Notice2022-19975
Bernadette U. Iguh, M.D.; Decision and Order
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Published
September 15, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 87 Issue 178 (Thursday, September 15, 2022)</title>
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[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56709-56712]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19975]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 22-9]
Bernadette U. Iguh, M.D.; Decision and Order
On November 10, 2021, the Drug Enforcement Administration
(hereinafter, DEA or Government),
[[Page 56710]]
issued an Order to Show Cause (hereinafter, OSC), seeking to revoke the
DEA Certificate of Registration, Control No. FI1112084, of Bernadette
U. Iguh, M.D., (hereinafter, Respondent) of Houston, Texas, pursuant to
21 U.S.C. 824(a)(5). OSC, at 1, 3. The Government alleged that
Respondent 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.
A hearing was held before an Administrative Law Judge (hereinafter,
the ALJ) on March 1, 2022. On May 19, 2022, the ALJ issued his
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge (hereinafter, Recommended Decision or
RD), which recommended that the Agency revoke Respondent's
registration. RD, at 19. Neither party filed exceptions.
I. Findings of Fact
A. Witness Credibility
The Government presented its case through the testimony of a single
witness, a DEA Diversion Investigator (hereinafter, the DI). Tr. 13-23.
The ALJ found the DI's testimony to be credible and afforded it
considerable weight. RD, at 5. Respondent presented her case through
the testimony of a single witness, herself. Tr. 24-41. The ALJ noted
some minor inconsistencies in Respondent's testimony regarding the
status of her registration, as well as in Respondent's testimony
regarding the dollar amount of kickbacks that she received. RD, at 9.
Nonetheless, the ALJ found Respondent's testimony to be generally
consistent, genuine, and credible and afforded it significant weight.
Id. Here, the Agency adopts the ALJ's summary of both the DI's and the
Respondent's testimony and the ALJ's credibility determinations. Id. at
3-5, 5-9.
B. Respondent's Criminal Conviction and Exclusion
Respondent is a Texas physician who holds a DEA registration to
handle controlled substances in Schedules II-V. Government Exhibit
(hereinafter, GX) 1 (Respondent's COR FI1112084); see also RD, at 2
(Stipulations 1-2). Respondent operated a solo family medicine practice
in Houston from 2009 to August 2021. Tr. 26-27. From August 2009
through July 2013, Respondent submitted fraudulent certifications to
Medicare for home health services. GX 4 (HHS Appeals Board Decision),
at 3. Specifically, Respondent would ``certify that beneficiaries were
homebound and that home health services were medically necessary
regardless of whether the patients needed home health.'' \1\ GX 4, at
3. According to Respondent, she did not understand the definition of
``homebound'' at the time, and she thought that she was properly
evaluating the files of these patients and certifying them as homebound
based on a proper medical assessment. Tr. 27, 45, 48.\2\ Respondent
``was paid for each certification by the owner of [a] home health
agency'' and received ``at least $17,800 \3\ in kickbacks . . . for her
false certifications.'' GX 4, at 3. As a result of the false
certifications, ``Medicare paid about $884,585 to the home health
agency.'' Id.
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\1\ Respondent testified that she charged for these orders and
billed them to Medicare. Tr. 28. She explained that if she saw a
patient in Houston, she would charge the patient $100, while if she
saw a patient away from Houston, because she had to travel, she
would charge the patient $150. Id. Respondent admitted that these
charges were ``very inappropriate,'' but stated that at the time,
she did not know that they were inappropriate. Id.
\2\ Respondent testified that she now understands that
``homebound'' has a much narrower definition than she had previously
thought, and pertained to patients who have a medical necessity for
home care and who are ``not able to go from place to place, other
than [a] medical office or the clinic for their medical needs.'' Id.
at 45-46.
\3\ Respondent testified that she only received ``up to
$15,000.'' Id. at 52.
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On October 3, 2017, Respondent pled guilty to one count of
conspiracy to commit healthcare fraud in violation of 18 U.S.C. 1349.
GX 2 (Criminal Judgment Against Respondent), at 1; see also RD, at 3
(Stipulation 4). Judgment was entered on March 5, 2021 and as a result
of her guilty plea, Respondent was sentenced to time served and 15
months of supervised release and was ordered to pay $884,585 in
restitution.\4\ GX 2, at 1-5; see also RD, at 3 (Stipulations 4-5).
Based on Respondent's guilty plea and conviction, on May 28, 2021, the
Department of Health and Human Services, Office of Inspector General
(hereinafter, HHS/OIG) excluded Respondent from participation in
Medicare, Medicaid, and all federal health care programs for a minimum
period of 10 years pursuant to 42 U.S.C. 1320a-7(a). GX 3 (HHS
Mandatory Exclusion Letter), at 1; see also RD, at 3 (Stipulations 6-
7).\5\
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\4\ Respondent testified that this was ``money that they said
that [her] signature allowed the home health people to make'' and
that she did not profit from it. Tr. 51-52.
\5\ Respondent later appealed her exclusion, not challenging its
imposition but its length of 10 years. See GX 4 (HHS Appeals Board
Decision), at 1.
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C. Respondent's Rehabilitation and Controlled Substance Prescribing
Following her criminal conviction, Texas permitted Respondent to
continue practicing medicine. Id. at 30. In August 2021, Respondent's
medical license was put on a three-year probation that limited
Respondent to group practice and required that she complete 12 hours of
CME (four hours of billing and eight hours of ethics). Id. at 31-32.
Respondent testified that, as of March 1, 2022, she still had two more
months of probation and that she has been ``100 percent compliant''
thus far, and current in her restitution payments. Id. at 30, 52.
Respondent also testified that she has completed 30 total hours of CME,
including the 12 required hours of billing and ethics, as well as
additional hours in opioid and diversion awareness screening. Id. at
31-33. Since her conviction, Respondent has worked in a group medical
practice and has been teaching nursing school clinicals.\6\ Id. at 33.
Respondent testified that because of what she has learned, she has
completed community service, has given lectures, and has talked to many
doctors about what she went through ``so they won't have to go through
it'' and to teach them about the risks and the potential consequences.
Id. at 40-41. Additionally, Respondent testified that she provided
records and testimony in matters related to home health agencies to the
Government, and stated that, as of March 1, 2022, she has given the
Government 12 interviews. Id. at 34-35. Respondent testified that she
was helping the Government voluntarily, not as part of her criminal
settlement or medical board discipline. Id. at 36.\7\
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\6\ Respondent stated that she was a nurse for 20 years before
she went to medical school. Id. at 34.
\7\ When asked why she was conducting these interviews,
Respondent stated, ``I don't know if I have to go in attendance, but
I worked so hard to come to where I am right now, and I felt like
what happened to me should not--the hours you have to pay for, the
price for what happened to me, because I have been--I have done
everything. I think life is difficult for the years I've paid.'' Id.
at 35-36.
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Regarding Respondent's controlled substance prescribing, Respondent
noted that her criminal conviction did not relate at all to controlled
substances and that the Texas Medical Board did not restrict her
ability to prescribe controlled substances. Id. at 30, 33. Regarding
her previous practices related to controlled substances, Respondent
testified that she implemented safety measures to ensure that her
prescribing was appropriate including: (1) checking a prescription
monitoring system before issuing or renewing any controlled substance
prescription to a patient; (2) restricting such patients to one
pharmacy of their choice; and (3) referring any pain management
patients to two pain specialists. Id. 36-39.
[[Page 56711]]
II. Discussion
Under Section 824(a) of the Controlled Substances Act (hereinafter,
CSA), a registration ``may be suspended or revoked'' upon a finding of
one or more of five grounds. 21 U.S.C. 824. 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. Here, there is no dispute in the record
that Respondent is mandatorily excluded from federal health care
programs under 42 U.S.C. 1320a-7(a). The Government has presented
substantial evidence of Respondent's exclusion and the underlying
criminal conviction that led to that exclusion and Respondent has
admitted to the same. See GX 2-4; Respondent's Post-Hearing Brief, at
1. Accordingly, the Agency will sustain the Government's allegation
that Respondent 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).\8\ Where, as here, the
Government has met its prima facie burden of showing that a ground for
revocation exists, the burden shifts to the Respondent to show why she
can be entrusted with a registration. See Stein, 84 FR 46972.
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\8\ The Government correctly argues, Government's Post-Hearing
Brief, at 5-6, and Respondent did not rebut, Respondent's Post-
Hearing Brief, at 3, that 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 46968, 46971-72 (2019); see
also Narciso Reyes, M.D., 83 FR 61678, 61681 (2018); KK Pharmacy, 64
FR 49507, 49,510 (1999) (collecting cases); Melvin N. Seglin, M.D.,
63 FR 70431, 70433 (1998); Stanley Dubin, D.D.S., 61 FR 60727, 60728
(1996).
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III. Sanction
The Government has established grounds to deny a registration;
therefore, the Agency will review any evidence and argument the
Respondent submitted to determine whether or not the Respondent has
presented ``sufficient mitigating evidence to assure the Administrator
that [she] can be trusted with the responsibility carried by such a
registration.'' Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 (2007)
(quoting Leo R. Miller, M.D., 53 FR 21,931, 21,932 (1988)). ``
`Moreover, because ``past performance is the best predictor of future
performance,'' ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452
(7th Cir. 1995), [the Agency] has repeatedly held that where a
registrant has committed acts inconsistent with the public interest,
the registrant must accept responsibility for [her] actions and
demonstrate that [she] will not engage in future misconduct.' '' Jayam
Krishna-Iyer, M.D., 74 FR 459, 463 (2009) (quoting Medicine Shoppe, 73
FR 364, 387 (2008)); see also Samuel S. Jackson, D.D.S., 72 FR 23,853;
John H. Kennedy, M.D., 71 FR 35,705, 35,709 (2006); Prince George
Daniels, D.D.S., 60 FR 62,884, 62,887 (1995). The issue of trust is
necessarily a fact-dependent determination based on the circumstances
presented by the individual respondent; therefore, the Agency looks at
factors, such as the acceptance of responsibility and the credibility
of that acceptance as it relates to the probability of repeat
violations or behavior and the nature of the misconduct that forms the
basis for sanction, while also considering the Agency's interest in
deterring similar acts. See Arvinder Singh, M.D., 81 FR 8247, 8248
(2016).
A. Acceptance of Responsibility
Here, Respondent stated multiple times that she takes full
responsibility for her actions and said, ``I learned that you can't
just sign signatures like I signed to get me in trouble, and you can't
just accept money for signing signatures that I signed. And that has
been a very big lesson on my part.'' Tr. 27, 40-41; see also
Respondent's Post-Hearing Brief, at 3. Respondent testified that she
now understands that what she did was ``bad,'' because it was
``unethical,'' Tr. 41; however, it is unclear how Respondent did not
know prior to being caught that she ``wasn't supposed to fill medicine
and at the same time take money.'' Tr. 49. It is noted that Respondent
pled guilty to the criminal charges against her and self-reported her
conviction to the Texas Medical Board and that she testified that she
can be trusted with a DEA registration. Tr. 30-31, 41; GX 2, at 1; see
also RD, at 3 (Stipulation 4). Nonetheless, the Agency finds
Respondent's acceptance of responsibility to be insufficient due to her
attempts to minimize her misconduct and failure to acknowledge its full
scope. See Stein, 84 FR at 46972.
Early in her testimony, Respondent stated that she was convicted
because she ``wasn't so sure of homeboundedness,'' but noted that she
pled guilty because ``it was [her] signature.'' Tr. 27. However,
Respondent also testified that she properly evaluated the files of
these patients and that when she signed an order related to their
``homeboundedness,'' it was based on a proper medical assessment. Id.
at 28. On cross-examination, Respondent clarified, ``At that point, I
thought it was but I didn't know--understand the definition. There was
a different definition of homeboundedness. I did not understand it.
That's why I said I had to plead.'' Id. at 45. Ultimately, Respondent's
emphasis on her ignorance as the cause of her misconduct, in tandem
with Respondent's notable lack of emphasis on the damages she caused,
both serve to downplay the extent to which her own actions and
decisions were harmful. Further, Respondent testified that she signed
the fraudulent certifications to Medicare ``not knowing that some home
health agencies [were] not doing what they're supposed to do'' in an
attempt to shift blame from herself to the home health agencies. Id. at
27-28. Finally, Respondent minimized her financial gain in direct
contradiction with the record. As the ALJ noted, Respondent understated
the amount that she received in kickbacks--testifying that she only
received what the home health agency paid to her, which was ``up to
$15,000,'' while the ALJ in the HHS Appeals Board Decision found that
Respondent received $17,800. RD, at 15; see also Tr. 52; GX 4, at 3.\9\
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\9\ Even if Respondent's acceptance of responsibility for her
wrongdoing had been sufficient such that the Agency would reach the
matter of remedial measures, Respondent has not offered adequate
remedial measures to assure the Agency that she can be trusted with
registration. See Carol Hippenmeyer, M.D., 86 FR 33748, 33,773
(2021). Respondent has been compliant in completing her probation as
well as current in her restitution payments, Tr. 30, 52, and she has
completed community service, has given lectures, has talked to other
doctors, and has conducted voluntary interviews with the Government
regarding her experience. Id. at 34-36, 40-41. However, as the ALJ
stated, it is difficult ``to gauge the impact, if any, of the
outreach the Respondent has conducted with other medical
professionals given her very limited and non-specific testimony on
her efforts in this regard.'' RD, at 16. Moreover, Respondent's
statement that she conducted this outreach to other medical
professionals ``so they won't have to go through it'' suggests that
Respondent has failed to grasp the greater harm caused by her
misconduct beyond what she has personally suffered. Tr. 41.
Similarly, Respondent's explanation as to why she provided
interviews to the Government in which she concluded that ``life
[was] difficult for the years [she has] paid,'' further suggests
that she has not truly learned from her experience and continues to
only understand the negative consequences of her actions as those
that have impacted her own life. Id. at 35-36. In both instances,
Respondent's focus on the harm caused to herself rather than on the
harm caused to her patients and the community undermines the
remedial value of her efforts. Finally, although Respondent
testified to completing 30 total hours of CME, including additional
hours in opioid and diversion awareness screening beyond what was
required by her probation, Tr. 31-33, Respondent failed to provide
any documentation certifying her completion of these hours.
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[[Page 56712]]
B. Specific and General Deterrence
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 74800, 74810 (2015). Specific
deterrence is the DEA's interest in ensuring that a registrant complies
with the laws and regulations governing controlled substances in the
future. Id. General deterrence concerns the DEA's responsibility to
deter conduct similar to the proven allegations against the respondent
for the protection of the public at large. Id. In this case, the Agency
believes a sanction of revocation would deter Respondent and the
general registrant community from unethical behavior involving the
acceptance of money for unlawful and unethical acts. It is not
difficult to imagine, as the Agency has repeatedly encountered, this
situation repeating itself in the context of receiving money for
controlled substance prescriptions.
C. Egregiousness
The Agency also looks to the egregiousness and the extent of the
misconduct as significant factors in determining the appropriate
sanction. Garrett Howard Smith, M.D., 83 FR 18882, 18910 (2018)
(collecting cases). In the current matter, Respondent received $17,800
in kickbacks over a period of almost four years and cost Medicare
$884,585. GX 4, at 3. Moreover, Respondent's exclusion letter from HHS/
OIG indicates that in Respondent's case, the minimum exclusion period
of five years was increased to ten years due to three aggravating
factors: (1) the financial loss to a Government program was over
$50,000; (2) Respondent's acts underlying her conviction lasted for
over one year; and (3) Respondent's sentence included incarceration,
although Respondent was sentenced to time served and location
monitoring for a period of 15 months.\10\ Id. at 1-2; see also Michael
Jones, M.D., 86 FR 20728, 20732 (2021) (considering the length of the
HHS exclusion in assessing egregiousness).
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\10\ HHS/OIG considered as a mitigating factor that Respondent
cooperated with federal and state officials. GX 3, at 2.
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As discussed above, to avoid sanction when grounds for revocation
exist, a respondent must convince the Administrator that she can be
entrusted with a registration. The Agency finds that Respondent has not
met this burden. Accordingly, the Agency shall order the sanctions the
Government requested, as contained in the Order below.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
FI1112084 issued to Bernadette U. Iguh, M.D. Further, pursuant to 28
CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I
hereby deny any pending application to renew or modify this
registration, as well as any other pending application of Bernadette U.
Iguh, M.D., for registration in Texas. This Order is effective October
17, 2022.
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 8, 2022, 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. 2022-19975 Filed 9-14-22; 8:45 am]
BILLING CODE 4410-09-P
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