Agency Information Collection Activities: Submission for OMB Review; Comment Request, 45396-45397 [05-15505]
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45396
Federal Register / Vol. 70, No. 150 / Friday, August 5, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–220, CMS–R–
273, CMS–10151, CMS–10152, CMS–R–10,
CMS–R–79]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
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), 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 of a currently
approved collection; Title of
Information Collection: HIPAA
Standard Unique Employer Identifier
and Supporting Regulations in 45 CFR
Parts 160 and 162; Form Nos.: CMS–R–
220(OMB # 0938–0874); Use: Section
1173b of Subtitle F of Title II of the
Health Insurance Portability and
Accountability Act of 1996 (Pub. L.
104–191) requires the Secretary of the
Department of Health and Human
Services to adopt standards for unique
health identifiers for individuals,
employers, health plans, and health care
providers. The use of this standard
improves the Medicare and Medicaid
programs, other Federal health programs
and private health programs, by
simplifying the administration of the
system and enabling the efficient
electronic transmission of certain health
information; Frequency: Other—onetime; Affected Public: Business or other
for-profit, Not-for-profit institutions,
Federal Government, and State, Local or
Tribal Government; Number of
Respondents: 2,550,000; Total Annual
AGENCY:
VerDate jul<14>2003
15:34 Aug 04, 2005
Jkt 205001
Responses: 2,550,000; Total Annual
Hours: 1.
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Community
Mental Health Center Site Visit
Assessment Tool and Supporting
Regulations in 42 CFR 410.2; Form No.:
CMS–R–273 (OMB # 0938–0770); Use:
This collection instrument aids CMS in
its efforts to ensure that new and
existing Community Mental Health
Centers (CMHC) are compliant with
Medicare provider requirements, and all
applicable Federal and State
requirements. The collection pertains to
CMHC’s provision of pre-admission
screening to State mental health
facilities and to expanding the
collection tool’s use into other program
areas as a means to screen applicants,
enrollees, and existing providers/
suppliers to ensure their legitimacy to
participate in the Medicare Program;
Frequency: Reporting-Other, upon
initial application or re-enrollment into
the Medicare program; Affected Public:
Business or other for-profit, Not-forprofit institutions, and State, Local or
Tribal Government; Number of
Respondents: 4,731; Total Annual
Responses: 4,731; Total Annual Hours:
20,372.
3. Type of Information Collection
Request: New Collection; Title of
Information Collection: Data Collection
for Medicare Beneficiaries Receiving
Implantable Cardioverter-defibrillators
for Primary Prevention of Sudden
Cardiac Death; Form Nos.: CMS–
10151(OMB # 0938–NEW); Use: CMS
provides coverage for implantable
cardioverter-defibrillators (ICDs) for
secondary prevention of sudden cardiac
death based on extensive evidence
showing that use of ICDs among patients
with a certain set of physiologic
conditions are effective. Accordingly,
CMS considers coverage for ICDs
reasonable and necessary under Section
1862 (a)(1)(A) of the Social Security Act.
However, evidence for use of ICDs for
primary prevention of sudden cardiac
death is less compelling for certain
patients. To encourage responsible and
appropriate use of ICDs, CMS issued a
Decision Memo for Implantable
Defibrillators on January 27, 2005,
indicating that ICDs will be covered for
primary prevention of sudden cardiac
death if the beneficiary is enrolled in
either an FDA-approved category B
Investigational Device Exemption (IDE)
clinical trial (see 42 CFR § 405.201), a
trial under the CMS Clinical Trial Policy
(see NCD Manual § 310.1) or a
qualifying prospective data collection
system (either a practical clinical trial or
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
prospective systematic data collection,
which is sometimes referred to as a
registry).; Frequency: Other—as needed;
Affected Public: Business or other forprofit, Individuals or Households, and
Not-for-profit institutions; Number of
Respondents: 1217; Total Annual
Responses: 50,000; Total Annual Hours:
4167.
4. Type of Information Collection
Request: New Collection; Title of
Information Collection: Data Collection
for Medicare Beneficiaries Receiving
FDG Positron Emissions Tomography
(PET) for Brain, Cervical, Ovarian,
Pancreatic, Small Cell Lung and
Testicular Cancers; Form Nos.: CMS–
10152(OMB # 0938–NEW); Use: In the
Decision Memo #CAG–00181N issued
on January 27, 2005, CMS determined
that the evidence is sufficient to
conclude that for Medicare beneficiaries
receiving FDG positron emission
tomography (PET) for brain, cervical,
ovarian, pancreatic, small cell lung, and
testicular cancers is reasonable and
necessary only when the provider is
participating in and patients are
enrolled in a systematic data collection
project. CMS will consider prospective
data collection systems to be qualified if
they provide assurance that specific
hypotheses are addressed and they
collect appropriate data elements. The
data collection should include baseline
patient characteristics; indications for
the PET scan; PET scan type and
characteristics; FDG PET results; results
of all other imaging studies; facility and
provider characteristics; cancer type,
grade, and stage; long-term patient
outcomes; disease management changes;
and anti-cancer treatment received.;
Frequency: Other—as needed; Affected
Public: Business or other for-profit,
Individuals or Households, and Not-forprofit institutions; Number of
Respondents: 2,000; Total Annual
Responses: 50,000; Total Annual Hours:
4167.
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Information
Collection Requirements Contained in
BPD–718: Advance Directives (Medicare
and Medicaid) and Supporting
Regulations in 42 CFR Sections 417.436,
417.801, 422.128, 430.12, 431.20,
431.107, 438.6, 440.170, 483.10, 484.10,
and 489.102; Form No.: CMS–R–10
(OMB# 0938–0610); Use: Steps have
been taken at both the Federal and State
level, to afford greater opportunity for
the individual to participate in
decisions made concerning the medical
treatment to be received by an adult
patient in the event that the patient is
unable to communicate to others, a
E:\FR\FM\05AUN1.SGM
05AUN1
Federal Register / Vol. 70, No. 150 / Friday, August 5, 2005 / Notices
preference about medical treatment. The
individual may make his preference
known through the use of an advance
directive, which is a written instruction
prepared in advance, such as a living
will or durable power of attorney. This
information is documented in a
prominent part of the individual’s
medical record. Advance directives as
described in the Patient SelfDetermination Act (enacted in 1991)
have increased the individual’s control
over decisions concerning medical
treatment. The advance directives
requirement was enacted because
Congress wanted individuals to know
that they have a right to make health
care decisions and to refuse treatment
even when they are unable to
communicate.; Frequency: On occasion;
Affected Public: Business or other forprofit; Number of Respondents: 33,096;
Total Annual Responses: 33,096; Total
Annual Hours: 924,120.
6. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Payment
Adjustment for Sole Community
Hospitals and Supporting Regulations in
42 CFR Section 412.92; Form No.: CMS–
R–79 (OMB# 0938–0477); Use: This
collection provides that if a hospital that
is classified as a sole community
hospital (SCH) experiences, due to
circumstances beyond its control, a
decrease of more than 5 percent in its
total number of discharges compared to
the immediately preceding cost
reporting period, the hospital may apply
for a payment adjustment. To qualify for
this adjustment to its payment rate an
SCH must submit documentation,
including cost information as requested
by CMS, to the intermediary; Frequency:
On occasion; Affected Public: Not-forprofit institutions, Business or other forprofit, and State, Local or Tribal
Government; Number of Respondents:
40; Total Annual Responses: 40; Total
Annual Hours: 160.
To obtain copies of the supporting
statement and any related forms for
these paperwork collections referenced
above, access CMS Web site address at
https://www.cms.hhs.gov/regulations/
pra/, 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.
Written comments and
recommendations for these information
collections will be considered if they are
mailed within 30 days of this notice
directly to the OMB desk officer: OMB
Human Resources and Housing Branch,
Attention: Christopher Martin, New
VerDate jul<14>2003
15:34 Aug 04, 2005
Jkt 205001
Executive Office Building, Room 10235,
Washington, DC 20503.
Dated: July 29, 2005.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 05–15505 Filed 8–4–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Privacy Act of 1974; Report of a New
System of Records
Department of Health and
Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a New System of
Records.
AGENCY:
SUMMARY: In accordance with the
requirements of the Privacy Act of 1974,
we are proposing to establish a new
system titled ‘‘Federal Reimbursement
of Emergency Health Services Furnished
to Undocumented Aliens (Section
1011),’’ System No. 09–07–0546. The
system will contain enrollment and
payment request information, in support
of a short-term program which pays
hospitals, certain physicians, and
ambulance providers (including Indian
Health Service (IHS) facilities whether
operated by the IHS or by an Indian
Tribe or tribal organization) for their
otherwise un-reimbursed costs of
services provided under the provisions
of section 1867 (Emergency Medical
Treatment and Labor Act) (EMTALA) of
the Social Security Act (the Act) and
related hospital inpatient and outpatient
services and ambulance services
furnished to undocumented aliens,
aliens paroled into the United States
(U.S.) at a U. S. port of entry for the
purposes of receiving such services, and
Mexican citizens permitted temporary
entry to the U.S. for not more than 30
days under the authority of a biometric
machine readable border crossing
identification card (also referred to as a
‘‘laser visa’’) issued in accordance with
the requirements of regulations
prescribed under the Immigration and
Nationality Act. This system is being
established under provisions of Section
1011 of the Medicare Prescription Drug,
Improvement and Modernization Act of
2003 Modernization Act of 2003
(MMA).
The primary purpose of the system is
to maintain information collected on
individuals who submit an enrollment
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
45397
application and make payment requests
associated with Section 1011 of the
MMA, and other information designed
to support the enrollment, claims
payment, and research reporting
functions of the Section 1011 program.
Information retrieved from this system
will also be disclosed to: (1) Support
regulatory, payment activities, and
policy functions performed within the
agency or by a designated contractor or
consultant; (2) combat fraud and abuse
in certain health benefits programs; (3)
assist another Federal or state agency
with information to enable such agency
to administer a Federal health benefits
program, or to enable such agency to
fulfill a requirement of a Federal statute
or regulation that implements a health
benefits program funded in whole or in
part with Federal; (4) funds support
constituent requests made to a
Congressional representative; and, (5)
support litigation involving the agency.
We have provided background
information about the new system in the
SUPPLEMENTARY INFORMATION section
below. Although the Privacy Act
requires only that the ‘‘routine use’’
portion of the system be published for
comment, CMS invites comments on all
portions of this notice. See DATES
section for comment period.
DATES: CMS filed a new system report
with the Chair of the House Committee
on Government Reform and Oversight,
the Chair of the Senate Committee on
Governmental Affairs, and the
Administrator, Office of Information
and Regulatory Affairs, Office of
Management and Budget (OMB) on July
21, 2005. In any event, we will not
disclose any information under a
routine use until 40 days after
publication. We may defer
implementation of this system or one or
more of the routine use statements listed
below if we receive comments that
persuade us to defer implementation.
ADDRESSES: The public should address
comments to: CMS Privacy Officer,
Division of Privacy Compliance Data
Development (DPCDD), CMS, Mail Stop
N2–04–27, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
Comments received will be available for
review at this location, by appointment,
during regular business hours, Monday
through Friday from 9 a.m.–3 p.m.,
eastern time zone.
FOR FURTHER INFORMATION CONTACT:
Section 1011 Project Officer, Center for
Medicare Management, CMS, Mailstop
C4–10–07, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
SUPPLEMENTARY INFORMATION: Sections
1866(a)(1)(I), 1866(a)(1)(N), and 1867 of
the Act impose specific obligations on
E:\FR\FM\05AUN1.SGM
05AUN1
]]>Agencies
[Federal Register Volume 70, Number 150 (Friday, August 5, 2005)]
[Notices]
[Pages 45396-45397]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15505]
[[Page 45396]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-220, CMS-R-273, CMS-10151, CMS-10152, CMS-
R-10, CMS-R-79]
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
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 of a currently
approved collection; Title of Information Collection: HIPAA Standard
Unique Employer Identifier and Supporting Regulations in 45 CFR Parts
160 and 162; Form Nos.: CMS-R-220(OMB 0938-0874); Use:
Section 1173b of Subtitle F of Title II of the Health Insurance
Portability and Accountability Act of 1996 (Pub. L. 104-191) requires
the Secretary of the Department of Health and Human Services to adopt
standards for unique health identifiers for individuals, employers,
health plans, and health care providers. The use of this standard
improves the Medicare and Medicaid programs, other Federal health
programs and private health programs, by simplifying the administration
of the system and enabling the efficient electronic transmission of
certain health information; Frequency: Other--one-time; Affected
Public: Business or other for-profit, Not-for-profit institutions,
Federal Government, and State, Local or Tribal Government; Number of
Respondents: 2,550,000; Total Annual Responses: 2,550,000; Total Annual
Hours: 1.
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Community Mental
Health Center Site Visit Assessment Tool and Supporting Regulations in
42 CFR 410.2; Form No.: CMS-R-273 (OMB 0938-0770); Use: This
collection instrument aids CMS in its efforts to ensure that new and
existing Community Mental Health Centers (CMHC) are compliant with
Medicare provider requirements, and all applicable Federal and State
requirements. The collection pertains to CMHC's provision of pre-
admission screening to State mental health facilities and to expanding
the collection tool's use into other program areas as a means to screen
applicants, enrollees, and existing providers/suppliers to ensure their
legitimacy to participate in the Medicare Program; Frequency:
Reporting-Other, upon initial application or re-enrollment into the
Medicare program; Affected Public: Business or other for-profit, Not-
for-profit institutions, and State, Local or Tribal Government; Number
of Respondents: 4,731; Total Annual Responses: 4,731; Total Annual
Hours: 20,372.
3. Type of Information Collection Request: New Collection; Title of
Information Collection: Data Collection for Medicare Beneficiaries
Receiving Implantable Cardioverter-defibrillators for Primary
Prevention of Sudden Cardiac Death; Form Nos.: CMS-10151(OMB
0938-NEW); Use: CMS provides coverage for implantable cardioverter-
defibrillators (ICDs) for secondary prevention of sudden cardiac death
based on extensive evidence showing that use of ICDs among patients
with a certain set of physiologic conditions are effective.
Accordingly, CMS considers coverage for ICDs reasonable and necessary
under Section 1862 (a)(1)(A) of the Social Security Act. However,
evidence for use of ICDs for primary prevention of sudden cardiac death
is less compelling for certain patients. To encourage responsible and
appropriate use of ICDs, CMS issued a Decision Memo for Implantable
Defibrillators on January 27, 2005, indicating that ICDs will be
covered for primary prevention of sudden cardiac death if the
beneficiary is enrolled in either an FDA-approved category B
Investigational Device Exemption (IDE) clinical trial (see 42 CFR Sec.
405.201), a trial under the CMS Clinical Trial Policy (see NCD Manual
Sec. 310.1) or a qualifying prospective data collection system (either
a practical clinical trial or prospective systematic data collection,
which is sometimes referred to as a registry).; Frequency: Other--as
needed; Affected Public: Business or other for-profit, Individuals or
Households, and Not-for-profit institutions; Number of Respondents:
1217; Total Annual Responses: 50,000; Total Annual Hours: 4167.
4. Type of Information Collection Request: New Collection; Title of
Information Collection: Data Collection for Medicare Beneficiaries
Receiving FDG Positron Emissions Tomography (PET) for Brain, Cervical,
Ovarian, Pancreatic, Small Cell Lung and Testicular Cancers; Form Nos.:
CMS-10152(OMB 0938-NEW); Use: In the Decision Memo
CAG-00181N issued on January 27, 2005, CMS determined that the
evidence is sufficient to conclude that for Medicare beneficiaries
receiving FDG positron emission tomography (PET) for brain, cervical,
ovarian, pancreatic, small cell lung, and testicular cancers is
reasonable and necessary only when the provider is participating in and
patients are enrolled in a systematic data collection project. CMS will
consider prospective data collection systems to be qualified if they
provide assurance that specific hypotheses are addressed and they
collect appropriate data elements. The data collection should include
baseline patient characteristics; indications for the PET scan; PET
scan type and characteristics; FDG PET results; results of all other
imaging studies; facility and provider characteristics; cancer type,
grade, and stage; long-term patient outcomes; disease management
changes; and anti-cancer treatment received.; Frequency: Other--as
needed; Affected Public: Business or other for-profit, Individuals or
Households, and Not-for-profit institutions; Number of Respondents:
2,000; Total Annual Responses: 50,000; Total Annual Hours: 4167.
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Information
Collection Requirements Contained in BPD-718: Advance Directives
(Medicare and Medicaid) and Supporting Regulations in 42 CFR Sections
417.436, 417.801, 422.128, 430.12, 431.20, 431.107, 438.6, 440.170,
483.10, 484.10, and 489.102; Form No.: CMS-R-10 (OMB 0938-
0610); Use: Steps have been taken at both the Federal and State level,
to afford greater opportunity for the individual to participate in
decisions made concerning the medical treatment to be received by an
adult patient in the event that the patient is unable to communicate to
others, a
[[Page 45397]]
preference about medical treatment. The individual may make his
preference known through the use of an advance directive, which is a
written instruction prepared in advance, such as a living will or
durable power of attorney. This information is documented in a
prominent part of the individual's medical record. Advance directives
as described in the Patient Self-Determination Act (enacted in 1991)
have increased the individual's control over decisions concerning
medical treatment. The advance directives requirement was enacted
because Congress wanted individuals to know that they have a right to
make health care decisions and to refuse treatment even when they are
unable to communicate.; Frequency: On occasion; Affected Public:
Business or other for-profit; Number of Respondents: 33,096; Total
Annual Responses: 33,096; Total Annual Hours: 924,120.
6. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Payment
Adjustment for Sole Community Hospitals and Supporting Regulations in
42 CFR Section 412.92; Form No.: CMS-R-79 (OMB 0938-0477);
Use: This collection provides that if a hospital that is classified as
a sole community hospital (SCH) experiences, due to circumstances
beyond its control, a decrease of more than 5 percent in its total
number of discharges compared to the immediately preceding cost
reporting period, the hospital may apply for a payment adjustment. To
qualify for this adjustment to its payment rate an SCH must submit
documentation, including cost information as requested by CMS, to the
intermediary; Frequency: On occasion; Affected Public: Not-for-profit
institutions, Business or other for-profit, and State, Local or Tribal
Government; Number of Respondents: 40; Total Annual Responses: 40;
Total Annual Hours: 160.
To obtain copies of the supporting statement and any related forms
for these paperwork collections referenced above, access CMS Web site
address at https://www.cms.hhs.gov/regulations/pra/, 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.
Written comments and recommendations for these information
collections will be considered if they are mailed within 30 days of
this notice directly to the OMB desk officer: OMB Human Resources and
Housing Branch, Attention: Christopher Martin, New Executive Office
Building, Room 10235, Washington, DC 20503.
Dated: July 29, 2005.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 05-15505 Filed 8-4-05; 8:45 am]
BILLING CODE 4120-01-P
