[Federal Register Volume 86, Number 52 (Friday, March 19, 2021)]
[Notices]
[Pages 14926-14927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05809]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-29, CMS-437, CMS-10185 and CMS-10452]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
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 May 18, 2021.

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.

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-29 Verification of Clinic Data--Rural Health Clinic Form and 
Supporting Regulations
CMS-437 Psychiatric Unit Criteria Work Sheet
CMS-10185 Medicare Part D Reporting Requirements
CMS-10452 CMS Identity Management (IDM) System

    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: Verification of 
Clinic Data--Rural Health Clinic Form and Supporting Regulations; Use: 
The form is utilized as an application to be completed by suppliers of 
Rural Health Clinic (RHC) services requesting participation in the 
Medicare program. This form initiates the process of obtaining a 
decision as to whether the conditions for certification are met as a 
supplier of RHC services. It also promotes data reduction or 
introduction to and retrieval from the Automated Survey Process 
Environment (ASPEN) and related survey and certification databases by 
the CMS Regional Offices. Should any question arise regarding the 
structure of the organization, this information is readily available. 
Form Number: CMS-29 (OMB control number 0938-0074); Frequency: 
Occasionally (initially and then every six years); Affected Public: 
Private Sector (Business or other for-profit and Not-for-profit 
institutions); Number of Respondents: 1,887; Total Annual Responses: 
5,661; Total Annual Hours: 1,269. (For policy questions regarding this 
collection contact Shonte Carter at 410-786-3532.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Psychiatric Unit 
Criteria Work Sheet; Use: Certain specialty hospitals and hospital 
specialty distinct-part units may be excluded from the Inpatient 
Medicare Prospective Payment System (IPPS) and be paid at a different 
rate. These specialty hospitals and distinct-part units of hospitals 
include Inpatient Rehabilitation Facilities (IRFs) units, Inpatient 
Rehabilitation Facilities (IRFs) hospitals and Inpatient Psychiatric 
Facilities (IPFs).
    CMS regulations at 42 CFR 412.20 through 412.29 describe the 
criteria under which these specialty hospitals and specialty distinct-
part hospital units are excluded from the IPPS. Form CMS-437 is used by 
Inpatient Psychiatric Facilities (IPFs) to attest to meeting the 
necessary requirements that make them exempt for receiving payment from 
Medicare under the IPPS. These IPFs must use CMS-437 to attest that 
they meet the requirements for IPPS exempt status prior to being placed 
into excluded status. The IPFs must re-attest to meeting the exclusion 
criteria annually. Form Number: CMS-437 (OMB control number: 0938-
0358); Frequency: Annually; Affected Public: Private sector--Business 
or other for-profits; Number of Respondents: 1,598; Total Annual 
Responses: 1,598; Total Annual Hours: 1,732. (For policy questions 
regarding this collection

[[Page 14927]]

contact Caroline Gallaher at 410-786-8705.)
    3. Type of Information Collection Request: Revision of a previously 
approved collection;
    Title of Information Collection: Medicare Part D Reporting 
Requirements; Use: Section 1860D-12(b)(3)(D) of the Act provides broad 
authority for the Secretary to add terms to the contracts with Part D 
sponsors, including terms that require the sponsor to provide the 
Secretary with information as the Secretary may find necessary and 
appropriate. Pursuant to our statutory authority, we codified these 
information collection requirements for Part D sponsors in regulation 
at 42 CFR 423.514(a).
    Data collected via the Medicare Part D reporting requirements will 
be an integral resource for oversight, monitoring, compliance, and 
auditing activities necessary to ensure quality provision of the 
Medicare Prescription Drug Benefit to beneficiaries. For all reporting 
sections (Enrollment and Disenrollment, Medication Therapy Management 
(MTM) Programs, Grievances, Improving Drug Utilization Review Controls, 
Coverage Determinations and Redeterminations, and Employer/Union 
Sponsored Sponsors), data are reported electronically to CMS. The data 
collected via the MTM and Grievances reporting sections are used in the 
Medicare Part C and D Star Ratings and Display Measures. The other 
reporting sections' data are analyzed for program oversight to ensure 
the availability, accessibility, and acceptability of sponsors' 
services, such as coverage determinations and appeals processes, and 
opioid safety edits at the time of dispensing. Form Number: CMS-10185 
(OMB control number: 0938-0992); Frequency: Yearly; Affected Public: 
Business or other for-profits; Number of Respondents: 814; Total Annual 
Responses: 12,575; Total Annual Hours: 16,463. (For policy questions 
regarding this collection contact Chanelle Jones at 410-786-8008).
    4. Type of Information Collection Request: Extension of a 
previously approved
    collection; Title of Information Collection: CMS Identity 
Management (IDM) System; Use: HIPAA regulations require covered 
entities to verify the identity of the person requesting Personal 
Health Information (PHI) and the person's authority to have access to 
that information. Per the HIPAA Security Rule, covered entities, 
regardless of their size, are required under Section164.312(a)(2)(i) to 
``assign a unique name and/or number for identifying and tracking user 
identity.'' A `user' is defined in Section 164.304 as a ``person or 
entity with authorized access''. Accordingly, the Security Rule 
requires covered entities to assign a unique name and/or number to each 
employee or workforce member who uses a system that receives, maintains 
or transmits electronic PHI, so that system access and activity can be 
identified and tracked by user. This pertains to workforce members 
within health plans, group health plans, small or large provider 
offices, clearinghouses and beneficiaries.
    The information collected will be gathered and used solely by CMS, 
approved contractor(s), and state health insurance exchanges to prove 
the identity of an individual requesting electronic access to CMS 
protected information or services. Information confidentiality will 
conform to the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 and the Federal Information Security Management Act 
(FISMA) requirements. Respondents may also access CMS' Terms of Service 
and Privacy Statement on the CMS Portal and IDM websites.
    CMS has moved from this centralized on premise model for enterprise 
identity management to a cloud-based solution, IDM, with multiple 
products providing specialized services: Okta Identity as a Service 
(IDaaS), which includes Multi-Factor Authentication (MFA) services; 
Experian Remote Identity Proofing (RIDP) services; and Cloud Computing 
Services-Amazon Web Services/Information Technology Operations (CCS-
AWS/ITOps) Hub Hosting. In order to prove the identity of an individual 
requesting electronic access to CMS protected information or services, 
IDM (leveraging Experian Precise ID RIDP services) will collect a core 
set of attributes about that individual. Form Number: CMS-10452 (OMB 
control number: 0938-1236); Frequency: Yearly; Affected Public: 
Individuals and Households; Number of Respondents: 560,000; Total 
Annual Responses: 560,000; Total Annual Hours: 186,667. (For policy 
questions regarding this collection contact Malachi Robinson at 410-
786-1849).

    Dated: March 16, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-05809 Filed 3-18-21; 8:45 am]
BILLING CODE 4120-01-P