83 FR 49095 - Richard M. Fleming; Denial of Hearing; Final Debarment Order
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 189 (September 28, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 189 (September 28, 2018)
| Page Range | 49095-49097 | |
| FR Document | 2018-21210 |
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)] [Notices] [Pages 49095-49097] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21210] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0333] Richard M. Fleming; Denial of Hearing; Final Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is denying a request for a hearing submitted by Richard M. Fleming (Fleming) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Fleming for 10 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Fleming was convicted of two felonies under Federal law that involved fraud. Additionally, Fleming has demonstrated a pattern of conduct sufficient to find that there is reason to believe that he may violate requirements under the FD&C Act relating to drug products. In determining the appropriateness and period of Fleming's debarment, FDA considered the relevant factors listed in the FD&C Act. Fleming failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action. DATES: The order is applicable September 28, 2018. ADDRESSES: Any application for termination of debarment by Fleming under section 306(d) of the FD&C Act (application) may be submitted as follows: Electronic SubmissionsFederal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. An application submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your application will be made public, you are solely responsible for ensuring that your application does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your application, that information will be posted on https://www.regulations.gov. If you want to submit an application with confidential information that you do not wish to be made available to the public, submit the application as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ''Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For a written/paper application submitted to the Dockets Management Staff, FDA will post your application, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: Your application must include the Docket No. FDA- 2013-N- [[Page 49096]] 0333. An application will be placed in the docket and, unless submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit an application with confidential information that you do not wish to be made publicly available, submit your application only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of your application. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your application and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 between 9 a.m. and 4 p.m., Monday through Friday. Publicly available submissions may be seen in the docket. FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931. 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: (1) Has been convicted of a felony 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 (2) based on the conviction and other information, the individual has demonstrated a pattern of conduct sufficient to find that there is reason to believe that the person may violate requirements under the FD&C Act relating to drug products. On April 24, 2009, Fleming, the president of, and sole physician at, Fleming Heart and Health Institute, P.C. (FHHI), pled guilty to one felony count of healthcare fraud, in violation of 18 U.S.C. 1347 and 2, and one felony count of mail fraud, in violation of 18 U.S.C. 1341 and 2. On August 20, 2009, the U.S. District Court for the District of Nebraska entered a judgment of conviction against Fleming on these counts and sentenced Fleming to 5 years of probation. Fleming's convictions stemmed from two separate actions. Fleming, through his practice at FHHI, performed various imaging studies and submitted reimbursement claims to Medicare and Medicaid. Fleming pled guilty to one count of felony healthcare fraud in violation of 18 U.S.C. 1347 and 2 for conduct related to the submission of a reimbursement claim. Fleming admitted to knowingly executing and attempting to execute a scheme to defraud Medicare and Medicaid healthcare benefit programs in connection with the delivery of and payment for healthcare benefits, items, and services, namely by submitting payment claims for tomographic myocardial perfusion imaging studies that he did not actually perform. Fleming also pled guilty to one count of felony mail fraud in violation of 18 U.S.C. 1341 and 2 for conduct relating to money paid him to conduct a clinical study of a soy chip food product for the purpose of evaluating health benefits. As Fleming admitted during his guilty plea, he received approximately $35,000 for conducting a clinical trial, but he fabricated data for certain subjects. By letter dated November 18, 2013, FDA's Office of Regulatory Affairs (ORA) notified Fleming of its proposal to debar him for 10 years from providing services in any capacity to a person having an approved or pending drug product application. The proposal explained that the proposed debarment period was based on both felony fraud convictions. ORA stated that these convictions establish Fleming's disregard for his professional obligations and the law and provide 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, ORA found that Fleming was subject to debarment under section 306(b)(2)(B)(ii)(I) of the FD&C Act. The proposal noted that the maximum debarment period for each offense is 5 years and that FDA may determine whether debarment periods for multiple offenses should run concurrently or consecutively. The proposal outlined findings concerning the four relevant factors that ORA considered in determining the appropriateness and period of debarment, as provided in section 306(c)(3) of the FD&C Act: (1) The nature and seriousness of any offense, (2) the nature and extent of management participation in any offense, (3) the nature and extent of voluntary steps to mitigate the impact on the public, and (4) prior convictions under the FD&C Act or other acts involving matters within FDA's jurisdiction. ORA found that the first three were unfavorable factors and that the last was a favorable factor for Fleming. The notice concluded that ``the unfavorable factors cumulatively far outweigh the sole favorable factor.'' Accordingly, FDA determines that debarment is appropriate, and that the 5-year period of debarment for each of the two offenses should be served consecutively, resulting in a total debarment period of 10 years. Fleming timely responded to the proposal to debar and requested a hearing. Fleming's response included multiple documents in which he raises variations of two central arguments, namely that: (1) His guilty plea ``does not state a crime'' and (2) he is ``actually innocent.'' Fleming contends that his guilty plea was a ``holographic plea'' to protect his children. Under the authority delegated to him by the Commissioner of Food and Drugs, the Director of the Office of Scientific Integrity (OSI) has considered Fleming's request for a hearing. Hearings are granted only if there is a genuine and substantial issue of fact. Hearings will not be granted on issues of policy or law, on mere allegations, denials or general descriptions of positions and contentions, or on data and information insufficient to justify the factual determination urged (see 21 CFR 12.24(b)). OSI has considered Fleming's arguments and concludes that they are unpersuasive and fail to raise a genuine and substantial issue of fact requiring a hearing. [[Page 49097]] II. Arguments Fleming submitted multiple documents in support of his arguments that his guilty plea ``does not state a crime'' and that he is ``actually innocent.'' However, section 306(l) of the FD&C Act defines conviction as when a Federal or State court's judgment of conviction or when a Federal or State court's acceptance of a guilty plea. In Fleming's ``Petition to Enter a Plea of Guilty,'' he stated that he understood the charges against him and that he was voluntarily entering his guilty plea. The court entered a judgment of conviction after accepting Fleming's guilty plea. Federal court is the proper venue for any challenge to Fleming's guilty plea based on a claim of actual innocence, not this remedial proceeding. OSI carefully reviewed Fleming's submission in its entirety, and Fleming does not dispute that the court entered a judgment of conviction or that the court accepted his guilty plea; therefore, Fleming's arguments regarding his actual innocence fail to raise a genuine and substantial issue of fact warranting a hearing. Under section 306(b)(2)(B)(ii)(I) of the FD&C Act, FDA has the authority to debar an individual convicted of certain Federal felonies, involving, among other things, fraud, if FDA finds that the individual has demonstrated a pattern of conduct giving reason to believe that he may violate requirements under the FD&C Act relating to drug products. The relevant factual issues are whether Fleming was, in fact, convicted of a felony involving fraud and whether there is reason to believe that he may violate requirements under the FD&C Act relating to drug products. Fleming does not dispute that he pled guilty to felony healthcare fraud and felony mail fraud or that, based on these convictions, there is reason to believe that he may violate requirements under the FD&C Act relating to drug products. Therefore, Fleming has failed to raise a genuine and substantial issue of fact warranting a hearing regarding whether he is subject to debarment. Fleming's response included one argument that may be construed to be a challenge to ORA's proposed findings on the nature and seriousness of his offense. Fleming appears to claim that the imaging studies he performed on his patients were safer than the imaging studies he billed to Medicare and Medicaid. In the proposal to debar, in evaluating the nature and seriousness of the offenses, ORA noted that Fleming was convicted of two felonies, healthcare fraud and mail fraud. ORA considered that he billed Medicare and Medicaid for procedures other than those that he had performed, that he falsified clinical trial data, and that his actions ``have the potential for causing significant loss of public confidence in the healthcare system.'' Fleming's actions took place over a period of several months and demonstrated multiple instances of fraud. While Fleming contends that he performed safer imaging studies than those billed, FDA must weigh this claim against the serious nature of the fraud he committed. Construing Fleming's argument in a light most favorable to him, whether he performed safer imaging studies does not sufficiently counter the very serious nature of fraudulent conduct and is not enough to establish that a shorter debarment period would be appropriate. Based on the factual findings in the proposal to debar and on the record, OSI finds that a 5-year debarment period for each felony offense is appropriate. The nature and seriousness of Fleming's offense, Fleming's managerial participation, and his lack of voluntary steps to mitigate the impact on the public weigh in favor of debarment. Although Fleming does not appear to have prior criminal convictions involving matters within FDA's jurisdiction, a debarment period of 5 years for each felony conviction is appropriate. As noted in the proposal to debar, the conduct underlying the offenses involved submitting claims for payment for procedures other than the procedures Fleming performed and falsifying clinical trial data, and ``[t]he conduct that form[ed] the basis of [his] conviction occurred in the course of [his] profession and showed disregard for the obligations of [his] profession and the law.'' Based on the pattern of fraudulent conduct, FDA has reason to believe that Fleming may violate the requirements under the FD&C Act relating to drug products. Furthermore, given that Fleming has offered no arguments challenging the proposed determination regarding the extent to which his debarment periods should run concurrently or consecutively, OSI further determines that the 5-year debarment period for each felony conviction should run consecutively, resulting in a total debarment of 10 years. III. Findings and Order Therefore, the Director of OSI, under section 306(b)(2)(B)(i)(I) of the FD&C Act and authority delegated to him by the Commissioner of Food and Drugs, finds that: (1) Fleming 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 (2) based on the conviction and other information, Fleming has demonstrated a pattern of conduct giving reason to believe that he may violate requirements under the FD&C Act relating to drug products. FDA considered the applicable factors listed in section 306(c)(3) of the FD&C Act and determined that a debarment of 10 years is appropriate. As a result of the foregoing findings, Fleming is debarred for 10 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 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and 21 U.S.C. 321(dd)). Any person with an approved or pending drug product application, who knowingly uses the services of Fleming, in any capacity during his period of 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 Fleming, during his period of debarment, provides services in any capacity to a person with an approved or pending drug product application, 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 Fleming during his period of debarment (section 306(c)(1)(B) of the FD&C Act). Dated: September 25, 2018. George M. Warren, Director, Office of Scientific Integrity. [FR Doc. 2018-21210 Filed 9-27-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices 49095
proposed collection(s) summarized in the establishment of new Affordable involved fraud. Additionally, Fleming
this notice, you may make your request Insurance Exchanges (Exchanges), also has demonstrated a pattern of conduct
using one of following: called Marketplaces, including the sufficient to find that there is reason to
1. Access CMS’ website address at Small Business Health Options Program believe that he may violate requirements
website address at https://www.cms.gov/ (SHOP). Revised requirements under the FD&C Act relating to drug
Regulations-and-Guidance/Legislation/ pertaining to agents/brokers completing products. In determining the
PaperworkReductionActof1995/PRA- Federally-facilitated Exchange (FFE) appropriateness and period of Fleming’s
Listing.html. registration are discussed in the final debarment, FDA considered the relevant
2. Email your request, including your rule published on February 27, 2015 for factors listed in the FD&C Act. Fleming
address, phone number, OMB number, the Patient Protection and Affordable failed to file with the Agency
and CMS document identifier, to Care Act; HHS Notice of Benefit and information and analyses sufficient to
Paperwork@cms.hhs.gov. Payment Parameters for 2016 (CMS– create a basis for a hearing concerning
3. Call the Reports Clearance Office at 9944–F). These updated requirements this action.
(410) 786–1326. direct agents/brokers to submit DATES: The order is applicable
FOR FURTHER INFORMATION CONTACT: additional fields related to basic contact September 28, 2018.
William Parham at (410) 786–1326. information and National Producer ADDRESSES: Any application for
SUPPLEMENTARY INFORMATION: Number (NPN). Current state licensure termination of debarment by Fleming
and relevant health lines of authority under section 306(d) of the FD&C Act
Contents (LOA) are then validated using the (application) may be submitted as
This notice sets out a summary of the National Insurance Producer Registry follows:
use and burden associated with the (NIPR) database. This ICR serves as the
following information collections. More formal request for renewal and also Electronic Submissions
detailed information can be found in includes some of the information • Federal eRulemaking Portal:
each collection’s supporting statement collection requirements from the https://www.regulations.gov. Follow the
and associated materials (see previously approved final rule. Form instructions for submitting comments.
ADDRESSES). Number: CMS–10464 (OMB control An application submitted electronically,
CMS–10464 Agent/Broker Data number: 0938–1204); Frequency: including attachments, to https://
Collection in Federally Facilitated Annually; Affected Public: Private www.regulations.gov will be posted to
Health Insurance Exchanges Sector (Business or other for-profits); the docket unchanged. Because your
Number of Respondents: 52,000; application will be made public, you are
Under the PRA (44 U.S.C. 3501– Number of Responses: 52,000; Total solely responsible for ensuring that your
3520), federal agencies must obtain Annual Hours: 12,480. (For questions application does not include any
approval from the Office of Management regarding this collection contact confidential information that you or a
and Budget (OMB) for each collection of Madeline Pellish at 301–492–4390.) third party may not wish to be posted,
information they conduct or sponsor. such as medical information, your or
Dated: September 25, 2018.
The term ‘‘collection of information’’ is anyone else’s Social Security number, or
defined in 44 U.S.C. 3502(3) and 5 CFR William N. Parham, III,
Director, Paperwork Reduction Staff, Office
confidential business information, such
1320.3(c) and includes agency requests as a manufacturing process. Please note
or requirements that members of the of Strategic Operations and Regulatory
Affairs. that if you include your name, contact
public submit reports, keep records, or information, or other information that
[FR Doc. 2018–21171 Filed 9–27–18; 8:45 am]
provide information to a third party. identifies you in the body of your
Section 3506(c)(2)(A) of the PRA BILLING CODE 4120–01–P
application, that information will be
requires federal agencies to publish a posted on https://www.regulations.gov.
60-day notice in the Federal Register • If you want to submit an
DEPARTMENT OF HEALTH AND
concerning each proposed collection of application with confidential
HUMAN SERVICES
information, including each proposed information that you do not wish to be
extension or reinstatement of an existing Food and Drug Administration made available to the public, submit the
collection of information, before application as a written/paper
submitting the collection to OMB for [Docket No. FDA–2013–N–0333]
submission and in the manner detailed
approval. To comply with this (see ‘‘Written/Paper Submissions’’ and
Richard M. Fleming; Denial of Hearing;
requirement, CMS is publishing this ’’Instructions’’).
Final Debarment Order
notice.
AGENCY: Food and Drug Administration, Written/Paper Submissions
Information Collection
HHS. Submit written/paper submissions as
1. Title of Information Collection: ACTION: Notice. follows:
Agent/Broker Data Collection in • Mail/Hand delivery/Courier (for
Federally Facilitated Health Insurance SUMMARY: The Food and Drug written/paper submissions): Dockets
Exchanges; Type of Information Administration (FDA or the Agency) is Management Staff (HFA–305), Food and
Collection Request: Revision of a denying a request for a hearing Drug Administration, 5630 Fishers
currently approved collection; Use: The submitted by Richard M. Fleming Lane, Rm. 1061, Rockville, MD 20852.
Patient Protection and Affordable Care (Fleming) and is issuing an order under • For a written/paper application
Act, Public Law 111–148, enacted on the Federal Food, Drug, and Cosmetic submitted to the Dockets Management
amozie on DSK3GDR082PROD with NOTICES1
March 23, 2010, and the Health Care Act (FD&C Act) debarring Fleming for Staff, FDA will post your application, as
and Education Reconciliation Act, 10 years from providing services in any well as any attachments, except for
Public Law 111–152, enacted on March capacity to a person that has an information submitted, marked and
30, 2010 (collectively, ‘‘Affordable Care approved or pending drug product identified, as confidential, if submitted
Act’’), expands access to health application. FDA bases this order on a as detailed in ‘‘Instructions.’’
insurance for individuals and finding that Fleming was convicted of Instructions: Your application must
employees of small businesses through two felonies under Federal law that include the Docket No. FDA–2013–N–
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![Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices 49097
II. Arguments Medicaid for procedures other than fraud, perjury, false statement,
Fleming submitted multiple those that he had performed, that he racketeering, blackmail, extortion,
documents in support of his arguments falsified clinical trial data, and that his falsification or destruction of records, or
that his guilty plea ‘‘does not state a actions ‘‘have the potential for causing interference with, obstruction of an
crime’’ and that he is ‘‘actually significant loss of public confidence in investigation into, or prosecution of, any
innocent.’’ However, section 306(l) of the healthcare system.’’ Fleming’s criminal offense and (2) based on the
the FD&C Act defines conviction as actions took place over a period of conviction and other information,
when a Federal or State court’s several months and demonstrated Fleming has demonstrated a pattern of
judgment of conviction or when a multiple instances of fraud. While conduct giving reason to believe that he
Federal or State court’s acceptance of a Fleming contends that he performed may violate requirements under the
guilty plea. In Fleming’s ‘‘Petition to safer imaging studies than those billed, FD&C Act relating to drug products.
Enter a Plea of Guilty,’’ he stated that he FDA must weigh this claim against the FDA considered the applicable factors
serious nature of the fraud he listed in section 306(c)(3) of the FD&C
understood the charges against him and
committed. Construing Fleming’s Act and determined that a debarment of
that he was voluntarily entering his
argument in a light most favorable to 10 years is appropriate.
guilty plea. The court entered a
him, whether he performed safer As a result of the foregoing findings,
judgment of conviction after accepting
imaging studies does not sufficiently Fleming is debarred for 10 years from
Fleming’s guilty plea. Federal court is
counter the very serious nature of providing services in any capacity to a
the proper venue for any challenge to
fraudulent conduct and is not enough to person with an approved or pending
Fleming’s guilty plea based on a claim
establish that a shorter debarment drug product application under sections
of actual innocence, not this remedial
period would be appropriate. 505, 512, or 802 of the FD&C Act (21
proceeding. OSI carefully reviewed Based on the factual findings in the
Fleming’s submission in its entirety, U.S.C. 355, 360b, or 382), or under
proposal to debar and on the record, OSI section 351 of the Public Health Service
and Fleming does not dispute that the finds that a 5-year debarment period for
court entered a judgment of conviction Act (42 U.S.C. 262), effective (see DATES)
each felony offense is appropriate. The (see 21 U.S.C. 335a(c)(1)(B) and
or that the court accepted his guilty nature and seriousness of Fleming’s
plea; therefore, Fleming’s arguments (c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
offense, Fleming’s managerial Any person with an approved or
regarding his actual innocence fail to participation, and his lack of voluntary
raise a genuine and substantial issue of pending drug product application, who
steps to mitigate the impact on the knowingly uses the services of Fleming,
fact warranting a hearing. public weigh in favor of debarment.
Under section 306(b)(2)(B)(ii)(I) of the in any capacity during his period of
Although Fleming does not appear to debarment, will be subject to civil
FD&C Act, FDA has the authority to have prior criminal convictions
debar an individual convicted of certain money penalties (section 307(a)(6) of the
involving matters within FDA’s FD&C Act (21 U.S.C. 335b(a)(6))). If
Federal felonies, involving, among other jurisdiction, a debarment period of 5
things, fraud, if FDA finds that the Fleming, during his period of
years for each felony conviction is debarment, provides services in any
individual has demonstrated a pattern appropriate. As noted in the proposal to
of conduct giving reason to believe that capacity to a person with an approved
debar, the conduct underlying the or pending drug product application, he
he may violate requirements under the offenses involved submitting claims for
FD&C Act relating to drug products. The will be subject to civil money penalties
payment for procedures other than the
relevant factual issues are whether (section 307(a)(7) of the FD&C Act). In
procedures Fleming performed and
Fleming was, in fact, convicted of a addition, FDA will not accept or review
falsifying clinical trial data, and ‘‘[t]he
felony involving fraud and whether any abbreviated new drug applications
conduct that form[ed] the basis of [his]
there is reason to believe that he may submitted by or with the assistance of
conviction occurred in the course of
violate requirements under the FD&C Fleming during his period of debarment
[his] profession and showed disregard
Act relating to drug products. Fleming (section 306(c)(1)(B) of the FD&C Act).
for the obligations of [his] profession
does not dispute that he pled guilty to and the law.’’ Based on the pattern of Dated: September 25, 2018.
felony healthcare fraud and felony mail fraudulent conduct, FDA has reason to George M. Warren,
fraud or that, based on these believe that Fleming may violate the Director, Office of Scientific Integrity.
convictions, there is reason to believe requirements under the FD&C Act [FR Doc. 2018–21210 Filed 9–27–18; 8:45 am]
that he may violate requirements under relating to drug products. Furthermore, BILLING CODE 4164–01–P
the FD&C Act relating to drug products. given that Fleming has offered no
Therefore, Fleming has failed to raise a arguments challenging the proposed
genuine and substantial issue of fact determination regarding the extent to DEPARTMENT OF HEALTH AND
warranting a hearing regarding whether which his debarment periods should HUMAN SERVICES
he is subject to debarment. run concurrently or consecutively, OSI
Fleming’s response included one further determines that the 5-year Food and Drug Administration
argument that may be construed to be a debarment period for each felony
challenge to ORA’s proposed findings [Docket No. FDA–2018–D–3304]
conviction should run consecutively,
on the nature and seriousness of his resulting in a total debarment of 10 The Special 510(k) Program; Draft
offense. Fleming appears to claim that years. Guidance for Industry and Food and
the imaging studies he performed on his
III. Findings and Order Drug Administration Staff; Availability
patients were safer than the imaging
amozie on DSK3GDR082PROD with NOTICES1
studies he billed to Medicare and Therefore, the Director of OSI, under AGENCY: Food and Drug Administration,
Medicaid. In the proposal to debar, in section 306(b)(2)(B)(i)(I) of the FD&C HHS.
evaluating the nature and seriousness of Act and authority delegated to him by ACTION: Notice of availability.
the offenses, ORA noted that Fleming the Commissioner of Food and Drugs,
was convicted of two felonies, finds that: (1) Fleming has been SUMMARY: The Food and Drug
healthcare fraud and mail fraud. ORA convicted of a felony which involves Administration (FDA or Agency) is
considered that he billed Medicare and bribery, payment of illegal gratuities, announcing the availability of the draft
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Document Created: 2018-09-28 01:23:25
Document Modified: 2018-09-28 01:23:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The order is applicable September 28, 2018. | |
| Contact | Rachael Vieder Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931. | |
| FR Citation | 83 FR 49095 |
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