[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)]
[Notices]
[Pages 58572-58574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25312]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10511, CMS-10575, and CMS-2552-10]
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 January 22, 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://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: Reports Clearance Office 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
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detailed information can be found in each collection's supporting
statement and associated materials (see ADDRESSES).
CMS-10511 Medicare Coverage of Items and Services in FDA
Investigational Device Exemption Clinical Studies-Revision of Medicare
Coverage
CMS-10575 Generic Clearance for the Health Care Payment Learning and
Action Network
CMS-2552-10 Hospitals and Health Care Complex Cost Report
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; Title of
Information Collection: Medicare Coverage of Items and Services in FDA
Investigational Device Exemption Clinical Studies--Revision of Medicare
Coverage; Use: Section 1862(m) of the Social Security Act (and
regulations at 42 CFR Subpart B (sections 405.201-405.215) allows for
payment of the routine costs of care furnished to Medicare
beneficiaries in a Category A investigational device exemption (IDE)
study and authorizes the Secretary to establish criteria to ensure that
Category A IDE trials conform to appropriate scientific and ethical
standards. Medicare does not cover the Category A device itself because
Category A (Experimental) devices do not satisfy the statutory
requirement that Medicare pay for devices determined to be reasonable
and necessary. Medicare may cover Category B (Non-experimental)
devices, and associated routine costs of care, if they are considered
reasonable and necessary and if all other applicable Medicare coverage
requirements are met.
Under the current centralized review process, interested parties
(such as study sponsors) that wish to seek Medicare coverage related to
Category A or B IDE studies have a centralized point of contact for
submission, review and determination of Medicare coverage IDE study
requests. In order for CMS (or its designated entity) to determine if
the Medicare coverage criteria are met, as described in our
regulations, CMS (or its designated entity) must review documents
submitted by interested parties or study sponsors. Such information
submitted will be a FDA IDE approval letter, IDE study protocol, IRB
approval letter, National Clinical Trials (NCT) number, and Supporting
materials as needed. Form Number: CMS-10511 (OMB control number: 0938-
1250); Frequency: Yearly; Affected Public: Private Sector (Business or
other for-profits, Not-for-Profit Institutions); Number of Respondents:
100; Total Annual Responses: 100; Total Annual Hours: 200. (For policy
questions regarding this collection contact Cheryl Gilbreath at 410-
786-5919.)
2. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Generic Clearance for the Health Care Payment Learning and Action
Network; Use: The Center for Medicare and Medicaid Services (CMS),
through the Center for Medicare and Medicaid Innovation, develops and
tests innovative new payment and service delivery models in accordance
with the requirements of section 1115A and in consideration of the
opportunities and factors set forth in section 1115A(b)(2) of the Act.
To date, CMS has built a portfolio of models (in operation or already
announced) that have attracted participation from a broad array of
health care providers, states, payers, and other stakeholders. During
the development of models, CMS builds on ideas received from
stakeholders--consulting with clinical and analytical experts, as well
as with representatives of relevant federal and state agencies.
CMS will continue to partner with stakeholders across the health
care system to catalyze transformation through the use of alternative
payment models. To this end, CMS launched the Health Care Payment
Learning and Action Network, an effort to accelerate the transition to
alternative payment models, identify best practices in their
implementation, collaborate with payers, providers, consumers,
purchasers, and other stakeholders, and monitor the adoption of value-
based alternative payment models across the health care system. A
system wide transition to alternative payment models will strengthen
the ability of CMS to implement existing models and design new models
that improve quality and decrease costs for CMS beneficiaries.
The information collected from LAN participants will be used by the
CMS Innovation Center to potentially inform the design, selection,
testing, modification, and expansion of innovative payment and service
delivery models in accordance with the requirements of section 1115A,
while monitoring the percentage of payments tied to alternative payment
models across the U.S. health care system. In addition, the requested
information will be made publically available so that LAN participants
(payers, providers, consumers, employers, state agencies, and patients)
can use the information to inform decision making and better understand
market dynamics in relation to alternative payment models. Form Number:
CMS-10575 (OMB control number: 0938-1297); Frequency: Occasionally;
Affected Public: Individuals; Private Sector (Business or other For-
profit and Not-for-profit institutions), State, Local and Tribal
Governments; Number of Respondents: 30,110; Total Annual Responses:
23,110; Total Annual Hours: 25,917. (For policy questions regarding
this collection contact Dustin Allison at 410-786-8830.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Hospitals and
Health Care Complex Cost Report; Use: Under the authority of sections
1815(a) and 1833(e) of the Act, CMS requires that providers of services
participating in the Medicare program submit information to determine
costs for health care services rendered to Medicare beneficiaries. CMS
requires that providers follow reasonable cost principles under
1861(v)(1)(A) of the Act when completing the Medicare cost report.
Under the regulations at 42 CFR 413.20 and 413.24, CMS defines adequate
cost data and requires cost reports from providers on an annual basis.
The Form CMS-2552-10 cost report is needed to determine a provider's
reasonable cost incurred in furnishing medical services to Medicare
beneficiaries and calculate the hospital settlement amounts. These
providers, paid under the inpatient prospective payment system (IPPS)
and the outpatient prospective payment system (OPPS), may receive
reimbursement outside of the PPS for hospital-specific adjustments such
as Medicare reimbursable bad debts, disproportionate share,
uncompensated care, direct and indirect medical education costs, and
organ acquisition
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costs. The Form CMS-2552-10 cost report is also used for rate setting
and payment refinement activities, including developing a hospital
market basket. Additionally, the Medicare Payment Advisory Commission
(MedPAC) uses the hospital cost report data to calculate Medicare
margins, to formulate recommendations to Congress regarding the IPPS
and OPPS, and to conduct additional analysis of the IPPS and OPPS. Form
Number: CMS-2552-10 (OMB control number: 0938-0050); Frequency: Yearly;
Affected Public: Private Sector (Business or other For-profit and Not-
for-profit institutions), State, Local and Tribal Governments, Federal
Government; Number of Respondents: 6,088; Total Annual Responses:
6,088; Total Annual Hours: 4,097,224. (For policy questions regarding
this collection contact Gail Duncan at 410-786-7278.)
Dated: November 15, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2018-25312 Filed 11-19-18; 8:45 am]
BILLING CODE 4120-01-P