[Federal Register Volume 72, Number 197 (Friday, October 12, 2007)]
[Notices]
[Pages 58096-58098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20150]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10185, CMS-10137, CMS-10240, CMS-10237 and 
10214, CMS-855, and CMS-R-39]


Agency Information Collection Activities: Submission for OMB 
Review; 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), 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: Revision of a currently 
approved collection; Title of Information Collection: Medicare Part D

[[Page 58097]]

Reporting Requirements and Supporting Regulations under 42 CFR section 
423.505; Form Number: CMS-10185 (OMB: 0938-0992); Use: 42 CFR 
423.514, requires each Part D Sponsor to have an effective procedure to 
provide statistics indicating: The cost of its operations, the patterns 
of utilization of its services, the availability, accessibility, and 
acceptability of its services, information demonstrating it has a 
fiscally sound operation and other matters as required by CMS. In 
addition, Sec.  423.505 of the regulation, establishes a contract 
provision that Part D Sponsors must comply with the reporting 
requirements for submitting drug claims and related information to CMS. 
Data collected via Medicare Part D Reporting Requirements will be an 
integral resource for oversight, monitoring, compliance and auditing 
activities necessary to ensure quality provision of the Medicare 
Prescription Drug Benefit to beneficiaries. Refer to the ``Revisions 
from 60-day Comment Period to CY 2008 Part D Reporting Requirements'' 
document to view a list of current changes. Frequency: Reporting--
Monthly, Annually, Quarterly and Semi-annually; Affected Public: 
Business or other for-profit; Number of Respondents: 4,857; Total 
Annual Responses: 330,276; Total Annual Hours: 287,132.
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Application for 
Prescription Drug Plans (PDP); Application for Medicare Advantage 
Prescription Drug (MA-PD); Application for Cost Plans to Offer 
Qualified Prescription Drug Coverage; Application for Employer Group 
Waiver Plans to Offer Prescription Drug Coverage; Service Area 
Expansion Application for Prescription Drug Coverage; Use: Collection 
of this information is mandated in Part D of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003. The application 
requirements are codified in Subpart K of 42 CFR 423. Coverage for the 
prescription drug benefit is provided through prescription drug plans 
(PDPs) that offer drug-only coverage, or through Medicare Advantage 
(MA) organizations that offer integrated prescription drug and health 
care coverage (MA-PD plans). PDPs must offer a basic drug benefit. 
Medicare Advantage Coordinated Care Plans (MA-CCPs) must offer either a 
basic benefit or may offer broader coverage for no additional cost. 
Medicare Advantage Private Fee for Service Plans (MA-PFFS) may choose 
to offer a Part D benefit. Cost Plans that are regulated under Section 
1876 of the Social Security Act, and Employer Group Plans may also 
provide a Part D benefit. If any of the contracting organizations meet 
basic requirements, they may also offer supplemental benefits through 
enhanced alternative coverage for an additional premium.
    The information will be collected under the solicitation of 
proposals from PDP, MA-PD, Cost Plan, and Employer Group Waiver Plans 
applicants. The collected information will be used by CMS to: (1) 
Insure that applicants meet CMS requirements, and (2) support the 
determination of contract awards.
    Refer to the ``High-Level Summary of Changes in Employer/Union 
Group Waiver Plan Part D Applications'' and ``High-Level Summary of All 
Part D Application Revisions from 2008 Solicitation for the 2009 
Solicitation'' documents to review a list of changes from 2008 to 2009; 
Form Number: CMS-10137 (OMB: 0938-0936); Frequency: Reporting: 
Once; Affected Public: Business or other for-profit and Not-for-profit 
institutions; Number of Respondents: 455; Total Annual Responses: 455; 
Total Annual Hours: 11,890.
    3. 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. Refer to the ``Summary of 
Changes to Data collection for the Nursing Home Value-Based Purchasing 
(NHVBP) Demonstration'' documents to review a list of changed items. 
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.
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Advantage (MA) Applications--Part C; Use: An entity seeking a contract 
as an MA organization must be able to provide Medicare's basic benefits 
plus meet the organizational requirements set out in regulations at 42 
CFR Part 422. An applicant must demonstrate that it can meet the 
benefit and other requirements within the specific geographic area it 
is requesting. The application forms are designed to give CMS the 
information they need about the health plan to determine compliance 
with Federal regulations at 42 CFR Part 422 in an efficient manner. The 
cited regulations outline the MA application process that begins with 
submission of an application in the form and manner that the Secretary 
provides. The MA application forms will be used by CMS to determine 
whether an entity is eligible to enter into a contract to provide 
services to Medicare beneficiaries. Refer to the ``High Level Summary 
of Key Changes Between The 2008 Part C Applications and The 2009 Part C 
Applications'' and the ``High-Level Summary of Changes in Employer/
Union-Only Group Waiver Plan MAO Applications'' documents to review a 
list of the changes. Form Number: CMS-10237 and 10214 (OMB: 
0938-0935); Frequency: Reporting: Yearly; Affected Public: Business or 
other for-profit and Not-for-profit institutions; Number of 
Respondents: 241; Total Annual

[[Page 58098]]

Responses: 241; Total Annual Hours: 5858.
    5. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare 
Enrollment Application; Form Number: CMS-855 (OMB: 0938-0685); 
Use: The primary function of the Medicare enrollment application is to 
gather information from a provider or supplier that tells us who it is, 
whether it meets certain qualifications to be a health care provider or 
supplier, where it practices or renders its services, the identity of 
the owners of the enrolling entity, and information necessary to 
establish the correct claims payment. The goal of evaluating and 
revising the Medicare enrollment applications is to simplify and 
clarify the information collection without jeopardizing our need to 
collect specific information.
    We are proposing revisions to the CMS-855B to incorporate changes 
adopted in CMS-1321-FC (71 FR 69624), ``Revisions to Payment Policies 
and Five-Year Review of Relative Value Units Under the Physician Fee 
Schedule for CY 2007 and Other Changes to Payment Under Part B; 
Revisions to Ambulance Fee Schedule; Ambulatory Inflation Factor Update 
for CY 2007.'' Specifically, CMS is revising the CMS-855B to:
     Add instructions to Attachment 2 that explain the 
independent diagnostic testing facility (IDTF) liability insurance 
requirements in 42 CFR Sec.  410.33(g)(6).
     Require that an IDTF submit copies of its comprehensive 
liability insurance policy in Section 17.
     List all of the new IDTF standards on a separate page in 
Attachment 2.
     Remove the supplier type ``Voluntary Health/Charitable 
Agency'' from Section 2A.
    In addition, we are trying to enhance our ability to identify 
whether a hospital qualifies as a ``specialty hospital.'' To this end, 
we propose to revise the CMS-855A to include a specific box that 
specialty hospitals must check when completing the application. 
Instructions explaining the definition of a ``specialty hospital'' will 
also be added to the form. We also provide clarification of the term 
``primary practice location'' in the instructions in Section 4 of the 
CMS-855A. This clarification does not change any data elements on the 
form. We are also removing the data element ``Medicare Year-End Cost 
Report Date'' in Section 2 of the CMS-855A, as this information is no 
longer needed. Frequency: Recordkeeping and Reporting--On occasion; 
Affected Public: Business or other for-profit and Not-for-profit 
institutions; Number of Respondents: 400,000; Total Annual Responses: 
400,000; Total Annual Hours: 1,001,503.33.
    6. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Home Health 
Conditions of Participation (CoP) Information Collection Requirements 
and Supporting Regulations in 42 CFR 484.10, 484.12, 484.16, 484.18, 
484.36, 484.48, 484.52; Form Numbers: CMS-R-39 (OMB: 0938-
0365); Use: The information collection requirements contained in this 
request are part of the requirements classified as the conditions of 
participation (CoPs) which are based on criteria prescribed in law and 
are standards designed to ensure that each facility has properly 
trained staff to provide the appropriate safe physical environment for 
patients. These particular standards reflect comparable standards 
developed by industry organizations such as the Joint Commission on 
Accreditation of Healthcare Organizations, and the Community Health 
Accreditation Program. The primary users of this information will be 
State agency surveyors, the regional home health intermediaries, CMS 
and home health agencies (HHAs) for the purpose of ensuring compliance 
with Medicare CoPs as well as ensuring the quality of care provided by 
HHA patients. Frequency: Recordkeeping and Reporting--Annually, On 
occasion; Affected Public: Business or for-profits, Not-for-profit 
institutions, and State, Local or Tribal governments; Number of 
Respondents: 9,354; Total Annual Responses: 9,354; Total Annual Hours: 
1,048,483.5.
    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 by the OMB desk 
officer at the address below, no later than 5 p.m. on November 13, 
2007.
    OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, 
New Executive Office Building, Room 10235, Washington, DC 20503, Fax 
Number: (202) 395-6974.

    Dated: October 4, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
 [FR Doc. E7-20150 Filed 10-11-07; 8:45 am]
BILLING CODE 4120-01-P