[Federal Register Volume 86, Number 242 (Tuesday, December 21, 2021)]
[Notices]
[Pages 72244-72245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27603]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Document Identifier: CMS-10621, CMS-10141 and CMS-10630]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
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 22, 2022.

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.

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-10621 Quality Payment Program/Merit-Based Incentive Payment System 
(MIPS)
CMS-10141 Medicare Prescription Drug Benefit Program
CMS-10630 The PACE Organization (PO) Monitoring and Audit Process in 42 
CFR part 460

    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: Extension of a currently 
approved collection; Title of Information Collection: Quality Payment 
Program/Merit-Based Incentive Payment System (MIPS); Use: The Merit-
based Incentive Payment System (MIPS) is a program for certain eligible 
clinicians that makes Medicare payment adjustments based on performance 
on quality, cost and other measures and activities. MIPS and Advanced 
Alternative Payment Models (AAPMs) are the two paths for clinicians 
available through the Quality Payment Program authorized by the 
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). As 
prescribed by MACRA, MIPS focuses on the following performance areas: 
Quality--a set of evidence-based, specialty-specific standards; 
improvement activities that focus on practice-based improvements; cost; 
and use of Certified Electronic Health Record Technology (CEHRT) to 
support interoperability and advanced quality objectives in a single, 
cohesive program that avoids redundancies.
    Under the AAPM path, eligible clinicians may become Qualifying APM 
Participants (QPs) and are excluded from MIPS. Partial Qualifying APM 
Participants (Partial QPs) may opt to report and be scored under MIPS. 
APM Entities and eligible clinicians must also submit all of the 
required information about the Other Payer Advanced APMs in which they 
participate, including those for which there is a pending request for 
an Other Payer Advanced APM determination, as well as the payment 
amount and patient count information sufficient for us to make QP 
determinations by December 1 of the calendar year that is 2 years to 
prior to the payment year, which we refer to as the QP Determination 
Submission Deadline (82 FR 53886).
    The implementation of MIPS requires the collection of quality, 
Promoting Interoperability, and improvement activities performance 
category data. For the quality performance category, MIPS eligible 
clinicians and groups will have the option to submit data using various 
submission types, including Medicare claims, direct, log in and upload, 
CMS Web Interface and CMS-approved survey vendors. For the improvement 
activities and Promoting Interoperability, clinicians and groups can 
submit data through direct, log in and upload, or log in and attest 
submission types. As finalized in the CY 2021 PFS final rule (85 FR 
84860), for clinicians in APM Entities, the APM Performance Pathway 
will be available for both ACOs and non ACOs to submit quality data. 
Due to data limitations and our inability to determine who would use 
the APM Performance Pathway versus the traditional MIPS submission 
mechanism for the CY 2022 performance period/2024 MIPS payment year, we 
assume ACO APM Entities will submit data through the APM Performance 
Pathway, using the CMS Web Interface option, and non-ACO APM Entities 
would participate through traditional MIPS, thereby submitting as an 
individual or group rather than as an entity. We are finalizing in the 
CY 2022 PFS final rule

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the policy to extend the CMS Web Interface measures as a quality 
performance category collection type/submission type for the CY 2022 
performance period/2024 MIPS payment year. We note that we are 
finalizing to extend the CMS Web Interface as a collection type/
submission type for clinicians in Shared Savings Program reporting the 
APM Performance Pathway through the CY 2024 performance period/2026 
MIPS payment year. We are also finalized the sunsetting of the CMS Web 
interface measures as a quality performance category collection type/
submission type starting with the CY 2023 performance period/2025 MIPS 
payment year.
    In the CY 2022 PFS final rule, we finalized to implement voluntary 
MIPS Value Pathways (MVP) reporting for eligible clinicians beginning 
with January 1 of the CY 2023 performance period/2025 MIPS payment 
year. Beginning with the CY 2023 performance period/2025 MIPS payment 
year, we also finalized voluntary subgroup reporting within MIPS 
limited to eligible clinicians reporting through the MVPs or the APP.
    For the Promoting Interoperability performance category, in the CY 
2022 PFS final rule, we finalized that, beginning with the CY 2022 
performance period/2024 MIPS payment year, eligible clinicians must 
attest to conducting an annual assessment of the High Priority Guides 
of the SAFER Guides beginning January 1 of CY 2022. We finalized to 
automatically reweight the Promoting Interoperability for small 
practices who previously had to apply for reweighting of this 
performance category.
    For the improvement activities performance category, beginning with 
the CY 2022 Annual Call for MIPS improvement activities, we finalized 
two new criteria for nomination of improvement activities. We are also 
requesting to add three new ICRs that are currently with OMB for 
approval: MVP registration, MVP quality submissions, and Subgroup 
registration. The MVP registration reflects the burden associated with 
the finalized registration process for clinicians reporting MVPs 
beginning with the CY 2023 performance period/2025 MIPS payment year. 
Subgroup registration reflects the burden associated with the finalized 
registration process for subgroups reporting the MVPs. The MVP quality 
submission reflects the decrease in burden associated with the 
finalized MVP Inventory available for MIPS eligible clinicians. Form 
Number: CMS-10621 (OMB control number: 0938-1314); Frequency: Annually; 
Affected Public: Individuals or Households and Business or other for-
profit institutions; Number of Respondents: 239,813; Total Annual 
Responses: 633,021; Total Annual Hours: 2,825,380. (For policy 
questions regarding this collection contact Michelle Peterman at 410-
786-2591)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Prescription Drug Benefit Program; Use: Plan sponsor and State 
information is used by CMS to approve contract applications, monitor 
compliance with contract requirements, make proper payment to plans, 
and ensure that correct information is disclosed to potential and 
current enrollees. Form Number: CMS-10141 (OMB control number: 0938-
0964); Frequency: Annually; Affected Public: Private Sector and 
Business or other for-profit institutions; Number of Respondents: 
11,771,497; Total Annual Responses: 675,231,213; Total Annual Hours: 
9,261,354. (For policy questions regarding this collection contact Chad 
D. Buskirk at 410-786-1630)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: The PACE 
Organization (PO) Monitoring and Audit Process in 42 CFR part 460; Use: 
Sections 1894(e)(4) and 1934(e)(4) of the Act and the implementing 
regulations at 42 CFR 460.190 and 460.192 state that CMS, in 
conjunction with the State Administering Agency (SAA), must oversee a 
PACE organization's continued compliance with the requirements for a 
PACE organization.
    The data collected with the data request tools included in this 
package allow CMS to conduct a comprehensive review of PACE 
organizations' compliance in accordance with specific federal 
regulatory requirements. 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), as well as the SAA, 
to assess POs' compliance with PACE program requirements. If outliers 
or other data anomalies are detected, other offices within CMS will 
work in collaboration with MOEG for follow-up and resolution. 
Additionally, POs will receive the audit results, and will be required 
to implement corrective action to correct any identified deficiencies. 
Form Number: CMS-10630 (OMB control number: 0938-1327); Frequency: 
Annually; Affected Public: Private Sector, State, Local, or Tribal 
Governments and Business or other for-profit institutions; Number of 
Respondents: 40; Total Annual Responses: 40; Total Annual Hours: 
31,200. (For policy questions regarding this collection contact 
Kathleen Flannery at 410-786-6722).

    Dated: December 16, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-27603 Filed 12-20-21; 8:45 am]
BILLING CODE 4120-01-P