This PDF is the current document as it appeared on Public Inspection on 02/09/2017 at 08:45 am.
On June 30, 2016, the Assistant Administrator, Division of Diversion Control, issued an Order to Show Cause to John P. Moore, III, M.D. (Respondent), of Centerville, Ohio. The Show Cause Order proposed the revocation of Respondent's DEA Certificate of Registration No. FM1335353. GX 2, at 1.
With respect to the Agency's jurisdiction, the Show Cause Order alleged that Respondent is the holder of Certificate of Registration No. FM1335353, which “is valid for Drug Schedules II-V,” at the address of 950 E. Alex Bell Road, Centerville, Ohio. Id. at 2. The Order further alleged that this registration does not expire until January 31, 2018. Id.
The Show Cause Order further alleged three separate grounds for the proposed action. First, it alleged that on April 5, 2016, Respondent pled guilty in the Ohio courts to four state felony counts of knowingly selling or offering to sell zolpidem and diazepam (both schedule IV controlled substances) and Suboxone (buprenorphine and naloxone, a schedule III controlled substance), as well as a further felony count of knowingly permitting real estate or other premises to be used for drug trafficking. Id. (citing Ohio Rev. Code §§ 2925.03, 2925.13). See also 21 U.S.C. 824(a)(2).
Second, the Show Cause Order alleged that on May 11, 2016, Respondent's Ohio medical license was suspended and that he is currently without authority to dispense controlled substances in the State in which he is registered with the Agency. GX 2, at 2 (citing 21 U.S.C. 802(21), 824(a)(3)). And third, the Show Cause Order alleged that Respondent has also been “convicted of felony Medicaid fraud,” thus rendering him subject to mandatory exclusion from participation in federal health care programs under 42 U.S.C. 1320a-7(a) and subjecting his registration to revocation for this reason as well. GX 2, at 2 (citing 21 U.S.C. 824(a)(5)).
The Show Cause Order also notified Respondent of his right to request a hearing on the allegations of the Order or to submit a written statement of position while waiving his right to a hearing, the procedure for electing either option (including the time period for filing), and the consequence of failing to elect either option as well as the failure to do so in compliance with the Agency's regulations. Id. at 3 (citing 21 CFR 1301.43). Finally, the Show Cause Order informed Respondent of his right to submit a corrective action plan under 21 U.S.C. 824(c)(2)(C). Id.
On or about June 30, 2016, the Government sent the Show Cause Order by certified mail, return receipt requested, addressed to Respondent at his residence in the Correctional Reception Center in Orient, Ohio. GX 5, Appendix A, at 1, 3-4. As evidenced by the signed return receipt card, on July 6, 2016, the Government accomplished service. Id. at 3,Start Printed Page 10399
On August 11, 2016, Respondent filed a request for a hearing with the Office of Administrative Law Judges and the matter was assigned to Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ). GXs 3, 4. In his hearing request, Respondent's counsel acknowledged that his request was out of time. GX 3, at 3. Respondent, however, invoked 21 CFR 1316.47(b), which provides that “[t]he Administrative Law Judge, upon request and showing of good cause, may grant a reasonable extension of the time allowed for a response to an Order to Show Cause.”  Respondent thus argued that “good cause exists for a reasonable extension of time” to respond to the Show Cause Order because he “did not have timely access to his mail while incarcerated.” GX 3, at 3. Respondent's counsel further argued that the request came “less than 7 days beyond the . . . 30-day time frame for a response” and that the Agency was not “materially prejudiced by the” delay. Id.
Upon receipt of Respondent's hearing request, the CALJ issued an order, directing, inter alia, that the Government submit “proof of the date of service” of the Show Cause Order, as well as a response to Respondent's request for an extension or a motion to terminate the proceeding. GX 4, at 1-2. In response, the Government timely submitted a motion to terminate the proceeding and opposing Respondent's request for an extension. GX 5.
Therein, the Government represented that the Show Cause Order had been served on Respondent by both certified mail which was received on July 6, 2016, as well as hand delivery by prison personnel on July 7, 2016. Id. at 1-2. The Government then noted that Respondent “was released from [prison] on approximately July 27, 2016” and that the Ohio Medical Board had conducted a hearing on July 28, 2016, at which he was physically present and was represented by the same counsel that was representing him in the DEA proceeding. Id. at 2. The Government argues that “[e]ven if Respondent did not have timely access to mail for communicating with his counsel regarding the” Show Cause Order, he certainly could have done so on July 28 and thus, he has failed to offer good cause for the untimely submission of his hearing request. Id. While the Government acknowledged that it was not prejudiced by Respondent's untimely hearing request, it argued that Respondent was seeking to gain a “tactical advantage” by drawing out the proceedings in the hope that the Ohio Board would reinstate his license. Id. at 2-3.
Upon receipt of the Government's motion, the CALJ provided Respondent with an opportunity to respond to the Government's motion and Respondent filed a response. GXs 7, 8. Therein, Respondent explained that “[b]ecause of [his] preoccupation with defending the [State Board's] allegations, he did not notify his counsel of the [DEA] matter until [t]he morning of August 8, 2016,” on which date his “counsel immediately filed a request for [h]earing.” GX 8, at 1. After noting the Government's concession that the untimely filing of the request had not caused it prejudice, Respondent “denie[d]” that he sought the extension to obtain “a tactical advantage” and stated that he “is willing and able to defend his interests in this matter without a final determination by the Ohio Medical Board.” Id. Respondent then argued that he had shown “good cause” under 21 CFR 1316.47(b) based on “the importance of the constitutionally protected interest involved in this matter” and because only a “minor 2-day extension” was requested. Id. at 1-2.
Upon review, the CALJ granted the Government's motion to terminate the proceeding. GX 9, at 5. The CALJ noted that the language of 21 CFR 1316.47(b) “is arguably supportive of an interpretation limiting the authority to extend the time to file a hearing request only during the time when the [Administrative Law] Judge has potential jurisdiction over the case, to wit, prior to the expiration of the thirty-day . . . period” from the date of service for requesting a hearing. Id. at 2. However, the CALJ further noted that in contrast to several other agency regulations, including 21 CFR 1316.47(a), which states that “[a]ny person entitled to a hearing and desiring a hearing shall, within the period permitted for filing, file a request for a hearing,” (emphasis added), section 1316.47(b) sets no time limit for requesting “a reasonable extension of the time allowed for response to an Order to Show Cause.” GX 9, at 2-3. The CALJ concluded, however, that regardless of whether he had authority to rule on a request for an extension filed more than 30 days after the date of service of the Show Cause Order, “the Agency has made clear that it is prepared to find a hearing waiver when an untimely hearing request is not supported by good cause for its tardiness.” Id. at 3 (citing 21 CFR 1301.43(d) (“If any person entitled to a hearing . . . fails to file a request for a hearing . . . such person shall be deemed to have waived the opportunity for a hearing . . . unless such person shows good cause for such failure.”); Shannon L. Gallentine, 76 FR 45864, 45864 (2011)).
The CALJ then found that while Respondent initially argued that he “did not have timely access to his mail while incarcerated,” once the Government refuted this argument (by showing that he had been released from custody on July 27, 2016), he then changed his position and maintained that his “pre-occupation” with the Ohio Board's hearing had led him to miss the filing deadline. GX 9, at 4. The CALJ rejected the latter explanation as sufficient to establish “good cause,” explaining that “in a regulatory environment where parallel proceedings . . . are common, even ubiquitous, `preoccupation' borne of participation in those proceedings, standing alone, cannot constitute good cause. . . . [T]he Respondent's only obligation—and the[ ] only task negligently accomplished—was to deliver his [Show Cause Order] to the attorney who was already representing him on related proceedings.” Id. Continuing, the CALJ explained that although it is “undeniably true that counsel promptly attended to the matter once the Respondent supplied the [Order], promptness on the part of his attorney can offer no dispensation here. No excuse has been propounded to Start Printed Page 10400excuse his delay in providing his counsel with the” Order. Id. at 4-5. The CALJ thus concluded that Respondent had not demonstrated “good cause” to excuse his untimely filing and granted the Government's motion to terminate the hearing. Id. at 5.
Thereafter, the Government submitted a Request for Final Agency Action and an evidentiary record to my Office. As an initial matter, I agree with the CALJ that Respondent has failed to demonstrate “good cause” to excuse the untimely filing of his hearing request.
While DEA has interpreted the “good cause” standard for assessing the timeliness of hearing requests as encompassing cases of excusable neglect, mistake or inadvertence, see Keith Ky Ly, 80 FR 29025, 29027 & n.2 (2015) (citing Tony T. Bui, 75 FR 49979, 49980 (2010)), Respondent has failed to make a sufficient showing to warrant relief. While Respondent initially claimed that his untimely filing should be excused because he did not have timely access to his mail, the evidence shows that the Show Cause Order was hand-delivered to him. As for his subsequent claim that his untimeliness should be excused because he was preoccupied with the State Board proceeding, Respondent has failed to explain why he was so pre-occupied with the Board proceeding in the three weeks that passed from the date the Order was hand delivered to him until he was released from prison that he could not have devoted the de minimis amount of time it would have taken to mail the Order to his attorney or to personally prepare and mail his hearing request. Moreover, even assuming that Respondent was preoccupied with the Board hearing during the day(s) on which the hearing took place, he offers no explanation for why he did not provide the Show Cause Order to his attorney for another 10 days after the Board hearing concluded. And as for Respondent's contention that his untimeliness should be excused because of “the importance of the constitutionally protected interest involved in this matter,” this is true of every case brought by the Government against a registrant or applicant. It thus provides no reason to excuse his neglect, even if it the period of his untimeliness would not prejudice the Government.
Accordingly, I conclude that Respondent has failed to established “good cause” to excuse his untimely filing and has therefore waived his right to a hearing. See 21 CFR 1301.43(d). I therefore issue this Decision and Order based on the record submitted by the Government and make the following findings of fact.
Respondent is the holder of DEA Certificate of Registration No. FM1335353, as well DATA-Waiver identification number XM1335353. GX 1. Pursuant to his registration, Respondent is authorized to dispense controlled substances in schedules II through V as a practitioner and pursuant to his DATA-Waiver identification number, he is authorized to dispense or prescribe schedule III-V narcotic controlled substances which “have been approved by the Food and Drug Administration . . . specifically for use in maintenance or detoxification treatment” for up to 100 patients.” 21 CFR 1301.28(a) & (b)(iii); see also GX 1. Respondent's registered address is 950 E. Alex Bell Road, Centerville, Ohio; his registration and the authority provided by his DATA-Waiver number do not expire until January 31, 2018. GX 1.
On April 5, 2016, the Prosecuting Attorney for Greene County, Ohio issued an Information which charged Respondent with multiple felony controlled substance offenses under Ohio law; the Information also charged Respondent with Medicaid Fraud. GX 11, at 2-4 (citing Ohio Rev. Code § 2913.40(B) and (E); id. § 2925.03) With respect to the controlled substance offenses, Respondent was charged with, inter alia: (1) Two counts of trafficking in zolpidem, a schedule IV controlled substance, from “on or about February 12, 2009 to September 30, 2014”; (2) trafficking in suboxone, a schedule III controlled substance, “on or about February 12, 2009”; and (3) trafficking in diazepam, a schedule IV controlled substance, also “on or about February 12, 2009.” Id. at 2-3 (citing Ohio Rev. Code § 2925.03). Finally, Respondent was charged with knowingly permitting real property to “be use for the commission of a felony drug offense, to wit, trafficking . . . by another person.” Id. at 3-4 (citing Ohio Rev. Code § 2925.13).
The same day, Respondent appeared in court and pled guilty to each of these offenses. Id. at 11-12. On May 26, 2016, the state court entered judgment and sentenced Respondent to a term of imprisonment of 10 months on each of the above counts, but provided that the sentence for Medicaid Fraud and permitting real property to be used for the commission of a drug offense were “to be served consecutively to each other, but concurrently to the remaining counts for a total sentence of 20 months.” Id. at 14, 17. The court also ordered that Respondent forfeit $85,000, which included $5,531.08 in restitution to two entities. Id. at 19. Thus, I find that Respondent has been convicted of felony offenses under Ohio law, “relating to any substance defined in [the Controlled Substances Act] as a controlled substance.” 21 U.S.C. 824(a)(2); see also Ohio Rev. Code § 2925.03(A)(1) (“No person shall knowingly . . . [s]ell or offer to sell a controlled substance or a controlled substance analog.”); id. § 2925.03(C)(2)(a) (if drug is in schedules III through V, offense is a fifth degree felony). See also Ohio Rev. Code § 2925.13(B) (“No person who is the owner, lessee, or occupant, or who has custody, control, or supervision, of premises or real estate . . . shall knowingly permit the premises or real estate . . . to be used for the commission of a felony drug offense by another person.”).
Moreover, on May 11, 2016, the State Medical Board of Ohio issued Respondent a Notice of Immediate Suspension and Opportunity for Hearing, pursuant to which his license to practice medicine and surgery in the State was suspended. GX 6, Attachment 1, at 1. The Board's Order was based on Respondent's guilty pleas to the four felony counts of Trafficking in Drugs (Ohio Rev. Code § 2925.03) and the felony count of Permitting Drug Abuse (Ohio Rev. Code § 2925.13). According to the Medical Board's Web site of which I take official notice, on October 19, 2016, the Board ordered the permanent revocation of Respondent's license to practice medicine and surgery based upon his convictions on the four trafficking counts, as well as the single counts of Permitting Drug Abuse and Medicaid Fraud; this Order became effective the next day. See Ohio License Center (John Pease Moore, III), https://license.ohio.gov/lookup/default.asp. (last visited February 1, 2017). I therefore find that Respondent is currently without authority to dispense controlled substances in Ohio.Start Printed Page 10401
In addition, the record includes a July 29, 2016 letter from the Office of Inspector General, Department of Health and Human Services, to Respondent; the letter notified Respondent that he was “being excluded from participation in any capacity in the Medicare, Medicaid, and all Federal health care programs as defined in section 1128B(f) of the Social Security Act . . . for the minimum period of 5 years.” GX 12, at 1. The letter explained that Respondent was being excluded based on his “felony conviction[s]” for “a criminal offense related to the delivery of an item or service under the Medicare or a State health care program,” and for “criminal offense[s] related to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance as defined under Federal or State law.” Id. (citing 42 U.S.C. 1320a-7(a)(1) and (4)).
Under Section 304(a) of the Controlled Substances Act, “[a] registration pursuant to section 823 of [the Act] to . . . dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant—
(2) has been convicted of a felony under this subchapter . . . or any other law of the United States, or of any State, relating to any substance defined in this subchapter as a controlled substance . . . ;
(3) 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 . . . ;
(5) has been excluded . . . from participation in a program pursuant to section 1320a-7(a) of Title 42.
21 U.S.C. 824(a).
The Government has “the burden of proving that the requirements for such revocation or suspension pursuant to section 304(a) . . . (21 U.S.C. 824(a) . . .) are satisfied. 21 CFR 1301.44(e). Thus, even where a registrant waives his right to a hearing, the Government is required to produce substantial evidence to support the proposed action. In this matter, having considered the evidence submitted by the Government, I conclude that there are three separate and independent grounds to revoke Respondent's registration.
First, as found above, on May 26, 2016, the Common Pleas Court of Greene County, Ohio entered a judgment convicting Respondent of four counts of trafficking in drugs (suboxone, zolpidem, and diazepam) under Ohio law, as well as a single count of knowingly permitting real estate he owned or controlled to be used for drug trafficking. See Ohio Rev. Code §§ 2925.03(A); 2925.13(B). Both of these provisions are felony offenses under Ohio law. Thus, I find that Respondent “has been convicted of a felony offense . . . relating to any substance defined in [the CSA] as a controlled substance.” 21 U.S.C. 824(a)(2). This finding provides reason alone to revoke Respondent's registration and his DATA-Waiver identification number.
Second, the evidence shows that based on his guilty pleas in the criminal case, on May 11, 2016, the Ohio Board immediately suspended Respondent's license to practice medicine and surgery in the State, and that on October 20, 2016, the Board revoked his license. By virtue of the Board's actions, Respondent lacks authority to dispense controlled substances under the laws of the State of Ohio, the State in which he is registered with DEA, and thus, he is no longer a practitioner within the meaning of the Act. See 21 U.S.C. 802(21) (defining “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”); see also id. § 823(f) (directing 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”).
As the Agency has long held, “[s]tate authorization to dispense or otherwise handle controlled substances is a prerequisite to the issuance and maintenance of a Federal controlled substances registration.” Frederick Marsh Blanton, 43 FR 27616 (1978). Because the possession of state authority is a prerequisite to the maintenance of a practitioner's registration, the Agency has long held that revocation is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the State in which he practices medicine. See, e.g., James L. Hooper, 76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988); Blanton, 43 FR at 27616. Accordingly, Respondent's registration (and DATA-Waiver number) are subject to revocation for this reason as well. 21 U.S.C. 824(a)(3).
Finally, the evidence shows that Respondent has now been excluded “from participation in any Federal health care program” based on his state conviction for Medicaid fraud, as well as his felony convictions relating to the distribution of controlled substances. See 42 U.S.C. 1320a-7(a)(1) & (4); see also GX 12. Respondent has thus been excluded pursuant to the mandatory exclusion provisions of 42 U.S.C. 1320a-7(a). Accordingly, his registration (and DATA-Waiver number) are also subject to revocation under 21 U.S.C. 824(a)(5).
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 FM1335353 issued to John P. Moore, III, M.D., be, and it hereby is, revoked. I further order that DATA-Waiver identification number XM1335353 issued to John P. Moore, II, M.D., be, and it hereby is, revoked. This Order is effective immediately.Start Signature
Dated: February 2, 2017.
1. While I find that the mailing provided constitutionally adequate service, the Government also produced evidence showing that it had emailed a copy of the Show Cause Order to corrections officers at the Ohio Correctional Reception Center and that Respondent was personally served with a copy of the order on July 7, 2016. GX 5, Appendix A, at 2, 5.Back to Citation
2. While Respondent cited this provision as authority to excuse his untimely filing, it is clear that he submitted a hearing request which is also subject to the good cause standard. See 21 CFR 1301.43(d). The Agency has previously explained on interlocutory review that “where an ALJ receives an untimely hearing request, it is within [the ALJ's] authority to conduct such proceedings as are necessary to determine whether the respondent has established good cause.” Mark S. Cukierman, Denial of Interlocutory Appeal, Slip Op. at 7. This is so even where a respondent does not establish good cause as part of the hearing request. Id. However, as also explained in Cukierman, once the Government submits a request for final agency action to this Office, the forwarding of the record divests the ALJ of authority to rule on whether there is good cause to excuse an untimely request for a hearing and the timeliness of the hearing request is to be reviewed by this Office. In those instances in which a respondent submits a hearing request after the Government has filed its Request for Final Agency Action, the Government should inform the ALJ that the matter has been forwarded to this Office and the ALJ should issue an order forwarding the hearing request to this Office.Back to Citation
3. In this filing, Respondent replied to the Government's Motion to Terminate by challenging the Government's Motion for Summary Disposition. GX 8, at 2-3. I address these arguments later in this Decision.Back to Citation
4. Of course, Respondent's initial contention is also refuted by the evidence that a correction officer hand-delivered the Show Cause Order to him on July 7, 2016, nearly three weeks before he was released from prison.Back to Citation
5. See also Ohio Rev. Code § 2925.13(C)(3) (“Permitting drug abuse is a felony of the fifth degree[.]”).Back to Citation
6. In accordance with 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). To allow Respondent the opportunity to refute the facts of which I take official notice, Respondent may file a motion for reconsideration within 15 calendar days of the date of service of this Order which shall commence on the date this Order is mailed.Back to Citation
7. Thus, even if Respondent were to credibly accept responsibility for his criminal conduct and put forward sufficient evidence of remedial measures, the revocation of his state authority would still require that I revoke his DEA registration and DATA-waiver number. I further reject Respondent's contention that I have discretion in the case of a practitioner to not revoke his registration based on his loss of state authority. See GX 8, at 2-3; see Hooper v. Holder, 481 Fed. Appx. at 827-28; see also Rezik A. Saqer, 81 FR 22122, 22124-27 (2016).Back to Citation
[FR Doc. 2017-02729 Filed 2-9-17; 8:45 am]
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