[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Pages 13988-13989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06645]
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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.
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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 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 [email protected].
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