Agency Information Collection Activities: Proposed Collection; Comment Request, 48145-48148 [2019-19711]
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Federal Register / Vol. 84, No. 177 / Thursday, September 12, 2019 / Notices
Federal Deposit Insurance Corporation
Valerie Best,
Assistant Executive Secretary.
[FR Doc. 2019–19715 Filed 9–11–19; 8:45 am]
BILLING CODE 6714–01–P
FEDERAL MARITIME COMMISSION
Notice of Agreements Filed
The Commission hereby gives notice
of the filing of the following agreement
under the Shipping Act of 1984.
Interested parties may submit comments
on the agreements to the Secretary by
email at Secretary@fmc.gov, or by mail,
Federal Maritime Commission,
Washington, DC 20573, within twelve
days of the date this notice appears in
the Federal Register. Copies of
agreements are available through the
Commission’s website (www.fmc.gov) or
by contacting the Office of Agreements
at (202)-523–5793 or tradeanalysis@
fmc.gov.
Agreement No.: 012056–001.
Agreement Name: WWOcean/EUKOR
Joint Operating Agreement.
Parties: Wallenius Wilhelmsen Ocean
AS and EUKOR Car Carriers, Inc.
Filing Party: Wayne Rohde; Cozen
O’Connor.
Synopsis: The amendment changes
name of the WW party to the
Agreement; updates addresses of the
parties; updates the description of
corporate relationship between parties;
and revises officials of agreement and
delegations of authority.
Proposed Effective Date: 9/5/2019.
Location: https://www2.fmc.gov/
FMC.Agreements.Web/Public/
AgreementHistory/2021.
Dated: September 9, 2019.
Rachel Dickon,
Secretary.
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than October 15,
2019.
A. Federal Reserve Bank of Dallas
(Robert L. Triplett III, Senior Vice
President) 2200 North Pearl Street,
Dallas, Texas 75201–2272:
1. Kidd Partners, Ltd., Tyler, Texas; to
acquire up to 11.74 percent of the voting
shares of Spirit of Texas Bancshares,
Inc., Conroe, Texas, and thereby
indirectly acquire shares of Spirit of
Texas Bank, SSB, College Station,
Texas.
2. Spirit of Texas Bancshares, Inc.,
Conroe, Texas; to acquire 100 percent of
the voting shares of Chandler Bancorp,
Inc., Tyler, Texas, and thereby
indirectly acquire shares of Chandler
Bancorp of Nevada, Inc., Carson City,
Nevada, and Citizens State Bank, Tyler,
Texas.
Board of Governors of the Federal Reserve
System, September 9, 2019.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2019–19749 Filed 9–11–19; 8:45 am]
BILLING CODE 6731–AA–P
[FR Doc. 2019–19788 Filed 9–11–19; 8:45 am]
BILLING CODE P
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FEDERAL RESERVE SYSTEM
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
Centers for Medicare & Medicaid
Services
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[Document Identifier: CMS–1500/1490S,
CMS–10221, CMS–10237, CMS–R–5, CMS–
10224 and CMS–287–19]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
AGENCY:
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ACTION:
48145
Notice.
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
November 12, 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 https://
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 ll, 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
https://www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
SUMMARY:
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Federal Register / Vol. 84, No. 177 / Thursday, September 12, 2019 / Notices
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
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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–1500/1490S Health Insurance
Common Claims Form
CMS–10221 Independent Diagnostic
Testing Facilities (IDTFs) Site
Investigation Form Revisions
CMS–10237 Applications for Part C
Medicare Advantage, 1876 Cost
Plans, and Employer Group Waiver
Plans to Provide Part C Benefits
CMS–R–5 Physician Certifications/
Recertification’s in Skilled Nursing
Facilities Manual Instructions
CMS–10224 Healthcare Common
Procedure Coding System
(HCPCS)—Level II Code
Modification Request Process
CMS–287–19 Home Office Cost
Statement
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: Extension of a currently
approved collection; Title of
Information Collection: Health
Insurance Common Claims Form and
Supporting Regulations at 42 CFR part
424, subpart C (CMS–1500 and CMS–
1490S); Use: The CMS–1500 and the
CMS–1490S forms are used to deliver
information to CMS in order for CMS to
reimburse for provided services.
Medicare Administrative Contractors
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use the data collected on the CMS–1500
and the CMS–1490S to determine the
proper amount of reimbursement for
Part B medical and other health services
(as listed in section 1861(s) of the Social
Security Act) provided by physicians
and suppliers to beneficiaries. The
CMS–1500 is submitted by physicians/
suppliers for all Part B Medicare.
Serving as a common claim form, the
CMS–1500 can be used by other thirdparty payers (commercial and nonprofit
health insurers) and other Federal
programs (e.g., TRICARE, RRB, and
Medicaid). The CMS–1490S (Patient’s
Request for Medical Payment) was
explicitly developed for easy use by
beneficiaries who file their own claims.
Form Number: CMS–1500/1490S (OMB
control number: 0938–1197); Frequency:
Yearly; Affected Public: State, Local, or
Tribal Governments; Number of
Respondents: 2,029,505; Total Annual
Responses: 1,033,839,906; Total Annual
Hours: 18,847,500. (For policy questions
regarding this collection contact
Charlene Parks at 410–786–8684.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Independent
Diagnostic Testing Facilities (IDTFs)
Site Investigation Form Revisions; Use:
The data collection is used by Medicare
contractors and/or their subcontractors
on site visits to verify compliance with
required IDTF performance standards. If
a subcontractor is used, the
subcontractor collects the information
from the IDTF through an interview and
forwards it to the Medicare contractor
for evaluation. The collection and
verification of this information defends
and protects our beneficiaries from
illegitimate IDTFs. These procedures
also protect the Medicare Trust Fund
against fraud. The data collected also
ensures that the applicant has the
necessary credentials to provide the
health care services for which they
intend to bill Medicare. Form Number:
CMS–10221 (OMB control number:
0938–1029); Frequency: Occasionally;
Affected Public: Private Sector (Business
or other for-profit and Not-for-profit
institutions); Number of Respondents:
727; Total Annual Responses: 727; Total
Annual Hours: 1,454. (For policy
questions regarding this collection
contact Kimberly McPhillips at 410–
786–5374.)
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Applications for
Part C Medicare Advantage, 1876 Cost
Plans, and Employer Group Waiver
Plans to Provide Part C Benefits; Use:
This information collection includes the
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process for organizations wishing to
provide healthcare services under MA
plans. These organizations must
complete an application annually (if
required), file a bid, and receive final
approval from CMS. The MA
application process has two options for
applicants that include (1) request for
new MA product or (2) request for
expanding the service area of an existing
product. CMS utilizes the application
process as the means to review, assess
and determine if applicants are
compliant with the current
requirements for participation in the
MA program and to make a decision
related to contract award. This
collection process is the only
mechanism for organizations to
complete the required MA application
process. The application process is open
to all health plans that want to
participate in the MA program. The
application is distinct and separate from
the bid process, and CMS issues a
determination on the application prior
to bid submissions, or before the first
Monday in June.
Collection of this information is
mandated by the Code of Federal
Regulations, MMA, and CMS
regulations at 42 CFR 422, subpart K, in
‘‘Application Procedures and Contracts
for Medicare Advantage Organizations.’’
In addition, the Medicare Improvement
for Patients and Providers Act of 2008
(MIPPA) further amended titles XVII
and XIX of the Social Security Act.
Form Number: CMS–10237 (OMB
control number: 0938–0935); Frequency:
Occasionally; Affected Public: Private
Sector (Business or other for-profit and
Not-for-profit institutions); Number of
Respondents: 435; Total Annual
Responses: 435; Total Annual Hours:
6,754. (For policy questions regarding
this collection contact Keith Penn-Jones
at 410–786–3104.)
4. 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
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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).
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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.)
5. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Healthcare
Common Procedure Coding System
(HCPCS)—Level II Code Modification
Request Process; Use: In October 2003,
the Secretary of Health and Human
Services (HHS) delegated authority
under the Health Insurance Portability
and Accountability Act (HIPAA)
legislation to Centers for Medicare and
Medicaid Services (CMS) to maintain
and distribute HCPCS Level II Codes. As
stated in 42 CFR Sec. 414.40 (a) CMS
establishes uniform national definitions
of services, codes to represent services,
and payment modifiers to the codes.
The HCPCS code set has been
maintained and distributed via
modifications of codes, modifiers and
descriptions, as a direct result of data
received from applicants. Thus,
information collected in the application
is significant to codeset maintenance.
The HCPCS code set maintenance is an
ongoing process, as changes are
implemented and updated annually;
therefore, the process requires continual
collection of information from
applicants on an annual basis. As new
technology evolves and new devices,
drugs and supplies are introduced to the
market, applicants submit applications
to CMS requesting modifications to the
HCPCS Level II codeset. Applications
have been received prior to HIPAA
implementation and must continue to
be collected to ensure quality decisionmaking. The HIPAA of 1996 required
CMS to adopt standards for coding
systems that are used for reporting
health care transactions. The regulation
that CMS published on August 17, 2000
(45 CFR 162.10002) to implement the
HIPAA requirement for standardized
coding systems established the HCPCS
Level II codes as the standardized
coding system for describing and
identifying health care equipment and
supplies in health care transactions.
HCPCS Level II was selected as the
standardized coding system because of
its wide acceptance among both public
and private insurers. Public and private
insurers were required to be in
compliance with the August 2000
regulation by October 1, 2002.
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48147
Modifications to the HCPCS are
initiated via application form submitted
by any interested stakeholder. These
applications have been received on an
on-going basis with an annual deadline
for each cycle. The purpose of the data
provided is to educate the decisionmaking body about products and
services for which a modification is
requested so that an informed decision
can be reached in response to the
recommended coding. Form Number:
CMS–10224 (OMB control number:
0938–1042); Frequency: Annually;
Affected Public: Private Sector (Business
or other for-profit and Not-for-profit
institutions); Number of Respondents:
100; Total Annual Responses: 100; Total
Annual Hours: 1,100. (For policy
questions regarding this collection
contact Kimberlee Combs Miller at 410–
786–6707.)
6. 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
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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:
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.)
Dated: September 6, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–19711 Filed 9–11–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3885]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Center for Tobacco
Products, Food and Drug
Administration Funded Trainee/
Scholar Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
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 and
to allow 60 days for public comment in
SUMMARY:
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response to the notice. This notice
solicits comments on ‘‘Center for
Tobacco Products, Food and Drug
Administration Funded Trainee/Scholar
Survey.’’
DATES: Submit either electronic or
written comments on the collection of
information by November 12, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 12,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 12, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
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information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–3885 for ‘‘Center for Tobacco
Products, Food and Drug
Administration Funded Trainee/Scholar
Survey.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
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12SEN1
Agencies
[Federal Register Volume 84, Number 177 (Thursday, September 12, 2019)]
[Notices]
[Pages 48145-48148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19711]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-1500/1490S, CMS-10221, CMS-10237, CMS-R-5,
CMS-10224 and CMS-287-19]
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 November 12, 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
https://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 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].
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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-1500/1490S Health Insurance Common Claims Form
CMS-10221 Independent Diagnostic Testing Facilities (IDTFs) Site
Investigation Form Revisions
CMS-10237 Applications for Part C Medicare Advantage, 1876 Cost Plans,
and Employer Group Waiver Plans to Provide Part C Benefits
CMS-R-5 Physician Certifications/Recertification's in Skilled Nursing
Facilities Manual Instructions
CMS-10224 Healthcare Common Procedure Coding System (HCPCS)--Level II
Code Modification Request Process
CMS-287-19 Home Office Cost Statement
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: Extension of a currently
approved collection; Title of Information Collection: Health Insurance
Common Claims Form and Supporting Regulations at 42 CFR part 424,
subpart C (CMS-1500 and CMS-1490S); Use: The CMS-1500 and the CMS-1490S
forms are used to deliver information to CMS in order for CMS to
reimburse for provided services. Medicare Administrative Contractors
use the data collected on the CMS-1500 and the CMS-1490S to determine
the proper amount of reimbursement for Part B medical and other health
services (as listed in section 1861(s) of the Social Security Act)
provided by physicians and suppliers to beneficiaries. The CMS-1500 is
submitted by physicians/suppliers for all Part B Medicare. Serving as a
common claim form, the CMS-1500 can be used by other third-party payers
(commercial and nonprofit health insurers) and other Federal programs
(e.g., TRICARE, RRB, and Medicaid). The CMS-1490S (Patient's Request
for Medical Payment) was explicitly developed for easy use by
beneficiaries who file their own claims. Form Number: CMS-1500/1490S
(OMB control number: 0938-1197); Frequency: Yearly; Affected Public:
State, Local, or Tribal Governments; Number of Respondents: 2,029,505;
Total Annual Responses: 1,033,839,906; Total Annual Hours: 18,847,500.
(For policy questions regarding this collection contact Charlene Parks
at 410-786-8684.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Independent
Diagnostic Testing Facilities (IDTFs) Site Investigation Form
Revisions; Use: The data collection is used by Medicare contractors
and/or their subcontractors on site visits to verify compliance with
required IDTF performance standards. If a subcontractor is used, the
subcontractor collects the information from the IDTF through an
interview and forwards it to the Medicare contractor for evaluation.
The collection and verification of this information defends and
protects our beneficiaries from illegitimate IDTFs. These procedures
also protect the Medicare Trust Fund against fraud. The data collected
also ensures that the applicant has the necessary credentials to
provide the health care services for which they intend to bill
Medicare. Form Number: CMS-10221 (OMB control number: 0938-1029);
Frequency: Occasionally; Affected Public: Private Sector (Business or
other for-profit and Not-for-profit institutions); Number of
Respondents: 727; Total Annual Responses: 727; Total Annual Hours:
1,454. (For policy questions regarding this collection contact Kimberly
McPhillips at 410-786-5374.)
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Applications for
Part C Medicare Advantage, 1876 Cost Plans, and Employer Group Waiver
Plans to Provide Part C Benefits; Use: This information collection
includes the process for organizations wishing to provide healthcare
services under MA plans. These organizations must complete an
application annually (if required), file a bid, and receive final
approval from CMS. The MA application process has two options for
applicants that include (1) request for new MA product or (2) request
for expanding the service area of an existing product. CMS utilizes the
application process as the means to review, assess and determine if
applicants are compliant with the current requirements for
participation in the MA program and to make a decision related to
contract award. This collection process is the only mechanism for
organizations to complete the required MA application process. The
application process is open to all health plans that want to
participate in the MA program. The application is distinct and separate
from the bid process, and CMS issues a determination on the application
prior to bid submissions, or before the first Monday in June.
Collection of this information is mandated by the Code of Federal
Regulations, MMA, and CMS regulations at 42 CFR 422, subpart K, in
``Application Procedures and Contracts for Medicare Advantage
Organizations.'' In addition, the Medicare Improvement for Patients and
Providers Act of 2008 (MIPPA) further amended titles XVII and XIX of
the Social Security Act. Form Number: CMS-10237 (OMB control number:
0938-0935); Frequency: Occasionally; Affected Public: Private Sector
(Business or other for-profit and Not-for-profit institutions); Number
of Respondents: 435; Total Annual Responses: 435; Total Annual Hours:
6,754. (For policy questions regarding this collection contact Keith
Penn-Jones at 410-786-3104.)
4. 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
[[Page 48147]]
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.)
5. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Healthcare Common
Procedure Coding System (HCPCS)--Level II Code Modification Request
Process; Use: In October 2003, the Secretary of Health and Human
Services (HHS) delegated authority under the Health Insurance
Portability and Accountability Act (HIPAA) legislation to Centers for
Medicare and Medicaid Services (CMS) to maintain and distribute HCPCS
Level II Codes. As stated in 42 CFR Sec. 414.40 (a) CMS establishes
uniform national definitions of services, codes to represent services,
and payment modifiers to the codes. The HCPCS code set has been
maintained and distributed via modifications of codes, modifiers and
descriptions, as a direct result of data received from applicants.
Thus, information collected in the application is significant to
codeset maintenance. The HCPCS code set maintenance is an ongoing
process, as changes are implemented and updated annually; therefore,
the process requires continual collection of information from
applicants on an annual basis. As new technology evolves and new
devices, drugs and supplies are introduced to the market, applicants
submit applications to CMS requesting modifications to the HCPCS Level
II codeset. Applications have been received prior to HIPAA
implementation and must continue to be collected to ensure quality
decision-making. The HIPAA of 1996 required CMS to adopt standards for
coding systems that are used for reporting health care transactions.
The regulation that CMS published on August 17, 2000 (45 CFR 162.10002)
to implement the HIPAA requirement for standardized coding systems
established the HCPCS Level II codes as the standardized coding system
for describing and identifying health care equipment and supplies in
health care transactions. HCPCS Level II was selected as the
standardized coding system because of its wide acceptance among both
public and private insurers. Public and private insurers were required
to be in compliance with the August 2000 regulation by October 1, 2002.
Modifications to the HCPCS are initiated via application form submitted
by any interested stakeholder. These applications have been received on
an on-going basis with an annual deadline for each cycle. The purpose
of the data provided is to educate the decision-making body about
products and services for which a modification is requested so that an
informed decision can be reached in response to the recommended coding.
Form Number: CMS-10224 (OMB control number: 0938-1042); Frequency:
Annually; Affected Public: Private Sector (Business or other for-profit
and Not-for-profit institutions); Number of Respondents: 100; Total
Annual Responses: 100; Total Annual Hours: 1,100. (For policy questions
regarding this collection contact Kimberlee Combs Miller at 410-786-
6707.)
6. 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
[[Page 48148]]
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: 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.)
Dated: September 6, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2019-19711 Filed 9-11-19; 8:45 am]
BILLING CODE 4120-01-P