[Federal Register Volume 89, Number 26 (Wednesday, February 7, 2024)]
[Notices]
[Pages 8435-8436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
http://www.regulations.gov. 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: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

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 
[email protected])
    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