Agency Information Collection Activities: Submission for OMB Review; Comment Request, 68936-68938 [2019-27139]
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Federal Register / Vol. 84, No. 242 / Tuesday, December 17, 2019 / Notices
toxicological effects of ENMs. NIOSH is
also seeking information on studies that
include evaluating the dose-response
relationships between exposure to
ENMs and the development of adverse
lung effects including inflammation,
fibrosis, or neoplasia. Supporting
information for published studies
should include a full citation. For
unpublished studies please include
authors, affiliations, year, and any
context on how the data were collected.
NIOSH will publish a Technical
Report which describes the data,
methods, and findings for the
development of categorical OELs for
ENMs, which may include relevant
information submitted in response to
this request. The draft Technical Report
will be made available for public
comment in a subsequent notice.
References
[ISO 2016] Nanotechnologies—Overview of
available frameworks for the
development of occupational exposure
limits and bands for nano-objects and
their aggregates and agglomerates
(NOAAs). International Organization for
Standardization (ISO) Technical Report.
ISO/TR 18637, published November 21.
ISO, Geneva, Switzerland.
[NIOSH 2019] Technical report: The NIOSH
occupational exposure banding process
for chemical risk management. By Lentz
TJ, Seaton M, Rane P, Gilbert SJ,
McKernan LT, Whittaker C. Cincinnati,
OH: U.S. Department of Health and
Human Services, Centers for Disease
Control and Prevention, National
Institute for Occupational Safety and
Health, DHHS (NIOSH) Publication No.
2019–132
John J. Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2019–27169 Filed 12–16–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10638, CMS–
R–5, CMS–287–19, and CMS–10088]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
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AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
SUMMARY:
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information from the public. Under the
Paperwork Reduction Act of 1995
(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
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate 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 on the collection(s) of
information must be received by the
OMB desk officer by January 16, 2020.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR Email:
OIRA_submission@omb.eop.gov.
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/PRAListing.html.
1. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
2. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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
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submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-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 that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision with change of a
currently approved collection; Title of
Information Collection: Application for
New Medical Services and Technologies
Seeking to Qualify for Add-On
Payments Under the Hospital Inpatient
Prospective Payment System; Use:
Section 1886(d)(5)(K) authorizes the
Secretary to establish a special payment
methodology for new medical services
and technologies used in inpatient
procedures. To qualify for additional
payments under this provision; a new
technology must represent a substantial
clinical improvement; data reflecting
the cost of new technology must not yet
be available in the data used to
recalibrate the Medicare severity
diagnosis-related groups (MS–DRGs);
and the MS–DRG payment rate
otherwise applicable to the new
technology would be inadequate (see 42
CFR 412.87(b)). we are revising the
estimated annual number of
respondents from 32 to 62, based on the
proposed alternative new technology
add-on payment pathway for certain
devices included in the FY 2020 IPPS
proposed rule (CMS–1716–P). The
existing regulations at 42 CFR 412.87
implement these provisions and specify
three criteria for a new medical service
or technology to receive the additional
payment: (1) The medical service or
technology must be new; (2) the medical
service or technology must be costly
such that the DRG rate otherwise
applicable to discharges involving the
medical service or technology is
determined to be inadequate; and (3) the
service or technology must demonstrate
a substantial clinical improvement over
existing services or technologies.
In the FY 2020 IPPS proposed rule (84
FR 19371—19373), we proposed an
alternative new technology add-on
payment pathway for certain devices.
Specifically, for applications received
for new technology add-on payments for
FY 2021 and subsequent fiscal years, we
proposed that a medical device that has
received Federal Drug Administration
(FDA) marketing authorization (that is,
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Federal Register / Vol. 84, No. 242 / Tuesday, December 17, 2019 / Notices
has been approved or cleared by, or had
a De Novo classification request granted
by, the FDA) and that is part of the
FDA’s Breakthrough Devices Program
would need to meet the cost criterion
(that is, the medical device must be
costly such that the DRG rate otherwise
applicable to discharges involving the
medical device is determined to be
inadequate). To implement this
proposal, we proposed to revise the
existing regulations at 42 CFR 412.87.
We use the application in order to
determine if a technology meets the new
technology criteria under the existing
pathway, and would revise the
application to reflect the information
required to determine if a device meets
the new technology criteria the
proposed alternative pathway for certain
devices. The revise application that
would be used if the proposed
alternative new technology add-on
payment pathway for certain devices is
finalized in the FY 2020 IPPS final rule,
which is expected to be issued by
August 1, 2019. Form Number: CMS–
10638 (OMB control number: 0938–
1347); Frequency: Yearly; Affected
Public: Private Sector: Business or Other
for-profits, Not for-profit Institutions;
Number of Respondents: 62; Total
Annual Responses: 62; Total Annual
Hours: 1,655. (For policy questions
regarding this collection contact
Michele Hudson at 410–786–5490.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Physician
Certifications/Recertifications in Skilled
Nursing Facilities Manual Instructions;
Use: Section 1814(a) of the Social
Security Act (the Act) requires specific
certifications in order for Medicare
payments to be made for certain
services. Before the enactment of the
Omnibus Budget Reconciliation Act of
1989 (OBRA1989, Pub. L. 101–239),
section 1814(a)(2) of the Act required
that, in the case of post-hospital
extended care services, a physician
certify that the services are or were
required to be given because the
individual needs or needed, on a daily
basis, skilled nursing care (provided
directly by or requiring the supervision
of skilled nursing personnel) or other
skilled rehabilitation services that, as a
practical matter, can only be provided
in a SNF on an inpatient basis. The
physician certification requirements
were included in the law to ensure that
patients require a level of care that is
covered by the Medicare program and
because the physician is a key figure in
determining the utilization of health
services. In addition, it set forth
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qualification requirements that a nurse
practitioner or clinical nurse specialist
must meet in order to sign certification
or recertification statements (these
requirements were later revised in the
Balanced Budget Act of 1997).
Effective with items and services
furnished on or after January 1, 2011,
section 3108 of the Affordable Care Act
added physician assistants to the
existing authority for nurse practitioners
and clinical nurse specialists.
Regulations implementing this
provision were promulgated in the
calendar year (CY) 2011 Medicare
Physician Fee Schedule (MPFS) final
rule with comment period (75 FR 73387,
73602, 73626–27, November 29, 2010).
The requirements at 42 CFR 424.20(a)
and (b) concern the initial certification
of a beneficiary’s need for a SNF level
of care, which must be made upon
admission or as soon thereafter as is
reasonable and practicable. The
requirements at 42 CFR 424.20(c) and
(d) concern recertification of a
beneficiary’s need for continued SNF
level of care, and also require an
estimate of the time the individual will
need to remain in the SNF, plans for
home treatment, and, if appropriate,
whether continued services are needed
for a condition that occurred after
admission to the SNF and while still
receiving treatment for the condition for
which he or she had received inpatient
hospital services. These sections require
recertification at specific intervals (the
initial recertification must occur no later
than the 14th day of SNF care, with
subsequent recertification at least every
30 days thereafter) that posthospital
SNF care is or was required because the
individual needs or needed skilled care
on a daily basis. The following CMS
internet-Only Manuals provide more
detailed instructions regarding the
required certification and recertification
of covered post-hospital extended care
services for a Medicare beneficiary:
Chapter 4, sections 40ff and 80 in the
Medicare General Information,
Eligibility, and Entitlement Manual
(CMS Pub. 100–01), chapter 8, sections
40ff. in the Medicare Benefit Policy
Manual (CMS Pub. 100–02), and chapter
6, section 6.3 in the Medicare Program
Integrity Manual (CMS Pub. 100–08).
Form Number: CMS–R–5 (OMB control
number: 0938–0454); Frequency:
Occasionally; Affected Public: Private
Sector (Not-for-profit institutions);
Number of Respondents: 2,746,550;
Total Annual Responses: 2,746,550;
Total Annual Hours: 615,149. (For
policy questions regarding this
collection contact Kia Sidbury at 410–
786–7816.)
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3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Home Office
Cost Statement; Use: Home offices of
chain organizations vary greatly in size,
number of locations, staff, mode of
operations, and services furnished to the
facilities in the chain. The home office
of a chain is not in itself certified by
Medicare. The relationship of the home
office is that of a related organization to
participating providers (See 42 CFR
413.17). When a provider claims costs
on its cost report that are allocated from
a home office, the Home Office Cost
Statement constitutes the documentary
support required of the provider to be
reimbursed for home office costs in the
provider’s cost report. Each contractor
servicing a provider in a chain must be
furnished with a detailed Home Office
Cost Statement as a basis for
reimbursing the provider for cost
allocations from a home office or chain
organization. Home offices usually
furnish central management and
administrative services, e.g., centralized
accounting, purchasing, personnel
services, management direction and
control, and other services. To the
extent that the home office furnishes
services related to patient care to a
provider, the reasonable costs of such
services are included in the provider’s
cost report and are reimbursable as part
of the provider’s costs. If the home
office of the chain provides no services
related to patient care, the costs of the
home office may not be recognized in
determining the allowable costs of the
providers in the chain. Under the
authority of sections 1815(a) and
1833(e) of the Social Security Act (42
U.S.C. 1395g), 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. Providers receiving Medicare
reimbursement must provide adequate
cost data based on financial and
statistical records, which can be verified
by qualified auditors. The Form CMS–
287–19 home office cost statement is
needed to determine a provider’s
reasonable cost incurred in furnishing
medical services to Medicare
beneficiaries and reimbursement due to
or from a provider. Form Number:
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Federal Register / Vol. 84, No. 242 / Tuesday, December 17, 2019 / Notices
CMS–287–19 (OMB control number:
0938–0202); Frequency: Annually;
Affected Public: Private Sector (Business
or other for-profit and Not-for-profit
institutions); Number of Respondents:
1,507; Total Annual Responses: 1,507;
Total Annual Hours: 702,262. (For
policy questions regarding this
collection contact Yaakov Feinstein at
410–786–3137.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Notification of
FLS and CMS of Co-Located Medicare
Providers; Use: Many long-term care
hospitals (LTCHs) are co-located with
other Medicare providers (acute care
hospitals, inpatient rehabilitation
facilities (IRFs), skilled nursing facilities
(SNFs), inpatient psychiatric facilities
(IPFs)), which could lead to potential
gaming of the Medicare system based on
inappropriate patient shifting. In
regulations at 42 CFR 412.22(e)(3) and
(h)(6) CMS requires LTCHs to notify
Medicare Administrative Contractors
(MACs) and CMS of co-located
providers. The requirement regarding
collection of information at § 412.22
concerning a LTCH’s (or a LTCH
satellite’s) notification to its MAC and
CMS of its co-located status is needed
in order for Medicare to appropriately
pay co-located hospitals-withinhospitals (HwHs) and satellites. Under
§§ 412.22(e)(3) and (h)(6), an LTCH or a
satellite of an LTCH that occupies space
in a building used by another hospital,
or in one or more entire buildings
located on the same campus as
buildings used by another hospital must
notify its MAC and CMS in writing of
its co-location within 60 days of its first
cost reporting period that began on or
after October 1, 2002. Form Number:
CMS–10088 (OMB control number:
0938–0897); Frequency: Yearly; Affected
Public: Private Sector (Business or other
for-profit, not-for-profit institutions);
Number of Respondents: 25; Total
Annual Responses: 25; Total Annual
Hours: 6. (For policy questions
regarding this collection contact Emily
Lipkin at 410–786–3633.)
Dated: December 12, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–27139 Filed 12–16–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day
Information Collection: Application for
Participation in the IHS Scholarship
Program
Indian Health Service.
Notice and request for
comments. Request for extension of
approval.
AGENCY:
ACTION:
In compliance the Paperwork
Reduction Act of 1995, the Indian
Health Service (IHS) invites the general
public to comment on the information
collection titled, ‘‘Application for
Participation in the IHS Scholarship
Program,’’ Office of Management and
Budget (OMB) Control No. 0917–0006.
IHS is requesting OMB to approve an
extension for this collection, which
expires on March 31, 2020.
DATES: Comment Due Date: February 18,
2020. Your comments regarding this
information collection are best assured
of having full effect if received within
60 days of the date of this publication.
ADDRESSES: Send your written
comments, requests for more
information on the collection, or
requests to obtain a copy of the data
collection instrument and instructions
to Ms. Reta Brewer by one of the
following methods:
• Mail: Reta Brewer, Branch Chief,
Scholarship Programs, Division of
Health Professions Support, Indian
Health Service, 5600 Fishers Lane, Mail
Stop: OHR 11E53A, Rockville, MD
20857.
• Phone: (301) 443–2349.
• Email: reta.brewer@ihs.gov.
• Fax: 301–443–6048.
SUPPLEMENTARY INFORMATION: This
previously approved information
SUMMARY:
Number of
respondents
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Data collection instrument(s)
Scholarship Online Application ....................................
Verification of Acceptance or Decline of Award (IHS–
856–7).
Recipient’s Initial Program Progress Report (IHS–
856–8).
Notification of Academic Problem (IHS–856–9) ..........
Change of Status (IHS–856–10) .................................
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Responses
per
respondent
collection project was last published in
the Federal Register (81 FR 60368), on
September 1, 2016 and allowed 30 days
for public comment. No public
comment was received in response to
the notice. The purpose of this notice is
to allow 60 days for public comment. A
copy of the supporting statement is
available at www.regulations.gov (see
Docket ID IHS–2020–01).
Information Collection: Title:
‘‘Application for Participation in the
IHS Scholarship Program,’’ OMB
Control No. 0917–0006. Type of
Information Collection Request:
Extension of the currently approved
information collection ‘‘Application for
Participation in the IHS Scholarship
Program,’’ OMB Control No. 0917–0006.
Form Number(s): IHS–856–07 through
856–16, IHS–856–19 through 856–23,
IHS–817, and IHS–818 are retained for
use by the IHS Scholarship Program
(IHSSP) as part of this current
Information Collection Request.
Reporting forms are found on the IHS
website at www.ihs.gov/scholarship.
Forms IHS–856–03, IHS–856–05, and
IHS–856–06 have been moved to the
online application process and can be
found at www.ihs.gov/scholarship/
applynow/. Need and Use of
Information Collection: The IHS
Scholarship Branch needs this
information for program administration
and uses the information to: Solicit,
process, and award IHS Pre-graduate,
Preparatory, and/or Health Professions
Scholarship recipients; monitor the
academic performance of recipients; and
to place recipients at payback sites. The
IHSSP application is electronically
available on the internet at the IHS
website at: https://www.ihs.gov/
scholarship/applynow/.
Affected Public: Individuals, not-forprofit institutions and State, local or
Tribal Governments. Type of
Respondents: Students pursuing health
care professions.
The table below provides: Types of
data collection instruments, Estimated
number of respondents, Number of
responses per respondent, Annual
number of responses, Average burden
hour per response, and Total annual
burden hours.
Total annual
response
Burden hour
per response *
Annual
burden hours
850
300
1
1
850
300
1.00 (60 min) .........
0.13 (8 min) ...........
850
39
800
1
800
0.13 (8 min) ...........
104
20
50
1
1
20
50
0.13 (8 min) ...........
.045 (25 min) .........
3
21
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]]>Agencies
[Federal Register Volume 84, Number 242 (Tuesday, December 17, 2019)]
[Notices]
[Pages 68936-68938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27139]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10638, CMS-R-5, CMS-287-19, and CMS-10088]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 (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 a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate 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 on the collection(s) of information must be received by
the OMB desk officer by January 16, 2020.
ADDRESSES: When commenting on the proposed information collections,
please reference the document identifier or OMB control number. To be
assured consideration, comments and recommendations must be received by
the OMB desk officer via one of the following transmissions: OMB,
Office of Information and Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395-5806 OR Email:
[email protected].
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.
1. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
2. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(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 (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-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 that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Revision with change of
a currently approved collection; Title of Information Collection:
Application for New Medical Services and Technologies Seeking to
Qualify for Add-On Payments Under the Hospital Inpatient Prospective
Payment System; Use: Section 1886(d)(5)(K) authorizes the Secretary to
establish a special payment methodology for new medical services and
technologies used in inpatient procedures. To qualify for additional
payments under this provision; a new technology must represent a
substantial clinical improvement; data reflecting the cost of new
technology must not yet be available in the data used to recalibrate
the Medicare severity diagnosis-related groups (MS-DRGs); and the MS-
DRG payment rate otherwise applicable to the new technology would be
inadequate (see 42 CFR 412.87(b)). we are revising the estimated annual
number of respondents from 32 to 62, based on the proposed alternative
new technology add-on payment pathway for certain devices included in
the FY 2020 IPPS proposed rule (CMS-1716-P). The existing regulations
at 42 CFR 412.87 implement these provisions and specify three criteria
for a new medical service or technology to receive the additional
payment: (1) The medical service or technology must be new; (2) the
medical service or technology must be costly such that the DRG rate
otherwise applicable to discharges involving the medical service or
technology is determined to be inadequate; and (3) the service or
technology must demonstrate a substantial clinical improvement over
existing services or technologies.
In the FY 2020 IPPS proposed rule (84 FR 19371--19373), we proposed
an alternative new technology add-on payment pathway for certain
devices. Specifically, for applications received for new technology
add-on payments for FY 2021 and subsequent fiscal years, we proposed
that a medical device that has received Federal Drug Administration
(FDA) marketing authorization (that is,
[[Page 68937]]
has been approved or cleared by, or had a De Novo classification
request granted by, the FDA) and that is part of the FDA's Breakthrough
Devices Program would need to meet the cost criterion (that is, the
medical device must be costly such that the DRG rate otherwise
applicable to discharges involving the medical device is determined to
be inadequate). To implement this proposal, we proposed to revise the
existing regulations at 42 CFR 412.87. We use the application in order
to determine if a technology meets the new technology criteria under
the existing pathway, and would revise the application to reflect the
information required to determine if a device meets the new technology
criteria the proposed alternative pathway for certain devices. The
revise application that would be used if the proposed alternative new
technology add-on payment pathway for certain devices is finalized in
the FY 2020 IPPS final rule, which is expected to be issued by August
1, 2019. Form Number: CMS-10638 (OMB control number: 0938-1347);
Frequency: Yearly; Affected Public: Private Sector: Business or Other
for-profits, Not for-profit Institutions; Number of Respondents: 62;
Total Annual Responses: 62; Total Annual Hours: 1,655. (For policy
questions regarding this collection contact Michele Hudson at 410-786-
5490.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Physician
Certifications/Recertifications in Skilled Nursing Facilities Manual
Instructions; Use: Section 1814(a) of the Social Security Act (the Act)
requires specific certifications in order for Medicare payments to be
made for certain services. Before the enactment of the Omnibus Budget
Reconciliation Act of 1989 (OBRA1989, Pub. L. 101-239), section
1814(a)(2) of the Act required that, in the case of post-hospital
extended care services, a physician certify that the services are or
were required to be given because the individual needs or needed, on a
daily basis, skilled nursing care (provided directly by or requiring
the supervision of skilled nursing personnel) or other skilled
rehabilitation services that, as a practical matter, can only be
provided in a SNF on an inpatient basis. The physician certification
requirements were included in the law to ensure that patients require a
level of care that is covered by the Medicare program and because the
physician is a key figure in determining the utilization of health
services. In addition, it set forth qualification requirements that a
nurse practitioner or clinical nurse specialist must meet in order to
sign certification or recertification statements (these requirements
were later revised in the Balanced Budget Act of 1997).
Effective with items and services furnished on or after January 1,
2011, section 3108 of the Affordable Care Act added physician
assistants to the existing authority for nurse practitioners and
clinical nurse specialists. Regulations implementing this provision
were promulgated in the calendar year (CY) 2011 Medicare Physician Fee
Schedule (MPFS) final rule with comment period (75 FR 73387, 73602,
73626-27, November 29, 2010). The requirements at 42 CFR 424.20(a) and
(b) concern the initial certification of a beneficiary's need for a SNF
level of care, which must be made upon admission or as soon thereafter
as is reasonable and practicable. The requirements at 42 CFR 424.20(c)
and (d) concern recertification of a beneficiary's need for continued
SNF level of care, and also require an estimate of the time the
individual will need to remain in the SNF, plans for home treatment,
and, if appropriate, whether continued services are needed for a
condition that occurred after admission to the SNF and while still
receiving treatment for the condition for which he or she had received
inpatient hospital services. These sections require recertification at
specific intervals (the initial recertification must occur no later
than the 14th day of SNF care, with subsequent recertification at least
every 30 days thereafter) that posthospital SNF care is or was required
because the individual needs or needed skilled care on a daily basis.
The following CMS internet-Only Manuals provide more detailed
instructions regarding the required certification and recertification
of covered post-hospital extended care services for a Medicare
beneficiary: Chapter 4, sections 40ff and 80 in the Medicare General
Information, Eligibility, and Entitlement Manual (CMS Pub. 100-01),
chapter 8, sections 40ff. in the Medicare Benefit Policy Manual (CMS
Pub. 100-02), and chapter 6, section 6.3 in the Medicare Program
Integrity Manual (CMS Pub. 100-08). Form Number: CMS-R-5 (OMB control
number: 0938-0454); Frequency: Occasionally; Affected Public: Private
Sector (Not-for-profit institutions); Number of Respondents: 2,746,550;
Total Annual Responses: 2,746,550; Total Annual Hours: 615,149. (For
policy questions regarding this collection contact Kia Sidbury at 410-
786-7816.)
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Home Office Cost
Statement; Use: Home offices of chain organizations vary greatly in
size, number of locations, staff, mode of operations, and services
furnished to the facilities in the chain. The home office of a chain is
not in itself certified by Medicare. The relationship of the home
office is that of a related organization to participating providers
(See 42 CFR 413.17). When a provider claims costs on its cost report
that are allocated from a home office, the Home Office Cost Statement
constitutes the documentary support required of the provider to be
reimbursed for home office costs in the provider's cost report. Each
contractor servicing a provider in a chain must be furnished with a
detailed Home Office Cost Statement as a basis for reimbursing the
provider for cost allocations from a home office or chain organization.
Home offices usually furnish central management and administrative
services, e.g., centralized accounting, purchasing, personnel services,
management direction and control, and other services. To the extent
that the home office furnishes services related to patient care to a
provider, the reasonable costs of such services are included in the
provider's cost report and are reimbursable as part of the provider's
costs. If the home office of the chain provides no services related to
patient care, the costs of the home office may not be recognized in
determining the allowable costs of the providers in the chain. Under
the authority of sections 1815(a) and 1833(e) of the Social Security
Act (42 U.S.C. 1395g), 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.
Providers receiving Medicare reimbursement must provide adequate cost
data based on financial and statistical records, which can be verified
by qualified auditors. The Form CMS-287-19 home office cost statement
is needed to determine a provider's reasonable cost incurred in
furnishing medical services to Medicare beneficiaries and reimbursement
due to or from a provider. Form Number:
[[Page 68938]]
CMS-287-19 (OMB control number: 0938-0202); Frequency: Annually;
Affected Public: Private Sector (Business or other for-profit and Not-
for-profit institutions); Number of Respondents: 1,507; Total Annual
Responses: 1,507; Total Annual Hours: 702,262. (For policy questions
regarding this collection contact Yaakov Feinstein at 410-786-3137.)
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Notification of
FLS and CMS of Co-Located Medicare Providers; Use: Many long-term care
hospitals (LTCHs) are co-located with other Medicare providers (acute
care hospitals, inpatient rehabilitation facilities (IRFs), skilled
nursing facilities (SNFs), inpatient psychiatric facilities (IPFs)),
which could lead to potential gaming of the Medicare system based on
inappropriate patient shifting. In regulations at 42 CFR 412.22(e)(3)
and (h)(6) CMS requires LTCHs to notify Medicare Administrative
Contractors (MACs) and CMS of co-located providers. The requirement
regarding collection of information at Sec. 412.22 concerning a LTCH's
(or a LTCH satellite's) notification to its MAC and CMS of its co-
located status is needed in order for Medicare to appropriately pay co-
located hospitals-within-hospitals (HwHs) and satellites. Under
Sec. Sec. 412.22(e)(3) and (h)(6), an LTCH or a satellite of an LTCH
that occupies space in a building used by another hospital, or in one
or more entire buildings located on the same campus as buildings used
by another hospital must notify its MAC and CMS in writing of its co-
location within 60 days of its first cost reporting period that began
on or after October 1, 2002. Form Number: CMS-10088 (OMB control
number: 0938-0897); Frequency: Yearly; Affected Public: Private Sector
(Business or other for-profit, not-for-profit institutions); Number of
Respondents: 25; Total Annual Responses: 25; Total Annual Hours: 6.
(For policy questions regarding this collection contact Emily Lipkin at
410-786-3633.)
Dated: December 12, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2019-27139 Filed 12-16-19; 8:45 am]
BILLING CODE 4120-01-P
