[Federal Register Volume 74, Number 161 (Friday, August 21, 2009)]
[Notices]
[Pages 42307-42308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20127]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10174, CMS-10287 and CMS-R-305]


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 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 the 
currently approved collection.
    Title of Information Collection: Collection of Drug Event Data From 
Contracted Part D Providers for Payment.
    Use: In December 2003, Congress enacted the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003 referred to as the 
Medicare Modernization Act (MMA). The Medicare Prescription Drug 
Benefit program (Part D) was established by section 101 of the MMA and 
is codified in section 1860D-1 through 1860 D-41 of the Social Security 
Act. Effective January 1, 2006, the Part D program establishes an 
optional prescription drug benefit for individuals who are entitled to 
Medicare Part A and/or enrolled in Part B. Part D plans have 
flexibility in terms of benefit design. This flexibility includes, but 
is not limited to, authority to establish a formulary that limits 
coverage to specific drugs within each therapeutic class of drugs, and 
the ability to have a cost-sharing structure other than the statutorily 
defined structure (subject to certain actuarial tests). Coverage under 
the new prescription drug benefit is provided predominately through 
private at-risk prescription drug plans that offer drug-only coverage 
(PDPs), Medicare Advantage (MA) plans that offer integrated 
prescription drug and health care coverage (MA-PD plans) or through 
Cost Plans that offer prescription drug benefits.
    The transmission of the data will be in an electronic format. The 
information users will be Pharmacy Benefit Managers (PBM), third party 
administrators and pharmacies and the PDPs, MA-PDs, Fallbacks and other 
plans that offer coverage of outpatient

[[Page 42308]]

prescription drugs under the Medicare Part D benefit to Medicare 
beneficiaries. The data is used primarily for payment, and is used for 
claim validation as well as for other legislated functions such as 
quality monitoring, program integrity and oversight.
    Form Number: CMS-10174 (OMB: 0938-0982).
    Frequency: Reporting--Monthly.
    Affected Public: Business or other for-profits and not-for-profit 
institutions.
    Number of Respondents: 747.
    Total Annual Responses: 947,881,770.
    Total Annual Hours: 1896.
    (For policy questions regarding this collection contact Bobbie 
Knickman at 410-786-4161. For all other issues call 410-786-1326.)
    2. Type of Information Collection Request: New collection.
    Title of Information Collection: Medicare Quality of Care Complaint 
Form.
    Use: In accordance with Section 1154(a)(14) of the Social Security 
Act, Quality Improvement Organizations (QIOs) are required to conduct 
appropriate reviews of all written complaints submitted by 
beneficiaries concerning the quality of care received. The Medicare 
Quality of Care Complaint Form will be used by Medicare beneficiaries 
to submit quality of care complaints. This form will establish a 
standard form for all beneficiaries to utilize and ensure pertinent 
information is obtained by QIOs to effectively process these 
complaints.
    Form Number: CMS-10287 (OMB: 0938-New).
    Frequency: Reporting--on occasion.
    Affected Public: Individuals or households.
    Number of Respondents: 3,500.
    Total Annual Responses: 3,500.
    Total Annual Hours: 583.
    (For policy questions regarding this collection contact Tom Kessler 
at 410-786-1991. For all other issues call 410-786-1326.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection.
    Title of Information Collection: External Quality Review Protocols.
    Use: The results of Medicare reviews, Medicare accreditation 
services, and Medicaid external quality reviews will be used by States 
in assessing the quality of care provided to Medicaid beneficiaries by 
managed care organizations and to provide information on the quality of 
care provided to the general public upon request.
    Form Number: CMS-R-305 (OMB: 0938-0786).
    Frequency: Reporting--Yearly.
    Affected Public: State, Local or Tribal Governments.
    Number of Respondents: 40.
    Total Annual Responses: 40.
    Total Annual Hours: 520,000.
    (For policy questions regarding this collection contact Gary B. 
Jackson at 410-786-1218. 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 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 September 21, 
2009:

OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-6974, E-mail: [email protected].

    Dated: August 14, 2009.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. E9-20127 Filed 8-20-09; 8:45 am]
BILLING CODE 4120-01-P