of Desoxyn, a Schedule II controlled
substance, with two refills. Thereafter, on March 23, 1992, the
undercover agent telephoned Respondent and told him that the Desoxyn
prescription was not on a triplicate form as required. Respondent
informed the agent that he did not issue triplicate prescriptions.
However, he would issue her a prescription for Ionamin, a Schedule IV
controlled substance, which she picked up on March 24, 1992. The expert
witness concluded that none of these prescriptions were issued for a
legitimate medical purpose. In addition, he testified that the refills
on the Desoxyn prescription were not proper since Schedule II
prescriptions cannot be refilled.
Respondent testified that he saw no problem with his prescribing
for this agent, as long as she took the medication as it had been
prescribed. Respondent stated that he does not believe that
amphetamines are physically addictive.
Finally, a seventh undercover agent went to Respondent's office on
April 9,
[[Page 44280]]
1992. Ultimately the undercover agent received a prescription for
Prelu-II, a Schedule III controlled substance. However, Judge Randall
found that ``(t)he actual events of the undercover operation and the
transactions between (the undercover agent) and the Respondent and his
staff are unclear.'' At the hearing, it was discovered that part of the
agency's visit to Respondent's office was not reflected in the tape
recording nor the transcript of the visit. Judge Randall ruled that the
tape recording was inadmissible due to the possibility of taint to the
exhibit, since after the tape had been admitted into evidence, the
Government removed if for analysis without her permission or notice to
Respondent. In addition, Judge Randall found that the transcript was
incomplete since it did not reflect the undercover agent's
conversations while in the waiting room for approximately 30 minutes.
The agent monitoring the undercover visit testified that she turned the
tape recorder off while the undercover agent was in the waiting room.
The Acting Deputy Administrator agrees with Judge Randall's rulings
and findings. It is important to know what if anything was discussed
while the undercover agent was in the waiting room because there is a
discrepancy between the transcript of the visit and the patient chart
for the undercover agent. The transcript does not indicate that the
undercover agent gave any medical need for the Prelu-II prescription,
while the patient chart indicates that the agent stated that she wanted
to ``lose weight--modeling.'' In addition, the Acting Deputy
Administrator finds that even though the undercover agent testified at
the hearing, no testimony was elicited as to what if any reason was
given for wanting the prescription. Accordingly, the Acting Deputy
Administrator agrees with Judge Randall that a determination cannot be
made as to the legitimacy of the prescription issued to this undercover
agent.
The United States Attorney's Office was provided with the results
of the investigation of Respondent. A determination was made not to
bring any charges against Respondent. In addition, no complaints have
been filed against Respondent with the California Medical Board.
Two of Respondent's employees at the Western Medical Group
testified at the hearing in this matter, indicating that there were a
maximum of two employees assisting Respondent at any one time. One of
the employees had worked for Respondent for 10 years in various
positions performing both administrative and clinical functions. She
would screen patients to determine whether they were drug seekers. She
testified that if she thought an individual was only seeking drugs, she
would either send him/her away or she would warn Respondent about her
suspicions. The other employee had worked for Respondent for seven
years as of the date of the hearing, first at the Western Medical Group
and now at the HMO where Respondent is currently employed. This
employee testified that while at the Western Medical Group, she was
trained in how to handle drug seeking individuals.
A physician testified on behalf of Respondent who practiced in the
same neighborhood as the Western Medical Group. He described his and
Respondent's practice as in a community with very low incomes, high
crime rates, a lack of physicians, and a serious drug abuse problem
among the patient population. The physician testified that he had the
opportunity to observe Respondent's prescribing practices since he and
Respondent covered for each other in the care of patients. He stated
that he had never seen Respondent improperly prescribe controlled
substances.
A physician who was part of the Western Medical Group also
testified on behalf of Respondent. He testified as to the problem of
drug seeking patients in the practice. This physician served on the
Board of Medical Quality, a committee that provides quality review of
medical services in response to patient complaints. he testified that
he would routinely cover Respondent's patients and therefore had the
opportunity to review Respondent's patient charts. He stated that he
had never seen any inappropriate prescribing or care by Respondent.
Respondent testified at the hearing in this matter regarding the
nature of his practice with the Western Medical Group. The practice was
located in a low income area. Some of the problems his patients faced
were illiteracy, single parent status, domestic violence, and drug
abuse.
Respondent testified that since 1994 he has been employed by an
HMO. As an employee, he must adhere to the HMO's medical and
administrative practices, which include specific requirements for
patient charts. In addition, he now has more support staff, his patient
load has decreased, and there are fewer walk-in patients than at
Western Medical Group.
Pursuant to 21 U.S.C. 832(f) and 824(a), the Deputy Administrator
may revoke a DEA Certificate of Registration and deny any pending
application for renewal of such registration if he determines that such
registration would be inconsistent with the public interest. In
determining the public interest, the following factors are considered:
(1) The recommendation of 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., 54 FR 16, 422 (1989).
As to factor one, it is undisputed that the California Medical
Board (Board) has not only taken no action against Respondent's medical
license, but no complaints have ever been filed against Respondent with
the Board.
Factors two and four, Respondent's experience in dispensing
controlled substances and his compliance with applicable laws related
to the handling of controlled substances, are relevant to the public
interest determination in this proceeding. The Government asserts that
the prescriptions issued by Respondent to the undercover agents were
not issued for a legitimate medical purpose as required by 21 U.S.C.
829 and 21 CFR 1306.04(a). The Government's expert reviewed the
reports, tapes, transcripts, and patient charts of each visit and
determined that in his opinion, none of the prescriptions in question
were issued for a legitimate medical purpose.
The Respondent asserts that if a finding is made that the
prescriptions were not issued for a legitimate medical purpose, he
should not be held responsible because he was entrapped by the
undercover agents. Respondent does not cite to any Federal court cases
or DEA administrative cases to support his position that an entrapment
defense is available to him in his proceeding. Conversely, the
Government argues that such a defense is not available to Respondent as
a matter of law, since this is an administrative adjudication to
determine the public interest and not a
[[Page 44281]]
punitive proceeding. In support of its position, the Government cites
two analogous cases where Federal courts have held that the entrapment
defense is not applicable to administrative proceedings. See Yousef v.
United States, 647 F. Supp. 127, 131 (M.D. Fla. 1986; Tyer v. United
States, 645 F. Supp. 1528, 1532 (N.D. Miss. 1986).
The Administrative Law Judge recommended that the Acting Deputy
Administrator find that the entrapment defense is not applicable, as a
matter of law, to DEA administrative proceedings. The Acting Deputy
Administrator recognizes that DEA has allowed the entrapment defense to
be raised in proceedings such as these in the past, but has ruled that
the defense has failed on a factual basis. See, e.g., Lowell O. Kirk,
M.D., 58 FR 15,378 (1993). However, the Acting Deputy Administrator
finds the Government's argument compelling. The entrapment defense is
not appropriate in DEA administrative proceedings where the protection
of the public health and safety is at issue.
In evaluating the circumstances surrounding the issuance of the
prescriptions to the undercover agents, the Acting Deputy Administrator
agrees with the Administrative Law Judge. The evidence is not as clear
cut as the Government argues that all of the prescriptions were issued
for no legitimate medical purpose.
As to the first undercover visit on May 7, 1991, Judge Randall
found that ``a preponderance of the evidence does not support a
conclusion that this prescription was issued without a legitimate
medical purpose.'' In support of this conclusion, Judge Randall found
it significant that Respondent told the undercover agent not to return,
and indicated ``no more refills'' on the agent's chart. Respondent
admitted at the hearing that the patient chart did not reflect his
diagnosis of anxiety neurosis. However, Judge Randall found ``that the
Respondent's testimony concerning his diagnosis and the basis of this
diagnosis credible.'' Judge Randall concluded that while ``Respondent
was lax in his recordkeeping practices, the preponderance of the
evidence in this instance does not support a conclusion that the
Respondent lacked a legitimate medical purpose in issuing this
prescription in 1991.'' The Acting Deputy Administrator agrees with
Judge Randall's conclusion that a finding cannot be made as to the
legitimacy of this prescription. However, the Acting Deputy
Administrator is troubled by Respondent's lax recordkeeping and by the
fact that Respondent issued the undercover agent a prescription for 100
dosage units of Valium even though the agent only asked for 50 dosage
units.
Regarding the two Tylenol with codeine prescriptions issued to the
second undercover agent, Judge Randall agreed with the Government's
expert witness that the first prescription issued on June 24, 1991, by
Respondent was for no legitimate medical purpose. The undercover agent
did not indicate that she was in any pain, there is no diagnosis in the
patient chart for this visit, and Respondent did not testify about his
diagnosis. The Acting Deputy Administrator concurs with the conclusion
that this prescription was not issued for a legitimate medical purpose.
The undercover agent was refused a prescription on his second visit,
since it had not been a month since she had received the first
prescription. However, on August 5, 1991, Respondent issued the agent
another prescription for Tylenol with codeine. The patient chart
indicates that the agent suffered from menses pain and back pain, but
the transcript of the conversation between Respondent and the
undercover agent does not reflect any discussion regarding pain. Judge
Randall found that this lack of discussion between Respondent and the
agent is not conclusive as to the issue of the legitimacy of the
prescription because the conversation between the undercover agent and
Respondent's nurse was not transcribed. In addition, the Government did
not present the testimony of the undercover agent nor offer any other
evidence to refute the chart entries. Consequently, the Acting Deputy
Administrator agrees with Judge Randall's conclusion ``that a
preponderance of the evidence does not support a finding that this
second prescription for Tylenol with codeine to [the second undercover
agent] was issued without a legitimate medical purpose.''
It is undisputed that Respondent refused to issue the third
undercover agent a controlled substance prescription. But, on November
21, 1991, Respondent did issue the fourth undercover agent a
prescription for Tylenol with codeine. Respondent testified that he did
not know why he issued this prescription, because there is no notation
in the chart that she had presented any pain symptoms. His only
explanation was that he had issued the prescription as a part of her
continuing care, since the agent had represented that she had received
pain medication ``back home.'' Respondent testified that he believed
the undercover agent needed the medication and did not believe that she
was a drug abuser. However, there is no evidence in the record that
Respondent made any attempt to locate the agent's previous physician to
verify that the medication was needed or to independently verify the
diagnosis of pain. Judge Randall found that Respondent's ``[f]ailure to
take such precautions in handling controlled substances shows a serious
disregard for the physician's prescribing practice responsibilities
necessary in handling controlled substance prescriptions.''
The Government filed an exception to Judge Randall's conclusion
regarding this prescription, because Judge Randall did not specifically
find that this prescription was issued without a legitimate medical
purpose. The Acting Deputy Administrator is unable to conclude that a
preponderance of the evidence presented supports a finding that there
was no legitimate medical purpose of this prescription. At the very
least however, Respondent's issuance of this prescription indicates
extremely lax prescribing practices.
It is undisputed that Respondent refused to issue the fifth
undercover agent a controlled substance prescription. However,
Respondent did issue the sixth undercover agent three controlled
substance prescriptions in March 1992, after the agent requested diet
pills to give her more energy. Respondent testified that he saw no
problem with prescribing diet medication to help the agent stay more
alert; that the agent would not have experienced any adverse effects if
she had consumed the medication as prescribed; and that he did not
believe that amphetamines were physically addictive. Judge Randall
concluded and the Acting Deputy Administrator agrees, that these
prescriptions were issued without a legitimate medical purpose. In
addition, Respondent's authorization of a refill of the Desoxyn
prescription was unlawful since Schedule II prescriptions cannot be
refilled pursuant to 21 U.S.C. 829 and 21 CFR 1306.12.
The Government filed an exception to Judge Randall's conclusion
regarding these prescriptions arguing that Judge Randall should have
specifically found that Respondent falsified the prescription for
Ionamin by noting on the prescription that it was to decrease appetite.
The Acting Deputy Administrator is extremely troubled by the fact that
Respondent made this notation on the prescription knowing that the
medication was not going to be used for appetite suppression, and
agrees with the Government's contention that this prescription contains
false information.
As discussed above, the Acting Deputy Administrator agrees with
Judge
[[Page 44282]]
Randall's conclusion that a determination cannot be made as to the
legitimacy of the prescription issued to the seventh undercover agent.
The Acting Deputy Administrator concludes that Respondent issued
four controlled substance prescriptions to the undercover agents for no
legitimate medical purpose during the course of the investigation. In
addition, at the very least, Respondent's issuance of the prescription
to the fourth undercover agent raises serious concerns regarding
Respondent's appreciation of the serious nature of controlled
substances.
Regarding factor three, it is undisputed that Respondent has not
been convicted of any offense related to the manufacture, distribution
or dispensing of controlled substances. Further, it is undisputed that
the United States Attorney's Office declined to prosecute Respondent
following the investigation conducted in 1991 and 1992.
As to factor five, the Acting Deputy Administrator is deeply
concerned about Respondent's apparent disregard for the tremendous
responsibility that accompanies a DEA registration. His cavalier
attitude regarding the addictive quality of amphetamines, as well as
his failure to accept any responsibility for any dangers his practices
may have created, raise concerns regarding his future prescribing of
controlled substances and the risk created to the public health and
safety.
The Acting Deputy Administrator concludes that the Government has
presented a prima facie case and therefore, grounds exist for the
revocation of Respondent's DEA Certificate of Registration. However,
the Acting Deputy Administrator does not believe that the severe
sanction of revocation is warranted in this case. Two physicians who
have been in a position to observe Respondent's controlled substance
prescribing practices both testified that they have never seen any
inappropriate prescribing by Respondent. In addition, as a member of
the American Academy of Family Physicians and the American Board of
Family Physicians, Respondent's patient charts are periodically
reviewed and he must pass an examination that includes four different
areas regarding pharmaceuticals. Therefore, like Judge Randall, the
Acting Deputy Administrator concludes that the four prescriptions
issued for no legitimate medical purpose during the course of the
investigation in 1991 and 1992 do not appear to be indicative of
Respondent's overall practice.
Additionally, the Acting Deputy Administrator finds it significant
that Respondent's practice at the time of the hearing is very different
from his practice during the investigation in 1991 and 1992. As an
employee of a managed health care organization, Respondent is now
subject to routine peer review procedures; his charting and prescribing
practices are monitored by his employer; his patient load has
decreased; and his number of support staff has increased. As Judge
Randall noted, ``common sense leads to the conclusion that the
Respondent, now subject to standards established by an employer and
conscious of the scrutiny afforded his medical decisions and resulting
medical charts, will enhance his attention to detail in his prescribing
practices.''
Judge Randall concluded ``that the totality of the circumstances
justifies continuing the Respondent's Certificate of Registration with
certain requirements.'' Accordingly, Judge Randall recommended that
Respondent's registration be continued subject to the following
conditions:
``1. Within six months of the effective date of the Deputy
Administrator's final order the Respondent [shall] provide to the DEA
San Diego Field Division evidence of his successful completion of at
least 15 hours of training in the proper handling of controlled
substances, to include coverage of the addictive characteristics of
such substances.
2. For a period of three years from the effective date of the
Deputy Administrator's final order, the Respondent (shall) provide the
DEA San Diego Field Division, information of the Respondent's change of
employment, if any, thirty days prior to the effective date of the
actual change of employment. This requirement is especially necessary
for the protection of the public interest should the Respondent choose
to leave the HMO setting and return to private practice as a self-
employed physician.''
The Acting Deputy Administrator agrees with Judge Randall that
Respondent's registration should not be revoked at this time. Based
upon the evidence presented, Respondent's inappropriate prescribing in
1991 and 1992 appears to be an aberration from his normal course of
practice. Also, since the events in question, Respondent's employment
situation has changed dramatically. While these facts lead the Acting
Deputy Administrator to conclude that Respondent's registration should
be continued, the Acting Deputy Administrator agrees with Judge Randall
that some restrictions on Respondent's registration are necessary to
protect the public interest. The Acting Deputy Administrator is
extremely concerned by Respondent's failure to recognize the addictive
nature of amphetamines and by his failure to ensure that controlled
substances are only prescribed for a legitimate medical purpose.
The Government filed exceptions to Judge Randall's recommended
ruling, arguing that ``if the Acting Deputy Administrator chooses not
to revoke (Respondent's) registration * * * then at the very least
Respondent's registration should be suspended until and unless he
completes the 15 hours of training in the handling of controlled
substances as recommended by (Judge Randall).'' The Government argues
that suspending Respondent's registration is necessary ``(g)iven the
seriousness of the violations and Respondent's total lack of candor in
refusing to admit that his conduct violated the law * * *.''
Additionally, the Government argues that a suspension is appropriate
because ``(u)nder (Judge Randall's) recommendation, if Respondent did
not obtain the required training within 6 months or did not make any
attempt to commence this training * * * he would still be
registered(,)'' and ``DEA would have to issue another Order to Show
Cause based upon Respondent's failure to comply with this condition.''
The Government asserts that with a suspension, the burden of completing
the training would be on Respondent and ``the public health and safety
would be protected because Respondent would be without a DEA
registration unless and until he completed the controlled substance
training.'' In support of its contention, the Government cites to
Margaret E. Sarver, M.D., 61 FR 57,896 (1996), where DEA previously
suspended a DEA registration for at least 120 days or until the
registrant demonstrated that she had completed 24 hours of training in
pharmacology.
The Acting Deputy Administrator finds that the circumstances of
this case are markedly different from those in Sarver. In that case
there was significantly more evidence than here of a pattern of
mishandling of controlled substances. Most notably, Dr. Sarver
continued to prescribe a highly abused combination of drugs even after
having been warned of the danger and abuse potential of the drugs. The
Acting Deputy Administrator does not believe that Respondent's conduct
warrants a suspension of his registration.
The Acting Deputy Administrator appreciates the Government's
concern that should Respondent not comply with the training
requirement, the Government will be forced to issue
[[Page 44283]]
another Order to Show Cause to revoke Respondent's registration. In its
response to the Government's exceptions, Respondent indicates that
``although disagreeing with portions of the (Administrative Law
Judge's) opinion (R)espondent believes that in totality it is an
appropriate ruling. Respondent has accepted the ruling and has already
completed four hours training in the proper handing (sic) of controlled
substances.'' Respondent argues that there were no complaints regarding
his prescribing practices before the undercover visits and there has
been no complaints since the investigation approximately six years ago.
The Acting Deputy Administrator concludes that the public interest
would not be served by suspending Respondent's registration. However,
the Acting Deputy Administrator hereby orders that should Respondent
fail to comply with the training requirement imposed on his
registration, all involved in the administrative process to potentially
revoke Respondent's registration should act as expeditiously as
possible.
In addition, the Government takes exception to Judge Randall's
recommended requirement that Respondent merely has to notify DEA of any
change in his employment from the HMO. Judge Randall found the
oversight offered by the HMO to be significant in recommending that
Respondent's registration be continued and she therefore recommended
that Respondent be required to notify DEA of any change in employment.
The Government makes a compelling argument that ``if no additional
sanctions are imposed and Respondent leaves the HMO, gives DEA the
required notification and enters into private practice without
participating in an HMO, any putative advantages in Respondent's prior
participation in an HMO are dissipated. Yet DEA is left with no
recourse because Respondent has not violated any conditions.''
Consequently, the Government suggested that Respondent be required to
keep a log of his controlled substance handling and to make the log
available for inspection. The Acting Deputy Administrator agrees with
the Government that mere notification of a change in employment is not
enough to monitor Respondent's prescribing practices.
Therefore, the Acting Deputy Administrator finds that Respondent's
DEA Certificate of Registration should be continued subject to the
following conditions:
(1) Within six months of the effective date of this final order,
Respondent shall provide to the Special Agent in charge of the DEA San
Diego Field Division, or his designee, evidence of his successful
completion of at least 15 hours of training in the proper handling of
controlled substances, to include coverage of the addictive
characteristics of such substances.
(2) For a period of three years from the effective date of this
final order, Respondent shall notify in writing the Special Agent in
Charge of the DEA San Diego Field Division, or his designee, of any
change in employment. This notification shall be provided at least
thirty days prior to the effective date of the actual change of
employment.
(3) For three years from the effective date of this final order,
Respondent shall maintain a log of all controlled substances that he
prescribes. At a minimum, the log shall include the name of the
patient, the date that the controlled substance was prescribed, and the
name, dosage and quantity of the controlled substance prescribed. Upon
the request of the Special Agent in Charge of the DEA San Diego Field
Division, or his designee, Respondent shall submit or otherwise make
his prescription log available for inspection.
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 CFR 0.100(b) and 0.104, hereby orders
that DEA Certificate of Registration, AM0006571, issued to Merritt
Matthews, M.D., be continued, and any pending applications for renewal
be granted, subject to the above described restrictions. This order is
effective September 17, 1998.
Dated: August 11, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-22098 Filed 8-17-98; 8:45 am]
BILLING CODE 4410-09-M
