Fiaz Afzal, M.D.; Decision And Order, 61651-61655 [2014-24373]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 14–3]
Fiaz Afzal, M.D.; Decision And Order
On November 4, 2013, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Fiaz Afzal, M.D.
(Respondent), of Kenner, Louisiana. ALJ
Ex. 1. The Show Cause Order proposed
the revocation of Respondent’s DEA
Certificate of Registration BA5142308,
which authorizes him to dispense
controlled substances as a practitioner,
as well as the denial of any pending
application to renew or modify the
registration, on the ground that his
‘‘registration is inconsistent with the
public interest.’’ Id. at 1 (citing 21
U.S.C. 823(f) & 824(a)(4)).
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As the basis for the proceeding, the
Show Cause Order specifically alleged
that ‘‘[f]rom in or about 2006 through in
or about March of 2012, [Respondent]
issued prescriptions for controlled
substances to fifteen patients outside the
usual course of professional practice
and for other than a legitimate medical
purpose in violation of 21 CFR
1306.04(a).’’ Id. The Order also alleged
that the prescriptions Respondent
‘‘issued to these patients also violated
Louisiana . . . law pertaining to
controlled substances.’’ Id. at 1–2 (citing
La. Rev. Sta. § 37:1285A(6) & (14); La.
Rev. Stat. § 46:6921).
The Show Cause Order further alleged
that a medical expert had reviewed the
medical records of the fifteen patients
and found that Respondent ‘‘did not
take a sufficient, or, in some cases, any
objective medical history about the
patient, that there was often a lack of
diagnosis to support the continu[ed]
prescribing of controlled substances,
and that there was often no individual
treatment plan.’’ Id. at 2. The Order also
alleged that the expert had found that
Respondent ‘‘failed to commence
treatment with alternative treatments
. . . rather than commenc[e]
immediately with controlled substance
prescriptions.’’ Id.
On November 14, 2013, Respondent
requested a hearing on the allegations.
ALJ Ex. 2. The matter was placed on the
docket of the Office of Administrative
Law Judges, and assigned to ALJ
Christopher McNeil, who conducted an
evidentiary hearing on February 25,
2014 in New Orleans, Louisiana.
At the hearing, the Government
submitted various exhibits including
patient files for the record; it also
presented the testimony of an expert.
Respondent submitted no exhibits and
presented no testimony. Both parties
submitted post-hearing briefs.
Thereafter, the ALJ issued his
Recommended Decision (R.D.). Therein,
the ALJ found, inter alia, that the
Government had proved that
Respondent had issued controlledsubstance prescriptions to fifteen
patients ‘‘in a manner that was not in
the ordinary course of professional
medical practice and was not based
upon a legitimate medical justification.’’
R.D. at 66–67. Based on this finding, the
ALJ further concluded that the
Government had demonstrated ‘‘that
Respondent’s continued . . .
registration would be inconsistent with
the public interest.’’ Id. at 67. The ALJ
further found that Respondent ‘‘ha[d]
not provided substantial evidence that
he has acknowledged any
noncompliance with controlled
substance laws, nor that he has
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undertaken efforts to avoid such
noncompliance in the future,’’ and had
thus ‘‘failed to rebut the Government’s
prima facie case.’’ Id. at 69. The ALJ
thus recommended that I revoke
Respondent’s registration and deny any
pending application to renew or modify
his registration. Id.
Both parties filed exceptions to the
ALJ’s decision. Thereafter, the record
was forwarded to this Office for Final
Agency Action.
While the matter was under review,
the Government notified this Office that
on August 18, 2014, the Louisiana State
Board of Medical Examiners had issued
a Decision and Order in the case it had
brought against Respondent. Govt’s
Notification of, and Request to Add to
the Record, the Decision and Order of
the Louisiana State Board of Medical
Examiners, at 1. Therein, the
Government requested that the Board’s
Decision and Order be added to the
record and provided a copy of the
Decision and Order. Id. The
Government further served a copy of its
filing on Respondent, care of the South
Louisiana Correction Center in Basile,
Louisiana. Id. at 2.
Thereafter, Respondent submitted a
letter to this Office opposing the
Government’s request to add the
Louisiana Board’s Decision to the
record. See Opposition to Addition of
Record, at 1. Therein, Respondent
argues that he has requested both
rehearing by the Board and judicial
review of the Board’s action and that the
Decision and Order ‘‘is NOT final yet so
it is too early to add this to’’ the record.
Id. He further maintains that ‘‘[s]everal
issues regarding [the Government
Expert’s] testimony at [the] DEA hearing
are unanswered and were excluded
from [the] Louisiana State Board hearing
which is UNFAIR for [his] cause.’’ Id.
Having considered Respondent’s
contentions, I reject them. The Board’s
Decision and Order is clearly final as it
sets forth findings of fact, conclusions of
law, and orders the imposition of
various sanctions. La. Rev. Stat. § 49:958
(‘‘A final decision shall include findings
of fact and conclusions of law.’’). Also,
the decision is dated and signed by the
President of the Board, in the name of
the Board, and has since been posted on
the Board’s disciplinary actions Web
page. See La. Admin. Code 46:XLV.9927
(‘‘The final decision of the board in an
adjudication proceeding shall, if adverse
to the respondent . . . be, in writing,
shall include findings of fact and
conclusions of law, and shall be signed
by the presiding officer of the hearing
panel on behalf and in the name of the
board.’’). In short, the Decision and
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Order bears all of the hallmarks of a
final decision and order.
As for his suggestion that the Decision
and Order is not yet final because he has
sought rehearing before the Board,
Respondent has provided no evidence
that the Board has stayed its decision.
Nor does he cite to any provision of
either Louisiana law or the Board’s
regulations which provides that the
filing of a petition for rehearing renders
the Board’s decision non-final. As for
his further suggestion that the Board’s
Decision and Order is not final because
he has sought judicial review, under the
Louisiana Administrative Procedure
Act, ‘‘[t]he filing of the petition does not
itself stay enforcement of the agency
decision.’’ La. Rev. Stat. § 49:964.
Accordingly, I conclude that the
Board’s Decision and Order is final and
will consider it as evidence in this
matter. I make the following findings.
Findings
On some date not specified in its
Decision, the Louisiana Board issued an
Administrative Complaint to
Respondent charging him with six
different violations of Louisiana law and
the Board’s rules. See In re Afzal, No.
13–A–006 (La. Bd. Med. Exam’rs., Aug.
18, 2014). Of consequence here, the
charges included the following:
3. Pursuant to La. Rev. Stat. § 37:1285(6),
Prescribing, dispensing, or administering
legally controlled substances or any
dependency-inducing medication without
legitimate medical justification therefore or
in other than a legal or legitimate manner;
*
*
*
*
*
6. Board’s Pain and Obesity Rules, Section
6921 of the Board’s rules identify the
provisions to which physicians should
adhere in treating non-malignant chronic or
intractable pain with controlled substances
on a protracted basis (in excess of 12 weeks
during any 12 month period). Among the
items required by the rules, with which
Respondent failed to satisfy with respect to
this patient are the need to: perform an
evaluation of the patient; arrive at a medical
diagnosis; formulate a treatment plan;
document the medical necessity for the use
of more than one type or schedule of
controlled substance in the patient’s chart;
and document and maintain accurate and
complete records of history, physical and
other examinations and evaluations as
required by Section 6921 of the Board’s rules.
Id. at 2 (citing La. Admin. Code
46:XLV.6921).
On June 16, 2014, the Board held a
hearing at which Respondent was
present. Id. at 1. After noting that the
violations arose ‘‘out of Respondent’s
treatment of ten patients as a physician
licensed by the Board,’’ the Board
explained that the evidence ‘‘in support
of the complaint’’ included the
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‘‘medical records pertaining to each
patient’’ and the expert testimony of two
physicians. Id. at 2. Regarding the
testimony of the experts, the Board
made the following findings:
Dr. Aultman,1 Board Certified in Internal
Medicine, testified as to [R]espondent’s
treatment of the ten patients listed in the
complaint. She reviewed the medical records
of each patient. She was of the opinion that
Respondent, in each case, failed to perform
a complete physical exam, received no
medical history, did not formulate or
document a medical diagnosis, failed to
consider other remedies other than treatment
with drugs, did not develop an
individualized treatment plan and performed
no periodic assessments of the patients, all in
violation of the Board’s Rules on Treatment
of Chronic Pain. In addition, she was of the
opinion that Respondent’s treatment of these
patients failed to satisfy the physicians’
standard of care.
Dr. Kathy Willis, an internist, testified that
she reviewed all of these patients’ charts and
was of the same opinion as Dr. Aultman. . . .
She also testified that a number of
prescriptions were given by Respondent with
no visit shown on the chart. She was of the
opinion that Respondent distributed
controlled substances with no medical basis
for administering these drugs. She was also
of the opinion that Respondent was in
violation of the Board’s Rules on Treatment
of Chronic Pain and that his treatment of
these patients did not meet the standard of
care.
Id. at 2–3.
The Board thus found ‘‘that
Respondent failed to perform a
complete physical exam or formulate or
document a medical diagnosis and
failed to formulate an individualized
treatment plan for any of these
patients.’’ Id. at 3. The Board also found
that Respondent ‘‘received no medical
history on these patients,’’ ‘‘did not
consider other remedies . . . than
treatment with drugs,’’ and that he
‘‘performed no periodic assessments of
these patient’s [sic] progress.’’ Id.2 The
Board then found Respondent guilty of
each of the charges, including that he
violated the Board’s Pain Rules, see La.
Admin. Code 46:XLV.6921 & 6923, and
the provision of the Louisiana Medical
Practice Act prohibiting the
‘‘[p]rescribing, dispensing, or
administering [of] legally controlled
substances or any dependency-inducing
medication without legitimate medical
justification therefor or in other than a
legal or legitimate manner.’’ La. Rev.
Stat. § 37:1285(6).
Based on its findings, the Board
suspended Respondent’s medical
1 Dr. Aultman also testified for the Government in
the DEA proceeding. See Tr. 79–317.
2 The Board also found that Respondent had been
convicted in state court of thirty-five counts of
Medicaid Fraud. In re Afzal, at 3.
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license until the probation imposed by
the state court in the criminal
proceeding ‘‘is terminated or for two
years, whichever is longer.’’ In re Afzal,
at 4. The Board further ordered that
upon his reinstatement, Respondent
will be placed on probation subject to
conditions which include that ‘‘[f]or as
long as he holds a license to practice
medicine in Louisiana, [Respondent]
shall not prescribe . . . any substance
which may be classified, defined,
enumerated or included in 21 CFR
1308.11–15 . . . as a Controlled
Substance.’’ Id. at 5. Respondent may,
however, ‘‘apply for the ability to
prescribe controlled substances [in
schedules] III–IV after a period of five
(5) years from date of his
reinstatement.’’ Id.3
findings as to all of the factors.’’
Volkman, 567 F.3d at 222; see also
Hoxie v. DEA, 419 F.3d 477, 482 (6th
Cir. 2005); Morall v. DEA, 412 F.3d 165,
173–74 (D.C. Cir. 2005).
Here, I have considered all of the
factors. For reasons explained below, I
conclude that the Board’s findings that
Respondent violated Louisiana law, see
La. Rev. Stat. § 37:1285(6), and the
Board’s pain rules, see La. Admin. Code
46:XLV.6921 & 6923, establish that
Registrant has also violated the
prescription requirement of the
Controlled Substances Act. See 21 CFR
1306.04(a). I further conclude that
Respondent ‘‘has committed such acts’’
as to render his registration
‘‘inconsistent with the public interest.’’ 4
21 U.S.C. 824(a)(4).
Discussion
Factors Two and Four—Respondent’s
Experience in Dispensing Controlled
Substances and Compliance With
Applicable Laws Related to Controlled
Substances
To effectuate the dual goals of
conquering drug abuse and controlling
both the legitimate and illegitimate
traffic in controlled substances,
‘‘Congress devised a closed regulatory
system making it unlawful to
manufacture, distribute, dispense, or
possess any controlled substance except
in a manner authorized by the CSA.’’
Gonzales v. Raich, 545 U.S. 1, 13 (2005).
Consistent with the maintenance of the
closed regulatory system, a controlled
substance may only be dispensed upon
a lawful prescription issued by a
practitioner. Carlos Gonzalez, M.D., 76
FR 63118, 63141 (2011).
Fundamental to the CSA’s scheme is
the Agency’s longstanding regulation
which states that ‘‘[a] prescription for a
controlled substance [is not] effective
[unless it is] issued for a legitimate
medical purpose by an individual
practitioner acting in the usual course of
his professional practice.’’ 21 CFR
The Public Interest Analysis
Section 304(a) of the Controlled
Substances Act (CSA) provides that a
registration to ‘‘dispense a controlled
substance . . . may be suspended or
revoked by the Attorney General upon
a finding that the registrant . . . has
committed such acts as would render
his registration under section 823 of this
title inconsistent with the public
interest as determined under such
section.’’ 21 U.S.C. § 824(a)(4). With
respect to a practitioner, the Act
requires the consideration of the
following factors in making the public
interest determination:
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(1) The recommendation of the appropriate
State licensing board or professional
disciplinary authority.
(2) The applicant’s experience in
dispensing . . . controlled substances.
(3) The applicant’s conviction record under
Federal or State laws relating to the
manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to controlled
substances.
(5) Such other conduct which may threaten
the public health and safety.
Id. § 823(f).
‘‘These factors are . . . considered in
the disjunctive.’’ Robert A. Leslie, M.D.,
68 FR 15227, 15230 (2003). I ‘‘may rely
on any one or a combination of factors,
and may give each factor the weight [I]
deem[] appropriate in determining
whether a registration should be
revoked.’’ Id. (emphasis added); see also
Volkman v. DEA, 567 F.3d 215, 222 (6th
Cir. 2009). While I must consider each
factor, I am ‘‘not required to make
3 Based on the findings of the Louisiana Board’s
Decision and Order, I deem it unnecessary to make
any findings based on this Agency’s proceeding, or
to address either party’s Exceptions to the ALJ’s
Recommended Decision.
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4 As for factor one, while the Board has not made
a formal recommendation to DEA as to whether
Respondent should retain his registration, the State
Board has suspended Respondent’s medical license
for at least two years and also provided that even
upon his reinstatement, he is prohibited from
prescribing controlled substances for at least five
years thereafter. The consequence of the State’s
Order is discussed more fully below.
Regarding factor three, there is no evidence that
Respondent has been convicted of an offense
related to the manufacture, distribution or
dispensing of controlled substances. However, as
there are a number of reasons why a person may
never be convicted of an offense falling under this
factor, let alone be prosecuted for one, ‘‘the absence
of such a conviction is of considerably less
consequence in the public interest inquiry’’ and
thus, it is not dispositive. David A. Ruben, 78 FR
38363, 38379 n. 35 (2013) (citing Dewey C. MacKay,
75 FR 49956, 49973 (2010), pet. for rev. denied,
MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011)).
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1306.04(a). This regulation further
provides that ‘‘an order purporting to be
a prescription issued not in the usual
course of professional treatment . . . is
not a prescription within the meaning
and intent of [21 U.S.C. 829] and . . .
the person issuing it, shall be subject to
the penalties provided for violations of
the provisions of law relating to
controlled substances.’’ Id.
As the Supreme Court has explained,
‘‘the prescription requirement . . .
ensures patients use controlled
substances under the supervision of a
doctor so as to prevent addiction and
recreational abuse. As a corollary, [it]
also bars doctors from peddling to
patients who crave the drugs for those
prohibited uses.’’ Gonzales v. Oregon,
546 U.S. 243, 274 (2006) (citing United
States v. Moore, 423 U.S. 122, 135, 143
(1975)); United States v. Alerre, 430
F.3d 681, 691 (4th Cir. 2005), cert.
denied, 574 U.S. 1113 (2006) (the
prescription requirement stands as a
proscription against doctors acting not
‘‘as a healer[,] but as a seller of wares.’’).
Under the CSA, it is fundamental that
a practitioner must establish and
maintain a legitimate doctor-patient
relationship in order to act ‘‘in the usual
course of . . . professional practice’’
and to issue a prescription for a
‘‘legitimate medical purpose.’’ Paul H.
Volkman, 73 FR 30629, 30642 (2008),
pet. for rev. denied, 567 F.3d 215, 223–
24 (6th Cir. 2009); see also Moore, 423
U.S. at 142–43 (noting that evidence
established that the physician exceeded
the bounds of professional practice,
when ‘‘he gave inadequate physical
examinations or none at all,’’ ‘‘ignored
the results of the tests he did make,’’
and ‘‘took no precautions against . . .
misuse and diversion’’). The CSA,
however, generally looks to state law to
determine whether a doctor and patient
have established a legitimate doctorpatient relationship. Volkman, 73 FR at
30642.
As found above, subsequent to the
DEA hearing, the Louisiana Board also
conducted a hearing after which the
Board found ‘‘that Respondent failed to
perform a complete physical exam or
formulate or document a medical
diagnosis and failed to formulate an
individualized treatment plan for any of
these [ten] patients.’’ In re Afzahl, at 3.
The Board also found that Respondent
‘‘received no medical history on these
patients,’’ ‘‘did not consider other
remedies . . . than treatment with
drugs,’’ and that he ‘‘performed no
periodic assessments of these patient’s
[sic] progress.’’ Id.
The Board thus found Respondent
guilty of having violated the Board’s
Pain Rules. See La. Admin. Code
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46:XLV.6921 & 6923. Most importantly,
the Board found that Respondent
violated the provision of the Louisiana
Medical Practice Act which prohibits
‘‘[p]rescribing, dispensing, or
administering legally controlled
substances or any dependency-inducing
medication without legitimate medical
justification therefor or in other than a
legal or legitimate manner.’’ La. Rev.
Stat. § 37:1285(6).
Under the doctrine of collateral
estoppel, the Board’s findings of fact
and conclusions of law are entitled to
preclusive effect in this proceeding if
Respondent had an adequate
opportunity to litigate the issues in the
state proceeding. See Thomas
Neuschatz, 78 FR 76322, 76325 (2013)
(citing Robert L. Dougherty, M.D., 76 FR
16823, 16830 (2011)); Univ. of Tenn. v.
Elliot, 478 U.S. 788, 797–98 (1986)
(‘‘When an administrative agency is
acting in a judicial capacity and resolves
disputed issues of fact properly before it
which the parties have had an adequate
opportunity to litigate, the courts have
not hesitated to apply res judicata[.]’’)
(internal quotations and citations
omitted).
Here, having reviewed the Board’s
Decision and applicable Louisiana law,
I conclude that Respondent had an
adequate opportunity to litigate (and did
litigate) the issues raised in that
proceeding. Under the Board’s Rules of
Procedure, Respondent was entitled to
notice of the complaint, which was
required to set forth ‘‘the material facts
and matters alleged and to be proven,’’
including ‘‘the facts constituting legal
cause under law for administrative
action against’’ him. La. Admin. Code
tit.46:XLV.§ 9903.B; see also id. § 9905.
Moreover, while Respondent
represented himself, he was entitled to
‘‘be represented . . . by an attorney at
law duly admitted to practice in any
state.’’ Id. § 9907.B. He was entitled to
request subpoenas for both the
testimony of witnesses and the
production of documentary evidence.
Id. § 9917.A. Also, at the hearing, he
was entitled ‘‘to present evidence on all
issues of law and argument on all issues
of law and policy involved, to call,
examine, and cross-examine witnesses,
and to offer and introduce documentary
evidence and exhibits as may be
required for a full and true disclosure of
the facts and disposition of the
complaint.’’ Id. § 9921.B. Finally, he
was entitled to a written decision,
which included factual findings and
legal conclusions. Id. § 9927.A. I
therefore find that Respondent had an
adequate opportunity to litigate the
issues raised in the Board proceeding
and give preclusive effect to the Board’s
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findings of fact and conclusions of law.
See Neuschatz, 78 FR at 76325;
Dougherty, 76 FR at 16830.
I further hold that Board’s findings
and legal conclusions support the
conclusion that Respondent lacked a
legitimate medical purpose and acted
outside the usual course of professional
practice in prescribing controlled
substances to the ten patients who were
the subject of the Board proceeding. See
21 CFR 1306.04(a). This conclusion is
supported by both the Board’s factual
findings and its legal conclusion that
Respondent violated La. Rev. Stat.
§ 37:1285(6).
As for its factual findings, the Board
found ‘‘that Respondent failed to
perform a complete physical exam or
formulate or document a medical
diagnosis and failed to formulate an
individualized treatment plan for any of
these patients.’’ In re Afzahl, at 3. It also
found that Respondent ‘‘received no
medical history on these patients,’’ ‘‘did
not consider other remedies . . . than
treatment with drugs,’’ and that he
‘‘performed no periodic assessments of
these patient’s [sic] progress.’’ Id.
Numerous decisions of the courts
(including the Supreme Court in Moore)
and this Agency have recognized that
the prescribing of a controlled substance
(and the continued prescribing of a
controlled substance) under the
following circumstances establishes that
a physician lacked a legitimate medical
purpose and acted outside of the usual
course of professional practice and
therefore violated the CSA:
• Without performing an appropriate
physical examination,
• without utilizing appropriate
diagnostic testing,
• failing to devise and document a
written treatment plan,
• failing to periodically reassess the
effectiveness of the treatment,
• continuing to prescribe controlled
substances without pursuing alternative
therapies,
• repeatedly and continually
prescribing without referring the patient
to appropriate specialists, and
• failing to keep and maintain records
which contain adequate findings to
support a diagnosis and the need to
prescribe one or more medications.
See, e.g.; Paul H. Volkman, 73 FR
30630 (2008), pet. for rev. denied, 567
F.3d. 215 (6th Cir. 2009); see also David
A. Ruben, 78 FR 38363 (2013); Henri
Wetselaar,77 FR 57126 (2012); Jack A.
Danton, 76 FR 60900 (2011); George C.
Aycock, 74 FR 17529, 17544 (2009).
Accordingly, the Board’s factual
findings alone support the conclusion
that Respondent lacked a legitimate
medical purpose and acted outside of
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
the usual course of professional practice
when he prescribed to the ten patients
who were at issue in the Board
proceeding. See 21 CFR 1306.04(a).
Moreover, the Board specifically
found that in his treatment of the ten
patients, Respondent violated Section
37:1285(6) of the Louisiana Medical
Practice Act. As discussed above, this
provision prohibits ‘‘[p]rescribing,
dispensing, or administering legally
controlled substances or any
dependency-inducing medication
without legitimate medical justification
therefore or in other than a legal or
legitimate manner.’’ La. Rev. Stat.
§ 37:1285(6). This is not simply a
malpractice standard. Rather, this
standard is equivalent to the CSA’s
requirement that a controlled substance
prescription ‘‘must be issued for a
legitimate medical purpose by an
individual practitioner acting in the
usual course of his professional
practice.’’ 21 CFR 1306.04(a).
Accordingly, I hold that the Board’s
findings of fact and conclusions of law
establish that Respondent knowingly
diverted controlled substances to the ten
patients at issue in the State proceeding.
I further conclude that the Board’s
Order establishes that Respondent has
committed such acts as would render
his registration ‘‘inconsistent with the
public interest.’’ 21 CFR 1306.04(a). I
further hold that Respondent’s
misconduct is egregious and warrants
the revocation of his registration.
Loss of State Authority Grounds
Not only does the State Board’s Order
provide ground to revoke Respondent’s
registration under the public interest
standard, it also supports revocation
under the separate and independent
ground that he lacks state authority.
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to revoke
or suspend a registration ‘‘upon a
finding that the registrant . . . has had
his State license or registration
suspended, revoked, or denied by
competent State authority and is no
longer authorized by State law to engage
in the . . . distribution or dispensing of
controlled substances.’’ With respect to
a practitioner, DEA has repeatedly 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 James L.
Hooper, 76 FR 71371, 71372 (2011)
(citing Leonard F. Faymore, 48 FR
32886, 32887 (1983)), pet. for rev.
denied, Hooper v. Holder, 481 Fed.
E:\FR\FM\14OCN1.SGM
14OCN1
Federal Register / Vol. 79, No. 198 / Tuesday, October 14, 2014 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
Appx. 826, 828 (4th Cir. June 6, 2012)
(unpublished).
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) (emphasis added).
Because Congress has clearly
mandated that a practitioner possess
state authority in order to be deemed a
practitioner under the Act, DEA has
held repeatedly that revocation of a
practitioner’s registration is the
appropriate sanction if the practitioner
is no longer authorized to dispense
controlled substances under the laws of
the State in which he practices
medicine.5 See, e.g., Calvin Ramsey, 76
FR 20034, 20036 (2011); 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). It is of no
consequence that Respondent has
sought judicial review of the Board’s
decision. See Ramsey, 76 FR at 20036
(citing Michael G. Dolin, 65 FR 5661,
5662 (2000)). Under the CSA, all that
matters is that Respondent is no longer
5 It is unclear from the Board’s order whether
Respondent offered any evidence in the State
proceeding that he acknowledges his misconduct
and has undertaken remedial measures to prevent
its recurrence, and given the outcome of the
proceeding and the absence of any discussion in the
Order, it seems unlikely that he did. Indeed, while
in the DEA proceeding, Respondent faced similar
allegations of unlawful prescribing, he declined to
testify and offered no evidence at all. See R.D. at
61–62.
While under this Agency’s precedents, evidence
that a practitioner acknowledges his misconduct
and has undertaken remedial measures may refute
the Government’s prima facie case when it seeks
the revocation of a practitioner’s registration on
public interest grounds, it is unnecessary to
determine whether Respondent offered such
evidence in the board proceeding. This is so
because Respondent’s loss of his state authority
provides a separate and independent ground for
revoking his registration. And because under the
CSA, possessing authority under state law to
dispense controlled substances is a mandatory
requirement for obtaining and maintaining a DEA
practitioner’s registration, it does not matter
whether Respondent offered such evidence in the
state board proceeding.
VerDate Sep<11>2014
16:59 Oct 10, 2014
Jkt 235001
currently authorized to dispense
controlled substances in Louisiana. Id.
Here, the Louisiana Board has
suspended Respondent’s medical
license for at least two years, and even
in the event the Board reinstates his
license, he will be prohibited from
prescribing controlled substances for at
least five years from the date of
reinstatement. Accordingly, I conclude
that Registrant is without authority
under Louisiana law to handle
controlled substances in the State in
which he holds his DEA registration.
Because Respondent no longer meets
the CSA’s requirement that he be
currently authorized to dispense
controlled substances in the State in
which he holds his registration, I will
order that his registration be revoked.
See Craig Bammer, 73 FR 34327, 34329
(2008); Richard Carino, M.D., 72 FR
71955, 71956 (2007) (citing cases).
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a)(3) & (4),
as well as 28 CFR 0.100(b) and 0.104, I
order that DEA Certificate of
Registration BA5142308, issued to Fiaz
Afzal, M.D., be, and it hereby is,
revoked. I further order that any
application of Fiaz Afzal, M.D., to renew
or modify his registration, be, and it
hereby is, denied. This Order is
effectively immediately.6
Dated: October 2, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014–24373 Filed 10–10–14; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Office of the Secretary
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request;
Representative Payee Report,
Representative Payee Report Short
Form, and Physician’s/Medical
Officer’s Statement
ACTION:
The Department of Labor
(DOL) is submitting the Office of
Workers’ Compensation Programs
(OWCP) sponsored information
collection request (ICR) revision titled,
‘‘Representative Payee Report,
Representative Payee Report Short
6 Based on the extensive and egregious nature of
the misconduct proved by the Government, I
conclude that the public interest necessitates that
this Order be effectively immediately. 21 CFR
1316.67.
Frm 00060
Fmt 4703
Form, and Physician’s/Medical Officer’s
Statement,’’ to the Office of
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review and approval for use in
accordance with the Paperwork
Reduction Act (PRA) of 1995 (44 U.S.C.
3501 et seq.). Public comments on the
ICR are invited.
DATES: The OMB will consider all
written comments that agency receives
on or before November 13, 2014.
ADDRESSES: A copy of this ICR with
applicable supporting documentation;
including a description of the likely
respondents, proposed frequency of
response, and estimated total burden
may be obtained free of charge from the
RegInfo.gov Web site at https://www.
reginfo.gov/public/do/PRAViewICR
?ref_nbr=201405-1240-004 (this link
will only become active on the day
following publication of this notice) or
by contacting Michel Smyth by
telephone at 202–693–4129, TTY 202–
693–8064, (these are not toll-free
numbers) or sending an email to DOL_
PRA_PUBLIC@dol.gov.
Submit comments about this request
by mail or courier to the Office of
Information and Regulatory Affairs,
Attn: OMB Desk Officer for DOL–
OWCP, Office of Management and
Budget, Room 10235, 725 17th Street
NW., Washington, DC 20503; by Fax:
202–395–5806 (this is not a toll-free
number); or by email:
OIRA_submission@omb.eop.gov.
Commenters are encouraged, but not
required, to send a courtesy copy of any
comments by mail or courier to the U.S.
Department of Labor-OASAM, Office of
the Chief Information Officer, Attn:
Departmental Information Compliance
Management Program, Room N1301,
200 Constitution Avenue NW.,
Washington, DC 20210; or by email:
DOL_PRA_PUBLIC@dol.gov.
FOR FURTHER INFORMATION CONTACT:
Contact Michel Smyth by telephone at
202–693–4129, TTY 202–693–8064,
(these are not toll-free numbers) or
sending an email to
DOL_PRA_PUBLIC@dol.gov.
Authority: 44 U.S.C. 3507(a)(1)(D).
Notice.
SUMMARY:
PO 00000
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Sfmt 4703
This ICR
seeks approval under the PRA for
revisions to the Representative Payee
Report, Representative Payee Report
Short Form, and Physician’s/Medical
Officer’s Statement information
collection. Benefits due a DOL black
lung beneficiary may be paid to a
representative payee on behalf of the
beneficiary when he or she is unable to
manage the benefits due to incapability
or incompetence or because the
beneficiary is a minor. The
SUPPLEMENTARY INFORMATION:
E:\FR\FM\14OCN1.SGM
14OCN1
]]>Agencies
[Federal Register Volume 79, Number 198 (Tuesday, October 14, 2014)]
[Notices]
[Pages 61651-61655]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24373]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 14-3]
Fiaz Afzal, M.D.; Decision And Order
On November 4, 2013, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Fiaz Afzal, M.D. (Respondent), of Kenner, Louisiana. ALJ
Ex. 1. The Show Cause Order proposed the revocation of Respondent's DEA
Certificate of Registration BA5142308, which authorizes him to dispense
controlled substances as a practitioner, as well as the denial of any
pending application to renew or modify the registration, on the ground
that his ``registration is inconsistent with the public interest.'' Id.
at 1 (citing 21 U.S.C. 823(f) & 824(a)(4)).
As the basis for the proceeding, the Show Cause Order specifically
alleged that ``[f]rom in or about 2006 through in or about March of
2012, [Respondent] issued prescriptions for controlled substances to
fifteen patients outside the usual course of professional practice and
for other than a legitimate medical purpose in violation of 21 CFR
1306.04(a).'' Id. The Order also alleged that the prescriptions
Respondent ``issued to these patients also violated Louisiana . . . law
pertaining to controlled substances.'' Id. at 1-2 (citing La. Rev. Sta.
Sec. 37:1285A(6) & (14); La. Rev. Stat. Sec. 46:6921).
The Show Cause Order further alleged that a medical expert had
reviewed the medical records of the fifteen patients and found that
Respondent ``did not take a sufficient, or, in some cases, any
objective medical history about the patient, that there was often a
lack of diagnosis to support the continu[ed] prescribing of controlled
substances, and that there was often no individual treatment plan.''
Id. at 2. The Order also alleged that the expert had found that
Respondent ``failed to commence treatment with alternative treatments .
. . rather than commenc[e] immediately with controlled substance
prescriptions.'' Id.
On November 14, 2013, Respondent requested a hearing on the
allegations. ALJ Ex. 2. The matter was placed on the docket of the
Office of Administrative Law Judges, and assigned to ALJ Christopher
McNeil, who conducted an evidentiary hearing on February 25, 2014 in
New Orleans, Louisiana.
At the hearing, the Government submitted various exhibits including
patient files for the record; it also presented the testimony of an
expert. Respondent submitted no exhibits and presented no testimony.
Both parties submitted post-hearing briefs.
Thereafter, the ALJ issued his Recommended Decision (R.D.).
Therein, the ALJ found, inter alia, that the Government had proved that
Respondent had issued controlled-substance prescriptions to fifteen
patients ``in a manner that was not in the ordinary course of
professional medical practice and was not based upon a legitimate
medical justification.'' R.D. at 66-67. Based on this finding, the ALJ
further concluded that the Government had demonstrated ``that
Respondent's continued . . . registration would be inconsistent with
the public interest.'' Id. at 67. The ALJ further found that Respondent
``ha[d] not provided substantial evidence that he has acknowledged any
noncompliance with controlled substance laws, nor that he has
[[Page 61652]]
undertaken efforts to avoid such noncompliance in the future,'' and had
thus ``failed to rebut the Government's prima facie case.'' Id. at 69.
The ALJ thus recommended that I revoke Respondent's registration and
deny any pending application to renew or modify his registration. Id.
Both parties filed exceptions to the ALJ's decision. Thereafter,
the record was forwarded to this Office for Final Agency Action.
While the matter was under review, the Government notified this
Office that on August 18, 2014, the Louisiana State Board of Medical
Examiners had issued a Decision and Order in the case it had brought
against Respondent. Govt's Notification of, and Request to Add to the
Record, the Decision and Order of the Louisiana State Board of Medical
Examiners, at 1. Therein, the Government requested that the Board's
Decision and Order be added to the record and provided a copy of the
Decision and Order. Id. The Government further served a copy of its
filing on Respondent, care of the South Louisiana Correction Center in
Basile, Louisiana. Id. at 2.
Thereafter, Respondent submitted a letter to this Office opposing
the Government's request to add the Louisiana Board's Decision to the
record. See Opposition to Addition of Record, at 1. Therein, Respondent
argues that he has requested both rehearing by the Board and judicial
review of the Board's action and that the Decision and Order ``is NOT
final yet so it is too early to add this to'' the record. Id. He
further maintains that ``[s]everal issues regarding [the Government
Expert's] testimony at [the] DEA hearing are unanswered and were
excluded from [the] Louisiana State Board hearing which is UNFAIR for
[his] cause.'' Id.
Having considered Respondent's contentions, I reject them. The
Board's Decision and Order is clearly final as it sets forth findings
of fact, conclusions of law, and orders the imposition of various
sanctions. La. Rev. Stat. Sec. 49:958 (``A final decision shall
include findings of fact and conclusions of law.''). Also, the decision
is dated and signed by the President of the Board, in the name of the
Board, and has since been posted on the Board's disciplinary actions
Web page. See La. Admin. Code 46:XLV.9927 (``The final decision of the
board in an adjudication proceeding shall, if adverse to the respondent
. . . be, in writing, shall include findings of fact and conclusions of
law, and shall be signed by the presiding officer of the hearing panel
on behalf and in the name of the board.''). In short, the Decision and
Order bears all of the hallmarks of a final decision and order.
As for his suggestion that the Decision and Order is not yet final
because he has sought rehearing before the Board, Respondent has
provided no evidence that the Board has stayed its decision. Nor does
he cite to any provision of either Louisiana law or the Board's
regulations which provides that the filing of a petition for rehearing
renders the Board's decision non-final. As for his further suggestion
that the Board's Decision and Order is not final because he has sought
judicial review, under the Louisiana Administrative Procedure Act,
``[t]he filing of the petition does not itself stay enforcement of the
agency decision.'' La. Rev. Stat. Sec. 49:964.
Accordingly, I conclude that the Board's Decision and Order is
final and will consider it as evidence in this matter. I make the
following findings.
Findings
On some date not specified in its Decision, the Louisiana Board
issued an Administrative Complaint to Respondent charging him with six
different violations of Louisiana law and the Board's rules. See In re
Afzal, No. 13-A-006 (La. Bd. Med. Exam'rs., Aug. 18, 2014). Of
consequence here, the charges included the following:
3. Pursuant to La. Rev. Stat. Sec. 37:1285(6), Prescribing,
dispensing, or administering legally controlled substances or any
dependency-inducing medication without legitimate medical
justification therefore or in other than a legal or legitimate
manner;
* * * * *
6. Board's Pain and Obesity Rules, Section 6921 of the Board's
rules identify the provisions to which physicians should adhere in
treating non-malignant chronic or intractable pain with controlled
substances on a protracted basis (in excess of 12 weeks during any
12 month period). Among the items required by the rules, with which
Respondent failed to satisfy with respect to this patient are the
need to: perform an evaluation of the patient; arrive at a medical
diagnosis; formulate a treatment plan; document the medical
necessity for the use of more than one type or schedule of
controlled substance in the patient's chart; and document and
maintain accurate and complete records of history, physical and
other examinations and evaluations as required by Section 6921 of
the Board's rules.
Id. at 2 (citing La. Admin. Code 46:XLV.6921).
On June 16, 2014, the Board held a hearing at which Respondent was
present. Id. at 1. After noting that the violations arose ``out of
Respondent's treatment of ten patients as a physician licensed by the
Board,'' the Board explained that the evidence ``in support of the
complaint'' included the ``medical records pertaining to each patient''
and the expert testimony of two physicians. Id. at 2. Regarding the
testimony of the experts, the Board made the following findings:
Dr. Aultman,\1\ Board Certified in Internal Medicine, testified
as to [R]espondent's treatment of the ten patients listed in the
complaint. She reviewed the medical records of each patient. She was
of the opinion that Respondent, in each case, failed to perform a
complete physical exam, received no medical history, did not
formulate or document a medical diagnosis, failed to consider other
remedies other than treatment with drugs, did not develop an
individualized treatment plan and performed no periodic assessments
of the patients, all in violation of the Board's Rules on Treatment
of Chronic Pain. In addition, she was of the opinion that
Respondent's treatment of these patients failed to satisfy the
physicians' standard of care.
---------------------------------------------------------------------------
\1\ Dr. Aultman also testified for the Government in the DEA
proceeding. See Tr. 79-317.
---------------------------------------------------------------------------
Dr. Kathy Willis, an internist, testified that she reviewed all
of these patients' charts and was of the same opinion as Dr.
Aultman. . . . She also testified that a number of prescriptions
were given by Respondent with no visit shown on the chart. She was
of the opinion that Respondent distributed controlled substances
with no medical basis for administering these drugs. She was also of
the opinion that Respondent was in violation of the Board's Rules on
Treatment of Chronic Pain and that his treatment of these patients
did not meet the standard of care.
Id. at 2-3.
The Board thus found ``that Respondent failed to perform a complete
physical exam or formulate or document a medical diagnosis and failed
to formulate an individualized treatment plan for any of these
patients.'' Id. at 3. The Board also found that Respondent ``received
no medical history on these patients,'' ``did not consider other
remedies . . . than treatment with drugs,'' and that he ``performed no
periodic assessments of these patient's [sic] progress.'' Id.\2\ The
Board then found Respondent guilty of each of the charges, including
that he violated the Board's Pain Rules, see La. Admin. Code
46:XLV.6921 & 6923, and the provision of the Louisiana Medical Practice
Act prohibiting the ``[p]rescribing, dispensing, or administering [of]
legally controlled substances or any dependency-inducing medication
without legitimate medical justification therefor or in other than a
legal or legitimate manner.'' La. Rev. Stat. Sec. 37:1285(6).
---------------------------------------------------------------------------
\2\ The Board also found that Respondent had been convicted in
state court of thirty-five counts of Medicaid Fraud. In re Afzal, at
3.
---------------------------------------------------------------------------
Based on its findings, the Board suspended Respondent's medical
[[Page 61653]]
license until the probation imposed by the state court in the criminal
proceeding ``is terminated or for two years, whichever is longer.'' In
re Afzal, at 4. The Board further ordered that upon his reinstatement,
Respondent will be placed on probation subject to conditions which
include that ``[f]or as long as he holds a license to practice medicine
in Louisiana, [Respondent] shall not prescribe . . . any substance
which may be classified, defined, enumerated or included in 21 CFR
1308.11-15 . . . as a Controlled Substance.'' Id. at 5. Respondent may,
however, ``apply for the ability to prescribe controlled substances [in
schedules] III-IV after a period of five (5) years from date of his
reinstatement.'' Id.\3\
---------------------------------------------------------------------------
\3\ Based on the findings of the Louisiana Board's Decision and
Order, I deem it unnecessary to make any findings based on this
Agency's proceeding, or to address either party's Exceptions to the
ALJ's Recommended Decision.
---------------------------------------------------------------------------
Discussion
The Public Interest Analysis
Section 304(a) of the Controlled Substances Act (CSA) provides that
a registration to ``dispense a controlled substance . . . may be
suspended or revoked by the Attorney General upon a finding that the
registrant . . . has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C. Sec.
824(a)(4). With respect to a practitioner, the Act requires the
consideration of the following factors in making the public interest
determination:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing . . . controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id. Sec. 823(f).
``These factors are . . . considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or
a combination of factors, and may give each factor the weight [I]
deem[] appropriate in determining whether a registration should be
revoked.'' Id. (emphasis added); see also Volkman v. DEA, 567 F.3d 215,
222 (6th Cir. 2009). While I must consider each factor, I am ``not
required to make findings as to all of the factors.'' Volkman, 567 F.3d
at 222; see also Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005);
Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).
Here, I have considered all of the factors. For reasons explained
below, I conclude that the Board's findings that Respondent violated
Louisiana law, see La. Rev. Stat. Sec. 37:1285(6), and the Board's
pain rules, see La. Admin. Code 46:XLV.6921 & 6923, establish that
Registrant has also violated the prescription requirement of the
Controlled Substances Act. See 21 CFR 1306.04(a). I further conclude
that Respondent ``has committed such acts'' as to render his
registration ``inconsistent with the public interest.'' \4\ 21 U.S.C.
824(a)(4).
---------------------------------------------------------------------------
\4\ As for factor one, while the Board has not made a formal
recommendation to DEA as to whether Respondent should retain his
registration, the State Board has suspended Respondent's medical
license for at least two years and also provided that even upon his
reinstatement, he is prohibited from prescribing controlled
substances for at least five years thereafter. The consequence of
the State's Order is discussed more fully below.
Regarding factor three, there is no evidence that Respondent has
been convicted of an offense related to the manufacture,
distribution or dispensing of controlled substances. However, as
there are a number of reasons why a person may never be convicted of
an offense falling under this factor, let alone be prosecuted for
one, ``the absence of such a conviction is of considerably less
consequence in the public interest inquiry'' and thus, it is not
dispositive. David A. Ruben, 78 FR 38363, 38379 n. 35 (2013) (citing
Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied,
MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011)).
---------------------------------------------------------------------------
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Related to Controlled
Substances
To effectuate the dual goals of conquering drug abuse and
controlling both the legitimate and illegitimate traffic in controlled
substances, ``Congress devised a closed regulatory system making it
unlawful to manufacture, distribute, dispense, or possess any
controlled substance except in a manner authorized by the CSA.''
Gonzales v. Raich, 545 U.S. 1, 13 (2005). Consistent with the
maintenance of the closed regulatory system, a controlled substance may
only be dispensed upon a lawful prescription issued by a practitioner.
Carlos Gonzalez, M.D., 76 FR 63118, 63141 (2011).
Fundamental to the CSA's scheme is the Agency's longstanding
regulation which states that ``[a] prescription for a controlled
substance [is not] effective [unless it is] issued for a legitimate
medical purpose by an individual practitioner acting in the usual
course of his professional practice.'' 21 CFR 1306.04(a). This
regulation further provides that ``an order purporting to be a
prescription issued not in the usual course of professional treatment .
. . is not a prescription within the meaning and intent of [21 U.S.C.
829] and . . . the person issuing it, shall be subject to the penalties
provided for violations of the provisions of law relating to controlled
substances.'' Id.
As the Supreme Court has explained, ``the prescription requirement
. . . ensures patients use controlled substances under the supervision
of a doctor so as to prevent addiction and recreational abuse. As a
corollary, [it] also bars doctors from peddling to patients who crave
the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S.
243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143
(1975)); United States v. Alerre, 430 F.3d 681, 691 (4th Cir. 2005),
cert. denied, 574 U.S. 1113 (2006) (the prescription requirement stands
as a proscription against doctors acting not ``as a healer[,] but as a
seller of wares.'').
Under the CSA, it is fundamental that a practitioner must establish
and maintain a legitimate doctor-patient relationship in order to act
``in the usual course of . . . professional practice'' and to issue a
prescription for a ``legitimate medical purpose.'' Paul H. Volkman, 73
FR 30629, 30642 (2008), pet. for rev. denied, 567 F.3d 215, 223-24 (6th
Cir. 2009); see also Moore, 423 U.S. at 142-43 (noting that evidence
established that the physician exceeded the bounds of professional
practice, when ``he gave inadequate physical examinations or none at
all,'' ``ignored the results of the tests he did make,'' and ``took no
precautions against . . . misuse and diversion''). The CSA, however,
generally looks to state law to determine whether a doctor and patient
have established a legitimate doctor-patient relationship. Volkman, 73
FR at 30642.
As found above, subsequent to the DEA hearing, the Louisiana Board
also conducted a hearing after which the Board found ``that Respondent
failed to perform a complete physical exam or formulate or document a
medical diagnosis and failed to formulate an individualized treatment
plan for any of these [ten] patients.'' In re Afzahl, at 3. The Board
also found that Respondent ``received no medical history on these
patients,'' ``did not consider other remedies . . . than treatment with
drugs,'' and that he ``performed no periodic assessments of these
patient's [sic] progress.'' Id.
The Board thus found Respondent guilty of having violated the
Board's Pain Rules. See La. Admin. Code
[[Page 61654]]
46:XLV.6921 & 6923. Most importantly, the Board found that Respondent
violated the provision of the Louisiana Medical Practice Act which
prohibits ``[p]rescribing, dispensing, or administering legally
controlled substances or any dependency-inducing medication without
legitimate medical justification therefor or in other than a legal or
legitimate manner.'' La. Rev. Stat. Sec. 37:1285(6).
Under the doctrine of collateral estoppel, the Board's findings of
fact and conclusions of law are entitled to preclusive effect in this
proceeding if Respondent had an adequate opportunity to litigate the
issues in the state proceeding. See Thomas Neuschatz, 78 FR 76322,
76325 (2013) (citing Robert L. Dougherty, M.D., 76 FR 16823, 16830
(2011)); Univ. of Tenn. v. Elliot, 478 U.S. 788, 797-98 (1986) (``When
an administrative agency is acting in a judicial capacity and resolves
disputed issues of fact properly before it which the parties have had
an adequate opportunity to litigate, the courts have not hesitated to
apply res judicata[.]'') (internal quotations and citations omitted).
Here, having reviewed the Board's Decision and applicable Louisiana
law, I conclude that Respondent had an adequate opportunity to litigate
(and did litigate) the issues raised in that proceeding. Under the
Board's Rules of Procedure, Respondent was entitled to notice of the
complaint, which was required to set forth ``the material facts and
matters alleged and to be proven,'' including ``the facts constituting
legal cause under law for administrative action against'' him. La.
Admin. Code tit.46:XLV.Sec. 9903.B; see also id. Sec. 9905. Moreover,
while Respondent represented himself, he was entitled to ``be
represented . . . by an attorney at law duly admitted to practice in
any state.'' Id. Sec. 9907.B. He was entitled to request subpoenas for
both the testimony of witnesses and the production of documentary
evidence. Id. Sec. 9917.A. Also, at the hearing, he was entitled ``to
present evidence on all issues of law and argument on all issues of law
and policy involved, to call, examine, and cross-examine witnesses, and
to offer and introduce documentary evidence and exhibits as may be
required for a full and true disclosure of the facts and disposition of
the complaint.'' Id. Sec. 9921.B. Finally, he was entitled to a
written decision, which included factual findings and legal
conclusions. Id. Sec. 9927.A. I therefore find that Respondent had an
adequate opportunity to litigate the issues raised in the Board
proceeding and give preclusive effect to the Board's findings of fact
and conclusions of law. See Neuschatz, 78 FR at 76325; Dougherty, 76 FR
at 16830.
I further hold that Board's findings and legal conclusions support
the conclusion that Respondent lacked a legitimate medical purpose and
acted outside the usual course of professional practice in prescribing
controlled substances to the ten patients who were the subject of the
Board proceeding. See 21 CFR 1306.04(a). This conclusion is supported
by both the Board's factual findings and its legal conclusion that
Respondent violated La. Rev. Stat. Sec. 37:1285(6).
As for its factual findings, the Board found ``that Respondent
failed to perform a complete physical exam or formulate or document a
medical diagnosis and failed to formulate an individualized treatment
plan for any of these patients.'' In re Afzahl, at 3. It also found
that Respondent ``received no medical history on these patients,''
``did not consider other remedies . . . than treatment with drugs,''
and that he ``performed no periodic assessments of these patient's
[sic] progress.'' Id.
Numerous decisions of the courts (including the Supreme Court in
Moore) and this Agency have recognized that the prescribing of a
controlled substance (and the continued prescribing of a controlled
substance) under the following circumstances establishes that a
physician lacked a legitimate medical purpose and acted outside of the
usual course of professional practice and therefore violated the CSA:
Without performing an appropriate physical examination,
without utilizing appropriate diagnostic testing,
failing to devise and document a written treatment plan,
failing to periodically reassess the effectiveness of the
treatment,
continuing to prescribe controlled substances without
pursuing alternative therapies,
repeatedly and continually prescribing without referring
the patient to appropriate specialists, and
failing to keep and maintain records which contain
adequate findings to support a diagnosis and the need to prescribe one
or more medications.
See, e.g.; Paul H. Volkman, 73 FR 30630 (2008), pet. for rev.
denied, 567 F.3d. 215 (6th Cir. 2009); see also David A. Ruben, 78 FR
38363 (2013); Henri Wetselaar,77 FR 57126 (2012); Jack A. Danton, 76 FR
60900 (2011); George C. Aycock, 74 FR 17529, 17544 (2009).
Accordingly, the Board's factual findings alone support the
conclusion that Respondent lacked a legitimate medical purpose and
acted outside of the usual course of professional practice when he
prescribed to the ten patients who were at issue in the Board
proceeding. See 21 CFR 1306.04(a).
Moreover, the Board specifically found that in his treatment of the
ten patients, Respondent violated Section 37:1285(6) of the Louisiana
Medical Practice Act. As discussed above, this provision prohibits
``[p]rescribing, dispensing, or administering legally controlled
substances or any dependency-inducing medication without legitimate
medical justification therefore or in other than a legal or legitimate
manner.'' La. Rev. Stat. Sec. 37:1285(6). This is not simply a
malpractice standard. Rather, this standard is equivalent to the CSA's
requirement that a controlled substance prescription ``must be issued
for a legitimate medical purpose by an individual practitioner acting
in the usual course of his professional practice.'' 21 CFR 1306.04(a).
Accordingly, I hold that the Board's findings of fact and
conclusions of law establish that Respondent knowingly diverted
controlled substances to the ten patients at issue in the State
proceeding. I further conclude that the Board's Order establishes that
Respondent has committed such acts as would render his registration
``inconsistent with the public interest.'' 21 CFR 1306.04(a). I further
hold that Respondent's misconduct is egregious and warrants the
revocation of his registration.
Loss of State Authority Grounds
Not only does the State Board's Order provide ground to revoke
Respondent's registration under the public interest standard, it also
supports revocation under the separate and independent ground that he
lacks state authority. Pursuant to 21 U.S.C. 824(a)(3), the Attorney
General is authorized to revoke or suspend a registration ``upon a
finding that the registrant . . . has had his State license or
registration suspended, revoked, or denied by competent State authority
and is no longer authorized by State law to engage in the . . .
distribution or dispensing of controlled substances.'' With respect to
a practitioner, DEA has repeatedly 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 James L. Hooper, 76 FR 71371, 71372 (2011) (citing
Leonard F. Faymore, 48 FR 32886, 32887 (1983)), pet. for rev. denied,
Hooper v. Holder, 481 Fed.
[[Page 61655]]
Appx. 826, 828 (4th Cir. June 6, 2012) (unpublished).
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) (emphasis added).
Because Congress has clearly mandated that a practitioner possess
state authority in order to be deemed a practitioner under the Act, DEA
has held repeatedly that revocation of a practitioner's registration is
the appropriate sanction if the practitioner is no longer authorized to
dispense controlled substances under the laws of the State in which he
practices medicine.\5\ See, e.g., Calvin Ramsey, 76 FR 20034, 20036
(2011); 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). It is of no consequence that Respondent has sought judicial
review of the Board's decision. See Ramsey, 76 FR at 20036 (citing
Michael G. Dolin, 65 FR 5661, 5662 (2000)). Under the CSA, all that
matters is that Respondent is no longer currently authorized to
dispense controlled substances in Louisiana. Id.
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\5\ It is unclear from the Board's order whether Respondent
offered any evidence in the State proceeding that he acknowledges
his misconduct and has undertaken remedial measures to prevent its
recurrence, and given the outcome of the proceeding and the absence
of any discussion in the Order, it seems unlikely that he did.
Indeed, while in the DEA proceeding, Respondent faced similar
allegations of unlawful prescribing, he declined to testify and
offered no evidence at all. See R.D. at 61-62.
While under this Agency's precedents, evidence that a
practitioner acknowledges his misconduct and has undertaken remedial
measures may refute the Government's prima facie case when it seeks
the revocation of a practitioner's registration on public interest
grounds, it is unnecessary to determine whether Respondent offered
such evidence in the board proceeding. This is so because
Respondent's loss of his state authority provides a separate and
independent ground for revoking his registration. And because under
the CSA, possessing authority under state law to dispense controlled
substances is a mandatory requirement for obtaining and maintaining
a DEA practitioner's registration, it does not matter whether
Respondent offered such evidence in the state board proceeding.
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Here, the Louisiana Board has suspended Respondent's medical
license for at least two years, and even in the event the Board
reinstates his license, he will be prohibited from prescribing
controlled substances for at least five years from the date of
reinstatement. Accordingly, I conclude that Registrant is without
authority under Louisiana law to handle controlled substances in the
State in which he holds his DEA registration. Because Respondent no
longer meets the CSA's requirement that he be currently authorized to
dispense controlled substances in the State in which he holds his
registration, I will order that his registration be revoked. See Craig
Bammer, 73 FR 34327, 34329 (2008); Richard Carino, M.D., 72 FR 71955,
71956 (2007) (citing cases).
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a)(3) & (4), as well as 28 CFR 0.100(b) and 0.104, I order that DEA
Certificate of Registration BA5142308, issued to Fiaz Afzal, M.D., be,
and it hereby is, revoked. I further order that any application of Fiaz
Afzal, M.D., to renew or modify his registration, be, and it hereby is,
denied. This Order is effectively immediately.\6\
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\6\ Based on the extensive and egregious nature of the
misconduct proved by the Government, I conclude that the public
interest necessitates that this Order be effectively immediately. 21
CFR 1316.67.
Dated: October 2, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-24373 Filed 10-10-14; 8:45 am]
BILLING CODE 4410-09-P
