[Federal Register Volume 87, Number 250 (Friday, December 30, 2022)]
[Notices]
[Pages 80539-80540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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, please access 
the CMS PRA website by copying and pasting the following web address 
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

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