[Federal Register Volume 85, Number 110 (Monday, June 8, 2020)]
[Notices]
[Pages 35095-35096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12285]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10114, CMS-10199, CMS-R-52 and CMS-R-26]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid 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 August 7, 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 
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 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-10114 National Provider Identifier (NPI) Application and Update 
Form and Supporting Regulations in 45 CFR 142.408, 45 CFR 162.406, 45 
CFR 162.408
CMS-10199 Data Collection for Medicare Facilities Performing Carotid 
Artery Stenting with Embolic Protection in Patients at High Risk for 
Carotid Endarterectomy
CMS-R-52 Conditions for Coverage of Suppliers of End Stage Renal 
Disease (ESRD) Services and Supporting Regulations
CMS-R-26 Clinical Laboratory Improvement Amendments (CLIA) Regulations

    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: Extension of a currently 
approved collection; Title of Information Collection: National Provider 
Identifier (NPI) Application and Update Form and Supporting Regulations 
in 45 CFR 142.408, 45 CFR 162.406, 45 CFR 162.408; Use: The National 
Provider Identifier Application and Update Form is used by health care 
providers to apply for NPIs and furnish updates to the information they 
supplied on their initial applications. The form is also used to 
deactivate their NPIs if necessary. The form is available on paper or 
can be completed via a web-based process. Health care providers can 
mail a paper application, complete the application via the web-based 
process via the National Plan and Provider Enumeration System (NPPES), 
or have a trusted organization submit the application on their behalf 
via the Electronic File Interchange (EFI) process. The Enumerator uses 
the NPPES to process the application and generate the NPI. NPPES is the 
Medicare contractor tasked with issuing NPIs, and maintaining and 
storing NPI data. Form Number: CMS-10114 (OMB Control

[[Page 35096]]

Number: 0938-0931); Frequency: Reporting--On occasion; Affected Public: 
Business or other for-profit, Not-for-profit institutions, and Federal 
government; Number of Respondents: 996,042; Total Annual Responses: 
996,042; Total Annual Hours: 169,327. (For policy questions regarding 
this collection contact Da'Vona Boyd at 410-786-7483.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Data Collection 
for Medicare Facilities Performing Carotid Artery Stenting with Embolic 
Protection in Patients at High Risk for Carotid Endarterectomy; Use: 
CMS provides coverage for carotid artery stenting (CAS) with embolic 
protection for patients at high risk for carotid endarterectomy and who 
also have symptomatic carotid artery stenosis between 50 percent and 70 
percent or have asymptomatic carotid artery stenosis >=80 percent in 
accordance with the Category B IDE clinical trials regulation (42 CFR 
405.201), a trial under the CMS Clinical Trial Policy (NCD Manual Sec.  
310.1, or in accordance with the National Coverage Determination on CAS 
post approval studies (Medicare NCD Manual 20.7 CMS also covers CAS 
with embolic protection for patients at high risk for carotid 
endarterectomy and who also have symptomatic carotid artery stenosis 
>=70 percent performed in facilities that have been determined to be 
competent in performing the evaluation, procedure and follow-up 
necessary to ensure optimal patient outcomes. In accordance with this 
criteria, we consider coverage for CAS reasonable and necessary 
(section 1862 (A)(1)(a) of the Social Security Act). Form Number: CMS-
10199 (OMB control number: 0938-1011); Frequency: Yearly; Affected 
Public: Business or other for-profit and Not-for-profit institutions; 
Number of Respondents: 1,420; Total Annual Responses: 3,313; Total 
Annual Hours: 30,057. (For policy questions regarding this collection 
contact Sarah Fulton at 410-786-2749.)
    3. Type of Information Collection Request: Extension of a 
previously approved collection; Title of Information Collection: 
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) 
Services and Supporting Regulations; Use: The information collection 
requirements described herein are part of the Medicare and Medicaid 
Programs; Conditions for Coverage for End-Stage Renal Disease 
Facilities. The requirements fall into three categories: Record 
keeping, reporting, and disclosure. With regard to the record keeping 
requirements, CMS uses these conditions for coverage to certify health 
care facilities that want to participate in the Medicare or Medicaid 
programs. For the reporting requirements, the information is needed to 
assess and ensure proper distribution and effective utilization of ESRD 
treatment resources while maintaining or improving quality of care. All 
of the reports specified in this document are geared toward ensuring 
that facilities achieve quality and cost-effective service provision. 
Collection of this information is authorized by Section 1881 of the Act 
and required by 42 CFR 405.2100 through 405.2171 (now at 42 CFR 
414.330, 488.60, and 494.100-494.180). Depending on the outcome of 
litigation, disclosures may be required by Medicare-certified dialysis 
facilities that make payments of premiums for individual market health 
plans. Form Number: CMS-R-52 (OMB Control Number: 0938-0386); 
Frequency: Annually; Affected Public: Private sector--Business or other 
for-profit; Number of Respondents: 8,246; Total Annual Responses: 
171,795; Total Annual Hours: 1,260,491. (For policy questions regarding 
this collection contact Eric Laib at 410-786-9759.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Clinical 
Laboratory Improvement Amendments (CLIA) Regulations; Use: The 
information is necessary to determine an entity's compliance with the 
Congressionally-mandated program with respect to the regulation of 
laboratory testing (CLIA). In addition, laboratories participating in 
the Medicare program must comply with CLIA requirements as required by 
section 6141 of OBRA 89. Medicaid, under the authority of section 
1902(a)(9)(C) of the Social Security Act, pays for services furnished 
only by laboratories that meet Medicare (CLIA) requirements. Form 
Number: CMS-R-26 (OMB Control Number: 0938-0612); Frequency: Monthly, 
occasionally; Affected Public: Business or other for-profits and Not-
for-profit institutions, State, Local or Tribal Governments, and the 
Federal government; Number of Respondents: 34,579; Total Annual 
Responses: 74,476,376; Total Annual Hours: 14,514,802. (For policy 
questions regarding this collection contact Raelene Perfetto at 410-
786-6876).

    Dated: June 2, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-12285 Filed 6-5-20; 8:45 am]
BILLING CODE 4120-01-P