82 FR 49665 - Harinder Takyar, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 206 (October 26, 2017)

[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Pages 49665-49668]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-23338]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Harinder Takyar, M.D.; Decision and Order

    On January 24, 2017, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause to Harinder Takyar, M.D. 
(hereinafter, Respondent) of Mesa, Arizona. GX 4. The Show Cause Order 
proposed the revocation of Respondent's Certificate of Registration on 
the grounds that Respondent does ``not have authority to handle 
controlled substances in the State of Arizona,'' the State in which he 
is registered, and that Respondent's ``registration would be 
inconsistent with the public interest.'' GX 4, at 1 (citing 21 U.S.C. 
823(f), 824(a)(3) and (4)).
    As to the Agency's jurisdiction, the Show Cause Order alleged that 
Respondent holds DEA Certificate of Registration No. BT9321150 which 
authorizes him to dispense controlled substances in schedules II 
through V as a practitioner at the registered address of 9341 East 
McKellips Road, Mesa, Arizona 85207. GX 4, at 1. See also GX 1 
(Controlled Substance Registration Certificate) (including ``Reform 
Physicians'') and GX 2, at 1 (Certification of Registration History) 
(9341 E McKellips Road, Mesa, AZ 85207-8520). The Show Cause Order 
alleged that this registration expires on November 30, 2019. GX 4, at 
1. See also GX 2, at 1.
    As the first substantive ground for the proceeding, the Show Cause 
Order alleged that Respondent is ``currently without authority to 
handle controlled substances in Arizona.'' GX 4, at 1. It alleged that, 
on December 21, 2016, Respondent ``entered into an Interim Consent 
Agreement for Practice Restriction with the Arizona Medical Board'' 
which ``prohibited [Respondent] from engaging in the practice of 
medicine in the State of Arizona . . . until he applies to the 
Executive Director and receives permission to do so.'' GX 4, at 1 and 
GX 3, at 5 (Interim Consent Agreement For Practice Restriction), 
respectively. The Show Cause Order alleged that Respondent was ``still 
currently prohibited from practicing medicine in the state in which . . 
. [he is] registered with the DEA . . . [and] therefore, the DEA must 
revoke . . . [his] DEA . . . [registration] based upon . . . [his] lack 
of authority to handle controlled substances in the State of Arizona.'' 
GX 4, at 2 (citing 21 U.S.C. 802(21), 823(f), and 824(a)(3)).
    As the second substantive ground for the proceeding, the Show Cause 
Order alleged that the Arizona Attorney General's Office and the Pinal 
County (Arizona) Task Force ``initiated an investigation of . . . 
[Respondent's] medical practice after receiving information from a 
cooperating source that . . . [he] routinely prescribed large 
quantities of oxycodone, a Schedule II controlled substance, without 
performing an examination.'' GX 4, at 2. After summarizing two law 
enforcement officers' undercover visits to Respondent's medical 
practice, the Show Cause Order alleged that, concerning the first 
undercover officer, Respondent prescribed schedule II and IV controlled 
substances ``after conducting only a cursory medical examination[, or 
no physical examination but falsely documenting a full physical exam] . 
. . without inquiring about whether the agent experienced 
sleeplessness, anxiety, or panic[, and without] . . . properly 
execut[ing] . . . a prescription . . . as required by 21 CFR 1306.05(a) 
by not listing the full address of the patient on the face of the 
prescription . . . [or] maintain[ing] an adequate patient chart.'' GX 
4, at 2-3.
    Concerning the second undercover officer, the Show Cause Order 
alleged that Respondent prescribed a schedule II controlled substance 
the first time ``despite the agent informing . . . [Respondent] that he 
felt no pain during . . . [Respondent's] brief examination of him . . . 
[, and a second time without] conduct[ing] a physical exam . . . and 
falsely documenting a full physical

[[Page 49666]]

exam.'' GX 4, at 4. The Show Cause Order concluded that Respondent 
``unlawfully prescribed controlled substances to undercover law 
enforcement officers for other than a legitimate medical purpose and 
outside the usual course of professional practice'' in violation of 
Federal and State law, and violated Arizona medical practice standards 
when he ``failed to maintain appropriate patient records that supported 
the prescribing of controlled substances and . . . failed to conduct an 
appropriate physical examination, or establish a . . . doctor-patient 
relationship before prescribing a controlled substance.'' GX 4, at 2 
(citing 21 CFR 1306.04(a), Ariz. Rev. Stat. Sec.  32-1401.27(e), (j), 
(q), and (SS), and Ariz. Rev. Stat. Sec.  32-901(15)).
    The Show Cause Order notified Respondent of his right to request a 
hearing on the allegations or to submit a written statement while 
waiving his right to a hearing, the procedures for electing each 
option, and the consequences for failing to elect either option. GX 4, 
at 5 (citing 21 CFR 1301.43). The Show Cause Order also notified 
Respondent of the opportunity to submit a Corrective Action Plan. GX 4, 
at 5 (citing 21 U.S.C. 824(c)(2)(C)).
    By letter dated February 22, 2017, Respondent, by his counsel, 
asked the Administrative Law Judge for ``an extension of 30 days within 
which to file a written request for hearing concerning the Order to 
Show Cause.'' GX 5. The letter alleged that ``good cause'' supported 
the request because Respondent's counsel ``has only recently been 
retained,'' the ``discovery concerning the listed allegations is 
voluminous,'' and counsel ``needed [time] to gather necessary 
information concerning the allegations . . . and more effectively 
complete the request for hearing letter.'' Id. By Order dated March 1, 
2017, the Chief Administrative Law Judge, John J. Mulrooney, II, 
granted an ``enlargement of the time allotted to request a hearing . . 
. to the extent (but only to the extent) that, if the Respondent elects 
to request a hearing, he must do so no later than March 17, 2017.'' GX 
6, at 2 (Order Granting in Part the Respondent's Request for an 
Extension of the Time to File a Request for Hearing).
    By Motion dated March 27, 2017, the Government requested that 
further proceedings be terminated because ``[a]s of the date of this 
filing, Respondent has not notified this tribunal or Government counsel 
of any request for hearing.'' GX 7, at 2 (Government's Motion for 
Termination of Proceedings). By Order dated April 3, 2017, the 
Presiding Judge issued an Order Terminating Proceedings, finding that 
``no request for a hearing was filed.'' GX 8 (Order Terminating 
Proceedings).
    I find that the Government's service of the Show Cause Order on 
Respondent was legally sufficient, that the Respondent did not timely 
request a hearing, and that Respondent has waived his right to a 
hearing and his right to submit a written statement. 21 CFR 1301.43(d). 
I therefore issue this Decision and Order based on the record submitted 
by the Government. 21 CFR 1301.43(e).

Findings of Fact

Respondent's DEA Registration

    Respondent currently holds DEA practitioner registration BT9321150 
authorizing him to dispense controlled substances in schedules II 
through V at the address of Reform Physicians, 9341 E McKellips Road, 
Mesa, AZ 85207-8520. GX 1. This registration expires on November 30, 
2019. Id.

The Investigations of Respondent and the Status of Respondent's State 
Licenses

    On December 21, 2016, Respondent and the Executive Director of the 
Arizona Medical Board (hereinafter, ``Board'') signed an ``Interim 
Consent Agreement for Practice Restriction.'' GX 3. Pursuant to the 
Interim Consent Agreement for Practice Restriction, Respondent elected 
to relinquish all rights to a hearing and to appeal, and agreed not to 
dispute, but did not concede, its allegations. GX 3, at 6, 4, 
respectively. It contained the allegations that Respondent ``deviated 
from the standard of care'' for one patient by ``failing to 
substantiate and justify a reason for prescribing opioids to . . . 
her[,] to acknowledge and deal with aberrant behavior manifested by 
frequent Emergency Room . . . visits usually for overdoses and 
documentation [sic] cocaine use[,] . . . to utilize urine drug 
screens[,] . . . to access [the patient's] Controlled Substance 
Prescription Monitoring Program (``CSPMP'') profile to monitor [the 
patient's] prescription medication use[, and] . . . by performing 
trigger point injections without identifying physical trigger points on 
examination, usually with a concomitant IM injection of Toradol.'' GX 
3, at 2. The Interim Consent Agreement for Practice Restriction 
contained the allegation that this patient ``experienced actual harm as 
Respondent caused or contributed to her abuse and apparent addiction of 
controlled substances.'' Id.
    The Interim Consent Agreement for Practice Restriction also 
contained allegations that Respondent deviated from the standard of 
care for another patient ``by failing to substantiate and justify a 
reason for prescribing opioids to . . . [her], failing to monitor his 
opioid prescribing, failing to access the CSPMP, and failing to utilize 
urine drug screens.'' GX 3, at 3. Those allegations included that 
Respondent ``failed to identify aberrant behavior including frequent ER 
visits, and claims of lost or stolen medications and requests for early 
refills.'' Id. According to the allegations, Respondent's patient 
``experienced actual harm in that Respondent either created an 
addictive state or contributed to a pre-existing addictive state.'' Id.
    The Interim Consent Agreement for Practice Restriction contained 
allegations concerning a third patient of Respondent's. Those 
allegations included that ``Respondent deviated from the standard of 
care for . . . [the patient] by failing to identify a source of pain 
for . . . [him], and failing to demonstrate that the prescribing of 
opioids met the goals of reduction of pain and improvement of 
function.'' Id. Additional allegations concerning the third patient 
were that ``Respondent failed to monitor his opioid prescribing, failed 
to access the CSPMP and failed to utilize urine drug screens until 
April of 2016.'' Id. According to the allegations, Respondent's patient 
``experienced actual harm in that Respondent ignored abnormal urine 
drug screens and aberrant behavior,'' and faced the ``potential for 
harm'' due to ``inappropriate medication prescribing, including side 
effects such as sedation, gastrointestinal dysfunction, cognitive 
impairment, respiratory depression, insomnia and addiction.'' GX 3, at 
3-4.
    The Interim Consent Agreement for Practice Restriction explicitly 
stated that Respondent agreed not to dispute its allegations ``[f]or 
the purposes of entering this Interim Consent Agreement and for these 
purposes only.'' GX 3, at 4. It also stated that Respondent did ``not 
concede these allegations and this Interim Consent Agreement is not 
intended for use in any subsequent proceeding, either civil or 
criminal, as evidence of any kind.'' Id.
    The Interim Consent Agreement for Practice Restriction's Interim 
Order prohibited Respondent from engaging in the practice of medicine 
in the State of Arizona ``until he applies to the Executive Director 
and receives permission to do so.'' GX 3, at 5 (citing A.R.S. Sec.  32-
1401(22)). The Interim Order stated that Respondent may request release 
and/or modification of the Interim Consent Agreement for

[[Page 49667]]

Practice Restriction in writing accompanied by ``information 
demonstrating that he is safe to practice medicine, including having 
successfully completed a competency evaluation at a facility approved 
by the Board or its staff.'' GX 3, at 5. Among other things, the 
Interim Order also stated that it is not a ``final decision by the 
Board,'' is ``subject to further consideration,'' and ``[o]nce the 
investigation is complete, it will be promptly provided to the Board 
for its review and appropriate action.'' Id. The Interim Consent 
Agreement for Practice Restriction was ``effective on the date signed 
by the Board's Executive Director,'' December 21, 2016. GX 3, at 5, 8-
9. Respondent entered into the Interim Consent Agreement for Practice 
Restriction voluntarily. GX 3, at 6. He understood that ``any violation 
of this Interim Consent Agreement constitutes unprofessional conduct 
under A.R.S. Sec.  32-1401(27)(r).'' GX 3, at 8.
    On May 9, 2017, the DEA Diversion Investigator assigned to the 
investigation of Respondent's medical practice (hereinafter, DI) signed 
a Declaration. GX 9. According to that Declaration, the DI 
``confirmed'' with the Senior Investigator for the Board that ``the 
current prohibition on . . . [Respondent's] practice of medicine also 
includes a prohibition on his authorization to handle controlled 
substances.'' GX 9, at 2. Further, as of April 24, 2017, the 
Declaration stated that the Board's Senior Investigator informed the DI 
that Respondent ``remains prohibited from practicing medicine in 
Arizona, pending revocation proceedings currently before the Board.'' 
Id.
    As found above, Respondent waived his right to a hearing and to 
submit a written statement while waiving his right to a hearing 
concerning the Show Cause Order. Accordingly, there is no evidence to 
refute the allegations of the Show Cause Order. I, therefore, find that 
Respondent currently is prohibited from engaging in the practice of 
medicine, and currently is without authority to dispense controlled 
substances, in Arizona, the State in which he is registered.

Discussion

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized 
to suspend or revoke a registration issued under section 823 of the 
Controlled Substances Act (hereinafter, CSA), ``upon a finding that the 
registrant . . . has had his State License or registration suspended 
[or] revoked by competent State authority and is no longer authorized 
by State law to engage in the . . . dispensing of controlled 
substances.'' With respect to a practitioner, the DEA has also long 
held that the possession of authority to dispense controlled substances 
under the laws of the State in which a practitioner engages in 
professional practice is a fundamental condition for obtaining and 
maintaining a practitioner's registration. See, e.g., James L. Hooper, 
M.D., 76 FR 71,371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 
(4th Cir. 2012); Bourne Pharmacy, Inc., 72 FR 18,273, 18,274 (2007) 
(``Under the Controlled Substances Act . . . , it is irrelevant that 
Respondent's state registration is being held in escrow pending state 
proceedings. Under the Act, a practitioner must be currently authorized 
to handle controlled substances in `the jurisdiction in which [it] 
practices' in order to maintain its DEA registration.''); Anne Lazar 
Thorn, M.D., 62 FR 12,847, 12, 848 (1997) (The ``controlling question'' 
is ``whether the Respondent is currently authorized to handle 
controlled substances in the state.''); Frederick Marsh Blanton, M.D., 
43 FR 27,616 (1978).
    This rule derives from the text of two provisions of the CSA. 
First, Congress defined the term ``practitioner'' [to] mean[ ] a . . . 
physician . . . 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 . . . .'' 21 U.S.C. 801(21). 
Second, in setting the requirements for obtaining a practitioner's 
registration, Congress directed that ``[t]he Attorney General shall 
register practitioners . . . if the applicant is authorized to dispense 
. . . controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated 
that a practitioner possess State authority in order to be deemed a 
practitioner under the CSA, the DEA has held repeatedly that revocation 
of a practitioner's registration is the appropriate sanction whenever 
he is no longer authorized to dispense controlled substances under the 
laws of the State in which he practices. See, e.g., Hooper, supra, 76 
FR at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131 
(2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby 
Watts, 53 FR 11,919, 11,920 (1988); Thorn, supra, 62 FR at 12,848; 
Blanton, supra, 43 FR at 27,616.
    Under Arizona law, a ``doctor of medicine'' is a ``natural person 
holding a license, registration or permit to practice medicine pursuant 
to this chapter.'' A.R.S. Sec.  32-1401(10) (2017). See also A.R.S. 
Sec.  32-1401(21) (2017) (A ``physician'' is a ``doctor of medicine who 
is licensed pursuant to this chapter.'') The ``practice of medicine'' 
means ``the diagnosis, the treatment or the correction of or the 
attempt or the claim to be able to diagnose, treat or correct any and 
all human diseases . . . by any means, method, devices or 
instrumentalities . . . .'' A.R.S. Sec.  32-1401(22) (2017). 
``Medicine'' means ``allopathic medicine as practiced by the recipient 
of a degree of doctor of medicine.'' A.R.S. Sec.  32-1401(19) (2017). 
``Restrict'' means ``taking a disciplinary action that alters the 
physician's practice or professional activities if the board determines 
that there is evidence that the physician is or may be medically 
incompetent or guilty of unprofessional conduct.'' A.R.S. Sec.  32-
1401(23) (2017). Further, a physician who ``wishes to dispense a 
controlled substance . . . shall be currently licensed to practice 
medicine in Arizona.'' Arizona Medical Board Licensure, R4-16-301 
(2017). ``Dispense,'' under Arizona law, means ``the delivery by a 
doctor of medicine of a prescription drug or device to a patient . . . 
and includes the prescribing, administering, packaging, labeling and 
security necessary to prepare and safeguard the drug or device for 
delivery.'' A.R.S. Sec.  32-1401(9) (2017).
    In this case, the Arizona Medical Board and Respondent entered into 
an ``Interim Consent Agreement for Practice Restriction'' which 
prohibits Respondent from engaging in the practice of medicine in the 
State of Arizona ``until he applies to the Executive Director and 
receives permission to do so.'' GX 3, at 5 (citing A.R.S. Sec.  32-
1401(22)). Further, the unrefuted DI Declaration stated that ``the 
current prohibition on . . . [Respondent's] practice of medicine also 
includes a prohibition on his authorization to handle controlled 
substances.'' GX 9, at 2. Consequently, Respondent is not currently 
authorized to handle controlled substances in the State of Arizona, the 
State in which he is registered and, therefore, he is not entitled to 
maintain his DEA registration. Thorn, supra; Blanton, supra. 
Accordingly, I will order that his registration be revoked and that any 
pending application for the renewal or modification of his registration 
be denied. 21 U.S.C. 824(a)(3).

Order

    Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well 
as 28 CFR 0.100(b), I order that DEA Certificate of Registration 
BT9321150 issued to

[[Page 49668]]

Harinder Takyar, M.D., be, and it hereby is, revoked. I further order 
that any pending application of Harinder Takyar, M.D., to renew or 
modify this registration, as well as any other pending application by 
him for registration in the State of Arizona, be, and it hereby is, 
denied. This order is effective November 27, 2017.

    Dated: October 18, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-23338 Filed 10-25-17; 8:45 am]
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