Agency Information Collection Activities: Proposed Collection; Comment Request, 51730-51732 [2013-20400]
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mstockstill on DSK4VPTVN1PROD with NOTICES
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Federal Register / Vol. 78, No. 162 / Wednesday, August 21, 2013 / Notices
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
We are, however, requesting an
emergency review of the information
collection referenced below. In
compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, we have
submitted to the Office of Management
and Budget (OMB) the following
requirements for emergency review.
This is necessary to ensure compliance
with an initiative of the Administration.
We are requesting an emergency review
under 5 CFR Part 1320(a)(2)(i) because
public harm is reasonably likely to
result if the normal clearance
procedures are followed. The approval
of this data collection process is
essential to ensuring that Information
Security (IS) incidents, which also
include Personally Identifiable
Information (PII) and Protected Health
Information (PHI), are captured within
the specified timeframe. In absence of
this change, a significant number of
incidents will not be detected; therefore
causing harm and potential risk to the
public’s identity with identity fraud.
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Title State
Health Insurance Exchange Incident
Report; Use: We have implemented a
Computer Matching Agreement (CMA)
with the State-Based Administering
Entities (AEs). This agreement
establishes the terms, conditions,
safeguards, and procedures under which
CMS will disclose certain information to
the AEs in accordance with the Patient
Protection and Affordable Care Act of
2010 (Pub. L. 111–148), as amended by
the Health Care and Education
Reconciliation Act (Pub. L. 111–152),
which are referred to collectively as the
Affordable Care Act (ACA),
amendments to the Social Security Act
made by the ACA, and the
implementing regulations. The AEs,
which are state entities administering
Insurance Affordability Programs, will
use the data, accessed through the CMS
Data Services Hub (Hub), to make
Eligibility Determinations for Insurance
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16:29 Aug 20, 2013
Jkt 229001
Affordability Programs and certificates
of exemption.
The AEs shall report suspected or
confirmed incidents affecting loss or
suspected loss of PII within one hour of
discovery to their designated Center for
Consumer Information and Insurance
Oversight State Officer who will then
notify the affected Federal agency data
sources, i.e., Internal Revenue Service,
Department of Defense, Department of
Homeland Security, Social Security
Administration, Peace Corps, Office of
Personnel Management and Veterans
Health Administration. Additionally,
AEs shall contact the office of the
appropriate Special Agent-in-Charge,
Treasury Inspector General for Tax
Administration (TIGTA), and the IRS
Office of Safeguards within 24 hours of
discovery of any potential breach, loss,
or misuse of Return Information. Form
Number: CMS–10496 (OCN: 0938–
New); Frequency: Occasionally;
Affected Public: State, Local or Tribal
governments; Number of Respondents:
18; Total Annual Responses: 936; Total
Annual Hours: 234.
We are requesting OMB review and
approval of this collection by September
25, 2013, with a 180-day approval
period. Written comments and
recommendation will be considered
from the public if received by the
individuals designated below by the
noted deadline below.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’s Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995 or Email
your request, including your address,
phone number, OMB number, and CMS
document identifier, to Paperwork@
cms.hhs.gov, or call the Reports
Clearance Office on (410) 786–1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by September 20, 2013:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address:
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development, Attention:
Document Identifier (CMS–10496),
Room C4–26–05, 7500 Security
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
Boulevard, Baltimore, Maryland 21244–
1850.
and,
OMB Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, New Executive Office Building,
Room 10235, Washington, DC 20503,
Fax Number: (202) 395–6974.
Dated: August 16, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–20396 Filed 8–20–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–194, CMS–
10497 and CMS–10250]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
any of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments must be received by
October 21, 2013.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number (OCN). To be
assured consideration, comments and
SUMMARY:
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Federal Register / Vol. 78, No. 162 / Wednesday, August 21, 2013 / Notices
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number __, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–R–194 Medicare
Disproportionate Share Adjustment
Procedures and Criteria and
Supporting Regulations
CMS–10497 Evaluation of the
Medicare Health Care Quality
(MHCQ) Demonstration Evaluation:
Focus Group and Interview Protocols
CMS–10250 Hospital Outpatient
Quality Reporting (OQR) Program
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
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16:29 Aug 20, 2013
Jkt 229001
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collections
1. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection:
Medicare Disproportionate Share
Adjustment (DSH) Procedures and
Criteria and Supporting Regulations;
Use: Section 1886(d)(5)(F) of the Social
Security Act established the Medicare
disproportionate share adjustment
(DSH) for hospitals, which provides
additional payment to hospitals that
serve a disproportionate share of the
indigent patient population. This
payment is an add-on to the set amount
per case that we pay to hospitals under
the Medicare Inpatient Prospective
Payment System (IPPS).
Under current regulations at 42 CFR
412.106, in order to meet the qualifying
criteria for this additional DSH
payment, a hospital must prove that a
disproportionate percentage of its
patients are low income using
Supplemental Security Income (SSI)
and Medicaid as proxies for this
determination. This percentage includes
two computations: (1) The ‘‘Medicare
fraction’’ or the ‘‘SSI ratio’’ which is the
percent of patient days for beneficiaries
who are eligible for Medicare Part A and
SSI and (2) the ‘‘Medicaid fraction’’
which is the percent of patient days for
patients who are eligible for Medicaid
but not Medicare. Once a hospital
qualifies for this DSH payment, we also
determine a hospital’s payment
adjustment. Form Number: CMS–R–194
(OCN: 0938–0691); Frequency:
Occasionally; Affected Public: Private
sector—business or other for-profits and
not-for-profit institutions; Number of
Respondents: 800; Total Annual
Responses: 800; Total Annual Hours:
400. (For policy questions regarding this
collection contact JoAnne Cerne at 410–
786–4530.)
2. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Evaluation of
the Medicare Health Care Quality
(MHCQ) Demonstration Evaluation:
Focus Group and Interview Protocols;
Use: The Medicare Health Care Quality
(MHCQ) Demonstration was developed
to address concerns about the U.S.
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
51731
health care system, which typically
fragments care while also encouraging
both omissions in and duplication of
care. To rectify this situation, Congress
has directed us to test major changes to
the delivery and payment systems to
improve the quality of care while also
increasing efficiency across the health
care system. This would be achieved
through several types of interventions:
Adoption and use of information
technology and decision support tools
by physicians and their patients, such as
evidence-based medicine guidelines,
best practice guidelines, and shared
decision-making programs; reform of
payment methodologies; improved
coordination of care among payers and
providers serving defined communities;
measurement of outcomes; and
enhanced cultural competence in the
delivery of care.
The MHCQ Demonstration programs
are designed to examine the extent to
which major, multifaceted changes to
traditional Medicare’s health delivery
and financing systems lead to
improvements in the quality of care
provided to Medicare beneficiaries
without increasing total program
expenditures. Each demonstration site
uses a different approach for changing
health delivery and financing systems,
but all share the goal of improving the
quality and efficiency of medical care
provided to Medicare beneficiaries.
Focus groups and individual interviews
will be conducted at 2 demonstration
sites that are active in the
demonstration: Gundersen Health
System (GHS) and Meridian Health
System (MHS).
This MHCQ Demonstration evaluation
will include analysis of both
quantitative and qualitative sources of
information. This multifaceted approach
will enable this evaluation to consider
a broad variety of evidence for
evaluating the nature and impact of
each site’s interventions. We are seeking
approval to conduct in-person focus
groups and individual interviews with
beneficiaries and their caregivers to
inform our evaluation of the MHCQ
Demonstration at the GHS and MHS
demonstration sites. Form Number:
CMS–10497 (OCN: 0938-New);
Frequency: Occasionally; Affected
Public: Individuals or households;
Number of Respondents: 36; Total
Annual Responses: 36; Total Annual
Hours: 108. (For policy questions
regarding this collection contact
Normandy Brangan at 410–786–6640.)
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Hospital
Outpatient Quality Reporting (OQR)
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mstockstill on DSK4VPTVN1PROD with NOTICES
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Federal Register / Vol. 78, No. 162 / Wednesday, August 21, 2013 / Notices
Program; Use: Section 109(a) of the Tax
Relief and Health Care Act of 2006
(TRHCA) (Pub. L. 109–432) amended
section 1833(t) of the Social Security
Act by adding a new subsection (17)
that affects the payment rate update
applicable to Outpatient Prospective
Payment System (OPPS) payments for
services furnished by hospitals in
outpatient settings on or after January 1,
2009. Section 1833(t)(17)(A) of the Act,
which applies to hospitals as defined
under section 1886(d)(1)(B) of the Act,
requires that hospitals that fail to report
data required for quality measures
selected by the Secretary in the form
and manner required by the Secretary
under section 1833(t)(17)(B) of the Act
will incur a reduction in their annual
payment update (APU) factor to the
hospital outpatient department fee
schedule by 2.0 percentage points.
Sections 1833(t)(17)(C)(i) and (ii) of the
Act require the Secretary to develop
measures appropriate for the
measurement of the quality of care
furnished by hospitals in outpatient
settings. Such measures must reflect
consensus among affected parties and,
to the extent feasible and practicable,
must be set forth by one or more
national consensus building entities.
The Secretary also has the authority to
replace measures or indicators as
appropriate and requires the Secretary
to establish procedures for making the
data submitted available to the public.
Such procedures must provide the
hospitals the opportunity to review such
data prior to public release. Our
program established under these
amendments is referred to as the
Hospital Outpatient Quality Reporting
(OQR) Program.
Hospital OQR Program payment
determinations are made based on OQR
quality measure data reported and
supporting forms submitted by hospitals
as specified through rulemaking. To
reduce burden, a variety of different
data collection mechanisms are
employed, with every consideration
taken to employ existing data and data
collection systems. The complete list of
measures and data collection forms are
organized by type of data collected and
data collection mechanism.
The Medicare program has a
responsibility to ensure that Medicare
beneficiaries receive the health care
services of appropriately high quality
that are comparable to that received by
those under other payers. The Hospital
OQR Program seeks to encourage care
that is both efficient and of high quality
in the hospital outpatient setting
through collaboration with the hospital
community to develop and implement
quality measures that are fully and
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16:29 Aug 20, 2013
Jkt 229001
specifically reflective of the quality of
hospital outpatient services. Form
Number: CMS–10250 (OCN: 0938–
1109); Frequency: Occasionally;
Affected Public: Private sector—Forprofit and not for institutions; Number
of Respondents: 3,200; Total Annual
Responses: 3,200; Total Annual Hours:
949,590. (For policy questions regarding
this collection contact Anita Bhatia at
410–786–7236.)
Dated: August 16, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–20400 Filed 8–20–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
The Food and Drug Administration/
European Medicines Agency Orphan
Product Designation and Grant Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration’s
(FDA) Office of Orphan Products
Development is announcing the
following meeting entitled ‘‘The Food
and Drug Administration/European
Medicines Agency Orphan Product
Designation and Grant Workshop.’’ This
1-day workshop is intended to provide
valuable information about the FDA and
European Medicines Agency (EMA)
Orphan Drug Designation programs, the
FDA Humanitarian Use Device (HUD)
Designation program, and the FDA
Orphan Products Grant program to
participants representing
pharmaceutical, biotechnology, and
device companies, as well as academics.
Date and Time: The meeting will be
held on October 4, 2013, from 8:30 a.m.
to 4 p.m.
Location: The meeting will be held at
FDA White Oak Campus, 10903 New
Hampshire Ave., Bldg. 31 Conference
Center, the Great Room (rm. 1503),
Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
WhiteOakCampusInformation/
ucm241740.htm.
Contact Person: Eleanor Dixon-Terry,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm.
5279, Silver Spring, MD 20993–0002,
301–796–8660, FAX: 301–847–8621,
Eleanor.Dixon-Terry@fda.hhs.gov.
Registration: Interested participants
may register for this meeting at the
following Web site: https://eventssupport.com/events/FDA_Orphan_
Workshop. If you need sign language
interpretation during this meeting,
please contact Eleanor Dixon-Terry at
Eleanor.Dixon-Terry@fda.hhs.gov by
September 20, 2013.
Attendance: Online registration for
the workshop will be limited to 240
participants for the morning session, of
which approximately 50 teams (up to
150 participants) may register for the
one-on-one sessions. There will be no
registration fee for the workshop.
For participants who cannot attend
the morning meetings, simultaneous
live interactive Webcasts will be made
available. Participants may access the
drug and biologics Webcast by visiting
the following site: https://
collaboration.fda.gov/odd100413/. The
medical devices Webcast can be
accessed by visiting: https://
collaboration.fda.gov/hudd100413/.
SUPPLEMENTARY INFORMATION: The FDA/
EMA Orphan Product Designation and
Grant Workshop is being conducted in
partnership with the European
Organisation for Rare Diseases, Genetic
Alliance, and the National Organization
for Rare Disorders.
The morning program includes two
simultaneous sessions. The first will
provide an overview of the FDA and
EMA Orphan Drug Designation
programs, respectively, while the
second will provide an overview of the
FDA HUD Designation Program and
Pediatric Device Consortia Grant
Program. Both morning sessions will
also cover the Orphan Products Grant
Program as they relate to drugs,
biologics, and devices. Both of these
morning sessions will also be available
by Webcast.
The afternoon session (no Webcast),
provides an opportunity for
appropriately registered participants to
have one-on-one meetings with FDA
staff members onsite, to discuss the
specifics on how to apply for an orphan
product grant, a HUD designation, or
orphan drug designation. It also
provides for videoconference sessions
with EMA staff representatives on EMA
orphan drug designation. Participants
requesting one-on-one meetings are
expected to bring information for at
E:\FR\FM\21AUN1.SGM
21AUN1
Agencies
[Federal Register Volume 78, Number 162 (Wednesday, August 21, 2013)]
[Notices]
[Pages 51730-51732]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20400]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-194, CMS-10497 and CMS-10250]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (the PRA), federal agencies are required to publish notice
in the Federal Register concerning each proposed collection of
information (including each proposed extension or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
DATES: Comments must be received by October 21, 2013.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number (OCN). To be assured consideration, comments and
[[Page 51731]]
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number ----, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-R-194 Medicare Disproportionate Share Adjustment Procedures and
Criteria and Supporting Regulations
CMS-10497 Evaluation of the Medicare Health Care Quality (MHCQ)
Demonstration Evaluation: Focus Group and Interview Protocols
CMS-10250 Hospital Outpatient Quality Reporting (OQR) Program
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. The term
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA requires federal agencies
to publish a 60-day notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
or reinstatement of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, CMS is publishing this notice.
Information Collections
1. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: Medicare Disproportionate Share Adjustment (DSH) Procedures
and Criteria and Supporting Regulations; Use: Section 1886(d)(5)(F) of
the Social Security Act established the Medicare disproportionate share
adjustment (DSH) for hospitals, which provides additional payment to
hospitals that serve a disproportionate share of the indigent patient
population. This payment is an add-on to the set amount per case that
we pay to hospitals under the Medicare Inpatient Prospective Payment
System (IPPS).
Under current regulations at 42 CFR 412.106, in order to meet the
qualifying criteria for this additional DSH payment, a hospital must
prove that a disproportionate percentage of its patients are low income
using Supplemental Security Income (SSI) and Medicaid as proxies for
this determination. This percentage includes two computations: (1) The
``Medicare fraction'' or the ``SSI ratio'' which is the percent of
patient days for beneficiaries who are eligible for Medicare Part A and
SSI and (2) the ``Medicaid fraction'' which is the percent of patient
days for patients who are eligible for Medicaid but not Medicare. Once
a hospital qualifies for this DSH payment, we also determine a
hospital's payment adjustment. Form Number: CMS-R-194 (OCN: 0938-0691);
Frequency: Occasionally; Affected Public: Private sector--business or
other for-profits and not-for-profit institutions; Number of
Respondents: 800; Total Annual Responses: 800; Total Annual Hours: 400.
(For policy questions regarding this collection contact JoAnne Cerne at
410-786-4530.)
2. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Evaluation of the Medicare Health Care Quality (MHCQ) Demonstration
Evaluation: Focus Group and Interview Protocols; Use: The Medicare
Health Care Quality (MHCQ) Demonstration was developed to address
concerns about the U.S. health care system, which typically fragments
care while also encouraging both omissions in and duplication of care.
To rectify this situation, Congress has directed us to test major
changes to the delivery and payment systems to improve the quality of
care while also increasing efficiency across the health care system.
This would be achieved through several types of interventions: Adoption
and use of information technology and decision support tools by
physicians and their patients, such as evidence-based medicine
guidelines, best practice guidelines, and shared decision-making
programs; reform of payment methodologies; improved coordination of
care among payers and providers serving defined communities;
measurement of outcomes; and enhanced cultural competence in the
delivery of care.
The MHCQ Demonstration programs are designed to examine the extent
to which major, multifaceted changes to traditional Medicare's health
delivery and financing systems lead to improvements in the quality of
care provided to Medicare beneficiaries without increasing total
program expenditures. Each demonstration site uses a different approach
for changing health delivery and financing systems, but all share the
goal of improving the quality and efficiency of medical care provided
to Medicare beneficiaries. Focus groups and individual interviews will
be conducted at 2 demonstration sites that are active in the
demonstration: Gundersen Health System (GHS) and Meridian Health System
(MHS).
This MHCQ Demonstration evaluation will include analysis of both
quantitative and qualitative sources of information. This multifaceted
approach will enable this evaluation to consider a broad variety of
evidence for evaluating the nature and impact of each site's
interventions. We are seeking approval to conduct in-person focus
groups and individual interviews with beneficiaries and their
caregivers to inform our evaluation of the MHCQ Demonstration at the
GHS and MHS demonstration sites. Form Number: CMS-10497 (OCN: 0938-
New); Frequency: Occasionally; Affected Public: Individuals or
households; Number of Respondents: 36; Total Annual Responses: 36;
Total Annual Hours: 108. (For policy questions regarding this
collection contact Normandy Brangan at 410-786-6640.)
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Hospital
Outpatient Quality Reporting (OQR)
[[Page 51732]]
Program; Use: Section 109(a) of the Tax Relief and Health Care Act of
2006 (TRHCA) (Pub. L. 109-432) amended section 1833(t) of the Social
Security Act by adding a new subsection (17) that affects the payment
rate update applicable to Outpatient Prospective Payment System (OPPS)
payments for services furnished by hospitals in outpatient settings on
or after January 1, 2009. Section 1833(t)(17)(A) of the Act, which
applies to hospitals as defined under section 1886(d)(1)(B) of the Act,
requires that hospitals that fail to report data required for quality
measures selected by the Secretary in the form and manner required by
the Secretary under section 1833(t)(17)(B) of the Act will incur a
reduction in their annual payment update (APU) factor to the hospital
outpatient department fee schedule by 2.0 percentage points. Sections
1833(t)(17)(C)(i) and (ii) of the Act require the Secretary to develop
measures appropriate for the measurement of the quality of care
furnished by hospitals in outpatient settings. Such measures must
reflect consensus among affected parties and, to the extent feasible
and practicable, must be set forth by one or more national consensus
building entities. The Secretary also has the authority to replace
measures or indicators as appropriate and requires the Secretary to
establish procedures for making the data submitted available to the
public. Such procedures must provide the hospitals the opportunity to
review such data prior to public release. Our program established under
these amendments is referred to as the Hospital Outpatient Quality
Reporting (OQR) Program.
Hospital OQR Program payment determinations are made based on OQR
quality measure data reported and supporting forms submitted by
hospitals as specified through rulemaking. To reduce burden, a variety
of different data collection mechanisms are employed, with every
consideration taken to employ existing data and data collection
systems. The complete list of measures and data collection forms are
organized by type of data collected and data collection mechanism.
The Medicare program has a responsibility to ensure that Medicare
beneficiaries receive the health care services of appropriately high
quality that are comparable to that received by those under other
payers. The Hospital OQR Program seeks to encourage care that is both
efficient and of high quality in the hospital outpatient setting
through collaboration with the hospital community to develop and
implement quality measures that are fully and specifically reflective
of the quality of hospital outpatient services. Form Number: CMS-10250
(OCN: 0938-1109); Frequency: Occasionally; Affected Public: Private
sector--For-profit and not for institutions; Number of Respondents:
3,200; Total Annual Responses: 3,200; Total Annual Hours: 949,590. (For
policy questions regarding this collection contact Anita Bhatia at 410-
786-7236.)
Dated: August 16, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2013-20400 Filed 8-20-13; 8:45 am]
BILLING CODE 4120-01-P