[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Notices]
[Pages 79005-79006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31776]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0235]


Ehigiator O. Akhigbe: 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 
Ehigiator O. Akhigbe, MD for 25 years from providing services in any 
capacity to a person that has an approved or pending drug product 
application. We base this order on a finding that Dr. Akhigbe was 
convicted of 17 felonies for conduct involving fraud, false statement 
and falsification or destruction of records. Dr. Akhigbe was given 
notice of the proposed debarment and an opportunity to request a 
hearing within the timeframe prescribed by regulation. Dr. Akhigbe 
failed to respond. Dr. Akhigbe's failure to respond constitutes a 
waiver of his right to a hearing concerning this action.

DATES: This Order is effective December 17, 2010.

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, 5600 Fishers Lane, Rockville, MD 
20857, 240-632-6844.

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 has been convicted of a felony which 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 that individual may violate 
requirements under the Act relating to drug products.
    On March 19, 2010, the United States District Court for the 
District of Columbia entered judgment against Dr. Akhigbe for one count 
of health care fraud in violation of 18 U.S.C. 1347, and 16 counts of 
false statements in health care matters in violation of 18 U.S.C. 1035.
    FDA's finding that debarment is appropriate is based on the felony 
convictions referenced herein. The factual basis for those convictions 
is as follows: Dr. Akhigbe was a medical doctor with licenses to 
practice in the District of Columbia, Maryland, Pennsylvania, and 
Virginia. The District of Columbia Medicaid Program contracted with 
Amerigroup Corp. (Amerigroup) to act as its fiscal agent for the 
processing and payment of claims submitted by Medicaid providers. On or 
about December 6, 2001, Dr. Akhigbe entered into a Participating 
Physician Agreement with Amerigroup whereby he agreed to provide 
healthcare services to District of Columbia Medicaid beneficiaries.
    Dr. Akhigbe prepared and submitted his own billing to Amerigroup 
for medical services he purportedly provided to his patients. For each 
billed visit, Dr. Akhigbe or others acting at his direction, generated 
insurance claim forms which included his certification that all of the 
information on the claim forms was accurate. From on or about December 
6, 2001, until the termination of his contract with Amerigroup on June 
24, 2004, Dr. Akhigbe submitted approximately 3,957 claims to 
Amerigroup for services he purportedly provided to Medicaid patients 
and sought approximately $807,347.00 from Amerigroup.
    Beginning in approximately December 2002, and continuing to 
approximately May 2005, in the District of Columbia and elsewhere, Dr. 
Akhigbe knowingly, willfully, and with intent to defraud, executed a 
scheme and artifice to defraud Amerigroup as to material matters in 
connection with the delivery of any payment for health care benefits, 
items, and services, and to obtain money from Amerigroup by means of 
material false and fraudulent pretenses and representations and the 
concealment of material facts in connection with the delivery of and 
payment for health care benefits, items, and services. As part of his 
scheme, Dr. Akhigbe repeatedly prepared and submitted false claims in 
which he purported to have performed surgical or invasive medical 
procedures on District of Columbia Medicaid patients that were never 
performed, he billed for office visits that never occurred, and he 
continued to bill for a period of time after a minor or major procedure 
during which no additional bills could be submitted. In order to 
conceal from Amerigroup that he was billing for procedures that he had 
not performed, Dr. Akhigbe created false progress notes indicating the 
dates, times and medical procedures that he claimed to have performed 
and inserted the false progress notes into his patients' medical files 
to corroborate a number of false claims.
    As a result of his convictions, on September 13, 2010, FDA sent Dr. 
Akhigbe a notice by certified mail proposing to debar him for 25 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 (21 U.S.C. 
335a(b)(2)(B)(ii)(I)), that Dr. Akhigbe was convicted of felonies for 
conduct involving fraud, false statement and falsification or 
destruction of records and that Dr. Akhigbe has demonstrated a pattern 
of conduct sufficient to find that there is reason to believe that 
individual may violate requirements under the FD&C Act relating to drug 
products. The proposal also offered Dr. Akhigbe 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. Dr. Akhigbe 
failed to respond within the timeframe prescribed by regulation and 
has, therefore, waived his opportunity for a hearing and waived any 
contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of 
Regulatory Affairs, under Section 306(b)(2)(B)(ii)(I) of the FD&C Act 
(21 U.S.C. 335a(b)(2)(B)(ii)(I)) under authority delegated to him 
(Staff Manual Guide 1410.35), finds that Ehigiator O. Akhigbe has been 
convicted of felonies for conduct involving fraud, false statement and 
falsification or destruction of records.
    As a result of the foregoing finding, Dr. Akhigbe is debarred for 
25 years from providing services in any capacity to a person with an 
approved or

[[Page 79006]]

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 
section 306(c)(1)(B), (c)(2)(A)(iii), and 201(dd) of the FD&C Act (21 
U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), and 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 Dr. Akhigbe, in any capacity during Dr. Akhigbe's 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 Dr. Akhigbe 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 submitted by or with 
the assistance of Dr. Akhigbe during his period of debarment (section 
306(c)(1)(B) of the FD&C Act (21 U.S.C. 335a(c)(1)(B)).
    Any application by Dr. Akhigbe for termination of debarment under 
section 306(d)(4) of the FD&C Act should be identified with Docket No. 
FDA-2010-N-0235 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 19, 2010.
Howard R. Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2010-31776 Filed 12-16-10; 8:45 am]
BILLING CODE 4160-01-P