Notice2023-09053
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 28, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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 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.
Full Text
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<title>Federal Register, Volume 88 Issue 82 (Friday, April 28, 2023)</title>
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[Federal Register Volume 88, Number 82 (Friday, April 28, 2023)]
[Notices]
[Pages 26311-26313]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.
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
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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
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