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###### Department of Health and Human Services

###### Food and Drug Administration

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

# 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 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                           ( print 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