[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Pages 71931-71934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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