[Federal Register Volume 87, Number 5 (Friday, January 7, 2022)]
[Notices]
[Pages 980-982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00119]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10398 #13, #24, #73, #74, and #75]


Medicaid and Children's Health Insurance Program (CHIP) Generic 
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: On May 28, 2010, the Office of Management and Budget (OMB) 
issued Paperwork Reduction Act (PRA) guidance \1\ related to the 
``generic'' clearance process. Generally, this is an expedited process 
by which agencies may obtain OMB's approval of collection of 
information requests that are ``usually voluntary, low-burden, and 
uncontroversial collections,'' do not raise any substantive or policy 
issues, and do not require policy or methodological review. The process 
requires the submission of an overarching plan that defines the scope 
of the individual collections that would fall under its umbrella. On 
October 23, 2011, OMB approved our initial request to use the generic 
clearance process under control number 0938-1148 (CMS-10398). It was 
last approved on April 26, 2021, via the standard PRA process which 
included the publication of 60- and 30-day Federal Register notices. 
The scope of the April 2021 umbrella accounts for Medicaid and CHIP 
State plan amendments, waivers, demonstrations, and reporting. This 
Federal Register notice seeks public comment on one or more of our 
collection of information requests that we believe are generic and fall 
within the scope of the umbrella. Interested persons are invited to 
submit 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.
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    \1\ https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/assets/inforeg/PRA_Gen_ICRs_5-28-2010.pdf.

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DATES: Comments must be received by January 21, 2022.

ADDRESSES: When commenting, please reference the applicable form number 
(see below) and the OMB control number (0938-1148). 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: CMS-10398 (#74)/OMB 
control number: 0938-1148, 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 
access CMS' website 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: Following is a summary of the use and burden 
associated with the subject information collection(s). More detailed 
information can be found in the collection's supporting statement and 
associated materials (see ADDRESSES).

Generic Information Collections

    1. Title of Information Collection: Medicaid Accountability--
Nursing Facility, Outpatient Hospital and Inpatient Hospital Upper 
Payment Limits; Type of Information Collection Request: Revision of a 
currently approved collection; Use: Starting in 2013, CMS required 
states to submit annual upper payment limit (UPL) demonstrations on an 
annual basis. Previously this information was collected or updated only 
when a state was proposing an amendment to a reimbursement methodology 
in its Medicaid state plan. Specifically, in 2013, we required that 
states submit UPL demonstrations for inpatient hospital services, 
outpatient hospital services, and nursing facilities. In 2014, states 
were then required to submit annual UPL demonstrations for the services 
listed above as well as clinics, physician services (for states that 
reimburse targeted physician supplemental payments), Intermediate care 
facilities for individuals with intellectual disabilities (ICF/IID), 
psychiatric residential treatment facilities (PRTFs) and institutes for 
mental disease (IMDs). These annual demonstrations included provider 
specific data reporting on all payments made to the providers, 
including supplemental payments.
    Through this process, States were also asked as part of the 
submission to identify the source of the non-federal share of funding. 
for the payments described in the UPL. This is consistent with the 
overall requirements to identify sources of non-federal funding set 
forth in section 1903(d)(1) of the Social Security Act. Such 
information will allow CMS and the State to have a better understanding 
of the variables surrounding rate levels, supplemental payments, and 
total providers participating in the programs and the funding 
supporting each of the payments described in the UPL demonstration.
    In early 2021 CMS developed and revised the templates in 
conjunction with the States and a CMS contractor for use with each of 
the 3 services of the UPL demonstration within this package--Nursing 
Facility, Outpatient Hospital, and Inpatient Hospital. These templates 
are helping to standardize the data collection and allow the States to 
quickly transfer data from their existing UPL demonstration reporting 
tools into the new UPL demonstration templates for reporting to CMS. 
These templates have allowed the States to report the UPL 
demonstrations more efficiently with embedded formulas to help complete 
required areas of the UPL demonstrations, saving States time and effort 
in their reporting. Standardizing the templates has helped CMS to 
review the annual UPL demonstrations, by being able to look at one 
template format, instead of up to 54 different templates in each UPL 
demonstration types.
    In this December 2021 revision, CMS is moving its Guidance and 
Instruction documents into an online format within the MACFin system. 
The Guidance and Instruction documents for each of the service type 
have been revised and will be collected online, a change from the 
previous collection of information where States responded via a Word 
type document and sent those responses to a dedicated UPL email box. 
Now States will be able to fill in the Guidance and Instruction 
documents as needed online. These two documents are now

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combined in the online format and answered online as shown in the 
attached materials. Attached here are a walkthrough of the proposed 
changes for each service type and separate files for each of the screen 
pictures of the proposed questions and logical flow of the questions, 
that will become the online format for each service type. After 
answering the new online Guidance and Instructions, State personnel 
will then upload their UPL templates directly into the MACFin system 
for processing.
    CMS has revised the Guidance and Instruction and the UPL templates. 
These changes are minor but substantive. The Guidance and Instruction 
documents were revised to accommodate an online format and to clarify 
the questions and data sources States use in calculating the UPL. Some 
additional questions have been asked (3), some eliminated (10), and 
others have been clarified, but the overall burden for States of 40 
hours for each UPL package remains the same, though CMS anticipates the 
changes will save burden to States, as the online system will allow for 
a logical flow to the questions and only ask the relevant questions for 
each State's UPL submission.
    The UPL templates have been revised to clarify definitions and 
instructions in filling out the UPL templates. The nursing facility 
template adds a tab to give States the option to use the Medicare 
created Patient Driven Payment Model (PDPM) as an option for the 
nursing facility UPL reporting. The new PDPM tab gives states the 
option of this new payment methodology, but does not require new data 
to be collected. None of the changes add burden to States, and CMS 
anticipates the new MACFin system will make it easier for States to 
upload and track their required UPL submissions. Form Number: CMS-10398 
(#13) (OMB control number: 0938-1148); Frequency: Yearly; Affected 
Public: State, Local, or Tribal Governments; Number of Respondents: 54; 
Total Annual Responses: 54; Total Annual Hours: 2,160. (For policy 
questions regarding this collection contact: Richard Kimball at 410-
786-2278.)
    2. Title of Information Collection: Medicaid Accountability--Upper 
Payment Limits for Clinics, Physician Services, ICF/IID, PRTFs, and 
IMDs; Type of Information Collection Request: Revision of a currently 
approved collection; Use: Starting in 2013, CMS required states to 
submit annual upper payment limit (UPL) demonstrations on an annual 
basis. Previously this information was collected or updated only when a 
state was proposing an amendment to a reimbursement methodology in its 
Medicaid state plan. Specifically, in 2013, we required that states 
submit UPL demonstrations for inpatient hospital services, outpatient 
hospital services, nursing facilities. In 2014, states were required to 
submit annual UPL demonstrations for the services listed above and 
clinics, physician services (for states that reimburse targeted 
physician supplemental payments), intermediate care facilities for 
Individuals with Intellectual Disabilities (ICF/IID), psychiatric 
residential treatment facilities (PRTFs) and institutes for mental 
disease (IMDs). These annual demonstrations included provider specific 
data reporting on all payments made to the providers, including 
supplemental payments.
    Through this process, States are also asked as part of the 
submission to identify the source of non-federal funding for the 
payments described in the UPL. This is consistent with overall 
requirements to identify sources of non-federal funding set forth in 
section 1903(d)(1) of the Social Security Act. Such information will 
allow CMS and the state to have a better understanding of the variables 
surrounding rate levels, supplemental payments and total providers 
participating in the programs and the funding supporting each of the 
payments described in the UPL demonstration.
    In early 2021 CMS developed and revised the templates in 
conjunction with the States and a CMS contractor for use with each of 
the 5 services of the UPL demonstration within this package--
Intermediate care facilities for individuals with intellectual 
disabilities (ICF/IID), Clinic services, Medicaid qualified 
practitioner services (Physician), other Psychiatric Residential 
Treatment Facilities (PRTFs), and Institutes for mental diseases 
(IMDs). These templates are helping to standardize the data collection 
and allow the states to quickly transfer data from their existing UPL 
demonstration reporting tools into the new UPL demonstration templates 
for reporting to CMS. These templates have allowed the states to report 
the UPL demonstrations more efficiently with embedded formulas to help 
complete required areas of the UPL demonstrations, saving States time 
and effort in their reporting. Standardizing the templates has helped 
CMS to review the annual UPL demonstrations, by being able to look at 
one template format, instead of up to 54 different templates in each 
UPL demonstration types. Instructions on the use of the templates are 
attached to each template, along with a data dictionary.
    In this December 2021 revision, CMS is moving its Guidance and 
Instruction documents into an online format within the MACFin system. 
The Guidance and Instruction documents for each of the service type 
have been revised and will be collected online, a change from the 
previous collection of information where States responded via a Word 
type document and sent those responses to a dedicated UPL email box. 
Now States will be able to fill in the Guidance and Instruction 
documents as needed online. These two documents are now combined in the 
online format and answered online as shown in the attached materials. 
Attached here are a walkthrough of the proposed changes for each 
service type and separate files for each of the screen pictures of the 
proposed questions and logical flow of the questions, that will become 
the online format for each service type. After answering the new online 
Guidance and Instructions, State personnel will then upload their UPL 
templates directly into the MACFin system for processing.
    CMS has revised the Guidance and Instruction and the UPL templates. 
The IMD guidance and instructions were previously the same as the 
inpatient hospital guidance and instructions. Now the IMD has its own 
specific guidance and instructions.
    These changes are minor but substantive. The Guidance and 
Instruction documents were revised as noted in the changes document to 
accommodate an online format and to clarify the questions and data 
sources States use in calculating the UPL. Some additional questions 
have been asked (50), some eliminated (36), and others have been 
clarified, but the overall burden for States of 40 hours for each UPL 
package remains the same, though CMS anticipates the changes will save 
burden to States, as the online system will allow for a logical flow to 
the questions and only ask the relevant questions for each State's UPL 
submission.
    The UPL templates have been revised to clarify definitions and 
instructions in filling out the UPL templates. None of the changes add 
burden to States, and CMS anticipates the new MACFin system will make 
it easier for States to upload and track their required UPL 
submissions.
    The standard funding questions have been revised for consistency 
with language in reviewing state plan amendments, instead of referring 
to the SMDL, we now refer to the state plan pages relevant to the 
funding

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questions--attachments 4.19-A, 4.19-B, and 4.-19-D. The questions 
concerning the source of funding have not changed, therefore there is 
no change in the burden to States. Form Number: CMS-10398 (#24) (OMB 
control number: 0938-1148); Frequency: Yearly; Affected Public: State, 
Local, or Tribal Governments; Number of Respondents: 54; Total Annual 
Responses: 54; Total Annual Hours: 2,160. (For policy questions 
regarding this collection contact: Richard Kimball at 410-786-2278.)
    3. Title of Information Collection: Supplemental Payment Reporting 
under the Consolidated Appropriations Act; Type of Information 
Collection Request: Extension of a currently approved collection; Use: 
Through passage of Division CC, Title II, Section 202 of the 
Consolidated Appropriations Act (CAA), Congress added subsection (bb) 
to section 1903 of the Act, which requires the Secretary of Health and 
Human Services to establish a system for states to submit reports on 
supplemental payments as defined in section 1903(bb)(2) of the Act. 
States are required to submit ``reports, as determined appropriate by 
the Secretary, on supplemental payment data, as a requirement for a 
State plan or State plan amendment [SPA] that would provide for a 
supplemental payment'' as required by section 1903(bb)(1) of the Act.
    CMS is implementing section 202 of the CAA of 2021 by adding new 
screens to the CMS-64 in the MBES system for states to report all 
supplemental payments. States will be expected to use the form starting 
for their first quarter Federal fiscal year 2022 expenditures beginning 
on January 15, 2022. The statute requires CMS to set up a data 
collection system for all state supplemental payments. Form Number: 
CMS-10398 (#73) (OMB control number: 0938-1148); Frequency: Yearly; 
Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 54; Total Annual Responses: 54; Total Annual Hours: 3,240. 
(For policy questions regarding this collection contact: Richard 
Kimball at 410-786-2278.)
    4. Title of Information Collection: Coverage of Routine Patient 
Cost for Items & Services in Qualifying Clinical Trials; Type of 
Information Collection Request: New collection; Use: Section 210 of the 
Consolidated Appropriations Act of 2021 amended section 1905(a) of the 
Social Security Act (the Act) to add a new mandatory benefit at 
1905(a)(30). The new benefit mandates coverage of routine patient 
services and costs furnished in connection with participation by 
Medicaid beneficiaries in qualifying clinical trials. Routine costs for 
services provided in connection with participation in a qualifying 
clinical trial generally include any item or service provided to the 
individual under the qualifying clinical trial, including any item or 
service provided to prevent, diagnose, monitor, or treat complications 
resulting from participation in the qualified clinical trial, to the 
extent that the provision of such items or services to the individual 
would otherwise be covered under the state plan or waiver.
    We propose that States and territories review the preprints 
completed for a Medicaid beneficiary to receive coverage of routine 
patient services and costs furnished in connection with participation 
in qualifying clinical trials. Completion of the preprint pages 
verifies in the Medicaid state plan that the mandatory clinical trials 
benefit is being furnished by a state. Completion of the preprint 
verifies that the requirements of a federally sponsored clinical trial 
is appropriate for the Medicaid beneficiary. Form Number: CMS-10398 
(#74) (OMB control number: 0938-1148); Frequency: Yearly; Affected 
Public: State, Local, or Tribal Governments; Number of Respondents: 56; 
Total Annual Responses: 56; Total Annual Hours: 56. (For policy 
questions regarding this collection contact Kirsten Jensen at 410-786-
8146.)
    5. Title of Information Collection: American Rescue Plan (ARP) 1135 
State Plan Amendment; Type of Information Collection Request: New 
collection; Use: Section 9811 of the ARP established new mandatory 
benefits at section 1905(a)(4)(E) for COVID-19 vaccine and vaccine 
administration and section 1905(a)(4)(F) for COVID-19 testing and 
treatment for both Medicaid and CHIP. The effective date time period 
for these mandatory benefits is March 11, 2021, ending on the last day 
of the first calendar quarter that begins one year after the last day 
of the emergency period described in section 1135(g)(1)(B) of the 
Social Security Act (the Act). Given that regular state plan rules do 
not allow for effective dates prior to the first day of the quarter in 
which the state plan amendment (SPA) was submitted, we are allowing 
states to use Section 1135 SPA process waiver authority to allow states 
to meet the required timeframes of these provisions. The SPAs will 
implement mandatory Medicaid coverage and reimbursement for COVID-19 
vaccine and vaccine administration and COVID-19 testing and treatment 
are considered part of the Agency's emergency response to COVID. CMS 
has issued guidance for each of these provisions.
    In large part, states have already been providing these services 
throughout the course of the pandemic and these SPAs will reflect what 
states have been doing. CMS is primarily using an attestation approach 
for states to affirm that they are in compliance with the requirements 
of the provisions.
    Form Number: CMS-10398 (#75) (OMB control number: 0938-1148); 
Frequency: Once and on occasion; Affected Public: State, Local, or 
Tribal Governments; Number of Respondents: 56; Total Annual Responses: 
56; Total Annual Hours: 168. (For policy questions regarding this 
collection contact Kirsten Jensen at 410-786-8146.)

    Dated: January 4, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2022-00119 Filed 1-6-22; 8:45 am]
BILLING CODE 4120-01-P