[Federal Register Volume 72, Number 139 (Friday, July 20, 2007)]
[Notices]
[Pages 39812-39813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13904]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10224, CMS-10240 and CMS-10052]


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

[[Page 39813]]

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 [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 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.
 [FR Doc. E7-13904 Filed 7-19-07; 8:45 am]
BILLING CODE 4120-01-P