[Federal Register Volume 85, Number 158 (Friday, August 14, 2020)]
[Notices]
[Pages 49654-49655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17852]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10418, CMS-10199, CMS-R-52 and CMS-R-26]


Agency Information Collection Activities: Submission for OMB 
Review; 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 (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 September 14, 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/PRA-Listing.html.
    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:
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Annual MLR and 
Rebate Calculation Report and MLR Rebate Notices; Use: Under Section 
2718 of the Affordable Care Act and implementing regulation at 45 CFR 
part 158, a health insurance issuer (issuer) offering group or 
individual health insurance coverage must submit a report to the 
Secretary concerning the amount the issuer spends each year on claims, 
quality improvement expenses, non-claims costs, Federal and State taxes 
and licensing and regulatory fees, the amount of earned premium, and 
beginning with the 2014 reporting year, the amounts related to the 
transitional reinsurance, risk corridors, and risk adjustment programs 
established under sections 1341, 1342, and 1343, respectively, of the 
Affordable Care Act. An issuer must provide an annual rebate if the 
amount it spends on certain costs compared to its premium revenue 
(excluding Federal and States taxes and licensing and regulatory fees) 
does not meet a certain ratio, referred to as the medical loss ratio 
(MLR). Each issuer is required to submit annually MLR data, including 
information about any rebates it must provide, on a form prescribed by 
CMS, for each State in which the issuer conducts business. Each issuer 
is also required to provide a rebate notice to each policyholder that 
is owed a rebate and each subscriber of policyholders that are owed a 
rebate for any given MLR reporting year. Additionally, each issuer is 
required to maintain for a period of seven years all documents, records 
and other evidence that support the data included in each issuer's 
annual report to the Secretary.
    Based upon CMS' experience in the MLR data collection and 
evaluation process, CMS is updating its annual burden hour estimates to 
reflect the actual numbers of submissions, rebates and rebate notices. 
The 2019 MLR Reporting Form and Instructions reflect changes for the 
2018 reporting year and beyond. The 2019 MLR Reporting Form and 
instructions are also modified to eliminate the reporting elements that 
were required under the risk corridors data submission requirements in 
45 CFR 153.530 for the 2014 through 2016 benefit years. For 2019, it is 
expected that issuers will submit fewer reports and on average, send 
fewer notices and rebate checks in the mail to policyholders and 
subscribers, which will reduce burden on issuers. In addition, issuers 
of qualified health plans will no longer have to submit on the annual 
report the data for the risk corridors program established under 
section 1342 of the Patient Protection and Affordable Care Act. Form 
Number: CMS-10418 (OMB control number: 0938-1164); Frequency: Annually; 
Affected Public: Private Sector, Business or other for-profit and not-
for-profit institutions; Number of Respondents: 494; Number of 
Responses: 1,896; Total Annual Hours: 232,427. For policy questions 
regarding this collection

[[Page 49655]]

contact Stephanie Watson at 301-492-4238.
    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: Reinstatement 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: August 11, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-17852 Filed 8-13-20; 8:45 am]
BILLING CODE 4120-01-P