```

[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Notices]
[Pages 25488-25489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09167]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10052]

Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

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 (the 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 June 28, 2022.

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, you may make 
your request using one of following:
    1. Access CMS' website address at website address at 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-10052 Recognition of Pass-Through Payment for Additional (New) 
Categories of Devices under the Outpatient Prospective Payment System 
and Supporting Regulations

    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. Title of Information Collection: Recognition of Pass-Through 
Payment for Additional (New) Categories of Devices under the Outpatient 
Prospective Payment System and

[[Page 25489]]

Supporting Regulations; Type of Information Collection Request: 
Revision with change of a currently approved collection; Use: The 
transitional pass-through provision provides a way for ensuring 
appropriate payment for new technologies whose use and costs are not 
adequately represented in the base year claims data on which the 
outpatient PPS is constructed as required by law. Categories of medical 
devices will receive transitional pass-through payments for 2 to 3 
years from the date payments are initiated for the category. However, 
the underlying provision is permanent and provides an on-going 
mechanism for reflecting timely introduction of new items into the 
payment structure.
    Interested parties such as hospitals, device manufacturers, 
pharmaceutical companies, and physicians apply for transitional pass-
through payment for certain items used with services covered in the 
outpatient PPS. After we receive all requested information, we evaluate 
the information to determine if the creation of an additional category 
of medical devices for transitional pass-through payments is justified. 
We may request additional information related to the proposed new 
device category, as needed. We advise the applicant of our decision, 
and update the outpatient PPS during its next scheduled quarterly 
payment update cycle to reflect any newly approved device categories. 
We list below the information that we require from all applicants. The 
following information is required to process requests for additional 
categories of medical devices for transitional pass-through payments. 
Form Number: CMS-10052 (OMB control number: 0938-0857); Frequency: 
Annually; Affected Public: Private Sector, Business or other for-
profits; Number of Respondents: 10; Number of Responses: 10; Total 
Annual Hours: 160. (For questions regarding this collection contact 
Kimberly A. Campbell at 410-786-2289.)

     Dated: April 25, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2022-09167 Filed 4-28-22; 8:45 am]
BILLING CODE 4120-01-P
```