[Federal Register Volume 84, Number 235 (Friday, December 6, 2019)]
[Notices]
[Pages 66912-66913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26385]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10717]


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 February 4, 2020.

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

[[Page 66913]]

proposed collection(s) summarized in this notice, you may make your 
request using one of following:
    1. Access CMS' website address at 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 N. 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-10717 Medicare Part C and Part D Program Audit and Industry-Wide 
Part C Timeliness Monitoring Project (TMP) Protocols

    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: New Collection (Request 
for a new OMB control number); Title of Information Collection: 
Medicare Part C and Part D Program Audit and Industry-Wide Part C 
Timeliness Monitoring Project (TMP) Protocols; Use: Under the Medicare 
Prescription Drug, Improvement, and 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. CMS' 
annual audit plan ensures that we evaluate sponsoring organizations' 
compliance with these requirements by conducting program audits that 
focus on high-risk areas that have the greatest potential for 
beneficiary harm. As such, CMS has developed the following audit 
protocols for use by sponsoring organizations to prepare for their 
audit:

 Compliance Program Effectiveness (CPE)
 Part D Formulary and Benefit Administration (FA)
 Part D Coverage Determinations, Appeals, and Grievances (CDAG)
 Part C Organization Determinations, Appeals, and Grievances 
(ODAG)
 Special Needs Plans Care Coordination (SNPCC)

    CMS generally conducts program audits at the parent organization 
level in an effort to reduce burden and, for routine audits, subjects 
each sponsoring organization to all applicable program area protocols. 
For example, if a sponsoring organization does not offer a special 
needs plan, or an accrediting organization has deemed a special needs 
plan compliant with CMS regulations and standards, CMS would not apply 
the SNPCC protocol. Likewise, CMS would not apply the ODAG audit 
protocol to an organization that offers only a standalone prescription 
drug plan since that organization does not offer the MA benefit. 
Conversely, ad hoc audits resulting from referral may be limited in 
scope and, therefore, all program area protocols may not be applied.
    In addition, as part of the robust program audit process, CMS also 
requires sponsoring organizations that have undergone a program audit 
and found to have deficiencies to undergo a validation audit to ensure 
correction. The validation audit uses the same audit protocols, but 
only tests the elements where deficiencies were found as opposed to re-
administering the entire audit. Finally, CMS conducts annual industry-
wide timeliness monitoring of all Part C organizations by using a 
subset of the ODAG protocol. However, sponsoring organizations that 
successfully submitted all of their Part C data in response to a 
program audit in the prior year are excluded from submitting new data 
for the timeliness monitoring effort in the year following their 
program audit.
    The information gathered during this program audit will be used by 
the Medicare Parts C and D Oversight and Enforcement Group (MOEG) 
within the Center for Medicare (CM) and CMS Regional Offices to assess 
sponsoring organizations' compliance with Medicare program 
requirements. If outliers or other data anomalies are detected, 
Regional Offices will work in collaboration with MOEG and other 
divisions within CMS for follow-up and resolution. Additionally, MA and 
Part D organizations will receive the audit results and will be 
required to implement corrective action to correct any identified 
deficiencies. Form Number: CMS-10717 (OMB control number: 0938-New); 
Frequency: Yearly; Affected Public: Private Sector, Business or other 
for-profits, Not-for-profits institutions; Number of Respondents: 190; 
Total Annual Responses: 179; Total Annual Hours: 36,082. (For policy 
questions regarding this collection contact Kellie Simons at 410-786-
0886.)

    Dated: December 3, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-26385 Filed 12-5-19; 8:45 am]
 BILLING CODE 4120-01-P