Reginald James Newsome, M.D.; Decision and Order, 56708-56709 [2022-19989]

Download as PDF 56708 Federal Register / Vol. 87, No. 178 / Thursday, September 15, 2022 / Notices lotter on DSK11XQN23PROD with NOTICES1 and long distances. RD, at 62–64; supra, at Findings of Fact C. For many of these patients, the prescriptions filled contained multiple unresolved red flags at once. See, e.g., RD 38–40 (Patient D.M. on January 23, 2019, Respondent dispensed two short-acting opioids along with a benzodiazepine, which raised red flags for both therapeutic duplication and cocktail prescribing, and on March 20, 2020, Respondent dispensed hydrocodone six days early along with alprazolam, which raised red flags for both early refills and cocktail prescribing). Accordingly, the Agency agrees with the RD that the Government has established by substantial evidence that Respondent filled numerous prescriptions to seventeen patients outside the usual course of professional practice and without fulfilling its corresponding responsibility in violation of 21 CFR 1306.04(a) and 1306.06. Further, the Government established by substantial evidence that Respondent acted in violation of Texas law as set forth in 22 Texas Admin. Code §§ 291.29 and 291.33 and Texas Health & Safety Code § 481.074(a). See RD, at 64. The Government has made a prima facie case that the Respondent has committed acts that render its registration inconsistent with the public interest, and its misconduct supports the revocation of its registration. RD, at 64. III. Sanction Where, as here, the Government has established grounds to revoke Respondent’s registration, the burden shifts to the respondent to show why it can be entrusted with the responsibility carried by a registration. Garret Howard Smith, M.D., 83 FR 18,882, 18,910 (2018). When a registrant has committed acts inconsistent with the public interest, it must both accept responsibility and demonstrate that it has undertaken corrective measures. Holiday CVS LLC dba CVS Pharmacy Nos 219 and 5195, 77 FR 62,316, 62,339 (2012) (internal quotations omitted). Trust is necessarily a fact-dependent determination based on individual circumstances; therefore, the Agency looks at factors such as the acceptance of responsibility, the credibility of that acceptance as it relates to the probability of repeat violations or behavior, the nature of the misconduct that forms the basis for sanction, and the Agency’s interest in deterring similar acts. See, e.g., Robert Wayne Locklear, M.D., 86 FR 33,738, 33,746 (2021). Here, Respondent has failed to unequivocally accept responsibility. Respondent did admit that it violated its corresponding responsibility with VerDate Sep<11>2014 16:56 Sep 14, 2022 Jkt 256001 respect to retail patients J.C. and C.G., Tr. 1087, 1091, but then proceeded to deny that retail patient J.T.’s prescriptions presented a red flag based on distance in spite of clear Texas law to the contrary. RD, at 66 (internal citations omitted). Respondent also consistently denied that the controlled substance prescriptions for its hospice patients presented any red flags. Tr. 1377–78; ALJ Ex. 30, at 2–5; see also, e.g., Tr. 1093–94, 1097, 1120–21, 1124– 28, 1130, 1132–34, 1140, 1142–46, 1148–50, 1204–23, 1273–76, 1279–80, 1290, 1293; RD, at 66. For example, PIC Thomas denied that Patient D.M.’s prescriptions presented red flags, despite his own expert testifying to the contrary. Compare Tr. 1105–06 (PIC Thomas), with Tr. 725–29, 731–32 (Ms. Head). A registrant’s acceptance of responsibility for misconduct is not adequate when the registrant does not understand what the law requires. See Zion Clinic Pharmacy, 83 FR 10,876, 10,903 (2018).12 Furthermore, Respondent’s misconduct was far from a one-time occurrence. Respondent filled multiple prescriptions for Schedule II controlled substances presenting numerous red flags. See Noah David, P.A., 87 FR 21,165, 21,174 (2022); see also Garrett Howard Smith, M.D., 83 FR 18,882, 18,910 (2018) (collecting cases) (‘‘The egregiousness and extent of the misconduct are significant factors in determining the appropriate sanction.’’) In sanction determinations, the Agency has historically considered its interest in deterring similar acts, both with respect to the respondent in a particular case and the community of registrants. See Joseph Gaudio, M.D., 74 FR 10,083, 10,095 (2009); Singh, 81 FR at 8248. The Agency finds that considerations of both specific and 12 When a registrant fails to make the threshold showing of acceptance of responsibility, the Agency need not address the registrant’s remedial measures. Ahuja, 84 FR at 5498 n.33; Daniel A. Glick, D.D.S., 80 FR 74,800, 74,801, 74,810 (2015); see also Jones Total Health Care Pharmacy, LLC, SND Healthcare, LLC, 881 F.3d 823, 833 (11th Cir. 2018) (upholding DEA’s refusal to consider pharmacy’s remedial measures given lack of acceptance). The Agency agrees with the ALJ that even if the Agency were to consider Respondent’s remedial measures, they would not affect the ultimate decision in this matter. RD, at 67. Here, Respondent has made no showing of remedial measures as to the hospice patients, because it denies any error that requires remediation. Id. As to the retail patients, Respondent’s PIC testified that he does in-house training, including ‘‘ten-minute huddles’’ on a daily basis to emphasize the need for documentation. Tr. 1379–80; RD, at 67. He also testified that the pharmacy has a new software system that allows pharmacists to scan and attach documents to the electronic patient file. Tr. 1074, 1253; RD, at 67. The Agency does not find such measures to be adequate in addressing the nature of the violations found here. See RD, at 67. PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 general deterrence weigh in favor of revocation in this case. A sanction less than revocation would send a message to the current and prospective registrant community that compliance with core controlled-substance legal principles is not a condition precedent to receiving and maintaining a DEA registration. Further, there is simply no evidence that Respondent’s behavior is not likely to recur in the future such that the Agency can entrust it with a CSA registration; in other words, the factors weigh in favor of revocation as a sanction. Accordingly, the Agency shall order the sanctions the Government requested, as contained in the Order below. Order Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration FL1670341 issued to Rayford ACP. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I further hereby deny any pending applications for renewal or modification of this registration, as well as any other pending application of Rayford ACP for registration in Texas. This order is effective October 17, 2022. Signing Authority This document of the Drug Enforcement Administration was signed on September 8, 2022, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register. Heather Achbach, Federal Register Liaison Officer, Drug Enforcement Administration. [FR Doc. 2022–19988 Filed 9–14–22; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Reginald James Newsome, M.D.; Decision and Order On March 16, 2022, the Drug Enforcement Administration (hereinafter, DEA or Government) E:\FR\FM\15SEN1.SGM 15SEN1 Federal Register / Vol. 87, No. 178 / Thursday, September 15, 2022 / Notices issued an Order to Show Cause (hereinafter, OSC) to Reginald James Newsome, M.D. (hereinafter, Registrant). OSC, at 1 and 4. The OSC proposed the revocation of Registrant’s Certificate of Registration No. FN0738344 at the registered address of 8865 Davis Blvd., Suite 100A, Keller, Texas 76248. Id. at 1. The OSC alleged that Registrant’s registration should be revoked because Registrant is ‘‘without authority to handle controlled substances in the State of Texas, the state in which [he is] registered with DEA.’’ Id. at 2 (citing 21 U.S.C. 824(a)(3)). The Agency makes the following findings of fact based on the uncontroverted evidence submitted by the Government in its Request for Final Agency Action (RFAA), submitted July 18, 2022.1 Findings of Fact lotter on DSK11XQN23PROD with NOTICES1 On February 15, 2022, the Texas Medical Board issued an Order of Temporary Suspension suspending Registrant’s license to practice medicine in Texas. RFAAX C (Temporary Suspension Order), at 6. According to Texas’s online records, of which the Agency takes official notice, Registrant’s Texas medical license is still suspended.2 Texas Medical Board Verification, https://profile. tmb.state.tx.us/Search.aspx?d2678354aafa-4f28-a2a0-96b1f74b617a (last visited date of signature of this Order). Accordingly, the Agency finds that Registrant is not currently licensed to engage in the practice of medicine in 1 Based on the Declaration from a DEA Diversion Investigator that the Government submitted with its RFAA, the Agency finds that the Government’s service of the OSC on Registrant was adequate. RFAA, Exhibit (hereinafter, RFAAX) B, at 2–3. Further, based on the Government’s assertions in its RFAA, the Agency finds that more than thirty days have passed since Registrant was served with the OSC and Registrant has neither requested a hearing nor submitted a written statement or corrective action plan and therefore has waived any such rights. RFAA, at 3; see also 21 CFR 1301.43(d) and 21 U.S.C. 824(c)(2)(C). 2 Under the Administrative Procedure Act, an agency ‘‘may take official notice of facts at any stage in a proceeding—even in the final decision.’’ United States Department of Justice, Attorney General’s Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an agency decision rests on official notice of a material fact not appearing in the evidence in the record, a party is entitled, on timely request, to an opportunity to show the contrary.’’ Accordingly, Registrant may dispute the Agency’s finding by filing a properly supported motion for reconsideration of findings of fact within fifteen calendar days of the date of this Order. Any such motion and response shall be filed and served by email to the other party and to Office of the Administrator, Drug Enforcement Administration at dea.addo.attorneys@dea.usdoj.gov. VerDate Sep<11>2014 16:56 Sep 14, 2022 Jkt 256001 Texas, the state in which he is registered with the DEA. 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 71371 (2011), pet. for rev. denied, 481 F. App’x 826 (4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27616 27617 (1978).3 According to Texas statute, ‘‘dispense’’ means ‘‘the delivery of a controlled substance in the course of professional practice or research, by a practitioner or person acting under the lawful order of a practitioner, to an ultimate user or research subject. The term includes the prescribing, administering, packaging, labeling or compounding necessary to prepare the substance for delivery.’’ Tex. Health & Safety Code § 481.002(12) (2022). Further, a ‘‘practitioner’’ means a ‘‘a physician, . . . licensed, registered, or otherwise permitted to distribute, dispense, analyze, conduct research with respect to, or administer a controlled substance in the course of 3 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. 802(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., James L. Hooper, 76 FR at 71371–72; Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, M.D., 58 FR 51104, 51105 (1993); Bobby Watts, M.D., 53 FR 11919, 11920 (1988); Frederick Marsh Blanton, 43 FR at 27617. PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 56709 professional practice or research in this state.’’ Id. at § 481.002(39)(A). Here, the undisputed evidence in the record is that Registrant currently lacks authority to practice medicine in Texas. A person must be a licensed practitioner to dispense a controlled substance in Texas. Thus, because Registrant lacks authority to practice medicine in Texas and, therefore, is not authorized to handle controlled substances in Texas, Registrant is not eligible to maintain a DEA registration. Accordingly, the Agency will order that Registrant’s DEA registration be revoked. Order Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. FN0738344 issued to Reginald James Newsome, M.D. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny any pending applications of Reginald James Newsome, M.D., to renew or modify this registration, as well as any other pending application of Reginald James Newsome, M.D., for additional registration in Texas. This Order is effective October 17, 2022. Signing Authority This document of the Drug Enforcement Administration was signed on September 8, 2022, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register. Heather Achbach, Federal Register Liaison Officer, Drug Enforcement Administration. [FR Doc. 2022–19989 Filed 9–14–22; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 22–9] Bernadette U. Iguh, M.D.; Decision and Order On November 10, 2021, the Drug Enforcement Administration (hereinafter, DEA or Government), E:\FR\FM\15SEN1.SGM 15SEN1

Agencies

[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56708-56709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19989]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Reginald James Newsome, M.D.; Decision and Order

    On March 16, 2022, the Drug Enforcement Administration 
(hereinafter, DEA or Government)

[[Page 56709]]

issued an Order to Show Cause (hereinafter, OSC) to Reginald James 
Newsome, M.D. (hereinafter, Registrant). OSC, at 1 and 4. The OSC 
proposed the revocation of Registrant's Certificate of Registration No. 
FN0738344 at the registered address of 8865 Davis Blvd., Suite 100A, 
Keller, Texas 76248. Id. at 1. The OSC alleged that Registrant's 
registration should be revoked because Registrant is ``without 
authority to handle controlled substances in the State of Texas, the 
state in which [he is] registered with DEA.'' Id. at 2 (citing 21 
U.S.C. 824(a)(3)).
    The Agency makes the following findings of fact based on the 
uncontroverted evidence submitted by the Government in its Request for 
Final Agency Action (RFAA), submitted July 18, 2022.\1\
---------------------------------------------------------------------------

    \1\ Based on the Declaration from a DEA Diversion Investigator 
that the Government submitted with its RFAA, the Agency finds that 
the Government's service of the OSC on Registrant was adequate. 
RFAA, Exhibit (hereinafter, RFAAX) B, at 2-3. Further, based on the 
Government's assertions in its RFAA, the Agency finds that more than 
thirty days have passed since Registrant was served with the OSC and 
Registrant has neither requested a hearing nor submitted a written 
statement or corrective action plan and therefore has waived any 
such rights. RFAA, at 3; see also 21 CFR 1301.43(d) and 21 U.S.C. 
824(c)(2)(C).
---------------------------------------------------------------------------

Findings of Fact

    On February 15, 2022, the Texas Medical Board issued an Order of 
Temporary Suspension suspending Registrant's license to practice 
medicine in Texas. RFAAX C (Temporary Suspension Order), at 6. 
According to Texas's online records, of which the Agency takes official 
notice, Registrant's Texas medical license is still suspended.\2\ Texas 
Medical Board Verification, https://profile.tmb.state.tx.us/Search.aspx?d2678354-aafa-4f28-a2a0-96b1f74b617a (last visited date of 
signature of this Order). Accordingly, the Agency finds that Registrant 
is not currently licensed to engage in the practice of medicine in 
Texas, the state in which he is registered with the DEA.
---------------------------------------------------------------------------

    \2\ Under the Administrative Procedure Act, an agency ``may take 
official notice of facts at any stage in a proceeding--even in the 
final decision.'' United States Department of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), 
``[w]hen an agency decision rests on official notice of a material 
fact not appearing in the evidence in the record, a party is 
entitled, on timely request, to an opportunity to show the 
contrary.'' Accordingly, Registrant may dispute the Agency's finding 
by filing a properly supported motion for reconsideration of 
findings of fact within fifteen calendar days of the date of this 
Order. Any such motion and response shall be filed and served by 
email to the other party and to Office of the Administrator, Drug 
Enforcement Administration at [email protected].
---------------------------------------------------------------------------

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 71371 (2011), pet. for rev. denied, 481 F. App'x 826 (4th 
Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27616 27617 (1978).\3\
---------------------------------------------------------------------------

    \3\ 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. 
802(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., James L. Hooper, 76 FR at 
71371-72; Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); 
Dominick A. Ricci, M.D., 58 FR 51104, 51105 (1993); Bobby Watts, 
M.D., 53 FR 11919, 11920 (1988); Frederick Marsh Blanton, 43 FR at 
27617.
---------------------------------------------------------------------------

    According to Texas statute, ``dispense'' means ``the delivery of a 
controlled substance in the course of professional practice or 
research, by a practitioner or person acting under the lawful order of 
a practitioner, to an ultimate user or research subject. The term 
includes the prescribing, administering, packaging, labeling or 
compounding necessary to prepare the substance for delivery.'' Tex. 
Health & Safety Code Sec.  481.002(12) (2022). Further, a 
``practitioner'' means a ``a physician, . . . licensed, registered, or 
otherwise permitted to distribute, dispense, analyze, conduct research 
with respect to, or administer a controlled substance in the course of 
professional practice or research in this state.'' Id. at Sec.  
481.002(39)(A).
    Here, the undisputed evidence in the record is that Registrant 
currently lacks authority to practice medicine in Texas. A person must 
be a licensed practitioner to dispense a controlled substance in Texas. 
Thus, because Registrant lacks authority to practice medicine in Texas 
and, therefore, is not authorized to handle controlled substances in 
Texas, Registrant is not eligible to maintain a DEA registration. 
Accordingly, the Agency will order that Registrant's DEA registration 
be revoked.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. 
FN0738344 issued to Reginald James Newsome, M.D. Further, pursuant to 
28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I 
hereby deny any pending applications of Reginald James Newsome, M.D., 
to renew or modify this registration, as well as any other pending 
application of Reginald James Newsome, M.D., for additional 
registration in Texas. This Order is effective October 17, 2022.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
September 8, 2022, by Administrator Anne Milgram. That document with 
the original signature and date is maintained by DEA. For 
administrative purposes only, and in compliance with requirements of 
the Office of the Federal Register, the undersigned DEA Federal 
Register Liaison Officer has been authorized to sign and submit the 
document in electronic format for publication, as an official document 
of DEA. This administrative process in no way alters the legal effect 
of this document upon publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-19989 Filed 9-14-22; 8:45 am]
BILLING CODE 4410-09-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.