[Federal Register Volume 70, Number 150 (Friday, August 5, 2005)]
[Notices]
[Pages 45396-45397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15505]



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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 [email protected], 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