[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56709-56712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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