[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)]
[Notices]
[Pages 22850-22851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10349]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10455 and CMS-10379]


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 June 19, 2019.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-5806 OR Email: OIRA_ 
[email protected].
    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.
    1. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    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: Report of a 
Hospital Death Associated with Restraint or Seclusion; Use: The final 
rule, which finalized the regulations at 42 CFR 482.13(g), published on 
May, 16, 2012 (77 FR 29074) included a reduction in the reporting 
requirements related to hospital deaths associated with the use of 
restraint or seclusion. Section Sec.  482.13(g) requires that hospitals 
must use form CMS-10455 to report those deaths associated with 
restraint and/or seclusion directly to the Centers for Medicare & 
Medicaid Services (CMS) Regional Office (RO). In addition, the final 
rule replaced the previous requirement for reporting via telephone to 
CMS, which proved to be cumbersome for both CMS and hospitals, with a 
requirement that allows the submission of reports on the form CMS-10455 
via facsimile or electronically, as determined by CMS. This reporting 
requirement applies to hospitals, Critical Access Hospitals (CAHs) and 
rehabilitation or psychiatric distinct part units (DPUs) in hospitals 
and CAHs. Currently, the hospital, CAH, or rehabilitation or 
psychiatric DPU must submit the form CMS-10455 to the CMS RO via fax or 
email, based on RO's preference. Beginning on May 9, 2014, hospitals 
were no longer required to report to CMS, those deaths that were not 
associated with the use of seclusion and where the only restraints used 
were 2-point soft wrist restraints. This reporting requirement change 
resulted in no necessary edits to the form CMS-10455. However, despite 
the change in reporting requirements, hospitals and CAHs continued to 
submit unnecessary CMS-10455 forms when there was only use of 2-point 
soft wrist restraints without the use of seclusion. Therefore, form 
CMS-10455 was modified in July 2018 to include instructions stating 
that the submission of this form is not required for deaths associated 
with the use of only 2-point soft wrist restraints without seclusion. 
It was estimated that this change would reduce the volume of reports to 
be submitted by 90 percent for hospitals.
    In this information collection request, CMS is seeking OMB approval 
for an electronically submitted version of the currently approved paper 
version of form CMS-10455. Form Number: CMS-10455 (OMB control number: 
0938-1210); Frequency: Occasionally; Affected Public: Private Sector; 
Number of Respondents: 6,389; Number of Responses: 6,389; Total Annual 
Hours: 6,389. (For policy questions regarding

[[Page 22851]]

this collection contact Caroline Gallaher at 410-786-8705.)
    2. Type of Information Collection Request: Revision of a previously 
approved information collection; Title of Information Collection: Rate 
Increase Disclosure and Review Requirements (45 CFR part 154); Use: 45 
CFR part 154 implements the annual review of unreasonable increases in 
premiums for health insurance coverage called for by section 2794. The 
regulation established a rate review program to ensure that all rate 
increases that meet or exceed an established threshold are reviewed by 
a state or the Centers for Medicare and Medicaid Services (CMS) to 
determine whether the rate increases are unreasonable. Accordingly, 
issuers offering non-grandfathered health insurance coverage in the 
individual and/or small group markets are required to submit Rate 
Filing Justifications to CMS. Section 154.103(b) exempts grandfathered 
health plan coverage as defined in 45 CFR 147.140 and excepted benefits 
as described in section 2791(c) of the PHS Act. In the Notice of 
Benefit and Payment Parameters for 2019 (2019 Payment Notice) (83 FR 
74, April 17, 2018), Section 154.103 was modified so that student 
health insurance coverage, as defined in Sec.  147.145, is also 
exempted from Federal rate review requirements for plans beginning on 
or after July 1, 2018.
    Section 154.200(a)(1) previously provided that a rate increase for 
single risk pool coverage beginning on or after January 1, 2017 was 
subject to a reasonableness review if: (1) The average increase, 
including premium rating factors described in Sec.  147.102, for all 
enrollees, weighted by premium volume for any plan within the product, 
meets or exceeds 10 percent; or (2) the increase exceeds a state-
specific threshold approved by the Secretary. In the 2019 Payment 
Notice, this provision was amended to establish a 15 percent federal 
default threshold for reasonableness review beginning with single risk 
pool rate filings submitted by issuers for plan or policy years 
beginning on or after January 1, 2019.
    The Rate Filing Justification consists of three parts. All issuers 
must continue to submit a Uniform Rate Review Template (URRT) (Part I 
of the Rate Filing Justification) for all single risk pool plans. 
Issuers that submit a rate filing that includes a plan that meets or 
exceeds the threshold must include a written description justifying the 
rate increase, also known as the consumer justification narrative (Part 
II of the Rate Filing Justification). We note that the threshold set by 
CMS constitutes a minimum standard and most states currently employ 
stricter rate review standards and may continue to do so. Issuers 
offering a QHP or any single risk pool submission containing a rate 
increase of any size must continue to submit an actuarial memorandum 
(Part III of the Rate Filing Justification). Form Number: CMS-10379 
(OMB control number: 0938-1141); Frequency: Annually; Affected Public: 
Private Sector; Businesses or other for-profits, Not-for-profit 
institutions; Number of Respondents: 589; Total Annual Responses: 
2,363; Total Annual Hours: 20,240. (For policy questions regarding this 
collection contact Lisa Cuozzo at 410-786-1746.)

    Dated: May 14, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-10349 Filed 5-17-19; 8:45 am]
 BILLING CODE 4120-01-P