Agency Information Collection Activities: Proposed Collection; Comment Request, 39568-39570 [2020-14088]
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39568
Federal Register / Vol. 85, No. 127 / Wednesday, July 1, 2020 / Notices
submissions will be made available to
the public upon request. Submitted
materials must be publicly available or
able to be made public.
Dated: June 25, 2020.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2020–14156 Filed 6–30–20; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2018–0094; NIOSH–321]
Infectious Diseases and
Circumstances Relevant to Notification
Requirements: Definition of
Emergency Response Employee
Centers for Disease Control and
Prevention, Health and Human Services
(HHS).
ACTION: Notice of availability and
response to comments.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), within
the Department of Health and Human
Services (HHS), has added a definition
of the term ‘‘emergency response
employees’’ to the definitions section of
the document entitled ‘‘Implementation
of Section 2695 (42 U.S.C. 300ff-131)
Public Law 111–87: Infectious Diseases
and Circumstances Relevant to
Notification Requirements.’’ This list of
potentially life-threatening infectious
diseases to which emergency response
employees may be exposed and
companion guidelines has been republished by the National Institute for
Occupational Safety and Health
(NIOSH) and is available on the NIOSH
website.
FOR FURTHER INFORMATION CONTACT:
Rachel Weiss, Office of the Director,
NIOSH; 1090 Tusculum Avenue, MS:C–
48, Cincinnati, OH 45226; telephone
(855) 818–1629 (this is a toll-free
number); email NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Statutory Authority
The Ryan White Comprehensive AIDS
Resources Emergency (CARE) Act of
1990 (Pub. L. 101–381) was
reauthorized in 1996, 2000, 2006, and
2009. The most recent reauthorization,
the Ryan White HIV/AIDS Treatment
Extension Act of 2009 (Pub. L. 111–87),
amended the Public Health Service Act
(PHS Act, 42 U.S.C. 201–300ii) and
requires the HHS Secretary to establish
the following: a list of potentially life-
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threatening infectious diseases,
including emerging infectious diseases,
to which emergency response
employees (ERE) may be exposed in
responding to emergencies; guidelines
describing circumstances in which EREs
may be exposed to these diseases, taking
into account the conditions under
which emergency response is provided;
and guidelines describing the manner in
which medical facilities should make
determinations about exposures.
In a Federal Register notice published
on July 14, 2010, the HHS Secretary
delegated this responsibility to the CDC
Director.1 The CDC Director further
assigned the responsibility to the
NIOSH Director and formally redelegated the authority to develop the
list and guidelines to NIOSH on August
27, 2018.2
II. Background
On November 2, 2011, CDC published
a notice in the Federal Register entitled
Implementation of Section 2695 (42
U.S.C. 300ff-131) Public Law 111–87:
Infectious Diseases and Circumstances
Relevant to Notification Requirements.3
The notice included ‘‘a list of
potentially life-threatening infectious
diseases, including emerging infectious
diseases, to which EREs may be exposed
in responding to emergencies . . .;
guidelines describing circumstances in
which employees may be exposed to
these diseases; and guidelines
describing the manner in which medical
facilities should make determinations
about exposures.’’ The list and
guidelines published in that notice did
not include a definition for ‘‘emergency
response employee.’’
In a request for information (RFI)
published in the Federal Register on
October 17, 2018,4 CDC solicited input
on a definition of ‘‘emergency response
employee.’’ In the RFI, CDC explained
that Congress included such a definition
in earlier iterations of the Ryan White
Act but inadvertently omitted it from
the current version of the Act.
Therefore, interested parties were
invited to participate in the RFI by
submitting written views, opinions,
recommendations, and data regarding
the definition of the term ‘‘emergency
response employee.’’
Five submissions were received from
the following commenters: Two private
individuals, a professional organization
representing fire chiefs, a union
representing emergency response
employees, and one city emergency
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1 75
FR 40842.
FR 50379 (October 4, 2018).
3 76 FR 67736.
4 83 FR 52454.
2 83
Frm 00050
Fmt 4703
Sfmt 4703
management agency; all commenters
were supportive of restoring the
definition of ‘‘emergency response
employee’’ to the publication. Two
commenters asked that the definition
offered in the RFI be revised to remove
the word ‘‘employee;’’ change ‘‘funeral
service practitioners’’ to ‘‘coroner’’ or
‘‘medical examiner;’’ and add the terms
‘‘rescuers’’ and ‘‘emergency
management personnel.’’
After careful consideration of the
requested revisions, CDC has
determined that adopting the original
statutory definition, without change, in
the definitions section accompanying
the NIOSH list and guidelines allows
the notification provisions to be
implemented as Congress originally
intended. Further, the definition
references ‘‘other individuals,’’ which
allows discretion in determining
whether individuals who are employed
in job categories other than those
enumerated can be considered EREs,
including the specific groups
recommended by the commenters.
Therefore, CDC is retaining the
definition of ‘‘emergency response
employee’’ provided in the RFI:
firefighters, law enforcement officers,
paramedics, emergency medical technicians,
funeral service practitioners, and other
individuals (including employees of legally
organized and recognized volunteer
organizations, without regard to whether
such employees receive nominal
compensation) who, in the course of
professional duties, respond to emergencies
in the geographic area involved.
NIOSH has updated the guidelines
and list with the ERE definition and has
re-published them on the NIOSH Ryan
White HIV/AIDS Treatment Extension
Act of 2009 topic page, at https://
www.cdc.gov/niosh/topics/ryanwhite/.
John J. Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2020–14201 Filed 6–30–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10633 and CMS–
10744]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
AGENCY:
E:\FR\FM\01JYN1.SGM
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Federal Register / Vol. 85, No. 127 / Wednesday, July 1, 2020 / Notices
ACTION:
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
August 31, 2020.
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 Numberlllll, Room C4–
26–05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/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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01:53 Jul 01, 2020
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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–10633 QIC Demonstration
Evaluation Contractor (QDEC): Analyze
Medicare Appeals To Conduct Formal
Discussions and Reopening’s with DME
Suppliers and Part A Providers
CMS–10744 Medicare Durable Medical
Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Competitive
Bidding Program—Contracting Forms
Under the PRA (44 U.S.C. 3501–
3520), Federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires Federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Revision with change of a
currently approved collection; Title of
Information Collection: QIC
Demonstration Evaluation Contractor
(QDEC): Analyze Medicare Appeals to
Conduct Formal Discussions and
Reopening’s with DME Suppliers and
Part A Providers; Use: The Formal
Telephone Discussion Demonstration
and Reopening’s Process is authorized
under Section 402(a)(1)(F), U.S.C. 1395–
1(a)(1)(F), of the Social Security
Amendments of 1967. Primary and
secondary data are needed to
understand the effectiveness of the
Demonstration in improving DME
suppliers’ and Part A providers’
understanding of claims denial during
Level 2 of the appeals process and
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Frm 00051
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39569
facilitating more accurate claim
submission over time. Primary data are
necessary to determine, from the
perspective of participating DME
suppliers and Part A providers, the
quality of the formal telephone
discussions, satisfaction with the formal
telephone discussion process, and the
effect of the formal telephone
discussions on submitting accurate
claims. These data will inform an
evaluation of the demonstration’s
effectiveness in achieving more accurate
claims submissions, and thus reducing
the number of claims CMS must process
each year.
All information collected through the
evaluation of the Formal Telephone
Demonstration and Reopening’s Process
will be used by CMS through the QDEC
(IMPAQ International and its partner,
Palmetto GBA) to conduct analyses of
satisfaction with the formal telephone
discussions, and determine whether
further engagement with the QIC
improves understanding of the reasons
for claim denials.
CMS will use the results of the
evaluation to make informed policy
decisions regarding the effectiveness of
this demonstration and whether or not
the demonstration should become a
permanent part of the appeals process.
Ultimately, if the information shows
that DME suppliers and Part A
providers were able to submit more
accurate claims on the first pass, and a
reduced number of claims are put
through the appeals process, the Federal
Government could realize cost savings.
Form Number: CMS–10633 (OMB
control number: 0938–1348); Frequency:
Yearly; Affected Public: Private Sector,
Business or other for-profits; Number of
Respondents: 5,288; Total Annual
Responses: 5,288; Total Annual Hours:
949.7. (For policy questions regarding
this collection contact Lynnsie G. Kelley
at 410–786–1155.)
2. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Medicare
Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
(DMEPOS) Competitive Bidding
Program—Contracting Forms; Use: The
Medicare Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
(DMEPOS) Competitive Bidding
Program was established by the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (‘‘Medicare Modernization Act’’ or
‘‘MMA’’). Section 302 of the MMA
amended Section 1847 of the Social
Security Act (the Act) to establish the
competitive acquisition program and
define program requirements.
E:\FR\FM\01JYN1.SGM
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39570
Federal Register / Vol. 85, No. 127 / Wednesday, July 1, 2020 / Notices
Under the MMA, the DMEPOS
Competitive Bidding Program was to be
phased in so that competition under the
program would first occur in 10 areas in
2007. The Centers for Medicare &
Medicaid Services (CMS) completed the
rulemaking process for the competitive
acquisition of DMEPOS items and
services in 42 CFR parts 411 and 414
published in the Federal Register
Volume 72 on April 10, 2007. CMS
conducted the Round 1 competition in
10 areas and for 10 DMEPOS product
categories, and implemented the
program on July 1, 2008. The Medicare
Improvements for Patients and
Providers Act of 2008 (MIPPA), enacted
on July 15, 2008, made limited changes
to the Competitive Bidding Program,
including termination of existing
contracts that were in effect and a
requirement to re-bid Round 1.
As required by MIPPA, CMS
conducted the competition for the
Round 1 Rebid in 2009. The Round 1
Rebid contracts and prices became
effective on January 1, 2011. The
Affordable Care Act (ACA), enacted on
March 23, 2010, expanded the Round 2
competition by adding an additional 21
metropolitan statistical areas (MSAs),
bringing the total MSAs for Round 2 to
91. The competition for Round 2 began
in December 2011. CMS also began a
competition for National Mail Order
(NMO) of diabetes testing supplies at
the same time as Round 2. The Round
2 and NMO contracts and prices were
implemented on July 1, 2013.
The MMA requires the Secretary to
recompete contracts not less often than
once every three years. The Round 1
Rebid contract period for all product
categories except mail-order diabetes
testing supplies expired on December
31, 2013. (Round 1 Rebid contracts for
mail-order diabetes testing supplies
ended on December 31, 2012.) The
competition for the Round 1 Recompete
began in August of 2012 and contracts
and prices became effective on January
1, 2014. The Round 1 Recompete
contract period expires on December 31,
2016. Round 1 2017 contracts will
become effective on January 1, 2017
through December 31, 2018. Round 2
and NMO contracts and prices expired
on June 30, 2016. Round 2 Recompete
and the NMO Recompete contracts
became effective on July 1, 2016, and
expired on December 31, 2018. CMS
will be implementing a consolidated
round of competition to include all
Round 1 2017 and Round 2 Recompete
competitive bidding areas, referred to as
Round 2021. Round 2021 will not
include NMO, which will be competed
again in future rounds of the program.
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01:53 Jul 01, 2020
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The forms included in this ICR were
previously included in the ICR currently
approved under 0938–1016. Due to the
temporary gap in the DMEPOS
Competitive Bidding Program, which
started on January 1, 2019, we do not
currently have any active PRA package
for this specific collection of
information (Form C, Subcontracting,
Change of Ownerships, and
Grandfathering). We are now seeking
approval of a PRA package based on
estimates from previous rounds of the
program (specifically Round 2
Recompete and Round 1 2017) and
without reference to changes in burden
Form Number: CMS–10744 (OMB
control number: 0938-New); Frequency:
Occasionally (varies by form); Affected
Public: Private Sector, Business or other
for-profits; Number of Respondents:
2,984; Total Annual Responses:
271,597; Total Annual Hours: 31,121.
(For policy questions regarding this
collection contact Julia Howard at 410–
786–8645.)
Dated: June 25, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–14088 Filed 6–30–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10219, CMS–R–
142 and CMS–10695]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
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
(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
SUMMARY:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
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 July 30, 2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
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
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:
E:\FR\FM\01JYN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 127 (Wednesday, July 1, 2020)]
[Notices]
[Pages 39568-39570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14088]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10633 and CMS-10744]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
[[Page 39569]]
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 August 31, 2020.
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 website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10633 QIC Demonstration Evaluation Contractor (QDEC): Analyze
Medicare Appeals To Conduct Formal Discussions and Reopening's with DME
Suppliers and Part A Providers
CMS-10744 Medicare Durable Medical Equipment, Prosthetics, Orthotics,
and Supplies (DMEPOS) Competitive Bidding Program--Contracting Forms
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. The term
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA requires Federal agencies
to publish a 60-day notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
or reinstatement of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, CMS is publishing this notice.
Information Collection
1. Type of Information Collection Request: Revision with change of
a currently approved collection; Title of Information Collection: QIC
Demonstration Evaluation Contractor (QDEC): Analyze Medicare Appeals to
Conduct Formal Discussions and Reopening's with DME Suppliers and Part
A Providers; Use: The Formal Telephone Discussion Demonstration and
Reopening's Process is authorized under Section 402(a)(1)(F), U.S.C.
1395-1(a)(1)(F), of the Social Security Amendments of 1967. Primary and
secondary data are needed to understand the effectiveness of the
Demonstration in improving DME suppliers' and Part A providers'
understanding of claims denial during Level 2 of the appeals process
and facilitating more accurate claim submission over time. Primary data
are necessary to determine, from the perspective of participating DME
suppliers and Part A providers, the quality of the formal telephone
discussions, satisfaction with the formal telephone discussion process,
and the effect of the formal telephone discussions on submitting
accurate claims. These data will inform an evaluation of the
demonstration's effectiveness in achieving more accurate claims
submissions, and thus reducing the number of claims CMS must process
each year.
All information collected through the evaluation of the Formal
Telephone Demonstration and Reopening's Process will be used by CMS
through the QDEC (IMPAQ International and its partner, Palmetto GBA) to
conduct analyses of satisfaction with the formal telephone discussions,
and determine whether further engagement with the QIC improves
understanding of the reasons for claim denials.
CMS will use the results of the evaluation to make informed policy
decisions regarding the effectiveness of this demonstration and whether
or not the demonstration should become a permanent part of the appeals
process. Ultimately, if the information shows that DME suppliers and
Part A providers were able to submit more accurate claims on the first
pass, and a reduced number of claims are put through the appeals
process, the Federal Government could realize cost savings. Form
Number: CMS-10633 (OMB control number: 0938-1348); Frequency: Yearly;
Affected Public: Private Sector, Business or other for-profits; Number
of Respondents: 5,288; Total Annual Responses: 5,288; Total Annual
Hours: 949.7. (For policy questions regarding this collection contact
Lynnsie G. Kelley at 410-786-1155.)
2. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Medicare Durable Medical Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Competitive Bidding Program--Contracting Forms; Use:
The Medicare Durable Medical Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Competitive Bidding Program was established by the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(``Medicare Modernization Act'' or ``MMA''). Section 302 of the MMA
amended Section 1847 of the Social Security Act (the Act) to establish
the competitive acquisition program and define program requirements.
[[Page 39570]]
Under the MMA, the DMEPOS Competitive Bidding Program was to be
phased in so that competition under the program would first occur in 10
areas in 2007. The Centers for Medicare & Medicaid Services (CMS)
completed the rulemaking process for the competitive acquisition of
DMEPOS items and services in 42 CFR parts 411 and 414 published in the
Federal Register Volume 72 on April 10, 2007. CMS conducted the Round 1
competition in 10 areas and for 10 DMEPOS product categories, and
implemented the program on July 1, 2008. The Medicare Improvements for
Patients and Providers Act of 2008 (MIPPA), enacted on July 15, 2008,
made limited changes to the Competitive Bidding Program, including
termination of existing contracts that were in effect and a requirement
to re-bid Round 1.
As required by MIPPA, CMS conducted the competition for the Round 1
Rebid in 2009. The Round 1 Rebid contracts and prices became effective
on January 1, 2011. The Affordable Care Act (ACA), enacted on March 23,
2010, expanded the Round 2 competition by adding an additional 21
metropolitan statistical areas (MSAs), bringing the total MSAs for
Round 2 to 91. The competition for Round 2 began in December 2011. CMS
also began a competition for National Mail Order (NMO) of diabetes
testing supplies at the same time as Round 2. The Round 2 and NMO
contracts and prices were implemented on July 1, 2013.
The MMA requires the Secretary to recompete contracts not less
often than once every three years. The Round 1 Rebid contract period
for all product categories except mail-order diabetes testing supplies
expired on December 31, 2013. (Round 1 Rebid contracts for mail-order
diabetes testing supplies ended on December 31, 2012.) The competition
for the Round 1 Recompete began in August of 2012 and contracts and
prices became effective on January 1, 2014. The Round 1 Recompete
contract period expires on December 31, 2016. Round 1 2017 contracts
will become effective on January 1, 2017 through December 31, 2018.
Round 2 and NMO contracts and prices expired on June 30, 2016. Round 2
Recompete and the NMO Recompete contracts became effective on July 1,
2016, and expired on December 31, 2018. CMS will be implementing a
consolidated round of competition to include all Round 1 2017 and Round
2 Recompete competitive bidding areas, referred to as Round 2021. Round
2021 will not include NMO, which will be competed again in future
rounds of the program.
The forms included in this ICR were previously included in the ICR
currently approved under 0938-1016. Due to the temporary gap in the
DMEPOS Competitive Bidding Program, which started on January 1, 2019,
we do not currently have any active PRA package for this specific
collection of information (Form C, Subcontracting, Change of
Ownerships, and Grandfathering). We are now seeking approval of a PRA
package based on estimates from previous rounds of the program
(specifically Round 2 Recompete and Round 1 2017) and without reference
to changes in burden Form Number: CMS-10744 (OMB control number: 0938-
New); Frequency: Occasionally (varies by form); Affected Public:
Private Sector, Business or other for-profits; Number of Respondents:
2,984; Total Annual Responses: 271,597; Total Annual Hours: 31,121.
(For policy questions regarding this collection contact Julia Howard at
410-786-8645.)
Dated: June 25, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2020-14088 Filed 6-30-20; 8:45 am]
BILLING CODE 4120-01-P
