Agency Information Collection Activities: Proposed Collection; Comment Request, 25012-25013 [2018-11492]
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25012
Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices
rates; clinic-specific discrepancy rates
are not reported. Any footnote added to
a clinic’s success rates page in the ART
Fertility Clinic Success Rates Report
will appear only for the reporting year
that the clinic was selected for
validation; it will be removed the
following reporting year.
Dated: May 24, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2018–11628 Filed 5–30–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers CMS–10599]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
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
July 30, 2018.
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://
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SUMMARY:
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17:46 May 30, 2018
Jkt 241001
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.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William 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–10599 Pre-Claim Review
Demonstration for Home Health
Services
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.
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Pre-Claim
Review Demonstration for Home Health
Services; Use: Section 402(a)(1)(J) of the
Social Security Amendments of 1967
(42 U.S.C. 1395b–1(a)(1)(J)) authorizes
the Secretary to ‘‘develop or
demonstrate improved methods for the
investigation and prosecution of fraud
in the provision of care or services
under the health programs established
by the Social Security Act (the Act).’’
Pursuant to this authority, the CMS
seeks to develop and implement a
Medicare demonstration project, which
CMS believes will help assist in
developing improved procedures for the
identification, investigation, and
prosecution of Medicare fraud occurring
among Home Health Agencies (HHA)
providing services to Medicare
beneficiaries.
This revised demonstration would
help assist in developing improved
procedures for the identification,
investigation, and prosecution of
potential Medicare fraud. The
demonstration would help make sure
that payments for home health services
are appropriate through either pre-claim
or postpayment review, thereby working
towards the prevention and
identification of potential fraud, waste,
and abuse; the protection of Medicare
Trust Funds from improper payments;
and the reduction of Medicare appeals.
CMS proposes initially implementing
the demonstration in Illinois, Ohio,
North Carolina, Florida, and Texas with
the option to expand to other states in
the Palmetto/JM jurisdiction. Under this
demonstration, CMS proposes to offer
choices for providers to demonstrate
their compliance with CMS’ home
health policies. Providers in the
demonstration states may participate in
either 100 percent pre-claim review or
100 percent postpayment review. These
providers will continue to be subject to
a review method until the HHA reaches
the target affirmation or claim approval
rate. Once a HHA reaches the target preclaim review affirmation or postpayment review claim approval rate, it
may choose to be relieved from claim
reviews, except for a spot check of their
claims to ensure continued compliance.
Providers who do not wish to
participate in either 100 percent preclaim or postpayment reviews have the
option to furnish home health services
and submit the associated claim for
payment without undergoing such
reviews; however, they will receive a 25
percent payment reduction on all claims
E:\FR\FM\31MYN1.SGM
31MYN1
Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices
submitted for home health services and
may be eligible for review by the
Recovery Audit Contractors.
The information required under this
collection is required by Medicare
contractors to determine proper
payment or if there is a suspicion of
fraud. Under the pre-claim review
option, HHA will send the pre-claim
review request along with all required
documentation to the Medicare
contractor for review prior to submitting
the final claim for payment. If a claim
is submitted without a pre-claim review
decision one file, the Medicare
contractor will request the information
from the HHA to determine if payment
is appropriate. For the postpayment
review option, the Medicare contractor
will also request the information from
the HHA provider who submitted the
claim for payment from the Medicare
program to determine if payment was
appropriate. Form Number: CMS–10599
(OMB control number: 0938–1311);
Frequency: Occasionally; Affected
Public: Private Sector (Business or other
for-profits and Not-for-profits); Number
of Respondents: 941,287; Total Annual
Responses: 1,330,980; Total Annual
Hours: 670,375. (For questions regarding
this collection contact Jennifer
McMullen (410) 786–7635).
Dated: May 23, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–11492 Filed 5–29–18; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2018–D–1636]
Assessment of Pressor Effects of
Drugs; Draft Guidance for Industry;
Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Assessment of Pressor Effects of
Drugs.’’ This guidance is intended to
advise sponsors on the premarketing
assessment of a drug’s effect on blood
pressure. Elevated blood pressure is
known to increase the risk of stroke,
heart attack, and death. The effect of a
drug on blood pressure may therefore be
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:46 May 30, 2018
Jkt 241001
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
Food and Drug Administration
AGENCY:
an important consideration in benefitrisk assessment.
DATES: Submit either electronic or
written comments on the draft guidance
by July 30, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–1636] for ‘‘Assessment of
Pressor Effects of Drugs; Draft Guidance
for Industry; Availability.’’ Received
comments 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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
25013
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Norman Stockbridge, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
E:\FR\FM\31MYN1.SGM
31MYN1
Agencies
[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Notices]
[Pages 25012-25013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11492]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers CMS-10599]
Agency Information Collection Activities: Proposed Collection;
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 (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 July 30, 2018.
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].
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William 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-10599 Pre-Claim Review Demonstration for Home Health Services
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 of a currently
approved collection; Title of Information Collection: Pre-Claim Review
Demonstration for Home Health Services; Use: Section 402(a)(1)(J) of
the Social Security Amendments of 1967 (42 U.S.C. 1395b-1(a)(1)(J))
authorizes the Secretary to ``develop or demonstrate improved methods
for the investigation and prosecution of fraud in the provision of care
or services under the health programs established by the Social
Security Act (the Act).'' Pursuant to this authority, the CMS seeks to
develop and implement a Medicare demonstration project, which CMS
believes will help assist in developing improved procedures for the
identification, investigation, and prosecution of Medicare fraud
occurring among Home Health Agencies (HHA) providing services to
Medicare beneficiaries.
This revised demonstration would help assist in developing improved
procedures for the identification, investigation, and prosecution of
potential Medicare fraud. The demonstration would help make sure that
payments for home health services are appropriate through either pre-
claim or postpayment review, thereby working towards the prevention and
identification of potential fraud, waste, and abuse; the protection of
Medicare Trust Funds from improper payments; and the reduction of
Medicare appeals. CMS proposes initially implementing the demonstration
in Illinois, Ohio, North Carolina, Florida, and Texas with the option
to expand to other states in the Palmetto/JM jurisdiction. Under this
demonstration, CMS proposes to offer choices for providers to
demonstrate their compliance with CMS' home health policies. Providers
in the demonstration states may participate in either 100 percent pre-
claim review or 100 percent postpayment review. These providers will
continue to be subject to a review method until the HHA reaches the
target affirmation or claim approval rate. Once a HHA reaches the
target pre-claim review affirmation or post-payment review claim
approval rate, it may choose to be relieved from claim reviews, except
for a spot check of their claims to ensure continued compliance.
Providers who do not wish to participate in either 100 percent pre-
claim or postpayment reviews have the option to furnish home health
services and submit the associated claim for payment without undergoing
such reviews; however, they will receive a 25 percent payment reduction
on all claims
[[Page 25013]]
submitted for home health services and may be eligible for review by
the Recovery Audit Contractors.
The information required under this collection is required by
Medicare contractors to determine proper payment or if there is a
suspicion of fraud. Under the pre-claim review option, HHA will send
the pre-claim review request along with all required documentation to
the Medicare contractor for review prior to submitting the final claim
for payment. If a claim is submitted without a pre-claim review
decision one file, the Medicare contractor will request the information
from the HHA to determine if payment is appropriate. For the
postpayment review option, the Medicare contractor will also request
the information from the HHA provider who submitted the claim for
payment from the Medicare program to determine if payment was
appropriate. Form Number: CMS-10599 (OMB control number: 0938-1311);
Frequency: Occasionally; Affected Public: Private Sector (Business or
other for-profits and Not-for-profits); Number of Respondents: 941,287;
Total Annual Responses: 1,330,980; Total Annual Hours: 670,375. (For
questions regarding this collection contact Jennifer McMullen (410)
786-7635).
Dated: May 23, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2018-11492 Filed 5-29-18; 4:15 pm]
BILLING CODE 4120-01-P