[Federal Register Volume 88, Number 82 (Friday, April 28, 2023)]
[Notices]
[Pages 26311-26313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09053]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10316, CMS-10260, CMS-367a-e, and CMS-10243]


Agency Information Collection Activities: Submission for OMB 
Review; 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 a second opportunity 
for public

[[Page 26312]]

comment on the notice. Interested persons are invited to send comments 
regarding the burden estimate 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 on the collection(s) of information must be received by 
the OMB desk officer by May 30, 2023.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    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 Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-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 that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. 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).
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Advantage and Prescription Drug Program: Final Marketing Provisions in 
42 CFR 422.111(a)(3) and 423.128(a)(3); Use: CMS requires MA 
organizations and Part D sponsors to use the standardized documents 
being submitted for OMB approval to satisfy disclosure requirements 
mandated by section 1851(d)(3)(A) of the Act and Sec.  422.111 for MA 
organizations and section 1860D-1(c) of the Act and Sec.  423.128(a)(3) 
for Part D sponsors. The regulatory provisions at Sec. Sec.  422.111(b) 
and 423.128(b) require MA organizations and Part D sponsors to disclose 
plan information, including: service area, benefits, access, grievance 
and appeals procedures, and quality improvement/assurance requirements. 
MA organizations and sponsors may send the ANOC separately from the 
EOC, but must send the ANOC for enrollee receipt by September 30. The 
required due date for the EOC is 15 days prior to the start of the AEP.
    CMS requires MA organization and Part D sponsors to submit 
marketing materials to CMS for review prior to the MA organization or 
sponsor distributing those materials to the public. In section 1851(h), 
paragraphs (1), (2), and (3) establish this requirement for MA 
organizations. Section 1860D-1(b)(1)(B)(vi) directs Part D sponsors to 
follow the same requirements in section 1851(h) that MA organizations 
must follow for this purpose. Form number: CMS-10260 (OMB control 
number: 0938-1051); Frequency: Annually; Affected Public: State, Local, 
or Tribal Governments; Number of Respondents: 800; Number of Responses: 
48,439; Total Burden Hours: 13,568. (For questions regarding this 
collection contact Elizabeth Jacob at 410-786-8658).
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicaid Drug 
Rebate Program Labeler Reporting Format; Use: Labelers transmit drug 
product and pricing data to CMS within 30 days after the end of each 
calendar month and quarter. CMS calculates the unit rebate amount (URA) 
and the unit rebate offset amount (UROA) for each new drug application 
(NDC) and distributes to all State Medicaid agencies. States use the 
URA to invoice

[[Page 26313]]

the labeler for rebates and the UROA to report onto CMS-64. The monthly 
data is used to calculate Federal Upper Limit (FUL) prices for 
applicable drugs and for states that opt to use this data to establish 
their pharmacy reimbursement methodology. In this 2023 iteration, we 
adding a new use of the reported data. The new use would allow us to 
calculate inflationary rebates under the Inflation Reduction Act of 
2022. The change has no impact on our burden estimates. We are not 
revising any of our reporting forms. Form Number: CMS-367a, b, c, d, 
and e (OMB control number: 0938-0578); Frequency: Monthly, quarterly, 
and on occasion; Affected Public: Private sector (Business or other 
for-profits); Number of Respondents: 818; Total Annual Responses: 
15,742; Total Annual Hours: 591,042. (For policy questions regarding 
this collection contact Andrea Wellington at 410-786-3490.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Testing 
Experience and Functional Tools (TEFT): Functional Assessment 
Standardized Items (FASI) Based on the CARE Tool; Use: As part of the 
National Testing Experience and Functional Assessment Tools (TEFT) 
demonstration, CMS tested the use of functional assessment standardized 
items (FASI) among community-based long term services and supports (CB-
LTSS) populations. The TEFT initiative built on the national efforts to 
create electronically exchangeable data across providers and the 
caregiving team to develop more person-centered services under the 
Medicare and Medicaid programs. After conclusion of the field test, 
states have begun implementing the related FASI performance measures 
and the FASI team continues to recruit additional states. While the 
team has not conducted data collection since the FASI field test in 
2017, and that there are no concrete immediate plans to collect new 
data, new data collection to support measure re-endorsement activities 
due in 2025 will be needed. The data collection may also need to be 
conducted sooner if significant changes are made to the measures' 
technical specifications, in the interim. Due to the uncertainty on 
when data collection may need to be done, an extension of the existing 
package and a subsequent revision would facilitate expedient resumption 
of the data collection and testing efforts, especially given the quick 
turnaround time for activities (such as National Quality Forum measure 
endorsement) which depend on the data collection.
    FASI is based on a subset of the July 27, 2007 (72 FR 144) 
Continuity Assessment Record and Evaluation (CARE) items which are now 
included in post-acute setting Federal assessment forms for nursing 
facilities--Resident Assessment Instrument (RAI) Minimum Data Set 
(MDS), Inpatient Rehabilitation Facilities Patient Assessment 
Instrument (IRF-PAI), and Long Term Care Hospitals Continuity 
Assessment Record & Evaluation (CARE) Data Set (LCDS) to measure 
function in a standardized way. The FASI items include the standardized 
mobility and self-care items included in the MDS, IRF-PAI, and, LCDS as 
well as some additional mobility items appropriate to measuring 
independence in the community and personal preferences or goals items 
related to function. Also included are certain instrumental activities 
of daily living and some modified caregiver assistance items from the 
Home Health Outcome and Assessment Information Set (OASIS) tool. A few 
additional items to describe the populations' age, gender, and 
geographic area of residence are also included. Use of the same items 
to measure functional status in nursing facilities and community-based 
programs will help states report on their rebalancing efforts. Also, 
because these items will have electronic specifications developed by 
CMS, they can assist state efforts to develop exchangeable electronic 
data to follow the person across services and estimate total costs as 
well as measure functional status across time. The complete FASI set is 
included in this information collection request. Form Number: CMS-10243 
(OMB control number: 0938-1037); Frequency: On occasion; Affected 
Public: Individuals and Households; Number of Respondents: 1,570; Total 
Annual Responses: 1,570; Total Annual Hours: 785. (For policy questions 
regarding this collection contact Kerry Lida at 410-786-4826.)

    Dated: April 25, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-09053 Filed 4-27-23; 8:45 am]
BILLING CODE 4120-01-P