[Federal Register Volume 87, Number 150 (Friday, August 5, 2022)]
[Notices]
[Pages 48030-48032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16869]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10003, CMS-1771, CMS-R-244 and CMS-10744]


Agency Information Collection Activities: Proposed Collection; 
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 (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 October 4, 2022.

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 
http://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.

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-10003--Notice of Denial of Medical Coverage (or Payment)
CMS-1771--Emergency and Foreign Hospital Services and Supporting 
Regulation in 42 CFR Section 424.103
CMS-R-244--Programs of All-Inclusive Care for the Elderly (PACE)

    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

[[Page 48031]]

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: Extension of a currently 
approved collection; Title: Notice of Denial of Medical Coverage (or 
Payment); Use: Section 1852(g)(1)(B) of the Social Security Act (the 
Act) requires Medicare health plans to provide enrollees with a written 
notice in understandable language of the reasons for the denial and a 
description of the applicable appeals processes.
    Medicare health plans, including Medicare Advantage plans, cost 
plans, and Health Care Prepayment Plans (HCPPs), are required to issue 
the Notice of Denial of Medical Coverage (or Payment) (NDMCP) when a 
request for either a medical service or payment is denied, in whole or 
in part. Additionally, the notices inform Medicare enrollees of their 
right to file an appeal, outlining the steps and timeframes for filing. 
All Medicare health plans are required to use these standardized 
notices. Form Number: CMS-10003 (OMB Control Number: 0938-0829); 
Frequency: Annually; Affected Public: Private Sector, Business or other 
for-profit and not-for-profit institutions; Number of Respondents: 937; 
Number of Responses: 16,191,812; Total Annual Hours: 2,697,556. (For 
policy questions regarding this collection contact Sabrina Edmonston at 
410-786-3209.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title: Emergency and Foreign Hospital Services and 
Supporting Regulation in 42 CFR Section 424.103; Use: Section 1866 of 
the Social Security Act states that any provider of services shall be 
qualified to participate in the Medicare program and shall be eligible 
for payments under Medicare if it files an agreement with the Secretary 
to meet the conditions outlined in this section of the Act. Section 
1814(d)(1) of the Social Security Act and 42 CFR 424.100, allows 
payment of Medicare benefits for a Medicare beneficiary to a 
nonparticipating hospital that does not have an agreement in effect 
with the Centers for Medicare and Medicaid Services. These payments can 
be made if such services were emergency services and if CMS would be 
required to make the payment if the hospital had an agreement in effect 
and met the conditions of payment. This form is used in connection with 
claims for emergency hospital services provided by hospitals that do 
not have an agreement in effect under Section 1866 of the Social 
Security Act.
    42 CFR 424.103(b) requires that before a non-participating hospital 
may be paid for emergency services rendered to a Medicare beneficiary, 
a statement must be submitted that is sufficiently comprehensive to 
support that an emergency existed. Form CMS-1771 contains a series of 
questions relating to the medical necessity of the emergency. The 
attending physician must attest that the hospitalization was required 
under the regulatory emergency definition (42 CFR 424.101 attached) and 
give clinical documentation to support the claim. A photocopy of the 
beneficiary's hospital records may be used in lieu of the CMS-1771 if 
the records contain all the information required by the form; Form 
Number: CMS-1771 (OMB Control Number: 0938-0023); Frequency: Annually; 
Affected Public: Private Sector, Business or other for-profit and not-
for-profit institutions; Number of Respondents: 100; Number of 
Responses: 200; Total Annual Hours: 50. (For policy questions regarding 
this collection contact Shauntari Cheely at 410-786-1818.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title: Programs of All-Inclusive Care for the 
Elderly (PACE); Use: PACE is a pre-paid, capitated plan that provides 
comprehensive health care services to frail, older adults in the 
community, who are eligible for nursing home care according to state 
standards. PACE programs must provide all Medicare and Medicaid covered 
services; financing of this model is accomplished through prospective 
capitation of both Medicare and Medicaid payments. Upon approval of a 
PACE application, CMS executes a three-way program agreement with the 
applicant entity and the applicable state. With certain exceptions, 
this information collection addresses all operational components of the 
PACE program, as defined in 42 CFR part 460. Form Number: CMS-R-244 
(OMB control number: 0938-0790); Frequency: Once and 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 Lauren Brandow at 410-786-9765.)
    4. Type of Information Collection Request: Revision of a currently 
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

[[Page 48032]]

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 Julia Howard at 410-786-845.)

    Dated: August 2, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2022-16869 Filed 8-4-22; 8:45 am]
BILLING CODE 4120-01-P