Notice2024-02444
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
February 7, 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 26 (Wednesday, February 7, 2024)</title>
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[Federal Register Volume 89, Number 26 (Wednesday, February 7, 2024)]
[Notices]
[Pages 8435-8436]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-02444]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10711 and CMS-10725]
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 April 8, 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-10711 Prior Authorization Process and Requirements for Certain
Hospital Outpatient Department (OPD) Services
CMS-10725 Pharmacy Benefit Manager Transparency for Qualified Health
Plans
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
[[Page 8436]]
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: New collection of
information; Title of Information Collection: Prior Authorization
Process and Requirements for Certain Hospital Outpatient Department
(OPD) Services; Use: Section 1833(t)(2)(F) of the Act authorizes CMS to
develop a method for controlling unnecessary increases in the volume of
covered OPD services. CMS believes the increases in volume associated
with certain covered OPD services are unnecessary because the data show
that the volume of utilization of these OPD service categories far
exceeds what would be expected in light of the average rate-of-increase
in the number of Medicare beneficiaries. Therefore, CMS is using the
authority under section 1833(t)(2)(F) of the Act to require prior
authorization for certain covered OPD services as a condition of
Medicare payment. The reviews conducted under the program help to
reduce unnecessary utilization and payments for these services.
The information required for the prior authorization request
includes all documentation necessary to show that the service meets
applicable Medicare coverage, coding, and payment rules. Trained
clinical reviewers at the Medicare Administrative Contractors (MACs)
receive and review the information required for this collection. Review
of that documentation is used to determine if the requested services
are medically necessary and meet Medicare requirements to help reduce
unnecessary increases for these services. Form Number: CMS-10711 (OMB
Control Number: 0938-1368); Frequency: Occasionally; Affected Public:
Business or other for-profits; Number of Respondents: 11,469; Number of
Responses: 564,010; Annual Hours: 316,412. (For policy questions
regarding this collection contact Yuliya Cook at
<a href="/cdn-cgi/l/email-protection#c198b4ada8b8a0ef82aeaeaa81a2acb2efa9a9b2efa6aeb7"><span class="__cf_email__" data-cfemail="ebb29e8782928ac5a8848480ab888698c5838398c58c849d">[email protected]</span></a>)
2. Title of Information Collection: Pharmacy Benefit Manager
Transparency for Qualified Health Plans; Type of Information Collection
Request: Revision of a currently approved collection; Use:
Implementation of section 1150A of the Social Security Act, as added by
section 6005 of the Patient Protection and Affordable Care Act (ACA),
requires, among other entities, Qualified Health Plans (QHPs) and
pharmacy benefit managers (PBMs) that serve QHP issuers to report
information on prescription drug benefits to the U.S. Department of
Health and Human Services (HHS). PBMs are third-party administrators of
prescription programs for a variety of types of health plans, including
QHPs. CMS finalized regulations for this reporting at 45 CFR 156.295
and 184.50.
Under these requirements a QHP issuer is required to report issuer
and plan level prescription drug data to CMS only when the QHP issuer
does not contract with a PBM to administer the prescription drug
benefit for their QHPs. Section 1150A(a)(1) of the Social Security Act
authorizes CMS to collect the same prescription drug and rebate
information from Prescription Drug Plan sponsors of a prescription drug
plan and Medicare Advantage organizations offering a Medicare Advantage
Prescription Drug Plan under part D of title XVIII. Since 2012, CMS has
collected these data from Part D sponsors as part of the Medicare Part
D Direct and Indirect Remuneration (DIR) reporting requirement, and
detailed drug information for each National Drug Code (NDC) from the
Prescription Drug Event (PDE) data that plans are required to submit.
CMS is requesting to renew this collection of information in
connection with submission from QHP issuers that do not contract with a
PBM and PBMs (hereinafter referred to as ``submitters''). The
information required from submitters and the process of submission has
changed since the previous collection was approved in 2021. The
submitters are now required to complete a web form that reports the
allocation methodology that is selected by the submitters to allocate
data, where necessary. Submitters are required to maintain internal
documentation of the allocation methodologies chosen, as CMS may need
to follow up with the submitters to better understand the methodology.
The burden estimates for the collection of information included in this
package reflect the time and effort for submitters to provide
prescription drug benefit information to CMS using the Health
Information Oversight System (HIOS) module. Form Number: CMS-10725 (OMB
control number: 0938-1394); Frequency: Annually; Affected Public:
Private Sector, Business or other For-Profits; Number of Respondents:
278; Number of Responses: 278; Total Annual Hours: 1,285. (For
questions regarding this collection, contact LeAnn Brodhead at (301)
492-4493.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-02444 Filed 2-6-24; 8:45 am]
BILLING CODE 4120-01-P
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