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