[Federal Register Volume 75, Number 180 (Friday, September 17, 2010)]
[Notices]
[Pages 57035-57037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10267, CMS-10137, CMS-10237, CMS-R-240, CMS-
10316 and CMS-10305]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services.
    In compliance with the requirement of section 3506I(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: QualityNet 
Identity Management System (QIMS) Account Form; Use: The QualityNet 
Identity Management System (QIMS) account registration form must be 
completed by any new persons needing access to Consolidated Renal 
Operations in a Web Enabled Network (CROWNWeb.) The 8,561 existing 
accounts owners will not have to reregister for new user accounts. The 
CROWNWeb user community is composed of CMS employees, ESRD Network 
Organization staff and dialysis facilities staff. The CROWNWeb system 
is the system used as the collection point of data necessary for 
entitlement of ESRD patients to Medicare benefits and Federal 
Government monitoring and assessing of quality and type of care 
provided to renal patients. The data collected in QIMS will provide the 
necessary security measures for creating and maintaining active 
CROWNWeb user accounts and collection of audit trail information 
required by the CMS Information Security Officers (ISSO). Form Number: 
CMS-10267 (OMB<greek-i>: 0938-1050); Frequency: Occasionally; Affected 
Public: Business or other for-profits and Not-for-profit institutions; 
Number of Respondents: 7,439; Total Annual Responses: 7,439; Total 
Annual Hours: 3,720. (For policy questions regarding this collection 
contact Michelle Tucker at 410-786-0376. For all other issues call 410-
786-1326.
    2. 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 
Applications for Part D sponsors to offer qualified prescription drug 
coverage are completed by entities seeking approval to offer Part D 
benefits under the Medicare Prescription Drug Benefit

[[Page 57036]]

program 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.
    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.
    The information will be collected under the solicitation of 
proposals from PDP, MA-PD, Cost Plan, PACE, and EGWP 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: Once; Affected Public: Business or other for-profits and 
Not-for-profit institutions; Number of Respondents: 295; Total Annual 
Responses: 295; Total Annual Hours: 3,576. (For policy questions 
regarding this collection contact Linda Anders at 410-786-0459. For all 
other issues call 410-786-1326.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Part C Medicare 
Advantage Application and 1876 Cost Plan Expansion Application; Use: 
The Balanced Budget Act of 1997 (BBA) established a new ``Part C'' in 
the Medicare statute (sections 1851 through 1859 of the Social Security 
Act (the Act) which provided for a Medicare+Choice (M+C) program. 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 (ESRD), could elect to receive benefits either 
through the Original Medicare Program or an M+C plan, if one was 
offered where he or she lived. The Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA), established the 
Medicare 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) 
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 expand their contracted area 
by completing the Service Area Expansion (SAE) application. Any current 
Cost Plan Contractor that wants to expand its Medicare cost-based 
contract with CMS under Section 1876 of the Act, as amended by the Tax 
Equity and Fiscal Responsibility Act of 1982 (TEFRA) and subsequent 
legislation can complete the application. Form Number: CMS-10237 
(OMB<greek-i>: 0938-0935); Frequency: Yearly; Affected Public: Business 
or other for-profits and Not-for-profit institutions; Number of 
Respondents: 870; Total Annual Responses: 870; Total Annual Hours: 
15,696. (For policy questions regarding this collection contact 
Letticia Ramsey at 410-786-5262. For all other issues call 410-786-
1326.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Prospective 
Payments for Hospital Outpatient Service and Supporting Regulations is 
42 CFR 413.65; Use: Section 1833(t) of the Social Security Act (the 
Act) requires the Secretary to establish a prospective payment system 
(PPS) for hospital outpatient services. Successful implementation of an 
outpatient PPS requires that CMS distinguish facilities or 
organizations that function as departments of hospitals from those that 
are freestanding, so that CMS can determine which services should be 
paid under the outpatient prospective payment system (OPPS), the 
clinical laboratory fee schedule, or other payment provisions 
applicable to services furnished to hospital outpatients.
    CMS will use the information from sections 413.65(b)(3) and (c) to 
determine whether a facility or organization acquired by a main 
provider should be treated as provider-based for Medicare 
certification, coverage, and payment purposes or whether a main 
provider has had a material change in its relationship to a provider-
based facility or organization that affects the provider-based status 
of the facility or organization. In addition, section 1866(b)(2) of the 
Act authorizes hospitals and other providers to impose deductible and 
coinsurance charges for facility services, but does not allow such 
charges by facilities or organizations which are not provider-based. 
Implementation of this provision requires that CMS have information 
from the required reports, so it can determine which facilities are 
provider-based. Form Number: CMS-R-240 (OMB<greek-i>: 0938-0798); 
Frequency: Occasionally; Affected Public: Business or other for-profits 
and Not-for-profit institutions; Number of Respondents: 905; Total 
Annual Responses: 500,405; Total Annual Hours: 26,563 (For policy 
questions regarding this collection contact Daniel Schroder at 410-786-
7452. For all other issues call 410-786-1326.)
    5. Type of Information Collection Request: New collection; Title of 
Information Collection: Medicare Prescription Drug Plan (PDP) and 
Medicare Advantage Prescription Drug Plan (MA-PD) Disenrollment Reasons 
Survey; Use: The Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA) requires the collection and reporting 
performance data for Part D prescription drug plans. Specifically, the 
MMA under section 1860D-4 (Beneficiary Protections for Qualified 
Prescription Drug Coverage) requires CMS to conduct consumer 
satisfaction surveys regarding PDPs and MA-PDs. CMS will use the survey 
to obtain information regarding beneficiaries' reasons for disenrolling 
from their chosen Part D plan, and their expectations relative to 
provided benefits and services. Determining the reasons for 
disenrollment from Part D plans will provide important information 
regarding potential dissatisfaction with some aspect of the plan, such 
as access, service, cost, quality of care, or the benefits provided. 
This information can be used by CMS to improve the design and 
functioning of the Part D program. Form Number: CMS-10316 
(OMB<greek-i>: 0938-New); Frequency: Yearly; Affected Public: 
Individuals and households; Number of Respondents: 120,000; Total 
Annual Responses: 120,000; Total Annual Hours: 34,800. (For policy 
questions regarding this collection contact Phyllis Nagy at 410-786-
6646. For all other issues call 410-786-1326.)
    6. Type of Information Collection Request: New collection; Title of 
Information Collection: Medicare Part C and Part D Data Validation (42 
CFR 422.516g and 423.514g); Use: Organizations contracted to offer 
Medicare Part C and Part D benefits are required to report data to the 
Centers for

[[Page 57037]]

Medicare & Medicaid Services on a variety of measures. In order for the 
data to be useful for monitoring and performance measurement, the data 
must be reliable, valid, complete, and comparable among sponsoring 
organizations. To meet this goal, CMS is developing reporting standards 
and data validation specifications with respect to the Part C and Part 
D reporting requirements. These standards will provide a review process 
for Medicare Advantage Organizations (MAOs), Cost Plans, and Part D 
sponsors to use to conduct data validation checks on their reported 
Part C and Part D data. Form Number: CMS-10305 (OMB<greek-i>: 0938-
NEW); Frequency: Yearly; Affected Public: Business or other for-profit; 
Number of Respondents: 634; Total Annual Responses: 634; Total Annual 
Hours: 237,127. (For policy questions regarding this collection contact 
Terry Lied at 410-786-8973. 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 <a href="/cdn-cgi/l/email-protection#227243524750554d504962414f510c4a4a510c454d54"><span class="__cf_email__" data-cfemail="9cccfdecf9eeebf3eef7dcfff1efb2f4f4efb2fbf3ea">[email protected]</span></a>, 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 October 18, 2010. 
OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-6974, E-mail: <a href="/cdn-cgi/l/email-protection#e0afa9b2a1bf9395828d899393898f8ea08f8d82ce858f90ce878f96"><span class="__cf_email__" data-cfemail="1a5553485b45696f78777369697375745a757778347f756a347d756c">[email protected]</span></a>.

    Dated: September 13, 2010.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 2010-23160 Filed 9-16-10; 8:45 am]
BILLING CODE 4120-01-P


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