Findings of Research Misconduct, 46438-46439 [2012-18990]
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Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices
A Federal Reserve Bank of New York
(Ivan Hurwitz, Vice President) 33
Liberty Street, New York, New York
10045–0001:
1. Westpac Banking Corporation,
Sydney, Australia, to engage de novo
through Westpac Capital Markets LLC,
New York, New York in securities
brokerage and riskless principal
transactions, pursuant to Sections
225.28(b)(7)(i) and 225.28(b)(7)(ii) of
Regulation Y.
Board of Governors of the Federal Reserve
System, July 30, 2012.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 2012–18933 Filed 8–2–12; 8:45 am]
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 877–
222–7570. Information requests can also
be submitted by email to
DCAS@CDC.GOV.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2012–19045 Filed 8–2–12; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
BILLING CODE 6210–01–P
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Final Effect of Designation of a Class
of Employees for Addition to the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
HHS gives notice concerning
the final effect of the HHS decision to
designate a class of employees from the
Feed Materials Production Center in
Fernald, Ohio, as an addition to the
Special Exposure Cohort (SEC) under
the Energy Employees Occupational
Illness Compensation Program Act of
2000. On June 27, 2012, as provided for
under 42 U.S.C. 7384q(b), the Secretary
of HHS designated the following class of
employees as an addition to the SEC:
SUMMARY:
TKELLEY on DSK3SPTVN1PROD with NOTICES
All employees of DOE, its predecessor
agencies, and their contractors, or
subcontractors who worked at the Feed
Materials Production Center (FMPC) in
Fernald, Ohio, from January 1, 1968 through
December 31, 1978, for a number of work
days aggregating at least 250 work days,
occurring either solely under this
employment, or in combination with work
days within the parameters established for
one or more other classes of employees
included in the Special Exposure Cohort.
This designation became effective on
July 27, 2012, as provided for under 42
U.S.C. 7384l(14)(C). Hence, beginning
on July 27, 2012, members of this class
of employees, defined as reported in
this notice, became members of the SEC.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
VerDate Mar<15>2010
17:33 Aug 02, 2012
Jkt 226001
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Mepur H. Ravindranath, Ph.D., John
Wayne Cancer Institute: Based on the
report of an investigation conducted by
the John Wayne Cancer Institute (JWCI)
and additional analysis conducted by
ORI in its oversight review, ORI found
that Dr. Mepur H. Ravindranath, former
Director of the Laboratory of
Glycoimmunotheraphy, JWCI, engaged
in research misconduct in research
supported by National Cancer Institute
(NCI), National Institutes of Health
(NIH), awards R21 CA107316 and R03
CA107831.
ORI found that the Respondent
engaged in research misconduct by
falsifying results reported for research
supported by U.S. Public Health Service
(PHS) grants R21 CA107316 and R03
CA107831, in progress reports for those
grants and in two publications in
scientific journals.
It is expressly understood that by
entering into a Voluntary Settlement
Agreement (Agreement), Respondent is
not admitting to any of the allegations
made against him by JWCI and/or ORI,
or any of their respective agents,
employees, associates, or related
persons, including but not limited to the
findings made by ORI listed in the
Agreement. Respondent agreed to enter
into the Agreement and not to contest
the findings contained therein solely
because contesting the findings would
cause Respondent undue financial
hardship and stress, and Respondent
wished to seek finality.
SUMMARY:
Specifically
1. Respondent falsified the number of
subjects accrued in the double-blind
study reported in the paper
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
Ravindranath, M.H., Muthugounder, S.,
Presser, N., Ye, X., Brosman, S., &
Morton, D.L. ‘‘Endogenous immune
response to gangliosides in patients
with confined prostate cancer.’’ Int. J.
Cancer 166:368–377, 2005
(subsequently referred to as the ‘‘IJC
paper) and later reviewed in
Ravindranath, M.H. Yesowitch, P.,
Sumobay, C., & Morton, D.L.
‘‘Glycoimmunomics of human cancer:
Current concepts and future
perspectives.’’ Future Oncology
3(2):201–214, 2007 (subsequently
referred to as the ‘‘Future Oncology
paper’’), by reporting data of 7 of 63
patients with serial bleeds taken at
different points in time and reporting
that the values from the 7 patients were
for different patients. This same
reporting data of individual patients
with serial bleeds taken at different
points in time and reporting that those
values were for different patients was
presented in the CA107316 and
CA107831 final reports.
2. The methodology used for the
Tables of ANOVA results comparing
Log Titers of IgM antibodies for the
different subject groups in the IJC and
Future Oncology papers and the
CA107316 and CA107831 final reports
is incorrect and false, since the papers
and reports fail to state that the results
are not for a simple ANOVA but include
various degrees of repeated measures on
the variables.
3. In Table 1 of the CA107831 Final
Report, Respondent reported mean log
titer values for GM1b for healthy, BHP,
and T3/4 CaP patients. These values
exactly matched with values published
for a different ganglioside, GM1, for
healthy, BHP, and T3/4 CaP patients,
earlier in the IJC (Table II) and Future
Oncology publications. The only
exception was the log titer value for T1/
2 CaP patients for GM1b (n = 20), which
matched with the earlier published
mean log titer value for GT1b (6.22 ±
1.40; n = 36). ORI finds the pairwisedifference in the log titer values of
GM1b between the T1/2 CaP and
healthy patients, claimed to be
significant (p<0.01), to therefore be
incorrect and false. Respondent
contends otherwise.
4. Because Respondent included
serial bleed values from individual
patients in Table 1 of the IJC paper, the
summary data for anti-ganglioside
antibody values, and the statistical
analyses derived from them in Tables II
and III of the IJC paper, Tables 1 and 2
of the Future Oncology paper, published
Tables A and B of the CA107316 final
report, and Tables 1 and 2B of the
CA107831 final report are incorrect and
false. The inclusion of serial bleeds from
E:\FR\FM\03AUN1.SGM
03AUN1
Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices
individual patients in Table 1 of the IJC
paper and their inappropriate impact on
the antibody values reported in Table II
of the IJC paper were reported in detail
by Respondent to the Managing Editor
in IJC in email communications dated
September 24 and 29, 2008.
Dr. Ravindranath has entered into a
Voluntary Settlement Agreement and
has voluntarily agreed for a period of
three (3) years, beginning on July 2,
2012:
(1) To have any PHS-supported
research supervised; Respondent agreed
that prior to the submission of an
application for PHS support for a
research project on which the
Respondent’s participation is proposed
and prior to Respondent’s participation
in any capacity on PHS-supported
research, Respondent shall ensure that a
plan for supervision of Respondent’s
duties is submitted to ORI for approval;
the supervision plan must be designed
to ensure the scientific integrity of
Respondent’s research contribution;
Respondent agreed that he shall not
participate in any PHS-supported
research until such a supervision plan is
submitted to and approved by ORI;
Respondent agreed to maintain
responsibility for compliance with the
agreed upon supervision plan;
(2) That any institution employing
him shall submit, in conjunction with
each application for PHS funds, or
report, manuscript, or abstract involving
PHS- supported research in which
Respondent is involved, a certification
to ORI that the data provided by
Respondent are based on actual
experiments or are otherwise
legitimately derived, that the data,
procedures, and methodology are
accurately reported in the application,
report, manuscript, or abstract, and that
the text in such submissions is his own
or properly cites the source of copied
language and ideas; and
(3) To exclude himself voluntarily
from serving in any advisory capacity to
PHS including, but not limited to,
service on any PHS advisory committee,
board, and/or peer review committee, or
as a consultant.
TKELLEY on DSK3SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
John Dahlberg,
Director, Division of Investigative Oversight,
Office of Research Integrity.
[FR Doc. 2012–18990 Filed 8–2–12; 8:45 am]
BILLING CODE 4150–31–P
VerDate Mar<15>2010
17:33 Aug 02, 2012
Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Decision To Evaluate a Petition To
Designate a Class of Employees From
the Baker Brothers Site in Toledo,
Ohio, To Be Included in the Special
Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services.
ACTION: Notice.
AGENCY:
NIOSH gives notice as
required by 42 CFR 83.12(e) of a
decision to evaluate a petition to
designate a class of employees from the
Bakers Brothers site in Toledo, Ohio, to
be included in the Special Exposure
Cohort under the Energy Employees
Occupational Illness Compensation
Program Act of 2000. The initial
proposed definition for the class being
evaluated, subject to revision as
warranted by the evaluation, is as
follows:
Facility: Baker Brothers.
Location: Toledo, Ohio.
Job Titles and/or Job Duties: All
employees who worked in any area.
Period of Employment: June 1, 1943 to
December 31, 1996.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 4676 Columbia
Parkway, MS C–46, Cincinnati, OH
45226, Telephone 877–222–7570.
Information requests can also be
submitted by email to DCAS@CDC.GOV.
SUMMARY:
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2012–19047 Filed 8–2–12; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–6042–N]
Medicare Program; Prior Authorization
for Power Mobility Device (PMD)
Demonstration
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces a 3year Medicare Prior Authorization for
Power Mobility Device (PMD)
SUMMARY:
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
46439
Demonstration for certain PMD codes in
seven states where there have been high
incidences of fraudulent claims and
improper payments
DATES: This demonstration begins on
September 1, 2012.
FOR FURTHER INFORMATION CONTACT:
Daniel Schwartz, 410–786–4197.
Questions regarding the Medicare
Prior Authorization for PMD
Demonstration should be sent to
pademo@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Power Mobility Devices have had
historically high incidents of fraud and
improper payments. PMD suppliers also
continue to be subject to significant law
enforcement investigation.
The Health Care Fraud Prevention
and Enforcement Action Team (HEAT)
Task Force was launched in May 2009
and is co-chaired by the Deputy
Secretary of HHS and the Deputy
Attorney General of DOJ. Medicare
Fraud Strike Force teams are a key
component of HEAT, since their
inception and based on data driven
investigations, prosecutors have filed
more than 600 cases charging more than
1,150 defendants who collectively billed
the Medicare program more than $2.9
billion in fraudulent claims. DME is a
primary focus of investigation for these
strike forces.
The Comprehensive Error Rate
Testing (CERT) Program noted in a 2010
Report 1 that 92.6 percent of claims for
motorized wheelchairs did not meet
Medicare coverage requirements.
Although we recognize that many
improper payments are not the result of
willful fraud, this error rate represents
over $822 million dollars in estimated
improper payments.
II. Legislative Authority
Section 402(a)(1)(J) of the Social
Security Amendments of 1967, 42
U.S.C. 1395b–1(a)(1)(J), authorizes the
Secretary to conduct demonstrations
designed to develop or demonstrate
improved methods for the investigation
and prosecution of fraud in the
provision of care or services provided
under the Medicare program. We plan to
conduct a demonstration that
implements a prior authorization
process for power mobility devices
(PMDs), an area with historically high
levels of fraud and improper payments,
to develop improved methods for the
investigation and prosecution of fraud
1 https://www.cms.gov/Research-Statistics-Dataand-Systems/Monitoring-Programs/CERT/
Downloads/CERT_Nov_2010_Appendix_-final.pdf
Supplemental Appendix, Table B2.
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 77, Number 150 (Friday, August 3, 2012)]
[Notices]
[Pages 46438-46439]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18990]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that the Office of Research Integrity
(ORI) has taken final action in the following case:
Mepur H. Ravindranath, Ph.D., John Wayne Cancer Institute: Based on
the report of an investigation conducted by the John Wayne Cancer
Institute (JWCI) and additional analysis conducted by ORI in its
oversight review, ORI found that Dr. Mepur H. Ravindranath, former
Director of the Laboratory of Glycoimmunotheraphy, JWCI, engaged in
research misconduct in research supported by National Cancer Institute
(NCI), National Institutes of Health (NIH), awards R21 CA107316 and R03
CA107831.
ORI found that the Respondent engaged in research misconduct by
falsifying results reported for research supported by U.S. Public
Health Service (PHS) grants R21 CA107316 and R03 CA107831, in progress
reports for those grants and in two publications in scientific
journals.
It is expressly understood that by entering into a Voluntary
Settlement Agreement (Agreement), Respondent is not admitting to any of
the allegations made against him by JWCI and/or ORI, or any of their
respective agents, employees, associates, or related persons, including
but not limited to the findings made by ORI listed in the Agreement.
Respondent agreed to enter into the Agreement and not to contest the
findings contained therein solely because contesting the findings would
cause Respondent undue financial hardship and stress, and Respondent
wished to seek finality.
Specifically
1. Respondent falsified the number of subjects accrued in the
double-blind study reported in the paper Ravindranath, M.H.,
Muthugounder, S., Presser, N., Ye, X., Brosman, S., & Morton, D.L.
``Endogenous immune response to gangliosides in patients with confined
prostate cancer.'' Int. J. Cancer 166:368-377, 2005 (subsequently
referred to as the ``IJC paper) and later reviewed in Ravindranath,
M.H. Yesowitch, P., Sumobay, C., & Morton, D.L. ``Glycoimmunomics of
human cancer: Current concepts and future perspectives.'' Future
Oncology 3(2):201-214, 2007 (subsequently referred to as the ``Future
Oncology paper''), by reporting data of 7 of 63 patients with serial
bleeds taken at different points in time and reporting that the values
from the 7 patients were for different patients. This same reporting
data of individual patients with serial bleeds taken at different
points in time and reporting that those values were for different
patients was presented in the CA107316 and CA107831 final reports.
2. The methodology used for the Tables of ANOVA results comparing
Log Titers of IgM antibodies for the different subject groups in the
IJC and Future Oncology papers and the CA107316 and CA107831 final
reports is incorrect and false, since the papers and reports fail to
state that the results are not for a simple ANOVA but include various
degrees of repeated measures on the variables.
3. In Table 1 of the CA107831 Final Report, Respondent reported
mean log titer values for GM1b for healthy, BHP, and T3/4 CaP patients.
These values exactly matched with values published for a different
ganglioside, GM1, for healthy, BHP, and T3/4 CaP patients, earlier in
the IJC (Table II) and Future Oncology publications. The only exception
was the log titer value for T1/2 CaP patients for GM1b (n = 20), which
matched with the earlier published mean log titer value for GT1b (6.22
1.40; n = 36). ORI finds the pairwise-difference in the
log titer values of GM1b between the T1/2 CaP and healthy patients,
claimed to be significant (p<0.01), to therefore be incorrect and
false. Respondent contends otherwise.
4. Because Respondent included serial bleed values from individual
patients in Table 1 of the IJC paper, the summary data for anti-
ganglioside antibody values, and the statistical analyses derived from
them in Tables II and III of the IJC paper, Tables 1 and 2 of the
Future Oncology paper, published Tables A and B of the CA107316 final
report, and Tables 1 and 2B of the CA107831 final report are incorrect
and false. The inclusion of serial bleeds from
[[Page 46439]]
individual patients in Table 1 of the IJC paper and their inappropriate
impact on the antibody values reported in Table II of the IJC paper
were reported in detail by Respondent to the Managing Editor in IJC in
email communications dated September 24 and 29, 2008.
Dr. Ravindranath has entered into a Voluntary Settlement Agreement
and has voluntarily agreed for a period of three (3) years, beginning
on July 2, 2012:
(1) To have any PHS-supported research supervised; Respondent
agreed that prior to the submission of an application for PHS support
for a research project on which the Respondent's participation is
proposed and prior to Respondent's participation in any capacity on
PHS-supported research, Respondent shall ensure that a plan for
supervision of Respondent's duties is submitted to ORI for approval;
the supervision plan must be designed to ensure the scientific
integrity of Respondent's research contribution; Respondent agreed that
he shall not participate in any PHS-supported research until such a
supervision plan is submitted to and approved by ORI; Respondent agreed
to maintain responsibility for compliance with the agreed upon
supervision plan;
(2) That any institution employing him shall submit, in conjunction
with each application for PHS funds, or report, manuscript, or abstract
involving PHS- supported research in which Respondent is involved, a
certification to ORI that the data provided by Respondent are based on
actual experiments or are otherwise legitimately derived, that the
data, procedures, and methodology are accurately reported in the
application, report, manuscript, or abstract, and that the text in such
submissions is his own or properly cites the source of copied language
and ideas; and
(3) To exclude himself voluntarily from serving in any advisory
capacity to PHS including, but not limited to, service on any PHS
advisory committee, board, and/or peer review committee, or as a
consultant.
FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852, (240) 453-8800.
John Dahlberg,
Director, Division of Investigative Oversight, Office of Research
Integrity.
[FR Doc. 2012-18990 Filed 8-2-12; 8:45 am]
BILLING CODE 4150-31-P
