[Federal Register: August 5, 2005 (Volume 70, Number 150)]
[Notices]
[Page 45396-45397]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05au05-53]
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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 http://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