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[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Notices]
[Pages 38655-38657]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16600]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10398, CMS-10399, CMS-10137, and CMS-10237]

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: Generic Clearance for Medicaid and CHIP State 
Plan, Waiver, and Program Submissions; Use: CMS is requesting a generic 
PRA clearance for a body of forms necessary to conduct ongoing business 
with State partners in the implementation of Medicaid and the 
Children's Health Insurance Program (CHIP). The specific forms have not 
yet been developed but will be developed over the 3-year approval 
period. The types of forms to be produced in this collection include 
State plan amendment templates, waiver and demonstration templates, and 
reporting templates. The development of streamlined submission forms is 
critical for States to implement timely health reform initiatives in 
Medicaid and CHIP state plans, demonstrations, and waivers, including 
legislative requirements enacted by the Affordable Care Act. The 
development of streamlined submissions forms enhances the collaboration 
and partnership between States and CMS by documenting CMS policy for 
States to use as they are developing program changes. Streamlined forms 
improve efficiency of administration by creating

[[Page 38656]]

a common and user-friendly understanding of the information needed by 
CMS to quickly process requests for State plan amendments, waivers, and 
demonstration, as well as ongoing reporting; Form Number: CMS-10398 
(OMB  0938-NEW); Frequency: Occasionally; Affected Public: 
State, Local, or Tribal Governments; Number of Respondents: 56; Total 
Annual Responses: 1120; Total Annual Hours: 28,747. (For policy 
questions regarding this collection contact Candice Payne at 410-786-
4453. For all other issues call 410-786-1326.)
    2. Type of Information Collection Request: New collection; Title of 
Information Collection: Analysis of Transportation Barriers to 
Utilization of Medicare Services by American Indian and Alaska Native 
Medicare Beneficiaries; Use: The purpose of the proposed study is to 
identify and analyze transportation barriers associated with the 
utilization of Medicare services by American Indian and Alaska Native 
(AI/AN) beneficiaries, to identify and analyze the health outcomes 
resulting from those barriers, and ultimately to identify potential 
solutions that could help mitigate the problem and produce meaningful 
improvements in health care use and health outcomes for this 
population. Specifically, the information that will be collected 
through the use of instruments and the study developed under the 
Analysis of Transportation Barriers to Utilization of Medicare Services 
by American Indian and Alaska Native Medicare Beneficiaries Project has 
not been collected or evaluated previously by any agency or individual, 
so data on the extent of transportation barriers for rural AI/AN 
beneficiaries to Medicare services by AI/AN Medicare beneficiaries are 
not available except from the proposed data collection activity.
    The information gathered as part of the project--through the use of 
survey, interview, and focus group instruments--will be used by CMS to 
identify transportation barriers to Medicare services for AI/AN 
Medicare beneficiaries. It will provide the first ever complete 
evaluation of transportation barriers to health care for this 
population.; Form Number: CMS-10399 (OMB  0938-NEW); 
Frequency: Occasionally; Affected Public: Individuals and Households, 
Private Sector; Number of Respondents: 3,418; Total Annual Responses: 
3,418; Total Annual Hours: 2,544. (For policy questions regarding this 
collection contact Roger Goodacre at 410-786-3209. For all other issues 
call 410-786-1326.)
    3. 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: The Medicare 
Prescription Drug Benefit program was established by section 101 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
(MMA) and is codified in section 1860D of the Social Security Act (the 
Act). Section 101 of the MMA amended Title XVIII of the Social Security 
Act by redesignating Part D as Part E and inserting a new Part D, which 
establishes the voluntary Prescription Drug Benefit Program (``Part 
D''). The MMA was amended on July 15, 2008 by the enactment of the 
Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), 
on March 23, 2010 by the enactment of the Patient Protection and 
Affordable Care Act and on March 30, 2010 by the enactment the Health 
Care and Education Reconciliation Act of 2010 (collectively the 
Affordable Care Act).
    Coverage for the prescription drug benefit is provided through 
contracted prescription drug plans (PDPs) or through Medicare Advantage 
(MA) plans that offer integrated prescription drug and health care 
coverage (MA-PD plans). Cost Plans that are regulated under Section 
1876 of the Social Security Act, and Employer Group Waiver Plans (EGWP) 
may also provide a Part D benefit. Organizations wishing to provide 
services under the Prescription Drug Benefit Program must complete an 
application, negotiate rates, and receive final approval from CMS. 
Existing Part D Sponsors may also expand their contracted service area 
by completing the Service Area Expansion (SAE) application.
    Effective January 1, 2006, the Part D program established an 
optional prescription drug benefit for individuals who are entitled to 
Medicare Part A or enrolled in Part B. In general, coverage for the 
prescription drug benefit is provided through PDPs that offer drug-only 
coverage, or through 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.
    Applicants may offer either a PDP or MA-PD plan with a service area 
covering the nation (i.e., offering a plan in every region) or covering 
a limited number of regions. MA-PD and Cost Plan applicants may offer 
local plans. There are 34 PDP regions and 26 MA regions in which PDPs 
or regional MA-PDs may be offered respectively. The MMA requires that 
each region have at least two Medicare prescription drug plans from 
which to choose, and at least one of those must be a PDP. Requirements 
for contracting with Part D Sponsors are defined in Part 423 of 42 CFR.
    This clearance request is for the information collected to ensure 
applicant compliance with CMS requirements and to gather data used to 
support determination of contract awards; Form Number: CMS-10137 (OMB 
 0938-0936); Frequency: Yearly; Affected Public: Privates 
Sector; Number of Respondents: 178; Total Annual Responses: 178; Total 
Annual Hours: 2,322. (For policy questions regarding this collection 
contact Linda Anders at 410-786-0459. For all other issues call 410-
786-1326.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Part C Medicare 
Advantage and 1876 Cost Plan Expansion Application; Use: Collection of 
this information is mandated in Part C of the Medicare Prescription 
Drug, Improvement and Modernization Act of 2003 (MMA) in Subpart K of 
42 CRF 422 entitled ``Contracts with Medicare Advantage 
Organizations.'' In addition, the Medicare Improvements for Patients 
and Providers Act of 2008 (MIPPA) amended titles XVII and XIX of the 
Social Security Act to improve the Medicare program.
    In general, 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 products (MA-PD

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plans). PDPs must offer a basic drug benefit. Medicare Advantage 
Coordinated Care Plans (MA-CCPs) either must offer 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 enrollees a 
Part D benefit. Employer Group Plans may also provide Part D benefits. 
If any of the contracting organizations meet basic requirements, they 
may also offer supplemental benefits through enhanced alternative 
coverage for an additional premium.
    Organizations wishing to provide healthcare services under MA and/
or MA-PD plans must complete an application, file a bid, and receive 
final approval from CMS. Existing MA plans may request to expand their 
contracted service area by completing the Service Area Expansion (SAE) 
application. Applicants may offer a local MA plan in a county, a 
portion of a county (i.e., a partial county) or multiple counties. 
Applicants may offer a MA regional plan in one or more of the 26 MA 
regions.
    This clearance request is for the information collected to ensure 
applicant compliance with CMS requirements and to gather data used to 
support determination of contract awards. The information will be 
collected under the solicitation of Part C application from MA, EGWP 
Plan, and Cost Plan applicants. The collection information will be used 
by CMS to: (1) Ensure that applicants meet CMS requirements, (2) 
support the determination of contract awards. Participation in all 
Programs is voluntary in nature. Only organizations that are interested 
in participating in the program will respond to the solicitation. MA-
PDs that voluntarily participate in the Part C program must submit a 
Part D application and successful bid. Form Number: CMS-10237 (OMB 
 0938-0935); Frequency: Yearly; Affected Public: Private 
Sector; Number of Respondents: 378; Total Annual Responses: 378; Total 
Annual Hours: 13,296. (For policy questions regarding this collection 
contact Letticia Ramsey at 410-786-5262. 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.gov/PaperworkReductionActof1995/PRAL/list.asp#TopOfPage 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 at 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 August 30, 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: June 28, 2011.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 2011-16600 Filed 6-30-11; 8:45 am]
BILLING CODE 4120-01-P
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