[Federal Register Volume 84, Number 159 (Friday, August 16, 2019)]
[Notices]
[Pages 41991-41993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17663]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10137 and 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 October 15, 2019.

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.

[[Page 41992]]

    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 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-10137 Title Solicitation for Applications for Medicare Prescription 
Drug Plan 2021 Contracts

CMS-10191 Medicare Parts C and D Program Audit Protocols and 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: Solicitation for 
Applications for Medicare Prescription Drug Plan 2021 Contracts; Use: 
Coverage for the prescription drug benefit is provided through 
contracted prescription drug plans (PDPs) or through Medicare Advantage 
(MA) plans that offer integrated prescription drug and health care 
coverage (MA-PD plans). Cost Plans that are regulated under Section 
1876 of the Social Security Act, and Employer Group Waiver Plans (EGWP) 
may also provide a Part D benefit. Organizations wishing to provide 
services under the Prescription Drug Benefit Program must complete an 
application, negotiate rates, and receive final approval from CMS. 
Existing Part D Sponsors may also expand their contracted service area 
by completing the Service Area Expansion (SAE) application.
    Collection of this information is mandated in Part D of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
(MMA) in Subpart 3. The application requirements are codified in 
Subpart K of 42 CFR 423 entitled ``Application Procedures and Contracts 
with PDP Sponsors.''
    The information will be collected under the solicitation of 
proposals from PDP, MA-PD, Cost Plan, Program of All Inclusive Care for 
the Elderly (PACE), and EGWP applicants. The collected information will 
be used by CMS to: (1) Ensure that applicants meet CMS requirements for 
offering Part D plans (including network adequacy, contracting 
requirements, and compliance program requirements, as described in the 
application), (2) support the determination of contract awards. Form 
Number: CMS-10137 (OMB control number: 0938-0936); Frequency: Yearly; 
Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 243; Total Annual Responses: 290; Total Annual Hours: 
1,384.79. (For policy questions regarding this collection contact 
Arianne Spaccarelli at 410-786-5715.)
    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 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. CMS program audits focus on high-
risk areas that have the greatest potential for beneficiary harm. As 
such, CMS has developed several audit protocols that are included 
within the program area data request documents and that are posted to 
the CMS website each year for use by sponsoring organizations to 
prepare for their audit. As part of a robust audit process, CMS also 
requires sponsoring organizations 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.
    Currently CMS utilizes the following 5 protocols to audit 
sponsoring organization performance: Part D Formulary and Benefit 
Administration (FA); Coverage Determinations, Appeals, and Grievances 
(CDAG); Organization Determinations, Appeals, and Grievances (ODAG); 
Special Needs Model of Care (SNP-MOC) (only administered on 
organizations who operate SNPs); and, Compliance Program Effectiveness 
(CPE). 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, this collection request includes a pre-audit 
issue summary, three CPE questionnaires, one CPE organizational 
structure presentation template, one FA impact analysis template, two 
CDAG impact analysis templates, four OAG impact analysis templates, and 
three SNP-MOC impact analysis templates.
    The information gathered during this 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-10191 (OMB control number: 0938-1000); 
Frequency: Yearly; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 201; Total Annual Responses: 207; 
Total Annual Hours: 17,525. (For policy questions regarding this 
collection contact Brenda Hudson at 303-844-7056.)


[[Page 41993]]


    Dated: August 13, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-17663 Filed 8-15-19; 8:45 am]
BILLING CODE 4120-01-P