[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

[[Page 58573]]

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