Daily Rules, Proposed Rules, and Notices of the Federal Government
On March 2, 2011, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause (Order) to Jose Gonzalo Zavaleta, M.D. (Applicant), of Alexandria, Louisiana (La.). The Order proposed the denial of Applicant's pending applications for DEA Certificates of Registration as a practitioner, which he filed on April 19, 2010 (Control Number W10020882C) and on December 9, 2010 (Control Number W10078290C), for the registered location of 1217 Willow Glen
The Show Cause Order incorporated by reference the allegations of a previous Show Cause Order which had been issued on February 23, 2009; a copy of the latter was attached to the second Show Cause Order.
In addition to these allegations, the Second Show Cause Order alleged that on June 24, 2010, Applicant had entered into a consent agreement with the Louisiana State Board of Medical Examiners which had found "that reasonable cause existed for recommending that a formal Administrative Complaint be filed against [him], charging [him] with violation of the Louisiana Medical Practice Act." Show Cause Order at 2. The Second Show Cause Order further alleged that "[t]o avoid the filing of a formal Administrative Complaint, [Applicant] entered into a consent order with the Board * * * in which [he] accepted a public reprimand and various conditions [were] place upon [his] medical license."
On March 7, 2011, the Second Show Cause Order, which also notified Applicant of his right to either request a hearing on the allegations or to submit a written statement in lieu of a hearing, the procedures for doing so, and the consequence if he failed to do either, was served on Applicant by certified mail addressed to him at the address listed on his second and third applications.
On July 27, 2011, I issued a Decision and Final Order denying Respondent's application which he filed on July 28, 2008 and which was the subject of the first Show Cause Order.
Applicant was previously the holder of DEA Certificate of Registration, BZ5998250, which authorized him to dispense controlled substances in schedules II through V as a practitioner at the registered location of 5629 Jackson Street Ext., Alexandria, Louisiana. 76 FR 49506. However, on March 26, 2008, concurrent with Applicant's arrest on state drug charges (the circumstances of which are set forth below), he voluntarily surrendered his registration.
On July 28, 2008, Applicant applied for a new DEA registration as a practitioner in schedules IV and V; this application was denied by my Order of August 10, 2011.
Applicant first came to the attention of law enforcement on January 17, 2008, when Louisiana State Police received a call from a pharmacist that he had authorized prescriptions for "excessive amounts of name brand narcotics with no generic substitutions allowed." 76 FR at 49506. Upon receipt of this information, an undercover state trooper (UC1) visited Applicant's clinic with audio/video recording equipment on January 23, 2008.
Five days later, on January 28, 2008, UC1 returned to Applicant's clinic seeking additional "pain pills."
Thereafter, on January 30, February 8, and February 28, 2008, a second state trooper (UC2) visited Applicant's clinic in an undercover capacity, while equipped with an audio/video recording device.
On March 20, 2008, after a state court judge issued a warrant for Applicant's arrest, Louisiana State Police alerted DEA to the investigation and pending arrest.
Respondent has presented no evidence that he acknowledges his misconduct and accepts responsibility for it.
Section 303(f) of the Controlled Substances Act (CSA) provides that an application for a practitioner's registration may be denied upon a determination "that the issuance of such registration would be inconsistent with the public interest." 21 U.S.C. 823(f). In making the public interest determination in the case of a practitioner, Congress directed that the following factors be considered:
"[T]hese factors are considered in the disjunctive."
In this matter, while I have considered all of the factors, I conclude that it is not necessary to make findings with respect to factors one (the recommendation of the state licensing board), three (applicant's conviction record) and five (such other conduct which may threaten public health and safety). Having previously found that Applicant has committed acts which render his registration "inconsistent with the public interest," 76 FR at 49507 (quoting 21 U.S.C. 823(f), 824(a)(4)), and Applicant having failed to present any evidence to rebut this conclusion, I will order that his pending applications for registration be denied.
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). This regulation further provides that "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 [CSA's] 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."
Under the CSA, it is fundamental that a practitioner must establish and maintain 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 purpose."
Under the regulation of the Louisiana Board of Medical Examiners, in the treatment of "intractable pain * * * a physician shall comply" with the Louisiana Pain Rules, including the requirements that a physician perform an "[e]valuation of the [p]atient" and make a "[m]edical [d]iagnosis." La. Admin. Code tit. 46:XLV.6921(A) (2008). "Evaluation of the patient shall initially include relevant medical, pain, alcohol and substance abuse histories, an assessment of the impact of pain on the patient's physical and psychological functions, a review of previous diagnostics studies, previously utilized therapies, an assessment of coexisting illnesses, diseases, or conditions, and an
Louisiana law also prohibits a physician from "[a]ssist[ing] a patient or any other person in obtaining a controlled dangerous substance through misrepresentation, fraud, forgery, deception, or subterfuge." La. Rev. Stat. Ann. SS 40:971.2 (2008) (effective Aug. 15, 2005). It is also unlawful for a physician to "prescribe * * * legally controlled substances beyond his respective prescribing authority or for a purpose other than accepted medical treatment of disease, condition, or illness.
As found in my Decision and Order of July 27, 2011, on four occasions, Applicant prescribed drugs containing hydrocodone (including Lortab and/or Lorcet), which are schedule III narcotics; Xanax, a schedule IV controlled substance; and Phenergan with codeine, a schedule V narcotic cough syrup; to Louisiana State Troopers acting in undercover capacities.
Moreover, both undercover agents initially denied they were in pain, but Applicant assisted the agents in obtaining controlled substances by encouraging them to make false statements.
I therefore hold again that granting Applicant's applications for a new registration "would be inconsistent with the public interest.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that the applications (Control Numbers W10020882C and W10078290C) of Jose Gonzalo Zavaleta, M.D., for a DEA Certificate of Registration as a practitioner be, and they hereby are, denied. This order is effective November 19, 2012.