82 FR 21408 - Judson J. Somerville, M.D.; Decision and Order
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 87 (May 8, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 87 (May 8, 2017)
| Page Range | 21408-21410 | |
| FR Document | 2017-09284 |
[Federal Register Volume 82, Number 87 (Monday, May 8, 2017)] [Notices] [Pages 21408-21410] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-09284] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 17-12] Judson J. Somerville, M.D.; Decision and Order On October 20, 2016, the Assistant Administrator, Division of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Judson J. Somerville, M.D. (Respondent), of Laredo, Texas. The Show Cause Order proposed the revocation of Respondent's Certificates of Registration, on the ground that he ``do[es] not have authority to handle controlled substances in Texas, the [S]tate in which [he is] registered with the'' Agency. Show Cause Order, at 1 (citing 21 U.S.C. 824(a)(3)). With respect to the Agency's jurisdiction, the Show Cause Order alleged that Respondent is registered as a practitioner in schedules II through V, pursuant to Certificate of Registration No. BS3909718, at the address of Saguaro Anesthesia Associates, d/b/a The Pain Clinic, 9114 McPherson Road, Suite 2508, Laredo, Texas.\1\ Id. The Show Cause Order alleged that this registration expires on February 28, 2018. Id. The Order also alleged that Respondent is registered as a practitioner in schedules II though V, pursuant to Certificate of Registration No. FS3571660, at the address of 4646 Corona Drive, Corpus Christi, Texas. Id. at 2. The Show Cause Order alleged that this registration expires on February 28, 2019. Id. --------------------------------------------------------------------------- \1\ In the Show Cause Order, the Government listed the number of this registration as BP3909718. Show Cause Order, at 1. However, on December 2, 2016, the Government notified the CALJ that the correct number was BS3909718. See Gov. Notice of Correction for the Order to Show Cause, at 1. --------------------------------------------------------------------------- As to the substantive ground for the proceeding, the Show Cause Order alleged that on October 6, 2016, the Texas Medical Board entered an Order of Temporary Suspension suspending Respondent's Texas Medical License effective the same day, ``which `shall remain in effect until it is superseded by a subsequent Order of the Board,' '' and that this ``order prohibits [him] from practicing medicine in the State of Texas.'' Id. The Order then alleged that ``[d]ue to the Order and under state law, [Respondent] lack[s] authority to handle controlled substances in Texas, the [S]tate in which [he is] registered'' and this ``constitutes grounds to revoke [his] [r]egistration.'' Id. (citing 21 U.S.C. 802(21) and 824(a)(3)) (other citations omitted).\2\ --------------------------------------------------------------------------- \2\ The Show Cause Order also notified Respondent of his right to request a hearing or to submit a written statement while waiving his right to a hearing, the procedure for electing either option, and the consequence of failing to elect either option. Show Cause Order, at 3 (citing 21 CFR 1301.43). Also, the Show Cause Order notified Respondent of his right to submit a Corrective Action Plan and the procedures for doing so. Id. (citing 21 U.S.C. 824(c)(2)(C)). --------------------------------------------------------------------------- Following service of the Show Cause Order, Respondent requested a hearing on the allegations. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ). On November 22, 2016, the CALJ ordered the Government to submit evidence to support the allegation and any motion for summary disposition no later than December 7, 2016. See Order Directing the Filing of Government Evidence of Lack of State Authority Allegation and Briefing Schedule, at 1. In the order, the ALJ also directed Respondent to file a response to any motion for summary disposition no later than December 21, 2016. Id. On December 2, 2016, the Government filed its Motion for Summary Disposition. Therein, it argued that it is undisputed that based on the Texas Medical Board's October 6, 2016 Order of Temporary Suspension, Respondent is prohibited from practicing medicine in the State of Texas and that his license remains suspended as of the date of its Motion. Gov. Motion, at 5. The Government further argued ``that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engaged in professional practice is a fundamental condition for both obtaining and maintaining a practitioner's registration,'' and that under the Agency's precedents, revocation is warranted even where a State has invoked summary process to suspend a practitioner's state authority and has yet to provide the practitioner with a hearing where he may prevail. Mot. for Summ. Disp., at 3-7 (citations omitted). As support for its motion, the Government attached a copy of the Medical Board's Order of Temporary Suspension and a printout from the Medical Board's Web site showing that his license status was ``SUSPENDED, ACTIVE.'' Id. at GXs C & D. Respondent did not dispute that his medical license has been suspended by the Texas Board. Resp.'s Reply to Gov. Mot. for Summ. Disp., at 1. Instead, he argued that the Board's Order cannot ``serve as a predicate for summary disposition'' because the Order is not a ``permanent action[] of the Board'' and is ``not valid until and unless the matters in the . . . order[] are brought before a panel of the Medical Board for an `Informal Settlement Conference' and if not resolved at the . . . conference, [a] formal adjudication[] . . . which must be initiated as soon as possible.'' Id. at 1-2. Respondent argued that the Medical Board has acted in violation of Texas law by exempting itself from the requirement that it initiate proceedings within 30 days from the date of the issuance of a summary suspension order. Id. at 2- 3. He further argued that subsequent to the issuance of the Board's Order, there has been no settlement conference and the Board did not commence formal administrative proceedings either within the 30 day period or `` `as soon as practicable' as mandated by Texas'' law. Id. at 4. Respondent thus maintains that the Government's Motion is based on the illegal actions of the Board. Id. Respondent requested that the CALJ deny the Government's Motion and ``hold in abeyance any decision on the Government's application until the proper exhaustion of administrative and judicial channels takes place in Texas.'' Id. at 5. The CALJ rejected Respondent's contentions, noting that ``the Controlled Substances Act (CSA) requires that, in order to obtain or maintain a DEA registration, a practitioner must be authorized to handle controlled substances in the State in which he practices.'' R.D. at 3-4 (citing 21 U.S.C. 823(f) and 802(21) (quotations omitted)). While he was ``not unmindful of Respondent's arguments regarding the legality of the Board's actions,'' the CALJ explained that ``it is not within this tribunal's authority to evaluate the lawfulness of the basis of a registrant's lack of state authority, and the validity of other entities' actions is not what is at issue in these proceedings.'' Id. at 4. The CALJ then explained that the ``disposition of the Government's Motion is wholly dependent upon the [[Page 21409]] single issue of whether or not the Respondent currently possesses the requisite authority under state law to handle controlled substances- which he does not.'' Id. The CALJ further denied Respondent's request to hold the proceeding in abeyance pending the exhaustion of his state remedies.\3\ Id. at 4. --------------------------------------------------------------------------- \3\ The CALJ noted that the Agency has previously held ``that a stay in administrative enforcement proceedings is `unlikely to ever be justified' due to ancillary proceedings involving the Respondent.'' R.D. 5 (quoting Grider Drug #1 & Grider Drug #2, 77 FR 44070, 44104 n.97 (2012)). I agree with this statement of the Agency's precedents. However, the CALJ also cited Odette L. Campbell, 80 FR 41062 (2015), as contrary authority. See id. The CALJ characterized Campbell as ``holding revocation proceedings in abeyance at the post-hearing adjudication level for a lengthy period pending the resolution of both criminal fraud charges and concurrent state administrative proceedings against the respondent.'' Id. I respectfully disagree with the CALJ's reading of Campbell. In Campbell, the respondent failed to comply with the Agency's regulation which, because she was subject to an Order to Show Cause, required her to file her renewal application at least 45 days before the expiration of her registration. 80 FR 41063. Of note, the respondent's registration expired one week after the evidentiary hearing, and she did not file a renewal application until three months later, after she received a largely favorable decision from the ALJ. Id. Thus, at the time the proceeding was held in abeyance, the proceeding did not involve a revocation as the respondent no longer held a registration. See 21 CFR 1301.36(i). Most significantly, one week before the evidentiary hearing, the respondent was indicted on 30 counts of Health Care Fraud, as well as five counts of altering records during a federal investigation. 80 FR at 41063. Had the respondent been convicted of Health Care Fraud, she would have been subject to mandatory exclusion from federal healthcare programs under 42 U.S.C. 1320a- 7(a) and her application would have been subject to denial on that basis. Id. at 41064 (citing 21 U.S.C. 824(a)(5)). Moreover, even after the respondent successfully completed pre-trial diversion and the charges were dismissed, the state medical board brought a proceeding against her license, and had the board suspended or revoked her medical license, denial of her application would have been required under the CSA. Id. (citing 21 U.S.C. 802(21) & 823(f)). Given the pending proceedings, Campbell was the rare case where withholding the issuance of a final decision was warranted. --------------------------------------------------------------------------- The CALJ then found that there was no dispute over the material fact that ``Respondent currently lacks state authority to handle controlled substances in Texas due to the Board['s] Order dated October 6, 2016, which temporarily suspended his state license to practice medicine.'' Id. at 6. Reasoning that ``[b]ecause . . . Respondent lacks state authority at the present time . . . he is not entitled to maintain his . . . registrations,'' the CALJ granted the Government's motion and recommended that his registrations be revoked and that any pending applications be denied. Id. Neither party filed exceptions to the CALJ's Recommended Decision. Thereafter, the record was forwarded to my Office for Final Agency Action. Having reviewed the record, I adopt the CALJ's finding that by virtue of the Texas Board's Order, Respondent is currently without authority to handled controlled substances in Texas, the State in which he holds his registrations with the Agency, and is thus, not entitled to maintain his registrations. I further adopt the CALJ's recommendation that I revoke his registrations and deny his pending applications. I make the following factual findings. Findings of Fact Respondent is a physician who holds Texas Medical License No. H- 6622. GX C, at 1. However, on October 6, 2016, the Disciplinary Panel of the Texas Medical Board issued an Order of Temporary Suspension to Respondent based on its finding that ``Respondent's continuation in the practice of medicine would constitute a continuing threat to the public welfare.'' Id. at 5. The Panel further ordered that the suspension be ``effective on the date rendered'' and ``shall remain in effect until it is superseded by a subsequent Order of the Board.'' Id. Respondent offered no evidence in its Opposition to the Government's Motion or at any time thereafter showing that the Board has lifted the suspension. Based on the above, I find that Respondent does not currently have authority under the laws of Texas to dispense controlled substances. Respondent is also the holder of two DEA Certificates of Registration, pursuant to which he was authorized to dispense controlled substances in schedules II through V as a practitioner. Pursuant to Registration No. BS3909718, Respondent was authorized to dispense controlled substances at the address of Saguaro Anesthesia Associates, d/b/a The Pain Management Clinic, 9114 McPherson Road, Suite 2508, Laredo, Texas. GX A. This registration does not expire until February 28, 2018. Id. Pursuant to Registration No. FS3571660, Respondent was authorized to dispense controlled substances at the address of 4646 Corona Drive, Suite 256, Corpus Christi, Texas. GX B. According to the declaration of a Diversion Investigator, this registration does not expire until February 28, 2019. GX F, at 2. 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 (CSA), ``upon a finding that the registrant . . . has had his State license . . . suspended [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.'' Also, DEA has 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, 76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); see also Frederick Marsh Blanton, 43 FR 27616 (1978) (``State authorization to dispense or otherwise handle controlled substances is a prerequisite to the issuance and maintenance of a Federal controlled substances registration.''). 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). Moreover, because ``the controlling question'' in a proceeding brought under 21 U.S.C. 824(a)(3) is whether the holder of a DEA registration ``is currently authorized to handle controlled substances in the [S]tate,'' Hooper, 76 FR at 71371 (quoting Anne Lazar Thorn, 62 FR 12847, 12848 (1997)), the Agency has also long held that revocation is warranted even where a practitioner has lost his state authority by virtue of the State's use of summary process and the State has yet to provide a hearing to challenge the suspension. Bourne Pharmacy, 72 FR 18273, 18274 (2007); Wingfield Drugs, 52 FR 27070, 27071 (1987). Thus, it is of no consequence that the Texas Medical Board has employed summary process in suspending Registrant's state license and that Respondent may prevail at the hearing schedule for late June. Respondent further argues that the Board's order cannot be the basis for revoking his registration because the Board has acted in violation of Texas law when it neither provided Respondent with an informal settlement conference nor commenced formal administrative proceedings within the time frame required by Texas law. DEA, [[Page 21410]] however, ``accepts as valid and lawful the actions of a state regulatory board unless that action is overturned by a state court . . . pursuant to state law.'' Kamal Tiwari, 76 FR 71604, 71607 (2011) (quoting George S. Heath, 51 FR 26610 (1986)). Rather, Respondent's challenge to the lawfulness of the Texas Board's Suspension Order must be raised in the forums provided by the State. Id. (quoting 51 FR at 26610). See also Calvin Ramsey, 76 FR 20034, 20036 (2011) (quoting Hicham K. Riba, 73 FR 75773, 75774 (2008) (``DEA has repeatedly held that a registrant cannot collaterally attack the results of a state criminal or administrative proceeding in a proceeding brought under section 304 [21 U.S.C. 824] of the CSA.'')). Here, there is no dispute over the material fact that Respondent is no longer currently authorized to dispense controlled substances in Texas, the State in which he is registered. Accordingly, he is not entitled to maintain his registrations. I will therefore adopt the CALJ's recommendation that I revoke Respondent's registrations and deny any pending applications to renew his registrations. R.D. 6. Order Pursuant to the authority vested in me by 21 U.S.C. 824(a)(3) and 28 CFR 0.100(b), I order that DEA Certificates of Registration Nos. BS3909718 and FS3571660 be, and they hereby are, revoked. Pursuant to the authority vested in me by 21 U.S.C. 823(f), I order that any applications to renew the above registrations be, and they hereby are, denied. This Order is effective immediately.\4\ --------------------------------------------------------------------------- \4\ For the same reasons which led the Texas Board to order the temporary suspension of Respondent's medical license, I conclude that the public interest necessitates that this Order be effective immediately. 21 CFR 1316.67. Dated: May 1, 2017. Chuck Rosenberg, Acting Administrator. [FR Doc. 2017-09284 Filed 5-5-17; 8:45 am] BILLING CODE 4410-09-P
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(total number of respondents) * .5 (30 Texas Medical Board entered an Order hearing where he may prevail. Mot. for
minutes). of Temporary Suspension suspending Summ. Disp., at 3–7 (citations omitted).
If additional information is required Respondent’s Texas Medical License As support for its motion, the
contact: Melody Braswell, Department effective the same day, ‘‘which ‘shall Government attached a copy of the
Clearance Officer, United States remain in effect until it is superseded by Medical Board’s Order of Temporary
Department of Justice, Justice a subsequent Order of the Board,’ ’’ and Suspension and a printout from the
Management Division, Policy and that this ‘‘order prohibits [him] from Medical Board’s Web site showing that
Planning Staff, Two Constitution practicing medicine in the State of his license status was ‘‘SUSPENDED,
Square, 145 N Street NE., 3E.405A, Texas.’’ Id. The Order then alleged that ACTIVE.’’ Id. at GXs C & D.
Washington, DC 20530. ‘‘[d]ue to the Order and under state law, Respondent did not dispute that his
Dated: May 3, 2017. [Respondent] lack[s] authority to handle medical license has been suspended by
Melody Braswell, controlled substances in Texas, the the Texas Board. Resp.’s Reply to Gov.
[S]tate in which [he is] registered’’ and Mot. for Summ. Disp., at 1. Instead, he
Department Clearance Officer for PRA, U.S.
Department of Justice. this ‘‘constitutes grounds to revoke [his] argued that the Board’s Order cannot
[r]egistration.’’ Id. (citing 21 U.S.C. ‘‘serve as a predicate for summary
[FR Doc. 2017–09213 Filed 5–5–17; 8:45 am]
802(21) and 824(a)(3)) (other citations disposition’’ because the Order is not a
BILLING CODE 4410–FY–P
omitted).2 ‘‘permanent action[] of the Board’’ and
Following service of the Show Cause is ‘‘not valid until and unless the
DEPARTMENT OF JUSTICE Order, Respondent requested a hearing matters in the . . . order[] are brought
on the allegations. The matter was before a panel of the Medical Board for
Drug Enforcement Administration placed on the docket of the Office of an ‘Informal Settlement Conference’ and
Administrative Law Judges and assigned if not resolved at the . . . conference, [a]
[Docket No. 17–12] to Chief Administrative Law Judge John formal adjudication[] . . . which must
J. Mulrooney, II (hereinafter, CALJ). On be initiated as soon as possible.’’ Id. at
Judson J. Somerville, M.D.; Decision
November 22, 2016, the CALJ ordered 1–2. Respondent argued that the
and Order
the Government to submit evidence to Medical Board has acted in violation of
On October 20, 2016, the Assistant support the allegation and any motion Texas law by exempting itself from the
Administrator, Division of Diversion for summary disposition no later than requirement that it initiate proceedings
Control, Drug Enforcement December 7, 2016. See Order Directing within 30 days from the date of the
Administration, issued an Order to the Filing of Government Evidence of issuance of a summary suspension
Show Cause to Judson J. Somerville, Lack of State Authority Allegation and order. Id. at 2–3. He further argued that
M.D. (Respondent), of Laredo, Texas. Briefing Schedule, at 1. In the order, the subsequent to the issuance of the
The Show Cause Order proposed the ALJ also directed Respondent to file a Board’s Order, there has been no
revocation of Respondent’s Certificates response to any motion for summary settlement conference and the Board did
of Registration, on the ground that he disposition no later than December 21, not commence formal administrative
‘‘do[es] not have authority to handle 2016. Id. proceedings either within the 30 day
controlled substances in Texas, the On December 2, 2016, the period or ‘‘ ‘as soon as practicable’ as
[S]tate in which [he is] registered with Government filed its Motion for mandated by Texas’’ law. Id. at 4.
the’’ Agency. Show Cause Order, at 1 Summary Disposition. Therein, it Respondent thus maintains that the
(citing 21 U.S.C. 824(a)(3)). argued that it is undisputed that based Government’s Motion is based on the
With respect to the Agency’s on the Texas Medical Board’s October 6, illegal actions of the Board. Id.
jurisdiction, the Show Cause Order 2016 Order of Temporary Suspension, Respondent requested that the CALJ
alleged that Respondent is registered as Respondent is prohibited from deny the Government’s Motion and
a practitioner in schedules II through V, practicing medicine in the State of ‘‘hold in abeyance any decision on the
pursuant to Certificate of Registration Texas and that his license remains Government’s application until the
No. BS3909718, at the address of suspended as of the date of its Motion. proper exhaustion of administrative and
Saguaro Anesthesia Associates, d/b/a Gov. Motion, at 5. The Government judicial channels takes place in Texas.’’
The Pain Clinic, 9114 McPherson Road, further argued ‘‘that the possession of Id. at 5.
Suite 2508, Laredo, Texas.1 Id. The authority to dispense controlled The CALJ rejected Respondent’s
Show Cause Order alleged that this substances under the laws of the State contentions, noting that ‘‘the Controlled
registration expires on February 28, in which a practitioner engaged in Substances Act (CSA) requires that, in
2018. Id. The Order also alleged that professional practice is a fundamental order to obtain or maintain a DEA
Respondent is registered as a condition for both obtaining and registration, a practitioner must be
practitioner in schedules II though V, maintaining a practitioner’s authorized to handle controlled
pursuant to Certificate of Registration registration,’’ and that under the substances in the State in which he
No. FS3571660, at the address of 4646 Agency’s precedents, revocation is practices.’’ R.D. at 3–4 (citing 21 U.S.C.
Corona Drive, Corpus Christi, Texas. Id. warranted even where a State has 823(f) and 802(21) (quotations omitted)).
at 2. The Show Cause Order alleged that invoked summary process to suspend a While he was ‘‘not unmindful of
this registration expires on February 28, practitioner’s state authority and has yet Respondent’s arguments regarding the
2019. Id. to provide the practitioner with a legality of the Board’s actions,’’ the
As to the substantive ground for the CALJ explained that ‘‘it is not within
asabaliauskas on DSK3SPTVN1PROD with NOTICES
proceeding, the Show Cause Order 2 The Show Cause Order also notified Respondent
this tribunal’s authority to evaluate the
alleged that on October 6, 2016, the of his right to request a hearing or to submit a lawfulness of the basis of a registrant’s
written statement while waiving his right to a
hearing, the procedure for electing either option, lack of state authority, and the validity
1 In the Show Cause Order, the Government listed
and the consequence of failing to elect either of other entities’ actions is not what is
the number of this registration as BP3909718. Show option. Show Cause Order, at 3 (citing 21 CFR at issue in these proceedings.’’ Id. at 4.
Cause Order, at 1. However, on December 2, 2016, 1301.43). Also, the Show Cause Order notified
the Government notified the CALJ that the correct Respondent of his right to submit a Corrective
The CALJ then explained that the
number was BS3909718. See Gov. Notice of Action Plan and the procedures for doing so. Id. ‘‘disposition of the Government’s
Correction for the Order to Show Cause, at 1. (citing 21 U.S.C. 824(c)(2)(C)). Motion is wholly dependent upon the
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single issue of whether or not the my Office for Final Agency Action. no longer authorized by State law to
Respondent currently possesses the Having reviewed the record, I adopt the engage in the . . . dispensing of
requisite authority under state law to CALJ’s finding that by virtue of the controlled substances.’’ Also, DEA has
handle controlled substances–which he Texas Board’s Order, Respondent is long held that the possession of
does not.’’ Id. The CALJ further denied currently without authority to handled authority to dispense controlled
Respondent’s request to hold the controlled substances in Texas, the State substances under the laws of the State
proceeding in abeyance pending the in which he holds his registrations with in which a practitioner engages in
exhaustion of his state remedies.3 Id. at the Agency, and is thus, not entitled to professional practice is a fundamental
4. maintain his registrations. I further condition for obtaining and maintaining
The CALJ then found that there was adopt the CALJ’s recommendation that a practitioner’s registration. See, e.g.,
no dispute over the material fact that I revoke his registrations and deny his James L. Hooper, 76 FR 71371 (2011),
‘‘Respondent currently lacks state pending applications. I make the pet. for rev. denied, 481 Fed. Appx. 826
authority to handle controlled following factual findings. (4th Cir. 2012); see also Frederick Marsh
substances in Texas due to the Board[’s] Blanton, 43 FR 27616 (1978) (‘‘State
Findings of Fact
Order dated October 6, 2016, which authorization to dispense or otherwise
temporarily suspended his state license Respondent is a physician who holds handle controlled substances is a
to practice medicine.’’ Id. at 6. Texas Medical License No. H–6622. GX prerequisite to the issuance and
Reasoning that ‘‘[b]ecause . . . C, at 1. However, on October 6, 2016, maintenance of a Federal controlled
Respondent lacks state authority at the the Disciplinary Panel of the Texas substances registration.’’).
present time . . . he is not entitled to Medical Board issued an Order of This rule derives from the text of two
maintain his . . . registrations,’’ the Temporary Suspension to Respondent provisions of the CSA. First, Congress
CALJ granted the Government’s motion based on its finding that ‘‘Respondent’s defined ‘‘the term ‘practitioner’ [to]
and recommended that his registrations continuation in the practice of medicine mean[] a . . . physician . . . or other
be revoked and that any pending would constitute a continuing threat to person licensed, registered or otherwise
applications be denied. Id. the public welfare.’’ Id. at 5. The Panel permitted, by . . . the jurisdiction in
Neither party filed exceptions to the further ordered that the suspension be which he practices . . . to distribute,
CALJ’s Recommended Decision. ‘‘effective on the date rendered’’ and dispense, [or] administer . . . a
Thereafter, the record was forwarded to ‘‘shall remain in effect until it is controlled substance in the course of
superseded by a subsequent Order of the professional practice.’’ 21 U.S.C.
3 The CALJ noted that the Agency has previously Board.’’ Id. Respondent offered no 802(21). Second, in setting the
held ‘‘that a stay in administrative enforcement evidence in its Opposition to the requirements for obtaining a
proceedings is ‘unlikely to ever be justified’ due to Government’s Motion or at any time practitioner’s registration, Congress
ancillary proceedings involving the Respondent.’’
R.D. 5 (quoting Grider Drug #1 & Grider Drug #2,
thereafter showing that the Board has directed that ‘‘[t]he Attorney General
77 FR 44070, 44104 n.97 (2012)). I agree with this lifted the suspension. Based on the shall register practitioners . . . if the
statement of the Agency’s precedents. However, the above, I find that Respondent does not applicant is authorized to dispense . . .
CALJ also cited Odette L. Campbell, 80 FR 41062 currently have authority under the laws controlled substances under the laws of
(2015), as contrary authority. See id. The CALJ
characterized Campbell as ‘‘holding revocation
of Texas to dispense controlled the State in which he practices.’’ 21
proceedings in abeyance at the post-hearing substances. U.S.C. 823(f).
adjudication level for a lengthy period pending the Respondent is also the holder of two Moreover, because ‘‘the controlling
resolution of both criminal fraud charges and DEA Certificates of Registration, question’’ in a proceeding brought
concurrent state administrative proceedings against pursuant to which he was authorized to
the respondent.’’ Id. I respectfully disagree with the
under 21 U.S.C. 824(a)(3) is whether the
CALJ’s reading of Campbell. In Campbell, the dispense controlled substances in holder of a DEA registration ‘‘is
respondent failed to comply with the Agency’s schedules II through V as a practitioner. currently authorized to handle
regulation which, because she was subject to an Pursuant to Registration No. BS3909718, controlled substances in the [S]tate,’’
Order to Show Cause, required her to file her Respondent was authorized to dispense Hooper, 76 FR at 71371 (quoting Anne
renewal application at least 45 days before the
expiration of her registration. 80 FR 41063. Of note, controlled substances at the address of Lazar Thorn, 62 FR 12847, 12848
the respondent’s registration expired one week after Saguaro Anesthesia Associates, d/b/a (1997)), the Agency has also long held
the evidentiary hearing, and she did not file a The Pain Management Clinic, 9114 that revocation is warranted even where
renewal application until three months later, after McPherson Road, Suite 2508, Laredo, a practitioner has lost his state authority
she received a largely favorable decision from the
ALJ. Id. Thus, at the time the proceeding was held Texas. GX A. This registration does not by virtue of the State’s use of summary
in abeyance, the proceeding did not involve a expire until February 28, 2018. Id. process and the State has yet to provide
revocation as the respondent no longer held a Pursuant to Registration No. FS3571660, a hearing to challenge the suspension.
registration. See 21 CFR 1301.36(i). Respondent was authorized to dispense Bourne Pharmacy, 72 FR 18273, 18274
Most significantly, one week before the (2007); Wingfield Drugs, 52 FR 27070,
evidentiary hearing, the respondent was indicted on
controlled substances at the address of
30 counts of Health Care Fraud, as well as five 4646 Corona Drive, Suite 256, Corpus 27071 (1987). Thus, it is of no
counts of altering records during a federal Christi, Texas. GX B. According to the consequence that the Texas Medical
investigation. 80 FR at 41063. Had the respondent declaration of a Diversion Investigator, Board has employed summary process
been convicted of Health Care Fraud, she would in suspending Registrant’s state license
have been subject to mandatory exclusion from
this registration does not expire until
federal healthcare programs under 42 U.S.C. 1320a- February 28, 2019. GX F, at 2. and that Respondent may prevail at the
7(a) and her application would have been subject hearing schedule for late June.
Discussion Respondent further argues that the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
to denial on that basis. Id. at 41064 (citing 21 U.S.C.
824(a)(5)). Moreover, even after the respondent Pursuant to 21 U.S.C. 824(a)(3), the Board’s order cannot be the basis for
successfully completed pre-trial diversion and the
charges were dismissed, the state medical board
Attorney General is authorized to revoking his registration because the
brought a proceeding against her license, and had suspend or revoke a registration issued Board has acted in violation of Texas
the board suspended or revoked her medical under section 823 of the Controlled law when it neither provided
license, denial of her application would have been Substances Act (CSA), ‘‘upon a finding Respondent with an informal settlement
required under the CSA. Id. (citing 21 U.S.C.
802(21) & 823(f)). Given the pending proceedings,
that the registrant . . . has had his State conference nor commenced formal
Campbell was the rare case where withholding the license . . . suspended [or] revoked administrative proceedings within the
issuance of a final decision was warranted. . . . by competent State authority and is time frame required by Texas law. DEA,
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![21410 Federal Register / Vol. 82, No. 87 / Monday, May 8, 2017 / Notices
however, ‘‘accepts as valid and lawful Houston, Texas and Dover, Florida. ALJ required to submit to the DEA Houston
the actions of a state regulatory board Ex. 1. The Show Cause Order proposed Division Office ‘‘on a quarterly basis,
unless that action is overturned by a the revocation of Respondent’s the total number of controlled
state court . . . pursuant to state law.’’ Certificates of Registration Nos. substances dispensed, to include the
Kamal Tiwari, 76 FR 71604, 71607 FZ2249743 and FZ2418401, the denial date dispensed, full name of patient,
(2011) (quoting George S. Heath, 51 FR of any pending applications to renew or address of patient, name of controlled
26610 (1986)). Rather, Respondent’s modify these registrations, and the substance dispensed, quantity
challenge to the lawfulness of the Texas denial of any applications for new dispensed and [the] dispenser’s
Board’s Suspension Order must be registrations, on the ground that his initials.’’ Id.
raised in the forums provided by the ‘‘continued registration is inconsistent The Show Cause Order alleged that
State. Id. (quoting 51 FR at 26610). See with the public interest.’’ Id. at 1 (citing ‘‘[b]etween August 28 and September
also Calvin Ramsey, 76 FR 20034, 20036 21 U.S.C. 824(a)(4) and 823(f)). 13[,] 2013,’’ DEA conducted inspections
(2011) (quoting Hicham K. Riba, 73 FR With respect to the Agency’s of each of the clinics and ‘‘determined
75773, 75774 (2008) (‘‘DEA has jurisdiction, the Show Cause Order that [Respondent] repeatedly violated
repeatedly held that a registrant cannot alleged that Respondent is the holder of the terms of paragraphs 8 and 9 of the
collaterally attack the results of a state Registration No. FZ2249743, pursuant to MOA.’’ Id. The Show Cause Order then
criminal or administrative proceeding in which he is authorized to dispense alleged that ‘‘controlled substances were
a proceeding brought under section 304 schedule II through V controlled dispensed and/or administered at four
[21 U.S.C. 824] of the CSA.’’)). substances as a practitioner, at the of the [clinics] during periods when the
Here, there is no dispute over the registered address of 12121 Jones Road, individual doing the dispensing and/or
material fact that Respondent is no Houston, Texas; the Order alleged that administering was not registered . . . at
longer currently authorized to dispense this registration was due to expire on the’’ clinic. Id. at 2.
controlled substances in Texas, the State May 31, 2016. Id. The Show Cause The Show Cause Order also alleged
in which he is registered. Accordingly, Order also alleged that Respondent is that Respondent failed to make and
he is not entitled to maintain his the holder of Registration No. maintain complete and accurate
registrations. I will therefore adopt the FZ22418401, pursuant to which he is controlled substance inventories at six
CALJ’s recommendation that I revoke authorized to dispense schedule II of the clinics; that he failed to make and
Respondent’s registrations and deny any through V controlled substances as a maintain complete and accurate
pending applications to renew his practitioner, at the registered address of dispensing records at five of the clinics;
registrations. R.D. 6. 14222 Melouga Preserve Trail, Dover, and that he failed to make and maintain
Florida; the Order alleged that this complete and accurate receipt records at
Order registration is due to expire on May 31, several of the clinics. Id. at 3 (citing 21
Pursuant to the authority vested in me 2017. Id. CFR 1304.11(e)(3); id. § 1304(c); 1 id.
by 21 U.S.C. 824(a)(3) and 28 CFR As grounds for the proposed actions, § 1304.22(c); and id. § 1304.22(a)(2)).
0.100(b), I order that DEA Certificates of the Show Cause Order alleged that on The Show Cause Order further alleged
Registration Nos. BS3909718 and September 20, 2010, Respondent that Respondent failed to timely submit
FS3571660 be, and they hereby are, ‘‘signed a Memorandum of Agreement’’ 10 of the required quarterly dispensing
revoked. Pursuant to the authority (MOA) which ‘‘imposed requirements reports, that 10 of the reports that were
vested in me by 21 U.S.C. 823(f), I order . . . regarding [the] operation, submitted ‘‘on July 20, 2013, were back-
that any applications to renew the above management and supervision of seven dated and hence, failed to indicate the
registrations be, and they hereby are, different clinics’’ he ‘‘own[s] and/or
true date they were prepared,’’ and that
denied. This Order is effective manage[s] and control[s]’’ which are
‘‘[a]ll of these reports’’ falsely
immediately.4 located in various Texas cities. Id. at 1–
represented that ‘‘neither [Respondent]
2. The Show Cause Order alleged that
Dated: May 1, 2017. nor any of the . . . clinics . . . have
‘‘pursuant to paragraph 8 of the MOA,
Chuck Rosenberg, dispensed any controlled substances to
[Respondent] agreed that ‘[i]f controlled
their patients for their medical needs.’’
Acting Administrator. substances in Schedules II through V are
Id.
[FR Doc. 2017–09284 Filed 5–5–17; 8:45 am] purchased for any clinic, to be
Finally, the Show Cause Order alleged
BILLING CODE 4410–09–P administered and/or dispensed to the
that Respondent ‘‘violated 21 CFR
clinic patient, [he] shall cause to be
1306.04(b) by issuing prescriptions ‘in
made and maintained all DEA required
order for an individual practitioner to
DEPARTMENT OF JUSTICE documents and information including
obtain controlled substances for
records, reports, and inventories’ ’’ and
Drug Enforcement Administration supplying the individual practitioner for
that ‘‘[a]ll required documentation shall
be maintained as required by federal the purpose of general dispensing to
[Docket No. 15–24] patients.’ ’’ Id. The Order then identified
and Texas laws and regulations.’’ Id. at
2. The Show Cause Order then alleged two instances in which Respondent
Roberto Zayas, M.D., Decision and allegedly issued prescriptions for
Order that pursuant to another part of
paragraph 8, Respondent ‘‘agreed . . . testosterone products which listed him
On May 18, 2015, the Deputy that ‘[i]f any controlled substance is (and in one instance, a clinic) as the
Assistant Administrator, of the then- administered or dispensed at any clinic patient. Id.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Office of Diversion Control, issued an including the [seven clinics he owns or Following service of the Show Cause
Order to Show Cause to Roberto Zayas, controls], the health care provider doing Order, Respondent requested a hearing
M.D. (hereinafter, Respondent), of the administering and/or dispensing to on the allegations. The matter was
the patient shall be registered at the placed on the docket of the Office of
4 For the same reasons which led the Texas Board
clinic as required by 21 U.S.C. 822(a)(2)
to order the temporary suspension of Respondent’s 1 While there is no such provision, this appears
medical license, I conclude that the public interest
and 21 CFR 1301.12.’’ Id. And with to be a mistaken citation to 21 CFR 1304.22(c),
necessitates that this Order be effective respect to paragraph 9 of the MOA, the which sets forth the records required to be
immediately. 21 CFR 1316.67. Order alleged that Respondent was maintained by dispensers.
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Document Created: 2017-05-06 02:21:49
Document Modified: 2017-05-06 02:21:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 82 FR 21408 |
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