Agency Information Collection Activities: Proposed Collection; Comment Request, 76988-76990 [2010-31071]
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Federal Register / Vol. 75, No. 237 / Friday, December 10, 2010 / Notices
easy use by beneficiaries who file their
own claims. The form can be obtained
from any Social Security office or
Medicare carrier. Frequency:
Reporting—On occasion; Affected
Public: State, Local, or Tribal
Government, Business or other-forprofit, Not-for-profit institutions;
Number of Respondents: 1,048,243;
Total Annual Responses: 991,160,925;
Total Annual Hours: 23,815,541. (For
policy questions regarding this
collection contact Brian Reitz at 410–
786–5001. 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 January 10, 2011.
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 6, 2010.
Michelle Shortt,
Director, Regulations Development Group
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2010–31075 Filed 12–9–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
mstockstill on DSKH9S0YB1PROD with NOTICES
[Document Identifier: CMS–21 and CMS–
21B, CMS–37, CMS–64, CMS–10120, CMS–
10224, CMS–10098, CMS–10292 and CMS–
10220]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
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
AGENCY:
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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: Extension without change of a
currently approved collection; Title of
Information Collection: CMS–21
(Quarterly Children’s Health Insurance
Program (CHIP) Statement of
Expenditures for the Title XXI Program)
and CMS–21B (State Children’s Health
Insurance Program Budget Report for
the Title XXI Program State Plan
Expenditures); Use: Forms CMS–21 and
–21B provide CMS with the information
necessary to issue quarterly grant
awards, monitor current year
expenditure levels, determine the
allowability of State claims for
reimbursement, develop CHIP financial
management information, provide for
State reporting of waiver expenditures,
and ensure that the Federally
established allotment is not exceeded.
Further, these forms are necessary in the
redistribution and reallocation of
unspent funds over the Federally
mandated timeframes; Form Numbers:
CMS–21 and CMS–21B (OMB#: 0938–
0731); Frequency: Quarterly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 448; Total
Annual Hours: 7,840. (For policy
questions regarding this collection
contact Jonas Eberly at 410–786–6232.
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: Medicaid
Program Budget Report; Use: Form
CMS–37 is prepared and submitted to
the Centers for Medicare & Medicaid
Services (CMS) by State Medicaid
agencies. Form CMS–37 is the primary
document used by CMS in developing
the national Medicaid budget estimates
that are submitted to the Office of
Management and Budget and the
Congress; Form Number: CMS–37
(OMB#: 0938–0101); Frequency:
Quarterly; Affected Public: State, Local,
or Tribal Governments; Number of
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Sfmt 4703
Respondents: 56; Total Annual
Responses: 224; Total Annual Hours:
7,616. (For policy questions regarding
this collection contact Jonas Eberly at
410–786–6232. For all other issues call
410–786–1326.)
3. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Quarterly
Medicaid Statement of Expenditures for
the Medical Assistance Program; Use:
Form CMS–64 has been used since
January 1980 by the Medicaid State
Agencies to report their actual program
benefit costs and administrative
expenses to CMS. CMS uses this
information to compute the Federal
financial participation (FFP) for the
State’s Medicaid Program costs. Certain
schedules of the CMS–64 form are used
by States to report budget, expenditure
and related statistical information
required for implementation of the
Medicaid portion of the State Children’s
Health Insurance Programs; Form
Number: CMS–64 (OMB#: 0938–0067);
Frequency: Quarterly; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 56; Total
Annual Responses: 224; Total Annual
Hours: 16,464. (For policy questions
regarding this collection contact Jonas
Eberly at 410–786–6232. For all other
issues call 410–786–1326.)
4. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: 1932 State Plan
Amendment Template; Use: Section
1932(a)(1)(A) of the Social Security Act
(the Act) grants states the authority to
enroll Medicaid beneficiaries on a
mandatory basis into managed care
entities, managed care organizations
(MCOs) and primary care case managers
(PCCMs). Under this authority, a state
can amend its Medicaid state plan to
require certain categories of Medicaid
beneficiaries to enroll in managed care
entities without being out of
compliance. This template may be used
by states to easily modify their state
plans if they choose to implement the
provisions of section 1932(a)(1)(A).
The State Medicaid Agencies will
complete the template. CMS will review
the information to determine if the state
has met all the requirements of section
1932(a)(1)(A) and 42 CFR 438.50. If the
requirements are met, CMS will approve
the amendment to the state’s title XIX
plan giving the state the authority to
enroll Medicaid beneficiaries on a
mandatory basis into managed care
entities MCOs and PCCMs. For a state
to receive Medicaid funding, there must
be an approved title XIX state plan;
Form Number: CMS–10120 (OMB#:
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0938–0933); Frequency: Occasionally;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 10; Total
Annual Hours: 100. (For policy
questions regarding this collection
contact Camille Dobson at 410–786–
7065. For all other issues call 410–786–
1326.)
5. Type of Information Collection
Request: Revision of currently approved
collection; Title of Information
Collection: Healthcare Common
Procedure Coding System (HCPCS); Use:
In October 2003, the Secretary of Health
and Human Services delegated the
Center for Medicare and Medicaid
Services (CMS) authority to maintain
and distribute HCPCS Level II Codes. As
a result, the National Panel was
delineated and CMS continued with the
decision-making process under its
current structure, the CMS HCPCS
Workgroup (herein referred to as ‘‘the
Workgroup’’. CMS’ HCPCS Workgroup
is an internal workgroup comprised of
representatives of the major components
of CMS, and private insurers, as well as
other consultants from pertinent Federal
agencies. Currently the application
intake is paper-based. However, the
process has grown and the HCPCS staff
is exploring electronic processes for the
collection and storage of applications.
We have received feedback on the
nature of the application; and have
streamlined the form into a userfriendly application. The content of the
material is the same, but the questions
have been refined in accordance with
comments received from industry
members; and the level of necessity of
the information required to render
quality coding decision as determined
by the CMS workgroup. The information
on the form is used to update the
HCPCS code set. All information is
received and distributed to CMS’
HCPCS workgroup and is reviewed and
discussed at workgroup meetings. In
turn, CMS’ HCPCS workgroup reaches a
decision as to whether a change should
be made to codes in the HCPCS code
set. The respondent who submits the
application form can be anyone who has
an interest in obtaining a code or
modifying an existing code. However,
respondents are usually manufacturers
of products, or consultants on behalf of
the manufacturer. Form Number: CMS–
10224 (OMB#: 0938–1042; Frequency:
Occasionally; Affected Public: Private
Sector, Business and other for-profit and
not-for-profit institutions; Number of
Respondents: 300; Total Annual
Responses: 300; Total Annual Hours:
3300. (For policy questions regarding
this collection contact Felicia Eggleston
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at 410–786–9287 or Lori Anderson at
410–786–6190. 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: Beneficiary
Satisfaction Survey; Use: The
Beneficiary Satisfaction survey is
performed to insure that the CMS
1–800–MEDICARE Helpline contractor
is delivering satisfactory service to the
Medicare beneficiaries. It gathers data
on several Helpline operations such as
print fulfillment and websites tool
hosted on https://www.medicare.gov.
Respondents to the survey are Medicare
beneficiaries that have contacted 1–800–
MEDICARE for information on benefits
and services. CMS is seeking approval
for additional questions to be added to
the original collection entitled 800Medicare Beneficiary Satisfaction
survey. The original set of questions was
used when placing outbound calls to
callers regarding the service they
received when they called the 800
Medicare Helpline with a Medicare
question. The new expanded collection
will include multiple survey methods to
measure customer satisfaction not only
with the Beneficiary Contact Center’s
(BCC’s) handling of issues via
telephone, but also the service provided
to beneficiaries when they write a letter
regarding their Medicare issue or use
the e-mail and/or web chat services
provided by the BCC. The use of
Customer Satisfaction Surveys is critical
to the CMS mission to provide service
to beneficiaries that is convenient,
accessible, accurate, courteous,
professional and responsive to the needs
of diverse groups. Form Number: CMS–
10098 (OMB#: 0938–0919); Frequency:
Weekly, Monthly, and Yearly; Affected
Public: Individuals and Households;
Number of Respondents: 36,144; Total
Annual Responses: 36,144; Total
Annual Hours: 6033. (For policy
questions regarding this collection
contact Mark Broccolino at 410–786–
6128. For all other issues call 410–786–
1326.)
7. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: State Medicaid
Health Information Technology Plan,
Planning-Advance Planning Document
and Update, Implementation Advance
Planning Document and Update, and
Annual Implementation of Advance
Planning Document to Implement
Section 4201 of the American
Reinvestment and Recovery Act of 2009;
Use: Section 4201 of Recovery Act
establishes 100 percent Federal
Financial Participation (FFP) as
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76989
reimbursement to States for making
incentive payments to providers for
meaningful use of certified electronic
health record technology and 90 percent
FFP for administering these payments.
Additionally, States are required to
conduct oversight of this program and
ensure no duplicate payments; thus,
CMS is requiring States to submit
information to CMS for prior approval
before drawing down funding. These
documents, if States choose to
implement these flexibilities, will
require a collection of information to
effectuate these changes.
The State Medicaid agencies will
complete the templates. CMS will
review the information to determine if
the State has met all of the requirements
of the Recovery Act provisions the
States choose to implement. If the
requirements are met, CMS will approve
the amendments giving the State the
authority to implement their Health
Information Technology (HIT) strategy
and implementation plans. For a State
to receive Medicaid Title XIX funding,
there must be an approved State
Medicaid HIT Plan, Planning Advance
Planning Document and
Implementation Advance Planning
Document; Form Number: CMS–10292
(OMB#: 0938–1088); Frequency: Yearly,
Once, Occasionally; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 56; Total
Annual Responses: 56; Total Annual
Hours: 56. (For policy questions
regarding this collection contact Sherry
Armstead at 410–786–4342. For all
other issues call 410–786–1326.)
8. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Provider
Enrollment, Chain and Ownership
System (PECOS) Security Consent Form;
Use: The primary function of the
Medicare enrollment application is to
obtain information about the provider or
supplier and whether the provider or
supplier meets Federal and/or State
qualifications to participate in the
Medicare program. In addition, the
Medicare enrollment application gathers
information regarding the provider or
supplier’s practice location, the identity
of the owners of the enrolling
organization, and information necessary
to establish the correct claims payment.
In establishing a Web based application
process, we allow providers and
suppliers the ability to enroll in the
Medicare program via the Internet. For
these applicants, no security consent
form is needed to enroll or make a
change in their Medicare enrollment
information. These applicants receive
complete access to their own
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enrollments through Internet-based
Provider Enrollment, Chain and
Ownership System (PECOS).
In order to allow a provider or
supplier to delegate the Medicare
credentialing process to another
individual or organization, it is
necessary to establish a Security
Consent Form for those providers and
suppliers who choose to have another
individual or organization access their
enrollment information and complete
enrollments on their behalf. These users
could consist of administrative staff,
independent contractors, or
credentialing departments and are
represented as Employer Organizations.
Employer Organizations and its
members must request access to
enrollment data through a Security
Consent Form. The security consent
form replicates business service
agreements between Medicare
applicants and organizations providing
enrollment services.
We are proposing two different
versions of the Security Consent Form.
The form, once signed, mailed and
approved, grants an employer
organization or its members access to all
current and future enrollment data for
the Medicare provider. Form Number:
CMS–10220 (OMB#: 0938–1035);
Frequency: Occasionally; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
197,500; Total Annual Responses:
197,500; Total Annual Hours: 49,375.
(For policy questions regarding this
collection contact Alisha Banks at 410–
786–0671. 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 February 8, 2011:
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.
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18:39 Dec 09, 2010
Jkt 223001
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 6, 2010.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2010–31071 Filed 12–9–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0510]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; COARTEM
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
COARTEM and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
SUMMARY:
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review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product COARTEM
(artemether/lumefantrine). COARTEM is
indicated for treatment of acute,
uncomplicated malaria infections due to
Plasmodium falciparum in patients of 5
kilograms bodyweight and above.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
COARTEM (U.S. Patent No. 5,677,331)
from Novartis AG, and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated February 17, 2010, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of COARTEM
represented the first permitted
commercial marketing or use of the
product. Thereafter, the Patent and
Trademark Office requested that FDA
determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
COARTEM is 285 days. Of this time,
zero days occurred during the testing
phase of the regulatory review period,
while 285 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C act) (21
U.S.C. 355(i)) became effective: not
applicable. FDA has verified the
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]]>Agencies
[Federal Register Volume 75, Number 237 (Friday, December 10, 2010)]
[Notices]
[Pages 76988-76990]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31071]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-21 and CMS-21B, CMS-37, CMS-64, CMS-10120,
CMS-10224, CMS-10098, CMS-10292 and CMS-10220]
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: Extension without change
of a currently approved collection; Title of Information Collection:
CMS-21 (Quarterly Children's Health Insurance Program (CHIP) Statement
of Expenditures for the Title XXI Program) and CMS-21B (State
Children's Health Insurance Program Budget Report for the Title XXI
Program State Plan Expenditures); Use: Forms CMS-21 and -21B provide
CMS with the information necessary to issue quarterly grant awards,
monitor current year expenditure levels, determine the allowability of
State claims for reimbursement, develop CHIP financial management
information, provide for State reporting of waiver expenditures, and
ensure that the Federally established allotment is not exceeded.
Further, these forms are necessary in the redistribution and
reallocation of unspent funds over the Federally mandated timeframes;
Form Numbers: CMS-21 and CMS-21B (OMB: 0938-0731); Frequency:
Quarterly; Affected Public: State, Local, or Tribal Governments; Number
of Respondents: 56; Total Annual Responses: 448; Total Annual Hours:
7,840. (For policy questions regarding this collection contact Jonas
Eberly at 410-786-6232. 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:
Medicaid Program Budget Report; Use: Form CMS-37 is prepared and
submitted to the Centers for Medicare & Medicaid Services (CMS) by
State Medicaid agencies. Form CMS-37 is the primary document used by
CMS in developing the national Medicaid budget estimates that are
submitted to the Office of Management and Budget and the Congress; Form
Number: CMS-37 (OMB: 0938-0101); Frequency: Quarterly;
Affected Public: State, Local, or Tribal Governments; Number of
Respondents: 56; Total Annual Responses: 224; Total Annual Hours:
7,616. (For policy questions regarding this collection contact Jonas
Eberly at 410-786-6232. For all other issues call 410-786-1326.)
3. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Quarterly Medicaid Statement of Expenditures for the Medical Assistance
Program; Use: Form CMS-64 has been used since January 1980 by the
Medicaid State Agencies to report their actual program benefit costs
and administrative expenses to CMS. CMS uses this information to
compute the Federal financial participation (FFP) for the State's
Medicaid Program costs. Certain schedules of the CMS-64 form are used
by States to report budget, expenditure and related statistical
information required for implementation of the Medicaid portion of the
State Children's Health Insurance Programs; Form Number: CMS-64
(OMB: 0938-0067); Frequency: Quarterly; Affected Public:
State, Local, or Tribal Governments; Number of Respondents: 56; Total
Annual Responses: 224; Total Annual Hours: 16,464. (For policy
questions regarding this collection contact Jonas Eberly at 410-786-
6232. For all other issues call 410-786-1326.)
4. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
1932 State Plan Amendment Template; Use: Section 1932(a)(1)(A) of the
Social Security Act (the Act) grants states the authority to enroll
Medicaid beneficiaries on a mandatory basis into managed care entities,
managed care organizations (MCOs) and primary care case managers
(PCCMs). Under this authority, a state can amend its Medicaid state
plan to require certain categories of Medicaid beneficiaries to enroll
in managed care entities without being out of compliance. This template
may be used by states to easily modify their state plans if they choose
to implement the provisions of section 1932(a)(1)(A).
The State Medicaid Agencies will complete the template. CMS will
review the information to determine if the state has met all the
requirements of section 1932(a)(1)(A) and 42 CFR 438.50. If the
requirements are met, CMS will approve the amendment to the state's
title XIX plan giving the state the authority to enroll Medicaid
beneficiaries on a mandatory basis into managed care entities MCOs and
PCCMs. For a state to receive Medicaid funding, there must be an
approved title XIX state plan; Form Number: CMS-10120 (OMB:
[[Page 76989]]
0938-0933); Frequency: Occasionally; Affected Public: State, Local, or
Tribal Governments; Number of Respondents: 56; Total Annual Responses:
10; Total Annual Hours: 100. (For policy questions regarding this
collection contact Camille Dobson at 410-786-7065. For all other issues
call 410-786-1326.)
5. Type of Information Collection Request: Revision of currently
approved collection; Title of Information Collection: Healthcare Common
Procedure Coding System (HCPCS); Use: In October 2003, the Secretary of
Health and Human Services delegated the Center for Medicare and
Medicaid Services (CMS) authority to maintain and distribute HCPCS
Level II Codes. As a result, the National Panel was delineated and CMS
continued with the decision-making process under its current structure,
the CMS HCPCS Workgroup (herein referred to as ``the Workgroup''. CMS'
HCPCS Workgroup is an internal workgroup comprised of representatives
of the major components of CMS, and private insurers, as well as other
consultants from pertinent Federal agencies. Currently the application
intake is paper-based. However, the process has grown and the HCPCS
staff is exploring electronic processes for the collection and storage
of applications. We have received feedback on the nature of the
application; and have streamlined the form into a user-friendly
application. The content of the material is the same, but the questions
have been refined in accordance with comments received from industry
members; and the level of necessity of the information required to
render quality coding decision as determined by the CMS workgroup. The
information on the form is used to update the HCPCS code set. All
information is received and distributed to CMS' HCPCS workgroup and is
reviewed and discussed at workgroup meetings. In turn, CMS' HCPCS
workgroup reaches a decision as to whether a change should be made to
codes in the HCPCS code set. The respondent who submits the application
form can be anyone who has an interest in obtaining a code or modifying
an existing code. However, respondents are usually manufacturers of
products, or consultants on behalf of the manufacturer. Form Number:
CMS-10224 (OMB: 0938-1042; Frequency: Occasionally; Affected
Public: Private Sector, Business and other for-profit and not-for-
profit institutions; Number of Respondents: 300; Total Annual
Responses: 300; Total Annual Hours: 3300. (For policy questions
regarding this collection contact Felicia Eggleston at 410-786-9287 or
Lori Anderson at 410-786-6190. 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: Beneficiary Satisfaction Survey; Use: The Beneficiary
Satisfaction survey is performed to insure that the CMS 1-800-MEDICARE
Helpline contractor is delivering satisfactory service to the Medicare
beneficiaries. It gathers data on several Helpline operations such as
print fulfillment and websites tool hosted on https://www.medicare.gov.
Respondents to the survey are Medicare beneficiaries that have
contacted 1-800-MEDICARE for information on benefits and services. CMS
is seeking approval for additional questions to be added to the
original collection entitled 800-Medicare Beneficiary Satisfaction
survey. The original set of questions was used when placing outbound
calls to callers regarding the service they received when they called
the 800 Medicare Helpline with a Medicare question. The new expanded
collection will include multiple survey methods to measure customer
satisfaction not only with the Beneficiary Contact Center's (BCC's)
handling of issues via telephone, but also the service provided to
beneficiaries when they write a letter regarding their Medicare issue
or use the e-mail and/or web chat services provided by the BCC. The use
of Customer Satisfaction Surveys is critical to the CMS mission to
provide service to beneficiaries that is convenient, accessible,
accurate, courteous, professional and responsive to the needs of
diverse groups. Form Number: CMS-10098 (OMB: 0938-0919);
Frequency: Weekly, Monthly, and Yearly; Affected Public: Individuals
and Households; Number of Respondents: 36,144; Total Annual Responses:
36,144; Total Annual Hours: 6033. (For policy questions regarding this
collection contact Mark Broccolino at 410-786-6128. For all other
issues call 410-786-1326.)
7. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: State Medicaid
Health Information Technology Plan, Planning-Advance Planning Document
and Update, Implementation Advance Planning Document and Update, and
Annual Implementation of Advance Planning Document to Implement Section
4201 of the American Reinvestment and Recovery Act of 2009; Use:
Section 4201 of Recovery Act establishes 100 percent Federal Financial
Participation (FFP) as reimbursement to States for making incentive
payments to providers for meaningful use of certified electronic health
record technology and 90 percent FFP for administering these payments.
Additionally, States are required to conduct oversight of this program
and ensure no duplicate payments; thus, CMS is requiring States to
submit information to CMS for prior approval before drawing down
funding. These documents, if States choose to implement these
flexibilities, will require a collection of information to effectuate
these changes.
The State Medicaid agencies will complete the templates. CMS will
review the information to determine if the State has met all of the
requirements of the Recovery Act provisions the States choose to
implement. If the requirements are met, CMS will approve the amendments
giving the State the authority to implement their Health Information
Technology (HIT) strategy and implementation plans. For a State to
receive Medicaid Title XIX funding, there must be an approved State
Medicaid HIT Plan, Planning Advance Planning Document and
Implementation Advance Planning Document; Form Number: CMS-10292
(OMB: 0938-1088); Frequency: Yearly, Once, Occasionally;
Affected Public: State, Local, or Tribal Governments; Number of
Respondents: 56; Total Annual Responses: 56; Total Annual Hours: 56.
(For policy questions regarding this collection contact Sherry Armstead
at 410-786-4342. For all other issues call 410-786-1326.)
8. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Provider
Enrollment, Chain and Ownership System (PECOS) Security Consent Form;
Use: The primary function of the Medicare enrollment application is to
obtain information about the provider or supplier and whether the
provider or supplier meets Federal and/or State qualifications to
participate in the Medicare program. In addition, the Medicare
enrollment application gathers information regarding the provider or
supplier's practice location, the identity of the owners of the
enrolling organization, and information necessary to establish the
correct claims payment. In establishing a Web based application
process, we allow providers and suppliers the ability to enroll in the
Medicare program via the Internet. For these applicants, no security
consent form is needed to enroll or make a change in their Medicare
enrollment information. These applicants receive complete access to
their own
[[Page 76990]]
enrollments through Internet-based Provider Enrollment, Chain and
Ownership System (PECOS).
In order to allow a provider or supplier to delegate the Medicare
credentialing process to another individual or organization, it is
necessary to establish a Security Consent Form for those providers and
suppliers who choose to have another individual or organization access
their enrollment information and complete enrollments on their behalf.
These users could consist of administrative staff, independent
contractors, or credentialing departments and are represented as
Employer Organizations. Employer Organizations and its members must
request access to enrollment data through a Security Consent Form. The
security consent form replicates business service agreements between
Medicare applicants and organizations providing enrollment services.
We are proposing two different versions of the Security Consent
Form. The form, once signed, mailed and approved, grants an employer
organization or its members access to all current and future enrollment
data for the Medicare provider. Form Number: CMS-10220 (OMB:
0938-1035); Frequency: Occasionally; Affected Public: State, Local, or
Tribal Governments; Number of Respondents: 197,500; Total Annual
Responses: 197,500; Total Annual Hours: 49,375. (For policy questions
regarding this collection contact Alisha Banks at 410-786-0671. 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 February 8, 2011:
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 6, 2010.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 2010-31071 Filed 12-9-10; 8:45 am]
BILLING CODE 4120-01-P
