[Federal Register Volume 72, Number 202 (Friday, October 19, 2007)]
[Notices]
[Pages 59293-59294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20649]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-102, 105 and CMS-10238]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Department of Health 
and Human 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: 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.

[[Page 59294]]

    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.
    As a result of comments received during the 60-day comment period 
from the notice that published July 27, 2007 (72 FR 41328), we revised 
the information collection. The revisions include clarified language, 
corrected time point guidance, improved alignment with items in the 
CARE tool, improved skip patterns that allow clinicians to bypass 
questions not relevant to patients, and the addition of response 
options that allow clinicians to document patient improvement. It is 
the opinion of CMS that these revisions have resulted in an improved 
tool that addresses many of the concerns expressed by commenters, with 
no increase in burden. 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. 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 by the OMB desk 
officer at the address below, no later than 5 p.m. on November 19, 
2007.

OMB Human Resources and Housing Branch, Attention: Katherine Astrich, 
New Executive Office Building, Room 10235, Washington, DC 20503, Fax 
Number: (202) 395-6974.

    Dated: October 11, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
 [FR Doc. E7-20649 Filed 10-18-07; 8:45 am]
BILLING CODE 4120-01-P