[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Notices]
[Pages 10444-10445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03533]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-267 and CMS-10396]


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 April 24, 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 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: 

[[Page 10445]]

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-R-267 Medicare Plus Choice Program Requirements Referenced in 42 
CFR 422.000--422.700
CMS-10396 Medication Therapy Management Program Improvements--
Standardized Format

    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 with change of 
a currently approved collection; Title of Information Collection: 
Medicare Plus Choice Program Requirements Referenced in 42 CFR 422.000-
422.700; Use: The information collection requirements are mandated by 
42 CFR part 422. Section 4001 of the Balanced Budget Act of 1997 (BBA) 
added sections 1851 through 1859 to the Social Security Act to 
establish the Managed Care program. The Medicare, Medicaid, and SCHIP 
Benefits Improvement Act and Protection Act of 2000, Public Law 106-554 
added requirements to the Managed Care program. The Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 
108-173) created the Medicare Advantage program.
    A major goal of the Medicare Advantage program is to provide ease 
of access for Original Medicare beneficiaries who wish to enroll in a 
Medicare Advantage program. Certain populations of beneficiaries such 
as the dually eligible population (those beneficiaries enrolled in both 
Medicaid and Medicare) have grown since the program was created and 
these populations require more flexibilities.
    MA organizations (formerly M+C organizations) and potential MA 
organizations (applicants) use the information collected based on the 
regulations at 42 CFR part 422 to comply with the application 
requirements and the MA contract requirements. CMS uses the information 
collected based on the regulations at 42 CFR part 422 to approve 
contract applications, monitor compliance with contract requirements, 
make proper payment to MA organizations, determine compliance with the 
new prescription drug benefit requirements established by the MMA, and 
to ensure that correct information is disclosed to Medicare 
beneficiaries, both potential enrollees and enrollees.
    Information supplied by organizations is used to determine 
eligibility for contracting with CMS, for determining compliance with 
contract requirements, and for calculating proper payment to the 
organizations. Information supplied by Medicare beneficiaries is used 
to determine eligibility to enroll in the M+C organization and to 
determine proper payment to the organization that enrolled the 
beneficiary. Separate OMB approval was sought for each form as 
required.
    The information collection request also incorporates the new 
minimum criteria for dual eligible special needs plans (D-SNPs) to 
integrate Medicare and Medicaid benefits detailed in Section 50311(b) 
of the Bipartisan Budget Act of 2018 and set forth in in Final rule 
(CMS-4185-F, RIN 0938-AT59) for CY2020 and 2021. The integration 
requirements improve care coordination, quality of care, and 
beneficiary satisfaction while reducing administrative burden. Form 
Number: CMS-R-267 (OMB control number: 0938-0753); Frequency: Yearly; 
Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 6,727,508; Total Annual Responses: 6,750,814; Total Annual 
Hours: 1,848,180. (For policy questions regarding this collection 
contact Marna Metcalf Akbar at 410-786-8251.)
    2. Type of Information Collection Request: Revision with change of 
a currently approved collection; Title of Information Collection: 
Medication Therapy Management Program Improvements--Standardized 
Format; Use: The Medicare Modernization Act of 2003 (MMA) under title 
42 CFR part 423, subpart D, establishes the requirements that Part D 
sponsors, an organization which has one or more contract(s) with CMS to 
provide Part D benefits to Medicare beneficiaries, must meet with 
regard to cost control and quality improvement including requirements 
for medication therapy management (MTM) programs. MTM is a patient-
centric and comprehensive approach to improve medication use, reduce 
the risk of adverse events, and improve medication adherence. At 
minimum, a Part D sponsors' MTM program must offer to its enrollees an 
annual comprehensive medication review with written summaries, 
quarterly targeted medication reviews, and follow-up interventions for 
both beneficiaries and prescribers when necessary.
    Information collected by Part D MTM programs as required by the 
Standardized Format for the CMR summary, which is used by beneficiaries 
or their authorized representatives, caregivers, and their healthcare 
providers to improve medication use and achieve better healthcare 
outcomes. The Standardized Format must comply with applicable industry 
standards for medication therapy management and electronic data 
interchange, and should enable CMR data elements to be captured for 
clinical, reporting or measurement purposes.
    After a CMR is performed, the sponsor creates and sends a summary 
of the CMR to the beneficiary that includes a medication action plan 
and personal medication list using the Standardized Format. The 
information users are beneficiaries or their authorized 
representatives, caregivers, and their healthcare providers as stated 
in this section. Form Number: CMS-10396 (OMB control number: 0938-
1154); Frequency: Yearly; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 735; Total Annual Responses: 
2,173,254; Total Annual Hours: 1,448,908. (For policy questions 
regarding this collection contact Victoria Dang at 410-786-3991.)

    Dated: February 18, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-03533 Filed 2-21-20; 8:45 am]
BILLING CODE 4120-01-P