Notice2022-28466
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 30, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Full Text
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<title>Federal Register, Volume 87 Issue 250 (Friday, December 30, 2022)</title>
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[Federal Register Volume 87, Number 250 (Friday, December 30, 2022)]
[Notices]
[Pages 80539-80540]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-28466]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10744]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
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 (PRA), federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by January 30, 2023.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. The term ``collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Revision of a currently
[[Page 80540]]
approved collection; Title: Medicare Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding
Program--Contracting Forms; Use: Since 1989, Medicare has been paying
for durable medical equipment, prosthetics, orthotics, and supplies
(DMEPOS) (other than customized items) using fee schedule amounts that
are calculated for each item or category of DMEPOS identified by a
Healthcare Common Procedure Coding System (HCPCS) code. Payments are
based on the average DMEPOS supplier charges on Medicare claims from
1986 and 1987 and are updated annually on a factor legislated by
Congress. For many years, the Government Accountability Office (GAO)
and the Office of Inspector General (OIG) of the United States (U.S.)
Department of Health and Human Services (HHS) have reported that these
fees are often highly inflated and that Medicare has paid higher than
market rates for several different types of DMEPOS. Due to reports of
Medicare overpayment of DMEPOS, Congress required that the Centers for
Medicare & Medicaid Services (CMS) conduct a competitive bidding
demonstration project for these items. Accordingly, CMS implemented a
demonstration project for this program from 1999-2002 which produced
significant savings for beneficiaries and taxpayers without hindering
access to DMEPOS and related services. Shortly after the successful
competitive bidding demonstrations, Congress passed the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and
mandated a phased-in approach to implement this program over the course
of several years beginning in 2007 in 10 metropolitan statistical areas
(MSAs). This statute specifically required the Secretary to establish
and implement programs under which competitive bidding areas (CBAs) are
established throughout the U.S. for contract award purposes for the
furnishing of certain competitively priced items and services for which
payment is made under Medicare Part B. This program is commonly known
as the Medicare DMEPOS Competitive Bidding Program (the Program).
CMS conducted its first round of bidding, Round 1, for the Program
in 2007 with the help of its contractor, the Competitive Bidding
Implementation Contractor (CBIC). CMS published a Request for Bids
(RFB) and instructions for DMEPOS suppliers to submit their bids to
participate in the Program. During this first round of bidding, DMEPOS
suppliers from across the U.S. submitted bids to furnish competitively
bid item(s) to Medicare beneficiaries residing or traveling to Round 1
CBAs. CMS evaluated these bids and contracted with those bidders that
met all program requirements. Round 1 was successfully implemented on
July 1, 2008.
On July 15, 2008, however, Congress delayed the Program in section
154 of the Medicare Improvements for Patients and Providers Act of 2008
(MIPPA). MIPPA mandated certain changes to the Program which included,
but was not limited to: a delay of Round 1 (competition to begin in
2009) and Round 2 of the Program (competition to begin in 2011 in 70
specific MSAs); the exclusion of Puerto Rico and negative pressure
wound therapy from Round 1 and Group 3 complex rehabilitative power
wheelchairs from all rounds of competition; a process for providing
feedback to bidders regarding missing financial documentation; and a
requirement for contract suppliers to disclose to CMS information
regarding subcontracting relationships. Section 154 of MIPPA specified
that the competition for national mail-order (NMO) items and services
may be phased in after 2010. This section of MIPPA also specified that
competitions to phase-in additional areas could occur after 2011. 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 MSAs,
bringing the total MSAs for Round 2 to 91. The competition for Round 2
began in December 2011. CMS also began a NMO competition for diabetes
testing supplies (DTS) at the same time as Round 2. The Round 2 and NMO
DTS 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 NMO DTS expired on December 31, 2013.
(Round 1 Rebid contracts for NMO DTS 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 expired on December 31, 2016. Round 1 2017
contracts were effective on January 1, 2017, and expired on December
31, 2018. Round 2 and NMO DTS contracts and prices expired on June 30,
2016. Round 2 Recompete and the NMO DTS Recompete contracts became
effective on July 1, 2016, and expired on December 31, 2018.
On October 31, 2018, CMS issued a final rule (CMS-1691-F) requiring
changes to bidding and pricing methodologies to be implemented under
the next round of the Program. As a result, starting January 1, 2019,
there was a temporary gap in the entire Program that lasted two years
until December 31, 2020. When the program resumed in January 2021, CMS
implemented a consolidated round of competition to include most Round 1
2017 and Round 2 Recompete CBAs for Round 2021. However, due to the
2019 novel coronavirus (COVID-19) pandemic, and the unexpected bid
evaluation results, CMS only awarded Round 2021 contracts for two
product categories: Off-The-Shelf (OTS) Back and OTS Knee Braces. As a
result, this Paperwork Reduction Act (PRA) package reflects a
significant reduction in burden, compared to previous packages, for
Round 2021 which was implemented on January 1, 2021, and will concluded
on December 31, 2023. This iteration of the package currently approved
under OMB control number 0938-1408 is based on data from the first year
of Round 2021 (January 1, 2021-December 31, 2021). Form Number: CMS-
10744 (OMB control number: 0938-1408); Frequency: Occasionally;
Affected Public: Private sector (Business or other for profits and Not-
for-profit institutions); Number of Respondents: 179; Total Annual
Responses: 121,407; Total Annual Hours: 97,069. (For policy questions
regarding this collection contact Joe Bryson at 410-786-2986.)
Dated: December 27, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2022-28466 Filed 12-29-22; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on December 30, 2022.
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