[Federal Register Volume 72, Number 144 (Friday, July 27, 2007)]
[Notices]
[Pages 41328-41329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-3647]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-249, CMS-10238, CMS-102, 105, CMS-10243 and 
CMS-10244]


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 of a currently 
approved collection; Title of Information Collection: Hospice Cost and 
Data Report and supporting regulations 42 CFR 413.20 and 42 CFR 413.24; 
Use: In accordance with sections 1815(a), 1833(e), 1861(v)(A)(ii) and 
1881(b)(2)(B) of the Social Security Act, providers of services in the 
Medicare program are required to submit annual information to receive 
reimbursement for health care services provided to Medicare 
beneficiaries. In addition, 42 CFR 413.20(b) requires that cost reports 
be filed with the provider's fiscal intermediary/Medicare 
Administrative Contractor (FI/MAC). The functions of the FI/MAC are 
described in section 1816 of the Social Security Act. The Center for 
Medicare and Medicaid Services will use the information from providers 
for rate evaluations for the Prospective Payment System. Form Number: 
CMS-R-249 (OMB: 0938-0758); Frequency: Reporting: Yearly; 
Affected Public: Business or other for-profit; Number of Respondents: 
1938; Total Annual Responses: 1938; Total Annual Hours: 341,088.
    2. Type of Information Collection Request: New collection; Title of 
Information Collection: Testing of Revised OASIS Instrument for Home 
Health Quality Measures & Data Analysis; Use: Medicare-certified home 
health agencies (HHAs) must meet the Conditions of Participation (COPs) 
as set forth at 42 CFR part 484 and 488. Since 1999, the COPs have 
mandated that HHAs use the ``Outcome and Assessment Information Set'' 
(OASIS) data set when evaluating adult, non-maternity patients 
receiving skilled services. The OASIS is a patient-specific, 
comprehensive assessment that identifies each patient's need for home 
care and that meets the patient's medical, nursing, rehabilitative, 
social and discharge planning needs.
    Since OASIS data collection was mandated in 1999, CMS has been 
systematically collecting input on ways to improve the OASIS instrument 
and reduce the burden of the collection effort. In 2002, CMS introduced 
the ``reduced-burden'' OASIS that was a product of the Secretary's 
Regulatory Reform Advisory Committee to help guide HHS' broader efforts 
to streamline unnecessarily burdensome or inefficient regulations that 
interfere with the quality of health care. Since the 2002 revision, CMS 
has continued to solicit input on potential refinements and 
enhancements of the OASIS instrument from HHAs, industry associations, 
consumer representatives, researchers and other stakeholders.
    Abt Associates and their subcontractor UCHSC were awarded a 
contract by CMS in September 2006 to continue the process of refining 
the OASIS data set, as well as for the testing of the instrument and 
analysis of the impact of proposed changes. Under this contract, 
researchers from Abt Associates, University of Colorado Health Sciences 
Center (UCHSC), and Case Western Reserve University have assisted CMS 
in carrying out the revisions based on the input described in the 
previous section. Changes to the OASIS instrument include the following 
removal and revision of items:
     Elimination of 7 original OASIS items not required for 
payment, quality or risk adjustment;
     Replacement of 44 original OASIS items with items that are 
revised and/or simplified to respond to industry concerns by increasing 
clarity and user-friendliness, and/or reducing complexity and burden 
(e.g., removal of ``prior status'' assessment for all Activity of Daily 
Living (ADL) and Instrumental Activity of Daily Living (IADL) items).
    The revised OASIS also includes the addition of the following 
process items to support evidence-based practices:
     A total of 7 process items to be collected only at Start 
of Care/Resumption of Care, 4 of which are to be asked seasonally 
(e.g.; flu vaccine);
     A total of 10 process items to be collected only at 
Follow-up, Transfer or Discharge, either seasonally or on a small 
subpopulation;
     A total of 13 process items to be collected at all OASIS 
time points, 6 of which are to be collected on a small subpopulation.
    We estimate the elimination, simplification and revision of 
existing OASIS items will have a burden impact equivalent to the 
complete elimination of 19 items. Since many of the process items will 
be collected only on small subpopulations or during specific months of 
the year, we estimate the impact of the addition of these items on 
burden to be equivalent to the addition of 20 items. Therefore, total 
impact of proposed OASIS revisions, including the elimination, revision 
and addition of items, changes the estimated burden of the OASIS very 
little while incorporating process measures needed to support evidence-
based practices across the post-acute care spectrum. Form Number: CMS-
10238 (OMB: 0938-NEW); Frequency: Reporting: One-time; 
Affected Public: Private Sector--Business or other for-profit and Not-
for-profit institutions; Number of Respondents: 11; Total Annual 
Responses: 11; Total Annual Hours: 173.58.
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Clinical 
Laboratory Improvement Amendment (CLIA) Budget Workload Reports and 
Supporting Regulations Contained in 42 CFR 493.1-.2001; Use: 
Information collected will be used by CMS in determining the amount of 
Federal Reimbursement for compliance surveys. Use of the information 
includes program evaluation, audit, budget formulation and budget 
approval; Form Number: CMS-102, 105 (OMB: 0938-0599); 
Frequency: Reporting: Quarterly; Affected Public: State, Local or 
Tribal Governments; Number of Respondents: 50; Total Annual Responses: 
550; Total Annual Hours: 4,500.
    4. Type of Information Collection Request: New collection; Title of 
Information Collection: Data Collection for Administering the Medicare 
Continuity Assessment Record and Evaluation (CARE) Instrument; Use: The 
Medicare Continuity Assessment Record and Evaluation (CARE) is a 
uniform

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patient assessment instrument designed to measure differences in 
patient severity, resource utilization, and outcomes for patients in 
acute and post-acute care settings. This tool will be used to (1) 
Standardize program information on Medicare beneficiaries' acuity at 
discharge from acute hospitals, (2) document medical severity, 
functional status and other factors related to outcomes and resource 
utilization at admission, discharge, and interim times during post 
acute treatment, and (3) understand the relationship between severity 
of illness, functional status, social support factors, and resource 
utilization. The CARE instrument will be used in the Post-Acute Care 
(PAC) Payment Reform Demonstration program mandated by Section 5008 of 
the Deficit Reduction Act of 2005 to develop payment groups that 
reflect patient severity and related cost and resource use across post 
acute settings. Specifically, the data collected using the CARE 
instrument during the Post-Acute Care Payment Demonstration will be 
used by CMS to develop a setting neutral post-acute care payment model 
as mandated by Congress. The data will be used to characterize patient 
severity of illness and level of function in order to predict resource 
use, post-acute care discharge placement, and beneficiary outcomes. CMS 
will use the data from the CARE instrument to examine the degree to 
which the items on the instrument can be used to predict beneficiary 
resource use and outcomes. Form Number: CMS-10243 (OMB: 0938-
NEW); Frequency: Reporting--Daily; Affected Public: Private Sector--
Business or other for-profit and Not-for-profit institutions; Number of 
Respondents: 388; Total Annual Responses: 244,292; Total Annual Hours: 
179,341.
    5. Type of Information Collection Request: New Collection; Title of 
Information Collection: Medicaid State Program Integrity Assessment 
(SPIA); Use: Under the provisions of the Deficit Reduction Act (DRA) of 
2005, Congress directed CMS to establish the Medicaid Integrity Program 
(MIP), CMS' first national strategy to combat Medicaid fraud, waste, 
and abuse. CMS has two broad responsibilities under the MIP:
    (1) Reviewing the actions of individuals or entities providing 
services or furnishing items under Medicaid; conducting audits of 
claims submitted for payment; identifying overpayments; and educating 
providers and others on payment integrity and quality of care; and
    (2) Providing effective support and assistance to States to combat 
Medicaid fraud, waste, and abuse.
    In order to fulfill the second of these requirements, CMS plans to 
develop a Medicaid State Program Integrity Assessment (SPIA) system. 
CMS is seeking approval from the Office of Management and Budget (OMB) 
to collect information from the States on an annual basis for input 
into a national SPIA system. Through the SPIA system, CMS will identify 
current Medicaid program integrity (PI) information, develop profiles 
for each State based on these data, determine areas to provide States 
with technical support and assistance, and use the data to develop 
performance measures to assess States' performance in an ongoing 
manner; Form Number: CMS-10244 (OMB: 0938-NEW); Frequency: 
Reporting: Yearly; Affected Public: State, Local or Tribal Governments; 
Number of Respondents: 56; Total Annual Responses: 56; Total Annual 
Hours: 1,400.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995, 
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.
    To be assured consideration, comments and recommendations for the 
proposed information collections must be received at the address below, 
no later than 5 p.m. on September 25, 2007.
    CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development--C, Attention: Bonnie L. Harkless, 
Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

    Dated: July 18, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 07-3647 Filed 7-26-07; 8:45 am]
BILLING CODE 4120-01-P