[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52487-52488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22581]


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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.

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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.gpo.gov/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


