83 FR 13988 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 63 (April 2, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 63 (April 2, 2018)
| Page Range | 13988-13989 | |
| FR Document | 2018-06645 |
[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)] [Notices] [Pages 13988-13989] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06645] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10191] 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 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 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 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 must be received by June 1, 2018. 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' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786-1326. FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669. 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-10191 Medicare Parts C and D Program Audit and Timeliness Monitoring Data Requests 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. Information Collection 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Parts C and D Program Audit and Timeliness Monitoring Data Requests; Use: Medicare Part D plan sponsors and Medicare Advantage organizations (collectively referred to as sponsoring organizations) are required to comply with all Medicare Parts C and D program requirements. In 2010, the explosive growth of these sponsoring organizations precipitated the need for CMS to develop an annual audit strategy to ensure that we evaluate sponsoring organizations compliance with the program requirements. In addition to describing how sponsoring organizations are selected for audit and which program areas will be audited, CMS' annual audit strategy reflected a move to a more targeted, data-driven, and risk-based audit approach. Since 2010, CMS has continued to focus on assisting the industry with improving their operations to ensure beneficiaries receive appropriate access to care. CMS has developed audit protocols that focus on high-risk areas that have the greatest potential for beneficiary harm. CMS' program audit protocols are posted to the CMS website each year for use by sponsoring organizations to prepare for their audit. Currently CMS utilizes the following 5 protocols to audit sponsoring organizations' performance: Compliance Program Effectiveness (CPE), Formulary Administration (FA); Coverage Determinations, Appeals, and Grievances (CDAG); Organization Determinations, Appeals, and Grievances (ODAG), Special Needs Program Model of Care (SNP-MOC) (only administered on organizations who operate SNPs). Beginning in audit [[Page 13989]] year 2019, the SNP-MOC program area has been more accurately renamed Special Needs Program Care Coordination Quality Improvement Performance Evaluation (SNP-CCQIPE). In addition, the Medication Therapy Management (MTM) pilot protocol has been suspended until further notice. For that reason, it is no longer posted to the CMS website. Beginning in audit year 2019, the data collected via program- specific record layouts, and collected via impact analyses on an as- needed basis, will be consolidated into each program area data request document. The pre-audit issue summary was updated for technical terminology changes. Three of the questionnaires and the power point template that previously have been distributed as part of our CPE audits will remain. However, the CPE self-assessment questionnaire and the CDAG and ODAG questionnaires have been removed. We have added new questionnaires for FA and SNP-CCQIPE. A revised template for collecting root cause analyses from organizations on an as-needed basis during the program audit has been included in this package. We have also included a new independent validation audit work plan template that will be collected from sponsors that are required to undergo an independent validation audit. The validation audit is part of our robust audit process where CMS requires sponsoring organizations that 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. This validation audit work plan template will be populated by the sponsoring organization's independent auditing firm to describe how it plans to test for correction of the deficiencies identified during the program audit. To assist in improving the audit process, we have also included an audit feedback questionnaire that is representative of the survey link we send to sponsoring organizations at the end of each program audit. Completion of this questionnaire is optional for sponsoring organizations to provide feedback on the audit process. The proposed changes to each data collection instrument, along with the new FA and SNP-CCQIPE questionnaires, root cause template, validation audit work plan template and audit feedback questionnaire are included in the posted PRA package. Finally, separate from the audit process and in order to address sponsoring organizations' concerns regarding undue harm in Star Ratings during audit years. The number of sponsoring organizations that are required to submit universes annually for their coverage/organization determinations and appeals increased. In 2016, CMS expanded this annual collection to all MA and Part D sponsoring organizations. The universes are submitted in the same format as required for audits under the Part D CDAG protocol and the Part C ODAG protocol. The universes are then analyzed for timeliness on an annual basis, across all sponsoring organizations, to allow a more comprehensive review of the accuracy of Part C and D appeals data to calculate Star Ratings. 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: 166; Total Annual Responses: 211; Total Annual Hours: 51,548. (For policy questions regarding this collection contact Brenda Hudson at 443-743-9299.) Dated: March 28, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018-06645 Filed 3-30-18; 8:45 am] BILLING CODE 4120-01-P
![13988 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
the meeting that will cover briefings and this collection of information, including approval from the Office of Management
BSC deliberation on the following the necessity and utility of the proposed and Budget (OMB) for each collection of
topics: Interval updates from the OPHPR information collection for the proper information they conduct or sponsor.
Director and OPHPR Divisions and performance of the agency’s functions, The term ‘‘collection of information’’ is
Offices; updates from the Biological the accuracy of the estimated burden, defined in 44 U.S.C. 3502(3) and 5 CFR
Agent Containment working group; ways to enhance the quality, utility, and 1320.3(c) and includes agency requests
discussion of Industry, Private Sector, clarity of the information to be or requirements that members of the
and Public Health Interactions collected, and the use of automated public submit reports, keep records, or
Supporting Emergency Preparedness collection techniques or other forms of provide information to a third party.
and Response; and Preparedness information technology to minimize the Section 3506(c)(2)(A) of the PRA
Updates from Liaison Representatives. information collection burden. requires federal agencies to publish a
Day two of the meeting will cover DATES: Comments must be received by 60-day notice in the Federal Register
briefings and BSC deliberation on the June 1, 2018. concerning each proposed collection of
following topics: OPHPR Office of ADDRESSES: When commenting, please information, including each proposed
Policy, Planning and Evaluation reference the document identifier or extension or reinstatement of an existing
activities; CDC’s Data Preparedness OMB control number. To be assured collection of information, before
activities; Public Health System consideration, comments and submitting the collection to OMB for
Perspectives on Hurricanes Response; recommendations must be submitted in approval. To comply with this
and Excellence in Response Operations any one of the following ways: requirement, CMS is publishing this
Initiative. Agenda items are subject to 1. Electronically. You may send your notice.
change as priorities dictate. comments electronically to http://
The Director, Management Analysis Information Collection
www.regulations.gov. Follow the
and Services Office, has been delegated instructions for ‘‘Comment or 1. Type of Information Collection
the authority to sign Federal Register Submission’’ or ‘‘More Search Options’’ Request: Revision of a currently
notices pertaining to announcements of to find the information collection approved collection; Title of
meetings and other committee document(s) that are accepting Information Collection: Medicare Parts
management activities, for both the comments. C and D Program Audit and Timeliness
Centers for Disease Control and 2. By regular mail. You may mail Monitoring Data Requests; Use:
Prevention and the Agency for Toxic written comments to the following Medicare Part D plan sponsors and
Substances and Disease Registry. address: CMS, Office of Strategic Medicare Advantage organizations
Operations and Regulatory Affairs (collectively referred to as sponsoring
Elaine Baker,
Division of Regulations Development organizations) are required to comply
Director, Management Analysis and Services with all Medicare Parts C and D
Office, Centers for Disease Control and Attention: Document Identifier/OMB
Prevention. Control Number __ Room C4–26–05 program requirements. In 2010, the
7500 Security Boulevard Baltimore, explosive growth of these sponsoring
[FR Doc. 2018–06546 Filed 3–30–18; 8:45 am]
Maryland 21244–1850. organizations precipitated the need for
BILLING CODE 4163–19–P
To obtain copies of a supporting CMS to develop an annual audit strategy
statement and any related forms for the to ensure that we evaluate sponsoring
proposed collection(s) summarized in organizations compliance with the
DEPARTMENT OF HEALTH AND
this notice, you may make your request program requirements. In addition to
HUMAN SERVICES
using one of following: describing how sponsoring
Centers for Medicare & Medicaid 1. Access CMS’ website address at organizations are selected for audit and
Services https://www.cms.gov/Regulations-and- which program areas will be audited,
Guidance/Legislation/Paperwork CMS’ annual audit strategy reflected a
[Document Identifier: CMS–10191] ReductionActof1995/PRA-Listing.html. move to a more targeted, data-driven,
2. Email your request, including your and risk-based audit approach. Since
Agency Information Collection 2010, CMS has continued to focus on
address, phone number, OMB number,
Activities: Proposed Collection; assisting the industry with improving
and CMS document identifier, to
Comment Request their operations to ensure beneficiaries
Paperwork@cms.hhs.gov.
AGENCY: Centers for Medicare & 3. Call the Reports Clearance Office at receive appropriate access to care. CMS
Medicaid Services, HHS. (410) 786–1326. has developed audit protocols that focus
ACTION: Notice. FOR FURTHER INFORMATION CONTACT: on high-risk areas that have the greatest
William Parham at (410) 786–4669. potential for beneficiary harm.
SUMMARY: The Centers for Medicare & SUPPLEMENTARY INFORMATION: CMS’ program audit protocols are
Medicaid Services (CMS) is announcing posted to the CMS website each year for
an opportunity for the public to Contents use by sponsoring organizations to
comment on CMS’ intention to collect This notice sets out a summary of the prepare for their audit. Currently CMS
information from the public. Under the use and burden associated with the utilizes the following 5 protocols to
Paperwork Reduction Act of 1995 (the following information collections. More audit sponsoring organizations’
PRA), federal agencies are required to detailed information can be found in performance: Compliance Program
publish notice in the Federal Register each collection’s supporting statement Effectiveness (CPE), Formulary
concerning each proposed collection of and associated materials (see Administration (FA); Coverage
daltland on DSKBBV9HB2PROD with NOTICES
information (including each proposed ADDRESSES). Determinations, Appeals, and
extension or reinstatement of an existing Grievances (CDAG); Organization
collection of information) and to allow CMS–10191 Medicare Parts C and D Determinations, Appeals, and
60 days for public comment on the Program Audit and Timeliness Grievances (ODAG), Special Needs
proposed action. Interested persons are Monitoring Data Requests Program Model of Care (SNP–MOC)
invited to send comments regarding our Under the PRA (44 U.S.C. 3501– (only administered on organizations
burden estimates or any other aspect of 3520), federal agencies must obtain who operate SNPs). Beginning in audit
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![Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices 13989
year 2019, the SNP–MOC program area Finally, separate from the audit requirements related to annual
has been more accurately renamed process and in order to address performance data from State grantees
Special Needs Program Care sponsoring organizations’ concerns under the Older Americans Act related
Coordination Quality Improvement regarding undue harm in Star Ratings to Title III and Title VII (Chapters 3 and
Performance Evaluation (SNP–CCQIPE). during audit years. The number of 4) of that act. Title III includes, for
In addition, the Medication Therapy sponsoring organizations that are example, home delivered and
Management (MTM) pilot protocol has required to submit universes annually congregate meal services, transportation
been suspended until further notice. For for their coverage/organization and caregiver service; and Title VII
that reason, it is no longer posted to the determinations and appeals increased. includes Elder Abuse Prevention and
CMS website. In 2016, CMS expanded this annual Legal Assistance Development (ICR
Beginning in audit year 2019, the data collection to all MA and Part D Rev).
collected via program-specific record sponsoring organizations. The universes DATES: Submit written comments on the
layouts, and collected via impact are submitted in the same format as collection of information by May 2,
analyses on an as-needed basis, will be required for audits under the Part D 2018.
consolidated into each program area CDAG protocol and the Part C ODAG
data request document. The pre-audit protocol. The universes are then ADDRESSES: Submit written comments
issue summary was updated for analyzed for timeliness on an annual on the collection of information by:
technical terminology changes. Three of basis, across all sponsoring (a) Email to: OIRA_submission@
the questionnaires and the power point organizations, to allow a more omb.eop.gov, Attn: OMB Desk Officer
template that previously have been comprehensive review of the accuracy for ACL;
distributed as part of our CPE audits of Part C and D appeals data to calculate (b) Fax to 202.395.5806, Attn: OMB
will remain. However, the CPE self- Star Ratings. Form Number: CMS–10191 Desk Officer for ACL; or
assessment questionnaire and the CDAG (OMB control number: 0938–1000); (c) By mail to the Office of
and ODAG questionnaires have been Frequency: Yearly; Affected Public: Information and Regulatory Affairs,
removed. We have added new Private Sector (business or other for- OMB, New Executive Office Bldg., 725
questionnaires for FA and SNP– profit and not-for-profit institutions); 17th St. NW, Rm. 10235, Washington,
CCQIPE. A revised template for Number of Respondents: 166; Total DC 20503, Attn: OMB Desk Officer for
collecting root cause analyses from Annual Responses: 211; Total Annual ACL.
organizations on an as-needed basis Hours: 51,548. (For policy questions FOR FURTHER INFORMATION CONTACT:
during the program audit has been regarding this collection contact Brenda ACL’s Office of Performance and
included in this package. Hudson at 443–743–9299.) Evaluation at SPRredesign.comments@
We have also included a new acl.hhs.gov.
Dated: March 28, 2018.
independent validation audit work plan William N. Parham, III, SUPPLEMENTARY INFORMATION: In
template that will be collected from Director, Paperwork Reduction Staff, Office compliance with 44 U.S.C. 3507, ACL
sponsors that are required to undergo an of Strategic Operations and Regulatory has submitted the following proposed
independent validation audit. The Affairs. collection of information to OMB for
validation audit is part of our robust [FR Doc. 2018–06645 Filed 3–30–18; 8:45 am] review and clearance. This collection is
audit process where CMS requires BILLING CODE 4120–01–P a revision of the 2016 approved version
sponsoring organizations that have been of the State Program Report and
audited and found to have deficiencies incorporates significant reduction in
to undergo a validation audit to ensure DEPARTMENT OF HEALTH AND data collected. This data collection is
correction. The validation audit utilizes HUMAN SERVICES essential to provide performance
the same audit protocols, but only tests measures as required by Congress and
the elements where deficiencies were Administration for Community Living the GPRA Modernization Act of 2010
found, as opposed to re-administering (GPRAMA). Significant revisions to the
the entire audit. This validation audit Agency Information Collection SPR were last implemented in 2005.
work plan template will be populated Activities; Submission for OMB This proposed collection is a revision of
by the sponsoring organization’s Review; Public Comment Request; the currently approved version
independent auditing firm to describe Older American Act Title III and Title VII (effective 2016–2019). The factors that
how it plans to test for correction of the (Chapters 3 and 4) Annual State influenced the proposed revision of the
deficiencies identified during the Program Reporting (Annual SPR, include: (1) The need to modernize
program audit. Performance Data Collection); This is a the data structure to allow for more
To assist in improving the audit Revision to the Existing State Program efficient reporting and the ability to use
process, we have also included an audit Report (OMB Approval 0985–0008) current technology for reporting and
feedback questionnaire that is AGENCY: Administration for Community analysis; (2) the interest in aligning data
representative of the survey link we Living (ACL), HHS. elements within and across data
send to sponsoring organizations at the ACTION: Notice. collections; (3) the need to consider
end of each program audit. Completion alternative data elements that reflect the
of this questionnaire is optional for SUMMARY: The Administration for current Aging Network and long-term
sponsoring organizations to provide Community Living is announcing that care services and supports; and (4) the
feedback on the audit process. the proposed collection of information need to reduce reporting burden while
daltland on DSKBBV9HB2PROD with NOTICES
The proposed changes to each data listed above has been submitted to the enhancing data quality. The proposed
collection instrument, along with the Office of Management and Budget SPR revision reduces the number of data
new FA and SNP–CCQIPE (OMB) for review and clearance as elements reported by 70% and the
questionnaires, root cause template, required under section 506(c)(2)(A) of amount of time for completion by 30%
validation audit work plan template and the Paperwork Reduction Act of 1995. as compared to the current 2016–2019
audit feedback questionnaire are This 30-Day notice collects comments SPR. This is a reduction of 874 hours
included in the posted PRA package. on the information collection from the previous version.
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Document Created: 2018-11-01 09:08:24
Document Modified: 2018-11-01 09:08:24
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by June 1, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 13988 |
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