Notice2024-11397
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
May 24, 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 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 89 Issue 102 (Friday, May 24, 2024)</title>
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[Federal Register Volume 89, Number 102 (Friday, May 24, 2024)]
[Notices]
[Pages 45898-45899]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11397]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10185 and CMS-10008]
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
[[Page 45899]]
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 June 24, 2024.
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: Medicare Part D
Reporting Requirements; Use: Section 1860D-12(b)(3)(D) of the Act
provides broad authority for the Secretary to add terms to the
contracts with Part D sponsors, including terms that require the
sponsor to provide the Secretary with information as the Secretary may
find necessary and appropriate. Pursuant to our statutory authority, we
codified these information collection requirements for Part D sponsors
in regulation at 42 CFR 423.514(a).
Data collected via the Medicare Part D reporting requirements will
be an integral resource for oversight, monitoring, compliance, and
auditing activities necessary to ensure quality provision of the
Medicare Prescription Drug Benefit to beneficiaries. For all reporting
sections (Enrollment and Disenrollment, Medication Therapy Management
(MTM) Programs, Grievances, Improving Drug Utilization Review Controls,
Coverage Determinations and Redeterminations, and Employer/Union
Sponsored Sponsors, and Medicare Prescription Payment Plan), data are
reported electronically to CMS. The data collected via the MTM and
Grievances reporting sections are used in the Medicare Part C and D
Star Ratings and Display Measures. The other reporting sections' data
are analyzed for program oversight to ensure the availability,
accessibility, and acceptability of sponsors' services, such as
coverage determinations and appeals processes, and opioid safety edits
at the time of dispensing. Form Number: CMS-10185 (OMB Control Number:
0938-0992); Frequency: Yearly; Affected Public: Business or other for-
profits; Number of Respondents: 1,019; Number of Responses: 14,325;
Total Annual Hours: 23,094. (For policy questions regarding this
collection contact Abigale Sanft at 410-786-6068.)
2. 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. 2024-11397 Filed 5-23-24; 8:45 am]
BILLING CODE 4120-01-P
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