80 FR 17049 - Odalys Fernandez: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 61 (March 31, 2015)

Page Range		17049-17050
FR Document		2015-07267

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.

Federal Register, Volume 80 Issue 61 (Tuesday, March 31, 2015)

[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17049-17050]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07267]


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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.

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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

Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17049

Estimated Total Annual Burden proposals, the disclosure of which believe she may violate requirements
Hours: 255. would constitute a clearly unwarranted under the FD&C Act relating to drug
In compliance with the requirements invasion of personal privacy. products. Ms. Fernandez was given
of section 3506(c)(2)(A) of the Name of Committee: National Institute of notice of the proposed debarment and
Paperwork Reduction Act of 1995, the Environmental Health Sciences Special an opportunity to request a hearing
Administration for Children and Emphasis Panel; NIH Loan Repayment within the timeframe prescribed by
Families is soliciting public comment Program (Clinical and Pediatric Researchers). regulation. Ms. Fernandez failed to
on the specific aspects of the Date: April 24, 2015. request a hearing. Ms. Fernandez’s
information collection described above. Time: 8:00 a.m. to 5:00 p.m. failure to request a hearing constitutes a
Copies of the proposed collection of Agenda: To review and evaluate contract waiver of her right to a hearing
information can be obtained and proposals. concerning this action.
comments may be forwarded by writing Place: National Institute of Environmental
Health Sciences, Keystone Building, 530 DATES: This order is effective March 31,
to the Administration for Children and 2015.
Davis Drive, Suite 3118, Research Triangle
Families, Office of Planning, Research Park, NC 27709, (Virtual Meeting). ADDRESSES: Submit applications for
and Evaluation, 370 L’Enfant Contact Person: RoseAnne M McGee, termination of debarment to the
Promenade SW., Washington, DC 20447, Scientific Review Officer, Scientific Review Division of Dockets Management (HFA–
Attn: OPRE Reports Clearance Officer. Branch, Division of Extramural Research and 305), Food and Drug Administration,
Email address: OPREinfocollection@ Training, Nat. Institute of Environmental
5630 Fishers Lane, Rm. 1061, Rockville,
acf.hhs.gov. All requests should be Health Sciences, P.O. Box 12233, MD EC–30,
Research Triangle Park, NC 27709 (919) 541– MD 20852.
identified by the title of the information
collection. 0752, mcgee1@niehs.nih.gov. FOR FURTHER INFORMATION CONTACT:
The Department specifically requests (Catalogue of Federal Domestic Assistance Kenny Shade, Division of Enforcement,
comments on (a) whether the proposed Program Nos. 93.115, Biometry and Risk Office of Enforcement and Import
collection of information is necessary Estimation—Health Risks from Operations, Office of Regulatory Affairs,
for the proper performance of the Environmental Exposures; 93.142, NIEHS Food and Drug Administration, 12420
Hazardous Waste Worker Health and Safety Parklawn Dr. (ELEM–4144), Rockville,
functions of the agency, including
Training; 93.143, NIEHS Superfund MD 20857, 301–796–4640.
whether the information shall have Hazardous Substances—Basic Research and
practical utility; (b) the accuracy of the SUPPLEMENTARY INFORMATION:
Education; 93.894, Resources and Manpower
agency’s estimate of the burden of the Development in the Environmental Health I. Background
proposed collection of information; (c) Sciences; 93.113, Biological Response to
the quality, utility, and clarity of the Environmental Health Hazards; 93.114, Section 306(b)(2)(B)(ii)(I) of the FD&C
information to be collected; and (d) Applied Toxicological Research and Testing, Act (21 U.S.C. 335a(b)(2)(B)(ii)(I))
ways to minimize the burden of the National Institutes of Health, HHS) permits debarment of an individual if
collection of information on Dated: March 25, 2015. FDA finds that the individual has been
respondents, including through the use convicted of a felony under Federal law
Carolyn Baum,
of automated collection techniques or for conduct which involves bribery,
Program Analyst, Office of Federal Advisory
other forms of information technology. payment of illegal gratuities, fraud,
Committee Policy.
Consideration will be given to perjury, false statement, racketeering,
[FR Doc. 2015–07249 Filed 3–30–15; 8:45 am]
comments and suggestions submitted blackmail, extortion, falsification or
BILLING CODE 4140–01–P
within 60 days of this publication. destruction of records, or interference
with, obstruction of an investigation
Karl Koerper, into, or prosecution of any criminal
Reports Clearance Officer. DEPARTMENT OF HEALTH AND
offense, and FDA finds, on the basis of
HUMAN SERVICES
[FR Doc. 2015–07316 Filed 3–30–15; 8:45 am] the conviction and other information,
BILLING CODE 4184–73–P Food and Drug Administration that such individual has demonstrated a
pattern of conduct sufficient to find that
[Docket No. FDA–2014–N–0563] there is reason to believe the individual
DEPARTMENT OF HEALTH AND may violate requirements under the
HUMAN SERVICES Odalys Fernandez: Debarment Order
FD&C Act relating to drug products.
AGENCY: Food and Drug Administration, On November 9, 2012, the U.S.
National Institutes of Health HHS. District Court for the Southern District
ACTION: Notice. of Florida entered judgment against Ms.
National Institute of Environmental
Fernandez after a jury found her guilty
Health Sciences; Notice of Closed SUMMARY: The U.S. Food and Drug of five counts of health care fraud in
Meeting Administration (FDA or Agency) is violation of 18 U.S.C. 1347, and one
Pursuant to section 10(d) of the issuing an order under the Federal count of conspiracy to commit health
Federal Advisory Committee Act, as Food, Drug, and Cosmetic Act (the care fraud in violation of 18 U.S.C.
amended (5 U.S.C. App.), notice is FD&C Act) debarring Odalys Fernandez 1349.
hereby given of the following meeting. from providing services in any capacity FDA’s finding that debarment is
The meeting will be closed to the to a person that has an approved or appropriate is based on the felony
public in accordance with the pending drug product application for a convictions referenced herein. The
asabaliauskas on DSK5VPTVN1PROD with NOTICES

provisions set forth in sections period of 6 years. FDA bases this order factual basis for these convictions is as
552b(c)(4) and 552b(c)(6), title 5 U.S.C., on a finding that Ms. Fernandez was follows: Ms. Fernandez was a registered
as amended. The contract proposals and convicted of five felony counts under nurse working for Ideal Home Health
the discussions could disclose Federal law for conduct involving Inc. (Ideal), which was a business in
confidential trade secrets or commercial health care fraud, and one count of Miami-Dade County, FL. Ideal
property such as patentable material, conspiracy to commit health care fraud, purportedly provided skilled nursing
and personal information concerning and that this pattern of conduct is services to Medicare beneficiaries who
individuals associated with the contract sufficient to find that there is reason to required home health services. As a

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17050 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices

registered nurse in the home health considered the conduct that forms the capacity to a person with an approved
field, it was Ms. Fernandez’s duty to basis of her conviction and the fact that or pending drug product application
provide skilled nursing services to this conduct occurred in the course of under sections 505, 512, or 802 of the
patients and maintain proper her profession and showed a disregard FD&C Act (21 U.S.C. 355, 360b, or 382),
documentation of all treatments for the obligations of her profession and or under section 351 of the Public
provided to patients. the law, FDA found that Ms. Fernandez Health Service Act (42 U.S.C. 262),
From on or about August 17, 2007, has demonstrated a pattern of conduct effective (see DATES)(see sections
through on or about March 19, 2009, sufficient to find that there is reason to 201(dd), 306(c)(1)(B), and
Ms. Fernandez conspired with others to believe that, if she were to provide 306(c)(2)(A)(ii) of the FD&C Act, (21
defraud Medicare. services to a person that has an U.S.C. 321(dd), 335a(c)(1)(B), and
Ms. Fernandez and her coconspirators approved or pending drug application, 335a(c)(2)(A)(ii)). Any person with an
submitted, and caused the submission she may violate requirements under the approved or pending drug product
of, false and fraudulent claims to FD&C Act relating to drug products. The application who knowingly employs or
Medicare, and concealed the submission proposal offered Ms. Fernandez an retains as a consultant or contractor, or
of these false and fraudulent claims. opportunity to request a hearing, otherwise uses the services of Ms.
Ms. Fernandez and her coconspirators providing her with 30 days from the Fernandez in any capacity during her
falsified and caused Medicare date of receipt of the letter in which to debarment, will be subject to civil
beneficiaries to falsify weekly visit/time file the request, and advised her that money penalties (section 307(a)(6) of the
record sheets, and falsified skilled failure to request a hearing constituted FD&C Act (21 U.S.C. 335b(a)(6))). If Ms.
nursing progress notes representing that a waiver of the opportunity for a hearing Fernandez provides services in any
she had administered insulin injections and of any contentions concerning this capacity to a person with an approved
and provided other medical services to action. The proposal was received on or pending drug product application
Medicare beneficiaries. She caused Ideal September 12, 2014. Ms. Fernandez during her period of debarment she will
to submit false and fraudulent claims to failed to respond within the timeframe be subject to civil money penalties
Medicare for home health benefits by prescribed by regulation and has, (section 307(a)(7) of the FD&C Act). In
falsely representing that she had therefore, waived her opportunity for a addition, FDA will not accept or review
provided these health services. As a hearing and has waived any contentions any abbreviated new drug applications
result of these fraudulent claims, she concerning her debarment (21 CFR part submitted by or with the assistance of
caused Medicare to make payments to 12). Odalys Fernandez during her period of
Ideal of approximately $82,040. Ms.
II. Findings and Order debarment (section 306(c)(1)(A) of the
Fernandez engaged in this criminal
FD&C Act).
conduct repeatedly over a period of Therefore, the Director, Office of
Any application by Ms. Fernandez for
approximately 19 months. Enforcement and Import Operations,
As a result of her convictions, on termination of debarment under section
Office of Regulatory Affairs, under
September 8, 2014, FDA sent Ms. 306(d)(4) of the FD&C Act should be
section 306(b)(2)(B)(ii)(I) of the FD&C
Fernandez a notice by certified mail identified with Docket No. FDA–2014–
Act, under authority delegated to the
proposing to debar her for 6 years from N–0563 and sent to the Division of
Director (Staff Manual Guide 1410.35),
providing services in any capacity to a Dockets Management (see ADDRESSES).
finds that Odalys Fernandez has been
person that has an approved or pending convicted of five counts of a felony and All such submissions are to be filed in
drug product application. The proposal one count of conspiracy to commit a four copies. The public availability of
was based on the finding, under section felony under Federal law for conduct information in these submissions is
306(b)(2)(B)(ii)(I) of the FD&C Act, that involving health care fraud and, on the governed by 21 CFR 10.20.
Ms. Fernandez was convicted of felonies basis of the conviction and other Publicly available submissions may
under Federal law for conduct involving information, finds that Ms. Fernandez be seen in the Division of Dockets
health care fraud and conspiracy to has demonstrated a pattern of conduct Management between 9 a.m. and 4 p.m.,
commit health care fraud, and the sufficient to find that there is reason to Monday through Friday.
Agency found, on the basis of the believe she may violate requirements Dated: March 24, 2015.
conviction and other information, that under the FD&C Act relating to drug Leslie Kux,
Ms. Fernandez had demonstrated a products. Associate Commissioner for Policy.
pattern of conduct sufficient to find that Based on the factors under section [FR Doc. 2015–07267 Filed 3–30–15; 8:45 am]
there is reason to believe she may 306(c)(2)(A)(iii) of the FD&C Act, FDA BILLING CODE 4164–01–P
violate requirements under the FD&C finds that each offense be accorded a
Act relating to drug products. This debarment period of 3 years. In the case
conclusion was based on the fact that of a person debarred for multiple DEPARTMENT OF HEALTH AND
Ms. Fernandez had legal and offenses, FDA shall determine whether HUMAN SERVICES
professional obligations to ensure that the periods of debarment shall run
she submitted accurate medical claims concurrently or consecutively (section Food and Drug Administration
for services she provided. Instead, Ms. 306(c)(2)(A)). FDA has concluded that
Fernandez submitted, and caused the the 3-year periods of debarment for the [Docket No. FDA–2010–D–0500]
submission of, false weekly visit/time five counts of health care fraud shall run
records and false daily blood sugar/ concurrently. The 3-year period of Early Clinical Trials With Live
asabaliauskas on DSK5VPTVN1PROD with NOTICES

insulin log sheets. She engaged in this debarment for the conspiracy conviction Biotherapeutic Products: Chemistry,
conduct repeatedly over a period of shall run consecutively to the periods of Manufacturing, and Control
almost 2 years. Her convictions indicate debarment for health care fraud Information; Guidance for Industry;
that she knowingly and willfully convictions, resulting in a total Request for Comments
disregarded her legal and professional debarment period of 6 years. AGENCY: Food and Drug Administration,
obligations to keep accurate medical As a result of the foregoing findings, HHS.
records and to submit accurate claims Odalys Fernandez is debarred for 6
ACTION: Notice; requests for comments.
for the services she provided. Having years from providing services in any

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Document Created: 2015-12-18 11:48:17
Document Modified: 2015-12-18 11:48:17

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		This order is effective March 31, 2015.
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.
FR Citation		80 FR 17049

80 FR 17049 - Odalys Fernandez: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 61 (March 31, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration