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. 

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 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. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices 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 

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. 

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: http://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 http://

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 


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