Agency Information Collection Activities: Submission for OMB Review; Comment Request
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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.
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<title>Federal Register, Volume 88 Issue 73 (Monday, April 17, 2023)</title>
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[Federal Register Volume 88, Number 73 (Monday, April 17, 2023)]
[Notices]
[Pages 23429-23431]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-08069]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10110, CMS-10537, CMS-10344 and CMS-10527]
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 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 17, 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: Manufacturer
Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs
and Biologicals; Use: Section 401 of
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Division CC of Title IV of the Consolidated Appropriations Act (CAA),
2021 amended section 1847A of the Social Security Act (the Act) to add
new section 1847A(f)(2) of the Act, which requires manufacturers
without a Medicaid drug rebate agreement to report average sales price
(ASP) information to CMS for calendar quarters beginning on January 1,
2022, for drugs or biologicals payable under Medicare Part B and
described in sections 1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of
the Act, including items, services, supplies, and products that are
payable under Part B as a drug or biological. The reported ASP data are
used to establish the Medicare payment amounts. Form Number: CMS-10110
(OMB control number: 0938-0921); Frequency: Quarterly; Affected Public:
Private sector, Business or other for-profit; Number of Respondents:
500; Total Annual Responses: 2,000; Total Annual Hours: 26,000. (For
policy questions regarding this collection contact Felicia Brown at
410-786-9287)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: CAHPS Hospice
Survey; Use: CMS is required to collect and publicly report information
on the quality of services provided by hospices under provisions in the
Social Security Act. Specifically, sections 1814(i)(5)(A) through (C)
of the Act, as added by section 3132(a) of the Patient Protection and
Affordable Care Act (PPACA) (Pub. L. 111-148), required hospices to
begin submitting quality data, based on measures specified by the
Secretary of the Department of Health and Human Services (the
Secretary) for FY 2014 and subsequent FYs.
The goal of the survey is to measure the experiences of patients
and their caregivers with hospice care. The survey was developed to:
<bullet> Provide a source of information from which selected
measures could be publicly reported to beneficiaries and their family
members as a decision aid for selection of a hospice program;
<bullet> Aid hospices with their internal quality improvement
efforts and external benchmarking with other facilities;
<bullet> Provide CMS with information for monitoring the care
provided.
Form Number: CMS-10537 (OMB control number: 0938-1257); Frequency:
Once; Affected Public: Individuals and Households; Number of
Respondents: 1,140,695; Total Annual Responses: 1,140,695; Total Annual
Hours: 198,481. (For policy questions regarding this collection contact
Lauren Fuentes at 410-786 2290 or 443-618-2123.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Elimination of
Cost-Sharing for full benefit dual-eligible Individuals Receiving Home
and Community-Based Services; Use: Section 1860 D-14 of the Social
Security Act sets forth requirements for premium and cost-sharing
subsidies for low-income beneficiaries enrolled in Medicare Part D.
Based on this statute, 42 CFR 423.771, provides guidance concerning
limitations for payments made by and on behalf of low-income Medicare
beneficiaries who enroll in Part D plans. 42 CFR 423.771 (b)
establishes requirements for determining a beneficiary's eligibility
for full subsidy under the Part D program. Regulations set forth in
423.780 and 423.782 outline premium and cost sharing subsidies to which
full subsidy eligible are entitled under the Part D program
Each month CMS deems individuals automatically eligible for the
full subsidy, based on data from State Medicaid Agencies and the Social
Security Administration (SSA). The SSA sends a monthly file of
Supplementary Security Income-eligible beneficiaries to CMS. Similarly,
the State Medicaid agencies submit Medicare Modernization Act files to
CMS that identify full subsidy beneficiaries. CMS deems the
beneficiaries as having full subsidy and auto-assigns these
beneficiaries to bench mark Part D plans. Part D plans receive premium
amounts based on the monthly assessments. Form Number: CMS-10344 (OMB
control number 0938-1127); Frequency: Monthly; Affected Public: Private
Sector (business or other for-profits, not-for-profit institutions);
Number of Respondents: 51; Number of Responses: 612; Total Annual
Hours: 621. (For policy questions regarding this collection contact
Roland Herrera at 410-786-0668).
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Annual
Eligibility Redetermination, Product Discontinuation and Renewal
Notices; Use: Section 1411(f)(1)(B) of the Affordable Care Act directs
the Secretary of Health and Human Services (the Secretary) to establish
procedures to redetermine the eligibility of individuals for premium
tax credits on a periodic basis in appropriate circumstances. Section
1321(a) of the Affordable Care Act provides authority for the Secretary
to establish standards and regulations to implement the statutory
requirements related to Exchanges, qualified health plans (QHPs) and
other components of title I of the Affordable Care Act. Under section
2703 of the Public Health Service Act (PHS Act), as added by the
Affordable Care Act, and former section 2712 and section 2741 of the
PHS Act, enacted by the Health Insurance Portability and Accountability
Act of 1996, health insurance issuers in the group and individual
markets must guarantee the renewability of coverage unless an exception
applies.
The 2014 final rule ``Patient Protection and Affordable Care Act;
Annual Eligibility Redeterminations for Exchange Participation and
Insurance Affordability Programs; Health Insurance Issuer Standards
Under the Affordable Care Act, Including Standards Related to
Exchanges'' (79 FR 52994, September 5, 2014), provides that an Exchange
may choose to conduct the annual redetermination process for a plan
year (1) in accordance with the existing procedures described in 45 CFR
155.335; (2) in accordance with procedures described in guidance issued
by the Secretary for the applicable benefit year; or (3) using an
alternative procedure proposed by the Exchange and approved by the
Secretary. The 2014 final rule established a renewal and reenrollment
hierarchy at 45 CFR 155.335(j) to minimize potential enrollment
disruptions. The 2016 final rule ``Patient Protection and Affordable
Care Act; HHS Notice of Benefit and Payment Parameters for 2017'' (81
FR 12204, March 8, 2016) amended the enrollment hierarchy to further
minimize potential disruptions of enrollee eligibility for cost-sharing
reductions. The final rule ``Patient Protection and Affordable Care
Act, HHS Notice of Benefit and Payment Parameters for 2024'' adopted
changes to 45 CFR 155.335(j) to allow the Exchange, beginning in the
2024 plan year, to direct re-enrollment for enrollees who are eligible
for cost-sharing reductions in accordance with Sec. 155.305(g) from a
bronze QHP to a silver QHP with a lower or equivalent premium after
advance payments of the premium tax credit within the same product and
QHP issuer, regardless of whether their current plan is available or
not, if certain conditions are met (referred to here as the ``bronze to
silver crosswalk policy'').
The guidance document ``Guidance on Annual Eligibility
Redetermination and Re-enrollment for Exchange Coverage for 2019 and
Later Years'' contains the procedures that the Secretary specified for
the coverage year, as noted in (2) above, and specified that these
procedures will be
[[Page 23431]]
used by all Exchanges using the Federal eligibility and enrollment
platform, unless otherwise specified in future guidance or rulemaking.
The 2014 final rule also amended the requirements for product
renewal and re-enrollment (or non-renewal) notices to be sent by QHP
issuers in the Exchanges and specifies content for these notices. The
guidance document ``Updated Federal Standard Renewal and Product
Discontinuation Notices, and Enforcement Safe Harbor for Product
Discontinuation Notices in Connection with the Open Enrollment Period
for Coverage in the Individual Market in the 2020 Benefit Year''
provides standard notices for product discontinuation and renewal to be
sent by issuers of individual market QHPs and issuers in the individual
market.
The Federal standard notices to be sent by issuers of individual
market QHPs and issuers in the individual market have been revised to
improve consumer understanding and update out-of-date information, and
to include language to reference the potential for a bronze to silver
crosswalk under 45 CFR 155.335(j)(4). The revised notices in this
information collection will be required for notices provided in
connection with coverage beginning in the 2024 plan year.
Issuers in the small group market may use the draft Federal
standard small group notices released in the June 26, 2014 bulletin
``Draft Standard Notices When Discontinuing or Renewing a Product in
the Small Group or Individual Market'', or any forms of the notice
otherwise permitted by applicable laws and regulations. States that are
enforcing the guaranteed renewability provisions of the Affordable Care
Act may develop their own standard notices for product discontinuances,
renewals, or both, provided the state-developed notices are at least as
protective as the Federal standard notices. Form Number: CMS-10527 (OMB
Control Number 0938-1254); Frequency: Annually; Affected Public:
Private Sector, State Governments; Number of Respondents: 1,340; Total
Annual Responses: 5,881; Total Annual Hours: 72,147. (For policy
questions regarding this collection contact Russell Tipps at 301-492-
4371.)
Dated: April 12, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-08069 Filed 4-14-23; 8:45 am]
BILLING CODE 4120-01-P
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