980 Federal Register / Vol. 87, No. 5 / Friday, January 7, 2022 / Notices 

1https://www.whitehouse.gov/sites/ 

whitehouse.gov/files/omb/assets/inforeg/PRA_Gen_

ICRs_5-28-2010.pdf. 

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. 

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. 

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/PRAListing.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 


tkelley on DSK125TN23PROD with NOTICE 
Federal Register / Vol. 87, No. 5 / Friday, January 7, 2022 / Notices 981 

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 nonfederal 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 


tkelley on DSK125TN23PROD with NOTICE 
982 Federal Register / Vol. 87, No. 5 / Friday, January 7, 2022 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Tenth Amendment to Declaration 

Under the Public Readiness and 

Emergency Preparedness Act for 

Medical Countermeasures Against 

COVID–19 

ACTION: Notice of amendment. 

SUMMARY: The Secretary issues this 

amendment pursuant to section 319F–3 

of the Public Health Service Act to 

expand the authority for certain 

Qualified Persons authorized to 

prescribe, dispense, and administer 

seasonal influenza vaccines under 

section VI of this Declaration. 

DATES: This amendment is effective as 

of January 7, 2022. 

FOR FURTHER INFORMATION CONTACT: L. 

Paige Ezernack, Office of the Assistant 

Secretary for Preparedness and 

Response, Office of the Secretary, 

Department of Health and Human 

Services, 200 Independence Avenue 

SW, Washington, DC 20201; 202–260– 

0365, paige.ezernack@hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Public Readiness and Emergency 

Preparedness Act (PREP Act) authorizes 

the Secretary of Health and Human 

Services (the Secretary) to issue a 

Declaration to provide liability 

immunity to certain individuals and 

entities (Covered Persons) against any 

claim of loss caused by, arising out of, 


tkelley on DSK125TN23PROD with NOTICE