Odalys Fernandez: Debarment Order, 17049-17050 [2015-07267]
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Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices
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Name of Committee: National Institute of
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Date: April 24, 2015.
Time: 8:00 a.m. to 5:00 p.m.
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Dated: March 25, 2015.
Carolyn Baum,
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Committee Policy.
[FR Doc. 2015–07249 Filed 3–30–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–07316 Filed 3–30–15; 8:45 am]
BILLING CODE 4184–73–P
Food and Drug Administration
[Docket No. FDA–2014–N–0563]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Odalys Fernandez: Debarment Order
AGENCY:
National Institutes of Health
ACTION:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
18:32 Mar 30, 2015
Jkt 235001
Notice.
The U.S. Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) debarring Odalys Fernandez
from providing services in any capacity
to a person that has an approved or
pending drug product application for a
period of 6 years. FDA bases this order
on a finding that Ms. Fernandez was
convicted of five felony counts under
Federal law for conduct involving
health care fraud, and one count of
conspiracy to commit health care fraud,
and that this pattern of conduct is
sufficient to find that there is reason to
SUMMARY:
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
VerDate Sep<11>2014
Food and Drug Administration,
HHS.
PO 00000
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Sfmt 4703
17049
believe she may violate requirements
under the FD&C Act relating to drug
products. Ms. Fernandez was given
notice of the proposed debarment and
an opportunity to request a hearing
within the timeframe prescribed by
regulation. Ms. Fernandez failed to
request a hearing. Ms. Fernandez’s
failure to request a hearing constitutes a
waiver of her right to a hearing
concerning this action.
DATES: This order is effective March 31,
2015.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Division of Enforcement,
Office of Enforcement and Import
Operations, Office of Regulatory Affairs,
Food and Drug Administration, 12420
Parklawn Dr. (ELEM–4144), Rockville,
MD 20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(ii)(I) of the FD&C
Act (21 U.S.C. 335a(b)(2)(B)(ii)(I))
permits debarment of an individual if
FDA finds that the individual has been
convicted of a felony under Federal law
for conduct which involves bribery,
payment of illegal gratuities, fraud,
perjury, false statement, racketeering,
blackmail, extortion, falsification or
destruction of records, or interference
with, obstruction of an investigation
into, or prosecution of any criminal
offense, and FDA finds, on the basis of
the conviction and other information,
that such individual has demonstrated a
pattern of conduct sufficient to find that
there is reason to believe the individual
may violate requirements under the
FD&C Act relating to drug products.
On November 9, 2012, the U.S.
District Court for the Southern District
of Florida entered judgment against Ms.
Fernandez after a jury found her guilty
of five counts of health care fraud in
violation of 18 U.S.C. 1347, and one
count of conspiracy to commit health
care fraud in violation of 18 U.S.C.
1349.
FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein. The
factual basis for these convictions is as
follows: Ms. Fernandez was a registered
nurse working for Ideal Home Health
Inc. (Ideal), which was a business in
Miami-Dade County, FL. Ideal
purportedly provided skilled nursing
services to Medicare beneficiaries who
required home health services. As a
E:\FR\FM\31MRN1.SGM
31MRN1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
17050
Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices
registered nurse in the home health
field, it was Ms. Fernandez’s duty to
provide skilled nursing services to
patients and maintain proper
documentation of all treatments
provided to patients.
From on or about August 17, 2007,
through on or about March 19, 2009,
Ms. Fernandez conspired with others to
defraud Medicare.
Ms. Fernandez and her coconspirators
submitted, and caused the submission
of, false and fraudulent claims to
Medicare, and concealed the submission
of these false and fraudulent claims.
Ms. Fernandez and her coconspirators
falsified and caused Medicare
beneficiaries to falsify weekly visit/time
record sheets, and falsified skilled
nursing progress notes representing that
she had administered insulin injections
and provided other medical services to
Medicare beneficiaries. She caused Ideal
to submit false and fraudulent claims to
Medicare for home health benefits by
falsely representing that she had
provided these health services. As a
result of these fraudulent claims, she
caused Medicare to make payments to
Ideal of approximately $82,040. Ms.
Fernandez engaged in this criminal
conduct repeatedly over a period of
approximately 19 months.
As a result of her convictions, on
September 8, 2014, FDA sent Ms.
Fernandez a notice by certified mail
proposing to debar her for 6 years from
providing services in any capacity to a
person that has an approved or pending
drug product application. The proposal
was based on the finding, under section
306(b)(2)(B)(ii)(I) of the FD&C Act, that
Ms. Fernandez was convicted of felonies
under Federal law for conduct involving
health care fraud and conspiracy to
commit health care fraud, and the
Agency found, on the basis of the
conviction and other information, that
Ms. Fernandez had demonstrated a
pattern of conduct sufficient to find that
there is reason to believe she may
violate requirements under the FD&C
Act relating to drug products. This
conclusion was based on the fact that
Ms. Fernandez had legal and
professional obligations to ensure that
she submitted accurate medical claims
for services she provided. Instead, Ms.
Fernandez submitted, and caused the
submission of, false weekly visit/time
records and false daily blood sugar/
insulin log sheets. She engaged in this
conduct repeatedly over a period of
almost 2 years. Her convictions indicate
that she knowingly and willfully
disregarded her legal and professional
obligations to keep accurate medical
records and to submit accurate claims
for the services she provided. Having
VerDate Sep<11>2014
19:34 Mar 30, 2015
Jkt 235001
considered the conduct that forms the
basis of her conviction and the fact that
this conduct occurred in the course of
her profession and showed a disregard
for the obligations of her profession and
the law, FDA found that Ms. Fernandez
has demonstrated a pattern of conduct
sufficient to find that there is reason to
believe that, if she were to provide
services to a person that has an
approved or pending drug application,
she may violate requirements under the
FD&C Act relating to drug products. The
proposal offered Ms. Fernandez an
opportunity to request a hearing,
providing her with 30 days from the
date of receipt of the letter in which to
file the request, and advised her that
failure to request a hearing constituted
a waiver of the opportunity for a hearing
and of any contentions concerning this
action. The proposal was received on
September 12, 2014. Ms. Fernandez
failed to respond within the timeframe
prescribed by regulation and has,
therefore, waived her opportunity for a
hearing and has waived any contentions
concerning her debarment (21 CFR part
12).
II. Findings and Order
Therefore, the Director, Office of
Enforcement and Import Operations,
Office of Regulatory Affairs, under
section 306(b)(2)(B)(ii)(I) of the FD&C
Act, under authority delegated to the
Director (Staff Manual Guide 1410.35),
finds that Odalys Fernandez has been
convicted of five counts of a felony and
one count of conspiracy to commit a
felony under Federal law for conduct
involving health care fraud and, on the
basis of the conviction and other
information, finds that Ms. Fernandez
has demonstrated a pattern of conduct
sufficient to find that there is reason to
believe she may violate requirements
under the FD&C Act relating to drug
products.
Based on the factors under section
306(c)(2)(A)(iii) of the FD&C Act, FDA
finds that each offense be accorded a
debarment period of 3 years. In the case
of a person debarred for multiple
offenses, FDA shall determine whether
the periods of debarment shall run
concurrently or consecutively (section
306(c)(2)(A)). FDA has concluded that
the 3-year periods of debarment for the
five counts of health care fraud shall run
concurrently. The 3-year period of
debarment for the conspiracy conviction
shall run consecutively to the periods of
debarment for health care fraud
convictions, resulting in a total
debarment period of 6 years.
As a result of the foregoing findings,
Odalys Fernandez is debarred for 6
years from providing services in any
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capacity to a person with an approved
or pending drug product application
under sections 505, 512, or 802 of the
FD&C Act (21 U.S.C. 355, 360b, or 382),
or under section 351 of the Public
Health Service Act (42 U.S.C. 262),
effective (see DATES)(see sections
201(dd), 306(c)(1)(B), and
306(c)(2)(A)(ii) of the FD&C Act, (21
U.S.C. 321(dd), 335a(c)(1)(B), and
335a(c)(2)(A)(ii)). Any person with an
approved or pending drug product
application who knowingly employs or
retains as a consultant or contractor, or
otherwise uses the services of Ms.
Fernandez in any capacity during her
debarment, will be subject to civil
money penalties (section 307(a)(6) of the
FD&C Act (21 U.S.C. 335b(a)(6))). If Ms.
Fernandez provides services in any
capacity to a person with an approved
or pending drug product application
during her period of debarment she will
be subject to civil money penalties
(section 307(a)(7) of the FD&C Act). In
addition, FDA will not accept or review
any abbreviated new drug applications
submitted by or with the assistance of
Odalys Fernandez during her period of
debarment (section 306(c)(1)(A) of the
FD&C Act).
Any application by Ms. Fernandez for
termination of debarment under section
306(d)(4) of the FD&C Act should be
identified with Docket No. FDA–2014–
N–0563 and sent to the Division of
Dockets Management (see ADDRESSES).
All such submissions are to be filed in
four copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20.
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: March 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07267 Filed 3–30–15; 8:45 am]
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Food and Drug Administration
[Docket No. FDA–2010–D–0500]
Early Clinical Trials With Live
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Manufacturing, and Control
Information; Guidance for Industry;
Request for Comments
AGENCY:
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Notice; requests for comments.
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[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17049-17050]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07267]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0563]
Odalys Fernandez: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The U.S. Food and Drug Administration (FDA or Agency) is
issuing an order under the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) debarring Odalys Fernandez from providing services in any
capacity to a person that has an approved or pending drug product
application for a period of 6 years. FDA bases this order on a finding
that Ms. Fernandez was convicted of five felony counts under Federal
law for conduct involving health care fraud, and one count of
conspiracy to commit health care fraud, and that this pattern of
conduct is sufficient to find that there is reason to believe she may
violate requirements under the FD&C Act relating to drug products. Ms.
Fernandez was given notice of the proposed debarment and an opportunity
to request a hearing within the timeframe prescribed by regulation. Ms.
Fernandez failed to request a hearing. Ms. Fernandez's failure to
request a hearing constitutes a waiver of her right to a hearing
concerning this action.
DATES: This order is effective March 31, 2015.
ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Enforcement,
Office of Enforcement and Import Operations, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr. (ELEM-4144),
Rockville, MD 20857, 301-796-4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(ii)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(ii)(I)) permits debarment of an individual if FDA finds
that the individual has been convicted of a felony under Federal law
for conduct which involves bribery, payment of illegal gratuities,
fraud, perjury, false statement, racketeering, blackmail, extortion,
falsification or destruction of records, or interference with,
obstruction of an investigation into, or prosecution of any criminal
offense, and FDA finds, on the basis of the conviction and other
information, that such individual has demonstrated a pattern of conduct
sufficient to find that there is reason to believe the individual may
violate requirements under the FD&C Act relating to drug products.
On November 9, 2012, the U.S. District Court for the Southern
District of Florida entered judgment against Ms. Fernandez after a jury
found her guilty of five counts of health care fraud in violation of 18
U.S.C. 1347, and one count of conspiracy to commit health care fraud in
violation of 18 U.S.C. 1349.
FDA's finding that debarment is appropriate is based on the felony
convictions referenced herein. The factual basis for these convictions
is as follows: Ms. Fernandez was a registered nurse working for Ideal
Home Health Inc. (Ideal), which was a business in Miami-Dade County,
FL. Ideal purportedly provided skilled nursing services to Medicare
beneficiaries who required home health services. As a
[[Page 17050]]
registered nurse in the home health field, it was Ms. Fernandez's duty
to provide skilled nursing services to patients and maintain proper
documentation of all treatments provided to patients.
From on or about August 17, 2007, through on or about March 19,
2009, Ms. Fernandez conspired with others to defraud Medicare.
Ms. Fernandez and her coconspirators submitted, and caused the
submission of, false and fraudulent claims to Medicare, and concealed
the submission of these false and fraudulent claims.
Ms. Fernandez and her coconspirators falsified and caused Medicare
beneficiaries to falsify weekly visit/time record sheets, and falsified
skilled nursing progress notes representing that she had administered
insulin injections and provided other medical services to Medicare
beneficiaries. She caused Ideal to submit false and fraudulent claims
to Medicare for home health benefits by falsely representing that she
had provided these health services. As a result of these fraudulent
claims, she caused Medicare to make payments to Ideal of approximately
$82,040. Ms. Fernandez engaged in this criminal conduct repeatedly over
a period of approximately 19 months.
As a result of her convictions, on September 8, 2014, FDA sent Ms.
Fernandez a notice by certified mail proposing to debar her for 6 years
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
the finding, under section 306(b)(2)(B)(ii)(I) of the FD&C Act, that
Ms. Fernandez was convicted of felonies under Federal law for conduct
involving health care fraud and conspiracy to commit health care fraud,
and the Agency found, on the basis of the conviction and other
information, that Ms. Fernandez had demonstrated a pattern of conduct
sufficient to find that there is reason to believe she may violate
requirements under the FD&C Act relating to drug products. This
conclusion was based on the fact that Ms. Fernandez had legal and
professional obligations to ensure that she submitted accurate medical
claims for services she provided. Instead, Ms. Fernandez submitted, and
caused the submission of, false weekly visit/time records and false
daily blood sugar/insulin log sheets. She engaged in this conduct
repeatedly over a period of almost 2 years. Her convictions indicate
that she knowingly and willfully disregarded her legal and professional
obligations to keep accurate medical records and to submit accurate
claims for the services she provided. Having considered the conduct
that forms the basis of her conviction and the fact that this conduct
occurred in the course of her profession and showed a disregard for the
obligations of her profession and the law, FDA found that Ms. Fernandez
has demonstrated a pattern of conduct sufficient to find that there is
reason to believe that, if she were to provide services to a person
that has an approved or pending drug application, she may violate
requirements under the FD&C Act relating to drug products. The proposal
offered Ms. Fernandez an opportunity to request a hearing, providing
her with 30 days from the date of receipt of the letter in which to
file the request, and advised her that failure to request a hearing
constituted a waiver of the opportunity for a hearing and of any
contentions concerning this action. The proposal was received on
September 12, 2014. Ms. Fernandez failed to respond within the
timeframe prescribed by regulation and has, therefore, waived her
opportunity for a hearing and has waived any contentions concerning her
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of Enforcement and Import
Operations, Office of Regulatory Affairs, under section
306(b)(2)(B)(ii)(I) of the FD&C Act, under authority delegated to the
Director (Staff Manual Guide 1410.35), finds that Odalys Fernandez has
been convicted of five counts of a felony and one count of conspiracy
to commit a felony under Federal law for conduct involving health care
fraud and, on the basis of the conviction and other information, finds
that Ms. Fernandez has demonstrated a pattern of conduct sufficient to
find that there is reason to believe she may violate requirements under
the FD&C Act relating to drug products.
Based on the factors under section 306(c)(2)(A)(iii) of the FD&C
Act, FDA finds that each offense be accorded a debarment period of 3
years. In the case of a person debarred for multiple offenses, FDA
shall determine whether the periods of debarment shall run concurrently
or consecutively (section 306(c)(2)(A)). FDA has concluded that the 3-
year periods of debarment for the five counts of health care fraud
shall run concurrently. The 3-year period of debarment for the
conspiracy conviction shall run consecutively to the periods of
debarment for health care fraud convictions, resulting in a total
debarment period of 6 years.
As a result of the foregoing findings, Odalys Fernandez is debarred
for 6 years from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section
351 of the Public Health Service Act (42 U.S.C. 262), effective (see
DATES)(see sections 201(dd), 306(c)(1)(B), and 306(c)(2)(A)(ii) of the
FD&C Act, (21 U.S.C. 321(dd), 335a(c)(1)(B), and 335a(c)(2)(A)(ii)).
Any person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Ms. Fernandez in any capacity during her
debarment, will be subject to civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))). If Ms. Fernandez provides
services in any capacity to a person with an approved or pending drug
product application during her period of debarment she will be subject
to civil money penalties (section 307(a)(7) of the FD&C Act). In
addition, FDA will not accept or review any abbreviated new drug
applications submitted by or with the assistance of Odalys Fernandez
during her period of debarment (section 306(c)(1)(A) of the FD&C Act).
Any application by Ms. Fernandez for termination of debarment under
section 306(d)(4) of the FD&C Act should be identified with Docket No.
FDA-2014-N-0563 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20.
Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: March 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07267 Filed 3-30-15; 8:45 am]
BILLING CODE 4164-01-P
