[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