83 FR 52487 - Isachi Gil; Denial of Hearing; Final Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 201 (October 17, 2018)

Page Range		52487-52488
FR Document		2018-22581

The Food and Drug Administration (FDA) is denying Isachi Gil's (Gil's) request for a hearing and issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Gil for 6 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Gil was convicted of 12 felonies under Federal Law involving fraud or falsification and that Gil 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. In determining the appropriateness and period of Gil's debarment, FDA considered the relevant factors listed in the FD&C Act. Gil failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.

Federal Register, Volume 83 Issue 201 (Wednesday, October 17, 2018)

[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52487-52488]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-22581]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1018]

Isachi Gil; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is denying Isachi Gil's
(Gil's) request for a hearing and issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C Act) debarring Gil for 6 years from
providing services in any capacity to a person that has an approved or
pending drug product application. FDA bases this order on findings that
Gil was convicted of 12 felonies under Federal Law involving fraud or
falsification and that Gil 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. In
determining the appropriateness and period of Gil's debarment, FDA
considered the relevant factors listed in the FD&C Act. Gil failed to
file with the Agency information and analyses sufficient to create a
basis for a hearing concerning this action.

DATES: This order is applicable October 17, 2018.

ADDRESSES: Any application for termination of debarment by Gil under
section 306(d) of the FD&C Act (application) may be submitted as
follows:

Electronic Submissions

Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your application,
that information will be posted on https://www.regulations.gov.
If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: Your application must include the Docket No. FDA-
2013-N-1018. An application will be placed in the docket and, unless
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of your application. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your application and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket, go to https://www.regulations.gov
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday. Publicly
available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Rachael V. Linowes, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.

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 FDA to debar an individual if it finds
that the individual: (1) Has been convicted of a felony that 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 (2)
based on the conviction and other information, has demonstrated a
pattern of conduct sufficient to find that there is reason to believe
that the person may violate requirements under the FD&C Act relating to
drug products.
On May 24, 2011, a jury found Gil guilty of 12 felonies. On
September 28, 2011, the U.S. District Court for the Southern District
of Florida entered judgment against her for five counts of felony
healthcare fraud, in violation of 18 U.S.C. 1347, and seven counts of
felony false statements related to healthcare matters, in violation of
18 U.S.C. 1035(a)(2). The court sentenced Gil to 43 months in prison,
with 3 years of supervised release.
Gil's convictions stemmed from her work as a registered nurse in
the home health field. From around March 14, 2007, through about July
15, 2009, Gil worked as a registered nurse, employed by a nursing
staffing company and local home health agencies. During this time, Gil
knowingly and willfully submitted and caused the submission of false
and fraudulent claims to Medicare, seeking reimbursement for various
home health services she had not provided. Specifically, Gil falsified
and caused

[[Page 52488]]

Medicare beneficiaries to falsify weekly visit/time record sheets
indicating that she provided skilled nursing services twice a day, 7
days a week, when she did not provide those services with such
frequency. Gil falsified daily blood sugar/insulin log sheets stating
that she administered insulin injections and provided other medical
services to Medicare beneficiaries when she did not provide those
services. Lastly, Gil created false weekly visit/time records claiming
that she provided skilled nursing services to two separate Medicare
beneficiaries at the same time and she caused local home health
agencies to submit false and fraudulent claims that falsely represented
that she provided home health services to eligible Medicare
beneficiaries.
By letter dated March 18, 2014, FDA's Office of Regulatory Affairs
(ORA) notified Gil of a proposal 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 explained that the
proposed debarment period was based on her 12 felony convictions. The
proposal stated that maximum debarment period for each offense is 5
years and that FDA may determine whether debarment periods for multiple
offenses should run concurrently or consecutively.
The proposal outlined findings regarding the four applicable
factors ORA considered in determining the appropriateness and period of
debarment, as provided in section 306(c)(3) of the FD&C Act: (1) The
nature and seriousness of the offense, (2) the nature and extent of
management participation in any offense, (3) the nature and extent of
voluntary steps to mitigate the impact on the public, and (4) prior
convictions under the FD&C Act or other acts involving matters within
FDA's jurisdiction. ORA found that the nature and seriousness of the
offenses and her failure to take voluntary steps to mitigate the impact
of her offenses were unfavorable factors for Gil. ORA found that her
lack of prior convictions was a favorable factor for Gil. Finally, ORA
found that the management participation factor was not applicable based
on the information in the record. ORA concluded that ``the unfavorable
factors cumulatively outweigh the favorable factors and that debarment
is appropriate.'' ORA proposed that each felony offense should have a
3-year debarment period. ORA further proposed that the 3-year debarment
period for each healthcare fraud conviction should run concurrently and
that the 3-year debarment period for each false statement conviction
should run concurrently, for a total debarment period of 6 years.
The proposal offered Gil the opportunity to request a hearing,
providing her 30 days from the date of receipt of the letter to file
the request and 60 days from the date of receipt of the letter to
support her request with information sufficient to justify a hearing.
In a letter dated May 9, 2014, through counsel, Gil filed a request for
hearing and indicated that she had not received the proposal until
April 10, 2014. She also stated that the information justifying the
hearing request would be forthcoming. More than 60 days have passed
from the date Gil represents she received FDA's letter, and she has not
filed any information, or any legal or policy arguments, to support her
request.
Under the authority delegated to him by the Commissioner of Food
and Drugs, the Acting Director of the Office of Scientific Integrity
(OSI) has considered Gil's request for a hearing. Hearings will not be
granted on issues of policy or law, on mere allegations, denials, or
general descriptions of positions and contentions, or on data and
information insufficient to justify the factual determination urged
(see 21 CFR 21.24(b)).
Inasmuch as Gil has not presented any information to support her
hearing request, OSI concludes that Gil has failed to raise a genuine
and substantial issue of fact requiring a hearing. Therefore, OSI
denies Gil's request for a hearing. Further, Gil has not presented any
arguments concerning whether debarment is appropriate for each of her
felony convictions or whether the proposed debarment periods are
appropriate. Based on the factual findings in the proposal to debar,
OSI finds that a 3-year debarment period for each felony offense is
appropriate and that the 3-year debarment period for each healthcare
fraud conviction should run concurrently and that the 3-year debarment
period for each false statement conviction should run concurrently, for
a resulting total debarment of 6 years.

II. Findings and Order

Therefore, the Director of OSI, under section 306(b)(2)(B)(i)(I) of
the FD&C Act and authority delegated to him by the Commissioner of Food
and Drugs, finds that: (1) Gil was convicted of a felony that 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 (2)
based on the conviction and other information, Gil demonstrated a
pattern of conduct giving reason to believe that she may violate
requirements under the FD&C Act relating to drug products. FDA
considered the applicable factors listed in section 306(c)(3) of the
FD&C Act and determined that a 6-year debarment is appropriate.
As a result of the foregoing findings, Isachi Gil 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 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and 21 U.S.C.
321(dd)). Any person with an approved or pending drug application who
knowingly uses the services of Gil, 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 Gil, during her period of
debarment, provides services in any capacity to a person with an
approved or pending drug product application, 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 Gil during her period of
debarment (section 306(c)(1)(B) of the FD&C Act).

Dated: October 10, 2018.
George M. Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2018-22581 Filed 10-16-18; 8:45 am]
BILLING CODE 4164-01-P

52488 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices

Medicare beneficiaries to falsify weekly statement conviction should run prosecution of, any criminal offense and
visit/time record sheets indicating that concurrently, for a total debarment (2) based on the conviction and other
she provided skilled nursing services period of 6 years. information, Gil demonstrated a pattern
twice a day, 7 days a week, when she The proposal offered Gil the of conduct giving reason to believe that
did not provide those services with such opportunity to request a hearing, she may violate requirements under the
frequency. Gil falsified daily blood providing her 30 days from the date of FD&C Act relating to drug products.
sugar/insulin log sheets stating that she receipt of the letter to file the request FDA considered the applicable factors
administered insulin injections and and 60 days from the date of receipt of listed in section 306(c)(3) of the FD&C
provided other medical services to the letter to support her request with Act and determined that a 6-year
Medicare beneficiaries when she did not information sufficient to justify a debarment is appropriate.
provide those services. Lastly, Gil hearing. In a letter dated May 9, 2014, As a result of the foregoing findings,
created false weekly visit/time records through counsel, Gil filed a request for Isachi Gil is debarred for 6 years from
claiming that she provided skilled hearing and indicated that she had not providing services in any capacity to a
nursing services to two separate received the proposal until April 10, person with an approved or pending
Medicare beneficiaries at the same time 2014. She also stated that the drug product application under sections
and she caused local home health information justifying the hearing 505, 512, or 802 of the FD&C Act (21
agencies to submit false and fraudulent request would be forthcoming. More U.S.C. 355, 360b, or 382), or under
claims that falsely represented that she than 60 days have passed from the date section 351 of the Public Health Service
provided home health services to Gil represents she received FDA’s letter, Act (42 U.S.C. 262), effective (see
eligible Medicare beneficiaries. and she has not filed any information, DATES), (see 21 U.S.C. 335a(c)(1)(B) and
By letter dated March 18, 2014, FDA’s or any legal or policy arguments, to (c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
Office of Regulatory Affairs (ORA) support her request. Any person with an approved or
notified Gil of a proposal to debar her Under the authority delegated to him pending drug application who
for 6 years from providing services in by the Commissioner of Food and knowingly uses the services of Gil, in
any capacity to a person that has an Drugs, the Acting Director of the Office any capacity during her debarment, will
approved or pending drug product of Scientific Integrity (OSI) has be subject to civil money penalties
application. The proposal explained considered Gil’s request for a hearing. (section 307(a)(6) of the FD&C Act (21
that the proposed debarment period was Hearings will not be granted on issues U.S.C. 335b(a)(6))). If Gil, during her
based on her 12 felony convictions. The of policy or law, on mere allegations, period of debarment, provides services
proposal stated that maximum denials, or general descriptions of in any capacity to a person with an
debarment period for each offense is 5 positions and contentions, or on data approved or pending drug product
years and that FDA may determine and information insufficient to justify
application, she will be subject to civil
whether debarment periods for multiple the factual determination urged (see 21
money penalties (section 307(a)(7) of the
offenses should run concurrently or CFR 21.24(b)).
Inasmuch as Gil has not presented FD&C Act). In addition, FDA will not
consecutively. accept or review any abbreviated new
The proposal outlined findings any information to support her hearing
request, OSI concludes that Gil has drug applications submitted by or with
regarding the four applicable factors
failed to raise a genuine and substantial the assistance of Gil during her period
ORA considered in determining the
issue of fact requiring a hearing. of debarment (section 306(c)(1)(B) of the
appropriateness and period of
Therefore, OSI denies Gil’s request for a FD&C Act).
debarment, as provided in section
306(c)(3) of the FD&C Act: (1) The hearing. Further, Gil has not presented Dated: October 10, 2018.
nature and seriousness of the offense, any arguments concerning whether George M. Warren,
(2) the nature and extent of management debarment is appropriate for each of her Director, Office of Scientific Integrity.
participation in any offense, (3) the felony convictions or whether the [FR Doc. 2018–22581 Filed 10–16–18; 8:45 am]
nature and extent of voluntary steps to proposed debarment periods are BILLING CODE 4164–01–P
mitigate the impact on the public, and appropriate. Based on the factual
(4) prior convictions under the FD&C findings in the proposal to debar, OSI
Act or other acts involving matters finds that a 3-year debarment period for DEPARTMENT OF HEALTH AND
within FDA’s jurisdiction. ORA found each felony offense is appropriate and HUMAN SERVICES
that the nature and seriousness of the that the 3-year debarment period for
offenses and her failure to take each healthcare fraud conviction should Food and Drug Administration
voluntary steps to mitigate the impact of run concurrently and that the 3-year
[Docket No. FDA–2011–D–0125]
her offenses were unfavorable factors for debarment period for each false
Gil. ORA found that her lack of prior statement conviction should run Agency Information Collection
convictions was a favorable factor for concurrently, for a resulting total Activities; Proposed Collection;
Gil. Finally, ORA found that the debarment of 6 years. Comment Request; Guidance for
management participation factor was Industry on Establishing That a
not applicable based on the information II. Findings and Order
Tobacco Product Was Commercially
in the record. ORA concluded that ‘‘the Therefore, the Director of OSI, under
Marketed in the United States as of
unfavorable factors cumulatively section 306(b)(2)(B)(i)(I) of the FD&C
February 15, 2007
outweigh the favorable factors and that Act and authority delegated to him by
debarment is appropriate.’’ ORA the Commissioner of Food and Drugs, AGENCY: Food and Drug Administration,
daltland on DSKBBV9HB2PROD with NOTICES

proposed that each felony offense finds that: (1) Gil was convicted of a HHS.
should have a 3-year debarment period. felony that involves bribery, payment of ACTION: Notice.
ORA further proposed that the 3-year illegal gratuities, fraud, perjury, false
debarment period for each healthcare statement, racketeering, blackmail, SUMMARY: The Food and Drug
fraud conviction should run extortion, falsification or destruction of Administration (FDA or Agency) is
concurrently and that the 3-year records, or interference with, announcing an opportunity for public
debarment period for each false obstruction of an investigation into, or comment on the proposed collection of

VerDate Sep<11>2014 19:46 Oct 16, 2018 Jkt 247001 PO 00000 Frm 00113 Fmt 4703 Sfmt 4703 E:\FR\FM\17OCN1.SGM 17OCN1

Document Created: 2018-10-17 01:47:09
Document Modified: 2018-10-17 01:47:09

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 applicable October 17, 2018.
Contact		Rachael V. Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.
FR Citation		83 FR 52487

83 FR 52487 - Isachi Gil; Denial of Hearing; Final Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 201 (October 17, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration