[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]
BILLING CODE 4410-09-M