E7-13904. 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: New collection; Title of Information Collection: HCPCS Level II Code Modification Request Process; Use: For Medicare and other health insurance programs to ensure that claims are processed in an orderly and consistent manner, standardized coding systems are essential. The Healthcare Common Procedure Coding System (HCPCS) Level II Code Set is one of the standard code sets used for this purpose. Level II of the HCPCS, also referred to as alpha-numeric codes, is a standardized coding system that is used primarily to identify products, supplies, and services not included in the Current Procedural Terminology (CPT) codes, such as ambulatory services and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) when used in the home or outpatient setting. As technology evolves and new products are developed, there are continuous changes to the HCPCS codeset. Modifications to the HCPCS are initiated via application form submitted by any interested stakeholder. These applications have been received on an on-going basis with an annual deadline for each cycle. In October 2003, the Secretary of Health and Human Services delegated CMS authority to maintain and distribute HCPCS Level II Codes. As a result, the National Panel was delineated and CMS continued with the decision-making process under its current structure, the CMS HCPCS Workgroup.

CMS' Council on Technological Innovation (CTI) has instituted a number of improvements to the HCPCS process. Specific process refinements include public notification of CMS' preliminary decisions, and a new opportunity to respond to CMS' preliminary decisions at a public meeting before a final decision is reached by the workgroup. CMS has streamlined the form into a user-friendly application. The content of the material is the same, but the questions have been refined. CMS is also preparing a system of records (SOR) notice.

Applications are received, and distributed to all workgroup members. Workgroup members review the material and provide comments at the HCPCS workgroup meetings. Discussions are posted to CMS' HCPCS website. Final decisions are released to the applicant via letter; and all resulting modifications to the HCPCS codes are reflected on the HCPCS update. Form Number: CMS-10224 (OMB#: 0938-New); Frequency: Reporting: Occasionally; Affected Public: Business or other for-profit and State, Local or Tribal Government; Number of Respondents: 300; Total Annual Responses: 300; Total Annual Hours: 3,300.

2. Type of Information Collection Request: New collection; Title of Information Collection: Data Collection for the Nursing Home Value-Based Purchasing (NHVBP) Demonstration; Use: The NHVBP Demonstration is a CMS “pay-for-performance” initiative to improve the quality of care furnished to Medicare beneficiaries residing in nursing homes. Under this three-year demonstration project, CMS will assess the performance of nursing homes based on selected quality measures, and then make additional payments to those nursing homes that achieve a higher performance based on those measures. In the first year of the demonstration, quality will be assessed based on the following four domains: staffing, appropriate hospitalizations, outcome measures from the minimum data set (MDS), and survey deficiencies. Additional quality measures may be added in the second and third years of the demonstration as deemed appropriate.

The main purpose of the NHVBP data collection effort is to gather information that will enable CMS to determine which nursing homes will be eligible to receive incentive payments under the NHVBP Demonstration. All measures included in the MDS outcomes, survey deficiency, and appropriate hospitalization domains can be calculated from existing secondary data sources, such as the MDS, annual nursing home certification surveys, and Medicare claims data. However, for the staffing domain, no satisfactory alternative source for these data has been identified. Therefore, CMS will collect payroll-based staffing and resident census information to help assess the quality of care in participating nursing homes. CMS will additionally collect data on two measures, staff immunization status and use of resident care experience surveys, which may be included in the payment determination during the second and third years of the demonstration. Form Number: CMS-10240 (OMB#: 0938-New); Frequency: Reporting: Once; Affected Public: Business or other for-profit and not-for-profit institutions; Number of Respondents: 1,250; Total Annual Responses: 2,000; Total Annual Hours: 49,170.

3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Recognition of pass-through payment for additional (new) categories of devices under the Outpatient Prospective Payment System and Supporting Regulations in 42 CFR, Part 419; Use: Section 201(b) of the Balanced Budget Act of 1999 amended section 1833(t) of the Social Security Act (the Act) by adding new section 1833(t)(6). This provision requires the Secretary to make additional payments to hospitals for a period of 2 to 3 years for certain drugs, radiopharmaceuticals, biological agents, medical devices and brachytherapy devices. Section 1833(t)(6)(A)(iv) establishes the criteria for determining the application of this provision to new items. Section 1833(t)(6)(C)(ii) provides that the additional payment for medical devices be the amount by which the hospital's charges for the device, adjusted to cost, exceed the portion of the otherwise applicable hospital outpatient department fee schedule amount determined by the Secretary to be associated with the device. Section 402 of the Benefits Improvement and Protection Act of 2000 made changes to the transitional pass-through provision for medical devices. The most significant change is the required use of categories as the basis for determining transitional pass-through eligibility for medical devices, through the addition of section 1833(t)(6)(B) of the Act.

Interested parties such as hospitals, device manufacturers, pharmaceutical companies, and physicians apply for transitional pass-through payment for certain items used with services covered in the outpatient prospective payment system. After CMS receives all requested information, CMS will evaluate the information to determine if the creation of an additional category of medical devices for transitional pass-through payments is justified. Form Number: CMS-10052 (OMB#: 0938-0857); Frequency: Reporting: Yearly; Affected Public: Business or other for-profit; Number of Respondents: 10; Total Annual Responses: 10; Total Annual Hours: 160.

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 at the address below, no later than 5 p.m. on September 18, 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 12, 2007.

Michelle Shortt,

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