[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