Agency Information Collection Activities; Proposals, Submissions, and Approvals

Federal Register: June 5, 2009 (Volume 74, Number 107)

Notices

Page 27040-27042

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr05jn09-63

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Document Identifier: CMS-10133, CMS-10279, CMS-250-254, CMS-10277,

CMS-10157 and CMS-10273

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

Page 27041

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: Competitive

Acquisition Program (CAP) for Medicare Part B Drugs: Vendor Application and Bid Form; Use: Section 303(d) of the Medicare Modernization Act

(MMA) requires the implementation of a competitive acquisition program for Medicare Part B drugs and biologicals not paid on a cost or prospective payment system basis. The CAP is an alternative to the

Average Sales Price (ASP or ``buy and bill'') method of acquiring many

Part B drugs and biologicals administered incident to a physician's services. The CAP Vendor Application and Bid Form, is used by bidders to provide a response to CMS' solicitation for approved CAP vendor bids and to submit their bid prices for CAP drugs. Though the program is currently on hold and a timeline for the resumption of the CAP has not been established, the CAP Vendor Application and Bid Form will be required to conduct the next round of vendor bidding. Form Number: CMS- 10133 (OMB: 0938-0955); Frequency: Reporting--Occasionally;

Affected Public: Private Sector; Business or other for-profits; Number of Respondents: 10; Total Annual Responses: 10; Total Annual Hours: 1.

(For policy questions regarding this collection contact Bonny Dahm at 410-786-4006. For all other issues call 410-786-1326.) 2. Type of Information Collection Request: New collection; Title of

Information Collection: Ambulatory Surgical Center Conditions for

Coverage; Form Number: CMS-10279 (OMB: 0938-New); Use: The

Ambulatory Surgical Center (ASC) Conditions for Coverage (CfCs) focus on a patient-centered, outcome-oriented, and transparent processes that promote, quality patient care. The CfCs are designed to ensure that each facility has properly trained staff to provide the appropriate type and level of care for that facility and provide a safe physical environment for patients. The CfCs are used by Federal or State surveyors as a basis for determining whether an ASC qualifies for approval or re-approval under Medicare. CMS and the healthcare industry believe that the availability to the facility of the type of records and general content of records, which this regulation specifies, is standard medical practice and is necessary in order to ensure the well- being and safety of patients and professional treatment accountability.

Frequency: Recordkeeping and Reporting--One time; Affected Public:

Business or other for-profit, Not-for-profit institutions; Number of

Respondents: 5,100; Total Annual Responses: 5,100; Total Annual Hours: 193,800. (For policy questions regarding this collection contact

Jacqueline Morgan at 410-786-4282. For all other issues call 410-786- 1326.) 3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare

Secondary Payer Information Collection and Supporting Regulations in 42

CFR 411.25, 489.2, and 489.20; Form Number: CMS 250-254 (OMB: 0938-0214); Use: Medicare Secondary Payer Information (MSP) is essentially the same concept known in the private insurance industry as coordination of benefits, and refers to those situations where Medicare does not have primary responsibility for paying the medical expenses of a Medicare beneficiary. Medicare Fiscal Intermediaries, Carriers, and now Part D plans, need information about primary payers in order to perform various tasks to detect and process MSP cases and make recoveries. MSP information is collected at various times and from numerous parties during a beneficiary's membership in the Medicare

Program. Collecting MSP information in a timely manner means that claims are processed correctly the first time, decreasing the costs associated with adjusting claims and recovering mistaken payments.

Frequency: Reporting--On occasion; Affected Public: Individuals or

Households, Business or other for-profit, Not-for-profit institutions;

Number of Respondents: 143,070,217; Total Annual Responses: 143,070,217; Total Annual Hours: 1,788,057. (For policy questions regarding this collection contact John Albert at 410-786-7457. For all other issues call 410-786-1326.) 4. Type of Information Collection Request: New collection; Title of

Information Collection: Hospice Conditions of Participation and

Supporting Regulations in 42 CFR 418.52, 418.54, 418.56, 418.58, 418.60, 418.64, 418.66, 418.70, 418.72, 418.74, 418.76, 418.78, 418.100, 418.106, 4118.108, 418.110, 418.112, and 418.114; Use: The

Conditions of Participation and accompanying requirements are used by

Federal or State surveyors as a basis for determining whether a hospice qualifies for approval or re-approval under Medicare. The healthcare industry and CMS believe that the availability to the hospice of the type of records and general content of records, which the final rule

(72 FR 32088) specifies, is standard medical practice, and is necessary in order to ensure the well-being and safety of patients and professional treatment accountability. Form Number: CMS-10277

(OMB: 0938-New); Frequency: Reporting and Recordkeeping--

Yearly; Affected Public: Business or other for-profit and Not-for- profit institutions; Number of Respondents: 2,872; Total Annual

Responses: 1,808,345; Total Annual Hours: 2,152,396. (For policy questions regarding this collection contact Danielle Shearer at 410- 786-6617. For all other issues call 410-786-1326.) 5. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: CMS Real-time

Eligibility Agreement and Access Request; Form Number: CMS-10157

(OMB: 0938-0960); Use: Federal law requires that CMS take precautions to minimize the security risk to Federal information systems. Accordingly, CMS is requiring that trading partners who wish to conduct the eligibility transaction on a real-time basis to access

Medicare beneficiary information provide certain assurances as a condition of receiving access to the Medicare database for the purpose of conducting eligibility verification. Health care providers, clearinghouses, and health plans that wish access to the Medicare database are required to complete this form. The information will be used to assure that those entities that access the Medicare database are aware of applicable provisions and penalties. Frequency:

Recordkeeping and Reporting--One time; Affected Public: Business or other for-profit, Not-for-profit institutions; Number of Respondents: 2,000; Total Annual Responses: 500; Total Annual Hours: 500. (For policy questions regarding this collection contact Vivian Rogers at 410-786-8142. For all other issues call 410-786-1326.) 6. Type of Information Collection Request: New collection; Title of

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Information Collection: Evaluation of the Medicare Care Management

Performance Demonstration (MCMP) and the Electronic Health Records

Demonstration (EHRD); Use: The MCMP demonstration was authorized under

Section 649 of the Medicare Prescription Drug, Improvement, and

Modernization Act of 2003. This is a three year pay for performance demonstration with physicians to promote the adoption and use of health information technology (HIT) to improve the quality of care for eligible chronically ill Medicare beneficiaries. MCMP targets small to medium sized primary care practices with up to 10 physicians. Practices must provide care to at least 50 Medicare beneficiaries. Physicians will receive payments for meeting or exceeding performance standards for quality of care. They will also receive an additional incentive payment for electronic submission of performance measures via their electronic health record (EHR) system. These payments are in addition to their normal payments for providing service to Medicare beneficiaries. The Office System Survey (OSS) will be used to assess progress of physician practices in implementation and use of EHRs and related HIT functionalities.

The EHR demonstration is authorized under Section 402 of the

Medicare Waiver Authority. The goal of this five year pay for performance demonstration is to foster the implementation and adoption of EHRs and HIT in order to improve the quality of care provided by physician practices. The EHRD expands upon the MCMP Demonstration and will test whether performance-based financial incentives (1) increase physician practices' adoption and use of electronic health records

(EHRs), and (2) improve the quality of care that practices deliver to chronically ill patients. The EHRD targets small to medium sized primary care practices with up to 20 physicians. Practices must provide care to at least 50 Medicare beneficiaries. Approximately 800 practices will be enrolled in the demonstration across four sites. Practices will be randomly assigned to a treatment and a control group. The OSS will be used to assess progress of physician practices in implementation and use of EHRs and related HIT functionalities, and to determine incentive payments for treatment practices. In-person and telephone discussions with community partners and physician practices will be used to learn about practices' experiences and strategies in adopting and using EHRs, as well as the factors that help or hinder their efforts. Refer to the supporting document ``High-Level Summary of Changes'' for a list of changes. Form Number: CMS-10273 (OMB0938-New); Frequency:

Annually, Biennially and Once; Affected Public: Business or other for- profit; Number of Respondents: 4,123; Total Annual Responses: 1,659;

Total Annual Hours: 934. (For policy questions regarding this collection contact Lorraine Johnson at 410-786-9457. For all other issues call 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 July 6, 2009.

OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk

Officer, Fax Number: (202) 395-6974, E-mail: OIRA_ submission@omb.eop.gov.

Dated: May 28, 2009.

Michelle Shortt,

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

FR Doc. E9-13151 Filed 6-4-09; 8:45 am

BILLING CODE 4120-01-P