Armando Santos: Debarment Order, 66728-66729 [2014-26562]
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66728
Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices
Dated: November 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–26596 Filed 11–7–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1106]
Armando Santos: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Armando Santos from providing
services in any capacity to a person that
has an approved or pending drug
product application for a period of 12
years. FDA bases this order on a finding
that Mr. Santos was convicted of seven
felony counts under Federal law for
conduct involving health care fraud,
conspiracy to commit health care fraud,
and false statements related to health
care matters and that this pattern of
conduct is sufficient to find that there
is reason to believe he may violate
requirements under the FD&C Act
relating to drug products. Mr. Santos
was given notice of the proposed
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation. Mr. Santos
failed to respond. Mr. Santos’s failure to
respond constitutes a waiver of his right
to a hearing concerning this action.
DATES: This order is effective November
10, 2014.
SUMMARY:
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., Element Bldg., Rm. 4144,
Rockville, MD 20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ADDRESSES:
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
VerDate Sep<11>2014
18:25 Nov 07, 2014
Jkt 235001
for conduct 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 it 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 August 15, 2011, the U.S. District
Court for the Southern District of
Florida entered judgment against Mr.
Santos after a jury found him guilty of
four counts of health care fraud in
violation of 18 U.S.C. 1347, one count
of conspiracy to commit health care
fraud in violation of 18 U.S.C. 1349, and
two counts of false statements related to
health care matters in violation of 18
U.S.C. 1035(a)(2).
The FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein. The
factual basis for these convictions is as
follows: Mr. Santos was a registered
nurse working for a home health agency
located in the Southern District of
Florida. As a registered nurse in the
home health field, it was Mr. Santos’s
duty to provide skilled nursing services
to patients and maintain proper
documentation of all treatments
provided to patients.
From on or about June 29, 2007,
through on or about March 13, 2009, Mr.
Santos conspired with others to defraud
Medicare. Mr. Santos and his
coconspirators, among other things,
submitted and caused the submission of
false and fraudulent claims to Medicare,
and paid kickbacks and bribes to
Medicare beneficiaries in exchange for
the use of their Medicare beneficiary
numbers as the bases of claims filed for
home health care. Mr. Santos and his
co-conspirators signed patient
assessment forms falsely certifying that
Medicare beneficiaries were in need of
home health services that were
medically unnecessary.
Mr. Santos created false weekly visit/
time records in which he claimed to be
providing skilled nursing services to
two separate Medicare beneficiaries at
the same time. On four separate
occasions, Mr. Santos submitted and
caused the submission of false and
fraudulent claims to Medicare,
representing that he had provided
various home health services to
beneficiaries pursuant to physicians’
plans of care. He caused a home health
agency to submit approximately
$230,315 in false and fraudulent claims
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
to Medicare for home health services
allegedly rendered to Medicare
beneficiaries, when such home health
services were not medically necessary
and had not been provided. As a result
of these fraudulent claims, Mr. Santos
caused Medicare to make payments of
approximately $152,664 to a MiamiDade County home health agency.
In addition, Mr. Santos knowingly
and willfully made materially false
statements and representations, in
connection with the delivery of and
payment for health care benefits, items,
and services. Specifically, Mr. Santos
prepared documents entitled ‘‘Skilled
Nursing Progress Note[s]’’ which falsely
stated that he had injected Medicare
beneficiaries with insulin on two
occasions, when he knew he had not
performed these services.
As a result of his convictions, on
April 9, 2014, FDA sent Mr. Santos a
notice by certified mail proposing to
debar him for 12 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
Mr. Santos was convicted of seven
felonies under Federal law for conduct
involving health care fraud, conspiracy
to commit health care fraud, and false
statements related to health care
matters, and that the Agency found, on
the basis of these convictions and other
information, that Mr. Santos had
demonstrated a pattern of conduct
sufficient to find that there is reason to
believe he may violate requirements
under the FD&C Act relating to drug
products. This conclusion was based on
the fact that Mr. Santos had legal and
professional obligations to ensure that
he kept accurate medical records for
each patient and that he submitted
accurate medical claims for services he
provided. Instead, Mr. Santos signed
patient assessment forms falsely
certifying that Medicare beneficiaries
were in need of home health services
that were medically unnecessary, and
he submitted false weekly visit/time
records. Mr. Santos additionally
prepared false ‘‘Skilled Nursing Progress
Note[s]’’ stating that he had injected two
Medicare beneficiaries with insulin
when he had not done so. He submitted
and caused the submission of false and
fraudulent claims to Medicare. He
engaged in this conduct repeatedly over
a period of almost 2 years. His
convictions indicate that he knowingly
and willfully disregarded his legal and
professional obligations to keep accurate
medical records and to submit accurate
claims for the services he provided.
E:\FR\FM\10NON1.SGM
10NON1
Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Having considered the conduct that
forms the basis of his conviction and the
fact that this conduct occurred in the
course of his profession and showed a
disregard for the obligations of his
profession, FDA finds that Mr. Santos
has demonstrated a pattern of conduct
sufficient to find that there is reason to
believe that, if he were to provide
services to a person that has an
approved or pending drug application,
he may violate requirements under the
FD&C Act relating to drug products.
Therefore, FDA has reason to believe
that, if Mr. Santos were to provide
services to a person that has an
approved or pending drug application,
he may violate requirements under the
FD&C Act relating to drug products.
The proposal offered Mr. Santos an
opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him 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 April 16,
2014. Mr. Santos failed to respond
within the timeframe prescribed by
regulation and has, therefore, waived
his opportunity for a hearing and any
contentions concerning his 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 him
(Staff Manual Guide 1410.35), finds that
Armando Santos has been convicted of
seven counts of felonies under Federal
law for conduct involving health care
fraud, conspiracy to commit health care
fraud, and false statements related to
health care matters, and, on the basis of
these convictions and other information,
finds that Mr. Santos has demonstrated
a pattern of conduct sufficient to find
that there is reason to believe he may
violate requirements under the FD&C
Act relating to drug products.
As a result of the foregoing finding,
Armando Santos is debarred for 12 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 306(c)(1)(B),
306(c)(2)(A)(iii), and 201(dd) of the
FD&C Act (21 U.S.C. 321(dd))). Any
person with an approved or pending
drug product application who
knowingly employs or retains as a
VerDate Sep<11>2014
18:25 Nov 07, 2014
Jkt 235001
consultant or contractor, or otherwise
uses the services of Mr. Santos, in any
capacity during his 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 Mr. Santos provides
services in any capacity to a person with
an approved or pending drug product
application during his period of
debarment he 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 from Mr. Santos
during his period of debarment (section
306(c)(1)(B) of the FD&C Act).
Any application by Mr. Santos for
termination of debarment under section
306(d)(4) of the FD&C Act should be
identified with Docket No. FDA–2013–
N–1106 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.
Any application by Mr. Santos for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2013–
N–1106 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(j).
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: November 4, 2014.
Armando Zamora,
Deputy Director, Office of Enforcement and
Import Operations, Office of Regulatory
Affairs.
[FR Doc. 2014–26562 Filed 11–7–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Bone, Reproductive and Urologic
Drugs Advisory Committee and the
Drug Safety and Risk Management
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of an advisory committee of the
Food and Drug Administration (FDA).
At least one portion of the meeting will
be closed to the public.
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
66729
Name of Committees: Bone,
Reproductive and Urologic Drugs
Advisory Committee and the Drug
Safety and Risk Management Advisory
Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 18, 2014, from 8:30
a.m. to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Kalyani Bhatt, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, email:
BRUDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The meeting will be closed to
permit discussion of whether FDA
should permit further clinical
development of an existing
investigational drug product, which will
include the review of trade secret and/
or confidential information.
Procedure: On December 18, 2014,
from 8:30 a.m. to 9:45 a.m., the meeting
is open to the public. Interested persons
may present data, information, or views,
orally or in writing, on issues pending
before the committees. Written
submissions may be made to the contact
person on or before December 4, 2014.
Oral presentations from the public will
be scheduled between approximately
8:45 a.m. and 9:45 a.m. Those
individuals interested in making formal
E:\FR\FM\10NON1.SGM
10NON1
]]>Agencies
[Federal Register Volume 79, Number 217 (Monday, November 10, 2014)]
[Notices]
[Pages 66728-66729]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26562]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1106]
Armando Santos: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring
Armando Santos from providing services in any capacity to a person that
has an approved or pending drug product application for a period of 12
years. FDA bases this order on a finding that Mr. Santos was convicted
of seven felony counts under Federal law for conduct involving health
care fraud, conspiracy to commit health care fraud, and false
statements related to health care matters and that this pattern of
conduct is sufficient to find that there is reason to believe he may
violate requirements under the FD&C Act relating to drug products. Mr.
Santos was given notice of the proposed debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation. Mr.
Santos failed to respond. Mr. Santos's failure to respond constitutes a
waiver of his right to a hearing concerning this action.
DATES: This order is effective November 10, 2014.
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., Element
Bldg., Rm. 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 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 it 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 August 15, 2011, the U.S. District Court for the Southern
District of Florida entered judgment against Mr. Santos after a jury
found him guilty of four counts of health care fraud in violation of 18
U.S.C. 1347, one count of conspiracy to commit health care fraud in
violation of 18 U.S.C. 1349, and two counts of false statements related
to health care matters in violation of 18 U.S.C. 1035(a)(2).
The FDA's finding that debarment is appropriate is based on the
felony convictions referenced herein. The factual basis for these
convictions is as follows: Mr. Santos was a registered nurse working
for a home health agency located in the Southern District of Florida.
As a registered nurse in the home health field, it was Mr. Santos's
duty to provide skilled nursing services to patients and maintain
proper documentation of all treatments provided to patients.
From on or about June 29, 2007, through on or about March 13, 2009,
Mr. Santos conspired with others to defraud Medicare. Mr. Santos and
his coconspirators, among other things, submitted and caused the
submission of false and fraudulent claims to Medicare, and paid
kickbacks and bribes to Medicare beneficiaries in exchange for the use
of their Medicare beneficiary numbers as the bases of claims filed for
home health care. Mr. Santos and his co-conspirators signed patient
assessment forms falsely certifying that Medicare beneficiaries were in
need of home health services that were medically unnecessary.
Mr. Santos created false weekly visit/time records in which he
claimed to be providing skilled nursing services to two separate
Medicare beneficiaries at the same time. On four separate occasions,
Mr. Santos submitted and caused the submission of false and fraudulent
claims to Medicare, representing that he had provided various home
health services to beneficiaries pursuant to physicians' plans of care.
He caused a home health agency to submit approximately $230,315 in
false and fraudulent claims to Medicare for home health services
allegedly rendered to Medicare beneficiaries, when such home health
services were not medically necessary and had not been provided. As a
result of these fraudulent claims, Mr. Santos caused Medicare to make
payments of approximately $152,664 to a Miami-Dade County home health
agency.
In addition, Mr. Santos knowingly and willfully made materially
false statements and representations, in connection with the delivery
of and payment for health care benefits, items, and services.
Specifically, Mr. Santos prepared documents entitled ``Skilled Nursing
Progress Note[s]'' which falsely stated that he had injected Medicare
beneficiaries with insulin on two occasions, when he knew he had not
performed these services.
As a result of his convictions, on April 9, 2014, FDA sent Mr.
Santos a notice by certified mail proposing to debar him for 12 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
Mr. Santos was convicted of seven felonies under Federal law for
conduct involving health care fraud, conspiracy to commit health care
fraud, and false statements related to health care matters, and that
the Agency found, on the basis of these convictions and other
information, that Mr. Santos had demonstrated a pattern of conduct
sufficient to find that there is reason to believe he may violate
requirements under the FD&C Act relating to drug products. This
conclusion was based on the fact that Mr. Santos had legal and
professional obligations to ensure that he kept accurate medical
records for each patient and that he submitted accurate medical claims
for services he provided. Instead, Mr. Santos signed patient assessment
forms falsely certifying that Medicare beneficiaries were in need of
home health services that were medically unnecessary, and he submitted
false weekly visit/time records. Mr. Santos additionally prepared false
``Skilled Nursing Progress Note[s]'' stating that he had injected two
Medicare beneficiaries with insulin when he had not done so. He
submitted and caused the submission of false and fraudulent claims to
Medicare. He engaged in this conduct repeatedly over a period of almost
2 years. His convictions indicate that he knowingly and willfully
disregarded his legal and professional obligations to keep accurate
medical records and to submit accurate claims for the services he
provided.
[[Page 66729]]
Having considered the conduct that forms the basis of his
conviction and the fact that this conduct occurred in the course of his
profession and showed a disregard for the obligations of his
profession, FDA finds that Mr. Santos has demonstrated a pattern of
conduct sufficient to find that there is reason to believe that, if he
were to provide services to a person that has an approved or pending
drug application, he may violate requirements under the FD&C Act
relating to drug products. Therefore, FDA has reason to believe that,
if Mr. Santos were to provide services to a person that has an approved
or pending drug application, he may violate requirements under the FD&C
Act relating to drug products.
The proposal offered Mr. Santos an opportunity to request a
hearing, providing him 30 days from the date of receipt of the letter
in which to file the request, and advised him 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
April 16, 2014. Mr. Santos failed to respond within the timeframe
prescribed by regulation and has, therefore, waived his opportunity for
a hearing and any contentions concerning his 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 him
(Staff Manual Guide 1410.35), finds that Armando Santos has been
convicted of seven counts of felonies under Federal law for conduct
involving health care fraud, conspiracy to commit health care fraud,
and false statements related to health care matters, and, on the basis
of these convictions and other information, finds that Mr. Santos has
demonstrated a pattern of conduct sufficient to find that there is
reason to believe he may violate requirements under the FD&C Act
relating to drug products.
As a result of the foregoing finding, Armando Santos is debarred
for 12 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 306(c)(1)(B), 306(c)(2)(A)(iii), and 201(dd)
of the FD&C Act (21 U.S.C. 321(dd))). 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 Mr. Santos,
in any capacity during his 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 Mr. Santos provides services in any capacity to a person with an
approved or pending drug product application during his period of
debarment he 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 from Mr. Santos during his period
of debarment (section 306(c)(1)(B) of the FD&C Act).
Any application by Mr. Santos for termination of debarment under
section 306(d)(4) of the FD&C Act should be identified with Docket No.
FDA-2013-N-1106 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.
Any application by Mr. Santos for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2013-N-1106 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(j).
Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: November 4, 2014.
Armando Zamora,
Deputy Director, Office of Enforcement and Import Operations, Office of
Regulatory Affairs.
[FR Doc. 2014-26562 Filed 11-7-14; 8:45 am]
BILLING CODE 4164-01-P
