Submission for OMB Review; Comment Request, 737-738 [2019-00405]
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Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices
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. Form Number: CMS–
10137 (OMB control number: 0938–
0935); Frequency: Annually; Affected
Public: Private Sector (Business or other
for-profits, Not-for-Profit Institutions);
Number of Respondents: 380; Total
Annual Responses: 400; Total Annual
Hours: 6,106. (For policy questions
regarding this collection contact Keith
Penn-Jones, at 410–786–3104.)
9. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Program; Prior Authorization Process for
Certain Durable Medical Equipment,
Prosthetic, Orthotics, and Supplies
(DMEPOS); Use: The CMS has had
longstanding concerns about the
improper payments related to DMEPOS
items. The Department of Health and
Human Services’ Office of the Inspector
General and the U.S. Government
Accountability Office have published
multiple reports indicating questionable
billing practices by suppliers,
inappropriate Medicare payments, and
questionable utilization of DMEPOS
items. The fiscal year (FY) 2017
Medicare FFS program improper
payment rate for the Durable Medical
Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) was 44.6%,
accounting for over $3.7 billion in
projected improper payments. The CMS
has implemented several initiatives in
recent years to address these issues,
such as the DMEPOS Competitive
Bidding Program, as well as heightened
screening of suppliers, as authorized by
the Affordable Care Act. In addition to
those actions, CMS is continuing the use
of prior authorization in fee for service
Medicare. Prior authorization is a
process through which a request for
provisional affirmation of coverage is
submitted for review before an item is
rendered to a Medicare patient and
before a claim is submitted for payment.
Prior authorization helps make sure that
applicable Medicare coverage, payment,
and coding rules are met before item(s)
are rendered. Prior to furnishing the
item to the beneficiary and prior to
submitting the claim for processing, a
requester must submit a prior
authorization request that includes
evidence that the item complies with all
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applicable Medicare coverage, coding,
and payment rules. Consistent with
§ 414.234(d), such evidence must
include the order, relevant information
from the beneficiary’s medical record,
and relevant supplier-produced
documentation. After receipt of all
applicable required Medicare
documentation, CMS or one of its
review contractors will conduct a
medical review and communicate a
decision that provisionally affirms or
non-affirms the request. A provisional
affirmative decision is a preliminary
finding that a future claim submitted to
Medicare for the DMEPOS item likely
meets Medicare’s coverage, coding, and
payment requirements. Suppliers who
receive a non-affirmative decision have
unlimited resubmission opportunities.
Form Number: CMS–10524 (OMB
control number: 0938–1293); Frequency:
Occasionally; Affected Public: Private
Sector (Business or other for-profits,
Not-for-Profit Institutions); Number of
Respondents: 321,551; Total Annual
Responses: 321,551; Total Annual
Hours: 160,775.68 (For policy questions
regarding this collection contact Yuliya
Cook at (410) 786–0157.)
10. Type of Information Collection
Request: Reinstatement; Title of
Information Collection: Medicare
Coverage of Items and Services in FDA
Investigational Device Exemption
Clinical Studies—Revision of Medicare
Coverage; Use . Section 1862(m) of the
Social Security Act (and regulations at
42 CFR Subpart B (sections 405.201–
405.215) allows for payment of the
routine costs of care furnished to
Medicare beneficiaries in a Category A
investigational device exemption (IDE)
study and authorizes the Secretary to
establish criteria to ensure that Category
A IDE trials conform to appropriate
scientific and ethical standards.
Medicare does not cover the Category A
device itself because Category A
(Experimental) devices do not satisfy
the statutory requirement that Medicare
pay for devices determined to be
reasonable and necessary. Medicare may
cover Category B (Non-experimental)
devices, and associated routine costs of
care, if they are considered reasonable
and necessary and if all other applicable
Medicare coverage requirements are
met.
Under the current centralized review
process, interested parties (such as
study sponsors) that wish to seek
Medicare coverage related to Category A
or B IDE studies have a centralized
point of contact for submission, review
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737
and determination of Medicare coverage
IDE study requests. In order for CMS (or
its designated entity) to determine if the
Medicare coverage criteria are met, as
described in our regulations, CMS (or its
designated entity) must review
documents submitted by interested
parties or study sponsors. Such
information submitted will be a FDA
IDE approval letter, IDE study protocol,
IRB approval letter, National Clinical
Trials (NCT) number, and Supporting
materials as needed. Form Number:
CMS–10511 (OMB control number:
0938–1250); Frequency: Yearly; Affected
Public: Private Sector (Business or other
for-profits, Not-for-Profit Institutions);
Number of Respondents: 100; Total
Annual Responses: 100; Total Annual
Hours: 200. (For policy questions
regarding this collection contact Cheryl
Gilbreath at 410–786–5919.)
Dated: January 28, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–00411 Filed 1–30–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: State Self-Assessment Review
and Report.
OMB No.: 0970–0223.
Description: Section 454(15)(A) of the
Social Security Act, as amended by the
Personal Responsibility and Work
Opportunity Act of 1996, requires each
State to annually assess the performance
of its child support enforcement
program in accordance with standards
specified by the Secretary of the
Department of Health and Human
Services, and to provide a report of the
findings to the Secretary. This
information is required to determine if
States are complying with Federal child
support mandates and providing the
best services possible. The report is also
intended to be used as management tool
to help States evaluate their programs
and assess performance.
Respondents: State Child Support
Enforcement Agencies or Department/
Agency/Bureau responsible for Child
Support Enforcement in each State.
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31JAN1
738
Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total
burden hours
Self-assessment report ....................................................................................
54
1
4
216
Estimated Total Annual Burden
Hours: 216.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW, Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–00405 Filed 1–30–19; 8:45 am]
BILLING CODE 4184–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No.: 0970–0114]
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Child Care and Development
Fund Plan for States/Territories for FFY
2019–2021 (ACF–118).
Description: The Child Care and
Development Fund (CCDF) Plan (the
Plan) for States and Territories is
required from each CCDF Lead agency
in accordance with Section 658E of the
Child Care and Development Block
Grant Act of 1990 (CCDBG Act), as
amended, CCDBG Act of 2014 (Pub. L.
113–186), and 42 U.S.C 9858. The Plan,
submitted on the ACF–118, is required
triennially, and remains in effect for
three years. The Plan provides ACF and
the public with a description of, and
assurance about the States’ and
Territories’ child care programs. These
Plans are the applications for CCDF
funds. The ACF–118 is currently
approved through December 31, 2018.
This Notice is required by the
Paperwork Reduction Act (PRA). The
PRA requires Federal agencies to
request approval from the Office of
Management and Budget (OMB) Office
of Information and Regulatory Affairs
(OIRA) for any information collection
that will ask the same question of ten or
more persons. The process includes
publication of an initial Federal
Register Notice (FRN) allowing 60 days
for public comments on the initial plan
for information collection, the
publication of a second FRN allowing
30 days for public comment on the final
proposed information collection, and
review and approval by the OMB Office
of Information and Regulatory Affairs.
Due to unanticipated events, the
Office of Child Care (OCC) could not
comply with the regular PRA clearance
process that calls for two Federal
Register Notices (60- and 30-day) and
comment periods by the July 1, 2018
CCDF Plan submission deadline. The
OCC requested and was granted
clearance for this FY 2019–2021 CCDF
Plan Preprint from OMB under
emergency clearance procedure for six
months with an expiration date of
December 31, 2018. Because the CCDF
Plan covers three year effective period,
we are initiating the full clearance
process to obtain OMB approval to use
this document for the entire three year
period.
The Office of Child Care (OCC) gave
thoughtful consideration to the
comments received from the 30-day
emergency Public Notice. OCC revised
the document to reflect some of the
changes made to minimize the
administrative burden of the collection
of information on respondents. The
revised document contains revisions to
improve the accuracy and clarity of
policy questions, definitions, and
guidance in order to improve the quality
of information that is collected.
Respondents: State and Territory
CCDF Lead Agencies (56).
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
amozie on DSK3GDR082PROD with NOTICES1
ACF–118 ..........................................................................................................
Estimated Total Annual Burden
Hours: 3,696.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
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56
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
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Sfmt 4703
Number of
responses per
respondent
0.33
Average
burden hours
per response
200
Total burden
hours
3,696
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
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31JAN1
Agencies
[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 737-738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00405]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: State Self-Assessment Review and Report.
OMB No.: 0970-0223.
Description: Section 454(15)(A) of the Social Security Act, as
amended by the Personal Responsibility and Work Opportunity Act of
1996, requires each State to annually assess the performance of its
child support enforcement program in accordance with standards
specified by the Secretary of the Department of Health and Human
Services, and to provide a report of the findings to the Secretary.
This information is required to determine if States are complying with
Federal child support mandates and providing the best services
possible. The report is also intended to be used as management tool to
help States evaluate their programs and assess performance.
Respondents: State Child Support Enforcement Agencies or
Department/Agency/Bureau responsible for Child Support Enforcement in
each State.
[[Page 738]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Self-assessment report...................... 54 1 4 216
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 216.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 330 C Street SW,
Washington, DC 20201. Attention Reports Clearance Officer. All requests
should be identified by the title of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Email:
OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration
for Children and Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-00405 Filed 1-30-19; 8:45 am]
BILLING CODE 4184-41-P