Arvinder Singh, M.D.; Decision and Order, 8247-8251 [2016-03361]
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Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
importer of butylone (7541), a basic
class of controlled substance listed in
schedule I.
The company plans to import the
above listed controlled substance for
analytical research and testing of
equipment. This authorization does not
extend to the import of a finished FDA
approved or non-approved dosage form
for commercial sale.
registrant’s business activity is
consistent with what is authorized
under to 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–03358 Filed 2–17–16; 8:45 am]
BILLING CODE 4410–09–P
[FR Doc. 2016–03353 Filed 2–17–16; 8:45 am]
DEPARTMENT OF JUSTICE
BILLING CODE 4410–09–P
Drug Enforcement Administration
[Docket No. DEA–392]
DEPARTMENT OF JUSTICE
Importer of Controlled Substances
Registration: Sigma Aldrich
International GMBH-Sigma Aldrich Co.
LLC
Drug Enforcement Administration
ACTION:
Notice of registration.
Sigma Aldrich International
GMBH-Sigma Aldrich Co. LLC applied
to be registered as an importer of a basic
class of controlled substance. The Drug
Enforcement Administration (DEA)
grants Sigma Aldrich International
GMBH-Sigma Aldrich Co. LLC
registration as an importer of this
controlled substance.
SUPPLEMENTARY INFORMATION: By notice
dated October 13, 2015, and published
in the Federal Register on October 21,
2015, 80 FR 63839, Sigma Aldrich
International GMBH-Sigma Aldrich Co.
LLC, 3500 Dekalb Street, Saint Louis,
Missouri 63118 applied to be registered
as an importer of a certain basic class of
controlled substance. No comments or
objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of
Sigma Aldrich International GMBHSigma Aldrich Co. LLC, to import the
basic class of controlled substance is
consistent with the public interest and
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971. The
DEA investigated the company’s
maintenance of effective controls
against diversion by inspecting and
testing the company’s physical security
systems, verifying the company’s
compliance with state and local laws,
and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the above-named
company is granted registration as an
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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[Docket No. 15–1]
Arvinder Singh, M.D.; Decision and
Order
On October 16, 2014, the Deputy
Assistant Administrator, Office of
Diversion Control, issued an Order to
Show Cause to Arvinder Singh, M.D.
(Respondent), of Clifton Park, New
York. ALJ Ex. 1. The Show Cause Order
proposed the denial of Respondent’s
application for a DEA Certificate of
Registration as a practitioner on three
grounds.
First, the Show Cause Order alleged
that on August 4, 2003, Respondent,
following a jury trial, was convicted on
16 counts of health care fraud in
violation of 18 U.S.C. 1347, one count
of conspiracy to distribute controlled
substances in violation of 21 U.S.C. 846,
and 24 counts of unlawful distribution
of controlled substances in violations of
21 U.S.C. 841(a)(1) and 18 U.S.C. 2. Id.
at 1–2. (citing 21 U.S.C. 824(a)(2)).
Second, the Show Cause Order
alleged that Respondent’s convictions
for violating the Controlled Substances
Act ‘‘were based on a scheme in which
[he] left pre-signed but otherwise blank
prescriptions for [his] nursing staff to
fill in and issue Schedule II controlled
substances prescriptions to patients
when neither [he] nor any other
physician saw the patient at the time
such prescriptions were issued.’’ Id. at
2. The Show Cause Order alleged that
Respondent’s scheme also violated 21
CFR 1306.04(a) and 1306.05(a), and that
this conduct constituted acts
inconsistent with the public interest. Id.
(citing 21 U.S.C. 824(a)(4) and 823(f)).
Third, the Show Cause Order alleged
that on May 8, 2004, the U.S.
Department of Health and Human
Services (HHS) excluded Respondent
from participation in federal health care
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programs for a period of 15 years based
on his convictions for Health Care Fraud
and for violating the Controlled
Substances Act. Id. The Government
further alleged that because ‘‘the
amount of the financial loss’’ was in
excess of $5,000; the time period of
Respondent’s illegal activity exceeded
more than one year; and Respondent
had been convicted of the CSA
violations; HHS imposed a 15-year
exclusion, which was three times the
minimum exclusion period. Id. (citing
21 U.S.C. 824(a)(5)).
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
(hereinafter, CALJ) John J. Mulrooney,
II. Following pre-hearing procedures,
the CALJ conducted a hearing at which
both parties introduced documentary
evidence and called witnesses to testify.
Thereafter, both parties submitted briefs
containing their proposed findings of
fact, conclusions of law, and arguments
regarding the ultimate disposition of
this matter.
On February 10, 2015, the CALJ
issued his Recommended Decision.
Therein, the CALJ found that the
Government had established a prima
facie case to deny Respondent’s
application for registration as a
practitioner on multiple grounds.1 R.D.
at 37.
These included that Respondent had
been convicted of twenty-four counts of
1 Pursuant to 21 U.S.C. 823(f), ‘‘[t]he Attorney
General may deny an application for [a
practitioner’s] registration . . . if [she] determines
that the issuance of such registration . . . would be
inconsistent with the public interest.’’ In making
this determination, section 823(f) directs the
Agency to consider the following factors:
(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.; see
also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir.
2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir.
2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir.
2005). Moreover, while I am required to consider
each of the factors, I ‘‘need not make explicit
findings as to each one.’’ MacKay, 664 F.3d at 816
(quoting Volkman, 567 F.3d at 222 (quoting Hoxie,
419 F.3d at 482)).
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violating 21 U.S.C. 841(a)(1) in that he
unlawfully caused and aided and
abetted the illegal distribution of
schedule II controlled substances by
providing pre-signed but otherwise
blank prescriptions to nurses who
worked for him, who filled in the
prescriptions with the name of the
patient, the name of the drug, the
quantity and dosing instructions, and
provided the prescriptions to the
patients, notwithstanding that the
nurses were not legally authorized to
dispense controlled substance
prescriptions and Respondent did not
see the patients. R.D. at 32–33. As
discussed in the Recommended
Decision, this conduct implicated three
of the public interest factors and
supports the conclusion that granting
Respondent’s application ‘‘would be
inconsistent with the public interest.’’
21 U.S.C. 823(f); see also R.D. at 32–37; 2
21 CFR 1306.05(a) (‘‘All prescriptions
for controlled substances shall be dated
as of, and signed on, the day when
issued and shall bear the full name and
address of the patient, the drug name,
strength, dosage form, quantity
prescribed, directions for use, and the
name, address and registration number
of the practitioner.’’).
In addition to the above, the evidence
also shows that Respondent ‘‘has been
excluded . . . from participation in’’
federal health care programs pursuant to
the mandatory exclusion provisions of
42 U.S.C. 1320a–7(a). See 21 U.S.C.
824(a)(5) (‘‘[a] registration pursuant to
section 823 of this title to . . . dispense
a controlled substance . . . may be
suspended or revoked by the Attorney
General upon a finding that the
registrant . . . has been excluded (or
directed to be excluded) from
participation in a program pursuant to
section 1320a–7(a) of Title 42’’).3 More
2 See R.D. at 32–33 (discussing application of
factor three—‘‘the applicant’s conviction record
under Federal . . . laws relating to the . . .
distribution[ ] or dispensing of controlled
substances.’’); id. at 33–36 (discussing application
of factor two—‘‘[t]he applicant’s experience in
dispensing . . . controlled substances’’—and factor
four—‘‘[c]ompliance with applicable laws . . .
related to controlled substances’’).
3 Notwithstanding that 21 U.S.C. 824(a)(5)
addresses the Agency’s authority to suspend or
revoke a registration upon a finding that a registrant
has been excluded from participation in federal
health care programs under the mandatory
exclusion provisions of 42 U.S.C. 1320a–7(a), DEA
‘‘ ‘has consistently held that where a registration
can be revoked under section 824, it can, a fortiori,
be denied under section 823 since the law would
not require an agency to indulge in the useless act
of granting a license on one day only to withdraw
it on the next.’ ’’ Kwan Bo Jin, 77 FR 35021, 35021
n.2 (2012) (quoting Serling Drug Co. v. Detroit
Prescription Wholesaler, Inc., 40 FR 11918, 11919
(1975)). See also John R. Amato, 40 FR 22852 (1975)
(Denying application where practitioner’s state
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specifically, the evidence shows that on
May 28, 2004, the Office of Inspector
General, Department of Health and
Human Services, excluded Respondent
‘‘from participat[ing] in the Medicare,
Medicaid, and all Federal health care
programs . . . for a minimum period of
15 years.’’ GX 6. The exclusion was
based on Respondent’s convictions ‘‘of
criminal offense[s] related to’’: (1) ‘‘the
delivery of an item or service under the
Medicare program’’; (2) ‘‘fraud, theft,
embezzlement, breach of fiduciary
responsibility, or other financial
misconduct in connection with the
delivery of a health care item or service
or any act or omission in a health care
program operated or financed by any
Federal, State, or local government
agency’’; and (3) ‘‘the unlawful
manufacture, distribution, prescription
or dispensing of a controlled
substance.’’ Id. (citing 42 U.S.C. 1320a–
7(a)(1), (3), (4)). As the ALJ found, these
convictions fall within the mandatory
exclusion provisions of 42 U.S.C.
1320a–7(a).
Turning to whether Respondent had
produced sufficient evidence to rebut
the Government’s prima facie case, the
CALJ found that ‘‘Respondent continues
to dispute the nature of the criminal
charges and their severity.’’ R.D. 38. The
CALJ further found that ‘‘instead of
accepting responsibility for the crimes
for which he was convicted, he has
emphasized isolated excerpts from
orders and transcripts where he
perceives he has been ‘exonerated,’ and/
or occasions when DEA or the state
licensing agency ‘had no problems’ with
him.’’ Id. (citations omitted).
Continuing, the CALJ explained that
‘‘[t]he Respondent has not accepted
responsibility for his actions,
persuasively expressed remorse for his
conduct, or presented evidence that
could reasonably support a finding that
the Administrator should entrust him
with a registration.’’ Id.
The CALJ also found that
Respondent’s misconduct was egregious
and ‘‘militates persuasively in favor of
denial of his application.’’ Id. at 39. On
the other hand, because Respondent’s
misconduct ‘‘ended nearly fifteen years
earlier’’ and he ‘‘has paid his debt to
society,’’ the CALJ found that granting
his application would not ‘‘adversely
license had been revoked, holding that section
823(f) ‘‘must logically give the Administrator the
authority to deny a registration if the practitioner
is not authorized by the State to dispense controlled
substances. . . . To hold otherwise would mean
that all applications would have to be granted only
to be revoked the next day under 21 U.S.C.
824(a)(3). This [A]gency has consistently held that
where a registration can be revoked under section
824, it can, a fortiori, be denied under section
823.’’).
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impact compliance expectations on the
regulated community in a significant
way,’’ and thus, the Agency’s interest in
‘‘general deterrence should not,
standing alone, constitute an
insurmountable impediment to
granting’’ his application. Id.
However, the CALJ then found that
‘‘[t]he issue of specific deterrence . . .
is a dramatically different issue.’’ Id.
The CALJ explained that ‘‘virtually
every documentary, testimonial, and
argumentative contribution made by the
Respondent in these proceedings makes
it overwhelmingly clear that he does not
believe he was mistaken in any way.’’
Id. The CALJ thus concluded that ‘‘until
. . . Respondent can convincingly show
he accepts the authority of the law and
those bodies charged with enforcing it
and regulating his activities, granting
him a DEA registration will gravely
endanger the public.’’ Id. at 40. The
CALJ thus recommended that
Respondent’s application be denied. Id.
Respondent filed Exceptions to the
Recommended Decision and the
Government filed a response to
Respondent’s Exceptions. Thereafter,
the record was forwarded to my Office
for Final Agency Action.
Having considered the record in its
entirety (including Respondent’s
Exceptions), I adopt the CALJ’s findings
of fact and conclusions of law to the
extent they are discussed herein.
Because I agree with the CALJ’s ultimate
findings that: (1) Multiple grounds exist
to deny Respondent’s application, (2)
Respondent has failed to adequately
acknowledge his misconduct, (3)
Respondent’s misconduct was
egregious, and (4) the Agency’s interest
in specific deterrence supports the
denial of his application, I will adopt
the CALJ’s recommendation that I deny
Respondent’s application. A discussion
of Respondent’s Exceptions follows.
Invoking Gonzales v. Oregon, 546
U.S. 243 (2006), Respondent’s first
contention is that ‘‘the [A]gency has
relied on factors which Congress has not
intended it to consider.’’ Exceptions, at
1. Fleshing out his argument,
Respondent contends that during the
hearing, ‘‘[t]he Government has not
shown a single case of [d]iversion.’’ Id.
at 2. He argues that the Government
‘‘failed to even scratch the surface of the
case where it is apparent that billing
issues were criminalized through the
use of [the] CSA despite no evidence of
[d]iversion or [p]ublic [s]afety [i]ssues,
by creating a [sic] interpretive rule, as in
Gonzales’’ and that ‘‘Congress does not
allow DEA to use its policing power to
regulate Medical Practices or make its
own rules to prosecute doctors.’’ Id.
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Gonzales, however, offers no comfort
to Respondent because here, the
Government’s case is based on his
convictions for aiding and abetting
violations of a duly enacted statute—21
U.S.C. 841(a)(1).4 Moreover, while most
prosecutions under 21 U.S.C. 841(a)(1)
are based on allegations of drug dealing,
the statute encompasses any knowing or
intentional distribution or dispensing of
a controlled substance, ‘‘[e]xcept as
authorized by’’ the Controlled
Substances Act. 21 U.S.C. 841(a)(1). As
the Court of Appeals explained in
affirming his convictions:
[n]urses are not authorized by law to write
[Schedule II controlled substance]
prescriptions, which must be written in
triplicate by licensed physicians only.5
[Respondent] developed a scheme that
enabled nurses to see patients alone, to issue
prescriptions for Schedule II [c]ontrolled
[s]ubstances, and to bill for such services. He
and the other physicians would pre-sign the
triplicate forms and provide them to nonphysician personnel to use during patient
visits. These employees, although not trained
or legally authorized to do so, filled in all the
required prescription information—drug
type, dosage, and quantity—and provided the
prescriptions to the patients.
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United States v. Singh, 390 F.3d 168,
176 (2d Cir. 2004). Indeed, the Court of
Appeals noted that ‘‘[d]ata extracted
from Singh’s office records revealed that
the nurses issued prescriptions for at
least 76,000 tablets of Schedule II
Controlled Substances when Singh was
not present in the Practice suite.’’ Id.
Contrary to Respondent’s contention,
the Government was not required to
show that any of the drugs obtained
through these prescriptions were
diverted. See Exceptions, at 2. As the
Supreme Court recognized in Gonzales,
one of the purposes of the CSA’s
prescription regulation (21 CFR
4 In discussing Respondent’s conviction record
for the unlawful distribution of controlled
substances under factor three, the Recommended
Decision refers to 18 U.S.C. 841(a)(1) in several
places. See R.D. 32. The correct provision is 21
U.S.C. 841(a)(1).
5 The CSA leaves to state law the determination
of the classes of health care providers that are
authorized to prescribe controlled substances. See
21 U.S.C. 823(f) (‘‘The Attorney General shall
register [a] practitioner[ ] . . . to dispense . . .
controlled substances . . . if the applicant is
authorized to dispense . . . controlled substances
under the laws of the State in which he practices.’’);
id. § 802(21) (‘‘The term ‘practitioner’ means a
physician, dentist, veterinarian . . . or other person
licensed, registered, or otherwise permitted, by the
United States or the jurisdiction in which he
practices . . . to dispense . . . a controlled
substance in the course of professional practice.
. . .’’). See also 21 CFR 1306.03(a) (‘‘A prescription
for a controlled substance may be issued only by
an individual practitioner who is . . . [a]uthorized
to prescribe controlled substances by the
jurisdiction in which he is licensed to practice his
profession and . . . [e]ither registered or exempted
from registration . . . .’’).
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1306.04(a)) is to ‘‘ensure[ ] patients use
controlled substances under the
supervision of a doctor so as to prevent
addiction and recreational abuse.’’ 546
U.S. at 274. Respondent’s nurses lacked
the necessary training in medicine to
properly supervise his patients and to
determine whether additional
prescriptions were warranted. Thus, by
providing his nurses with pre-signed
and otherwise blank prescriptions,
Respondent’s conduct created a
substantial risk that the drugs would be
diverted and abused. Moreover, as
Respondent did not see the patients on
those occasions when his nurses
provided the prescriptions to the
patients, he has no idea whether any of
the drugs were abused or diverted. Yet,
as the CALJ found, Respondent still
does not understand this. R.D. 37–38.
Respondent also argues ‘‘that billing
issues were criminalized through the
use of [the] CSA despite no evidence of
Diversion or Public Safety Issues.’’
Exceptions, at 2. However, in affirming
his convictions for health care fraud, see
18 U.S.C. 1347, the Second Circuit
reviewed the sufficiency of the evidence
presented at trial and found that there
were numerous instances in which
Respondent billed for office visits as if
he had seen the patients when, in fact,
the patients were seen only by his
nurses. See Singh, 390 F.3d at 187–89.
Not only are Respondent’s convictions
res judicata, the crime of health care
fraud does not require proof of either
diversion or public safety issues. See 18
U.S.C. 1347(a).
Respondent further argues that the
CALJ ignored substantial evidence in
concluding that he failed to
acknowledge his misconduct.
Exceptions, at 3. Respondent argues
that:
I admitted right from the start in 1999 that
I made the mistake of leaving Pre-Signed
Prescriptions for legitimate patients of the
practice with treatment plan spelled [out] in
the chart, and not for Diversion. I never tried
to trivialize it. . . . I admitted to the truth.
The Agency wants me to admit Diversion
(drug trafficking) when there was none.
Id.
My review of the record finds no
instance of the Agency attempting to
elicit from Respondent an admission
that he engaged in drug trafficking.
What the record does show, however, is
that Respondent still fails to
acknowledge the risk of diversion
created by his practice of providing presigned but otherwise blank
prescriptions to his nurses and
authorizing them to issue the
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prescriptions to the patients he did not
see.6
Moreover, at the hearing, Respondent
continued to dispute the extent of his
misconduct in pre-signing prescriptions.
Respondent testified that he engaged in
this practice only after November 25,
1997, when another physician suddenly
left his practice, and ‘‘I left a few, you
know, eight or 10 prescriptions
pre[-]signed without any patient name.’’
Tr. 250. The CALJ then asked
Respondent: ‘‘So your testimony is that
there were—in the entire practice that
you had there were only eight to 10
times that you pre[-]signed
prescriptions?’’ Id. Respondent
answered: ‘‘That’s right, Your Honor.’’
Id.
The CALJ again asked: ‘‘And that’s
your testimony under oath?’’ Id. at 250–
51. Respondent answered: ‘‘Yes, that’s
my testimony under oath. And all other
prescriptions nurses handed were
pre[-]filled and then handed to the
patient. Even if I was not there they can
give that because after that we learned
our lesson. We cannot do this.’’ Id. at
251.
After Respondent asserted that the
difference between pre-signed and prefilled prescriptions was that the former
did not have a patient’s name, the CALJ
again asked: ‘‘So . . . it’s your
recollection that there were only eight to
10 times that this occurred?’’ Id.
6 At one point, Respondent testified ‘‘that there
was no medical safety issue. And, yes, as you [the
CALJ] now present it to me—and I apologize for
that. This prescription could have been diverted,
yes. There is no doubt about that.’’ Tr. 269.
However, on further questioning by the CALJ as to
whether pre-signing the prescriptions was a safety
issue, Respondent testified: ‘‘No. Safety, I also—no,
I didn’t mean no safety issue with blank
prescription, no, not at all.’’ Id. Respondent then
explained that ‘‘[t]here was no public safety [issue]
in the sense that there was no issue that patient
could be harmed. I was thinking entirely
differently.’’ Id.
The CALJ then asked: ‘‘[s]o there was no safety
issue with some patient who you didn’t know was
going to get the prescription, with whatever drugs
that were written on it that you didn’t know, . . .
there was no way in your view that any of those
patients could be harmed?’’ Tr. 269–70. Respondent
answered: ‘‘They were following my previous
protocol.’’ Id. at 270.
Later, the CALJ asked: ‘‘[s]he [the Nurse] was
exercising her judgment for patients that you didn’t
know for medications that you had no idea because
you signed them?’’ Id. at 278. Respondent
answered: ‘‘I knew the patients Your Honor. I knew
the patients were coming in.’’ Id. In response, the
CALJ asked: ‘‘Back to that again?’’ Id. Respondent
answered: ‘‘No. I get back, yes, Your Honor. I
apologize. I fully agree that, yes, it could be a great
hazard. It could have been a great hazard.’’ Id.
In response, the CALJ stated: ‘‘I know those are
your words, but they’re not very convincing the
way that you say it. I must say that your tenor, it’s
not very convincing that you think that.’’ Id. I find
no reason to reject the CALJ’s assessment of
Respondent’s demeanor and the credibility of his
testimony. See Universal Camera, 340 U.S. at 496.
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Respondent answered: ‘‘That’s correct,
Your Honor.’’ Id. Following up, the
CALJ asked: ‘‘there were only eight to 10
total pre[-]signed prescriptions that you
ever made in your life?’’ Id. After
Respondent ascertained that the CALJ
meant that the prescriptions had been
signed but otherwise ‘‘left blank,’’
Respondent answered ‘‘[y]es.’’ Id. 252.
The evidence further shows that on
December 2, 1997, Investigators from
the New York State Bureau of
Controlled Substances went to his office
at Albany Memorial Hospital and found
six blank pre-signed prescriptions in the
possession of his nurse. RX 12, at 2. At
the hearing, Respondent testified that
‘‘[a]fter the investigation, we stopped
doing that.’’ 7 Tr. 398. Yet later in his
testimony, Respondent testified that this
practice continued until some
unspecified date in February 1998,
when he hired another doctor for the
practice, id. at 405–6, before returning
to his original story and asserting that
he had provided pre-signed
prescriptions only on December 2, 1997
and had ‘‘stopped that right away’’ after
the State’s Investigator had come to his
office. Id. at 411–12.
Respondent, however, was convicted
of twenty-four counts of causing an act
to be done and aiding and abetting the
unlawful distribution of schedule II
controlled substances based on his
having provided pre-signed but
otherwise blank prescriptions to his
employees. See GX 2, at 21–24
(Superseding Indictment); GX 5, at 1
(District Court’s Judgment). Moreover,
Respondent was convicted of having
committed this offense beginning as
early as November 25, 1996, and was
convicted of nineteen such offenses
before November 25, 1997, the date on
which his physician-employee quit the
practice. See GX 2, at 21–24; GX 5, at
1.
As for his testimony that he stopped
providing pre-signed prescriptions after
becoming aware of the investigation,
Respondent was convicted of having
committed the offense on five occasions
in January 1998, more than a month
after he became aware of the
investigation. See GX 2, at 23–24; GX 5,
at 1. Moreover, the Court of Appeals
found that on July 27, 1999—nearly 18
months after the visit by the State
Investigator—federal agents executed
7 According to the Investigator’s Report,
Respondent’s wife was present at his Albany office
and ‘‘called his attorney, who showed up at the
office within minutes’’ but ‘‘would not allow the
[Investigator] to make photocopies of those blanks
on’’ that date. RX 12, at 2. (The pre-signed
prescriptions were, however, surrendered several
days later. Id.) I therefore find that Respondent was
aware of the investigation on December 2, 1997.
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search warrants at Respondent’s offices
in Albany and Port Chester, as well as
his home, and found still more presigned prescriptions. See 390 F.3d at
178.
Likewise, with respect to his
convictions for health care fraud,
Respondent asserted that there were
only 15 or 20 times when he billed an
office visit as if he had seen the patient
when the patient had only been seen by
a nurse. Id. at 254. While Respondent
admitted that ‘‘the billing mistake was
actually a big mistake’’ and ‘‘was stupid
of me,’’ id. at 255, here too, he
attempted to minimize his misconduct
asserting, in essence, that he was
confused because ‘‘in some states . . . if
[the] doctor has set a plan, the nurse can
do it as to this doctor’s plan, [and the
visit] can be billed under [the] doctor.’’
Id. at 257. Unexplained is why, if
Respondent had overbilled only 15 to 20
times, the District Court ordered him to
pay more than $227,000 in restitution to
approximately 250 payees.8 See GX 5, at
7–13. The amount of the restitution he
was ordered to pay likewise refutes his
assertion that the overbilling was not
motivated by money. See Tr. 262
(Respondent’s testimony denying that
the overbilling was financially
motivated).
Finally, Respondent argues that the
CALJ improperly ignored the State’s
recommendation; he also provides a
laundry list of exhibits that he believes
the CALJ ignored. As for the decision of
the Peer Committee of the New York
State Department of Education
Committee in the Professions, the State
has not made a recommendation to the
Agency as to whether to grant a new
registration to Respondent. While the
State’s decision to issue Respondent a
new medical license establishes that he
again holds authority under state law to
dispense controlled substances and
thereby satisfies the CSA’s prerequisite
for obtaining a practitioner’s
registration, this ‘‘Agency has long held
that ‘the Controlled Substances Act
requires that the Administrator . . .
8 Of further note, the Court of Appeals also
rejected Respondent’s challenge to his convictions
for health care fraud, explaining that his
‘‘contention that the billing codes and rules were
sufficiently ambiguous to preclude a finding of
fraudulent intent on his part is belied by the
evidence. There are in fact no ambiguities in the
billing requirements.’’ 390 F.3d at 187. See also id.
at 187–88 (‘‘Nor could a rational jury find
ambiguities sufficient to negate fraudulent intent
. . . in the Medicare rules that allow billing for
services performed by registered nurses when those
services are ‘incident to’ a physician’s services. The
requirements for ‘incident to’ billing are that the
physician must be present in the office suite and
available to provide assistance. This requirement is
plain enough, and there is ample proof that Singh
did not comply with it.’’).
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
make an independent determination
[from that made by state officials] as to
whether the granting of controlled
substance privileges would be in the
public interest.’ ’’ David A. Ruben, 78
FR 38363, 38379 n.35 (2013) (quoting
Mortimer Levin, 57 FR 8680, 8681
(1992)).
Notably, under New York law, ‘‘an
applicant . . . does not have to admit
past wrongdoing the applicant does not
believe he committed . . . in order to be
readmitted to his profession.’’ GX 9F, at
12 (citation omitted). To be sure, in
exercising its sovereign power to
regulate the medical profession, the
State of New York may follow this
policy. See Ruben, 78FR at 38837 n.53.
However, DEA is charged with
protecting the public interest, see 21
U.S.C. 823(f), and based on the threat to
public health and safety caused by
intentional and knowing misconduct
involving controlled substances, it is
fully within DEA’s authority to require
an applicant for registration to
acknowledge the full extent of his
misconduct which has been proven on
the record of the proceeding. See
MacKay v. DEA, 664 F.3d 808, 821 (10th
Cir. 2011) (discussing Jayam KrishnaIyer, 74 FR 459, 462 (2009)). And while
both MacKay and Krishna-Iyer involved
practitioners who engaged in intentional
diversion (i.e., drug trafficking), the
same consideration applies here, where,
even though there is no evidence that
the drugs the patients obtained using
the pre-signed prescriptions were
diverted, Respondent engaged in
intentional or knowing misconduct
which created a substantial risk of
diversion.
Thus, while Respondent has put
forward evidence of his remedial
measures, his continued refusal to
acknowledge the full scope of his
criminal conduct precludes a finding
that his registration would be consistent
with the public interest. See R.D. at 37–
38. Indeed, in his post-hearing brief,
Respondent goes so far as to
characterize his convictions for
violating 21 U.S.C. 841(a)(1) as
‘‘technical convictions.’’ Resp. PostHrng. Br., at 12. They were not.
Moreover, as I have previously
explained, the record contains no
support for Respondent’s assertion
(Exceptions at 4) that he was required to
admit to having issued prescriptions
outside of the usual course of
professional practice and for other than
a legitimate medical purpose (i.e., drug
trafficking). See 21 CFR 1306.04(a).
What he was required to acknowledge
was the full scope of his criminal
behavior and the risk of diversion it
created, which, as established by his
E:\FR\FM\18FEN1.SGM
18FEN1
Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
convictions and the Second Circuit’s
opinion, went on for a far longer period
and to a far greater extent than he was
willing to acknowledge during this
proceeding.
Accordingly, I find the CALJ’s
conclusion that Respondent has not
accepted responsibility for his
misconduct to be fully supported by the
record and that he has not put forward
sufficient evidence ‘‘that could
reasonably support a finding that’’ he
can be entrusted with a registration.
R.D. at 38. Because I also agree with the
CALJ’s finding that Respondent’s
misconduct was egregious and that he
still ‘‘does not believe he was mistaken
in any way,’’ I also agree that these
factors support the denial of his
application. See id. at 39. I therefore
adopt the CALJ’s recommendation that
I deny Respondent’s application.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 28 CFR 0.100(b),
I order that the application of Arvinder
Singh, M.D., for a DEA Certificate of
Registration as a practitioner, be, and it
hereby is, denied. This Order is effective
immediately.
Dated: February 10, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016–03361 Filed 2–17–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Notice of Availability of Funds and
Funding Opportunity Announcement
for: Summer Jobs and Beyond: Career
Pathways for Youth (CPY)
Employment and Training
Administration, Labor.
ACTION: Funding Opportunity
Announcement (FOA).
mstockstill on DSK4VPTVN1PROD with NOTICES
AGENCY:
Funding Opportunity Number: FOA–
ETA–16–08.
SUMMARY: The Employment and
Training Administration (ETA), U.S.
Department of Labor, announces the
availability of up to $20,000,000 in grant
funds authorized by section 169(c) of
the Workforce Innovation and
Opportunity Act (WIOA), Public Law
113–128, Dislocated Worker
Demonstration Projects, and the
Consolidated Appropriation Act of
2016, Public Law 114–113 for the pilot
grant program, Summer Jobs and
Beyond: Career Pathways for Youth
(CPY). ETA plans to award
19:03 Feb 17, 2016
The closing date for receipt of
applications under this Announcement
is March 25, 2016. We must receive
applications no later than 4:00:00 p.m.
Eastern Time.
DATES:
Employment and Training
Administration
VerDate Sep<11>2014
approximately 10–11 grants of
approximately $2,000,000 each to Local
Workforce Development Boards
(LWDB). This program is designed to
provide employment-related services to
eligible youth who are new entrants to
the workforce, including those with
limited current or past work experience.
The program will provide youth with
work experience opportunities,
including summer and year-round
part-time job opportunities for in-school
youth and employment and work
experience opportunities throughout the
year for out-of-school youth, and
exposure to career pathways in
in-demand job sectors. The grants will
require partnerships between LWDBs
and local summer employment
programs, employers, Local Education
Agencies (LEAs), and re-engagement
centers. Other community partners may
provide services to eligible youth that
assist in the development of work
experience and entry into career
pathways.
The complete FOA and any
subsequent FOA amendments in
connection with this solicitation are
described in further detail on ETA’s
Web site at https://www.doleta.gov/
grants/ or https://www.grants.gov. The
Web sites provide application
information, eligibility requirements,
review and selection procedures, and
other program requirements governing
this solicitation.
Jkt 238001
FOR FURTHER INFORMATION CONTACT:
Janice Sheelor, Grants Management
Specialist, Office of Grants
Management, at (202) 693–3538.
Applicants should email all technical
questions to sheelor.janice@dol.gov and
reference the Funding Opportunity
Number listed in this notice.
The Grant Officer for this FOA is
Latifa Jeter.
Signed February 9, 2016 in Washington,
DC.
Eric D. Luetkenhaus,
Grant Officer/Division Chief, Employment
and Training Administration.
[FR Doc. 2016–03336 Filed 2–17–16; 8:45 am]
BILLING CODE 4510–FT–P
PO 00000
8251
DEPARTMENT OF LABOR
Office of the Secretary
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request;
Representative Fee Request
ACTION:
Notice.
The Department of Labor
(DOL) is submitting the Office of
Workers’ Compensation Programs
(OWCP) sponsored information
collection request (ICR) titled,
‘‘Representative Fee Request,’’ to the
Office of Management and Budget
(OMB) for review and approval for
continued use, without change, in
accordance with the Paperwork
Reduction Act of 1995 (PRA), 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 March 21, 2016.
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=201508-1240-002 or by contacting
Michel Smyth by telephone at 202–693–
4129, TTY 202–693–8064, (these are not
toll-free numbers) or by email at 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:
Michel Smyth by telephone at 202–693–
4129, TTY 202–693–8064, (these are not
toll-free numbers) or by email at DOL_
PRA_PUBLIC@dol.gov.
SUMMARY:
Authority: 44 U.S.C. 3507(a)(1)(D).
An
attorney or other representative may
SUPPLEMENTARY INFORMATION:
Frm 00079
Fmt 4703
Sfmt 4703
E:\FR\FM\18FEN1.SGM
18FEN1
Agencies
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Pages 8247-8251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03361]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 15-1]
Arvinder Singh, M.D.; Decision and Order
On October 16, 2014, the Deputy Assistant Administrator, Office of
Diversion Control, issued an Order to Show Cause to Arvinder Singh,
M.D. (Respondent), of Clifton Park, New York. ALJ Ex. 1. The Show Cause
Order proposed the denial of Respondent's application for a DEA
Certificate of Registration as a practitioner on three grounds.
First, the Show Cause Order alleged that on August 4, 2003,
Respondent, following a jury trial, was convicted on 16 counts of
health care fraud in violation of 18 U.S.C. 1347, one count of
conspiracy to distribute controlled substances in violation of 21
U.S.C. 846, and 24 counts of unlawful distribution of controlled
substances in violations of 21 U.S.C. 841(a)(1) and 18 U.S.C. 2. Id. at
1-2. (citing 21 U.S.C. 824(a)(2)).
Second, the Show Cause Order alleged that Respondent's convictions
for violating the Controlled Substances Act ``were based on a scheme in
which [he] left pre-signed but otherwise blank prescriptions for [his]
nursing staff to fill in and issue Schedule II controlled substances
prescriptions to patients when neither [he] nor any other physician saw
the patient at the time such prescriptions were issued.'' Id. at 2. The
Show Cause Order alleged that Respondent's scheme also violated 21 CFR
1306.04(a) and 1306.05(a), and that this conduct constituted acts
inconsistent with the public interest. Id. (citing 21 U.S.C. 824(a)(4)
and 823(f)).
Third, the Show Cause Order alleged that on May 8, 2004, the U.S.
Department of Health and Human Services (HHS) excluded Respondent from
participation in federal health care programs for a period of 15 years
based on his convictions for Health Care Fraud and for violating the
Controlled Substances Act. Id. The Government further alleged that
because ``the amount of the financial loss'' was in excess of $5,000;
the time period of Respondent's illegal activity exceeded more than one
year; and Respondent had been convicted of the CSA violations; HHS
imposed a 15-year exclusion, which was three times the minimum
exclusion period. Id. (citing 21 U.S.C. 824(a)(5)).
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 (hereinafter, CALJ) John J. Mulrooney, II.
Following pre-hearing procedures, the CALJ conducted a hearing at which
both parties introduced documentary evidence and called witnesses to
testify. Thereafter, both parties submitted briefs containing their
proposed findings of fact, conclusions of law, and arguments regarding
the ultimate disposition of this matter.
On February 10, 2015, the CALJ issued his Recommended Decision.
Therein, the CALJ found that the Government had established a prima
facie case to deny Respondent's application for registration as a
practitioner on multiple grounds.\1\ R.D. at 37.
---------------------------------------------------------------------------
\1\ Pursuant to 21 U.S.C. 823(f), ``[t]he Attorney General may
deny an application for [a practitioner's] registration . . . if
[she] determines that the issuance of such registration . . . would
be inconsistent with the public interest.'' In making this
determination, section 823(f) directs the Agency to consider the
following factors:
(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.; see also MacKay v. DEA, 664 F.3d 808, 816
(10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009);
Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I
am required to consider each of the factors, I ``need not make
explicit findings as to each one.'' MacKay, 664 F.3d at 816 (quoting
Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).
---------------------------------------------------------------------------
These included that Respondent had been convicted of twenty-four
counts of
[[Page 8248]]
violating 21 U.S.C. 841(a)(1) in that he unlawfully caused and aided
and abetted the illegal distribution of schedule II controlled
substances by providing pre-signed but otherwise blank prescriptions to
nurses who worked for him, who filled in the prescriptions with the
name of the patient, the name of the drug, the quantity and dosing
instructions, and provided the prescriptions to the patients,
notwithstanding that the nurses were not legally authorized to dispense
controlled substance prescriptions and Respondent did not see the
patients. R.D. at 32-33. As discussed in the Recommended Decision, this
conduct implicated three of the public interest factors and supports
the conclusion that granting Respondent's application ``would be
inconsistent with the public interest.'' 21 U.S.C. 823(f); see also
R.D. at 32-37; \2\ 21 CFR 1306.05(a) (``All prescriptions for
controlled substances shall be dated as of, and signed on, the day when
issued and shall bear the full name and address of the patient, the
drug name, strength, dosage form, quantity prescribed, directions for
use, and the name, address and registration number of the
practitioner.'').
---------------------------------------------------------------------------
\2\ See R.D. at 32-33 (discussing application of factor three--
``the applicant's conviction record under Federal . . . laws
relating to the . . . distribution[ ] or dispensing of controlled
substances.''); id. at 33-36 (discussing application of factor two--
``[t]he applicant's experience in dispensing . . . controlled
substances''--and factor four--``[c]ompliance with applicable laws .
. . related to controlled substances'').
---------------------------------------------------------------------------
In addition to the above, the evidence also shows that Respondent
``has been excluded . . . from participation in'' federal health care
programs pursuant to the mandatory exclusion provisions of 42 U.S.C.
1320a-7(a). See 21 U.S.C. 824(a)(5) (``[a] registration pursuant to
section 823 of this title to . . . dispense a controlled substance . .
. may be suspended or revoked by the Attorney General upon a finding
that the registrant . . . has been excluded (or directed to be
excluded) from participation in a program pursuant to section 1320a-
7(a) of Title 42'').\3\ More specifically, the evidence shows that on
May 28, 2004, the Office of Inspector General, Department of Health and
Human Services, excluded Respondent ``from participat[ing] in the
Medicare, Medicaid, and all Federal health care programs . . . for a
minimum period of 15 years.'' GX 6. The exclusion was based on
Respondent's convictions ``of criminal offense[s] related to'': (1)
``the delivery of an item or service under the Medicare program''; (2)
``fraud, theft, embezzlement, breach of fiduciary responsibility, or
other financial misconduct in connection with the delivery of a health
care item or service or any act or omission in a health care program
operated or financed by any Federal, State, or local government
agency''; and (3) ``the unlawful manufacture, distribution,
prescription or dispensing of a controlled substance.'' Id. (citing 42
U.S.C. 1320a-7(a)(1), (3), (4)). As the ALJ found, these convictions
fall within the mandatory exclusion provisions of 42 U.S.C. 1320a-7(a).
---------------------------------------------------------------------------
\3\ Notwithstanding that 21 U.S.C. 824(a)(5) addresses the
Agency's authority to suspend or revoke a registration upon a
finding that a registrant has been excluded from participation in
federal health care programs under the mandatory exclusion
provisions of 42 U.S.C. 1320a-7(a), DEA `` `has consistently held
that where a registration can be revoked under section 824, it can,
a fortiori, be denied under section 823 since the law would not
require an agency to indulge in the useless act of granting a
license on one day only to withdraw it on the next.' '' Kwan Bo Jin,
77 FR 35021, 35021 n.2 (2012) (quoting Serling Drug Co. v. Detroit
Prescription Wholesaler, Inc., 40 FR 11918, 11919 (1975)). See also
John R. Amato, 40 FR 22852 (1975) (Denying application where
practitioner's state license had been revoked, holding that section
823(f) ``must logically give the Administrator the authority to deny
a registration if the practitioner is not authorized by the State to
dispense controlled substances. . . . To hold otherwise would mean
that all applications would have to be granted only to be revoked
the next day under 21 U.S.C. 824(a)(3). This [A]gency has
consistently held that where a registration can be revoked under
section 824, it can, a fortiori, be denied under section 823.'').
---------------------------------------------------------------------------
Turning to whether Respondent had produced sufficient evidence to
rebut the Government's prima facie case, the CALJ found that
``Respondent continues to dispute the nature of the criminal charges
and their severity.'' R.D. 38. The CALJ further found that ``instead of
accepting responsibility for the crimes for which he was convicted, he
has emphasized isolated excerpts from orders and transcripts where he
perceives he has been `exonerated,' and/or occasions when DEA or the
state licensing agency `had no problems' with him.'' Id. (citations
omitted). Continuing, the CALJ explained that ``[t]he Respondent has
not accepted responsibility for his actions, persuasively expressed
remorse for his conduct, or presented evidence that could reasonably
support a finding that the Administrator should entrust him with a
registration.'' Id.
The CALJ also found that Respondent's misconduct was egregious and
``militates persuasively in favor of denial of his application.'' Id.
at 39. On the other hand, because Respondent's misconduct ``ended
nearly fifteen years earlier'' and he ``has paid his debt to society,''
the CALJ found that granting his application would not ``adversely
impact compliance expectations on the regulated community in a
significant way,'' and thus, the Agency's interest in ``general
deterrence should not, standing alone, constitute an insurmountable
impediment to granting'' his application. Id.
However, the CALJ then found that ``[t]he issue of specific
deterrence . . . is a dramatically different issue.'' Id. The CALJ
explained that ``virtually every documentary, testimonial, and
argumentative contribution made by the Respondent in these proceedings
makes it overwhelmingly clear that he does not believe he was mistaken
in any way.'' Id. The CALJ thus concluded that ``until . . . Respondent
can convincingly show he accepts the authority of the law and those
bodies charged with enforcing it and regulating his activities,
granting him a DEA registration will gravely endanger the public.'' Id.
at 40. The CALJ thus recommended that Respondent's application be
denied. Id.
Respondent filed Exceptions to the Recommended Decision and the
Government filed a response to Respondent's Exceptions. Thereafter, the
record was forwarded to my Office for Final Agency Action.
Having considered the record in its entirety (including
Respondent's Exceptions), I adopt the CALJ's findings of fact and
conclusions of law to the extent they are discussed herein. Because I
agree with the CALJ's ultimate findings that: (1) Multiple grounds
exist to deny Respondent's application, (2) Respondent has failed to
adequately acknowledge his misconduct, (3) Respondent's misconduct was
egregious, and (4) the Agency's interest in specific deterrence
supports the denial of his application, I will adopt the CALJ's
recommendation that I deny Respondent's application. A discussion of
Respondent's Exceptions follows.
Invoking Gonzales v. Oregon, 546 U.S. 243 (2006), Respondent's
first contention is that ``the [A]gency has relied on factors which
Congress has not intended it to consider.'' Exceptions, at 1. Fleshing
out his argument, Respondent contends that during the hearing, ``[t]he
Government has not shown a single case of [d]iversion.'' Id. at 2. He
argues that the Government ``failed to even scratch the surface of the
case where it is apparent that billing issues were criminalized through
the use of [the] CSA despite no evidence of [d]iversion or [p]ublic
[s]afety [i]ssues, by creating a [sic] interpretive rule, as in
Gonzales'' and that ``Congress does not allow DEA to use its policing
power to regulate Medical Practices or make its own rules to prosecute
doctors.'' Id.
[[Page 8249]]
Gonzales, however, offers no comfort to Respondent because here,
the Government's case is based on his convictions for aiding and
abetting violations of a duly enacted statute--21 U.S.C. 841(a)(1).\4\
Moreover, while most prosecutions under 21 U.S.C. 841(a)(1) are based
on allegations of drug dealing, the statute encompasses any knowing or
intentional distribution or dispensing of a controlled substance,
``[e]xcept as authorized by'' the Controlled Substances Act. 21 U.S.C.
841(a)(1). As the Court of Appeals explained in affirming his
convictions:
---------------------------------------------------------------------------
\4\ In discussing Respondent's conviction record for the
unlawful distribution of controlled substances under factor three,
the Recommended Decision refers to 18 U.S.C. 841(a)(1) in several
places. See R.D. 32. The correct provision is 21 U.S.C. 841(a)(1).
[n]urses are not authorized by law to write [Schedule II controlled
substance] prescriptions, which must be written in triplicate by
licensed physicians only.\5\ [Respondent] developed a scheme that
enabled nurses to see patients alone, to issue prescriptions for
Schedule II [c]ontrolled [s]ubstances, and to bill for such
services. He and the other physicians would pre-sign the triplicate
forms and provide them to non-physician personnel to use during
patient visits. These employees, although not trained or legally
authorized to do so, filled in all the required prescription
information--drug type, dosage, and quantity--and provided the
prescriptions to the patients.
---------------------------------------------------------------------------
\5\ The CSA leaves to state law the determination of the classes
of health care providers that are authorized to prescribe controlled
substances. See 21 U.S.C. 823(f) (``The Attorney General shall
register [a] practitioner[ ] . . . to dispense . . . controlled
substances . . . if the applicant is authorized to dispense . . .
controlled substances under the laws of the State in which he
practices.''); id. Sec. 802(21) (``The term `practitioner' means a
physician, dentist, veterinarian . . . or other person licensed,
registered, or otherwise permitted, by the United States or the
jurisdiction in which he practices . . . to dispense . . . a
controlled substance in the course of professional practice. . .
.''). See also 21 CFR 1306.03(a) (``A prescription for a controlled
substance may be issued only by an individual practitioner who is .
. . [a]uthorized to prescribe controlled substances by the
jurisdiction in which he is licensed to practice his profession and
. . . [e]ither registered or exempted from registration . . . .'').
United States v. Singh, 390 F.3d 168, 176 (2d Cir. 2004). Indeed, the
Court of Appeals noted that ``[d]ata extracted from Singh's office
records revealed that the nurses issued prescriptions for at least
76,000 tablets of Schedule II Controlled Substances when Singh was not
present in the Practice suite.'' Id.
Contrary to Respondent's contention, the Government was not
required to show that any of the drugs obtained through these
prescriptions were diverted. See Exceptions, at 2. As the Supreme Court
recognized in Gonzales, one of the purposes of the CSA's prescription
regulation (21 CFR 1306.04(a)) is to ``ensure[ ] patients use
controlled substances under the supervision of a doctor so as to
prevent addiction and recreational abuse.'' 546 U.S. at 274.
Respondent's nurses lacked the necessary training in medicine to
properly supervise his patients and to determine whether additional
prescriptions were warranted. Thus, by providing his nurses with pre-
signed and otherwise blank prescriptions, Respondent's conduct created
a substantial risk that the drugs would be diverted and abused.
Moreover, as Respondent did not see the patients on those occasions
when his nurses provided the prescriptions to the patients, he has no
idea whether any of the drugs were abused or diverted. Yet, as the CALJ
found, Respondent still does not understand this. R.D. 37-38.
Respondent also argues ``that billing issues were criminalized
through the use of [the] CSA despite no evidence of Diversion or Public
Safety Issues.'' Exceptions, at 2. However, in affirming his
convictions for health care fraud, see 18 U.S.C. 1347, the Second
Circuit reviewed the sufficiency of the evidence presented at trial and
found that there were numerous instances in which Respondent billed for
office visits as if he had seen the patients when, in fact, the
patients were seen only by his nurses. See Singh, 390 F.3d at 187-89.
Not only are Respondent's convictions res judicata, the crime of health
care fraud does not require proof of either diversion or public safety
issues. See 18 U.S.C. 1347(a).
Respondent further argues that the CALJ ignored substantial
evidence in concluding that he failed to acknowledge his misconduct.
Exceptions, at 3. Respondent argues that:
I admitted right from the start in 1999 that I made the mistake
of leaving Pre-Signed Prescriptions for legitimate patients of the
practice with treatment plan spelled [out] in the chart, and not for
Diversion. I never tried to trivialize it. . . . I admitted to the
truth. The Agency wants me to admit Diversion (drug trafficking)
when there was none.
Id.
My review of the record finds no instance of the Agency attempting
to elicit from Respondent an admission that he engaged in drug
trafficking. What the record does show, however, is that Respondent
still fails to acknowledge the risk of diversion created by his
practice of providing pre-signed but otherwise blank prescriptions to
his nurses and authorizing them to issue the prescriptions to the
patients he did not see.\6\
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\6\ At one point, Respondent testified ``that there was no
medical safety issue. And, yes, as you [the CALJ] now present it to
me--and I apologize for that. This prescription could have been
diverted, yes. There is no doubt about that.'' Tr. 269. However, on
further questioning by the CALJ as to whether pre-signing the
prescriptions was a safety issue, Respondent testified: ``No.
Safety, I also--no, I didn't mean no safety issue with blank
prescription, no, not at all.'' Id. Respondent then explained that
``[t]here was no public safety [issue] in the sense that there was
no issue that patient could be harmed. I was thinking entirely
differently.'' Id.
The CALJ then asked: ``[s]o there was no safety issue with some
patient who you didn't know was going to get the prescription, with
whatever drugs that were written on it that you didn't know, . . .
there was no way in your view that any of those patients could be
harmed?'' Tr. 269-70. Respondent answered: ``They were following my
previous protocol.'' Id. at 270.
Later, the CALJ asked: ``[s]he [the Nurse] was exercising her
judgment for patients that you didn't know for medications that you
had no idea because you signed them?'' Id. at 278. Respondent
answered: ``I knew the patients Your Honor. I knew the patients were
coming in.'' Id. In response, the CALJ asked: ``Back to that
again?'' Id. Respondent answered: ``No. I get back, yes, Your Honor.
I apologize. I fully agree that, yes, it could be a great hazard. It
could have been a great hazard.'' Id.
In response, the CALJ stated: ``I know those are your words,
but they're not very convincing the way that you say it. I must say
that your tenor, it's not very convincing that you think that.'' Id.
I find no reason to reject the CALJ's assessment of Respondent's
demeanor and the credibility of his testimony. See Universal Camera,
340 U.S. at 496.
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Moreover, at the hearing, Respondent continued to dispute the
extent of his misconduct in pre-signing prescriptions. Respondent
testified that he engaged in this practice only after November 25,
1997, when another physician suddenly left his practice, and ``I left a
few, you know, eight or 10 prescriptions pre[-]signed without any
patient name.'' Tr. 250. The CALJ then asked Respondent: ``So your
testimony is that there were--in the entire practice that you had there
were only eight to 10 times that you pre[-]signed prescriptions?'' Id.
Respondent answered: ``That's right, Your Honor.'' Id.
The CALJ again asked: ``And that's your testimony under oath?'' Id.
at 250-51. Respondent answered: ``Yes, that's my testimony under oath.
And all other prescriptions nurses handed were pre[-]filled and then
handed to the patient. Even if I was not there they can give that
because after that we learned our lesson. We cannot do this.'' Id. at
251.
After Respondent asserted that the difference between pre-signed
and pre-filled prescriptions was that the former did not have a
patient's name, the CALJ again asked: ``So . . . it's your recollection
that there were only eight to 10 times that this occurred?'' Id.
[[Page 8250]]
Respondent answered: ``That's correct, Your Honor.'' Id. Following up,
the CALJ asked: ``there were only eight to 10 total pre[-]signed
prescriptions that you ever made in your life?'' Id. After Respondent
ascertained that the CALJ meant that the prescriptions had been signed
but otherwise ``left blank,'' Respondent answered ``[y]es.'' Id. 252.
The evidence further shows that on December 2, 1997, Investigators
from the New York State Bureau of Controlled Substances went to his
office at Albany Memorial Hospital and found six blank pre-signed
prescriptions in the possession of his nurse. RX 12, at 2. At the
hearing, Respondent testified that ``[a]fter the investigation, we
stopped doing that.'' \7\ Tr. 398. Yet later in his testimony,
Respondent testified that this practice continued until some
unspecified date in February 1998, when he hired another doctor for the
practice, id. at 405-6, before returning to his original story and
asserting that he had provided pre-signed prescriptions only on
December 2, 1997 and had ``stopped that right away'' after the State's
Investigator had come to his office. Id. at 411-12.
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\7\ According to the Investigator's Report, Respondent's wife
was present at his Albany office and ``called his attorney, who
showed up at the office within minutes'' but ``would not allow the
[Investigator] to make photocopies of those blanks on'' that date.
RX 12, at 2. (The pre-signed prescriptions were, however,
surrendered several days later. Id.) I therefore find that
Respondent was aware of the investigation on December 2, 1997.
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Respondent, however, was convicted of twenty-four counts of causing
an act to be done and aiding and abetting the unlawful distribution of
schedule II controlled substances based on his having provided pre-
signed but otherwise blank prescriptions to his employees. See GX 2, at
21-24 (Superseding Indictment); GX 5, at 1 (District Court's Judgment).
Moreover, Respondent was convicted of having committed this offense
beginning as early as November 25, 1996, and was convicted of nineteen
such offenses before November 25, 1997, the date on which his
physician-employee quit the practice. See GX 2, at 21-24; GX 5, at 1.
As for his testimony that he stopped providing pre-signed
prescriptions after becoming aware of the investigation, Respondent was
convicted of having committed the offense on five occasions in January
1998, more than a month after he became aware of the investigation. See
GX 2, at 23-24; GX 5, at 1. Moreover, the Court of Appeals found that
on July 27, 1999--nearly 18 months after the visit by the State
Investigator--federal agents executed search warrants at Respondent's
offices in Albany and Port Chester, as well as his home, and found
still more pre-signed prescriptions. See 390 F.3d at 178.
Likewise, with respect to his convictions for health care fraud,
Respondent asserted that there were only 15 or 20 times when he billed
an office visit as if he had seen the patient when the patient had only
been seen by a nurse. Id. at 254. While Respondent admitted that ``the
billing mistake was actually a big mistake'' and ``was stupid of me,''
id. at 255, here too, he attempted to minimize his misconduct
asserting, in essence, that he was confused because ``in some states .
. . if [the] doctor has set a plan, the nurse can do it as to this
doctor's plan, [and the visit] can be billed under [the] doctor.'' Id.
at 257. Unexplained is why, if Respondent had overbilled only 15 to 20
times, the District Court ordered him to pay more than $227,000 in
restitution to approximately 250 payees.\8\ See GX 5, at 7-13. The
amount of the restitution he was ordered to pay likewise refutes his
assertion that the overbilling was not motivated by money. See Tr. 262
(Respondent's testimony denying that the overbilling was financially
motivated).
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\8\ Of further note, the Court of Appeals also rejected
Respondent's challenge to his convictions for health care fraud,
explaining that his ``contention that the billing codes and rules
were sufficiently ambiguous to preclude a finding of fraudulent
intent on his part is belied by the evidence. There are in fact no
ambiguities in the billing requirements.'' 390 F.3d at 187. See also
id. at 187-88 (``Nor could a rational jury find ambiguities
sufficient to negate fraudulent intent . . . in the Medicare rules
that allow billing for services performed by registered nurses when
those services are `incident to' a physician's services. The
requirements for `incident to' billing are that the physician must
be present in the office suite and available to provide assistance.
This requirement is plain enough, and there is ample proof that
Singh did not comply with it.'').
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Finally, Respondent argues that the CALJ improperly ignored the
State's recommendation; he also provides a laundry list of exhibits
that he believes the CALJ ignored. As for the decision of the Peer
Committee of the New York State Department of Education Committee in
the Professions, the State has not made a recommendation to the Agency
as to whether to grant a new registration to Respondent. While the
State's decision to issue Respondent a new medical license establishes
that he again holds authority under state law to dispense controlled
substances and thereby satisfies the CSA's prerequisite for obtaining a
practitioner's registration, this ``Agency has long held that `the
Controlled Substances Act requires that the Administrator . . . make an
independent determination [from that made by state officials] as to
whether the granting of controlled substance privileges would be in the
public interest.' '' David A. Ruben, 78 FR 38363, 38379 n.35 (2013)
(quoting Mortimer Levin, 57 FR 8680, 8681 (1992)).
Notably, under New York law, ``an applicant . . . does not have to
admit past wrongdoing the applicant does not believe he committed . . .
in order to be readmitted to his profession.'' GX 9F, at 12 (citation
omitted). To be sure, in exercising its sovereign power to regulate the
medical profession, the State of New York may follow this policy. See
Ruben, 78FR at 38837 n.53. However, DEA is charged with protecting the
public interest, see 21 U.S.C. 823(f), and based on the threat to
public health and safety caused by intentional and knowing misconduct
involving controlled substances, it is fully within DEA's authority to
require an applicant for registration to acknowledge the full extent of
his misconduct which has been proven on the record of the proceeding.
See MacKay v. DEA, 664 F.3d 808, 821 (10th Cir. 2011) (discussing Jayam
Krishna-Iyer, 74 FR 459, 462 (2009)). And while both MacKay and
Krishna-Iyer involved practitioners who engaged in intentional
diversion (i.e., drug trafficking), the same consideration applies
here, where, even though there is no evidence that the drugs the
patients obtained using the pre-signed prescriptions were diverted,
Respondent engaged in intentional or knowing misconduct which created a
substantial risk of diversion.
Thus, while Respondent has put forward evidence of his remedial
measures, his continued refusal to acknowledge the full scope of his
criminal conduct precludes a finding that his registration would be
consistent with the public interest. See R.D. at 37-38. Indeed, in his
post-hearing brief, Respondent goes so far as to characterize his
convictions for violating 21 U.S.C. 841(a)(1) as ``technical
convictions.'' Resp. Post-Hrng. Br., at 12. They were not.
Moreover, as I have previously explained, the record contains no
support for Respondent's assertion (Exceptions at 4) that he was
required to admit to having issued prescriptions outside of the usual
course of professional practice and for other than a legitimate medical
purpose (i.e., drug trafficking). See 21 CFR 1306.04(a). What he was
required to acknowledge was the full scope of his criminal behavior and
the risk of diversion it created, which, as established by his
[[Page 8251]]
convictions and the Second Circuit's opinion, went on for a far longer
period and to a far greater extent than he was willing to acknowledge
during this proceeding.
Accordingly, I find the CALJ's conclusion that Respondent has not
accepted responsibility for his misconduct to be fully supported by the
record and that he has not put forward sufficient evidence ``that could
reasonably support a finding that'' he can be entrusted with a
registration. R.D. at 38. Because I also agree with the CALJ's finding
that Respondent's misconduct was egregious and that he still ``does not
believe he was mistaken in any way,'' I also agree that these factors
support the denial of his application. See id. at 39. I therefore adopt
the CALJ's recommendation that I deny Respondent's application.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28
CFR 0.100(b), I order that the application of Arvinder Singh, M.D., for
a DEA Certificate of Registration as a practitioner, be, and it hereby
is, denied. This Order is effective immediately.
Dated: February 10, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-03361 Filed 2-17-16; 8:45 am]
BILLING CODE 4410-09-P