Agency Information Collection Activities: Submission for OMB Review; Comment Request, 1059-1060 [E9-31299]
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Federal Register / Vol. 75, No. 5 / Friday, January 8, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10142, CMS–R–
262, CMS–R–0282 and CMS–R–64]
pwalker on DSK8KYBLC1PROD with NOTICES
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare &
Medicaid Services, HHS.
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), 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: Revision of a currently
approved collection; Title of
Information Collection: CY 2011 Bid
Pricing Tool (BPT) for Medicare
Advantage (MA) Plans and Prescription
Drug Plans (PDP); Use: Under the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA), and implementing
regulations at 42 CFR, Medicare
Advantage organizations (MAO) and
Prescription Drug Plans are required to
submit an actuarial pricing ‘‘bid’’ for
each plan offered to Medicare
beneficiaries for approval by CMS.
MAOs and PDPs use the Bid Pricing
Tool (BPT) software to develop their
actuarial pricing bid. The information
provided in the BPT is the basis for the
plan’s enrollee premiums and CMS
payments for each contract year. The
tool collects data such as medical
expense development (from claims data
and/or manual rating), administrative
expenses, profit levels, and projected
plan enrollment information. By statute,
completed BPTs are due to CMS by the
first Monday of June each year. CMS
reviews and analyzes the information
provided on the Bid Pricing Tool.
VerDate Nov<24>2008
16:14 Jan 07, 2010
Jkt 220001
Ultimately, CMS decides whether to
approve the plan pricing (i.e., payment
and premium) proposed by each
organization. Refer to the supporting
document attachment ‘‘C’’ for a list of
changes. Form Number: CMS–10142
(OMB#: 0938–0944); Frequency:
Reporting—Yearly; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 550; Total Annual
Responses: 6,050; Total Annual Hours:
42,350. (For policy questions regarding
this collection contact Diane Spitalnic at
410–786–5745. For all other issues call
410–786–1326.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: CY 2011 Plan
Benefit Package (PBP) Software and
Formulary Submission; Use: Under the
Medicare Modernization Act (MMA),
Medicare Advantage (MA) and
Prescription Drug Plan (PDP)
organizations are required to submit
plan benefit packages for all Medicare
beneficiaries residing in their service
area. The plan benefit package
submission consists of the PBP software,
formulary file, and supporting
documentation, as necessary. MA and
PDP organizations use the PBP software
to describe their organization’s plan
benefit packages, including information
on premiums, cost sharing,
authorization rules, and supplemental
benefits. They also generate a formulary
to describe their list of drugs, including
information on prior authorization, step
therapy, tiering, and quantity limits.
Additionally, CMS uses the PBP and
formulary data to review and approve
the plan benefit packages proposed by
each MA and PDP organization.
CMS requires that MA and PDP
organizations submit a completed PBP
and formulary as part of the annual
bidding process. During this process,
organizations prepare their proposed
plan benefit packages for the upcoming
contract year and submit them to CMS
for review and approval. Based on
operational changes and policy
clarifications to the Medicare program
and continued input and feedback by
the industry, CMS has made the
necessary changes to the plan benefit
package submission. Refer to the
supporting document ‘‘Appendix B’’ for
a list of changes. Form Number: CMS–
R–262 (OMB#: 0938–0763); Frequency:
Reporting—Yearly; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 475; Total Annual
Responses: 4988; Total Annual Hours:
12,113. (For policy questions regarding
this collection contact Sara Walters at
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
1059
410–786–3330. 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
Advantage Appeals and Grievance Data
Disclosure Requirements (42 CFR
§ 422.111); Use: Medicare Advantage
(MA) organizations must disclose
information pertaining to the number of
disputes, and their disposition in the
aggregate, with the categories of
grievances and appeals to any
individual eligible to elect an MA
organization who requests this
information. Medicare demonstrations
also are required to conform to MA
appeals regulations and thus are
included in the count of organizations
affected by this requirement. MA
organizations also are required by the
statute and the MA regulation to
provide aggregate grievance data to MA
eligible beneficiaries upon request. MA
eligible individuals will use this
information to help them make
informed decisions about their
organization’s performance in the area
of appeals and grievances. Form
Number: CMS–R–0282 (OMB#: 0938–
0778); Frequency: Reporting—Semiannually and Yearly; Affected Public:
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 629; Total Annual
Responses: 47,175; Total Annual Hours:
4,931.36. (For policy questions
regarding this collection contact
Stephanie Simons at 206–615–2420. For
all other issues call 410–786–1326.)
4. Type of Information Collection
Request: Extension of the currently
approved collection; Title of
Information Collection: Indirect Medical
Education (IME) and Supporting
Regulations at 42 CFR 412.105; Direct
Graduate Medical Education (GME) and
Supporting Regulations at 42 CFR
413.75 through 413.83; Use: The
information collected on interns and
residents (IRs) is used by the Medicare
Part A fiscal intermediaries (FI) and Part
A Medicare Administrative Contractors
(MAC) to verify the number of IRs used
in the calculation of Medicare program
payments for indirect medical education
(IME) as well as direct graduate medical
education (GME). The IR data collected
from the hospitals is processed through
computers at FIs/MACs to identify any
duplicated time based upon the
accumulated time of each individual
that worked at one or more hospitals.
The identification of duplicate IRs is
necessary to ensure that no IR is
counted more than once.
The FIs/MACs use the information
collected on IRs to help ensure that all
E:\FR\FM\08JAN1.SGM
08JAN1
1060
Federal Register / Vol. 75, No. 5 / Friday, January 8, 2010 / Notices
program payments for IME and GME are
based upon an accurate number of FTE–
IRs, determined in accordance with
Medicare regulations. The IR data
submitted by the hospitals are used by
the FIs/MACs during their audits of the
providers’ cost reports. The audit
procedures help assure that the
information reported was correct, and
that IRs who should not have been
reported by the hospitals (or portions of
the IRs’ time) are not included in the
FTE count. The FIs/MACs also use
reports of duplicate IRs to prevent
improper payment for IME and GME.
Form Number: CMS–R–64 (OMB#:
0938–0456); Frequency: Reporting—
Yearly; Affected Public: Business or
other for-profit and Not-for-profit
institutions; Number of Respondents:
1,190; Total Annual Responses: 1,190;
Total Annual Hours: 2,380. (For policy
questions regarding this collection
contact Milton Jacobson at 410–786–
7553. 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
address 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.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on February 8, 2010.
OMB, Office of Information and
Regulatory Affairs. Attention: CMS Desk
Officer. Fax Number: 202–395–6974. Email: OIRA_submission@omb.eop.gov.
Dated: December 24, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–31299 Filed 1–7–10; 8:45 am]
pwalker on DSK8KYBLC1PROD with NOTICES
BILLING CODE 4120–01–P
VerDate Nov<24>2008
16:14 Jan 07, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–906]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare &
Medicaid Services, HHS.
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: The Fiscal
Soundness Reporting Requirements;
Use: CMS is assigned responsibility for
overseeing all Medicare Advantage
Organizations (MAO), Prescription Drug
Plan (PDP) sponsors, 1876 Cost Plans,
Demonstration Plans and PACE
organizations on-going financial
performance. Specifically, CMS needs
the requested collection of information
to establish that contracting entities
within those programs maintain fiscally
sound organizations. Refer to the
supporting documents for a list of
changes to this collection. Form
Number: CMS–906 (OMB#: 0938–0469);
Frequency: Reporting—Yearly and
Quarterly; Affected Public: Private
Sector: Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 514; Total Annual
Responses: 1039; Total Annual Hours:
346. (For policy questions regarding this
collection contact Robert Ahern at 410–
786–0073. 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
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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 March 9, 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: December 24, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–31301 Filed 1–7–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0568]
Draft Guidance for Industry on
Planning for the Effects of High
Absenteeism to Ensure Availability of
Medically Necessary Drug Products;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Planning for the
Effects of High Absenteeism to Ensure
Availability of Medically Necessary
Drug Products.’’ The draft guidance
encourages manufacturers of medically
necessary drug products (MNPs) and
components to develop contingency
production plans in the event of an
emergency that results in high
absenteeism at one or more production
E:\FR\FM\08JAN1.SGM
08JAN1
]]>Agencies
[Federal Register Volume 75, Number 5 (Friday, January 8, 2010)]
[Notices]
[Pages 1059-1060]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-31299]
[[Page 1059]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10142, CMS-R-262, CMS-R-0282 and CMS-R-64]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
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), 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: Revision of a currently
approved collection; Title of Information Collection: CY 2011 Bid
Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription
Drug Plans (PDP); Use: Under the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA), and implementing
regulations at 42 CFR, Medicare Advantage organizations (MAO) and
Prescription Drug Plans are required to submit an actuarial pricing
``bid'' for each plan offered to Medicare beneficiaries for approval by
CMS. MAOs and PDPs use the Bid Pricing Tool (BPT) software to develop
their actuarial pricing bid. The information provided in the BPT is the
basis for the plan's enrollee premiums and CMS payments for each
contract year. The tool collects data such as medical expense
development (from claims data and/or manual rating), administrative
expenses, profit levels, and projected plan enrollment information. By
statute, completed BPTs are due to CMS by the first Monday of June each
year. CMS reviews and analyzes the information provided on the Bid
Pricing Tool. Ultimately, CMS decides whether to approve the plan
pricing (i.e., payment and premium) proposed by each organization.
Refer to the supporting document attachment ``C'' for a list of
changes. Form Number: CMS-10142 (OMB: 0938-0944); Frequency:
Reporting--Yearly; Affected Public: Business or other for-profit and
Not-for-profit institutions; Number of Respondents: 550; Total Annual
Responses: 6,050; Total Annual Hours: 42,350. (For policy questions
regarding this collection contact Diane Spitalnic at 410-786-5745. For
all other issues call 410-786-1326.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: CY 2011 Plan
Benefit Package (PBP) Software and Formulary Submission; Use: Under the
Medicare Modernization Act (MMA), Medicare Advantage (MA) and
Prescription Drug Plan (PDP) organizations are required to submit plan
benefit packages for all Medicare beneficiaries residing in their
service area. The plan benefit package submission consists of the PBP
software, formulary file, and supporting documentation, as necessary.
MA and PDP organizations use the PBP software to describe their
organization's plan benefit packages, including information on
premiums, cost sharing, authorization rules, and supplemental benefits.
They also generate a formulary to describe their list of drugs,
including information on prior authorization, step therapy, tiering,
and quantity limits. Additionally, CMS uses the PBP and formulary data
to review and approve the plan benefit packages proposed by each MA and
PDP organization.
CMS requires that MA and PDP organizations submit a completed PBP
and formulary as part of the annual bidding process. During this
process, organizations prepare their proposed plan benefit packages for
the upcoming contract year and submit them to CMS for review and
approval. Based on operational changes and policy clarifications to the
Medicare program and continued input and feedback by the industry, CMS
has made the necessary changes to the plan benefit package submission.
Refer to the supporting document ``Appendix B'' for a list of changes.
Form Number: CMS-R-262 (OMB: 0938-0763); Frequency:
Reporting--Yearly; Affected Public: Business or other for-profit and
Not-for-profit institutions; Number of Respondents: 475; Total Annual
Responses: 4988; Total Annual Hours: 12,113. (For policy questions
regarding this collection contact Sara Walters at 410-786-3330. 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
Advantage Appeals and Grievance Data Disclosure Requirements (42 CFR
Sec. 422.111); Use: Medicare Advantage (MA) organizations must
disclose information pertaining to the number of disputes, and their
disposition in the aggregate, with the categories of grievances and
appeals to any individual eligible to elect an MA organization who
requests this information. Medicare demonstrations also are required to
conform to MA appeals regulations and thus are included in the count of
organizations affected by this requirement. MA organizations also are
required by the statute and the MA regulation to provide aggregate
grievance data to MA eligible beneficiaries upon request. MA eligible
individuals will use this information to help them make informed
decisions about their organization's performance in the area of appeals
and grievances. Form Number: CMS-R-0282 (OMB: 0938-0778);
Frequency: Reporting--Semi-annually and Yearly; Affected Public:
Business or other for-profits and Not-for-profit institutions; Number
of Respondents: 629; Total Annual Responses: 47,175; Total Annual
Hours: 4,931.36. (For policy questions regarding this collection
contact Stephanie Simons at 206-615-2420. For all other issues call
410-786-1326.)
4. Type of Information Collection Request: Extension of the
currently approved collection; Title of Information Collection:
Indirect Medical Education (IME) and Supporting Regulations at 42 CFR
412.105; Direct Graduate Medical Education (GME) and Supporting
Regulations at 42 CFR 413.75 through 413.83; Use: The information
collected on interns and residents (IRs) is used by the Medicare Part A
fiscal intermediaries (FI) and Part A Medicare Administrative
Contractors (MAC) to verify the number of IRs used in the calculation
of Medicare program payments for indirect medical education (IME) as
well as direct graduate medical education (GME). The IR data collected
from the hospitals is processed through computers at FIs/MACs to
identify any duplicated time based upon the accumulated time of each
individual that worked at one or more hospitals. The identification of
duplicate IRs is necessary to ensure that no IR is counted more than
once.
The FIs/MACs use the information collected on IRs to help ensure
that all
[[Page 1060]]
program payments for IME and GME are based upon an accurate number of
FTE-IRs, determined in accordance with Medicare regulations. The IR
data submitted by the hospitals are used by the FIs/MACs during their
audits of the providers' cost reports. The audit procedures help assure
that the information reported was correct, and that IRs who should not
have been reported by the hospitals (or portions of the IRs' time) are
not included in the FTE count. The FIs/MACs also use reports of
duplicate IRs to prevent improper payment for IME and GME. Form Number:
CMS-R-64 (OMB: 0938-0456); Frequency: Reporting--Yearly;
Affected Public: Business or other for-profit and Not-for-profit
institutions; Number of Respondents: 1,190; Total Annual Responses:
1,190; Total Annual Hours: 2,380. (For policy questions regarding this
collection contact Milton Jacobson at 410-786-7553. 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 address 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.
To be assured consideration, comments and recommendations for the
proposed information collections must be received by the OMB desk
officer at the address below, no later than 5 p.m. on February 8, 2010.
OMB, Office of Information and Regulatory Affairs. Attention: CMS
Desk Officer. Fax Number: 202-395-6974. E-mail: OIRA_submission@omb.eop.gov.
Dated: December 24, 2009.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E9-31299 Filed 1-7-10; 8:45 am]
BILLING CODE 4120-01-P
