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[Federal Register Volume 77, Number 198 (Friday, October 12, 2012)]
[Notices]
[Pages 62241-62242]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25062]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10237 and CMS-10137]

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: 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 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.
    Since the publication of the 60-day notice, the information 
collection request has been revised to provide clarification to 
applicants, to ensure consistency throughout the entire application, 
and to reduce confusion among applicants. As a result of those changes, 
the overall burden associated with the collection has decreased from 
22,995 to 21,581 hours. Form Number: CMS-10237 (OCN 0938-0935). 
Frequency: Yearly. Affected Public: Private Sector (Business or other 
for-profits, Not-for-profit institutions). Number of Respondents: 566. 
Total Annual Responses: 566. Total Annual Hours: 21,581. (For policy 
questions regarding this collection contact Barbara Gullick at 410-786-
0563. For all other issues call 410-786-1326.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title: Application for New and Expanding Medicare 
Prescription Drug Plans and Medicare Advantage Prescription Drug (MA-
PD), including Cost Plans and Employer Group Waiver Plans; 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

[[Page 62242]]

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.
    Collection of this information is mandated in Part D of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
(MMA) in Subpart 3. The application requirements are codified in 
Subpart K of 42 CFR 423 entitled ``Application Procedures and Contracts 
with PDP Sponsors.''
    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(OCN: 
0938-0936); Frequency: Yearly; Affected Public: Private Sector--
Business or other for-profits and Not-for-profit institutions; Number 
of Respondents: 241; Total Annual Responses: 241; Total Annual Hours: 
2,132. (For policy questions regarding this collection contact Linda 
Anders at 410-786-0459. For all other issues call 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, 
2012.

OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-6974, Email: OIRA_submission@omb.eop.gov.

    Dated: October 5, 2012.
Martique Jones,
Director, Regulations Development Group, Division B, Office of 
Strategic Operations and Regulatory Affairs.
[FR Doc. 2012-25062 Filed 10-11-12; 8:45 am]
BILLING CODE 4120-01-P
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