Notice2024-19731
Samirkumar Shah, M.D.; Decision and Order
Primary source
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Published
September 4, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 89 Issue 171 (Wednesday, September 4, 2024)</title>
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[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Pages 71931-71934]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19731]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 23-15]
Samirkumar Shah, M.D.; Decision and Order
On November 28, 2022, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Samirkumar Shah,
M.D., (Applicant) of Pittsburgh, Pennsylvania.
[[Page 71932]]
OSC, at 1, 3. The OSC proposed the denial of Applicant's application
for a DEA Certificate of Registration, Control No. W21057811C, alleging
that Applicant has been excluded from participation in Medicare,
Medicaid, and all federal health care programs pursuant to 42 U.S.C.
1320a-7(a). Id. at 1 (citing 21 U.S.C. 824(a)(5)).\1\
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\1\ In its OSC, the Government relies upon 21 U.S.C. 824(a),
grounds which Congress provided to support revocation or suspension,
not denial of an application. Prior Agency decisions have repeatedly
determined that it is appropriate to consider a provision of 21
U.S.C. 824(a) when determining whether to grant a practitioner
registration application. Robert Wayne Locklear, M.D., 86 FR 33,738,
33,744-33,745 (2021) (collecting cases); see also Dinorah Drug
Store, Inc., 61 FR 15,972, 15,973-15,974 (1996).
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A hearing was held before DEA Chief Administrative Law Judge John
J. Mulrooney, II (the Chief ALJ), who, on November 16, 2023, issued his
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
(Recommended Decision or RD), which recommended denial of Applicant's
application. RD, at 19. Following the issuance of the RD, Applicant
filed Exceptions.\2\ Having reviewed the entire record, the Agency
adopts and hereby incorporates by reference the entirety of the Chief
ALJ's rulings, credibility findings,\3\ findings of fact, conclusions
of law, sanctions analysis, and recommended sanction as found in the
RD.
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\2\ In Applicant's Exceptions document, dated November 22, 2023,
Applicant does not put forward any particular arguments contesting
the Chief ALJ's Recommended Decision, but simply requests an appeal
of the Decision. Applicant's Exceptions, at 1-2.
\3\ The Agency adopts the Chief ALJ's summary of each of the
witnesses' testimonies as well as the Chief ALJ's assessment of each
of the witnesses' credibility. See RD, at 3-10. The Agency agrees
with the Chief ALJ that the testimony from the DEA Diversion
Investigator (DI), which was primarily focused on the non-
controversial introduction of documentary evidence and the DI's
contact with the case, was sufficiently detailed, plausible, and
internally consistent without indication of any motive to fabricate
or exaggerate and thus warranted full credibility. Id. at 4. The
Agency also agrees with the Chief ALJ that the testimony from
Applicant, which was focused on Applicant's criminal conviction, the
underlying facts of Applicant's criminal conviction, and the
mandatory exclusion resulting from Applicant's criminal conviction,
was ``ubiquitously inconsistent, frequently lacking in detail, and
commonly bereft of even a modest level of basic plausibility.'' Id.
at 9. The Chief ALJ also noted, and the Agency agrees, that
Applicant was ``unwilling to acknowledge his own misconduct on any
level.'' Id. Based on these factors, the Chief ALJ found, and the
Agency agrees, that Applicant's testimony was lacking in credibility
and warranted reduced weight. Id. at 9-10.
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I. Findings of Fact
1. Applicant's Criminal Conviction and Exclusion
In 2021, Applicant was convicted of two felony counts of healthcare
fraud in violation of 18 U.S.C. 1347. RD, at 4; Government Exhibit (GX)
3. As a result of Applicant's conviction, the U.S. Department of Health
and Human Services, Office of Inspector General (HHS/OIG) excluded
Applicant, effective July 20, 2022, from participation in Medicare,
Medicaid, and all federal health care programs pursuant to 42 U.S.C.
1320a-7(a) for a period of twenty-seven years. RD, at 4; GX 4; Tr. 26-
28.
2. Applicant's Argument
Regarding the allegations underlying his criminal conviction,
Applicant testified that he started implementing in his practice a
cardiovascular therapy called ``external counter pulsation therapy''
(ECP) designed to help patients with heart failure. Tr. 59. Applicant
testified that he offered this therapy with 25 certified physicians in
Pennsylvania. Id. According to Applicant, ``[t]he mistake was the
billing of this therapy.'' RD; at 7; Tr. 59-60. Applicant testified
that he is ``not trained as a biller'' and he ``had a private company
who prepared all the codes and billing forms.'' RD, at 7; Tr. at 60.
Applicant asserted that he ``did not realize that the billing was not
done correctly,'' but also that he ``did everything by the book and the
law.'' RD, at 7; Tr. 60, 90. Nonetheless, Applicant stated, ``the
biller is responsible for what happened . . . my name was used, but
he's liable.'' RD, at 7; Tr. 104.
Notably, when Applicant appealed his criminal conviction, the
United States Court of Appeals for the Third Circuit (Court of Appeals)
found that the ECP therapy that Applicant was prescribing and billing
for was unnecessary. RD, at 7 (citing United States v. Shah, 43 F.4th
356, 366-367 (3d Cir. 2022)). Even so, Applicant testified that every
patient to whom he prescribed ECP therapy needed it. RD, at 7; Tr. 77,
85-86. The Court of Appeals also found that Applicant had advertised
his ECP therapy to accomplish unrealistic goals, such as that it would
make patients ``younger and smarter'' and could help with a plethora of
conditions including obesity, erectile disfunction, restless leg
syndrome, and blood pressure issues. RD, at 7 (citing United States v.
Shah, 43 F.4th at 361). According to Applicant, ``[t]hose comments were
made by a couple of [his] office employees without [his] knowledge.''
RD, at 7; Tr. 89. As for the finding by the Court of Appeals that
Applicant was often not present to supervise the ECP treatments, see
United States v. Shah, 43 F.4th at 361, Applicant testified that this
finding was ``bogus'' because other physicians were present. RD, at 7;
Tr. 89-90.
As highlighted by the Chief ALJ, Applicant also repeatedly
emphasized that he had ``hired a very awful attorney in Western
Pennsylvania as [his] attorney to defend [his] case.'' RD, at 7-8; Tr.
60. Specifically, Applicant took issue with his attorney's legal
strategy (which led to the attorney firing Applicant as a client) as
well as the fact that the attorney went on to accept an appointment as
a federal prosecutor, which Applicant characterized as creating a
conflict of interest regarding his case. RD, at 8; Tr. 61. As noted by
the Chief ALJ, Applicant's latter complaint was raised with the Court
of Appeals and found to be without merit. RD, at 8 (citing United
States v. Shah, 43 F.4th at 363-365). Furthermore, Applicant claimed he
was forced to go to trial without access to relevant medical files and
also was unable to have these files reviewed by a potential expert
witness. RD, at 8; Tr. 77, 81-82, 84. Again, the Court of Appeals found
this contention to be without merit. RD, at 8 (citing United States v.
Shah, 43 F.4th at 364-365). Finally, Applicant made claims as to the
Court of Appeals itself. Specifically, Applicant claimed incorrectly
that the panel of the Court of Appeals that affirmed his conviction was
split. RD, at 8 (citing United States v. Shah, 43 F.4th at 360); Tr.
83. Applicant also claimed that his request for an en banc
reconsideration of his case was denied ``because they're busy, they're
on vacations and everything, they denied my ten-judge panel appeal.''
RD, at 8; Tr. 83. Overall, Applicant characterized his conviction as a
``complete miscarriage of justice.'' RD, at 8; Tr. 88. Regarding the
findings of HHS/OIG, Applicant testified that HHS/OIG ``just had a
summary judgment'' without providing Applicant with a trial or hearing.
RD, at 9; Tr. 93.
Applicant testified that the criminal court had ordered $1.2
million in restitution and that he was paying $300 per month. RD, at 9;
Tr. 70. As for any potential remedial measures, Applicant testified
that when he restarts his practice, he will not need Medicare patients
and he plans to focus on weight loss and cosmetic procedures for
``cash-paying patients.'' RD, at 9; Tr. 70-71.
[[Page 71933]]
II. Discussion
1. The Five Public Interest Factors
Pursuant to Section 303(g)(1) of the Controlled Substances Act
(CSA), ``[t]he Attorney General shall register practitioners . . . to
dispense . . . controlled substances . . . if the applicant is
authorized to dispense . . . controlled substances under the laws of
the State in which he practices.'' 21 U.S.C. 823(g)(1). Section
303(g)(1) further provides that an application for a practitioner's
registration may be denied upon a determination that ``the issuance of
such registration . . . would be inconsistent with the public
interest.'' Id. In making the public interest determination, the CSA
requires consideration of the following factors:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(C) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(g)(1).
In the current matter, it is undisputed that Applicant holds a
valid state medical license and is authorized to dispense controlled
substances in the Commonwealth of Pennsylvania where he practices.
Moreover, because the Government has not alleged that Applicant's
registration is inconsistent with the public interest under section
823, and although the Agency has considered section 823, the Agency
will not analyze Applicant's application under the public interest
factors. Therefore, in accordance with prior agency decisions, the
Agency will move to assess whether the Government has proven by
substantial evidence that a ground for suspension exists under 21
U.S.C. 824(a). See supra n.1.
2. Mandatory Exclusion From Federal Health Care Programs
Under Section 824(a) of the CSA, a registration ``may be suspended
or revoked'' upon a finding of one or more of five grounds. 21 U.S.C.
824(a). The ground in 21 U.S.C. 824(a)(5) requires 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.'' Id. at Sec.
824(a)(5). Here, there is no dispute in the record that Applicant is
mandatorily excluded from federal health care programs under 42 U.S.C.
1320a-7(a). The Government has presented substantial evidence of
Applicant's exclusion and the underlying criminal conviction that led
to that exclusion, and Applicant has admitted to the same. GX 2-8;
Applicant's Post-Hearing Brief, at 4-5. Accordingly, the Agency will
sustain the Government's allegation that Applicant has been excluded
from participation in a program pursuant to section 1320a-7(a) of Title
42 and find that the Government has established that a ground exists
upon which a registration could be revoked pursuant to 21 U.S.C.
824(a)(5).
Further, although the language of 21 U.S.C. 824(a)(5) discusses
suspension and revocation of a registration, for the reasons discussed
above, see supra n.1, it may also serve as the basis for the denial of
a DEA registration application. Dinorah Drug Store, Inc., 61 FR at
15,973. Applicant's exclusion from participation in a program under 42
U.S.C. 1320a-7(a), therefore, serves as an independent basis for
denying his application for DEA registration. 21 U.S.C. 824(a)(5).\4\
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\4\ The underlying conviction forming the basis for a
registrant's mandatory exclusion from participation in federal
health care programs need not involve controlled substances to
provide the grounds for revocation or denial pursuant to section
824(a)(5). Jeffrey Stein, M.D., 84 FR 46,968, 46,971-46,972 (2019);
see also Narciso Reyes, M.D., 83 FR 61,678, 61,681 (2018); KK
Pharmacy, 64 FR 49,507, 49,510 (1999) (collecting cases); Melvin N.
Seglin, M.D., 63 FR 70,431, 70,433 (1998); Stanley Dubin, D.D.S., 61
FR 60,727, 60,728 (1996).
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III. Sanction
Where, as here, the Government has established sufficient grounds
for revocation or denial, the burden shifts to the registrant to show
why he can be entrusted with the responsibility carried by a
registration. Garret Howard Smith, M.D., 83 FR 18,882, 18,910 (2018).
To establish that he can be entrusted with registration, a registrant
must both accept responsibility and demonstrate that he has undertaken
corrective measures. Holiday CVS, L.L.C., dba CVS Pharmacy Nos 219 and
5195, 77 FR 62,316, 62,339 (2012) (internal quotations omitted). Trust
is necessarily a fact-dependent determination based on individual
circumstances; therefore, the Agency looks at factors such as the
acceptance of responsibility, the credibility of that acceptance as it
relates to the probability of repeat violations or behavior, the nature
of the misconduct that forms the basis for sanction, and the Agency's
interest in deterring similar acts. See, e.g., Robert Wayne Locklear,
M.D., 86 FR 33,738, 33,746 (2021).
Here, and as noted by the ALJ, ``[Applicant's] consistent
minimization and flat out denial of his wrongdoing supports the
proposition that he has not credibly and unequivocally accepted
responsibility for his actions.'' RD, at 14. Further, Applicant
repeatedly placed the blame on others, including his practice's third-
party billers, his office employees, his attorney, the Court of
Appeals, and HHS/OIG itself. Id. at 14-15. Ultimately, the ALJ
concluded, and the Agency agrees, that Applicant has not demonstrated
unequivocal acceptance of responsibility for his actions. Id. at 16.\5\
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\5\ When a registrant fails to make the threshold showing of
acceptance of responsibility, the Agency need not address the
registrant's remedial measures. Ajay S. Ahuja, M.D., 84 FR 5,479,
5,498 n.33 (2019) (citing Jones Total Health Care Pharmacy, L.L.C. &
SND Health Care, L.L.C., 81 FR 79,188, 79,202-03 (2016)); Daniel A.
Glick, D.D.S., 80 FR 74,800, 74,801, 74,810 (2015). Even so, in the
current matter, the Agency has considered Applicant's testimony that
when he restarts his practice, he intends to avoid Medicare patients
and instead focus on weight loss and cosmetic procedures for ``cash-
paying patients.'' Tr. 70-71.
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In addition to acceptance of responsibility, the Agency considers
both specific and general deterrence when determining an appropriate
sanction. Daniel A. Glick, D.D.S., 80 FR at 74,810. In this case, the
Agency agrees with the ALJ that, regarding specific deterrence,
``[w]ithout understanding the nature of his misconduct and his own
culpability in it, there is no rational reason [to] believe that
[Applicant] would make different choices in the face of the same
circumstances in the future.'' RD, at 17. Further, the Agency agrees
with the ALJ that the interests of general deterrence also support
revocation, as a lack of sanction in the current matter would send a
message to the registrant community that a registrant can commit
similar misconduct without consequences. Id. at 18. The Agency also
agrees with the ALJ that Applicant's actions were egregious, as
```defrauding federal health care programs is egregious.'' RD, at 18
(quoting Gilbert Y. Kim, D.D.S., 87 FR 21,139, 21,145 (2022)). As noted
by the ALJ, Applicant was convicted of two felony counts of healthcare
fraud, with the Court of Appeals itself highlighting that Applicant
``billed insurers for millions of dollars in ECP treatments where they
were either not medical necessary for the patient or delivered without
the required physician supervision or both.'' RD, at 18 (quoting United
States v. Shah, 43 F.4th at 367).
In sum, Applicant has not offered any credible evidence on the
record to rebut the Government's case for denial of his
[[Page 71934]]
application and Applicant has not demonstrated that he can be entrusted
with the responsibility of registration. Id. at 19. Accordingly, the
Agency will order that Applicant's application be denied.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823, I hereby deny the pending application for a DEA Certificate
of Registration, Control No. W21057811C, submitted by Samirkumar Shah,
M.D., as well as any other pending application of Samirkumar Shah,
M.D., for additional registration in Pennsylvania. This Order is
effective October 4, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
August 19, 2024, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-19731 Filed 9-3-24; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on September 4, 2024.
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