[Federal Register Volume 79, Number 217 (Monday, November 10, 2014)]
[Notices]
[Pages 66728-66729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26562]


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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.

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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