[Federal Register Volume 63, Number 189 (Wednesday, September 30, 1998)]
[Notices]
[Pages 52293-52296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26211]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 97-9]
John J. Cienki, M.D.; Revocation of Registration and Continuation
of Registration With Restrictions
On January 28, 1997, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to John J. Cienki, M.D. (Respondent) of Colorado
and Florida, notifying him of an opportunity to show cause as to why
DEA should not revoke his DEA Certificates of Registration BC1616929
and AC2221187, and deny any pending applications for renewal of such
registrations, pursuant to 21 U.S.C. 823(f), 824(a)(1) and (a)(4).
By letter dated February 22, 1997, Respondent, through counsel,
filed a timely request for a hearing, and following prehearing
procedures, a hearing was held in Miami, Florida on September 24 and
25, 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 March 18, 1998, Judge Randall issued her Opinion and Recommended
Ruling, recommending in effect that Respondent's DEA registration
issued to him in Colorado be revoked and that his Florida DEA
registration be continued with restrictions. On April 20, 1998, the
Government filed Exceptions to the Opinion and Recommended Ruling of
the Administrative Law Judge, and on April 30, 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 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 and
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 is board
certified in emergency medicine and toxicology. In the mid-1980's,
Respondent was fulfilling a service commitment in rural Florida when he
began abusing controlled substances. According to Respondent, he abused
opiates such as ``Demerol, Talwin, whatever I could get my hands on.''
His abuse occurred over a period of a few months and stopped
temporarily when he moved to Miami, Florida in 1985. By 1988, his drug
use had escalated to a point where he sought and received 28 days of
in-patient treatment for his addiction. Thereafter, he signed up with
the Physicians' Recovery Network (PRN) to monitor him for five years.
After completing his drug treatment in 1988, Respondent worked in
Philadelphia, Pennsylvania until sometime in 1991. During that time,
Respondent entered into a Physicians' Health Program contract and
remained involved with the program until he left Pennsylvania.
In 1991 Respondent moved to Mississippi and applied for a
Mississippi Medical license. On the application, he answered ``yes'' to
the question that asked whether he had a history of drug or alcohol
abuse. As a result of his response, Respondent agreed to submit to
certain conditions for licensure in a Consent Agreement including that
the would submit to random, unannounced and witnessed urine and/or
blood screens; that he would not administer, dispense or prescribe
drugs to himself; that he would not treat himself or family members;
and that he would comply with Federal and state laws governing the
practice of medicine. Respondent testified that he believed that the
Consent Agreement was the result of a non-disciplinary procedure and in
fact the records form the Mississippi Board specifically state that the
Consent Agreement was non-disciplinary. Respondent further testified
that he did not believe that this medical license was restricted as a
result of the Consent Agreement and the license itself did not indicate
that it was restricted. Respondent remained in Mississippi until
November 1993 when he moved to Denver, Colorado to do a toxicology
fellowship.
On October 1, 1993, Respondent submitted a renewal application for
DEA Certificate of Registration AC2221187, issued to him in Florida.
Respondent answered ``No'' to the question on the application
(hereinafter referred to as the liability question) which asked, ``Has
the applicant ever been convicted of a crime in connection with
controlled substances under State or Federal law, or ever surrendered
or had a Federal controlled substance registration revoked, suspended,
restricted or denied, or ever had a State professional license or
controlled substance registration revoked, suspended, denied,
restricted or placed on probation?''
On January 12, 1995, Respondent submitted a renewal application for
DEA Certificate of Registration BC1616929, issued to him in
Pennsylvania, along with a request, which was subsequently granted, to
transfer the registration to a Colorado address. Respondent answered
``No'' to the liability question on this application.
In June of 1994, Respondent relapsed and abused the non-controlled
substance Stadol until March 5, 1995. Stadol has a potential for abuse
due to its opiate-like effects and as a result, DEA has published a
proposed rule
[[Page 52294]]
which would place the drug in Schedule IV. Respondent acquired Stadol
for his own use by writing false prescriptions and by fraudulently
telephoning prescriptions to local pharmacies. Consequently, Respondent
was charged in Denver District Court with fraud and deceit to obtain a
prescription drug, as well as criminal impersonation. In June of 1995,
Respondent pled guilty to the misdemeanor charge of fraud and deceit to
obtain a prescription drug and the criminal impersonation charge was
dismissed.
As a result of his conviction, Respondent's Colorado medical
license was placed on probation, and he ultimately did not renew it. In
addition, Respondent surrendered his Mississippi medical license on
September 18, 1995.
Respondent returned to Pennsylvania and on August 23, 1995, he
entered into a contract with the Pennsylvania Physicians' Health
Program. Thereafter, the Pennsylvania Medical Board placed Respondent's
Pennsylvania medical license on probation for five years subject to
several conditions, including monitoring by the Professional Health
Monitoring Program.
On May 18, 1996, Respondent entered into another contract with
Florida's PRN which remains in effect as long as Respondent practices
medicine in the State of Florida. As part of this program, Respondent
is subject to random urine screens, which have all been negative. He
attends five to six Alcoholics Anonymous meetings per week,
professional group meetings twice a week, and PRN meetings once a week.
According to Respondent, he has not used any drugs improperly since
March 5, 1995.
On June 30, 1997, the Florida Board of Medicine issued a final
order suspending Respondent's medical license for 30 days, fining him
$1,500.00, and reprimanding him. Following the period of suspension,
Respondent's medical license was placed on probation for five years
subject to several restrictions.
A physician, who is the medical director of an addiction treatment
program, testified that he examined Respondent in 1988 and diagnosed
drug addiction. In his opinion, Respondent was in strong denial at that
time regarding his addiction. The physician again examined Respondent
on September 9, 1997, and determined that Respondent ``met criteria for
recovery, that he had treatment, he had for a substantial amount of
time had complied with his PRN contract, was attending meetings.''
According to the physician, Respondent is no longer in denial and is
committed to his recovery. In the physician's opinion, Respondent has
``a nine out of ten chance over the next five years'' for continued
successful recovery because of his PRN contract and his comprehensive
support system.
On August 31, 1996, Respondent's DEA Certificate of Registration
AC2221187, issued to him in Florida, expired by its own terms. He
submitted a renewal application for that registration on September 24,
1996, and answered ``Yes'' to the liability question. In explaining his
answer, Respondent stated that ``when I received my Mississippi
license, a Consent agreement was placed on my license * * * I did not
previously report this as I did not interpret this to be a suspension
or restriction on my license.'' This renewal application was treated as
timely, and was accepted for filing by DEA.
Before reaching the issue of whether Respondent's registrations
should be revoked, Judge Randall addressed whether there is anything to
revoke since Respondent filed his renewal applications after the
expiration date noted on the Certificates of Registration. DEA
regulations do not specify a deadline for filing renewal applications,
however DEA accepts renewal applications up to seven months following
the expiration of a registration. If no renewal application is received
within seven months following the expiration date, the registration
number is retired or purged from the registration system. According to
the Acting Chief of DEA's Registration and Program Support Section:
The DEA considers that the expiration date of a person's
registration represents expiration of their authority to handle
controlled substances. However, this event does not represent
expiration of that person's ability to become registered under that
same registration number, if a proper renewal application is
subsequently filed. By accepting Dr. Cienki's renewal application,
DEA considers his registration number, AC2221187, as reactivated and
capable of renewal or denial when administrative proceedings are
resolved.
Since a DEA registration is not retired or purged from the registration
system until seven months after its expiration, the Acting Chief
explains that the ``process allows what would have been an `expired'
registration number, to remain susceptible to renewal for approximately
seven months.''
Judge Randall then conducted an analysis of Administrative
Procedure Act (APA) rulemaking requirements to determine whether DEA is
authorized to renew expired registrations without subjecting the
practice to notice and comment. As Judge Randall noted, ``[a]ny agency
action must be properly implemented to be enforced against the
regulated public. Therefore, this DEA practice cannot be applied to the
Certificate of Registration at issue implementation through notice and
comment was required.''
The Acting Deputy Administrator agrees with Judge Randall's
conclusion that this practice did not require notice and comment since
it is not a legislative rule. DEA's practice has no negative
implications for the regulated public since it gives a registrant a
second chance to submit a renewal application rather than a new
application for registration. Instead, as Judge Randall finds, ``[t]he
DEA's practice may be best categorized as both an agency rule of
practice and procedure, and as an interpretative rule,'' both of which
do not require notice and comment before being implemented. The
practice can be considered an agency rule of practice and procedure
because ``[b]y following its practice, the agency is able to process a
large volume of applications. This process does not put a stamp of
approval or disapproval on the conduct of registrants.'' The practice
can also be considered an interpretative rule by interpreting and
supplementing the Controlled Substances Act and existing DEA
regulations which do not specifically address a deadline for filing a
renewal application. Accordingly, Judge Bittner concluded, and the
Acting Deputy Administrator agrees, that since DEA's practice of
accepting a renewal application after the expiration date of the
registration did not require notice and comment rulemaking, there are
valid pending renewal applications.
The Acting Deputy Administrator notes that the status of
Respondent's registration pending the resolution of these proceedings
is not at issue since Respondent did not contend that he was authorized
to handle controlled substances nor were there any allegations that
Respondent handled controlled substances without being properly
authorized. But, as Judge Randall notes, ``it appears to be the
Government's position that a registrant loses his ability to handle
controlled substances as soon as his registration expires.'' In his
affidavit, the Acting Chief of DEA's Registration and Support Section
states that ``[t]he DEA considers that the expiration date of a
person's registration represents expiration of their authority to
handle controlled substances.'' In addition, an internal DEA manual
indicates that ``[a] registration is legally invalid on the day after
it expires * * *.'' The Government
[[Page 52295]]
in its exceptions affirms that this is the Government's position.
However, some of the Government's arguments seem to support an
interpretation that once DEA accepts a renewal application for filing,
the registration remains valid pending the outcome of the proceedings.
In fact, Government counsel in its Memorandum filed on December 1,
1997, states that, ``[c]onsistent with DEA administrative case law
precedent, Respondent's DEA Certificates of Registration are being
maintained on a day-to-day basis * * *.'' Additionally, in its
Memorandum, Government counsel quoted a provision of the APA which
states that,
When the licensee has made timely and sufficient application for
a renewal or new license in accordance with agency rules, a license
with reference to an activity of a continuing nature does not expire
until the application has been finally determined by the agency. 5
U.S.C. 558(c).
The Government then asserted that, ``[i]n this matter, by its
acceptance for processing, DEA in effect determined that the
application was timely and sufficient.'' Therefore, it appears that the
Government is contending that because Respondent's renewal application
was considered timely, the registration does not expire until the
application is either granted or denied.
Consequently, the Acting Deputy Administrator finds that it is
unclear what the Government's position is as to the status of a
registration pending final disposition when the renewal application is
filed after the expiration date. But, the Acting Deputy Administrator
finds that it is unnecessary to resolve the issue here because the
status of Respondent's registrations following execution of his renewal
applications is not at issue in this proceeding. However, the
Government is directed to ensure that whatever position it takes, with
respect to the validity of a DEA registration if a renewal application
is accepted for filing after the expiration date, is consistent with
the APA and implemented in accordance with the APA's provisions.
Since there are valid pending renewal applications, the question
now becomes whether there registrations should be revoked. The Deputy
Administrator may revoke or suspend a DEA Certificate of Registration
under 21 U.S.C. 824(c), upon a finding that the registrant:
(1) Has materially falsified any application filed pursuant to or
required by this subchapter or subchapter II of this chapter;
(2) Has been convicted of a felony under this subchapter or
subchapter II of this chapter or any other law of the United States, or
of any State relating to any substance defined in this subchapter as a
controlled substance;
(3) Has had his State license or registration suspended, revoked,
or denied by competent State authority and is no longer authorized by
State law to engage in the manufacturing, distribution, or dispensing
of controlled substances or has had the suspension, revocation, or
denial of his registration recommended by competent State authority;
(4) Has committed such acts as would render his registration under
section 823 of this title inconsistent with the public interest as
determined under such section; or
(5) Has been excluded (or directed to be excluded) from
participation in a program pursuant to section 1320a-7(a) of Title 42.
Pursuant to 21 U.S.C. 823(f), the following factors are considered
by the Deputy Administrator in determining the public interest:
(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 FR 16,422 (1989).
First, as to DEA Certificate of Registration BC1616929, issued to
Respondent in Colorado, it is well-settled that DEA does not have the
statutory authority under the Controlled Substances Act to issue or
maintain a registration if the applicant or registrant is without state
authority to handle controlled substances. See 21 U.S.C. 802(21),
823(f) and 824(a)(3). This prerequisite has been consistently upheld.
See, e.g., Romeo J. Perez, M.D. 62 FR 16,193 (1997); Demetris A. Green,
M.D., 61 FR 60,728 (1996); Dominick A. Ricci, M.D., 58 FR 51,104
(1993).
Respondent did not renew his Colorado medical license and
therefore, he is not currently authorized to handle controlled
substances in the State of Colorado. It is reasonable to infer, and
Respondent does not deny, that because he is not authorized to practice
medicine in Colorado, he is also not authorized to handle controlled
substances in that state. As a result, Respondent is not currently
entitled to a DEA registration in Colorado. Consequently, the Acting
Deputy Administrator finds that DEA Certificate of Registration
BC1616929, must be revoked.
Next, the Acting Deputy Administrator considers whether grounds
exist to revoke DEA Certificate of Registration AC2221187, issued to
Respondent in Florida. Pursuant to 21 U.S.C. 824(a)(1), a registration
may be revoked if the registrant has materially falsified an
application for registration. DEA has previously held that in finding
that there has been a material falsification of an application, it must
be determined that the applicant knew or should have known that the
response given to the liability question was false. See, Martha
Hernandez, M.S. 62 FR 61,145 (1997); Herbert J. Robinson, M.D. 59 FR
6304 (1994).
On his renewal applications dated October 1, 1993, and January 12,
1995, Respondent answered ``No'' to the liability question which asks
in part whether the applicant has ``ever had a State professional
license or controlled substance registration revoked, suspended,
denied, restricted, or placed on probation.'' This answer was given
despite the fact that Respondent obtained a medical license in the
State of Mississippi pursuant to a Consent Agreement which prohibited
him from self-prescribing controlled substances. Respondent argues that
he did not believe that his license was restricted and that the records
from the Medical Board indicated that the Consent Agreement was non-
disciplinary. But, the Acting Deputy Administrator agrees with Judge
Randall's conclusion that ``[s]ince the Respondent had been prohibited
from self-prescribing controlled substances per the terms of the
Mississippi Consent Agreement in 1991, he `knew or should have known'
the appropriate response to the liability question was `yes' at the
time he prepared his October 1993 and January 1995 renewal
applications.''
Therefore, the Acting Deputy Administrator concludes that
Respondent materially falsified these applications and as a result,
grounds exist to revoke Respondent's registration. However, like Judge
Randall, the Acting Deputy Administrator finds it relevant that
[[Page 52296]]
Respondent answered ``Yes'' to the liability question on his September
24, 1996 renewal application, following the surrender of his
Mississippi medical license. As Judge Randall concludes, ``[b]y so
answering, the Respondent has demonstrated an awareness and a
willingness to answer truthfully this liability question.''
Finally, the Acting Deputy Administrator considers the factors set
forth in 21 U.S.C. 823(f) to determine whether Respondent's continued
registration would be inconsistent with the public interest pursuant to
21 U.S.C. 824(a)(4). Regarding factor one, on June 30, 1997, the
Florida Board of Medicine issued a final order suspending Respondent's
medical license for 30 days, fining him $1,500.00, and reprimanding
him. Following the period of suspension, Respondent's medical license
was placed on probation for five years subject to several restrictions,
including that he continue his recovery program under the supervision
of the Florida PRN as long as he practices medicine in the State of
Florida. Therefore, Respondent's Florida medical license is currently
on probation.
As to factors two and four, Respondent's experience in dispensing
controlled substances and his compliance with applicable laws related
to controlled substances, it is undisputed that beginning in the mid-
1980's, Respondent abused controlled substances. In 1988, he sought and
received treatment for his addiction. While he suffered a relapse in
1994, he abused Stadol which is not a controlled substance. Thus, there
is no evidence that Respondent abused or improperly dispensed
controlled substances after 1988.
Regarding factor three, there is no evidence that Respondent has a
conviction record under Federal or state laws relating to the
manufacture, distribution, or dispensing of controlled substances.
Respondent's conviction in 1995 related to his writing of false
prescriptions for the non-controlled substance Stadol.
As to factor five, the Acting Deputy Administrator agrees with
Judge Randall's concern regarding Respondent's abuse of Stadol and his
authorizing of false prescriptions to obtain the drug. However,
Respondents has not improperly used drugs since March 1995, and has
been actively involved in recovery since that time. Respondent's
contract with the Florida PRN requires random urine screens, and
attendance at Alcoholics Anonymous and professional group meetings.
According to the medical director of the addiction treatment facility
who testified at the hearing, Respondent's prognosis for continued
recovery is excellent, and a repalse would not go unnoticed given his
PRN contract and his comprehensive support system.
The Acting Deputy Administrator concludes that grounds exist to
revoke Respondent's Florida DEA registration. Respondent materially
falsified two renewal applications, and he has a history of substance
abuse. However like Judge Randall, the Acting Deputy Administrator does
not find that revocation is warranted in this case.
While Respondent did indeed materially falsify two renewal
applications, he answered the liability question correctly on his
September 1996 renewal application. This is significant since this
application was filed before the Order to Show Cause was issued in this
matter which alleged that Respondent materially falsified applications.
Also there is no question that Respondent has a history of substance
abuse. But as Judge Randall notes ``although it has been only three
years since the Respondent's last relapse, I find the Respondent's
testimony concerning his commitment to sobriety credible.'' In
addition, Respondent's medical license is on probation until June 30,
2002, and he must remain under contract with the Florida PRN as long as
he practices in Florida. Therefore, the Acting Deputy Administrator
agrees with Judge Randall that revocation would be ``too severe a
resolution in this case.''
But, an unrestricted registration is not warranted given
Respondent's history of substance abuse and his fraudulent prescribing
to obtain Stadol for his own use. Subjecting Respondent's registration
to some restrictions ``will allow the Respondent to demonstrate that he
can responsibly handle controlled substances in his medical practice,
yet simultaneouly protect the public by providing a mechanism for rapid
detection of any improper activity related to controlled substances.''
See Michael J. Septer, D.O. 61 FR 53,762 (1996); Steven M. Garbner,
M.D., 51 FR 12,576 (1986).
The Acting Deputy Administrator agrees with Judge Randall's
recommendation that Respondent's renewal application be granted subject
to the following restrictions for three years:
(1) Respondent shall not prescribe or otherwise dispence controlled
substances or Stadol for himself or his immediate family members.
(2) Respondent shall not order, administer, prescribe, or otherwise
dispense controlled substances or Stadol except in the course of his
employment in a medical clinic or hospital.
(3) Respondent shall maintain a log of his handling of controlled
substances and Stadol. At a minimum, the log shall include the date
that the controlled substance or Stadol is prescribed, administered or
dispensed, the name of the patient, and the name, dosage and quantity
of the substance prescribed, administered or dispensed. The log shall
be signed by Respondent's supervisor verifying the accuracy of the log,
and shall be sent on a quarterly basis to the Special Agent in Charge
of the DEA Miami Field Division, or his designee.
(4) Respondent shall inform the Special Agent in Charge of the
Miami Field Division, or his designee, of any action taken by any state
regarding his medical license or his authorization to handle controlled
substances. This notification must occur within 30 days of the state
action.
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 BC1616929, previously issued to
John J. Cienki, M.D., be, and it hereby is revoked. The Acting Deputy
Administrator further orders that DEA Certificate of Registration
AC2221187, issued to John J. Cienki, M.D., be renewed and continued,
subject to the above described restrictions. This order is effective
October 30, 1998.
Dated: September 24, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-26211 Filed 9-29-98; 8:45 am]
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