[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17049-17050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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