Agency Information Collection Activities: Proposed Collection; Comment Request, 34740-34742 [2010-14781]
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34740
Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices
Federal Communications Commission.
Marlene H. Dortch,
Secretary,
Office of the Secretary,
Office of Managing Director.
Dated: June 15, 2010.
Federal Deposit Insurance Corporation.
Robert E. Feldman,
Executive Secretary.
[FR Doc. 2010–14787 Filed 6–17–10; 8:45 am]
BILLING CODE P
[FR Doc. 2010–14906 Filed 6–16–10; 4:15 pm]
BILLING CODE 6712–01–S
FEDERAL MARITIME COMMISSION
FEDERAL DEPOSIT INSURANCE
CORPORATION
Sunshine Act Meeting
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Pursuant to the provisions of the
‘‘Government in the Sunshine Act’’ (5
U.S.C. 552b), notice is hereby given that
the Federal Deposit Insurance
Corporation’s Board of Directors will
meet in open session at 10 a.m. on
Tuesday, June 22, 2010, to consider the
following matters:
Summary Agenda: No substantive
discussion of the following items is
anticipated. These matters will be
resolved with a single vote unless a
member of the Board of Directors
requests that an item be moved to the
discussion agenda.
Disposition of minutes of previous
Board of Directors’ Meetings.
Summary reports, status reports, reports
of the Office of Inspector General, and
reports of actions taken pursuant to
authority delegated by the Board of
Directors.
Discussion Agenda:
Memorandum and resolution re: Final
Rule: Temporary Liquidity Guarantee
Program.
Memorandum re: Deposit Insurance
Fund Loss, Income and Reserve Ratio
Projection Update for the Restoration
Plan.
The meeting will be held in the Board
Room on the sixth floor of the FDIC
Building located at 550 17th Street,
NW., Washington, DC.
This Board meeting will be Webcast
live via the Internet and subsequently
made available on-demand
approximately one week after the event.
Visit https://www.vodium.com/goto/fdic/
boardmeetings.asp to view the event. If
you need any technical assistance,
please visit our Video Help page at:
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The FDIC will provide attendees with
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interpretation) required for this meeting.
Those attendees needing such assistance
should call (703) 562–6067 (Voice or
TTY), to make necessary arrangements.
Requests for further information
concerning the meeting may be directed
to Mr. Robert E. Feldman, Executive
Secretary of the Corporation, at (202)
898–7043.
VerDate Mar<15>2010
16:17 Jun 17, 2010
Federal
Maritime Commission.
TIME AND DATE: June 23, 2010—10 a.m.
PLACE: 800 North Capitol Street, NW.,
First Floor Hearing Room, Washington,
DC.
STATUS: Part of the meeting will be in
Open Session and the remainder of the
meeting will be in Closed Session.
MATTERS TO BE CONSIDERED:
AGENCY HOLDING THE MEETING:
Sunshine Act Meeting
Jkt 220001
Open Session
1. Fact Finding No. 27: Complaints or
Inquiries from Individual Shippers of
Household Goods or Private
Automobiles
Closed Session
1. Fact Finding Investigation No. 26:
Vessel Capacity and Equipment
Availability in the United States Export
and Import Liner Trades—Discussion of
the Fact Finding Officer’s Interim
Report Findings
2. Staff Briefing and Discussion
Regarding Passenger Vessel Financial
Responsibility Notice of Inquiry
Information Collection
CONTACT PERSON FOR MORE INFORMATION:
Karen V. Gregory, Secretary, (202) 523–
5725.
Karen V. Gregory,
Secretary.
[FR Doc. 2010–14939 Filed 6–16–10; 4:15 pm]
BILLING CODE 6730–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10219, CMS–
10317, CMS–10069, CMS–367, CMS–10068,
CMS–R–13 and CMS–2728]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare &
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
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.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Healthcare
Effectiveness Data and Information Set
(HEDIS®) Data Collection for Medicare
Advantage; Use: Medicare Advantage
Organizations (MAOs) and section 1876
cost contracting managed care are
required to submit HEDIS® data to CMS
on an annual basis. Sections 422.152
and 422.516 of Volume 42 of the Code
of Federal Regulations (CFR) specify
that Medicare Advantage organizations
must submit performance measures as
specified by the Secretary of the
Department of Health and Human
Services and by CMS. These
performance measures include HEDIS®.
HEDIS® is a widely used set of health
plan performance measures utilized by
both private and public health care
purchasers to promote accountability
and to assess the quality of care
provided by managed care
organizations. HEDIS® is designed for
private and public health care
purchasers to promote accountability
and to assess the quality of care
provided by managed care
organizations. CMS is committed to the
implementation of health care quality
assessment in the Medicare Advantage
program. In January 1997, CMS began
requiring Medicare managed care
organizations (MCOs) (these
organizations are now called Medicare
Advantage organizations or MAOs) to
collect and report performance
measures from HEDIS® relevant to the
Medicare managed care beneficiary
population.
The data are used by CMS staff to
monitor MAO performance and inform
audit strategies, and inform beneficiary
choice through their display in CMS’
consumer-oriented public compare tools
and Web sites. Medicare Advantage
organizations use the data for quality
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Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices
assessment and as part of their quality
improvement programs and activities.
Quality Improvement Organizations
(QIOs) and CMS contractors use HEDIS®
data in conjunction with their statutory
authority to improve quality of care, and
consumers who are making informed
health care choices. Form Number:
CMS–10219 (OMB#: 0938–1028);
Frequency: Yearly; Affected Public:
Business or other for-profits and not-forprofit institutions; Number of
Respondents: 483; Total Annual
Responses: 483; Total Annual Hours:
154,560. (For policy questions regarding
this collection contact Lori Teichman at
410–786–6684. For all other issues call
410–786–1326.)
2. Type of Information Collection
Request: New collection; Title of
Information Collection: The Medicare
Acute Care Episode Demonstration; Use:
Medicare’s Acute Care Episode (ACE)
Demonstration is authorized under
Section 646 of the MMA (Pub. L. 108–
173) that amends title XVIII (42 U.S.C.
1395) of the Social Security Act. The
ACE Demonstration stems from a
longstanding need for improved quality
of care and decreased costs.
As costs have risen over time, ideas to
improve Medicare payment systems and
efficiency have been developed. Moving
from a cost based payment arrangement
to a hospital prospective payment
system has dramatically simplified
billing and coding procedures and
generated important impacts on
Medicare savings and quality of care
measures. While prospective hospital
payments based on diagnosis related
groups (DRGs) for acute care was the
innovation of the 1980s, the Federal
government has taken interest in valuebased purchasing (VBP) in recent years.
The VBP strategy rests on linking
hospital performance to financial
incentives. VBP has been heralded as a
method to increase efficiency and
quality of care while decreasing cost. In
addition to its use as a payment system,
the VBP strategy allows for performance
scoring of hospitals based on the
designated VBP quality measures.
In the case of the ACE Demonstration,
the test has been designed to address the
use of a global payment for an episode
of care as an alternative approach to
payment under traditional Medicare.
The episode of care is defined as the
bundle of Part A and Part B services
provided during an inpatient stay for
Medicare FFS beneficiaries for included
Medicare severity-based diagnosisrelated groups (MS–DRGs). The ACE
Demonstration is limited to health care
groups (i.e., physician-hospital
organizations—PHOs) with at least one
physician group and at least one
VerDate Mar<15>2010
16:17 Jun 17, 2010
Jkt 220001
hospital and that routinely provide care
for at least one group of selected
orthopedic or cardiac procedures:
• Hip/knee replacement or revision
surgery; and/or
• Coronary artery bypass graft (CABG)
surgery or cardiac intervention
procedure (pace-maker and stent
placement).
Evaluation of ACE will reveal whether
the use of a bundled payment system
will produce savings for Medicare for
episodes of care involving the included
DRGs. In addition to cost savings, the
evaluation will assess changes to quality
of care at the demonstration sites;
whether or not the payment system
creates better collaboration between
physicians and facilities leading to
higher quality patient care. Form
Number: CMS–10317 (OMB#: 0938–
New); Frequency: Occasionally;
Affected Public: Individuals or
households; Number of Respondents:
509; Total Annual Responses: 509; Total
Annual Hours: 763.5. (For policy
questions regarding this collection
contact Jesse Levy at 410–786–6600. For
all other issues call 410–786–1326.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Waiver Demonstration Application; Use:
The currently approved application has
been used for several congressionally
mandated and Administration high
priority demonstrations. The
standardized proposal format is not
controversial and will reduce burden on
applicants and reviewers. Responses are
strictly voluntary. The standard format
will enable CMS to select proposals that
meet CMS objectives and show the best
potential for success. Form Number:
CMS–10069 (OMB#: 0938–0880);
Frequency: Once; Affected Public:
Private Sector: Business or other forprofits and Not-for-profit institutions;
Number of Respondents: 75; Total
Annual Responses: 75; Total Annual
Hours: 6,000. (For policy questions
regarding this collection contact Diane
Ross at 410–786–1169. For all other
issues call 410–786–1326.)
4. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicaid Drug
Program Monthly and Quarterly Drug
Reporting Format; Use: In order for
payment to be made under Medicaid,
the drug labeler must complete and sign
a drug rebate agreement and fill in the
information on the related documents.
The Patient Protection and Affordable
Care Act of 2010 added two new data
elements to potentially be reported by
manufacturers. In addition, the Food
PO 00000
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34741
and Drug Administration has informed
us that ‘‘DESI’’ is now obsolete;
therefore, we are replacing it with a
more appropriate ‘‘rebate eligibility
code’’ that will more accurately describe
how a product is eligible for coverage
under the drug rebate program. Form
Number: CMS–367 (OMB#: 0938–0578);
Frequency: Monthly and Quarterly;
Affected Public: Private Sector: Business
or other for-profits; Number of
Respondents: 580; Total Annual
Responses: 9,280; Total Annual Hours:
137,344. (For policy questions regarding
this collection contact Samone Angel at
410–786–1123. For all other issues call
410–786–1326.)
5. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: Beneficiary
Customer Service Feedback Survey;
Use: The Centers for Medicare &
Medicaid Services (CMS) stresses a
continuing need for setting customer
service goals that include providing
accurate, timely, and relevant
information to its customers. With these
goals in mind, the Division of Medicare
Ombudsman Assistance (DMOA) needs
to periodically survey its customers that
correspond with CMS to ensure that the
needs of Medicare beneficiaries are
being met. This survey will be used to
measure overall satisfaction of the
customer service that the DMOA
provides to Medicare beneficiaries and
their representatives. The need for this
previously OMB approved information
collection is to further meet the
customer service goals that the CMS has
established and to continue to create a
rapport within the Medicare
community. Form Number: CMS–10068
(OMB#: 0938–0894); Frequency:
Quarterly; Affected Public: Individuals
and Households; Number of
Respondents: 2,242; Total Annual
Responses: 2,242; Total Annual Hours:
224. (For policy questions regarding this
collection contact Nancy Conn at 410–
786–8374. For all other issues call 410–
786–1326.)
6. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: Conditions of
Coverage for Organ Procurement
Organizations and Supporting
Regulations in 42 CFR, Sections
486.301–.348; Use: Section 1138(b) of
the Social Security Act, as added by
section 9318 of the Omnibus Budget
Reconciliation Act of 1986 (Pub. L. 99–
509), sets forth the statutory
qualifications and requirements that
OPOs must meet in order for the costs
of their services in procuring organs for
transplant centers to be reimbursable
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34742
Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices
under the Medicare and Medicaid
programs. An OPO must be certified and
designated by the Secretary as an OPO
and must meet performance-related
standards prescribed by the Secretary.
The corresponding regulations are
found at 42 CFR Part 486 (Conditions
for Coverage of Specialized Services
Furnished by Suppliers) under subpart
G (Requirements for Certification and
Designation and Conditions for
Coverage: Organ Procurement
Organizations).
Since each OPO has a monopoly on
organ procurement within its donation
service area, CMS must hold OPOs to
high standards. Collection of this
information is necessary for CMS to
assess the effectiveness of each OPO and
determine whether it should continue to
be certified as an OPO and designated
for a particular donation service area by
the Secretary or replaced by an OPO
that can more effectively procure organs
within the donation service area. Form
Number: CMS–R–13 (OMB#: 0938–
0688); Frequency: Occasionally;
Affected Public: Not-for-profit
institutions; Number of Respondents:
79; Total Annual Responses: 79; Total
Annual Hours: 15,178. (For policy
questions regarding this collection
contact Diane Corning at 410–786–8486.
For all other issues call 410–786–1326.)
7. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: End Stage Renal
Disease Medical Evidence Report
Medicare Entitlement and/or Patient
Registration; Use: The End Stage Renal
Disease (ESRD) Medical Evidence
Report is completed for all ESRD
patients either by the first treatment
facility or by a Medicare-approved
ESRD facility when it is determined by
a physician that the patient’s condition
has reached that stage of renal
impairment that a regular course of
kidney dialysis or a kidney transplant is
necessary to maintain life. The data
reported on the CMS–2728 is used by
the Federal Government, ESRD
Networks, treatment facilities,
researchers and others to monitor and
assess the quality and type of care
provided to end stage renal disease
beneficiaries. The data collection
captures the specific medical
information required to determine the
Medicare medical eligibility of End
Stage Renal Disease claimants. Form
Number: CMS–2728 (OMB#: 0938–
0046); Frequency: Occasionally;
Affected Public: Individuals or
households; Number of Respondents:
100,000; Total Annual Responses:
100,000; Total Annual Hours: 75,000.
(For policy questions regarding this
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16:17 Jun 17, 2010
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collection contact Connie Cole at 410–
786–0257. For all other issues call 410–
786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
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 August 17, 2010:
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/OMB Control
Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: June 15, 2010.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2010–14781 Filed 6–17–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10179, CMS–R–
234, CMS–2540–10, CMS–10108, CMS–
10315, CMS–10302, CMS–2744 and CMS–
2746]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare &
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
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 function;
(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.
1. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Requests by
Hospitals for an Alternative Cost-toCharge Ratio. Use: Section 1886(d)(5)(A)
of the Act provides for additional
Medicare payments to Inpatient
Prospective Payment System (IPPS)
hospitals for cases that incur
extraordinarily high costs. To qualify for
outlier payments, a case must have costs
above a predetermined threshold
amount (a dollar amount by which the
estimated cost of a case must exceed the
Medicare payment). Hospital-specific
cost-to-charge ratios are applied to the
covered charges for a case to determine
the estimated cost of the case. In
general, additional outlier payments for
eligible cases are made based on a
marginal cost factor of 80 percent, i.e. a
fixed percentage of the costs. Therefore,
if the estimated cost of the case exceeds
the Medicare payment for that discharge
plus the outlier threshold, generally
Medicare will pay the hospital 80
percent of the excess amount. The
outlier threshold is updated annually at
the beginning of the Federal Fiscal Year.
Form Number: CMS–10179 (OMB#:
0938–1020); Frequency: Occasionally;
Affected Public: Private Sector and
Business or other for-profits, Not-forprofit institutions; Number of
Respondents: 18; Total Annual
Responses: 18; Total Annual Hours:
144. (For policy questions regarding this
collection contact Michael Treitel at
410–786–4552. For all other issues call
410–786–1326.)
2. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Subpart D—
Private Contracts and Supporting
Regulations contained in 42 CFR
405.410, 405.430, 405.435, 405.440,
405.445, and 405.455. Use: Section 4507
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Agencies
[Federal Register Volume 75, Number 117 (Friday, June 18, 2010)]
[Notices]
[Pages 34740-34742]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14781]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10219, CMS-10317, CMS-10069, CMS-367, CMS-
10068, CMS-R-13 and CMS-2728]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS) is publishing the following summary of proposed
collections for public comment. Interested persons are invited to send
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.
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Healthcare
Effectiveness Data and Information Set (HEDIS[supreg]) Data Collection
for Medicare Advantage; Use: Medicare Advantage Organizations (MAOs)
and section 1876 cost contracting managed care are required to submit
HEDIS[supreg] data to CMS on an annual basis. Sections 422.152 and
422.516 of Volume 42 of the Code of Federal Regulations (CFR) specify
that Medicare Advantage organizations must submit performance measures
as specified by the Secretary of the Department of Health and Human
Services and by CMS. These performance measures include HEDIS[supreg].
HEDIS[supreg] is a widely used set of health plan performance measures
utilized by both private and public health care purchasers to promote
accountability and to assess the quality of care provided by managed
care organizations. HEDIS[supreg] is designed for private and public
health care purchasers to promote accountability and to assess the
quality of care provided by managed care organizations. CMS is
committed to the implementation of health care quality assessment in
the Medicare Advantage program. In January 1997, CMS began requiring
Medicare managed care organizations (MCOs) (these organizations are now
called Medicare Advantage organizations or MAOs) to collect and report
performance measures from HEDIS[supreg] relevant to the Medicare
managed care beneficiary population.
The data are used by CMS staff to monitor MAO performance and
inform audit strategies, and inform beneficiary choice through their
display in CMS' consumer-oriented public compare tools and Web sites.
Medicare Advantage organizations use the data for quality
[[Page 34741]]
assessment and as part of their quality improvement programs and
activities. Quality Improvement Organizations (QIOs) and CMS
contractors use HEDIS[supreg] data in conjunction with their statutory
authority to improve quality of care, and consumers who are making
informed health care choices. Form Number: CMS-10219 (OMB:
0938-1028); Frequency: Yearly; Affected Public: Business or other for-
profits and not-for-profit institutions; Number of Respondents: 483;
Total Annual Responses: 483; Total Annual Hours: 154,560. (For policy
questions regarding this collection contact Lori Teichman at 410-786-
6684. For all other issues call 410-786-1326.)
2. Type of Information Collection Request: New collection; Title of
Information Collection: The Medicare Acute Care Episode Demonstration;
Use: Medicare's Acute Care Episode (ACE) Demonstration is authorized
under Section 646 of the MMA (Pub. L. 108-173) that amends title XVIII
(42 U.S.C. 1395) of the Social Security Act. The ACE Demonstration
stems from a longstanding need for improved quality of care and
decreased costs.
As costs have risen over time, ideas to improve Medicare payment
systems and efficiency have been developed. Moving from a cost based
payment arrangement to a hospital prospective payment system has
dramatically simplified billing and coding procedures and generated
important impacts on Medicare savings and quality of care measures.
While prospective hospital payments based on diagnosis related groups
(DRGs) for acute care was the innovation of the 1980s, the Federal
government has taken interest in value-based purchasing (VBP) in recent
years. The VBP strategy rests on linking hospital performance to
financial incentives. VBP has been heralded as a method to increase
efficiency and quality of care while decreasing cost. In addition to
its use as a payment system, the VBP strategy allows for performance
scoring of hospitals based on the designated VBP quality measures.
In the case of the ACE Demonstration, the test has been designed to
address the use of a global payment for an episode of care as an
alternative approach to payment under traditional Medicare. The episode
of care is defined as the bundle of Part A and Part B services provided
during an inpatient stay for Medicare FFS beneficiaries for included
Medicare severity-based diagnosis-related groups (MS-DRGs). The ACE
Demonstration is limited to health care groups (i.e., physician-
hospital organizations--PHOs) with at least one physician group and at
least one hospital and that routinely provide care for at least one
group of selected orthopedic or cardiac procedures:
Hip/knee replacement or revision surgery; and/or
Coronary artery bypass graft (CABG) surgery or cardiac
intervention procedure (pace-maker and stent placement).
Evaluation of ACE will reveal whether the use of a bundled payment
system will produce savings for Medicare for episodes of care involving
the included DRGs. In addition to cost savings, the evaluation will
assess changes to quality of care at the demonstration sites; whether
or not the payment system creates better collaboration between
physicians and facilities leading to higher quality patient care. Form
Number: CMS-10317 (OMB: 0938-New); Frequency: Occasionally;
Affected Public: Individuals or households; Number of Respondents: 509;
Total Annual Responses: 509; Total Annual Hours: 763.5. (For policy
questions regarding this collection contact Jesse Levy at 410-786-6600.
For all other issues call 410-786-1326.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare Waiver
Demonstration Application; Use: The currently approved application has
been used for several congressionally mandated and Administration high
priority demonstrations. The standardized proposal format is not
controversial and will reduce burden on applicants and reviewers.
Responses are strictly voluntary. The standard format will enable CMS
to select proposals that meet CMS objectives and show the best
potential for success. Form Number: CMS-10069 (OMB: 0938-
0880); Frequency: Once; Affected Public: Private Sector: Business or
other for-profits and Not-for-profit institutions; Number of
Respondents: 75; Total Annual Responses: 75; Total Annual Hours: 6,000.
(For policy questions regarding this collection contact Diane Ross at
410-786-1169. For all other issues call 410-786-1326.)
4. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicaid Drug
Program Monthly and Quarterly Drug Reporting Format; Use: In order for
payment to be made under Medicaid, the drug labeler must complete and
sign a drug rebate agreement and fill in the information on the related
documents. The Patient Protection and Affordable Care Act of 2010 added
two new data elements to potentially be reported by manufacturers. In
addition, the Food and Drug Administration has informed us that
``DESI'' is now obsolete; therefore, we are replacing it with a more
appropriate ``rebate eligibility code'' that will more accurately
describe how a product is eligible for coverage under the drug rebate
program. Form Number: CMS-367 (OMB: 0938-0578); Frequency:
Monthly and Quarterly; Affected Public: Private Sector: Business or
other for-profits; Number of Respondents: 580; Total Annual Responses:
9,280; Total Annual Hours: 137,344. (For policy questions regarding
this collection contact Samone Angel at 410-786-1123. For all other
issues call 410-786-1326.)
5. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Beneficiary Customer Service Feedback Survey; Use: The
Centers for Medicare & Medicaid Services (CMS) stresses a continuing
need for setting customer service goals that include providing
accurate, timely, and relevant information to its customers. With these
goals in mind, the Division of Medicare Ombudsman Assistance (DMOA)
needs to periodically survey its customers that correspond with CMS to
ensure that the needs of Medicare beneficiaries are being met. This
survey will be used to measure overall satisfaction of the customer
service that the DMOA provides to Medicare beneficiaries and their
representatives. The need for this previously OMB approved information
collection is to further meet the customer service goals that the CMS
has established and to continue to create a rapport within the Medicare
community. Form Number: CMS-10068 (OMB: 0938-0894); Frequency:
Quarterly; Affected Public: Individuals and Households; Number of
Respondents: 2,242; Total Annual Responses: 2,242; Total Annual Hours:
224. (For policy questions regarding this collection contact Nancy Conn
at 410-786-8374. For all other issues call 410-786-1326.)
6. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Conditions of Coverage for Organ Procurement Organizations
and Supporting Regulations in 42 CFR, Sections 486.301-.348; Use:
Section 1138(b) of the Social Security Act, as added by section 9318 of
the Omnibus Budget Reconciliation Act of 1986 (Pub. L. 99-509), sets
forth the statutory qualifications and requirements that OPOs must meet
in order for the costs of their services in procuring organs for
transplant centers to be reimbursable
[[Page 34742]]
under the Medicare and Medicaid programs. An OPO must be certified and
designated by the Secretary as an OPO and must meet performance-related
standards prescribed by the Secretary. The corresponding regulations
are found at 42 CFR Part 486 (Conditions for Coverage of Specialized
Services Furnished by Suppliers) under subpart G (Requirements for
Certification and Designation and Conditions for Coverage: Organ
Procurement Organizations).
Since each OPO has a monopoly on organ procurement within its
donation service area, CMS must hold OPOs to high standards. Collection
of this information is necessary for CMS to assess the effectiveness of
each OPO and determine whether it should continue to be certified as an
OPO and designated for a particular donation service area by the
Secretary or replaced by an OPO that can more effectively procure
organs within the donation service area. Form Number: CMS-R-13
(OMB: 0938-0688); Frequency: Occasionally; Affected Public:
Not-for-profit institutions; Number of Respondents: 79; Total Annual
Responses: 79; Total Annual Hours: 15,178. (For policy questions
regarding this collection contact Diane Corning at 410-786-8486. For
all other issues call 410-786-1326.)
7. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: End Stage Renal
Disease Medical Evidence Report Medicare Entitlement and/or Patient
Registration; Use: The End Stage Renal Disease (ESRD) Medical Evidence
Report is completed for all ESRD patients either by the first treatment
facility or by a Medicare-approved ESRD facility when it is determined
by a physician that the patient's condition has reached that stage of
renal impairment that a regular course of kidney dialysis or a kidney
transplant is necessary to maintain life. The data reported on the CMS-
2728 is used by the Federal Government, ESRD Networks, treatment
facilities, researchers and others to monitor and assess the quality
and type of care provided to end stage renal disease beneficiaries. The
data collection captures the specific medical information required to
determine the Medicare medical eligibility of End Stage Renal Disease
claimants. Form Number: CMS-2728 (OMB: 0938-0046); Frequency:
Occasionally; Affected Public: Individuals or households; Number of
Respondents: 100,000; Total Annual Responses: 100,000; Total Annual
Hours: 75,000. (For policy questions regarding this collection contact
Connie Cole at 410-786-0257. For all other issues call 410-786-1326.)
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS'
Web site at https://www.cms.hhs.gov/PaperworkReductionActof1995, or E-
mail 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 August 17, 2010:
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/OMB Control
Number, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland
21244-1850.
Dated: June 15, 2010.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 2010-14781 Filed 6-17-10; 8:45 am]
BILLING CODE 4120-01-P