[Federal Register Volume 88, Number 25 (Tuesday, February 7, 2023)]
[Notices]
[Pages 7976-7978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02580]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers CMS-10704, CMS-10387, CMS-10846, CMS-R-246 and 
CMS-10316]


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 (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 10, 2023.

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, please access 
the CMS PRA website by copying and pasting the following web address 
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

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-10704 Health Reimbursement Arrangements and Other Account-Based 
Group Health Plans
CMS-10387 Minimum Data Set 3.0 Nursing Home and Swing Bed Prospective 
Payment System (PPS) For the collection of data related to the Patient 
Driven Payment Model and the Skilled Nursing Facility Quality Reporting 
Program (QRP)
CMS-10846 Medicare Part D Manufacturer Discount Program Agreement
CMS-R-246 Medicare Advantage, Medicare Part D, and Medicare Fee-For-
Service Consumer Assessment of Healthcare Providers and Systems (CAHPS) 
Survey
CMS-10316 Implementation of the Medicare Prescription Drug Plan (PDP) 
and Medicare Advantage (MA) Plan Disenrollment Reasons Survey
    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

[[Page 7977]]

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: Health 
Reimbursement Arrangements and Other Account-Based Group Health Plans; 
Use: On June 20, 2019, the Department of the Treasury, the Department 
of Labor, and the Department of Health and Human Services 
(collectively, the Departments) issued final regulations titled 
``Health Reimbursement Arrangements and Other Account-Based Group 
Health Plans'' (84 FR 28888) under section 2711 of the PHS Act and the 
health nondiscrimination provisions of HIPAA, Public Law 104-191 (HIPAA 
nondiscrimination provisions). The regulations expanded the use of 
health reimbursement arrangements and other account-based group health 
plans (collectively referred to as HRAs) and recognized certain HRAs as 
limited excepted benefits (the excepted benefit HRA), for plan years 
beginning on or after January 1, 2020. In general, the regulations 
expanded the use of HRAs by eliminating the prohibition on integrating 
HRAs with individual health insurance coverage, thereby permitting 
employers to offer individual coverage HRAs to employees that can be 
integrated with individual health insurance coverage or Medicare Parts 
A and B, or Part C. Under the regulations, employees are permitted to 
use amounts in an individual coverage HRA to pay expenses for medical 
care (including premiums for individual health insurance coverage and 
Medicare), subject to certain requirements. This information collection 
includes provisions related to substantiation of individual health 
insurance coverage (45 CFR 146.123(c)(5)), the notice requirement for 
individual coverage HRAs (45 CFR 146.123(c)(6)), and notification of 
termination of coverage (45 CFR 146.123(c)(1)(iii)). In the final rule 
``Patient Protection and Affordable Care Act; HHS Notice of Benefit and 
Payment Parameters for 2021; Notice Requirement for Non-federal 
Governmental Plans'' (85 FR 29164), under 45 CFR 
146.145(b)(3)(viii)(E), excepted benefit HRAs offered by non-Federal 
governmental plan sponsors are required to provide a notice that 
describes conditions pertaining to eligibility to receive benefits, 
annual or lifetime caps or other limits on benefits under the excepted 
benefit HRA, and a description or summary of the benefits. This notice 
must be provided no later than 90 days after the employee becomes a 
participant in the excepted benefit HRA and annually thereafter. Form 
Number: CMS-10704 (OMB control number: 0938-1361); Frequency: Annually; 
Affected Public: Private Sector, State Governments; Number of 
Respondents: 11,574; Total Annual Responses: 1,037,674; Total Annual 
Hours: 5,889. (For policy questions regarding this collection contact 
Adam Pellillo at (667) 290-9621.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Minimum Data Set 
3.0 Nursing Home and Swing Bed Prospective Payment System (PPS) For the 
collection of data related to the Patient Driven Payment Model and the 
Skilled Nursing Facility Quality Reporting Program (QRP); Use: We are 
requesting to implement to the MDS 3.0 v1.18.11 beginning October 1, 
2023 to October 1, 2026 in order to meet the requirements of policies 
finalized in the Federal Fiscal Year (FY) 2020 Skilled Nursing Facility 
(SNF) Prospective Payment System (PPS) final rule (84 FR 38728). The 
compliance date for the finalized policies (10/01/2020) was delayed due 
to the COVID-19 public health emergency (PHE). While there has been no 
change in assessment-level burden since the approval of the MDS 3.0 
v1.17.2, there has been a change in total burden since 2019 when the 
package was originally approved due to a decrease in the number of MDS 
assessments completed and a change in the hourly rate for clinicians 
completing the assessment.
    We use the MDS 3.0 PPS Item Set to collect the data used to 
reimburse skilled nursing facilities for SNF-level care furnished to 
Medicare beneficiaries and to collect information for quality measures 
and standardized patient assessment data under the SNF QRP. There have 
been some revisions to the assessment tool since the approval of MDS 
3.0 v1.17.2. Form Number: CMS-10387 (OMB control number: 0938-1140); 
Frequency: Yearly; Affected Public: Private Sector: Business or other 
for-profit and not-for-profit institutions; Number of Respondents: 
15,472; Total Annual Responses: 3,371,993; Total Annual Hours: 
2,866,194. (For policy questions regarding this collection contact 
Heidi Magladry at 410-786-6034).
    3. Type of Information Collection Request: New Collection (Request 
for a new OMB control number); Title of Information Collection: 
Medicare Part D Manufacturer Discount Program Agreement; Use: Congress 
enacted the Inflation Reduction Act of 2022, Public Law 117-169 (IRA). 
Section 11201 of the IRA eliminates the coverage gap phase of the Part 
D benefit. It also sunsets the coverage gap discount program (CGDP) 
after December 31, 2024, and amends the Social Security Act (the Act) 
to add section 1860D-14C, requiring the Secretary to establish a new 
Medicare Part D manufacturer discount program (MDP) beginning January 
1, 2025. Under the MDP, participating manufacturers are required to 
provide discounts on their ``applicable drugs'' (brand drugs, 
biologics, and biosimilars) both in the initial coverage phase and in 
the catastrophic coverage phase of the Part D benefit.
    Information in this collection is needed to set up agreements 
between manufacturers and CMS. Under section 1860D-14C(a) of the Act, 
such agreements are required for manufacturers in order to participate 
in the MDP and, under section 1860D43(a) of the Act, for their 
applicable drugs to be covered under Part D beginning in 2025. The 
information collected from manufacturers in the Health Plan Management 
System (HPMS) (Appendix A) is needed to create and execute MDP 
agreements and to determine which manufacturers qualify as a specified 
manufacturer or specified small manufacturer for phased-in discounts 
under section 1860D-14C(g)(4) of the Act. Banking information collected 
by the TPA from manufacturers and plan sponsors (Appendix B) is needed 
to prepare invoices and process financial transactions (deposits and 
payments) through the ACH. Form Number: CMS-10846 (OMB control number: 
0938-New); Frequency: Once; Affected Public: Private Sector: Business 
or other for-profit and not-for-profit institutions; Number of 
Respondents: 659; Total Annual Responses: 659; Total Annual Hours: 
4,613. (For policy questions regarding this collection contact Beckie 
Peyton at 410-786-1572).
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Advantage, Medicare Part D, and Medicare Fee-For-Service Consumer 
Assessment of Healthcare Providers and Systems (CAHPS) Survey; Use: CMS 
is required to collect and report

[[Page 7978]]

information on the quality of health care services and prescription 
drug coverage available to persons enrolled in a Medicare health or 
prescription drug plan under provisions in the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003 (MMA). Specifically, 
the MMA under Sec. 1860D-4 (Information to Facilitate Enrollment) 
requires CMS to conduct consumer satisfaction surveys regarding 
Medicare prescription drug plans and Medicare Advantage plans and 
report this information to Medicare beneficiaries prior to the Medicare 
annual enrollment period. The Medicare CAHPS survey meets the 
requirement of collecting and publicly reporting consumer satisfaction 
information. The Balanced Budget Act of 1997 also requires the 
collection of information about fee-for-service plans.
    The primary purpose of the Medicare CAHPS surveys is to provide 
information to Medicare beneficiaries to help them make more informed 
choices among health and prescription drug plans available to them. 
Survey results are reported by CMS in the Medicare & You Handbook 
published each fall and on the Medicare Plan Finder website. 
Beneficiaries can compare CAHPS scores for each health and drug plan as 
well as compare MA and FFS scores when making enrollment decisions. The 
Medicare CAHPS also provides data to help CMS and others monitor the 
quality and performance of Medicare health and prescription drug plans 
and identify areas to improve the quality of care and services provided 
to enrollees of these plans. CAHPS data are included in the Medicare 
Part C & D Star Ratings and used to calculate MA Quality Bonus 
Payments. Form Number: CMS-R-246 (OMB control number: 0938- 0732); 
Frequency: Yearly; Affected Public: Individuals and Households; Number 
of Respondents: 794,500; Total Annual Responses: 794,500; Total Annual 
Hours: 192,265. (For policy questions regarding this collection contact 
Lauren Fuentes at 410-786-2290).
    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Implementation of 
the Medicare Prescription Drug Plan (PDP) and Medicare Advantage (MA) 
Plan Disenrollment Reasons Survey; Use: The Balanced Budget Act of 1997 
required that the CMS publicly report two years of disenrollment rates 
on all Medicare + Choice (M+C) organizations. Disenrollment rates are a 
useful measure of beneficiary dissatisfaction with a plan; this 
information is even more useful when reasons for disenrollment are 
provided to consumers, insurers, and other stakeholders. Advocacy 
organizations agree that CMS needs to report disenrollment reasons so 
that disenrollment rates can be interpreted correctly.
    Specifically, the MMA under Sec. 1860D-4 (Information to Facilitate 
Enrollment) requires CMS to conduct consumer satisfaction surveys 
regarding the PDP and MA contracts pursuant to section 1860D-4(d). Plan 
disenrollment is generally believed to be a broad indicator of 
beneficiary dissatisfaction with some aspect of plan services, such as 
access to care, customer service, cost of the plan, services, benefits 
provided, or quality of care.
    The information generated from the disenrollment survey supports 
CMS' ongoing efforts to assess plan performance and provide oversight 
to the functioning of Medicare Advantage (Part C) and PDP (Part D) 
plans, which provide health care services to millions of Medicare 
beneficiaries (i.e., 28 million for Part C coverage and 49 million for 
Part D coverage).
    Beneficiary experiences of care (as measured in the MCAHPS survey) 
and dissatisfaction (as measured in the disenrollment survey) with plan 
performance are both important sources of information for plan 
monitoring and oversight. The disenrollment survey assesses different 
aspects of dissatisfaction (i.e., reasons why beneficiaries voluntarily 
left a plan), which can identify problems with plan operations; 
performance areas evaluated include access to care, customer service, 
cost, coverage, benefits provided, and quality of care. Understanding 
how well plans perform on these dimensions of care and service helps 
CMS understand whether beneficiaries are satisfied with the care they 
are receiving from contracted plans. When and if plans are found to be 
performing poorly against an array of performance measures, including 
beneficiary disenrollment, CMS may take corrective action. Form Number: 
CMS-10316 (OMB control number: 0938-1113); Frequency: Yearly; Affected 
Public: Individuals and Households; Number of Respondents: 32,750; 
Total Annual Responses: 32,750; Total Annual Hours: 7,055. (For policy 
questions regarding this collection contact Beth Simons at 415-744-
3780).

    Dated: February 2, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-02580 Filed 2-6-23; 8:45 am]
BILLING CODE 4120-01-P