[Federal Register Volume 73, Number 193 (Friday, October 3, 2008)]
[Notices]
[Pages 57631-57632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23415]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10261, CMS-10182, CMS-10166 and CMS-10150]


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: New collection; Title of 
Information Collection: Part C Medicare Advantage (MA) Reporting 
Requirements and Supporting Regulations in 42 CFR 422.516 (a); Use: CMS 
has authority to establish reporting requirements for Medicare 
Advantage Organizations (MAOs) as described in 42 CFR 422.516(a). Under 
that authority, 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, and acceptability of its services, developments in the 
health status of its enrollees, and other matters that CMS may require.
    CMS will not require cost plans to comply with the following 
reporting requirements: Benefit utilization; procedure frequency; and 
serious reportable adverse events. However, CMS has determined that it 
is essential that all beneficiaries understand rules and requirements 
of the Medicare plans which they are being invited to join. Prospective 
enrollees in cost plans should be furnished accurate information by 
qualified sales people, consistent with CMS' expectation for 
prospective enrollees in other play types. Thus, CMS is requiring 
reporting on certain measures CMS' believes is critical in monitoring 
cost plans. Additionally, CMS believes that section 1876(i)(1)(D) of 
the Act, and 42 CFR 417.126(a)(6) permits CMS to require cost plans to 
report to CMS the data identified as follows: Provider network 
adequacy; grievances; organization determinations/reconsiderations; 
employer group plan sponsor; agent training and testing; agent 
commission structure and plan oversight of agents.
    Data collected via Medicare Part C Reporting Requirements will be 
an integral resource for oversight,

[[Page 57632]]

monitoring, compliance and auditing activities necessary to ensure 
quality provision of the benefits provided by MA plans to enrollees. 
Refer to the ``Summary of Revisions'' document for a list of the recent 
collection changes. Form Number: CMS-10261 (OMB 0938-New); 
Frequency: Yearly, Quarterly, and Semi-annually; Affected Public: 
Business or other for-profits; Number of Respondents: 718; Total Annual 
Responses: 12,709; Total Annual Hours: 286,944.
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Model Creditable 
Coverage Disclosure Notices; Use: Section 1860D-1 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and 
implementing regulations at 42 CFR 423.56 require that entities that 
offer prescription drug benefits under any of the types of coverage 
described in 42 CFR 423.56 (b) provide a disclosure of creditable 
coverage status to all Medicare Part D eligible individuals covered 
under the entity's plan informing them whether such coverage meets the 
actuarial requirements specified in guidelines provided by CMS.
    These disclosure notices must be provided to Part D eligible 
individuals, at minimum, at the following times: (1) Prior to an 
individual's initial enrollment period for Part D, as described under 
Sec.  423.38 (a); (2) prior to the effective date of enrollment in the 
entity's coverage, and upon any change in creditable status; (3) prior 
to the commencement of the Part D Annual Coordinated Election Period 
(ACEP) which begins on November 15 of each year, as defined in Sec.  
423.38 (b); and (4) upon request by the individual. In an effort to 
reduce the burden associated with providing these notices, our final 
regulations allow most entities to provide notices of creditable and 
non-creditable status with other information materials that these 
entities distribute to beneficiaries.
    This collection has been updated by eliminating the separate Model 
Personalized Disclosure Notice. CMS has incorporated the personalized 
information into the Model Creditable Disclosure Notice and the Model 
Non-Creditable Disclosure Notice for use by the public Form Number: 
CMS-10182 (OMB 0938-0990); Frequency: Yearly and Semi-
annually; Affected Public: Federal Government, Business or Other For-
Profits and Not-for-Profit Institutions, and State, Local or Tribal 
Governments; Number of Respondents: 1,225,173; Total Annual Responses: 
1,225,173; Total Annual Hours: 522,204.
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Payment Error 
Rate Measurement in Medicaid and the State Children Health Insurance 
Program (SCHIP); Use: The Improper Payments Information Act (IPIA) of 
2002 requires CMS to produce national error rates for Medicaid and 
State Children's Health Insurance Program (SCHIP). To comply with the 
IPIA, CMS will engage a Federal contractor to produce the error rates 
in Medicaid and SCHIP.
    The States will be requested to submit, at their option, test data 
which include full claims details to the contractor prior to the 
quarterly submissions to detect potential problems in the dataset and 
ensure the quality of the data. These States will be required to submit 
quarterly claims data to the contractor who will pull a statistically 
valid random sample, each quarter, by strata, so that medical and data 
processing reviews can be performed. State-specific error rates will be 
based on these review results.
    CMS needs to collect the claims data, medical policies, and other 
information from States as well as medical records from providers in 
order for the contractor to sample and review adjudicated claims in 
those States selected for review. Based on the reviews, state-specific 
error rates will be calculated which will serve as the basis for 
calculating national Medicaid and SCHIP error rates.
    This revision of the currently approved collection contains minor 
revisions to the information collection requirements. There is a 10-
hour increase in burden per State per program as part of a new process. 
Based on the past experience in PERM operation, the adjustment is made 
to ensure the quality of the data will comply with the data requirement 
during the measurement. Form Number: CMS-10166 (OMB 0938-
0974); Frequency: Quarterly, Yearly; Affected Public: State, Local or 
Tribal Governments; Number of Respondents: 34; Total Annual Responses: 
4,080; Total Annual Hours: 28,560.
    4.Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Collection of Drug Pricing and Network Pharmacy Data from Medicare 
Prescription Drug Plans (PDPs and MA-PDs) and Supporting Regulations in 
42 CFR 423.48; Use: Both stand alone prescription drug plans (PDPs) and 
Medicare Advantage Prescription Drug (MA-PDs) plans are required to 
submit drug pricing and pharmacy network data to CMS and these data are 
made publicly available to people with Medicare through the Medicare 
Prescription Drug Plan Finder Web tool on http://www.medicare.gov. Drug 
prices vary across a plans pharmacy network based on the contracts that 
each plan negotiates with each pharmacy or pharmacy chain in their 
networks. The pharmacy networks can change during the course of the 
year as new pharmacies open, close, change ownership, or plans 
negotiate new contracts with pharmacies resulting in different 
dispensing fees for prescriptions. Drug prices also change frequently 
due to the daily fluctuation of the Average Wholesale Price (AWP), thus 
plans increase or decrease their drug prices to reflect these changes. 
The purpose of the data is to enable prospective and current Medicare 
beneficiaries to compare, learn, select and enroll in a plan that best 
meets their needs. The database structure provides the necessary drug 
pricing and pharmacy network information to accurately communicate plan 
information in a comparative format. Form Number: CMS-10150 
(OMB 0938-0951); Frequency: Bi-weekly; Affected Public: 
Business or other for-profits; Number of Respondents: 680; Total Annual 
Responses: 17,680; Total Annual Hours: 70,720.
    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. onNovember 3, 2008.
    OMB, Office of Information and Regulatory Affairs, Attention: CMS 
Desk Officer, New Executive Office Building, Room 10235, Washington, DC 
20503, Fax Number: (202) 395-6974.

    Dated: September 26, 2008.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. E8-23415 Filed 10-2-08; 8:45 am]
BILLING CODE 4120-01-P