[Federal Register Volume 79, Number 202 (Monday, October 20, 2014)]
[Notices]
[Pages 62634-62635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24814]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0960]


Kelvin Soto: 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 
Kelvin Soto from providing services in any capacity to a person that 
has an approved or pending drug product application for a period of 6 
years. We base this order on a finding that Mr. Soto was convicted of 
four felony counts under Federal law for conduct involving health care 
fraud and conspiracy to commit health care fraud 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. 
Soto was given notice of the proposed debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Mr. 
Soto failed to request a hearing. Mr. Soto's failure to request a 
hearing constitutes a waiver of his right to a hearing concerning this 
action.

DATES: This order is effective October 20, 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, 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; interference with, obstruction 
of an investigation into, or prosecution of any criminal offense; and 
FDA 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 November 6, 2012, the U.S. District Court for the Southern 
District of Florida entered judgment against Mr. Soto after a jury 
found him guilty of four counts of health care fraud in violation of 18 
U.S.C. 1347 and one count of conspiracy to commit health care fraud in 
violation of 18 U.S.C. 1349.
    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. Soto was a registered nurse working for Ideal Home 
Health Inc. (Ideal), which was a business in Miami-Dade County, FL. 
Ideal purportedly provided skilled nursing services to Medicare 
beneficiaries who required home health services. As a registered nurse 
in the home health field, it was Mr. Soto's duty to provide skilled 
nursing services to patients and maintain proper documentation of all 
treatments provided to patients.
    Mr. Soto conspired with others to defraud Medicare. Mr. Soto and 
his coconspirators, among other things, submitted and caused the 
submission of false and fraudulent claims to Medicare and concealed the 
submission of these false and fraudulent claims.
    Mr. Soto and his co-conspirators falsified and caused Medicare 
beneficiaries to falsify weekly visit/time record sheets, falsified 
skilled nursing progress notes representing that Mr. Soto had 
administered insulin injections and provided various other medical 
services to Medicare beneficiaries, and caused Ideal to submit false 
and fraudulent claims to Medicare for home health benefits by falsely 
representing that they had provided these home health services. As a 
result of these fraudulent claims, Mr. Soto caused Medicare to make 
payments

[[Page 62635]]

to Ideal, which amounted to approximately $58,400.
    As a result of his conviction on April 9, 2014, FDA sent Mr. Soto a 
notice by certified mail proposing to debar him for 6 years from 
providing services in any capacity to a person that has an approved or 
pending drug product application. The proposal was based on a finding 
under section 306(b)(2)(B)(ii)(I) of the FD&C Act that Mr. Soto was 
convicted of felonies under Federal law for conduct which involved 
health care fraud, and the Agency found, on the basis of the conviction 
and other information, that Mr. Soto 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. Soto had legal and 
professional obligations to ensure that he submitted accurate medical 
claims for services he provided, as well as ensure that he provided the 
appropriate drug products to his patients. Instead, Mr. Soto submitted 
and caused the submission of false weekly visit/time record sheets and 
false daily blood sugar/insulin log sheets. He engaged in this conduct 
repeatedly over a period of more than 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. 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 and the law, FDA found that Mr. Soto 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 had reason to believe that, if Mr. Soto 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. Soto an opportunity to request a hearing, 
providing him with 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 14, 2014. Mr. Soto failed to respond within the timeframe 
prescribed by regulation and has, therefore, waived his opportunity for 
a hearing and has waived 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 the 
Director (Staff Manual Guide 1410.35), finds that Kelvin Soto has been 
convicted of four counts of a felony and one count of conspiracy to 
commit a felony under Federal law for conduct involving health care 
fraud, and on the basis of the conviction and other information, finds 
that Mr. Soto 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.
    Based on the factors under section 306(c)(2)(A)(iii) of the FD&C 
Act (21 U.S.C. 335a(c)(2)(A)(iii)), FDA finds that each offense be 
accorded a debarment period of 3 years. In the case of a person 
debarred for multiple offenses, FDA shall determine whether the periods 
of debarment shall run concurrently or consecutively (21 U.S.C. 
335a(c)(2)(A)). FDA has concluded that the 3-year period of debarment 
for each of the five offenses of conviction need not be served 
consecutively. Rather, FDA has concluded that the 3-year periods of 
debarment for the four counts of health care fraud shall run 
concurrently. The 3-year period of debarment for the conspiracy 
conviction shall run consecutively to the periods of debarment for the 
health care fraud convictions, resulting in a total debarment period of 
6 years.
    As a result of the foregoing finding, Kelvin Soto is debarred for a 
period of 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 sections 201(dd), 306(c)(1)(B), and 
306(c)(2)(A)(ii) of the FD&C Act (21 U.S.C. 321(dd), 335a(c)(1)(B), and 
335a(c)(2)(A)(ii)). Any person with an approved or pending drug product 
application who knowingly employs or retains Mr. Soto as a consultant 
or contractor, or otherwise uses the services of Kelvin Soto 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))). In 
addition, FDA will not accept or review any abbreviated new drug 
applications submitted by or with the assistance of Kelvin Soto during 
his period of debarment (section 306(c)(l)(A) of the FD&C Act).
    Any application by Mr. Soto for termination of debarment under 
section 306(d)(4) of the FD&C Act should be identified with Docket No. 
FDA-2013-N-0960 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: October 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24814 Filed 10-17-14; 8:45 am]
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