[Federal Register: January 6, 2009 (Volume 74, Number 3)]
[Notices]               
[Page 459-464]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja09-49]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 03-8]

 
Jayam Krishna-Iyer, M.D.; Suspension of Registration; Granting of 
Renewal Application Subject to Condition

    On September 1, 2006, I, the Deputy Administrator of the Drug 
Enforcement Administration, ordered that the DEA Certificate of 
Registration issued to Jayam Krishna-Iyer, M.D. (Respondent), of 
Clearwater, Florida, be revoked. Jayam Krishna-Iyer, M.D., 71 FR 52148, 
52159 (2006). The Order also denied Respondent's pending application 
for renewal of her registration.
    As grounds for the Order, I noted that Respondent had issued 
prescriptions for controlled substances to three separate undercover 
operatives notwithstanding that each of the operatives had indicated 
that he was not in pain, and had told Respondent that he was obtaining 
controlled substances from non-legitimate sources such as friends. Id. 
at 52158. I further noted that Respondent had failed to conduct a 
physical exam on each of the undercover operatives and had falsified 
each operative's medical record to indicate that she had done an exam. 
Id. I also noted that Respondent had made statements during each 
operative's visit indicating that she knew that the operative was 
seeking the drugs to abuse them and not to treat pain. Id. Finally, I 
noted that Respondent had pre-signed prescriptions and given them to a 
registered nurse in her employ, and that she allowed the nurse to issue 
prescriptions to one of the operatives even though she did not attend 
to the operative during the visit and the nurse lacked authority under 
both Federal law and Florida law to prescribe controlled substances. 
Id.
    In the decision, I noted that Respondent had undertaken substantial 
measures to reform her practice including hiring a private 
investigation firm to review patient records to determine which 
patients were likely substance abusers and should be discharged from 
her practice; the firm also developed procedures for recognizing drug 
abusers, doctor shoppers, prescription fraud, patients with a drug-
related criminal history, and dealing with claims of lost and stolen 
medications. Id. at 52156. I also noted that the firm had conducted 
extensive criminal history checks on Respondent's patients and that she 
had discharged a large of number of patients. Id.
    While I recognized the substantial measures that Respondent had 
undertaken to reform her practice, I adopted the ALJ's finding that 
Respondent failed to accept responsibility for her misconduct based on 
her testimony that she did not intentionally or knowingly distribute a 
controlled substance to the undercover operatives because she knew the 
drugs would not be sold on the street. Id. at 52159. As I explained in 
the Order, ``[i]t is no less a violation that the `patient' will 
personally use the drug rather than sell it on the street.'' Id. I 
further concluded that because Respondent had ``refuse[d] to 
acknowledge her responsibilities under the law,'' the reforms she had 
undertaken would ``still not adequately protect public health and 
safety,'' and that this finding was dispositive as to whether her 
continued registration would be consistent with the public interest. 
Id.
    Thereafter, Respondent filed a petition for review in the U.S. 
Court of Appeals for the Eleventh Circuit. On September 25, 2007, 
following briefing and oral argument, the Court vacated the Agency's 
Order in an unpublished opinion. Krishna-Iyer v. DEA, No. 06-15034 
(11th Cir. 2007), Slip Op. at 3. The Court declared:

    In considering Petitioner's experience in dispensing controlled 
substances under factor 2, the DEA identified only four visits by 
three undercover `patient,' who were all attempting to make a case 
against her. The DEA failed to consider Petitioner's experience with 
twelve patients whose medical charts were seized by the DEA, or with 
thousands of other patients. In short, the DEA did not consider any 
of Petitioner's positive experience in dispensing controlled 
substances. This is an arbitrary and unfair analysis of Petitioner's 
experience.

Id. The Court therefore vacated the Order and remanded the case for 
reconsideration, directing that ``DEA should pay particular attention 
to the entire corpus of Petitioner's record in dispensing controlled 
substances, not only the experience of [the] undercover officer.'' Id. 
The Court further ordered that ``[t]he five factors should * * * be re-
balanced.'' Id.
    On September 15, 2008, the Parties submitted a joint motion which 
proposed a resolution of the matter. More specifically, the Parties 
propose that I ``issue a new final Order consistent with the direction 
of the * * * Court of Appeals.'' Joint Motion at 2. The Parties also 
request that were I to find that ``revocation or suspension is still an 
appropriate outcome,'' that the sanction be limited ``to suspension of 
[her] registration for the time'' that the Final Order remained in 
effect. The Parties also requested that I direct that Respondent's 
pending renewal application be acted upon expeditiously. Finally, the 
Parties represented that if I concurred with their proposed resolution, 
they would enter into a Memorandum of Agreement (MOA) under which 
Respondent's registration will be renewed subject to the condition that 
for a one year period, she file monthly reports with the Agency's Miami 
Field Division providing information regarding her prescribing of 
controlled substances.
    Attached to the Joint Motion was Respondent's statement. In her

[[Page 460]]

statement, Respondent: (1) ``Acknowledge[d] wrongdoing for failing to 
conduct physical examinations of the three undercover patients in this 
case''; (2) ``acknowledge[d] wrongdoing for improperly indicating on 
the charts of the undercover patients that she had conducted a physical 
examination of'' them; and (3) ``acknowledge[d] that she had presigned 
various prescriptions and * * * understands that this was improper.'' 
Respondent's Statement at 1. Respondent also apologized for her conduct 
with respect to each of the above actions and promises that she will 
not engage in similar conduct in the future.\1\ Id.
    Respondent also stated that she has reviewed the Agency's earlier 
decision, that she ``has reexamined her conduct with respect to the 
three undercover patients in light of the [Agency's] decision and has 
re-evaluated the transcripts of the visits of the undercover patients 
in light of the * * * decision.'' Id. Respondent further stated that 
``she regret[ed] that she prescribed the medications which she 
prescribed to the undercover patients'' and ``apologized * * * for her 
conduct.'' Id. Respondent also promised that ``such conduct has not 
occurred since [the undercover visits] and will not occur again.'' \2\
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    \1\ With respect to the pre-signing of prescriptions, Respondent 
stated that ``she had not engaged in such conduct since being 
advised by the DEA that such conduct was improper and promises that 
she will not in the future.'' Respondent's Statement at 1.
    \2\ Respondent also expressed regret and apologized for doctor-
shopping and inappropriate diversion of drugs at her clinic. 
Respondent's Statement at 2. I acknowledge (as I did in the original 
decision) the extensive efforts Respondent has undertaken to prevent 
the diversion and abuse of drugs by her patients. I also acknowledge 
Respondent's successful completion of the one-year period of 
monitoring of her practice.
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Findings

    I incorporate by reference my findings of fact contained in the 
original order and found at pages 71 FR at 52149-56. As previously 
found, and as Respondent acknowledges, she issued controlled substance 
prescriptions to three undercover operatives without performing 
physical examinations on them and falsified medical records to indicate 
that she had performed a physical exam. Moreover, Respondent prescribed 
controlled substances to the undercover operatives even though each of 
them represented that they were not in pain and were obtaining the 
drugs from non-legitimate sources such as friends or family members. 
Moreover, during each of the visits, Respondent made statements that 
indicated that she knew the patients were seeking the drugs to abuse 
them and not to treat a legitimate medical condition. See id. at 52150 
(Respondent stating during first undercover visit: ``Lorcet 10/650. 
See, this is a shame then that you have to take the medicine for the 
habit.''); id. at 52152 (after acknowledging that second undercover 
operative had told her that he was taking four to five Vicodin a day 
even though he did not have pain, and was taking them because he 
``functioned better,'' Respondent asked him if he ``want[ed] to go to 
substance abuse program or * * * be maintained on the vicodin?''); id. 
(stating to second undercover operative ``maybe I'm sympathetic to the 
people that allow themselves to slip into drugs''); id. at 52154 
(during visit of third operative, when asked by her nurse, ``what's the 
source of the pain?,'' replying: ``I guess he feels no pain, he just 
feels better.''); id. (stating to third visitor: ``we will not be 
supporting just a drug habit'').
    Having reviewed--for a second time--the twelve patient files that 
were seized during the January 26, 2000 search, I further find that 
Respondent discharged five of these patients prior to the search. More 
specifically, I find that: (1) Respondent discharged K.L. on February 
2, 1998, upon her office's being notified that she had altered a 
prescription; (2) Respondent discharged R.H. on February 11, 1999, for 
various reasons including his having claimed that his drugs had been 
lost or stolen, and his coming in early to obtain new prescriptions 
claiming that he was going out of town; (3) Respondent discharged J.B. 
on December 1, 1998, after her office was notified that she had been 
arrested for photocopying prescriptions and presenting them for filling 
to multiple pharmacies; (4) Respondent discharged R.S. on December 2, 
1999, after being called by his mother who reported that he was abusing 
his medications; and (5) Respondent discharged J.L. on January 24, 
2000, after an anonymous caller reported to Respondent's office that he 
was simultaneously receiving treatment at a methadone clinic. See RX 
21, at 4, 17, 23, 24 & 34
    As stated above, the Court of Appeals vacated the original Order on 
the ground that it failed to consider ``any of'' what it termed 
[Respondent's] ``positive experience in dispensing controlled 
substances.'' Slip. Op. at 3. The Court specifically noted that I had 
not considered Respondent's experience with the twelve patients whose 
charts were seized in a search of her office, ``or with thousands of 
other patients.'' Id. at 3.
    The Court of Appeals did not cite to any decision of either this 
Agency or another court defining the term ``positive experience.'' Nor 
did the Court offer any guidance as to the meaning of this term, which 
is not to be found in the Act.
    For the purpose of resolving this matter, I therefore assume--
without deciding--that the twelve patient charts establish that 
Respondent's prescribing of controlled substance to these individuals 
constitutes ``positive experience''--whatever that means.\3\

[[Page 461]]

Moreover, although there is absolutely no evidence in the record 
regarding the propriety of Respondent's prescribing of controlled 
substances to the ``thousands of other patients'' she has treated, for 
the purpose of resolving this matter, I again assume that her 
prescribings to these individuals constitutes ``positive experience.''
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    \3\ Having carefully re-reviewed the charts, it should be noted 
that some of the files suggest that this is an assumption which is 
highly favorable to Respondent. Under agency precedent, DEA's 
authority to suspend or revoke a registration is not limited to 
those instances in which a practitioner intentionally diverts. See 
Paul J. Caragine, Jr., 63 FR 51592 (1998). A practitioner who 
ignores the warning signs that her patients are either personally 
abusing or diverting controlled substances commits ``acts 
inconsistent with the public interest,'' 21 U.S.C. 824(a)(4), even 
if she is merely gullible or na[iuml]ve. 63 FR at 51600. The twelve 
patient charts cited by Respondent as evidence of her ``positive 
experience'' included numerous instances in which Respondent appears 
to have ignored warning signs that the patient was either abusing or 
diverting controlled substances.
    For example, according to Respondent's evidence, ``[o]n 10/05/99 
a notation written in [C.A.'s] progress notes states, `That the 
patient called to say that a [D.M.] will call and tell you I'm 
selling my drugs.' It was later discovered that the patient was in 
jail for violation of probation and marijuana.'' RX 21, at 2. In her 
testimony, Respondent did not address what action she took in 
response to this unusual phone call. See Tr. 433-34. Moreover, the 
actual progress note for C.A.'s October 5 visit is missing. Also 
missing are the progress notes for numerous other office visits 
which occurred (according to Respondent's billing records) on 
October 7 and 25, November 8 and December 17.
    On July 28, 1998, Respondent issued a prescription for a drug 
(Soma) to C.C. RX 21, at 8. That same day, Respondent's office 
received a phone call from a Walgreens pharmacy reporting that two 
days earlier, C.C. had filled a prescription for the same drug which 
was issued by a different physician. Id. C.C. was thus clearly 
engaged in doctor shopping.
    Respondent saw C.C. three days later and yet there is no 
indication in the progress note that she even questioned him about 
the incident and whether he was seeing other doctors. RX 90, at 29. 
At this visit, Respondent issued him a prescription for Dilaudid, a 
schedule II controlled substance. Id. C.C. also demonstrated a 
consistent pattern of coming in early. Respondent nonetheless 
continued to prescribe controlled substances to him and did not 
discharge him until approximately a year and a half after the 
Walgreen's incident. RX 90, at 1.
    Respondent had previously discharged R.H. based on a drug test 
which showed that he was ``positive for drug dependency.'' RX 92, at 
22. Respondent, however, accepted him back into her practice. Id. It 
is acknowledged that upon his return to her practice, Respondent 
counseled R.H. that if he returned ``to the same state of 
medications taking'' as ``in the past, we will not be not be able to 
continue.'' Id. During the visit, Respondent issued him a 
prescription for Dilaudid. Id.
    Two days later, however, R.H. returned to Respondent and 
complained that he could only get part of his prescription filled 
and that he had come back to get the balance of forty tablets. 
Respondent ``continued his prescription for Dilaudid,'' id. at 21, 
even though the original prescription was still valid under Federal 
law.
    After a number of additional visits, in early October, R.H. came 
in and represented that his drugs had been ruined because he lived 
in a duplex and the landlord's hot water heater had failed and 
flooded the whole house. Id. at 16. As Respondent noted, R.H. had 
brought in ``the whole bottle of Dilaudid with water in it. I cannot 
tell if it is just a powder or medicine.'' Id. Respondent issued 
R.H. a new prescription notwithstanding the likely implausibility of 
his story and his past record as a drug abuser. Id. Nor is there any 
evidence that she attempted to verify whether the substance in the 
bottle was in fact Dilaudid. In addition, R.H. made numerous early 
visits, and on another occasion, obtained prescriptions for 
Oxycontin and Percocet after having claimed that he lost a 
prescription for Dilaudid. Id. at 9.
    While Respondent discharged J.B. on December 1, 1998, and 
represents that J.B. was discharged after being arrested for 
photocopying prescriptions, see RX 21, at 4; the online records of 
the Pinellas County, Florida courts indicate that she had been 
convicted on July 10, 1996, of attempting to obtain a controlled 
substance by fraud, and that on June 9, 1998, a new complaint 
charging her with obtaining or attempting to obtain a controlled 
substance by fraud had been filed against her. Moreover, J.B. made 
numerous early visits, a classic behavior of drug seekers. See RX 
93.
    R.C. came in on October 21, 1998, nine days after his initial 
visit with Respondent, and told her that he had to come in early 
because he was going to New York for four weeks and would run out of 
medicine while he was out of town. RX 94, at 12. Yet eight days 
later, R.C. was back to see Respondent and seeking additional 
narcotics because he was ``going to Puerto Rico for some relief 
work.'' Id. at 11. However, during R.C.'s initial visit, R.C. had 
stated that he was ``on disability'' and was ``not working.'' Id. at 
13. Respondent nonetheless issued him new prescriptions. Id. at 11. 
While it is unclear whether R.C. told Respondent that he would be 
gone for six weeks or six months, R.C. went back to see Respondent 
on November 18 and 24, as well as on December 1, 1998. Id. at 15.
    On August 21, 1998, Respondent gave B.B. a prescription for 
Dilaudid (and Soma) for pain in various body parts and indicated 
that she would be seen ``next month for the followup.'' RX 99, at 7. 
On September 2 (eleven days later), B.B. returned to Respondent and 
reported that ``she is going to Miami for about three to four weeks 
for her deposition.'' Id. at 6. Respondent ``continued[d] her 
prescriptions for Dilaudid and Soma.'' Id. Twelve days later, B.B. 
returned to Respondent. Id. at 5. According to the progress note: 
B.B. ``is going to Miami for her case. She will be gone four to six 
weeks. She came in early today because she does not have enough 
medicine for four to six weeks. `` Id. Respondent issued B.B. 
additional prescriptions for Dilaudid (and Soma) and indicated that 
she would be seen again in a month. Id. Ten days later, B.B. 
returned again to Respondent. Id. at 4. According to the progress 
note, B.B. ``came early today because she will be evacuated from the 
Fort Lauderdale area. No more court cases.'' Id. B.B. also told 
Respondent that the pharmacy had called and told her that ``they 
could not fill the prescription, because it was unreadable,'' (as if 
the pharmacy would not have called Respondent to verify the script) 
and that B.B. ``could not get the prescription back from the 
pharmacy, so she does not have any medicine [because] she had to 
leave it in Fort Lauderdale.'' Id.
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Discussion

    Section 304(a) of the Controlled Substances Act (CSA) provides that 
a registration to ``dispense a controlled substance* * * may be 
suspended or revoked by the Attorney General upon a finding that the 
registrant* * * 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.'' 21 U.S.C. Sec.  
824(a)(4) (emphasis added). With respect to a practitioner, the Act 
requires the consideration of the following factors in making the 
public interest determination:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing* * * 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.

Id. Sec.  823(f).

    [T]hese factors are * * * considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I 
``may rely on any one or a combination of factors, and may give each 
factor the weight [I] deem[] appropriate in determining whether a 
registration should be revoked.'' Id.; Hoxie v. DEA, 419 F.3d 477, 482 
(6th Cir. 2005). Moreover, I am ``not required to make findings as to 
all of the factors.'' See Hoxie, 419 F.3d at 482; see also Morall v. 
DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).59
    As explained below, I adhere to my initial findings regarding 
factors one through four. As found in the original Order, the State of 
Florida took no action against Respondent's state medical license and 
Respondent has not been convicted of an offense under either Federal or 
State laws relating to controlled substances. 71 FR at 52158-59. DEA 
has long held, however, that a State's failure to take action against a 
registrant's medical license is not dispositive in determining whether 
the continuation of a registration is in the public interest. See, 
e.g., Mortimer B. Levin, 55 FR 8209, 8210 (1990) (holding that 
practitioner's reinstatement by state board ``is not dispositive''; 
``DEA maintains a separate oversight responsibility with respect to the 
handling of controlled substances and has a statutory obligation to 
make its independent determination as to whether the granting of [a 
registration] would be in the public interest''). Nor is the fact that 
a registrant/applicant has not been convicted of a controlled substance 
offense dispositive of whether the continuation of her registration is 
in the public interest. See also Edmund Chein, 72 FR 6580, 6593 n.22 
(2007).
    Pursuant to the Court of Appeals' judgment, I have re-considered 
the additional evidence pertaining to Respondent's ``positive 
experience.'' Having done so, I again conclude that Respondent violated 
Federal law and regulations in issuing the prescriptions to the 
undercover operatives. I also conclude that Respondent violated Federal 
law and regulations when she pre-signed prescriptions (which she gave 
to her nurse) and delegated to him her authority to prescribe 
controlled substances, even though he was not registered to prescribe 
under Federal law and could not lawfully prescribe controlled 
substances under state law. I therefore conclude that Respondent 
committed acts inconsistent with the public interest and which support 
the suspension or revocation of her registration. 21 U.S.C. 824(a)(4).
    However, Respondent has now credibly acknowledged that her 
prescribing to the undercover operatives and her pre-signing of the 
prescriptions was improper. She has also credibly stated that she has 
not engaged in such conduct since the events at issue here and has 
promised that she will not do so in the future.\4\ I therefore further 
conclude that Respondent has accepted responsibility for her misconduct 
and can be entrusted with a new registration subject to the condition 
agreed to by the parties.
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    \4\ In the original Order, I acknowledged that Respondent had 
undertaken substantial measures to reform her practice. 71 FR at 
52156 & 52159.
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Factor Two and Four--Respondent's Experience in Dispensing Controlled 
Substances and Record of Compliance With Applicable Controlled 
Substance Laws

    Under a longstanding DEA regulation, a prescription for a 
controlled substance is not ``effective'' unless it is ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a). Under 
the CSA, it is fundamental that a practitioner must establish a 
bonafide doctor-patient relationship in order to act ``in the usual 
course of * * * professional practice'' and to issue a prescription for 
a ``legitimate medical

[[Page 462]]

purpose.'' See United States v. Moore, 423 U.S. 122 (1975); see also 21 
CFR 1306.04(a) (``an order purporting to be a prescription issued not 
in the usual course of professional treatment * * * is not a 
prescription within the meaning and intent of [21 U.S.C. 829] and * * * 
the person issuing it, shall be subject to the penalties provided for 
violations of the provisions of law related to controlled 
substances'').
    As the Supreme Court recently explained, ``the prescription 
requirement* * * ensures patients use controlled substances under the 
supervision of a doctor so as to prevent addiction and recreational 
abuse. As a corollary, [it] also bars doctors from peddling to patients 
who crave the drugs for those prohibited uses.'' Gonzales v. Oregon, 
546 U.S. 243, 274 (2006) (citing Moore, 423 U.S. 122, 135 & 143 
(1975)).
    In this matter, the Government's presentation largely focused on 
two allegations: (1) That Respondent lacked a legitimate purpose in 
issuing the prescriptions to the undercover operatives, and (2) that 
Respondent pre-signed blank prescriptions which she gave to her nurse 
and allowed him to prescribe drugs even though the nurse was not 
authorized under either Federal or State law to prescribe controlled 
substances.
    Whether this conduct is evaluated under factor two--the experience 
factor, or factor four--the compliance factor, or both, is of no legal 
consequence. In establishing its prima facie case, the fundamental 
question is whether Respondent ``has committed such acts as would 
render [her] registration * * * inconsistent with the public 
interest.'' 21 U.S.C. 824(a)(4). As explained above, this Agency has 
long held--and other courts of appeals have at least implicitly 
recognized--that findings under a single factor are sufficient to 
support the revocation of a registration. See Hoxie, 419 F.3d at 482; 
Morall, 412 F.3d at 173-74.
    In short, this is not a contest in which score is kept; the Agency 
is not required to mechanically count up the factors and determine how 
many favor the Government and how many favor the registrant. Rather, it 
is an inquiry which focuses on protecting the public interest; what 
matters is the seriousness of the registrant's misconduct.\5\
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    \5\ The Court of Appeals interpreted my prior decision as 
``[b]alancing the factors and according `dispositive' weight to 
factor five.'' Slip. Op. at 5. This suggests that the factors that 
favored Respondent's continued registration (factors one and three) 
were in equipoise with the factors that did not support her 
continued registration. They were not. As explained above, even if 
Respondent's conduct had been discussed under a single factor, the 
conduct still would have established a prima facie case that her 
continued registration was inconsistent with the public interest. 
Factor five was dispositive because once the Government established 
a prima facie case, the burden shifted to the Respondent to 
demonstrate that her continued registration was consistent with the 
public interest.
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    As previously found, on three separate occasions, undercover 
operatives went to Respondent seeking prescriptions for controlled 
substances. Each of the operatives stated that they were not in pain 
and that they had been obtaining controlled substances from such non-
legitimate sources as a ``girlfriend'' (first visitor), ``a friend'' 
(second visitor) and ``a family member who has a prescription'' (third 
visitor). 71 FR at 52150, 52152, and 52154. Respondent did not perform 
a physical examination on any of the three operatives, even though she 
acknowledged that performing a physical exam ``is the standard of 
practice'' and ``our Rule No.1.'' Id. at 52154. Moreover, she falsified 
each operative's medical record to indicate that she had performed a 
physical exam. Id. at 52150 (first visitor), 52153 (second visitor), & 
52154 (third visitor).
    Most significantly, Respondent's statements as recorded on the wire 
amply demonstrate that she knew that the operatives were seeking the 
drugs not for the purpose of treating a legitimate medical condition, 
but to abuse them. See 71 FR at 52150 (stating to first visitor: ``this 
is a shame * * * that you have to take the medicine for the habit,'' 
``you can tell me that you want to come out of drugs''); id. at 52152 
(asking second visitor: ``you don't have pain but you are taking 
vicodin?'' and do you ``want to go to substance abuse program or do you 
want to be maintained on the vicodin?''); id. (stating to second 
visitor: ``maybe I'm sympathetic to the people that allow themselves to 
slip into drugs''); id. at 52154 (during visit of third operative, when 
asked by her nurse, ``what's the source of the pain?'', replying: ``I 
guess he feels no pain, he just feels better.''); id. (stating to third 
visitor: ``we will not be supporting just a drug habit'').
    In various briefs, Respondent maintains that at the time of the 
search, she had already discharged 6 of the 12 patients ``for various 
reasons including non-compliance with the Prescription Pain Medication 
Agreement, criminal acts or arrest.'' Resp. Exceptions to ALJ Dec. at 
42. She contends that this is exculpatory evidence of her intent to not 
improperly prescribe drugs. Id.
    As found above, it is true that five of the patients whose files 
were seized had been discharged before the search was conducted. Yet 
even assuming that this evidence is relevant as to Respondent's intent 
with respect to her prescribings to the undercover operatives, it is 
not more probative of her intent during the visits than the evidence as 
to what actually occurred during those visits. Indeed, even if the 
operatives' initial statements to Respondent were ambiguous as to why 
they were seeking the drugs, Respondent did not perform a physical exam 
on any of the operatives (yet falsified the records to indicate that 
she had done so) and her subsequent statements during the visits made 
clear that she had resolved any doubt as to why the operatives were 
seeking the drugs. In short, the evidence is clear that Respondent 
issued prescriptions to each of the undercover operatives knowing that 
they were seeking controlled substances for the purpose of abusing them 
and not to treat a legitimate medical condition.\6\ I thus conclude 
that Respondent lacked a legitimate medical purpose and thus violated 
Federal law and DEA regulations when she issued the prescriptions to 
the undercover operatives.
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    \6\ I acknowledge that some courts allow a defendant in criminal 
matters to admit evidence of her ``prior good acts'' to prove she 
lacked criminal intent. See United States v. Thomas, 134 F.3d 975, 
979 (9th Cir. 1998); United States v. Garvin, 565 F.2d 519, 521-22 
(8th Cir. 1977). Putting aside that this is not a criminal 
proceeding and the Federal Rules of Evidence do not apply, 
Respondent made no showing that the factual circumstances 
surrounding her discharging of these patients were similar to the 
circumstances involved in the undercover visits. Indeed, in four of 
the five instances, the patients had been caught by others engaging 
in problematic behavior such as criminal acts present altering or 
photocopying prescriptions, (K.L. and J.B.), that the patient was 
receiving drugs from another clinic (J.L.), or a report from the 
patient's mother that he was abusing drugs (R.S.). RX 21, at 4, 23, 
24 and 34.
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    In her exceptions, Respondent argued that ``her treatment of each 
of the [twelve] patients [whose files were seized] was proper,'' and 
that the ``Government presented no evidence suggesting that the 
treatment of those twelve patients was anything but proper.'' Id. 
Respondent also contends that she ``properly treated thousands of 
patients for chronic pain,'' and that ``the Government was unable to 
present any evidence that there was any problem with any non-undercover 
patient.'' Id. at 64. Relatedly, the Court of Appeals has instructed 
that the experience factor be reconsidered ``pay[ing] particular 
attention to the entire corpus of Petitioner's record in dispensing 
controlled substances.'' Slip Op. at 3.
    As stated above, for the purpose of resolving this matter, I have 
assumed that Respondent's prescribings of

[[Page 463]]

controlled substances to every other person she has treated constitute 
``positive experience.'' Her prescribings to thousands of other 
patients do not, however, render her prescribings to the undercover 
officers any less unlawful, or any less acts which ``are inconsistent 
with the public interest.'' 21 U.S.C. Sec.  823(f).
    In enacting the CSA, Congress recognized that ``[m]any of the drugs 
included within [the CSA] have a useful and legitimate medical purpose 
and are necessary to maintain the health and general welfare of the 
American people.'' 21 U.S.C. 801(1). Moreover, under the CSA, a 
practitioner is not entitled to a registration unless she ``is 
authorized to dispense * * * controlled substances under the laws of 
the State in which [she] practices.'' 21 U.S.C. 823(f). Because under 
law, registration is limited to those who have authority to dispense 
controlled substances in the course of professional practice, and 
patients with legitimate medical conditions routinely seek treatment 
from licensed medical professionals, every registrant can undoubtedly 
point to an extensive body of legitimate prescribing over the course of 
her professional career.
    Thus, in past cases, this Agency has given no more than nominal 
weight to a practitioner's evidence that he has dispensed controlled 
substances to thousands of patients in circumstances which did not 
involve diversion. See, e.g., Caragine, 63 FR at 51599 (``[T]he 
Government does not dispute that during Respondent's 20 years in 
practice he has seen over 15,000 patients. At issue in this proceeding 
is Respondent's controlled substance prescribing to 18 patients.''); 
id. at 51600 (``[E]ven though the patients at issue are only a small 
portion of Respondent's patient population, his prescribing of 
controlled substances to these individuals raises serious concerns 
regarding [his] ability to responsibly handle controlled substances in 
the future.'').
    While in Caragine, my predecessor did consider ``that the patients 
at issue ma[de] up a very small percentage of Respondent's total 
patient population,'' he also noted--in contrast to the prescribings at 
issue here--``that [those] patients had legitimate medical problems 
that warranted some form of treatment.'' Id. at 51601. Moreover, in 
contrast to this case, in Caragine, there was no evidence that the 
practitioner had intentionally diverted. Id. See also Medicine Shoppe--
Jonesborough, 73 FR 364, 386 & n.56 (2008) (noting that pharmacy ``had 
17,000 patients,'' but that ``[n]o amount of legitimate dispensings can 
render * * * flagrant violations [acts which are] `consistent with the 
public interest.' ''), aff'd, Medicine Shoppe-Jonesborough v. DEA, 
slip. op. at 11 (6th Cir. Nov. 13, 2008). Indeed, DEA has revoked other 
practitioners' registrations for committing as few as two acts of 
diversion. See Alan H. Olefsky, 57 FR 928, 928-29 (1992) (revoking 
registration based on physician's presentation of two fraudulent 
prescriptions to pharmacy and noting that the respondent ``refuses to 
accept responsibility for his actions and does not even acknowledge the 
criminality of his behavior''). See also Sokoloff v. Saxbe, 501 F.2d 
571, 576 (2d Cir. 1974) (upholding revocation of practitioner's 
registration based on nolo contendere plea to three counts of unlawful 
distribution).
    Accordingly, evidence that a practitioner has treated thousands of 
patients does not negate a prima facie showing that the practitioner 
has committed acts inconsistent with the public interest. While such 
evidence may be of some weight in assessing whether a practitioner has 
credibly shown that she has reformed her practices, where a 
practitioner commits intentional acts of diversion and insists she did 
nothing wrong, such evidence is entitled to no weight. As I held in the 
original decision, I again conclude that Respondent's dispensings to 
the undercover officers and her pre-signing of prescriptions and 
unlawful delegation of her prescribing authority to her nurse, 
establish a prima facie case that her continued registration is 
``inconsistent with the public interest.''
    Under longstanding Agency precedent, where, as here, ``the 
Government has proved that a registrant has committed acts inconsistent 
with the public interest, a registrant must `present sufficient 
mitigating evidence to assure the Administrator that [he] can be 
entrusted with the responsibility carried by such a registration.' '' 
Medicine Shoppe, 73 FR at 387 (quoting Samuel S. Jackson, 72 FR 23848, 
23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988))). 
``Moreover, because `past performance is the best predictor of future 
performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), 
[DEA] has repeatedly held that where a registrant has committed acts 
inconsistent with the public interest, the registrant must accept 
responsibility for [her] actions and demonstrate that [she] will not 
engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also 
Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); 
Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. 
DEA, 419 F.3d at 483 (``admitting fault'' is ``properly consider[ed]'' 
by DEA to be an ``important factor[]'' in the public interest 
determination).
    In this matter, I previously revoked Respondent's registration 
because notwithstanding all of the measures she had undertaken to 
reform her practice, she was the person with the prescribing authority 
and had refused to acknowledge her responsibility under the law. 71 FR 
at 52159. Had this case come back to me with the same evidentiary 
record as before, I would again revoke her registration. Respondent, 
however, has now acknowledged wrongdoing with respect to both her 
prescribings to the undercover operatives, as well as her pre-signing 
of prescriptions and delegation of her prescribing authority to her 
nurse, who could not legally prescribe a controlled substance under 
either the CSA or Florida Law. Moreover, Respondent's registration was 
effectively suspended for a period of approximately one year. I 
therefore conclude that the parties' proposed resolution of this matter 
is in the public interest.
* * * * *
    The diversion of controlled substances has become an increasingly 
grave threat to this nation's public health and safety. According to 
The National Center on Addiction and Substance Abuse (CASA), ``[t]he 
number of people who admit abusing controlled prescription drugs 
increased from 7.8 million in 1992 to 15.1 million in 2003.'' National 
Center on Addiction and Substance Abuse, Under the Counter: The 
Diversion and Abuse of Controlled Prescription Drugs in the U.S. 3 
(2005). Moreover, ``[a]pproximately six percent of the U.S. population 
(15.1 million people) admitted abusing controlled prescription drugs in 
2003, 23 percent more than the combined number abusing cocaine (5.9 
million), hallucinogens (4.0 million), inhalants (2.1 million) and 
heroin (328,000).'' Id. Relatedly, ``[b]etween 1992 and 2003, there has 
been a * * * 140.5 percent increase in the self-reported abuse of 
prescription opioids,'' and in the same period, the ``abuse of 
controlled prescription drugs has been growing at a rate twice that of 
marijuana abuse, five times greater than cocaine abuse and 60 times 
greater than heroin abuse.'' Id. at 4.\7\
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    \7\ According to a recent newspaper article, ``[p]rescription 
painkiller and anti-anxiety drugs now kill about 500 people a year 
in the Tampa Bay area, triple the number killed by illegal drugs 
such as cocaine and heroin.'' Chris Tisch & Abbie Vansickle, Deadly 
Combinations, St. Petersburg Times (Feb. 17, 2008), at 1. This 
article further noted that while at the time of publication, the 
figures for the year 2007 were not complete, ``the area is on pace 
for about 550 deaths,'' and that ``prescription drug overdoses are 
likely to overtake car crashes as the leading cause of accidental 
death.'' Id. In contrast, in 2006, 433 people died of prescription 
drug overdoses, and in 2005, 339 died. Id. According to the Circuit 
Judge who runs the Pinellas County drug court, ``This has become an 
epidemic.'' Id.

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[[Page 464]]

    While some isolated decisions of this Agency may suggest that a 
practitioner who committed only a few acts of diversion was entitled to 
regain his registration even without having to accept responsibility 
for his misconduct, see Anant N. Mauskar, 63 FR 13687, 13689 (1998), 
the great weight of the Agency's decisions are to the contrary. In any 
event, the increase in the abuse of prescription controlled substances 
calls for a clarification of this Agency's policy. Because of the grave 
and increasing harm to public health and safety caused by the diversion 
of prescription controlled substances, even where the Agency's proof 
establishes that a practitioner has committed only a few acts of 
diversion, this Agency will not grant or continue the practitioner's 
registration unless he accepts responsibility for his misconduct.\8\ 
Put another way, even where the Government proves only a few instances 
of illegal prescribing in the ``entire corpus'' of a practitioner's 
experience, the Government has nonetheless made out a prima facie case 
and thus shifted the burden to the registrant to show why he should be 
entrusted with a new registration.\9\
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    \8\ Depending upon the facts and circumstances, a registrant/
applicant may also be required to show what corrective measures he/
she has instituted to prevent such acts from re-occurring.
    \9\ To the extent Mauskar, or any other decision of this Agency 
suggests otherwise, it is overruled.
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    I have abided by the judgment of the Court of Appeals in this 
matter. However, some may interpret the Court's decision as suggesting 
that ``the entire corpus'' of a practitioner's record in dispensing 
controlled substances can outweigh a practitioner's intentional acts of 
diversion where DEA only proves that a few acts of diversion have 
occurred.
    The Court's decision was not published and the Court did not 
instruct the Agency as to how much weight the entire corpus should be 
given. Nor did the Court explain whether ``the entire corpus'' should 
be considered as part of the Government's prima facie case, or as part 
of the registrant's rebuttal of the Government's case.
    DEA therefore does not interpret the decision as altering the 
manner in which similar arguments have been dealt with in prior cases. 
While such evidence may have some probative value, it does not negate a 
prima facie showing that a registrant/applicant has committed acts that 
are inconsistent with the public interest. It may, however, be entitled 
to some weight in assessing whether a registrant/applicant has 
demonstrated that she can be entrusted with a new registration where 
the Government's proof is limited to relatively few acts and a 
registrant puts forward credible evidence that she has accepted 
responsibility for her misconduct.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 
824(a), as well as 28 CFR 0.100(b) & 0.104, I hereby order that the DEA 
Certificate of Registration issued to Jayam Krishna-Iyer, M.D., be, and 
it hereby is, suspended. I further order that the suspension shall be 
retroactive and limited to the period beginning on October 2, 2006, and 
ending on October 2, 2007, when her registration was restored pursuant 
to the judgment of the Court of Appeals. I further order that the 
application of Jayam Krishna-Iyer, M.D., for renewal of her 
registration be, and it hereby is, granted subject to the condition 
that she file monthly reports with the Special Agent in Charge (or his 
designee) of the Miami Field Division for a period of one year. The 
reports shall list all controlled substances prescribed by the 
patient's name, the date, the name of the drug, its strength, the 
quantity prescribed, and the number of refills authorized. The reports 
shall be due no later than the tenth day of the subsequent month and 
shall list all patients in alphabetical order.\10\ Failure to comply 
with the terms of this Order shall be grounds for the suspension or 
revocation of Respondent's registration. This Order is effective 
immediately.
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    \10\ If a patient received multiple prescriptions, all 
prescriptions issued to the patient within the calendar month shall 
be listed before the prescriptions for the next patient are 
reported.

    Dated: December 19, 2008.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E8-31412 Filed 1-5-09; 8:45 am]

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