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[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Notices]
[Pages 79000-79001]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31541]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-102 and CMS-105, CMS-10241, CMS-10261, CMS-
10185, and CMS-10340]

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: Extension without change 
of a currently approved collection; Title of Information Collection: 
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Budget 
Workload Reports and Supporting Regulations in 42 CFR 493.1-.2001; Use: 
The collected information will be used by CMS to determine the amount 
of Federal reimbursement for surveys conducted. Use of the information 
includes program evaluation, audit, budget formulation and budget 
approval. Form CMS-102 is a multi-purpose form designed to capture and 
record all budget and expenditure data. Form CMS-105 captures the 
annual projected CLIA workload that the State survey agency will 
accomplish. It is also used by the CMS regional office to approve the 
annual projected CLIA workload. The information is required as part of 
the section 1864 agreement with the State; Form Numbers: CMS-102 and 
CMS-105 (OMB: 0938-0599); Frequency: Quarterly; Affected 
Public: State, Local, or Tribal Governments; Number of Respondents: 50; 
Total Annual Responses: 50; Total Annual Hours: 4,500. (For policy 
questions regarding this collection contact Carla Ausby at 410-786-
2153. For all other issues call 410-786-1326.)
    2. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Annual State Report and Annual State Performance Rankings; Use: Section 
6001(f) of the Deficit Reduction Act (DRA) requires CMS to contract 
with a vendor to conduct a monthly national survey of retail 
prescription drug prices and to report the prices to the States. These 
national average prices may be used as a benchmark by the States for 
the management of their prescription drug programs. The DRA also 
requires that the States submit pricing information for the 50 most 
widely prescribed drugs so that the States' prices can be compared to 
the national average prices obtained from the survey. The States 
pricing information will be compared and the States will be ranked. The 
Act also requires that States report their drug utilization rates for 
noninnovator multiple source (generic) drugs, their payment rates under 
their State plan, and their dispensing fees. The template has been 
developed to facilitate data collection; Form Number: CMS-10241 
(OMB: 0938-1041); Frequency: Yearly; Affected Public: State, 
Local, or Tribal Governments; Number of Respondents: 51; Total Annual 
Responses: 51; Total Annual Hours: 765. (For policy questions regarding 
this collection contact Joseph Fine at 410-786-2128. For all other 
issues call 410-786-1326.)
    3. Type of Information Collection Request: Revision of currently 
approved collection; Title of Information Collection: Part C Medicare 
Advantage (MA) Reporting Requirements and Supporting Regulations; Use: 
CMS has authority to establish reporting requirements for Medicare 
Advantage Organizations (MAO's) as described in 42 CFR Sec.  422.516 
(a). Each MAO must have an effective procedure to develop, compile, 
evaluate, and report to CMS, to its enrollees, and to the general 
public, at the times and in the manner that CMS requires, and while 
safeguarding the confidentiality of the doctor-patient relationship, 
statistics and other information with respect to the cost of its 
operations, patterns of service utilization, availability, 
accessibility,

[[Page 79001]]

and acceptability of its services, developments in the health status of 
its enrollees, and other matters that CMS may require. Data collected 
via Medicare Part C Reporting Requirements will be an integral resource 
for oversight, monitoring, compliance and auditing activities necessary 
to ensure quality provision of the benefits provided by MA plans to 
enrollees. Form Number: CMS-10261 (OMB 0938-1054); Frequency: 
Yearly, Quarterly; Affected Public: Business or other for-profits; 
Number of Respondents: 588; Total Annual Responses: 1158; Total Annual 
Hours: 245,528. (For policy questions regarding this collection contact 
Terry Leid at 410-786-8973. For all other issues call 410-786-1326.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare Part D 
Reporting Requirements and Supporting Regulations; Use: 42 CFR part 
423, Sec.  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, subsection 423.505 of the Medicare 
Prescription Drug, Improvement, and Modernization Act (MMA), 
establishes as 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. 
Data will be validated, analyzed, and utilized for trend reporting by 
the Division of Clinical and Operational Performance (DCOP) within the 
Medicare Drug Benefit Group. Form Number: CMS-10185 (OMB: 
0938-0992); Frequency: Yearly, Quarterly, Semi-Annually; Affected 
Public: Private sector, business or other for-profit; Number of 
Respondents: 2993; Total Annual Responses: 48,490; Total Annual Hours: 
128,754. (For policy questions regarding this collection contact 
LaToyia Grant at 410-786-5434. For all other issues call 410-786-1326.)
    5. Type of Information Collection Request: New collection; Title of 
Information Collection: Collection of Encounter Data from Medicare 
Advantage Organizations; Use: The Centers for Medicare and Medicaid 
Services (CMS) intends to collect encounter data, or data on each item 
or service delivered to an enrollee, from Medicare Advantage 
Organizations. Medicare Advantage organizations will obtain this data 
from providers. CMS would collect the data electronically from Medicare 
Advantage Organizations via the Health Insurance Portability and 
Accountability Act (HIPAA) compliant standard Health Care Claims 
transactions for professional data and institutional data. The 
information is used to submit health care claims or equivalent health 
encounter information, carry out health plan enrollments and 
disenrollments, determine health plan eligibility, send and receive 
health care payment and remittance advices, transmit health plan 
premium payments, determine health care claim status, provide referral 
certifications and authorizations, and coordinate the benefits for 
individuals who have more than one health plan. Form Number: CMS-10340 
(OMB: 0938-New); Frequency: Weekly; Affected Public: Private 
sector; businesses or other for-profits; Number of Respondents: 678; 
Total Annual Responses: 384,041,063; Total Annual Hours: 768. (For 
policy questions regarding this collection contact Sean Creighton at 
410-786-9302 or Deondra Moseley at 410-786-4577. For all other issues 
call 410-786-1326.)
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web Site at http://www.cms.hhs.gov/PaperworkReductionActof1995, or E-
mail your request, including your address, phone number, OMB number, 
and CMS document identifier, to Paperwork@cms.hhs.gov, or call the 
Reports Clearance Office on (410) 786-1326.
    In commenting on the proposed information collections please 
reference the document identifier or OMB control number. To be assured 
consideration, comments and recommendations must be submitted in one of 
the following ways by February 15, 2011:
    1. Electronically. You may submit your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.

    Dated: December 10, 2010.
Martique Jones,
Director, Regulations Development Division-B, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2010-31541 Filed 12-16-10; 8:45 am]
BILLING CODE 4120-01-P
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