Reimbursement Rates for Calendar Year 2011, 24496-24497 [2011-10623]
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24496
Federal Register / Vol. 76, No. 84 / Monday, May 2, 2011 / Notices
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I. Background
Various types of medical devices used
in healthcare settings, from surgical
suction tips to complex endoscopes, are
designed and labeled for use on
multiple patients. The workshop will
focus on medical devices that are
intended for reuse after reprocessing,
rather than third-party reprocessing of
single-use-only medical devices.
Thousands of reusable medical
devices requiring reprocessing are used
every day in diagnosing and treating
patients. FDA has received a number of
reports of patient exposure to
inadequately reprocessed medical
devices and subsequent healthcareassociated infections (HAIs). Several
reports contained evidence suggesting
that inadequate reprocessing may have
been a contributing factor in microbial
transmission and subsequent infection.
A definitive causal relationship between
reusable device reprocessing and any
patient infection is difficult to establish,
because inadequate reprocessing is not
often investigated as a cause when an
HAI is diagnosed. Ensuring adequate
reprocessing of reusable medical
devices could reduce the incidence of
HAIs associated with the use of a
reprocessed medical device. This will
decrease the public health burden of
HAIs in terms of morbidity, mortality
and cost.
The adequate reprocessing of reusable
medical devices is a critically important
factor in protecting patient safety.
Inadequate reprocessing between
patients can result in the retention of
blood, tissue, and other biological debris
(soil) in reusable medical devices. This
soil can allow microbes to survive the
high level disinfection or sterilization
process, potentially resulting in HAIs or
other adverse patient outcomes. FDA
receives reports of problems in all steps
of medical device reprocessing 1,
including cleaning, disinfecting and
sterilizing. Manufacturers, healthcare
facilities, healthcare professionals, and
the FDA all have a role in reducing the
risk of inadequately reprocessed
medical devices.
Because of the critical importance of
adequate reprocessing of medical
devices, the FDA has launched an
initiative to focus on improvements in
device design, reprocessing procedures
and validation methodologies, and
healthcare facility quality assurance
practices. To help address these issues,
1A
more comprehensive description of
reprocessing steps is available in FDA’s draft
guidance ‘‘Processing/Reprocessing Medical Devices
in Health Care Settings: Validation Methods and
Labeling’’ at https://www.fda.gov/
reprocessingreusabledevices.
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the FDA has engaged partners at the
Centers for Disease Control and
Prevention (CDC), the Centers for
Medicaid and Medicare Services (CMS),
the Veterans Health Administration
(VHA), and The Joint Commission (JC),
who bring valuable expertise in disease
control and healthcare practices to this
initiative.
II. Topics for Discussion at the Public
Workshop
The public workshop will be
organized to discuss the following topic
areas:
1. What are the nature, scope, and
impact of reusable medical device
reprocessing problems that have been
observed? What are the causes of these
problems?
2. What factors or criteria to facilitate
reprocessing should be considered
when designing reusable medical
devices? How can the design process be
improved to better incorporate
cleanability as a design endpoint?
3. What factors or criteria should be
considered when developing
reprocessing instructions and validation
protocols for devices to be used in
various healthcare environments (e.g.,
hospital, ambulatory surgical center,
physician’s office), based on the draft
guidance document ‘‘Processing/
Reprocessing Medical Devices in Health
Care Settings: Validation Methods and
Labeling’’ at https://www.fda.gov/
reprocessingreusabledevices.
4. What factors or criteria should be
considered by a healthcare facility when
developing reusable device reprocessing
procedures and quality assurance
processes?
5. How should problems with
reusable medical device reprocessing be
identified, reported, and acted upon by
industry and users?
III. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (HFI–35), Office
of Management Programs, Food and
Drug Administration, 5600 Fishers
Lane, rm. 6–30, Rockville, MD 20857. A
link to the transcripts will also be
available on the Internet at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
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default.htm (select this public workshop
from the posted events list),
approximately 45 days after the public
workshop.
Dated April 26, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–10532 Filed 4–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Reimbursement Rates for Calendar
Year 2011
AGENCY:
ACTION:
Indian Health Service, HHS.
Notice.
Notice is given that the
Director of Indian Health Service (IHS),
under the authority of sections 321(a)
and 322(b) of the Public Health Service
Act (42 U.S.C. 248 and 249(b)), Public
Law 83–568 (42 U.S.C. 2001(a)), and the
Indian Health Care Improvement Act
(25 U.S.C. 1601 et seq.), has approved
the following rates for inpatient and
outpatient medical care provided by IHS
facilities for Calendar Year 2011 for
Medicare and Medicaid beneficiaries
and beneficiaries of other Federal
programs. The Medicare Part A
inpatient rates are excluded from the
table below as they are paid based on
the prospective payment system. Since
the inpatient rates set forth below do not
include all physician services and
practitioner services, additional
payment may be available to the extent
that those services meet applicable
requirements.
SUMMARY:
Inpatient Hospital Per Diem Rate (Excludes
Physician/Practitioner Services)
Calendar Year 2011
Lower 48 States .............................
Alaska .............................................
$2,034
2,269
Outpatient Per Visit Rate (Excluding
Medicare)
Calendar Year 2011
Lower 48 States .............................
Alaska .............................................
294
490
Outpatient Per Visit Rate (Medicare)
Calendar Year 2011
Lower 48 States .............................
Alaska .............................................
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256
447
Federal Register / Vol. 76, No. 84 / Monday, May 2, 2011 / Notices
Medicare Part B Inpatient Ancillary Per
Diem Rate
Calendar Year 2011
Lower 48 States .............................
Alaska .............................................
443
756
Outpatient Surgery Rate (Medicare)
Established Medicare rates for
freestanding Ambulatory Surgery
Centers.
Effective Date for Calendar Year 2011
Rates
Consistent with previous annual rate
revisions, the Calendar Year 2011 rates
will be effective for services provided
on/or after January 1, 2011 to the extent
consistent with payment authorities
including the applicable Medicaid State
plan.
Dated: March 7, 2011.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. 2011–10623 Filed 4–29–11; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment
Request; Neuropsychosocial Measures
Formative Research Methodology
Studies for the National Children’s
Study
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Child Health and
Human Development (NICHD), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
SUMMARY:
mstockstill on DSKH9S0YB1PROD with NOTICES6
Proposed Collection
Title: Neuro-developmental and
Psycho-Social Measures Formative
Research Studies for the National
Children’s Study (NCS).
Type of Information Collection
Request: Generic Clearance.
Need and Use of Information
Collection: The Children’s Health Act of
2000 (Public Law 106–310) states:
(a) PURPOSE.—It is the purpose of this
section to authorize the National Institute of
Child Health and Human Development* to
conduct a national longitudinal study of
environmental influences (including
physical, chemical, biological, and
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psychosocial) on children’s health and
development.
(b) IN GENERAL.—The Director of the
National Institute of Child Health and
Human Development* shall establish a
consortium of representatives from
appropriate Federal agencies (including the
Centers for Disease Control and Prevention,
the Environmental Protection Agency) to—
(1) plan, develop, and implement a
prospective cohort study, from birth to
adulthood, to evaluate the effects of both
chronic and intermittent exposures on child
health and human development; and
(2) investigate basic mechanisms of
developmental disorders and environmental
factors, both risk and protective, that
influence health and developmental
processes.
(c) REQUIREMENT.—The study under
subsection (b) shall—
(1) incorporate behavioral, emotional,
educational, and contextual consequences to
enable a complete assessment of the physical,
chemical, biological, and psychosocial
environmental influences on children’s wellbeing;
(2) gather data on environmental
influences and outcomes on diverse
populations of children, which may include
the consideration of prenatal exposures; and
(3) consider health disparities among
children, which may include the
consideration of prenatal exposures.
To fulfill the requirements of the
Children’s Health Act, the results of
formative research will be used to
maximize the efficiency (measured by
scientific robustness, participant and
infrastructure burden, and cost) of tools
to assess language, behavior, and
neurodevelopment, psychosocial stress,
and health literacy and thereby inform
data collection methodologies for the
National Children’s Study (NCS)
Vanguard and Main Studies. With this
submission, the NCS seeks to obtain an
OMB generic clearance to conduct
formative research featuring neurodevelopmental and psycho-social
measures.
The NCS has obtained an OMB
generic clearance to conduct survey and
instrument design and administration,
focus groups, cognitive interviews, and
health and social service provider
feedback information collection
surrounding outreach, recruitment, and
retention (0925–0590; requesting
renewal). Under separate notice, the
NCS is also requesting an OMB generic
clearance to conduct formative research
featuring biospecimen and physical
measures, environmental, and study
logistic information collection. These
separate and distinct generic clearances
are requested to facilitate the efficiency
of submission and review of these
projects as required by the OMB Office
of Information and Regulatory Affairs.
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Background
The National Children’s Study is a
prospective, national longitudinal study
of the interaction between environment,
genetics on child health and
development. The Study defines
‘‘environment’’ broadly, taking a number
of natural and man-made
environmental, biological, genetic, and
psychosocial factors into account. By
studying children through their
different phases of growth and
development, researchers will be better
able to understand the role these factors
have on health and disease. Findings
from the Study will be made available
as the research progresses, making
potential benefits known to the public
as soon as possible. The National
Children’s Study is led by a consortium
of federal partners: the U.S. Department
of Health and Human Services
(including the Eunice Kennedy Shriver
National Institute of Child Health and
Human Development and the National
Institute of Environmental Health
Sciences of the National Institutes of
Health and the Centers for Disease
Control and Prevention), and the U.S.
Environmental Protection Agency.
To conduct the detailed preparation
needed for a study of this size and
complexity, the NCS was designed to
include a preliminary pilot study
known as the Vanguard Study. The
purpose of the Vanguard Study is to
assess the feasibility, acceptability, and
cost of the recruitment strategy, study
procedures, and outcome assessments
that are to be used in the NCS Main
Study. The Vanguard Study begins prior
to the NCS Main Study and will run in
parallel with the Main Study. At every
phase of the NCS, the multiple
methodological studies conducted
during the Vanguard phase will inform
the implementation and analysis plan
for the Main Study.
In this submission, NCS is requesting
an OMB generic clearance for formative
research activities relating to the
collection of neuro-developmental and
psycho-social measures. The results
from these formative research projects
will inform the feasibility (scientific
robustness), acceptability (burden to
participants and study logistics) and
cost of NCS Vanguard and Main Study
neuro-developmental and psycho-social
measures in a manner that minimizes
public information collection burden
compared to burden anticipated if these
projects were incorporated directly into
either the NCS Vanguard or Main Study.
The NCS has obtained generic
clearance for formative research
activities pertaining to outreach,
recruitment and retention (0925–0590).
E:\FR\FM\02MYN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Notices]
[Pages 24496-24497]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10623]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Reimbursement Rates for Calendar Year 2011
AGENCY: Indian Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is given that the Director of Indian Health Service
(IHS), under the authority of sections 321(a) and 322(b) of the Public
Health Service Act (42 U.S.C. 248 and 249(b)), Public Law 83-568 (42
U.S.C. 2001(a)), and the Indian Health Care Improvement Act (25 U.S.C.
1601 et seq.), has approved the following rates for inpatient and
outpatient medical care provided by IHS facilities for Calendar Year
2011 for Medicare and Medicaid beneficiaries and beneficiaries of other
Federal programs. The Medicare Part A inpatient rates are excluded from
the table below as they are paid based on the prospective payment
system. Since the inpatient rates set forth below do not include all
physician services and practitioner services, additional payment may be
available to the extent that those services meet applicable
requirements.
------------------------------------------------------------------------
------------------------------------------------------------------------
Inpatient Hospital Per Diem Rate (Excludes Physician/Practitioner
Services)
------------------------------------------------------------------------
Calendar Year 2011
------------------------------------------------------------------------
Lower 48 States............................................... $2,034
Alaska........................................................ 2,269
------------------------------------------------------------------------
Outpatient Per Visit Rate (Excluding Medicare)
------------------------------------------------------------------------
Calendar Year 2011
------------------------------------------------------------------------
Lower 48 States............................................... 294
Alaska........................................................ 490
------------------------------------------------------------------------
Outpatient Per Visit Rate (Medicare)
------------------------------------------------------------------------
Calendar Year 2011
------------------------------------------------------------------------
Lower 48 States............................................... 256
Alaska........................................................ 447
------------------------------------------------------------------------
[[Page 24497]]
Medicare Part B Inpatient Ancillary Per Diem Rate
------------------------------------------------------------------------
Calendar Year 2011
------------------------------------------------------------------------
Lower 48 States............................................... 443
Alaska........................................................ 756
------------------------------------------------------------------------
Outpatient Surgery Rate (Medicare)
Established Medicare rates for freestanding Ambulatory Surgery
Centers.
Effective Date for Calendar Year 2011 Rates
Consistent with previous annual rate revisions, the Calendar Year
2011 rates will be effective for services provided on/or after January
1, 2011 to the extent consistent with payment authorities including the
applicable Medicaid State plan.
Dated: March 7, 2011.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. 2011-10623 Filed 4-29-11; 8:45 am]
BILLING CODE 4165-16-P
