E7-20649. 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.

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 [e-mail], or call the Reports Clearance Office on [phone].

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: [phone].

Dated: October 11, 2007.

Michelle Shortt,

Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.