[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