[Federal Register Volume 84, Number 48 (Tuesday, March 12, 2019)]
[Notices]
[Pages 8872-8873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04490]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10052 and CMS-10629]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid 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 (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 May 13, 2019.

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://

[[Page 8873]]

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.html
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

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
CMS-10629 Waiver Application for Providers and Suppliers Subject to an 
Enrollment Moratorium

    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 
change of a currently approved collection; Title of Information 
Collection: Recognition of Pass-Through Payment for Additional (New) 
Categories of Devices under the Outpatient Prospective Payment System 
and Supporting Regulations; Use: Section 402 of the Benefits 
Improvement and Protection Act of 2000 (BIPA), enacted on December 21, 
2000, made changes in the provision for transitional pass-through 
payment for devices under the hospital OPPS. Section 402 of BIPA 
amended section 1833(t)(6) of the Act to require that we abandon the 
item-specific approach in determining the eligibility of medical 
devices for transitional pass-through payments. This provision mandated 
that we adopt a category approach for making such payments. In 
accordance with this requirement, we would pay for any device that 
falls in categories we establish for this purpose. This provision 
required us to establish the initial set of categories, to include 
devices previously determined eligible for transitional pass-through 
payments, effective April 1, 2001.
    The law made clear that application and approval processes are no 
longer required as the basis for determining an individual medical 
device's eligibility for transitional pass-through payments. However, 
we must assemble certain crucial information to be able to determine 
the appropriateness of establishing an additional (new) category. The 
information that we seek to collect is essential to determine whether 
additional categories of medical devices are appropriate for 
transitional pass-through payments. The intent of these provisions is 
to ensure that timely beneficiary access to new technologies is not 
jeopardized by inadequate payment levels.
    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. 
Form Number: CMS-10052 (OMB control number: 0938-0857); Frequency: 
Yearly; Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 10; Total Annual Responses: 10; Total Annual Hours: 160. 
(For policy questions regarding this collection contact AuSha 
Washington at 410-786-3736.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Waiver 
Application for Providers and Suppliers Subject to an Enrollment 
Moratorium; Use: The Provider Enrollment Moratoria Access Waiver 
Application, named the ``Waiver Application for Providers and Suppliers 
Subject to an Enrollment Moratorium'' has been created to collect that 
data, which will be completed by providers and suppliers to apply for a 
waiver in Moratoria locations. CMS will be collecting this data on an 
ad-hoc basis until the Paperwork Reduction Act Submission has been 
approved. The goal of the Waiver Application for Providers and 
Suppliers Subject to an Enrollment Moratorium is to provide a uniform 
application process that all providers and suppliers may follow so that 
CMS is able to administer the Medicaid or Children's Health Insurance 
Program moratorium process in a standardized and repeatable manner. 
This form creates a standardized process so that moratoria decisions 
are being made with the same criteria each time. Form Number: CMS-10629 
(OMB control number: 0938-1313); Frequency: Occasionally; Affected 
Public: Federal Government, State, Local, or Tribal Governments; Number 
of Respondents: 800; Total Annual Responses: 800; Total Annual Hours: 
6. (For policy questions regarding this collection contact Kim Jung at 
410-786-9370.)

    Dated: March 7, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-04490 Filed 3-11-19; 8:45 am]
BILLING CODE 4120-01-P