[Federal Register Volume 84, Number 158 (Thursday, August 15, 2019)]
[Notices]
[Pages 41723-41724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17516]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-282, CMS-10638, and CMS-10338]


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 October 15, 2019.

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 the 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-R-282 Health Plan Appeals and Grievance Data Collection and 
Reporting Requirements, Data Disclosure Requirements under section 
422.111.
    CMS-10638 Application for New Medical Services and Technologies 
Seeking to Qualify for Add-On Payments Under the Hospital Inpatient 
Prospective Payment System.
    CMS-10338 Affordable Care Act Internal Claims and Appeals and 
External Review Procedures for Non-grandfathered Group Health Plans and 
Issuers and Individual Market Issuers.
    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: Revision with change of 
a currently approved collection; Title of Information Collection: 
Health Plan Appeals and Grievance Data Collection and Reporting 
Requirements, Data Disclosure Requirements under section 422.111; Use: 
Part 422 of Title 42 of the Code of Federal Regulations (CFR) 
distinguishes between certain information a Medicare Advantage (MA) 
organization must provide to each enrollee (on an annual basis) and 
information that the MA organization must disclose to any MA eligible 
individual (upon request). This requirement can be found in Sec.  
1852(c)(2)(C) of the Social Security Act

[[Page 41724]]

and in 42 CFR 422.111(c)(3) which states that MA organizations must 
disclose information pertaining to the number of disputes, and their 
disposition in the aggregate, with the categories of grievances and 
appeals, to any individual eligible to elect an MA organization who 
requests this information.
    The appeals and grievance data form is an OMB approved form for use 
by Medicare Advantage organizations to disclose grievance and appeal 
data, upon request, to individuals eligible to elect an MA 
organization. By utilizing the form, MA organizations will meet the 
disclosure requirements set forth in regulations at 42 CFR 
422.111(c)(3).
    In an effort to identify opportunities to reduce burden for this 
collection, we compared data provided by plans to CMS in Part C 
reporting requirements (OMB 0938-1054) with the requirements to provide 
aggregate grievance and appeals data to MA eligible beneficiaries. We 
found that data reported to CMS in the Part C reporting requirements 
was data that would meet the disclosure requirements at Sec.  
1852(c)(2)(C) of the Social Security Act and 42 CFR 422.111(c).
    We are proposing to revise this form by allowing plans to use data 
collected for Part C reporting requirements (OMB 0938-1054) that also 
meet requirements for this collection. This change merges and aligns 
the collection and reporting periods, so MA plans do not need to keep 
two separate sets of data and reports each year.
    For CMS Part C reporting requirements, data is collected quarterly, 
but only reported annually. To match this and reduce plan burden, CMS 
is revising this form to use the data reported annually to CMS, and 
that data be valid for one year versus creating a new report every six 
months. Further, data provided to enrollees would be consistent with 
data provided to CMS. Form Number: CMS-R-282 (OMB control number: 0938-
0778); Frequency: Yearly; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 733; Total Annual Responses: 
59,133; Total Annual Hours: 5,405. (For policy questions regarding this 
collection contact Michele Hudson at 410-786-5490.)
    2. Type of Information Collection Request: Revision with change of 
a currently approved collection; Title of Information Collection: 
Application for New Medical Services and Technologies Seeking to 
Qualify for Add-On Payments Under the Hospital Inpatient Prospective 
Payment System; Use: Section 1886(d)(5)(K) authorizes the Secretary to 
establish a special payment methodology for new medical services and 
technologies used in inpatient procedures. To qualify for additional 
payments under this provision; a new technology must represent a 
substantial clinical improvement; data reflecting the cost of new 
technology must not yet be available in the data used to recalibrate 
the Medicare severity diagnosis-related groups (MS-DRGs); and the MS-
DRG payment rate otherwise applicable to the new technology would be 
inadequate (see 42 CFR 412.87(b)). we are revising the estimated annual 
number of respondents from 32 to 62, based on the proposed alternative 
new technology add-on payment pathway for certain devices included in 
the FY 2020 IPPS proposed rule (CMS-1716-P). The existing regulations 
at 42 CFR 412.87 implement these provisions and specify three criteria 
for a new medical service or technology to receive the additional 
payment: (1) The medical service or technology must be new; (2) the 
medical service or technology must be costly such that the DRG rate 
otherwise applicable to discharges involving the medical service or 
technology is determined to be inadequate; and (3) the service or 
technology must demonstrate a substantial clinical improvement over 
existing services or technologies.
    In the FY 2020 IPPS proposed rule (84 FR 19371-19373), we proposed 
an alternative new technology add-on payment pathway for certain 
devices. Specifically, for applications received for new technology 
add-on payments for FY 2021 and subsequent fiscal years, we proposed 
that a medical device that has received Federal Drug Administration 
(FDA) marketing authorization (that is, has been approved or cleared 
by, or had a De Novo classification request granted by, the FDA) and 
that is part of the FDA's Breakthrough Devices Program would need to 
meet the cost criterion (that is, the medical device must be costly 
such that the DRG rate otherwise applicable to discharges involving the 
medical device is determined to be inadequate). To implement this 
proposal, we proposed to revise the existing regulations at 42 CFR 
412.87. We use the application in order to determine if a technology 
meets the new technology criteria under the existing pathway, and would 
revise the application to reflect the information required to determine 
if a device meets the new technology criteria the proposed alternative 
pathway for certain devices. The revise application that would be used 
if the proposed alternative new technology add-on payment pathway for 
certain devices is finalized in the FY 2020 IPPS final rule, which is 
expected to be issued by August 1, 2019. Form Number: CMS-10638 (OMB 
control number: 0938-1347); Frequency: Yearly; Affected Public: Private 
Sector: Business or Other for-profits, Not for-profit Institutions; 
Number of Respondents: 62; Total Annual Responses: 62; Total Annual 
Hours: 1,655. (For policy questions regarding this collection contact 
Michele Hudson at 410-786-5490.)
    3. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Affordable Care Act Internal Claims and Appeals and External Review 
Procedures for Non-grandfathered Group Health Plans and Issuers and 
Individual Market Issuers; Use: The information collection requirements 
ensure that claimants receive adequate information regarding the plan's 
claims procedures and the plan's handling of specific benefit claims. 
Claimants need to understand plan procedures and plan decisions in 
order to appropriately request benefits and/or appeal benefit denials. 
The information collected in connection with the HHS-administered 
federal external review process is collected by HHS, and is used to 
provide claimants with an independent external review. Form Number: 
CMS-10338 (OMB control number: 0938-1099); Frequency: Occasionally; 
Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 4,711; Total Annual Responses: 4,711; Total Annual Hours: 
1,195,626. (For policy questions regarding this collection contact 
Laura Byabazaire at 410-786-6650.)

    Dated: August 12, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-17516 Filed 8-14-19; 8:45 am]
 BILLING CODE 4120-01-P