81_FR_38300 81 FR 38187 - Agency Information Collection Activities: Proposed Collection; Comment Request

81 FR 38187 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 113 (June 13, 2016)

Page Range38187-38189
FR Document2016-13917

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.

Federal Register, Volume 81 Issue 113 (Monday, June 13, 2016)
[Federal Register Volume 81, Number 113 (Monday, June 13, 2016)]
[Notices]
[Pages 38187-38189]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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



                                                                               Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Notices                                            38187

                                                  2. Type of Information Collection                     automated collection techniques or                       Personal Health Record (PHR) User
                                                Request: Revision of a currently                        other forms of information technology to                 Survey
                                                approved collection; Title of                           minimize the information collection                    CMS–R–246 Medicare Advantage,
                                                Information Collection: Electronic                      burden.                                                  Medicare Part D, and Medicare Fee-
                                                Funds Transfer Authorization                            DATES: Comments must be received by                      For-Service Consumer Assessment of
                                                Agreement; Use: The information is                      August 12, 2016.                                         Healthcare Providers and Systems
                                                needed to allow providers to receive                                                                             (CAHPS) Survey
                                                                                                        ADDRESSES: When commenting, please
                                                funds electronically in their bank                                                                               Under the PRA (44 U.S.C. 3501–
                                                                                                        reference the document identifier or
                                                accounts. Form Number: CMS–588                                                                                 3520), federal agencies must obtain
                                                                                                        OMB control number. To be assured
                                                (OMB control number: 0938–0626);                                                                               approval from the Office of Management
                                                                                                        consideration, comments and
                                                Frequency: On occasion; Affected                                                                               and Budget (OMB) for each collection of
                                                                                                        recommendations must be submitted in
                                                Public: Business or other for-profit, Not-                                                                     information they conduct or sponsor.
                                                                                                        any one of the following ways:
                                                for-profit institutions; Number of                        1. Electronically. You may send your                 The term ‘‘collection of information’’ is
                                                Respondents: 45,807; Total Annual                       comments electronically to http://                     defined in 44 U.S.C. 3502(3) and 5 CFR
                                                Responses: 45,807; Total Annual Hours:                  www.regulations.gov. Follow the                        1320.3(c) and includes agency requests
                                                22,543. (For policy questions regarding                 instructions for ‘‘Comment or                          or requirements that members of the
                                                this collection contact Kimberly                        Submission’’ or ‘‘More Search Options’’                public submit reports, keep records, or
                                                McPhillips at 410–786–4645.)                            to find the information collection                     provide information to a third party.
                                                   Dated: June 7, 2016.                                 document(s) that are accepting                         Section 3506(c)(2)(A) of the PRA
                                                William N. Parham, III,                                 comments.                                              requires federal agencies to publish a
                                                Director, Paperwork Reduction Staff, Office               2. By regular mail. You may mail                     60-day notice in the Federal Register
                                                of Strategic Operations and Regulatory                  written comments to the following                      concerning each proposed collection of
                                                Affairs.                                                address: CMS, Office of Strategic                      information, including each proposed
                                                [FR Doc. 2016–13800 Filed 6–10–16; 8:45 am]             Operations and Regulatory Affairs,                     extension or reinstatement of an existing
                                                BILLING CODE 4120–01–P                                  Division of Regulations Development.                   collection of information, before
                                                                                                          Attention: Document Identifier/OMB                   submitting the collection to OMB for
                                                                                                        Control Number, Room C4–26–05, 7500                    approval. To comply with this
                                                DEPARTMENT OF HEALTH AND                                Security Boulevard, Baltimore,                         requirement, CMS is publishing this
                                                HUMAN SERVICES                                          Maryland 21244–1850.                                   notice.
                                                                                                          To obtain copies of a supporting                       1. Type of Information Collection
                                                Centers for Medicare & Medicaid                         statement and any related forms for the                Request: Revision of a currently
                                                Services                                                proposed collection(s) summarized in                   approved collection; Title of
                                                [Document Identifiers: CMS–10105, CMS–                  this notice, you may make your request                 Information Collection: National
                                                10191, CMS–10525, CMS–10623, and CMS–                   using one of following:                                Implementation of the In-Center
                                                R–246]                                                    1. Access CMS’ Web site address at                   Hemodialysis CAHPS Survey; Use: Data
                                                                                                        http://www.cms.hhs.gov/                                collected in the national
                                                Agency Information Collection                           PaperworkReductionActof1995.                           implementation of the In-center
                                                Activities: Proposed Collection;                          2. Email your request, including your                Hemodialysis Consumer Assessment of
                                                Comment Request                                         address, phone number, OMB number,                     Healthcare Providers and Systems
                                                AGENCY: Centers for Medicare &                          and CMS document identifier, to                        (CAHPS) Survey will be used to: (1)
                                                Medicaid Services, HHS.                                 Paperwork@cms.hhs.gov.                                 Provide a source of information from
                                                                                                          3. Call the Reports Clearance Office at              which selected measures can be
                                                ACTION: Notice.
                                                                                                        (410) 786–1326.                                        publicly reported to beneficiaries as a
                                                SUMMARY:   The Centers for Medicare &                   FOR FURTHER INFORMATION CONTACT:                       decision aid for dialysis facility
                                                Medicaid Services (CMS) is announcing                   Reports Clearance Office at (410) 786–                 selection, (2) aid facilities with their
                                                an opportunity for the public to                        1326.                                                  internal quality improvement efforts
                                                comment on CMS’ intention to collect                    SUPPLEMENTARY INFORMATION:                             and external benchmarking with other
                                                information from the public. Under the                                                                         facilities, (3) provide CMS with
                                                Paperwork Reduction Act of 1995 (the                    Contents                                               information for monitoring and public
                                                PRA), federal agencies are require; to                    This notice sets out a summary of the                reporting purposes, and (4) support the
                                                publish notice in the Federal Register                  use and burden associated with the                     end-stage renal disease value-based
                                                concerning each proposed collection of                  following information collections. More                purchasing program. Form Number:
                                                information (including each proposed                    detailed information can be found in                   CMS–10105 (OMB control number:
                                                extension or reinstatement of an existing               each collection’s supporting statement                 0938–0926). Frequency: Occasionally;
                                                collection of information) and to allow                 and associated materials (see                          Affected Public: Individuals or
                                                60 days for public comment on the                       ADDRESSES).                                            households; Number of Respondents:
                                                proposed action. Interested persons are                 CMS–10105 National Implementation of                   109,328; Total Annual Responses:
                                                invited to send comments regarding our                    In-Center Hemodialysis CAHPS                         109,328; Total Annual Hours: 59,037.
                                                burden estimates or any other aspect of                   Survey                                               (For policy questions regarding this
                                                this collection of information, including               CMS–10191 Medicare Parts C and D                       collection contact Elizabeth Goldstein at
                                                any of the following subjects: (1) The                                                                         410–786–6665.)
srobinson on DSK5SPTVN1PROD with NOTICES




                                                                                                          Program Audit Protocols and Data
                                                necessity and utility of the proposed                     Requests                                               2. Type of Information Collection
                                                information collection for the proper                   CMS–10525 Program of all-Inclusive                     Request: Revision of a currently
                                                performance of the agency’s functions;                    Care for the Elderly (PACE) Quality                  approved collection; Title of
                                                (2) the accuracy of the estimated                         Data Entry in CMS Health Plan                        Information Collection: Medicare Parts
                                                burden; (3) ways to enhance the quality,                  Monitoring System                                    C and D Program Audit Protocols and
                                                utility, and clarity of the information to              CMS–10623 Testing Experience and                       Data Requests; Use: Under the Medicare
                                                be collected; and (4) the use of                          Functional Tools Demonstration:                      Prescription Drug, Improvement, and


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                                                38188                          Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Notices

                                                Modernization Act of 2003 and                           Hours: 13,640. (For policy questions                   three PACE Quality measures adopted
                                                implementing regulations at 42 CFR                      regarding this collection contact Dawn                 from the National Quality Forum (NQF)
                                                parts 422 and 423, Medicare Part D plan                 Johnson at 410–786–3159.)                              and modified for PACE use. These
                                                sponsors and Medicare Advantage                            3. Type of Information Collection                   modified PACE quarterly measures are
                                                organizations are required to comply                    Request: Revision of a currently                       Falls, Falls with Injury, and Pressure
                                                with all Medicare Parts C and D                         approved collection; Title of                          Injury Prevalence/Prevention. Currently,
                                                program requirements. In 2010, the                      Information Collection: Program of all-                the existing Level I and Level II
                                                explosive growth of these sponsoring                    Inclusive Care for the Elderly (PACE)                  elements have not been tested for
                                                organizations forced CMS to develop an                  Quality Data Entry in CMS Health Plan                  reliability or feasibility. By adopting
                                                audit strategy to ensure we continue to                 Monitoring System; Use: PACE                           NQF defined reliable data collection
                                                obtain meaningful audit results. As a                   organizations coordinate the care of                   process for these elements, certain
                                                result, CMS’ audit strategy reflected a                 each participant enrolled in the program               existing Level I and Level II elements
                                                move to a more targeted, data-driven                    based on his or her individual needs                   will then officially meet quality
                                                and risk-based audit approach. We                       with the goal of enabling older                        measures collection standards. These
                                                focused on high-risk areas that have the                individuals to remain in their                         measures will be used to improve
                                                greatest potential for beneficiary harm.                community. To be eligible to enroll in                 quality of care for participants in PACE.
                                                   To maximize resources, CMS will                      PACE, an individual must: be 55 or                     PACE Quality measures will be
                                                focus on assisting the industry to                      older, live in the service area of a PACE              implemented via the existing HPMS.
                                                improve their operations to ensure                      organization (PO), need a nursing home-                POs will be educated on data criteria,
                                                beneficiaries receive access to care. One               level of care (as certified by the state in            entry and will report quarterly. Form
                                                way to accomplish this is CMS will                      which he or she lives), and be able to                 Number: CMS–10525 (OMB control
                                                develop an annual audit strategy which                  live safely in the community with                      number: 0938–1264); Frequency:
                                                describes how sponsors will be selected                 assistance from PACE (42 CFR                           Quarterly and occasionally; Affected
                                                for audit and the areas that will be                    460.150(b)).                                           Public: Private sector (Business or other
                                                audited. CMS has developed several                         The PACE program provides                           for-profits and Not-for-profit
                                                audit protocols and these are posted to                 comprehensive care whereby an                          institutions); Number of Respondents:
                                                the CMS Web site each year for use by                   interdisciplinary team of health                       100; Total Annual Responses: 29,500;
                                                sponsors to prepare for their audit.                    professionals provides individuals with                Total Annual Hours: 211,500. (For
                                                Currently CMS utilizes the following 7                  coordinated care. The overall quality of               policy questions regarding this
                                                protocols to audit sponsor performance:                 care is analyzed by information                        collection contact Tamika Gladney at
                                                Formulary Administration (FA),                          collected and reported to CMS related to               410–786–0648).
                                                Coverage Determinations, Appeals &                      specific quality indicators that may                      4. Type of Information Collection
                                                Grievances (CDAG), Organization                         cause potential or actual harm. CMS                    Request: New collection (Request for a
                                                Determination, Appeals and Grievances                   analyzes the quality data to identify                  new OMB control number); Title of
                                                (ODAG), Special Needs Model of Care                     opportunities to improve the quality of                Information Collection: Testing
                                                (SNPMOC) (only administered on                          care, safety and PACE sustainability and               Experience and Functional Tools
                                                organizations who operate SNPs),                        growth.                                                Demonstration: Personal Health Record
                                                Compliance Program Effectiveness                           Previously, quality reporting was                   (PHR) User Survey; Use: The PHR user
                                                (CPE), Medication Therapy Management                    identified as Level I or Level II                      survey is important to the TEFT
                                                (MTM) and Provider Network Accuracy                     reporting. Level I reporting                           Program Evaluation and understanding
                                                (PNA). The data collected is detailed in                requirements refer to those data                       the impact of the TEFT PHR on
                                                each of these protocols and the exact                   elements that POs regularly report to                  Medicaid CB–LTSS beneficiaries. The
                                                fields are located in the record layouts,               CMS via the CMS Health Plan                            TEFT evaluation team’s approach
                                                at the end of each protocol. In addition,               Management System (HPMS) PACE                          includes monitoring state PHR
                                                questionnaires are distributed as part of               monitoring module. (Please see                         implementation efforts and fielding a
                                                our CDAG, ODAG and CPE audits.                          Appendix A for the list of data                        follow-up questionnaire to CB–LTSS
                                                These questionnaires are also included                  elements.) POs have been collecting,                   program participants that asks about
                                                in this package.                                        submitting and reporting data to CMS                   their experiences using the PHR. The
                                                   As part of a robust audit process, CMS               and State administering agencies (SAA)                 evaluation seeks to measure the degree
                                                also requires sponsors who have been                    since 1999.                                            to which the PHR is implemented in an
                                                audited and found to have deficiencies                     When analyzing the Level I data,                    accessible manner for Medicaid
                                                to undergo a validation audit to ensure                 findings may or may not trigger a                      beneficiaries of CB–LTSS. The survey
                                                correction. The validation audit utilizes               Quality Improvement (QI) process of                    also is designed to assess the user
                                                the same audit protocols, but only tests                analysis (e.g., Plan, Do, Study, Act                   experience of the PHR, including access
                                                the elements where deficiencies were                    known as PDSA). Findings may indicate                  and usability, as well as some measures
                                                found, as opposed to re-administering                   the need for a change in policies,                     of user satisfaction and perceived
                                                the entire audit. Finally, to assist in                 procedures, systems, clinical practice or              impacts of PHR use. Form Number:
                                                improving the audit process, CMS sends                  training. Level II reporting requirements              CMS–10623 (OMB control number:
                                                sponsors a link to a survey (Appendix                   apply specifically to unusual incidents                0938-New); Frequency: Once; Affected
                                                D) at the end of each audit to complete                 that result in serious adverse participant             Public: Individuals and households;
                                                in order to obtain the sponsors’                        outcomes, or negative national or                      Number of Respondents: 824; Total
                                                feedback. The sponsor is not required to                regional notoriety related to PACE.
srobinson on DSK5SPTVN1PROD with NOTICES




                                                                                                                                                               Annual Responses: 824; Total Annual
                                                complete the survey. Form Number:                          In this PRA package, we are making                  Hours: 192,113 (For policy questions
                                                CMS–10191 (OMB control number:                          title changes from Level I and Level II                regarding this collection contact Kerry
                                                0938–1000); Frequency: Yearly; Affected                 to PACE Quality Data. We are requesting                Lida at 410–786–4826).
                                                Public: Private Sector (business or other               to update and implement previously                        5. Type of Information Collection
                                                for-profit and not-for-profit institutions);            collected PACE data elements known as                  Request: Revision of a currently
                                                Number of Respondents: 40; Total                        Level I and Level II into PACE quality                 approved collection; Title of
                                                Annual Responses: 40; Total Annual                      data. Additionally, we are establishing                Information Collection: Medicare


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                                                                               Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Notices                                              38189

                                                Advantage, Medicare Part D, and                         collection for the proper performance of                 1. Type of Information Collection
                                                Medicare Fee-For-Service Consumer                       the agency’s functions; (2) the accuracy               Request: Extension of a currently
                                                Assessment of Healthcare Providers and                  of the estimated burden; (3) ways to                   approved collection; Title of
                                                Systems (CAHPS) Survey; Use: The                        enhance the quality, utility, and clarity              Information Collection: Detailed Notice
                                                primary purpose of the Medicare                         of the information to be collected; and                of Discharge (DND) and Supporting
                                                consumer assessment of healthcare                       (4) the use of automated collection                    Regulations in 42 CFR 405.1206 and
                                                providers and systems (CAHPS) surveys                   techniques or other forms of information               422.622; Use: A beneficiary or enrollee
                                                is to provide information to Medicare                   technology to minimize the information                 who wishes to appeal a determination
                                                beneficiaries to help them make more                    collection burden.                                     by a Medicare health plan (for a
                                                informed choices among health and                       DATES: Comments on the collection(s) of                managed care enrollee) or hospital (for
                                                prescription drug plans available to                    information must be received by the                    an original Medicare beneficiary) that
                                                them. The surveys also provides data to                 OMB desk officer by July 13, 2016.                     inpatient care is no longer necessary
                                                help CMS and others monitor the                                                                                may request Quality Improvement
                                                                                                        ADDRESSES: When commenting on the
                                                quality and performance of Medicare                                                                            Organization (QIO) review of the
                                                health and prescription drug plans and                  proposed information collections,
                                                                                                        please reference the document identifier               determination. On the date the QIO
                                                identify areas to improve the quality of                                                                       receives the beneficiary’s/enrollee’s
                                                care and services provided to enrollees                 or OMB control number. To be assured
                                                                                                        consideration, comments and                            request, it must notify the plan and
                                                of these plans. Form Number: CMS–R–
                                                                                                        recommendations must be received by                    hospital that the beneficiary/enrollee
                                                246 (OMB control number: 0938–0732);
                                                                                                        the OMB desk officer via one of the                    has filed a request for an expedited
                                                Frequency: Yearly; Affected Public:
                                                Individuals and households; Number of                   following transmissions: OMB, Office of                determination. The plan or hospital, in
                                                Respondents: 799,650; Total Annual                      Information and Regulatory Affairs,                    turn, must deliver a DND to the
                                                Responses: 799,650; Total Annual                        Attention: CMS Desk Officer, Fax                       enrollee/beneficiary. In this iteration the
                                                Hours: 192,113 (For policy questions                    Number: (202) 395–5806 OR Email:                       DND has been minimally changed to
                                                regarding this collection contact Sarah                 OIRA_submission@omb.eop.gov.                           include language informing
                                                Gaillot at 410–786–4637).                                 To obtain copies of a supporting                     beneficiaries of their rights under the
                                                                                                        statement and any related forms for the                Rehabilitation Act of 1973 (section 504),
                                                   Dated: June 8, 2016.
                                                                                                        proposed collection(s) summarized in                   by alerting the beneficiary to CMS’s
                                                William N. Parham, III,                                 this notice, you may make your request                 nondiscrimination practices and the
                                                Director, Paperwork Reduction Staff, Office             using one of following:                                availability of alternate forms of this
                                                of Strategic Operations and Regulatory
                                                                                                          1. Access CMS’ Web site address at                   notice if needed. There are no
                                                Affairs.
                                                                                                        http://www.cms.hhs.gov/Paperwork                       substantive changes to the DND form
                                                [FR Doc. 2016–13917 Filed 6–10–16; 8:45 am]
                                                                                                        ReductionActof1995.                                    and instructions. Form Number: CMS–
                                                BILLING CODE 4120–01–P
                                                                                                          2. Email your request, including your                10066 (OMB control number: 0938–
                                                                                                        address, phone number, OMB number,                     1019); Frequency: Occasionally;
                                                DEPARTMENT OF HEALTH AND                                and CMS document identifier, to                        Affected Public: Private sector (Business
                                                HUMAN SERVICES                                          Paperwork@cms.hhs.gov.                                 or other for-profit and Not-for-profit
                                                                                                          3. Call the Reports Clearance Office at              institutions); Number of Respondents:
                                                Centers for Medicare & Medicaid                         (410) 786–1326.                                        6,137; Total Annual Responses: 22,515;
                                                Services                                                FOR FURTHER INFORMATION CONTACT:                       Total Annual Hours: 22,515. (For policy
                                                                                                        Reports Clearance Office at (410) 786–                 questions regarding this collection
                                                [Document Identifiers: CMS–10066, CMS–
                                                                                                        1326.                                                  contact Janet Miller at 404–562–1799.)
                                                R–193, and CMS–R–282]
                                                                                                        SUPPLEMENTARY INFORMATION:     Under the                 2. Type of Information Collection
                                                Agency Information Collection                           Paperwork Reduction Act of 1995 (PRA)                  Request: Extension of a currently
                                                Activities: Submission for OMB                          (44 U.S.C. 3501–3520), federal agencies                approved collection; Title of
                                                Review; Comment Request                                 must obtain approval from the Office of                Information Collection: Important
                                                                                                        Management and Budget (OMB) for each                   Message from Medicare (IM); Use:
                                                ACTION:   Notice.                                                                                              Hospitals have used the IM to inform
                                                                                                        collection of information they conduct
                                                SUMMARY:    The Centers for Medicare &                  or sponsor. The term ‘‘collection of                   original Medicare, Medicare Advantage,
                                                Medicaid Services (CMS) is announcing                   information’’ is defined in 44 U.S.C.                  and other Medicare plan beneficiaries
                                                an opportunity for the public to                        3502(3) and 5 CFR 1320.3(c) and                        who are hospital inpatients about their
                                                comment on CMS’ intention to collect                    includes agency requests or                            hospital rights and discharge rights. In
                                                information from the public. Under the                  requirements that members of the public                particular, the IM provides information
                                                Paperwork Reduction Act of 1995                         submit reports, keep records, or provide               about when a beneficiary will and will
                                                (PRA), federal agencies are required to                 information to a third party. Section                  not be liable for charges for a continued
                                                publish a notice in the Federal Register                3506(c)(2)(A) of the PRA (44 U.S.C.                    stay in a hospital and offers a detailed
                                                concerning each proposed collection of                  3506(c)(2)(A)) requires federal agencies               description of the Quality Improvement
                                                information, including each proposed                    to publish a 30-day notice in the                      Organization review process. Please
                                                extension or reinstatement of an existing               Federal Register concerning each                       note that this iteration proposes non-
                                                collection of information, and to allow                 proposed collection of information,                    substantive changes to the form. Form
                                                a second opportunity for public                         including each proposed extension or                   Number: CMS–R–193 (OMB control
srobinson on DSK5SPTVN1PROD with NOTICES




                                                comment on the notice. Interested                       reinstatement of an existing collection                number: 0938–0692). Frequency: Yearly;
                                                persons are invited to send comments                    of information, before submitting the                  Affected Public: Private sector (Business
                                                regarding the burden estimate or any                    collection to OMB for approval. To                     or other for-profit and Not-for-profit
                                                other aspect of this collection of                      comply with this requirement, CMS is                   institutions); Number of Respondents:
                                                information, including any of the                       publishing this notice that summarizes                 6,142; Total Annual Responses:
                                                following subjects: (1) The necessity and               the following proposed collection(s) of                23,680,000; Total Annual Hours:
                                                utility of the proposed information                     information for public comment:                        3,404,000. (For policy questions


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Document Created: 2018-02-08 07:39:27
Document Modified: 2018-02-08 07:39:27
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments must be received by August 12, 2016.
ContactReports Clearance Office at (410) 786- 1326.
FR Citation81 FR 38187 

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