[Federal Register Volume 81, Number 232 (Friday, December 2, 2016)]
[Notices]
[Pages 87039-87041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10340, CMS-10476, CMS-10525, and CMS-10630]


Agency Information Collection Activities: Submission for OMB 
Review; 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 a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate or any

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other aspect of this collection of information, including any of the 
following subjects: The necessity and utility of the proposed 
information collection for the proper performance of the agency's 
functions; the accuracy of the estimated burden; ways to enhance the 
quality, utility, and clarity of the information to be collected; and 
the use of automated collection techniques or other forms of 
information technology to minimize the information collection burden.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by January 3, 2017.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-5806 OR, Email: 
[email protected].
    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: 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 (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-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 that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Collection of 
Encounter Data From: Medicare Advantage Organizations, Section 1876 
Cost HMOS/CMPS, Section 1833 Health Care Prepayment Plans (HCPPS), and 
PACE Organizations; Use: We collect encounter data or data on each item 
or service delivered to enrollees of Medicare Advantage (MA) plans 
offered by MA organizations. The MA organizations currently obtain this 
data from providers. We collect this information using standard 
transaction forms and code sets. We will use the data for determining 
risk adjustment factors for payment, updating the risk adjustment 
model, calculating Medicare DSH percentages, Medicare coverage 
purposes, and quality review and improvement activities. The data is 
also used to verify the accuracy and validity of the costs claimed on 
cost reports. For PACE organizations, encounter data would serve the 
same purpose it does related to the MA program and would be submitted 
in a similar manner. Form Number: CMS-10340 (OMB control number: 0938-
1152); Frequency: Weekly, bi-weekly, and monthly; Affected Public: 
Private sector (Business or other for-profits); Number of Respondents: 
691; Total Annual Responses: 18,854,605; Total Annual Hours: 54,054. 
(For policy questions regarding this collection contact Michael 
Massimini at 410-786-1566.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medical Loss 
Ratio (MLR) Report for Medicare Advantage (MA) Plans and Prescription 
Drug Plans (PDP); Use: We will use the data collection of annual 
reports provided by plan sponsors for each contract to ensure that 
beneficiaries are receiving value for their premium dollar by 
calculating each contract's medical loss ratio (MLR) and any 
remittances due for the respective MLR reporting year. The 
recordkeeping requirements will be used to determine plan sponsors' 
compliance with the MLR requirements, including compliance with how 
plan sponsors' experience is to be reported, and how their MLR and any 
remittances are calculated. Form Number: CMS-10476 (OMB control number: 
0938-1232); Frequency: Yearly; Affected Public: Private sector 
(Business or other for-profits and Not-for-profit institutions); Number 
of Respondents: 616; Total Annual Responses: 616; Total Annual Hours: 
130,004. (For policy questions regarding this collection contact Diane 
Spitalnic at 410-786-5745.)
    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

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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: The 
PACE Organization (PO) Monitoring and Audit Process in 42 CFR part 460; 
Use: Historically, the Programs of All-Inclusive Care for the Elderly 
(PACE) audit protocols have been included in the Medicare Advantage 
(MA) and Medicare Part D audit protocol's information collection 
request (CMS-10191, OMB 0938-1000). However, in examining previous 
submissions, we do not believe that including it with the MA and Part D 
audit protocols allowed for an accurate representation of the PACE 
burden. Due to PACE audits being substantially different from our MA 
and Part D audits, we have separated the PACE audit protocols from the 
MA and Part D protocols and created this information collection request 
which seeks OMB approval under a new control number.
    POs are required to comply with all PACE program requirements. The 
growth of these PACE 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 outcomes-based audit approach. We focused on high-risk areas 
that have the greatest potential for participant harm.
    CMS has developed an audit protocol and will post it to the CMS Web 
site each year for use by POs to prepare for their audit. The data 
collected for audit is detailed in this protocol and the exact fields 
are located in the record layouts, at the end of the protocol. In 
addition, a questionnaire will be distributed as part of our audit. 
This questionnaire is also included in this package. Form Number: CMS-
10630 (OMB control number: 0938--New); Frequency: Yearly; Affected 
Public: Private sector (Business or other for-profits and Not-for-
profits institutions); Number of Respondents: 72; Total Annual 
Responses: 72; Total Annual Hours: 12,960. (For policy questions 
regarding this collection contact Caroline Zeman at 410-786-0116.)

    Dated: November 29, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-29007 Filed 12-1-16; 8:45 am]
 BILLING CODE 4120-01-P