Registrant Actions - 2011
[Federal Register Volume 76, Number 223 (Friday, November 18, 2011)]
[Notices]
[Pages 71604-71607]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29708]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-53]
Kamal Tiwari, M.D.; Pain Management and Surgery Center of
Southern Indiana; Decision and Order
On April 23, 2010, I, the Administrator of the Drug Enforcement
Administration, issued an Order to Show Cause and Immediate Suspension
of Registration to Kamal Tiwari, M.D. (Respondent Tiwari), holder of
DEA Certificate of Registration BT2936411, and his principal place of
business, the Pain Management and Surgery Center (Respondent PMSC),
holder of DEA Certificate of Registration BP4917413, both of
Bloomington, Indiana. The Show Cause Order proposed the revocation of
each Respondent's registration, on the ground that Respondent Tiwari
had committed acts which render the continued registration of each
Respondent "inconsistent with the public interest." Show Cause Order,
at 1 (citing 21 U.S.C. 823(f) and 824(a)(4)).
The Show Cause Order specifically alleged that between March 2003
and August 2008, Respondent Tiwari issued "numerous" prescriptions
for controlled substances to three patients, who were addicts, and
"who did not exhibit any verifiable medical indications warranting the
prescribing of controlled substances." Id. at 2. The Order thus
alleged that Respondent lacked a legitimate medical purpose and acted
outside the usual course of professional practice in issuing the
prescriptions and violated federal and state laws. Id. (citing 21
U.S.C. 841(a)(1); 21 CFR 1306.04(a); Ind. Code Sec. 25-1-9-4(a)(9)).
With respect to these patients, the Show Cause Order further alleged
that Respondent prescribed controlled substances to them "in exchange
for their agreements to undergo medical procedures * * * for profit,"
and that "[t]his prescribing pattern indicates" that he issued the
"prescriptions without a legitimate medical purpose and outside the
scope of professional practice." Id. at 2-3.
The Show Cause Order also alleged that a medical expert concluded
that Respondent's prescribing to these three patients lacked "a
legitimate medical purpose and [was] outside the scope of professional
practice." Id. at 3. The Order further alleged that the expert
concluded with respect to these three patients, as well as nine other
patients, that Respondent's "actions encouraged the abuse of
controlled substances and allowed their misuse," that his prescribing
of controlled substances contributed to the deaths of six patients, and
that there was no justification for his "long-term prescribing of
controlled substances * * * or the administration of procedures using
controlled substances" to these patients. Id.
Next, the Show Cause Order alleged that a second medical expert
concluded that Respondent Tiwari had prescribed controlled substances
to, and/or performed medical procedures using controlled substances
without medical justification on, several other patients. Id. Finally,
the Show Cause Order alleged that "at least nine of" Respondent's
patients had died over a six-year period, the most recent being in
February 2009, and that Respondent had "continue[d] to prescribe
controlled substances to patients at per-patient rates that [we]re
similar to the prescribing rates in 2008, when two of [his] patients
died of conditions related to drug abuse." Id.
Based on the above, I concluded that Respondents' continued
registration during the pendency of the proceeding "constitutes an
imminent danger to the public health and safety." Id. at 4. I
therefore ordered that each Respondent's registration be immediately
suspended. Id.
On May 24, 2010, Respondents filed a request for a hearing and the
matter was assigned to an Administrative Law Judge (ALJ), who proceeded
to conduct pre-hearing procedures. However, on May 27, 2010, the
Government moved for Summary Disposition and filed a Motion to Stay the
Filing of Prehearing Statements. Mot. Summ. Disp., at 2-3.
The basis of the Government's motion was that each Respondent
currently lacks authority to handle controlled substances in the State
of Indiana, the jurisdiction where the Respondents are licensed to
practice medicine and hold their DEA registrations. Mot. Summ. Disp.,
at 1-2 (citing 21 U.S.C. 801(21), 823(f), 824(a)(3)). In support of its
motion, the Government attached a letter from the Medical Licensing
Board of Indiana (MLB) to Respondent Kamal Tiwari, dated May 26, 2010,
stating that
[[Page 71605]]
his Indiana controlled substance registration (CSR) Number 01034945B,
had been suspended pursuant to Indiana Code Sec. 35-48-3-5(e).\1\ Id.
at Ex. 3. The Government also attached a printout from the Indiana
Online Licensing Web site which shows that Indiana CSR Number
61100223B, held by Respondent PMSC, has also been suspended. Id. at Ex.
4.
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\1\ This provision states: "If the Drug Enforcement
Administration terminates, denies, suspends or revokes a federal
registration for the manufacture, distribution, or dispensing of
controlled substances, a registration issued by the board under this
chapter is automatically suspended." Ind. Code Sec. 35-48-3-5(e).
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Thereafter, the ALJ issued an Order for Respondents' Response to
Government's Motion for Summary Disposition and to Stay the Filing of
Prehearing Statements; she also stayed the filing of the Prehearing
statements. ALJ's Recommended Ruling (also ALJ), at 4.
On June 16, 2010, Respondents filed their Response. Therein,
Respondents argued that granting summary disposition based on their
lack of state authority to handle controlled substances would be
circular and violate their right to Due Process, because the State's
suspension of their state CSRs was based on the DEA Order to Show Cause
and Immediate Suspension of Registration. Resps. Response at 1, 3-6.
Respondents also argued that in suspending their state registrations,
the MLB cited "no basis for the State suspension other than the
federal suspension." Id. at 2. Respondents further maintain that the
MLB "has no authority concerning controlled substances registrations,
which are instead under the jurisdiction of the Indiana State Board of
Pharmacy." Id. at 2-3 (citations omitted).
Respondents also argued that in none of the cases cited by the
Government did it "attempt to rely * * * on a derivative state action
triggered by the Government's suspension," and that "[n]ot a single
one of the Government's cases revoke[d] a registration under 21 U.S.C.
843(a)(3) without some independent determination" by the respective
state authority. Id. at 4. Respondents thus maintained that
"[d]epriving a practitioner of the right to review of a DEA action
based solely on a State suspension that was in turn based solely on the
original DEA action would violate Due Process." Id. at 5. Finally,
Respondents also contended that "[p]ractitioners may not be able to
obtain review of either suspension, if the State takes the same
position that the [DEA] does here." Id.
On June 17, the Government filed its Reply to Opposition to
Government's Motion for Summary Disposition and to Stay the Filing of
Pre-hearing Statements (Reply). The Government argued that "Indiana
law specifically provides a basis for substantive review of any state
suspension which is triggered by a DEA suspension." Reply at 1 (citing
Ind. Code Sec. 35-48-3-5(f)).\2\ The Government further argues that
under DEA precedent, "when a state suspends a respondent's controlled
substance privileges, Federal revocation is warranted as long as the
respondent has some mechanism to challenge the state action." Id. at 2
(citing Odette Louise Campbell, M.D., No. 09-62, Order Remanding for
Further Proceedings).\3\
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\2\ "The board may reinstate a registration that has been
suspended under subsection (e), after a hearing, if the board is
satisfied that the applicant is able to manufacture, distribute, or
dispense controlled substances with reasonable skill and safety to
the public." Ind. Code Sec. 35-48-3-5(f).
\3\ The Government also argued that "to the extent that
Respondents argue that the Medical Licensing Board of Indiana * * *
has no authority concerning controlled substance registrations, that
jurisdictional argument must be made to the Board of Pharmacy," and
that in "its letter to [Respondent] Tiwari, the Medical Licensing
Board * * * merely informed Respondent that his CSR was suspended
pursuant to the appropriate statute." Reply at 3. Finally, the
Government attached a May 27, 2010 letter from the Indiana Board of
Pharmacy to Respondents which stated that Indiana CSR Number
61100223B, which is held by Respondent PMSC, had been suspended
pursuant to Ind. Code Sec. 35-48-3-5(e). Reply at 3, Ex. 3-A.
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On June 18, 2010, Respondents filed a Surreply in Opposition to
Government's Motion for Summary Disposition (Surreply), in which they
assert that the Government "fundamentally misunderstands the Indiana
statutory scheme." Surreply, at 1. Therein, the Respondents again
argued that the "Government's Motion for Summary Disposition should be
denied because it relies on a potential, nonbinding state hearing, a
theoretical possibility that cannot be triggered until the Indiana
Board that actually has authority to suspend the Respondents'
controlled substances registrations issues an order to show cause,
which it has not." Id. Respondents further maintained that "the
Indiana Advisory Committee could avoid the hearing provision on which
the Government relies solely by not issuing the show cause notice."
Id. at 2.
On June 21, 2010, the ALJ issued an Order for Government's Response
to Surreply in Opposition to Government's Motion for Summary
Disposition. On July 2, 2010, the Government filed its Response to
Surreply. The Government reiterated that the Respondents' Indiana CSRs
have been suspended and that while the issuance of the DEA Immediate
Suspension Orders "may have been the cause of the state suspension,
[they] do not govern whether those state suspensions remain in
effect." Response to Surreply, at 1.
The Government again argued that under Indiana law, the Board of
Pharmacy " 'may reinstate a [CSR] that has been suspended under
subsection (e), after a hearing, if the board is satisfied that the
applicant is able to * * * dispense controlled substances with
reasonable skill and safety to the public.' " Id. (quoting Ind. Code
Sec. 35-48-3-5(f)). The Government also noted that Respondents had
filed a Petition for Review of the state suspensions, albeit with the
Medical Licensing Board and not the Board of Pharmacy. Id. The
Government argued that this nonetheless demonstrated that Respondents
knew of, and were pursuing, their right to seek administrative review
of the State's suspensions, pursuant to section 35-48-3-5(f).
Next, the Government argued that Respondents' contention that
Indiana must issue an Order to Show Cause prior to suspending their
CSRs is without merit, and that in any case, the issue is a matter of
state law, and not a matter for a DEA ALJ to decide. Response to
Surreply, at 2. Finally, the Government argued that the Respondents'
interpretation of the Indiana statutes would render them inconsistent
and meaningless. Id. at 2-3.
On July 7, 2010, the ALJ issued her recommended decision
(hereinafter ALJ). Therein, the ALJ specifically found that the Indiana
Board of Pharmacy had automatically suspended the Indiana CSRs held by
the Respondents. ALJ at 5. Noting the settled Agency rule that
"possessing authority under state law to handle controlled substances
is an essential condition for holding a DEA registration," id. at 6
(quoting Joseph Baumstarck, M. D., 74 FR 17525, 17527 (2009)), and
rejecting Respondents' contention that granting summary disposition
would deny them their right to Due Process, the ALJ granted the
Government's Motion for Summary Disposition. ALJ at 5-7, 9. The ALJ
thus recommended that I revoke the Respondents' DEA Certificates of
Registration and deny any pending applications to renew their
registrations. Id. at 9.
Neither party filed exceptions to the ALJ's decision. Thereafter,
the record was forwarded to me for final agency action.
[[Page 71606]]
Having considered the record as a whole including the parties'
pleadings, I adopt the ALJ's findings of fact and recommended sanction.
I will therefore revoke Respondents' respective DEA Certificates of
Registration and deny any pending applications to renew their
registrations. I make the following findings.
Findings
Respondent Tiwari is the holder of Certificate of Registration
BT2936411, which authorizes him to dispense controlled substances in
schedules II through V, as a practitioner. While this registration was
due to expire on November 30, 2009, on October 2, 2009, Respondent
Tiwari submitted a timely renewal application. Respondent Tiwari's
registration thus remains active, albeit in suspended status, pending
the issuance of the Final Order in this matter. 5 U.S.C. 558(c).
Respondent PMSC is the holder of Certificate of Registration
BP4917413, which authorizes it to dispense controlled substances in
schedules II through V, as a hospital/clinic. This registration is due
to expire on March 31, 2011. According to the registration records of
this Agency, Respondent Tiwari has also submitted an application to
renew Respondent PMSC's registration.
On or about May 27, 2010, the Indiana Board of Pharmacy placed
Respondent PMSC's Indiana CSR in suspended status. See Reply to Opp. to
Gov. Mot. for Summ. Disp., at Ex. 3-A. Moreover, according to a letter
from the MLB to Respondent Tiwari, on or about May 26, 2010, his
Indiana CSR was placed in suspended status. Id. at Ex. 3. According to
the Indiana Online Licensing Web site, of which I take official notice,
each Respondent's CSR remains suspended as of the date of this Decision
and Final Order.\4\
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\4\ Under the Administrative Procedure Act (APA), an agency
"may take official notice of facts at any stage in a proceeding-
even in the final decision." U.S. Dept. of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and
DEA's regulations, Respondent is "entitled on timely request, to an
opportunity to show to the contrary." 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). Respondent can dispute the facts of which I take
official notice by filing a properly supported motion for
reconsideration within twenty days of service of this Order, which
shall begin on the date it is mailed.
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Discussion
Under the Controlled Substances Act (CSA), a practitioner must be
currently authorized to handle controlled substances in "the
jurisdiction in which he practices" in order to maintain a DEA
registration. See 21 U.S.C. 802(21) ("[t]he term 'practitioner' means
a physician * * * pharmacy, hospital, or other person licensed,
registered, or otherwise permitted, by * * * the jurisdiction in which
he practices * * * to distribute, dispense, [or] administer * * * a
controlled substance in the course of professional practice"). See
also id. Sec. 823(f) ("The Attorney General shall register
practitioners * * * if the applicant is authorized to dispense * * *
controlled substances under the laws of the State in which he
practices."). As these provisions make plain, possessing authority
under state law to handle controlled substances is an essential
condition for obtaining and maintaining a practitioner's registration.
Accordingly, DEA has held that revocation of a practitioner's
registration is warranted whenever his (or its) state authority to
dispense controlled substances has been suspended or revoked. David W.
Wang, 72 FR 54297, 54298 (2007); Sheran Arden Yeates, 71 FR 39130,
39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby
Watts, 53 FR 11919, 11920 (1988). See also 21 U.S.C. 824(a)(3)
(authorizing revocation of a registration "upon a finding that the
registrant * * * has had his State license or registration suspended
[or] revoked * * * and is no longer authorized by State law to engage
in the * * * distribution [or] dispensing of controlled substances").
DEA has further held that revocation is warranted even where a
practitioner's state authority has been summarily suspended and the
State has yet to provide the practitioner with a hearing to challenge
the State's action and at which he (or it) may ultimately prevail. See
Robert Wayne Mosier, 75 FR 49950 (2010) ("revocation is warranted * *
* even in those instances where a practitioner's state license has only
been suspended, and there is the possibility of reinstatement");
accord Bourne Pharmacy, 72 FR 18273, 18274 (2007); Anne Lazar Thorn, 62
FR 12847 (1997).
Here, it is undisputed that the State has suspended the state
controlled substance registration of each Respondent. DEA has long held
that the order of a state agency suspending or revoking a
practitioner's state authority cannot be collaterally attacked in a
proceeding under the CSA. See Hicham K. Riba, 73 FR 75773, 75774 (2008)
(rejecting claim that state proceeding was fundamentally unfair based
on alleged improper ex parte influence of director of state board as
"not addressable in" DEA proceeding); Sunil Bhasin, 72 FR at 5082,
5083 (2007) (rejecting claim that settlement agreement in which
Respondent surrendered state license was produced by fraud and was
unconscionable; "a DEA Show Cause Proceeding is not the proper forum
to litigate the issue"); see also Shahid Musud Siddiqui, 61 FR 14818
(1996); Robert A. Leslie, 60 FR 14004 (1995).
The underlying premise of these cases is that the States exercise
sovereign powers in regulating the medical profession and that
challenges to the validity of state board orders should be raised and
litigated in state forums. See, e.g., Riba, 73 FR at 75774 (claim that
"state proceeding was fundamentally unfair * * * is not addressable
in" DEA proceeding). These cases likewise implicitly recognize that
state boards and state courts are fully cognizant of their obligation
under the Due Process Clause to provide a full and fair opportunity to
litigate the issues. Cf. University of Tennessee v. Elliott, 478 U.S.
788, 797-98 (1986) ("When an administrative agency is acting in a
judicial capacity and resolves disputed issues of fact properly before
it which the parties have had an adequate opportunity to litigate, the
courts have not hesitated to apply res judicata[.]") (int. quotations
and citations omitted).
It is true that in Odette Louise Campbell, M.D., No. 09-62, I
denied the Government's request for a final order based on the
registrant's loss of her controlled substance prescribing authority
under Texas law where the State had suspended that authority based on
DEA's issuance of an immediate suspension order and remanded the matter
for further proceedings. Campbell, Order Remanding for Further
Proceedings, at 10-11. However, I noted that specific provisions of
Texas law and regulations suggested that the registrant was not
entitled to a hearing to challenge the merits of the state suspension
because it was based on the DEA immediate suspension. Id. at 9 (citing
Texas Health & Safety Code Sec. Sec. 481.063(e)(3), 481.063(h),
481.066(g), and Tex. Admin. Code Sec. 13.272(h)). Moreover, I ordered
the ALJ to first determine whether the State had provided, or would
provide, the registrant with a hearing; I further ordered that if the
State had provided or would provide a hearing, the Government could
renew its motion for summary disposition. Id. at 10.
By contrast, while the Indiana Board(s) suspended Respondents'
state registrations based on the state law provision that "[i]f the
Drug Enforcement Administration * * * suspends * * * a federal
registration for the * * * dispensing of controlled substances, a
registration issued by the board under this chapter is automatically
suspended," Ind. Code
[[Page 71607]]
Sec. 35-48-3-5(e), state law further provides that "[t]he board may
reinstate a registration that has been suspended under subsection(e)
after a hearing, if the board is satisfied that the applicant is able
to manufacture, distribute or dispense controlled substances with
reasonable skill and safety to the public." Id. Sec. 35-48-3-5(f).
(emphasis added). Thus, it appears that Respondents are entitled to a
hearing to challenge the underlying allegations before the State board.
Respondents contend that their right to a hearing under section 35-
48-3-5(f) "is not triggered until the Indiana Controlled Substances
Advisory Committee serves upon the * * * registrant an order to show
cause why registration should not be denied, revoked or suspended,"
and that "absent such a step, the purported suspension issued by the
board * * * is a nullity, and cannot form the basis for a federal
suspension." Surreply at 2 (citing Ind. Code Sec. 35-48-3-6(a)).\5\
Respondents further argue that "[i]f it could, then the Indiana
Advisory Committee could avoid the hearing provision on which the
Government relies solely by not issuing the show cause notice." Id.
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\5\ This provision states:
Before recommending a denial, suspension, or revocation of a
registration, or before refusing a renewal of registration, the
board shall serve upon the applicant or registrant an order to show
cause why registration should not be denied, revoked, or suspended *
* *. The order to show cause shall contain a statement of the basis
therefor [sic] and shall call upon the applicant or registrant to
appear before the board at a time and place not less than thirty
(30) days after the date of service of the order * * *.
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Beyond the fact that Respondents' argument appears to be based on
the speculative premise that the Indiana authorities will attempt to
prevent them from obtaining a hearing, the Indiana statute makes clear
that Respondents are entitled to a hearing. Presumably, the Indiana
courts are open and can provide an appropriate remedy in the event the
state board refuses to provide Respondents with a hearing. See Ind.
Code Sec. 34-27-3-1 ("An action for mandate may be prosecuted against
any inferior tribunal * * * public * * * officer, or person to compel
the performance of any * * * act that the law specifically
requires[.]").
Moreover, the question of whether the Indiana suspensions are a
nullity because the State did not serve Respondents with a Show Cause
Order is an issue of state law and for the Indiana courts to decide. As
such, it is outside the scope of this proceeding. See George S. Heath,
M.D., 51 FR 26610 (1986) ("DEA accepts as valid and lawful the action
of a state regulatory board unless that action is overturned by a state
court or otherwise pursuant to state law. * * * The [DEA] will not
consider a challenge to the lawfulness of a Georgia Board Order. Such a
challenge must be made in another forum."); see also Shahid Musud
Siddiqui, M.D., 61 FR 14818, 14818-19 (DEA 1996) (A "DEA
administrative proceeding is not an appropriate forum for wholesale
review of state criminal and administrative actions taken by the State
of New York arising out of the laws of the State of New York. To allow
it to be so would be to permit a wide collateral attack upon such
convictions.") (int. quotations and citation omitted).
Finally, Respondents argue that the suspensions of their state CSRs
are invalid because they were suspended by the MLB and only the
Pharmacy Board has authority under state law to suspend their
registrations. However, the Pharmacy Board's May 27, 2010 letter makes
clear that it (and not the MLB) was suspending Respondent PMSC's
registration, and even if Respondent Tiwari's controlled substance
registration was suspended by the MLB, the validity of this action is
also a question of state law and for the Indiana courts to decide.
Riba, 73 FR at 75774; Heath, 51 FR at 26610.
Because there is no dispute over the material fact that each
Respondent's Indiana controlled substance registration has been
suspended, each is without authority to hold a DEA registration.\6\ See
21 U.S.C. 802(21). Accordingly, Respondents' registrations will be
revoked and any pending applications will be denied.
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\6\ Where, as here, no material fact is in dispute, there is no
need for an evidentiary hearing and summary disposition is
appropriate. See Michael G. Dolin, M.D., 65 FR 5661 (2000); see also
Philip E. Kirk, M.D., 48 FR 32887 (1983), aff'd sub nom Kirk v.
Mullen, 749 F.2d 297 (6th Cir. 1984).
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 28 CFR 0.100(b) and 0.104, I order that DEA
Certificate of Registration, BT2936411, issued to Respondent Kamal
Tiwari, M.D., and DEA Certificate of Registration, BP4917413, issued to
Respondent Pain Management and Surgery Center of Southern Indiana, be,
and they hereby are, revoked. I further order that any pending
applications of Kamal Tiwari, M.D. and Pain Management and Surgery
Center of Southern Indiana, to renew or modify such registrations, be,
and they hereby are, denied. This Order is effective immediately.\7\
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\7\ For the same reason that I ordered that the Respondents'
registration be immediately suspended, I conclude that the public
interest necessitates that this Order be effective immediately. See
21 CFR 1316.67.
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Dated: November 8, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-29708 Filed 11-17-11; 8:45 am]
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NOTICE: This is an unofficial version. An official version of this publication may be obtained
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