[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]
[[Page 9526]]
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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