03-12227. Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:

Centers for Medicare and 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 and Medicaid Services (CMS) (formerly known as the Health Care Financing Administration (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 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: Limitation on Liability and Information Collection Requirements Referenced in 42 CFR 411.404, 411.406, and 411.408; Form No.: CMS-R-77) (OMB# 0938-0465); Use: The Medicare program requires to provide written notification of noncovered services to beneficiaries by the providers, practitioners and suppliers. The notification gives the beneficiary, provider, practitioner or supplier knowledge that Medicare will not pay for items or services mentioned in the notification. After this notification, any future claim for the same or similar services will not be paid by the program and the affected parties will be liable for the noncovered services.; Frequency: Other: as needed; Affected Public: Individuals or Households; Number of Respondents: 900,898; Total Annual Responses: 3,603,592; Total Annual Hours: 300,299.

2. Type of Information Collection Request: Reinstatement, without change, of a previously approved collection for which approval has expired; Title of Information Collection: Medicare/Medicaid Hospital Survey Report Form and Supporting Regulations in 42 CFR 482.2 through 482.57; Form No.: CMS-1537 (OMB# 0938-0382); Use: Section 1861(e) of the Social Security Act (the Act) provides that hospitals participating in Medicare under the Act must meet specific requirements. These requirements are presented as Condition of Participation. State agencies must determine compliance with these conditions through the use of this report form.; Frequency: Other: 3-5 years; Affected Public: State, Local, or Tribal Government, Business or other for-profit, Not-for-profit institutions; Number of Respondents: 3323; Total Annual Responses: 3323; Total Annual Hours: 553.

3. Type of Information Collection Request: New collection; Title of Information Collection: Pharmacy Plus Template for Low Income Seniors under Medicaid; Form No.: CMS-10067 (OMB# 0938-0889); Use: The template for the Pharmacy Plus program for low income seniors under Medicaid will enable states to apply, via a standard format, to provide a drug benefit to elderly recipients; use of this format will expedite the process of obtaining CMS review and approval of an application; Frequency: Other: 3 years after initial submission for the 1915(c) waiver; 5 years after initial submission for the 1115 demonstration; Affected Public: State Government; Number of Respondents: 51; Total Annual Responses: 25; Total Annual Hours: 115.

4. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Health Plan Employer Data and Information Set (HEDIS) and Health Outcome Survey (HOS) and supporting regulations at 42 CFR 422.152; Form No.: CMS-R-200) (OMB# 0938-0701); Use: The Centers for Medicare and Medicaid Services (formerly HCFA) collects quality performance measures in order to hold the Medicare managed care industry accountable for the care being delivered, to enable quality improvement, and to provide quality information to Medicare beneficiaries in order to promote informed choice. It is critical to CMS's mission that we collect and disseminate information that will help beneficiaries choose among health plans, contribute to improved quality of care through identification of improvement opportunities, and assist CMS in carrying out its oversight and purchasing responsibilities.; Frequency: Annually; Affected Public: Business or other for-profit, Not-for-profit institutions, and Individuals or Households; Number of Respondents: 166,709; Total Annual Responses: 70,992; Total Annual Hours: 498,436.

5. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Expanded Coverage for Diabetes Outpatient Self-Management Training Services and Supporting Regulations Contained in 42 CFR 410.141-410.145 and 414.63.; Form No.: CMS-R-247) (OMB# 0938-0818); Use: 42 CFR 410.141-410.145 and 414.63 provide for uniform coverage of diabetes outpatient self-management training services. These services include educational and training services furnished to a beneficiary with diabetes by an entity approved to furnish the services. The physician or qualified nonphysician practitioner treating the beneficiary's diabetes certifies that these services are needed as part of a comprehensive plan of care. The regulations set forth the quality standards that an entity is required to meet in order to participate in furnishing diabetes outpatient self-management training services.; Frequency: On occasion; Affected Public: Business or other for-profit; Number of Respondents: 1708; Total Annual Responses: 6832; Total Annual Hours: 53,013.5.

6. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Home Health Agency Survey and Deficiencies Report, Home Health Functional Assessment Instrument and Supporting Regulations in 42 CFR Part 484.1—484.52; Form No.: CMS-1515/1572 (OMB# 0938-0355); Use: In order to participate in the Medicare program as a Home Health Agency (HHA) provider, the HHA must meet Federal Standards. These forms are used to record information about patients' health and provider compliance with requirements; Frequency: Annually; Affected Public: Business or other for-profit, Not-for-profit institutions; Number of Respondents: 7,000; Total Annual Responses: 14,000; Total Annual Hours: 14,000.

7. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Post Laboratory Survey Questionnaire—Laboratory, and Supporting Regulations in 42 CFR 493; Form No.: CMS-668B (OMB# 0938-0653); Use: To provide an opportunity and a mechanism for CLIA laboratories surveyed by CMS or CMS” agent to express their satisfaction and concerns about the CLIA survey process; Frequency: Biennially; Affected Public: Business or other for-profit, Not-for-profit institutions; Number of Respondents: 22,500; Total Annual Responses: 11,250; Total Annual Hours: 2,813.

To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS's Web Site address at http://cms.hhs.gov/​regulations/​pra/​default.asp,, 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]. Written comments and recommendations for the proposed information collections must be mailed within 60 days of this notice directly to the CMS Paperwork Clearance Officer designated at the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development and Issuances, Attention: Dawn Willinghan, Room: C5-14-03, 7500 Security Boulevard, Baltimore, Maryland 21244-1850

Dated: May 8, 2003.

Dawn Willinghan,

CMS Reports Clearance Officer, Division of Regulations Development and Issuances, Office of Strategic Operations and Strategic Affairs.