Registrant Actions - 2016
[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18278]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Alaaeldin A. Babiker, M.D.; Decision and Order
On January 21, 2015, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Alaaeldin A. Babiker, M.D. (hereinafter, Registrant), of Yuma, Arizona. The Show Cause Order proposed the revocation of Registrant's DEA Certificate of Registration BB7566461, pursuant to which he is authorized to dispense controlled substances in schedules II through V as a practitioner, as well as the denial of any applications, on two grounds. GX 1, at 1.
First, the Show Cause Order alleged that on October 4, 2014, the Arizona Medical Board issued Registrant an "Order for Decree of Censure, Probation, and Practice Restriction and Consent to the Same" which "restricted [him] from prescribing any controlled substances." Id. The Show Cause Order thus alleged that because Registrant does not have authority to dispense controlled substances in Arizona, the State in which he is registered with DEA, his registration is subject to revocation. Id. (citing 21 U.S.C. 802(21), 823(f), 824(a)(3)).
Second, based on various findings of fact and legal conclusions contained in the Board's Order, the Show Cause Order alleged that Registrant had committed acts which render his registration "inconsistent with the public interest" in that he "did not comply with applicable state law related to controlled substances." Id. at 2 (citing 21 U.S.C. 823(f)(4)). More specifically, the Show Cause Order alleged that: (1) "[F]rom 2008 through 2012, [Registrant] issued controlled substance prescriptions to [his] wife"; and that (2) on December 8, 2012, he was "diagnosed with opioid dependence, Xanax abuse and Adderall abuse." Id. Ariz. Rev. Stat. Sec. 32-1401(27)(h) & (g)).
The Show Cause Order then made multiple allegations regarding Registrant's prescribing of narcotics to patient B.S. These included that: (1) During the period he prescribed oxycodone to B.S., he "added morphine to the patient's medications" and also increased B.S.'s oxycodone prescriptions without explaining why he did so in B.S.'s chart; (2) he "did not treat [B.S.'s] chronic pain with additional evaluations or other therapeutic interventions"; and (3) that he "deviated from the standard of care by failing to address" lab results which suggested that B.S. was using marijuana as well as by failing to adequately document B.S.'s marijuana usage. Id. (citing Ariz. Rev. Stat. Sec. 32-1401(27)(e) & (q)).
Finally, the Show Cause Order notified Registrant of his right to request a hearing on the allegations or to submit a written statement of position while waiving his right to a hearing, the procedure for electing either option, and the consequence of failing to elect either option. GX 1, at 2-3 (citing 21 CFR 1301.43; id. Sec. 1301.46). On January 29, 2015, a Special Agent went to an address in Yuma, Arizona which was identified as Registrant's address by a lawyer who had represented him before the Arizona Medical Board. According to the Special Agent, he arrived at the residence at 4:30 p.m. at which time he "encountered no persons at the residence" and there were "[n]o vehicles or indications of any persons at the residence during the time" he was present. GX 7, at 1. The Special Agent reported that he left a copy of the Show Cause Order "in the door jamb of the front door in plain sight." Id. However, at this juncture, the Government undertook no other steps to effect service.
Several months later, the Government submitted a Request for Final Agency Action contending that 30 days had passed since Registrant was served with the Show Cause Order and that neither he, nor anyone representing him, had requested a hearing or sent any correspondence to DEA. Request for Final Agency Action, at 7-8. On review by my Office, service was deemed to be inadequate and the Government was directed to re-serve Registrant with the Show Cause Order.
On October 2, 2015, a Diversion Investigator mailed the Show Cause Order to Registrant at his residence address (as identified by his lawyer) by first class mail. GX 9, at 2 (Supplemental Declaration of DI). Thereafter, "[o]n or about January 20, 2016," the DI mailed the Show Cause Order to Registrant by Certified Mail, Return Receipt Requested addressed to him at the same address as well as at two other reported addresses. Id. However, each of these mailings was returned unclaimed. Id. Subsequently, on April 6, 2016, the DI re-mailed the Show Cause Order to Registrant by regular First Class Mail to each of the three addresses. Id. According to the affidavit of a Legal Assistant with the Office of Chief Counsel, as of July 13, 2016, the Office of Administrative Law Judges had not received either a hearing
request or a written statement of position from him.
Based on the above, I find that the Government has satisfied its obligation under the Due Process Clause "to provide 'notice reasonably calculated, under all the circumstances, to apprise interested parties of the pendency of the action and afford them an opportunity to present their objections.' " Jones v. Flowers, 547 U.S. 220, 226 (2006) (quoting Mullane v. Central Hanover Bank & Trust Co., 339 U.S. 306, 314 (1950)). As more than 30 days have now passed since Registrant was served with the Show Cause Order and neither Registrant nor anyone representing him has either requested a hearing or submitted a written statement of position, I find that Registrant has waived his right to a hearing or to submit a written statement. I therefore issue this Decision and Order based on relevant evidence contained in the Investigative File. I make the following findings.
Findings of Fact
Registrant is the holder of DEA Certificate of Registration BB7566461, pursuant to which he is authorized to dispense controlled substances in schedules II through V, as a practitioner, at the registered address of 2140 W. 24th St., Suite A, Yuma, Arizona. GX 2. Registrant's registration does not expire until July 31, 2016. Id.
Registrant also previously held a medical license issued by the Arizona Medical Board. GX 3, at 1. While as of the date on which the Show Cause Order was issued, Registrant still had a license, albeit one which was restricted to prohibit him from prescribing controlled substances, on March 17, 2016, Registrant entered into an Order For Surrender Of License And Consent To The Same with the Board, which the latter approved on April 7, 2016. GX 9, at 9,11.
Therein, the Board found that pursuant to its October 3, 2014 Order for Decree of Censure, Probation, and Practice Restriction and Consent to the Same, Registrant was required to participate in the Board's Physician Health Program (PHP).\1\ Id. at 5. Pursuant to the Order, Registrant was required to "submit to random biological fluid, hair, or nail testing to ensure compliance with the PHP" and call in to a hotline "on a daily basis to determine if he [wa]s required to submit to a drug test." Id. Registrant did not, however, call in "[f]rom February 3 through February 8, 2015," and "completely ceased checking in with the hotline on February 12, 2015." Id. Based on his noncompliance with the PHP and the Board's Order, on February 26, 2015, Registrant entered into an Interim Consent Agreement for Practice Restriction with the Board which barred him from practicing medicine in the State. Id. at 5-6.
\1\ The October 2014 Order found that in December 2013, Registrant underwent a clinical evaluation and was diagnosed "with opioid dependence, alcohol abuse, Xanax abuse, and Adderall abuse." GX 3, at 2-3. After Registrant completed inpatient and outpatient treatment, the Board determined that he could resume practicing, subject to probationary terms and restrictions, if he was "enrolled in the PHP for a five year term." Id. at 3.
In the October 3, 2014 Order, the Board also made various findings regarding Registrant's prescribing of controlled substances to both his wife and patient B.S. GX 3, at 1-2, 4-5. As to the former, the Board found that Registrant "had prescribed controlled substances to his wife on multiple occasions beginning in 2008" and that in an August 2013 "interview with Board staff, [he] said that he had only prescribed controlled substances to [her] a few times starting in 2012." Id. at 1. The Board also found that Registrant only "began to maintain medical records for his wife in 20011" and "did not maintain complete records for" her. Id. at 2.
As to his patient B.S., the Board found that Registrant first treated B.S. in April 2012, when the latter "requested prescriptions so he could continue with the same dosing of Alprazolam 1mg (TID), oxycodone 30mg 6/day, and oxycodone 15mg 6/day" and that Registrant kept B.S. on this regimen until September 2012, when he added morphine sulfate 30mg 2/day. Id. at 4. The Board found, however, that Registrant did not document an explanation in B.S.'s chart for adding the morphine. Id.
The Board further found that in May 2013, Registrant prescribed "an additional 60 pills of oxycodone 30mg and an additional 60 pills of OxyContin 80mg for the month." Id. at 4-5. While the Board found that "this was the only month in which the increase occurred, there [was] no explanation in the patient's chart to explain the change." Id.
The Board also found that Registrant conducted drug testing on B.S. several times during the course of treatment. While the Board found that B.S. properly tested positive for the medications he was prescribed, "he also tested positive for THC, suggesting marijuana usage." Id. The Board further found that while the positive test for marijuana "was circled on one of the lab reports," it was "not otherwise documented in the chart." Id. (emphasis added).
The Board then found that Registrant deviated from the standard of care in multiple ways. First, he deviated by failing to address B.S.'s positive test for marijuana. Id. Second, he deviated "by managing B.S.'s chronic pain with pain medications without additional evaluations or other therapeutic interventions." Id. Third, he deviated "by dramatically increasing B.S.'s pain medication in May 2013," and that "[a]s a result of the dramatic increase, B.S. could have suffered an accidental overdose." Id. Finally, the Board found that Registrant "failed to maintain adequate, legible medical records." Id. at 6.
Based on these findings, the Board found that Registrant had engaged in multiple forms of unprofessional conduct. These included by: (1) "failing or refusing to maintain adequate records on a patient"; (2) "habitual intemperance in the use of alcohol or habitual substance abuse"; (3) "using controlled substances except if prescribed by another physician for use during a prescribed course of treatment"; (4) "prescribing or dispensing controlled substances to members of the physician's immediate family"; (5) engaging in "[a]ny conduct or practice that is or might be harmful or dangerous to the health of the patient or the public"; and (6) "making a false or misleading statement to the board." Id. at 6 (citing Ariz. Rev. Stat. Sec. 32-1401(27) (e), (f), (g), (h), (q), and (jj)).\2\
\2\ In agreeing to the Order, Registrant waived "any rights to a hearing or judicial review in state or federal court on the matters alleged." GX 3, at 13. He also agreed that "[t]his Order is a public record that will be publicly disseminated as a formal disciplinary action of the Board." Id. at 14. Thus, as between Registrant and the Board, the Order was entitled to preclusive effect even though the issues were not litigated. See Chaney Building Co., v. City of Tuscon, 716 P.2d 28, 30 (Ariz. 1986) (en banc) (even where a judgment is entered by stipulation or consent, it "may be conclusive, with respect to one or more issues, if the parties have entered an agreement manifesting such intention")(citing Restatement (Second) of Judgments Sec. 27 comment e)). The Order nonetheless states that:
[a]ll admissions made by [Registrant] are solely for final disposition of this matter and any subsequent related administrative proceedings or civil litigation involving the Board and [Registrant]. Therefore, said admissions by [Registrant] are not intended or made for any other use, such as in the context of another state or federal government regulatory agency proceeding, civil or criminal court proceeding, in the State of Arizona or any other state or federal court.
GX 3, at 13.
Notwithstanding this language, I give preclusive effect to the findings of the October 2014 Board Order. Notably, most of the findings discussed above do not appear to be based on admissions made by Registrant but on other evidence. See David A. Ruben, 78 FR 38363, 38366-66 n.7 (2013), pet. for review denied, Ruben v. DEA, 617 Fed. Appx. 837, 838-39 (Mem.) (9th Cir. 2015). To the extent any of these findings relied on Registrant's admissions, neither the Arizona Medical Board nor Registrant can dictate to an Agency of the United States what weight it can attach to the Order's findings. Cf. id. at 38365-67.
Loss of State Authority
Pursuant to 21 U.S.C. 824(a)(3), "[a] registration . . . to . . . dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has had his State license or registration suspended, revoked, or denied by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances." This Agency has further held that notwithstanding that this provision grants the Agency authority to suspend or revoke a registration, other provisions of the Controlled Substances Act "make plain that a practitioner can neither obtain nor maintain a DEA registration unless the practitioner currently has authority under state law to handle controlled substances." James L. Hooper, 76 FR 71371, 71372 (2011), pet. for rev. denied, Hooper v. Holder, 481 F. App'x 826 (4th Cir. 2012). See also Frederick Marsh Blanton, M.D., 43 FR 27616, 27617 (1978) ("State authorization to dispense or otherwise handle controlled substances is a prerequisite to the issuance and maintenance of a Federal controlled substances registration.").
These provisions include section 102(21), which defines the term "practitioner" to "mean[ ] a physician . . . 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. 802(21), as well as section 303(f), which directs that "[t]he Attorney General shall register practitioners . . . to dispense . . . controlled substances . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices." Id. Sec. 823(f). As the Supreme Court has explained, "[i]n the case of a physician, this scheme contemplates that he is authorized by the State to practice medicine and to dispense drugs in connection with his professional practice." United States v. Moore, 423 U.S. 122, 140-41 (1975).
Here, the evidence shows that Registrant has been without state authority since the Board's October 3, 2014 Order restricted his prescribing authority and the Board has since ordered Registrant to surrender his medical license. I therefore find that Registrant is without authority to dispense controlled substances in Arizona, the State in which he is registered. Because Registrant no longer meets the CSA's prerequisite for maintaining a practitioner's registration, I will order that his registration be revoked and that any pending application be denied.
Public Interest Grounds
Under the CSA, "[a] registration pursuant to section 823 of this title to manufacture, distribute, or 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. 824(a)(4). The Act further provides that in determining "the public interest" with respect to a practitioner, the following factors are to be considered:
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The [registrant's] experience in dispensing, or conducting research with respect to controlled substances.
(3) The [registrant'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.
21 U.S.C. 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.; see also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to consider each of the factors, I "need not make explicit findings as to each one." MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).\3\
\3\ While I have considered all of the factors, the Government does not argue that any of the other factors are relevant in making the public interest determination in this matter. Be that as it may, "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." Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration. See MacKay, 664 F.3d at 821.
The Government has the burden of proving, by a preponderance of the evidence, that the requirements for revocation or suspension pursuant to 21 U.S.C. 824(a) are met. 21 CFR 1301.44(e). This is so even in a non-contested case.
In this matter, the Government argues that the Board's findings of fact and conclusions of law are entitled to preclusive effect and establish that Registrant "violated applicable controlled substance state laws under" factor four of the public interest standard. Request for Final Agency Action, at 6 (citing 21 U.S.C. 823(f)(4)). I agree that Registrant failed to comply with state laws related to controlled substances as evidenced by the findings that he prescribed controlled substances to his wife, notwithstanding that under Arizona law, "[p]rescribing or dispensing controlled substances to members of the physician's immediate family" is "unprofessional conduct." Ariz. Rev. Stat. Sec. 32-1401(27)(h). Based on the plain language of this provision, I conclude that even though it is found in the State's medical practice act, it is a law "relating to controlled substances." 21 U.S.C. 823(f)(4).
The Board also found that Registrant has been diagnosed as dependent on opioids, and that he has abused both Xanax (alprazolam), a schedule IV benzodiazepine, and Adderall, (amphetamine and dextroamphetamine), a schedule II stimulant. See 21 CFR 1308.14(c)(2); id. 1308.12 (d)(1). Based on these findings, the Board concluded that Registrant has committed "unprofessional conduct" by engaging in "habitual substance abuse" and "using controlled substances except if prescribed by another physician for use during a prescribed course of treatment." Ariz. Rev. Stat. Sec. 32-1301(27)(f) & (g). Here too, while these provisions are located in the State's medical practice act, the plain language of these provisions supports the conclusion that they are laws "relating to controlled substances." 21 U.S.C. 823(f) (4).\4\
\4\ While not cited by the Government, DEA has long held that a practitioner's self-abuse of a controlled substance is actionable under factor five as "[s]uch other conduct which may threaten public health and safety." See Tony T. Bui, 75 FR 49979, 49989 (2010) (citing cases).
The Board also made several findings that Registrant deviated from the standard of care when he prescribed narcotic controlled substances to B.S. and which are highly suggestive of a finding that he acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing to B.S. 21 CFR 1306.04(a). These include that he failed to address B.S.'s positive test for marijuana, that he did not perform additional evaluations or use therapeutic interventions other than prescribing controlled substances, that he dramatically increased B.S.'s pain medications and did not document an explanation for doing so, and that he failed to maintain adequate and legible medical records.
The Board did not, however, find that Registrant engaged in "[p]rescribing, dispensing, or administering any controlled substance . . . for other than accepted therapeutic purposes," Ariz. Rev. Stat. Sec. 32-1401(27)(j), a standard similar to that of 21 CFR 1306.04(a). See GX 3, at 6; see also Kenneth Harold Bull, 78 FR 62666, 62674 (2013) (holding that physician's violation of a State's "injudicious prescribing" standard did not establish a violation of 21 CFR 1306.4(a) when the State also had a standard prohibiting "prescribing . . . or dispensing of narcotic, stimulant or hypnotic drugs for other than accepted therapeutic purposes" but did not find a violation). Instead, the Board found that he committed unprofessional conduct by engaging in "[a]ny conduct or practice that is or might be harmful or dangerous to the health of the patient or the public." GX 3, at 6 (citing Ariz. Rev. Stat. Sec. 32-1401(27)(q)).
In its Request for Final Agency Action, the Government did not allege that the Board's findings with respect to B.S. supported a finding that Registrant violated 21 CFR 1306.04(a). Nor did it argue that the Board's findings establish reckless or negligent conduct in the handling of controlled substances, which is a basis to revoke a registration under Paul J. Caragine, 63 FR 51592, 51601 (1998).
Moreover, the Government offers no argument as to why the Board's standard of "[a]ny conduct or practice that is or might be harmful or dangerous to the health of the patient or the public" is a law related to controlled substances under factor four. I therefore do not consider whether this provision falls within factor four. Nor do I consider the Board's findings with respect to B.S.
The Board's conclusions of law that Registrant committed unprofessional conduct by prescribing controlled substances to his wife, as well as by engaging in habitual substance abuse and using controlled substances which were not prescribed to him by another physician in the course of treatment, support the conclusion that he has committed such acts as to render his registration "inconsistent with the public interest." 21 U.S.C. 824(a)(4). These findings provide an additional and independent basis to revoke Registrant's registration.
Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 823(f), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration BB7566461 issued to Alaaeldin Babiker, M.D., be, and it hereby is, revoked. I further other that any application of Alaaeldin Babiker, M.D., to renew or modify this registration, or for any other registration, be, and it hereby is denied. This Order is effective immediately.\5\
\5\ For the same reasons which led the Board to order Registrant to immediately surrender his state license, I conclude that this Order should be effective immediately. GX 9, at 9; see also 21 CFR 1316.67.
Dated: July 22, 2016.
[FR Doc. 2016-18278 Filed 8-1-16; 8:45 am]
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