[Federal Register Volume 73, Number 182 (Thursday, September 18, 2008)]
[Notices]
[Pages 54160-54161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21669]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[Document Identifier: CMS-10137 and CMS-10237 and 10214]


Emergency Clearance: Public Information Collection Requirements 
Submitted to the Office of Management and Budget (OMB)

AGENCY: Center for Medicare and 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 and 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 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.
    We are, however, requesting an emergency review of the information 
collection referenced below. In compliance with the requirement of 
section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have 
submitted to the Office of Management and Budget (OMB) the following 
requirements for emergency review. We are requesting an emergency 
review because the collection of this information is needed before the 
expiration of the normal time limits under OMB's regulations at 5 CFR 
part 1320(a)(2)(iii). This is necessary to ensure compliance with an 
initiative of the Administration. We cannot reasonably comply with the 
normal clearance procedures because the use of normal clearance 
procedures is reasonably likely to cause a statutory deadline to be 
missed.
    The Balanced Budget Act of 1997, established a new ``Part C'' in 
the Medicare statute, sections 1851 through 1859 of the Social Security 
Act, which provided for a Medicare+Choice (M+C) program. The Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) was 
enacted on December 8, 2003. The MMA established the Medicare 
Prescription Drug Benefit Program under section 101 of the MMA and is 
codified in section 1860D of the Social Security Act which establishes 
the voluntary Prescription Drug Benefit Program (``Part D''), and made 
revisions to the provisions of Medicare Part C, governing what is now 
called the Medicare Advantage (MA) program (formerly Medicare+Choice). 
The MMA was amended on July 15, 2008 by the enactment of the Medicare 
Improvements for Patients and Providers Act of 2008 (MIPPA).
    CMS is in the process of publishing regulations that are intended 
to be released as an interim final rule with comment. Many of the 
provisions included in MIPPA that impact the Part C and Part D programs 
are self-implementing, meaning these provisions will go into effect 
without any further regulatory clarification or changes to the Part C 
and Part D solicitations. As part of the revised information collection 
request, CMS will implement into the Part C solicitations, sections 
163, 164, and 165 of MIPPA, and implement into the Part D 
solicitations, sections 171, 172 and 173 of MIPPA. These sections amend 
the contractual requirements that Part C and Part D sponsors 
(applicants) must have with CMS and with any downstream or related 
entities performing Part C and Part D functions on the sponsor's 
behalf. Currently CMS provides templates that contain the required 
language for the contracts based on the statute and regulations. While 
applicants do not have to use the exact CMS contract templates, they 
will be responsible for including the required language in the 
contracts when they submit materials to CMS for the 2010 contract year.
    The solicitations do not represent new policy, but rather implement 
the provisions that will exist in the forthcoming regulations, and 
include clarifying edits and updates as well. Therefore, CMS is seeking 
an emergency PRA clearance to amend the Part C and Part D solicitations 
to reflect the new MIPPA requirements.
    1. 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: Collection 
of this information is mandated in Part D of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003 and under supporting 
regulations Subpart K of 42 CFR 423 entitled ``Application Procedures 
and Contracts with PDP Sponsors.''
    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. The 
information will be collected under the solicitation of proposals from 
PDP, MA-PD, Cost Plan, PACE, and EGWP Plan applicants. The collected 
information will be used by CMS to: (1) Ensure that applicants meet CMS 
requirements, (2) support the determination of contract awards. Form 
Number: CMS-10137 (OMB<greek-i>: 0938-0936); Frequency: Reporting--
Once; Affected Public: Business or other for-profit and Not-for-profit 
institutions; Number of Respondents: 455 Total Annual Responses: 455; 
Total Annual Hours: 11,890.
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Advantage Applications--Part C; 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.'' Under section 
1851(a)(1) of the Act, every individual entitled to Medicare Part A and 
enrolled under Part B, except for most individuals with end-stage renal 
disease, could elect to receive benefits either through the Original 
Medicare

[[Page 54161]]

Program or an M+C plan, if one was offered where he or she lived.
    Coverage for the prescription drug benefit is provided through 
contracted prescription drug plans or through Medicare Advantage (MA) 
plans that offer integrated prescription drug and health care coverage 
(MA-PD plans). Cost plans that are required 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 MA and MA-PD plans must complete an application, negotiate 
rates and receive final approval from CMS. Certain existing MA plans 
may also expand their contracted area by completing the Service Area 
Expansion (SAE) application. The information will be collected under 
the solicitation of proposals from MA-PD, Cost Plan, EGWP 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. Form Number: CMS-10237 and 10214 
(OMB<greek-i>: 0938-0935); Frequency: Reporting--Yearly; Affected 
Public: Business or other for-profit and Not-for-profit institutions; 
Number of Respondents: 267; Total Annual Responses: 267; Total Annual 
Hours: 6,709.
    CMS is requesting OMB review and approval of this collection by 
December 12, 2008, with a 180-day approval period. Written comments and 
recommendation will be considered from the public if received by the 
individuals designated below by the noted deadline below.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS's 
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 <a href="/cdn-cgi/l/email-protection#b9e9d8c9dccbced6cbd2f9dad4ca97d1d1ca97ded6cf"><span class="__cf_email__" data-cfemail="d585b4a5b0a7a2baa7be95b6b8a6fbbdbda6fbb2baa3">[email protected]</span></a>, 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 October 20, 2008:
    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; and, 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 8, 2008.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. E8-21669 Filed 9-15-08; 9:00 am]
BILLING CODE 4120-01-P


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