[Federal Register Volume 81, Number 113 (Monday, June 13, 2016)]
[Notices]
[Pages 38187-38189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13917]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10105, CMS-10191, CMS-10525, CMS-10623, and 
CMS-R-246]


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 (the PRA), federal agencies are require; 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 12, 2016.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. 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: 

Contents

    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-10105 National Implementation of In-Center Hemodialysis CAHPS 
Survey
CMS-10191 Medicare Parts C and D Program Audit Protocols and Data 
Requests
CMS-10525 Program of all-Inclusive Care for the Elderly (PACE) Quality 
Data Entry in CMS Health Plan Monitoring System
CMS-10623 Testing Experience and Functional Tools Demonstration: 
Personal Health Record (PHR) User Survey
CMS-R-246 Medicare Advantage, Medicare Part D, and Medicare Fee-For-
Service Consumer Assessment of Healthcare Providers and Systems (CAHPS) 
Survey

    Under the 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.
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: National 
Implementation of the In-Center Hemodialysis CAHPS Survey; Use: Data 
collected in the national implementation of the In-center Hemodialysis 
Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey 
will be used to: (1) Provide a source of information from which 
selected measures can be publicly reported to beneficiaries as a 
decision aid for dialysis facility selection, (2) aid facilities with 
their internal quality improvement efforts and external benchmarking 
with other facilities, (3) provide CMS with information for monitoring 
and public reporting purposes, and (4) support the end-stage renal 
disease value-based purchasing program. Form Number: CMS-10105 (OMB 
control number: 0938-0926). Frequency: Occasionally; Affected Public: 
Individuals or households; Number of Respondents: 109,328; Total Annual 
Responses: 109,328; Total Annual Hours: 59,037. (For policy questions 
regarding this collection contact Elizabeth Goldstein at 410-786-6665.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare Parts C 
and D Program Audit Protocols and Data Requests; Use: Under the 
Medicare Prescription Drug, Improvement, and

[[Page 38188]]

Modernization Act of 2003 and implementing regulations at 42 CFR parts 
422 and 423, Medicare Part D plan sponsors and Medicare Advantage 
organizations are required to comply with all Medicare Parts C and D 
program requirements. In 2010, the explosive growth of these sponsoring 
organizations forced CMS to develop an audit strategy to ensure we 
continue to obtain meaningful audit results. As a result, CMS' audit 
strategy reflected a move to a more targeted, data-driven and risk-
based audit approach. We focused on high-risk areas that have the 
greatest potential for beneficiary harm.
    To maximize resources, CMS will focus on assisting the industry to 
improve their operations to ensure beneficiaries receive access to 
care. One way to accomplish this is CMS will develop an annual audit 
strategy which describes how sponsors will be selected for audit and 
the areas that will be audited. CMS has developed several audit 
protocols and these are posted to the CMS Web site each year for use by 
sponsors to prepare for their audit. Currently CMS utilizes the 
following 7 protocols to audit sponsor performance: Formulary 
Administration (FA), Coverage Determinations, Appeals & Grievances 
(CDAG), Organization Determination, Appeals and Grievances (ODAG), 
Special Needs Model of Care (SNPMOC) (only administered on 
organizations who operate SNPs), Compliance Program Effectiveness 
(CPE), Medication Therapy Management (MTM) and Provider Network 
Accuracy (PNA). The data collected is detailed in each of these 
protocols and the exact fields are located in the record layouts, at 
the end of each protocol. In addition, questionnaires are distributed 
as part of our CDAG, ODAG and CPE audits. These questionnaires are also 
included in this package.
    As part of a robust audit process, CMS also requires sponsors who 
have been audited and found to have deficiencies to undergo a 
validation audit to ensure correction. The validation audit utilizes 
the same audit protocols, but only tests the elements where 
deficiencies were found, as opposed to re-administering the entire 
audit. Finally, to assist in improving the audit process, CMS sends 
sponsors a link to a survey (Appendix D) at the end of each audit to 
complete in order to obtain the sponsors' feedback. The sponsor is not 
required to complete the survey. Form Number: CMS-10191 (OMB control 
number: 0938-1000); Frequency: Yearly; Affected Public: Private Sector 
(business or other for-profit and not-for-profit institutions); Number 
of Respondents: 40; Total Annual Responses: 40; Total Annual Hours: 
13,640. (For policy questions regarding this collection contact Dawn 
Johnson at 410-786-3159.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Program of all-
Inclusive Care for the Elderly (PACE) Quality Data Entry in CMS Health 
Plan Monitoring System; Use: PACE organizations coordinate the care of 
each participant enrolled in the program based on his or her individual 
needs with the goal of enabling older individuals to remain in their 
community. To be eligible to enroll in PACE, an individual must: be 55 
or older, live in the service area of a PACE organization (PO), need a 
nursing home-level of care (as certified by the state in which he or 
she lives), and be able to live safely in the community with assistance 
from PACE (42 CFR 460.150(b)).
    The PACE program provides comprehensive care whereby an 
interdisciplinary team of health professionals provides individuals 
with coordinated care. The overall quality of care is analyzed by 
information collected and reported to CMS related to specific quality 
indicators that may cause potential or actual harm. CMS analyzes the 
quality data to identify opportunities to improve the quality of care, 
safety and PACE sustainability and growth.
    Previously, quality reporting was identified as Level I or Level II 
reporting. Level I reporting requirements refer to those data elements 
that POs regularly report to CMS via the CMS Health Plan Management 
System (HPMS) PACE monitoring module. (Please see Appendix A for the 
list of data elements.) POs have been collecting, submitting and 
reporting data to CMS and State administering agencies (SAA) since 
1999.
    When analyzing the Level I data, findings may or may not trigger a 
Quality Improvement (QI) process of analysis (e.g., Plan, Do, Study, 
Act known as PDSA). Findings may indicate the need for a change in 
policies, procedures, systems, clinical practice or training. Level II 
reporting requirements apply specifically to unusual incidents that 
result in serious adverse participant outcomes, or negative national or 
regional notoriety related to PACE.
    In this PRA package, we are making title changes from Level I and 
Level II to PACE Quality Data. We are requesting to update and 
implement previously collected PACE data elements known as Level I and 
Level II into PACE quality data. Additionally, we are establishing 
three PACE Quality measures adopted from the National Quality Forum 
(NQF) and modified for PACE use. These modified PACE quarterly measures 
are Falls, Falls with Injury, and Pressure Injury Prevalence/
Prevention. Currently, the existing Level I and Level II elements have 
not been tested for reliability or feasibility. By adopting NQF defined 
reliable data collection process for these elements, certain existing 
Level I and Level II elements will then officially meet quality 
measures collection standards. These measures will be used to improve 
quality of care for participants in PACE. PACE Quality measures will be 
implemented via the existing HPMS. POs will be educated on data 
criteria, entry and will report quarterly. Form Number: CMS-10525 (OMB 
control number: 0938-1264); Frequency: Quarterly and occasionally; 
Affected Public: Private sector (Business or other for-profits and Not-
for-profit institutions); Number of Respondents: 100; Total Annual 
Responses: 29,500; Total Annual Hours: 211,500. (For policy questions 
regarding this collection contact Tamika Gladney at 410-786-0648).
    4. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Testing 
Experience and Functional Tools Demonstration: Personal Health Record 
(PHR) User Survey; Use: The PHR user survey is important to the TEFT 
Program Evaluation and understanding the impact of the TEFT PHR on 
Medicaid CB-LTSS beneficiaries. The TEFT evaluation team's approach 
includes monitoring state PHR implementation efforts and fielding a 
follow-up questionnaire to CB-LTSS program participants that asks about 
their experiences using the PHR. The evaluation seeks to measure the 
degree to which the PHR is implemented in an accessible manner for 
Medicaid beneficiaries of CB-LTSS. The survey also is designed to 
assess the user experience of the PHR, including access and usability, 
as well as some measures of user satisfaction and perceived impacts of 
PHR use. Form Number: CMS-10623 (OMB control number: 0938-New); 
Frequency: Once; Affected Public: Individuals and households; Number of 
Respondents: 824; Total Annual Responses: 824; Total Annual Hours: 
192,113 (For policy questions regarding this collection contact Kerry 
Lida at 410-786-4826).
    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare

[[Page 38189]]

Advantage, Medicare Part D, and Medicare Fee-For-Service Consumer 
Assessment of Healthcare Providers and Systems (CAHPS) Survey; Use: The 
primary purpose of the Medicare consumer assessment of healthcare 
providers and systems (CAHPS) surveys is to provide information to 
Medicare beneficiaries to help them make more informed choices among 
health and prescription drug plans available to them. The surveys also 
provides data to help CMS and others monitor the quality and 
performance of Medicare health and prescription drug plans and identify 
areas to improve the quality of care and services provided to enrollees 
of these plans. Form Number: CMS-R-246 (OMB control number: 0938-0732); 
Frequency: Yearly; Affected Public: Individuals and households; Number 
of Respondents: 799,650; Total Annual Responses: 799,650; Total Annual 
Hours: 192,113 (For policy questions regarding this collection contact 
Sarah Gaillot at 410-786-4637).

    Dated: June 8, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-13917 Filed 6-10-16; 8:45 am]
 BILLING CODE 4120-01-P