[Federal Register Volume 78, Number 125 (Friday, June 28, 2013)]
[Notices]
[Pages 38986-38989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15558]



[[Page 38986]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10199, CMS-10484, CMS-R-38, CMS-10237, CMS-
10198, CMS-R-267, CMS-10137, CMS-43, CMS-1763, CMS-1728-94, CMS-10174, 
CMS-10305 and CMS-10488]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of information 
(including each proposed extension or reinstatement of an existing 
collection of information) and to allow 60 days for public comment on 
the proposed action. Interested persons are invited to send comments 
regarding our burden estimates 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.

DATES: Comments must be received by August 27, 2013:

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number (OCN). To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send 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) that are 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.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.

SUPPLEMENTARY INFORMATION: This notice sets out a summary of the use 
and burden associated with the following information collections. More 
detailed information can be found in each collection's supporting 
statement and associated materials (see ADDRESSES).

CMS-10199 Data Collection for Medicare Facilities Performing Carotid 
Artery Stenting with Embolic Protection in Patients at High Risk for 
Carotid Endarterectomy
CMS-10484 End Stage Renal Disease (ESRD) Application Access Request 
Form
CMS-R-38 Conditions of Certification for Rural Health Clinics
CMS-10266 Conditions of Participation: Requirements for Approval and 
Reapproval of Transplant Centers to Perform Organ Transplants
CMS-10237 Part C--Medicare Advantage and 1876 Cost Plan Expansion 
Application
CMS-10198 Collection Requirements Pertaining to the Creditable Coverage 
Disclosure to CMS On-Line Form and Instructions
CMS-R-267 Medicare Advantage Program Requirements
CMS-10137 Solicitation for Applications for Medicare Prescription Drug 
Plan 2015 Contracts
CMS-43 Application for Hospital Insurance Benefits for Individuals with 
End Stage Renal Disease
CMS-1763 Request for Termination of Premium Hospital and/or 
Supplementary Medical Insurance
CMS-1728-94 Home Health Agency Cost Report
CMS-10174 Collection of Prescription Drug Event Data from Contracted 
Part D Providers for Payment
CMS-10305 Part C Medicare Advantage Reporting Requirements and 
Supporting Regulations
CMS-10488 Enrollee Satisfaction Survey Data Collection

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. The term ``collection of information'' is defined 
in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests 
or requirements that members of the public submit reports, keep 
records, or provide information to a third party. Section 3506(c)(2)(A) 
of the PRA requires federal agencies to publish a 60-day notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension or reinstatement of an existing 
collection of information, before submitting the collection to OMB for 
approval. To comply with this requirement, CMS is publishing this 
notice.

Information Collections

    1. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: Data Collection for Medicare Facilities Performing Carotid 
Artery Stenting with Embolic Protection in Patients at High Risk for 
Carotid Endarterectomy; Use: We provide coverage for carotid artery 
stenting (CAS) with embolic protection for patients at high risk for 
carotid endarterectomy and who also have symptomatic carotid artery 
stenosis between 50 percent and 70 percent or have asymptomatic carotid 
artery stenosis >= 80 percent in accordance with the Category B IDE 
clinical trials regulation (42 CFR 405.201), a trial under the CMS 
Clinical Trial Policy (NCD Manual Sec.  310.1, or in accordance with 
the National Coverage Determination on CAS post approval studies 
(Medicare NCD Manual 20.7).
    Accordingly, we consider coverage for CAS reasonable and necessary 
(section 1862(A)(1)(a) of the Social Security Act). However, evidence 
for use of CAS with embolic protection for patients with high risk for 
carotid endarterectomy and who also have symptomatic carotid artery 
stenosis >= 70 percent who are not enrolled in a study or trial is less 
compelling. To encourage responsible and appropriate use of CAS with 
embolic protection, we issued a Decision Memo for Carotid Artery 
Stenting on March 17, 2005, indicating that CAS with embolic protection 
for symptomatic carotid artery stenosis >= 70 percent will be covered 
only if performed in facilities that have been

[[Page 38987]]

determined to be competent in performing the evaluation, procedure and 
follow-up necessary to ensure optimal patient outcomes. In accordance 
with this criteria, we consider coverage for CAS reasonable and 
necessary (section 1862(A)(1)(a) of the Social Security Act). Form 
Number: CMS-10199 (OCN: 0938-1011); Frequency: Yearly; Affected Public: 
Business or other for-profit, Not-for-profit institutions; Number of 
Respondents: 1,000; Total Annual Responses: 1,000; Total Annual Hours: 
500. (For policy questions regarding this collection contact Lori Ashby 
at 410-786-6322.)
    2. Type of Information Collection Request: New Collection (Request 
for a new OMB control number); Title of Information Collection: End 
Stage Renal Disease (ESRD) Application Access Request Form; Use: We are 
developing a new suite of systems to support the End Stage Renal 
Disease (ESRD) program. Due to the sensitivity of the data being 
collected and reported, we must ensure that only authorized personnel 
have access to data. Personnel are given access to the ESRD systems 
through the creation of user IDs and passwords within the QualityNet 
Identity Management System (QIMS); however, once within the system, the 
system determines the rights and privileges the personnel has over the 
data within the system. Such access rights include: Viewing and 
reporting, updating adding and deleting.
    The sole purpose of the ESRD Application Access Request Form is to 
identify the individual's data access rights once within the ESRD 
system. This data collection is currently being accomplished under 
``Part B'' of the QualityNet Identity Management System Account Form. 
Once the ESRD Application Access Form is approved, the QualityNet 
Identity Management System (QIMS) Account Form will be revised to 
remove Part B from the QIMS data collection. The ESRD Application 
Access Request Form will be a new form and will be assigned its own OMB 
Control number. The ESRD system accounts created using the current QIMS 
Account Form--Part B will not need to submit an ESRD Application Access 
Form for the creation of their account since that information was 
collected under Part B.
    The QIMS Account Registration and the ESRD Application Access 
Request forms are required for identity and security management of 
individuals accessing the Consolidated Renal Operations in a Web 
Enabled Network (CROWNWeb) system and the End Stage Renal Disease 
Quality Incentive Program (ESRD QIP) system. The CROWNWeb system is the 
system that is mandated for the Medicare and Medicaid Programs 
Conditions of Coverage for End-Stage Renal Disease Facilities, Final 
Rule published April 15, 2008. Form Number: CMS-10484 (OCN: 0938-NEW); 
Frequency: Annually; Affected Public: Business and other for-profits; 
and not-for-profits; Number of Respondents: 27,000; Total Annual 
Responses: 27,000; Total Annual Hours: 6,750. (For policy questions 
regarding this collection contact Victoria Schlining at 410-786-6878.)
    3. Type of Information Collection Request: Reinstatement with 
change of a currently approved collection; Title of Information 
Collection: Conditions of Certification for Rural Health Clinics; Use: 
The Rural Health Clinic (RHC) conditions of certification are based on 
criteria prescribed in law and are designed to ensure that each 
facility has a properly trained staff to provide appropriate care and 
to assure a safe physical environment for patients. We use these 
conditions of participation to certify RHCs wishing to participate in 
the Medicare program. These requirements are similar in intent to 
standards developed by industry organizations such as the Joint 
Commission on Accreditation of Hospitals, and the National League of 
Nursing and the American Public Association and merely reflect accepted 
standards of management and care to which rural health clinics must 
adhere. Form Number: CMS-R-38 (OCN: 0938-0334); Frequency: 
Recordkeeping and Reporting--Annually; Affected Public: Business or 
other for-profits; Number of Respondents: 9,716; Total Annual 
Responses: 9,716; Total Annual Hours: 33,304. (For policy questions 
regarding this collection contact Mary Collins at 410-786-3189.)
    4. Type of Information Collection Request: Reinstatement with 
change of a currently approved collection; Title of Information 
Collection: Conditions of Participation: Requirements for Approval and 
Reapproval of Transplant Centers to Perform Organ Transplants; Use: The 
Conditions of Participation and accompanying requirements specified in 
the regulations are used by our surveyors as a basis for determining 
whether a transplant center qualifies for approval or re-approval under 
Medicare. We, along with the healthcare industry, believe that the 
availability to the facility of the type of records and general content 
of records is standard medical practice and is necessary in order to 
ensure the well-being and safety of patients and professional treatment 
accountability. Form Number: CMS-10266 (OCN: 0938-1069); Frequency: 
Yearly; Affected Public: Business or other for-profits and Not-for-
profit institutions; Number of Respondents: 226; Total Annual 
Responses: 528; Total Annual Hours: 2,523. (For policy questions 
regarding this collection contact Diane Corning at 410-786-8486.)
    5. 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: Organizations 
wishing to provide healthcare services under Medicare Advantage (MA) 
and/or MA organizations that offer integrated prescription drug and 
health care products must complete an application, file a bid, and 
receive final approval from us. Existing MA plans may request to expand 
their contracted service area by completing the Service Area Expansion 
application. Any current 1876 Cost Plan Contractor that wants to expand 
its Medicare cost-based contract with CMS can complete the application. 
Information is collected to ensure applicant compliance with our 
requirements and to gather data used to support its determination of 
contract awards. Form Number: CMS-10237 (OCN 0938-0935); Frequency: 
Yearly; Affected Public: Business or other for-profits and Not-for-
profits institutions; Number of Respondents: 566; Total Annual 
Responses: 566; Total Annual Hours: 22,955. (For policy questions 
regarding this collection contact Melissa Staud at 410-786-3669.)
    6. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: Creditable Coverage Disclosure to CMS On-Line Form and 
Instructions; Use: Most entities that currently provide prescription 
drug benefits to any Medicare Part D eligible individual must disclose 
whether their prescription drug benefit is creditable (expected to pay 
at least as much, on average, as the standard prescription drug plan 
under Medicare). The disclosure must be provided annually and upon any 
change that affects whether the coverage is creditable prescription 
drug coverage. Form Number: CMS-10198 (OCN: 0938-1013). Frequency: 
Yearly and semi-annually; Affected Public: Business or other for-
profits and not-for-profit institutions, State, Local, or Tribal 
Governments. Number of Respondents: 85,610; Total Annual Responses: 
87,265; Total Annual Hours: 7,272. (For policy questions regarding this

[[Page 38988]]

collection contact Roslyn Thomas at 410-786-9621.)
    7. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Medicare Advantage Program Requirements; Use: Medicare Advantage (MA) 
organizations and potential MA organizations (applicants) use the 
information to comply with the application requirements and the MA 
contract requirements. We will use this information to: Approve 
contract applications, monitor compliance with contract requirements, 
make proper payment to MA organizations, determine compliance with the 
new prescription drug benefit requirements, and to ensure that correct 
information is disclosed to Medicare beneficiaries (both potential 
enrollees and enrollees). Form Number: CMS-R-267 (OCN: 0938-0753). 
Frequency: Yearly. Affected Public: Individuals or households and 
Business or other for-profits; Number of Respondents: 18,043,776; Total 
Annual Responses: 21,935,728; Total Annual Hours: 8,529,541. (For 
policy questions regarding this collection contact Dana Burley at 410-
786-4547.)
    8. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Solicitation for 
Applications for Medicare Prescription Drug Plan 2015 Contracts; Use: 
The information will be collected under the solicitation of proposals 
from prescription drug plans, Medicare Advantage (MA) plans that offer 
integrated prescription drug and health care coverage, Cost Plans, 
PACE, and EGWP applicants. We will use the information collected to 
ensure that applicants meet our requirements and to support the 
determination of contract awards. Form Number: CMS-10137 (OCN: 0938-
0936); Frequency: Yearly; Affected Public: Business or other for-
profits and Not-for-profits institutions; Number of Respondents: 254; 
Total Annual Responses: 254; Total Annual Hours: 2,319. (For policy 
questions regarding this collection contact Linda Anders at 410-786-
0459.)
    9. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: Application for Hospital Insurance Benefits for Individuals 
with End Stage Renal Disease; Use: The CMS-43 application is used (in 
conjunction with CMS-2728) to establish entitlement to, and enrollment 
in, Medicare Part A (and Part B) for individuals with end stage renal 
disease. The application is completed by a Social Security 
Administration (SSA) claims representative or field representative 
using information provided by the individual during an interview. The 
CMS-43 application follows the questions and requirements used by SSA 
to determine Title II eligibility. This is done not only for 
consistency purposes, but because certain Title II and Title XVIII 
insured status and relationship requirements must be met in order to 
qualify for Medicare under the end stage renal disease provisions. Form 
Number: CMS-43 (OCN: 0938-0800); Frequency: Once; Affected Public: 
Individuals or households; Number of Respondents: 60,000; Total Annual 
Responses: 60,000; Total Annual Hours: 24,960. (For policy questions 
regarding this collection contact Lindsay Smith at 410-786-6843.)
    10. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: Request for Termination of Premium Hospital and 
Supplementary Medical Insurance; Use: The CMS-1763 provides us and the 
Social Security Administration (SSA) with the enrollee's request for 
termination of Part B, Part A or both Part B and A premium coverage. 
The form is completed by an SSA claims or field representative using 
information provided by the Medicare enrollee during an interview. The 
purpose of the form is to provide to the enrollee with a standardized 
format to request termination of Part B, Part A premium coverage or 
both, explain why the enrollee wishes to terminate such coverage, and 
to acknowledge that the ramifications of the decision are understood. 
Form Number: CMS-1763 (OCN: 0938-0025); Frequency: Once; Affected 
Public: Individuals or households; Number of Respondents: 14,000; Total 
Annual Responses: 14,000; Total Annual Hours: 5,833. (For policy 
questions regarding this collection contact Lindsay Smith at 410-786-
6843.)
    11. Type of Information Collection Request: Extension without 
change of a currently approved collection; Title of Information 
Collection: Home Health Agency Cost Report; Use: In accordance with 
sections 1815(a), 1833(e) and 1861(v)(1)(A) of the Social Security Act, 
providers of service in the Medicare program are required to submit 
annual information to achieve reimbursement for health care services 
rendered to Medicare beneficiaries. In addition, 42 CFR 413.20(b) 
requires that cost reports are required from providers on an annual 
basis. Such cost reports are required to be filed with the provider's 
Medicare contractor. The Medicare contractor uses the cost report not 
only to make settlement with the provider for the fiscal period covered 
by the cost report, but also in deciding whether to audit the records 
of the provider. Section 413.24(a) requires providers receiving payment 
on the basis of reimbursable cost provide adequate cost data based on 
their financial and statistical records that must be capable of 
verification by qualified auditors. Besides determining program 
reimbursement, the data submitted on the cost reports supports the 
management of federal programs. The data is extracted from the cost 
report and used for making projections of Medicare Trust Fund 
requirements and for analysis to rebase home health agency prospective 
payment system. The data is also available to Congress, researchers, 
universities, and other interested parties. While the collection of 
data is a secondary function of the cost report, its primary function 
is to reimburse providers for services rendered to program 
beneficiaries. Form Number: CMS-1728-94 (OCN: 0938-0022): Frequency: 
Yearly; Affected Public: Business or other for-profits and Not-for-
profit institutions; Number of Respondents: 11,563; Total Annual 
Responses: 11,563; Total Annual Hours: 2,613,238. (For policy questions 
regarding this collection contact Angela Havrilla at 410-786-4516.)
    12. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: Collection of Prescription Drug Event Data from Contracted 
Part D Providers for Payment; Use: The information users for this 
information collection request include Pharmacy Benefit Managers, third 
party administrators and pharmacies and prescription drug plans, 
Medicare Advantage plans that offer integrated prescription drug and 
health care coverage, Fallbacks and other plans that offer coverage of 
outpatient prescription drugs under the Medicare Part D benefit to 
Medicare beneficiaries. The data is used primarily for payment, but is 
also used for claim validation as well as for other legislated 
functions such as quality monitoring, program integrity, and oversight. 
Form Number: CMS-10174 (OCN: 0938-0982); Frequency: Monthly; Affected 
Public: Business or other for-profits and Not-for-profit institutions; 
Number of Respondents: 747; Total Annual Responses: 947,881,770; Total 
Annual Hours: 1,896. (For policy questions regarding this collection 
contact Ivan Iveljic at 410-786-3312.)

[[Page 38989]]

    13. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Part C Medicare 
Advantage Reporting Requirements and Supporting Regulations; Use: There 
are a number of information users of Part C reporting, including 
central and regional office staff that use this information to monitor 
health plans and to hold them accountable for their performance. Other 
government agencies such as the Government Accountability Office have 
inquired about this information. Health plans can use this information 
to measure and benchmark their performance. CMS intends to make some of 
these data available for public reporting as ``display measures'' in 
2013. Form Number: CMS-10305 (OCN: 0938-1115); Frequency: Yearly and 
semi-annually; Affected Public: Business or other for-profits; Number 
of Respondents: 588; Total Annual Responses: 6,715; Total Annual Hours: 
200,918. (For policy questions regarding this collection contact Terry 
Lied at 410-786-8973.)
    14. Type of Information Collection Request: New Collection (Request 
for a new OMB control number; Title of Information Collection: Enrollee 
Satisfaction Survey Data Collection; Use: Section 1311(c)(4) of the 
Affordable Care Act (ACA) requires the Department of Health and Human 
Services (HHS) to develop an enrollee satisfaction survey system that 
assesses consumer experience with qualified health plans (QHPs) offered 
through an Exchange. It also requires public display of enrollee 
satisfaction information by the Exchange to allow individuals to easily 
compare enrollee satisfaction levels between comparable plans. HHS 
intends to establish an enrollee satisfaction survey system that 
assesses consumer experience with the Marketplaces and the qualified 
health plans (QHPs) offered through the Marketplaces. The surveys will 
include topics to assess consumer experience with the Marketplace such 
as enrollment and customer service, as well as experience with the 
health care system such as communication skills of providers and ease 
of access to health care services. We are considering using the 
Consumer Assessment of Health Providers and Systems (CAHPS[supreg]) 
principles (http://www.cahps.ahrq.gov/about.htm) for developing the 
surveys. We are also considering an application and approval process 
for enrollee satisfaction survey vendors who want to participate in 
collecting ESS data. The application form for survey vendors includes 
information regarding organization name and contact(s) as well as 
minimum business requirements such as relevant survey experience, 
organizational survey capacity, and quality control procedures.
    The Marketplace Survey will provide (1) actionable information that 
the Marketplaces can use to improve performance, (2) information that 
we and state regulatory organizations can use for oversight, and (3) a 
longitudinal database for future Marketplace research. The 
CAHPS[supreg] family of instruments does not have a survey that 
assesses entities similar to Marketplaces, so the Marketplace survey 
items were generated by the project team. The QHP survey will (1) help 
consumers choose among competing health plans, (2) provide actionable 
information that the QHPs can use to improve performance, (3) provide 
information that regulatory and accreditation organizations can use to 
regulate and accredit plans, and (4) provide a longitudinal database 
for consumer research. CMS plans to base the QHP survey on the 
CAHPS[supreg] Health Plan Survey.
    We are planning for two rounds of developmental testing for the 
Marketplace and QHP surveys. The 2014 survey field tests will help 
determine psychometric properties and provide an initial measure of 
performance for Marketplaces and QHPs to use for quality improvement. 
Based on field test results, there will be further refinement of the 
questionnaires and sampling designs to conduct the 2015 beta test of 
each survey. We plan to request clearance for two additional rounds of 
national implementation with public reporting of scores for each survey 
in the future. A summary of findings from the testing rounds will be 
included when requesting clearance for the additional two rounds of 
national implementation with public reporting, which will take place in 
2016 and 2017. Form Number: CMS-10488 (OCN: 0938-NEW); Frequency: 
Annually; Affected Public: Individuals and Households, Business or 
other for-profits and Not-for-profit institutions; Number of 
Respondents: 251,671; Total Annual Responses: 251,671; Total Annual 
Hours: 86,014. (For policy questions regarding this collection contact 
Kathleen Jack at 410-786-7214.)

    Dated: June 25, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2013-15558 Filed 6-27-13; 8:45 am]
BILLING CODE 4120-01-P