Notice2024-05291
Agency Information Collection Activities: Proposed Collection; 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
March 13, 2024
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 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.
Full Text
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<title>Federal Register, Volume 89 Issue 50 (Wednesday, March 13, 2024)</title>
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[Federal Register Volume 89, Number 50 (Wednesday, March 13, 2024)]
[Notices]
[Pages 18411-18412]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-05291]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10279, CMS-10316 and CMS-10008]
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 May 13, 2024.
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
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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: <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 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-10279 Ambulatory Surgical Center Conditions for Coverage
CMS-10316 Implementation of the Medicare Prescription Drug Plan (PDP)
and Medicare Advantage (MA) Plan Disenrollment Reasons Survey
CMS-10008 Transitional Pass-through payments related to Drugs,
Biologicals, and Radiopharmaceuticals to determine eligibility under
the Outpatient Prospective Payment System
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: Reinstatement with
changes to a previously approved collection; Title of Information
Collection: Ambulatory Surgical Center Conditions for Coverage; Use:
The purpose of this package is to request from the Office of Management
and Budget (OMB) the approval to reinstate, with changes, the
collection of
[[Page 18412]]
information. The Cfc for ASCs are regulation based on criteria
described and codified at Sec. 42 CFR 416. The Cfc establish standards
designed to ensure that each ASC has properly trained staff to provide
the appropriate type and level of care for the environment of ASC
patients.
To determine ASC compliance with CMS standards, CMS, via the
Secretary, authorizes States, through contracts, to survey ASC
facilities. For Medicare purposes, certification is based on the State
survey agency's recording of an ASC provider's compliance or non-
compliance with the health and safety Cfc as published and codified in
42 CFR 416.40 to 485.54. The information collections aid surveyors as
they assess ASC compliance or non-compliance.
The previous iteration of this information collection request had a
burden of 262,946 annual hours at an annual cost of $28,144,370. For
this requested reinstatement, with changes, the adjusted annual hourly
burden is 97,527 hours at a cost of $11,089,427. The reasons for this
change, is the previous iteration of this IC assumed the development
associated with IC-1 and IC-2 occurred frequently. We have revised this
as development of drafts only occur on a one-time basis. Form Number:
CMS-10279 (OMB control number: 0938-1071); Frequency: Annual; Affected
Public: Business or other for-profit and Not-for-profit institutions;
Number of Respondents: 6,257; Total Annual Responses: 6,257; Total
Annual Hours: 97,527. (For policy questions regarding this collection
contact Claudia Molinar at 410-786-8445.)
2. 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: Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA) provides a requirement
to collect and report performance data for Part D prescription drug
plans. 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.
This data collection complements the enrollee beneficiary
experience data collected through the Medicare Consumer Assessment of
Healthcare Providers and Systems (Medicare CAHPS) survey by providing
information on the reasons for disenrollment from a Medicare Advantage
(with or without prescription drug coverage) or Prescription Drug Plan.
The Disenrollment Survey results are an important source of
information used by CMS to monitor contract performance and to identify
potential problems (e.g., plans providing incorrect information to
beneficiaries or creating access problems). CMS uses the results to
monitor the quality of service that Medicare beneficiaries get from
contracted plans and their providers and to understand beneficiaries'
expectations relative to provided benefits and services for MA and
PDPs. CMS uses information from the Disenrollment Survey to support
quality improvement efforts of individual contracts. Form Number: CMS-
10316 (OMB control number: 0938-1113); Frequency: Yearly; Affected
Public: Individuals and Households; Number of Respondents: 36,050;
Total Annual Responses: 36,050; Total Annual Hours: 6,730. (For policy
questions regarding this collection contact Beth Simon at 415-744-
3780.)
3. Type of Information Collection Request: Extension currently
approved collection; Title of Information Collection: Transitional Pass
through payments related to Drugs, Biologicals, and
Radiopharmaceuticals to determine eligibility under the Outpatient
Prospective Payment System; Use: Section 1833(t)(6)(D)(i) of the Act
sets the payment rate for pass-through eligible drugs and biologicals
(assuming that no pro rata reduction in pass-through payment is
necessary) as the amount determined under section 1842(o) of the Act.
Section 303(c) of Public Law 108-173 amended Title XVIII of the Act by
adding new section 1847A. This new section establishes the use of the
average sales price (ASP) methodology for payment for drugs and
biologicals described in section 1842(o)(1)(C) of the Act furnished on
or after January 1, 2005. Therefore, as we stated in the November 15,
2004 Federal Register (69 FR 65776), in CY 2005, we will pay under the
OPPS for drugs, biologicals and radiopharmaceuticals with pass-through
status consistent with the provisions of section 1842(o) of the Act as
amended by Public Law 108-173 at a rate that is equivalent to the
payment these drugs and biologicals will receive in the physician
office setting, and established in accordance with the methodology
described in the CY 2005 Physician Fee Schedule final rule.
Interested parties such as hospitals, pharmaceutical companies, and
physicians will apply for transitional pass-through payment for drugs,
biologicals, and radiopharmaceuticals used with services covered under
the hospital OPPS. After we receive all requested information, we will
evaluate the information to determine if the criteria for making a
transitional pass-through payment are met and if an interim healthcare
common procedure coding system (HCPCS) code for a new drug, biological,
or radiopharmaceutical is necessary. We will advise the applicant of
our decision, and update the hospital OPPS during its next scheduled
quarterly update to reflect any newly approved drug, biological, or
radiopharmaceutical. Based on experience gained in processing
transitional pass-through and new technology applications, we have
reworded some of the statements for clarity and have more clearly
requested information in a format that will allow us to determine if
the drug, biological, or radiopharmaceutical meets the cost
significance test, as well as to estimate the associated pass-through
payment amount. In addition, we have also eliminated the requirement
for applicants to obtain a national Level II HCPCS code prior to
seeking transitional pass-through payment eligibility, or provide us
with a copy of their application for a national HCPCS code, as we had
originally required in the April 7, 2000 final rule. Form Number: CMS-
10008 (OMB control number: 0938-0802); Frequency: Once; Affected
Public: Private Sector, Business or other for-profit and Not-for-profit
institutions; Number of Respondents: 35; Total Annual Responses: 35;
Total Annual Hours: 560. (For policy questions regarding this
collection contact Andrew Wang at 410-786-8233.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-05291 Filed 3-12-24; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on March 13, 2024.
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