Agency Information Collection Activities: Submission for OMB Review; Comment Request
| Published date | 14 August 2020 |
| Citation | 85 FR 49654 |
| Record Number | 2020-17852 |
| Section | Notices |
| Court | Centers For Medicare & Medicaid Services,Health And Human Services Department |
Federal Register, Volume 85 Issue 158 (Friday, August 14, 2020)
[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
