[Federal Register Volume 84, Number 51 (Friday, March 15, 2019)]
[Notices]
[Pages 9526-9527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04895]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10630, CMS-R-263, CMS-437A and CMS-437B]


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 14, 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: 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-10630 Programs of All-Inclusive Care for the Elderly (PACE) 2020 
Audit Protocol
CMS-R-263 Site Investigation for Suppliers of Durable Medical 
Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
CMS-437A and CMS-437B State Agency Sheets for Verifying Exclusions from 
the Inpatient Prospective Payment System and Supporting Regulations 
Rehabilitation Unit/Rehabilitation Hospital Criteria Worksheets

    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: Revision with changes of 
a currently approved collection; Title of Information Collection: 
Programs of All-Inclusive Care for the Elderly (PACE) 2020 Audit 
Protocol; Use: Sections 1894(e)(4) and 1934(e)(4) of the Act and the 
implementing regulations at 42 CFR 460.190 and 460.192 mandate that 
CMS, in conjunction with the SAA, audit PACE organizations (POs) 
annually for the first 3 years (during the trial period), and then at 
least every 2 years following the trial period. The information 
gathered during this audit will be used by the Medicare Parts C and D 
Oversight and Enforcement Group (MOEG) within the Center for Medicare 
(CM) and CMS Regional Offices, as well as the SAA, to assess PO's 
compliance with PACE program requirements. If outliers or other data 
anomalies are detected, CMS' Regional Offices will work in 
collaboration with MOEG and other divisions within CMS for follow-up 
and resolution. Additionally, POs will receive the audit results, and 
will be required to implement corrective action to correct any 
identified deficiencies.
    CMS currently uses 18 data collection instruments for conducting 
PACE audits. These instruments are categorized as a PACE audit process 
and data request, a questionnaire, a pre- audit issue summary, a Root 
Cause Analysis template and 14 impact analyses templates. Beginning in 
audit year 2020, the number of data collection tools will increase from 
18 to the following 31 documents. The data collected with the data 
request tools included in this package allow CMS to conduct a 
comprehensive review of PACE organizations' compliance in accordance 
with specific federal regulatory requirements.
    CMS developed and implemented a revised PACE audit protocol. The 
audit protocol was designed to account for the continued growth of the 
PACE program and CMS' commitment to a more targeted, data-driven and 
outcomes-based audit approach, focused on high-risk areas that have the 
greatest potential for participant harm. Form Number: CMS-10630 (OMB 
control number: 0938-1327); Frequency: Yearly; Affected Public: State, 
Local, or Tribal Governments; Number of Respondents: 70; Total Annual 
Responses: 70; Total Annual Hours: 42,000. (For policy questions 
regarding this collection contact Caroline Zeman at 410 786-0116.)
    2. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Site Investigation for Suppliers of Durable Medical Equipment, 
Prosthetics, Orthotics and Supplies (DMEPOS); Use:

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The primary function of the site investigation form is to provide a 
standardized, uniform tool to gather information from a DMEPOS supplier 
that tells us whether it meets certain qualifications to be a DMEPOS 
supplier (as found in 42 CFR 424.57(c)) and where it practices or 
renders its services. This site investigation form also aides the 
Medicare contractor (the National Supplier Clearinghouse Medicare 
Administrative Contractor (NSC MAC)) in verifying compliance with the 
required supplier standards found in 42 CFR 424.57(c). Form Number: 
CMS-R-263 (OMB control number: 0938-0749); Frequency: Yearly; Affected 
Public: Private Sector--Business or other for-profits and not-for-
profit institutions; Number of Respondents: 4,811; Total Annual 
Responses: 1,603; Total Annual Hours: 1,603. (For policy questions 
regarding this collection contact Thomas Pryor at 410-786-1132.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection. Title of Information Collection: State Agency 
Sheets for Verifying Exclusions from the Inpatient Prospective Payment 
System and Supporting Regulations--Rehabilitation Unit/Rehabilitation 
Hospital Criteria Worksheets; Use: The purpose of this information 
collection is to renew forms CMS-437A and 437B. Inpatient 
Rehabilitation Facility (IRF) hospitals and units must initially attest 
that they meet the Inpatient Prospective Payment System (IPPS) 
exclusion criteria set forth at 42 CFR 412.20 to 412.29 prior to being 
placed into IPPS exempt status. Form CMS-437A must be completed by IRF 
units and form CMS-437B must be completed by IRF hospitals.
    For first time verification requests for exclusion from the IPPS, 
an IRF unit or hospital must notify the Regional Office (RO) servicing 
the State in which it is located that it believes it meets the criteria 
for exclusion from the IPPS. Currently, all new IRF units or hospitals 
must provide written certification that the inpatient population it 
intends to serve will meet the requirements of the IPPS exclusion 
criteria for IRFs. The completed CMS-437A and 437B forms are submitted 
to the State Agency (SA) no later than 5 months before the date the IRF 
unit or hospital would become subject to Inpatient Rehabilitation 
Facility Prospective Payment System (IRF-PPS). For IRF units and 
hospitals already excluded from the IPPS, annual onsite re-verification 
surveys by the SA are no longer required. IRF units and hospitals must 
now re-attest to meeting the exclusion criteria every 3 years 
thereafter.
    IRF units and hospitals that have already been excluded need not 
reapply for exclusion. These facilities will automatically be 
reevaluated yearly to determine whether they continue to meet the 
exclusion criteria. For the tri-annual re-verification, IRF units and 
hospitals will be provided with a copy of the appropriate CMS-437 
worksheet at least 5-months prior to the beginning of its cost 
reporting period, so that the IRF unit or hospital official may 
complete and sign an attestation statement and complete and return the 
appropriate form CMS-437A or CMS-437B at least 5-months prior to the 
beginning of the cost reporting period. However, Fiscal Intermediaries 
(FIs) will continue to verify, on an annual basis, compliance with the 
60 percent rule (42 CFR 412.29(b)(2)) for IRF units and hospitals 
through a sample of medical records and the SA will verify the medical 
director requirement.
    The SA will notify the RO at least 60 days prior to the end of the 
IRF unit's or hospital's cost reporting period of the status of 
compliance or non-compliance with the payment requirements. The 
information collected on the 437A and 437B forms, along with other 
information submitted by the IRF is necessary for determining the IRF's 
IPPS exclusion status. Form Number: CMS-437A and CMS-437B (OMB control 
number: 0938-0986); Frequency: Tri-annually; Affected Public: Private 
sector (Business or other for-profits); Number of Respondents: 1,126; 
Total Annual Responses: 1,126; Total Annual Hours: 1,126. (For policy 
questions regarding this collection contact Caroline Gallaher at 410-
786-8705).

    Dated: March 12, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-04895 Filed 3-14-19; 8:45 am]
 BILLING CODE 4120-01-P