[Federal Register Volume 86, Number 94 (Tuesday, May 18, 2021)]
[Notices]
[Pages 26921-26923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-185, CMS-10166, CMS-10178, CMS-10184, CMS-
10417 and CMS-372(S)]


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 July 19, 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: CMS-P-0015A, 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-R-185--Granting and Withdrawal of Deeming Authority to Private 
Nonprofit Accreditation Organizations and CLIA Exemption Under State 
Laboratory
CMS-10166--Fee-for-Service Improper Payment Rate Measurement in 
Medicaid and the Children's Health Insurance Program
CMS-10178--Medicaid and Children's Health Insurance (CHIP) Managed Care 
Payments and Related Information
CMS-10184--Payment Error Rate Measurement--State Medicaid and CHIP 
Eligibility
CMS-10417--Medicare Fee-for-Service Prepayment Review of Medical 
Records
CMS-372(S)--Annual Report on Home and Community Based Services Waivers 
and Supporting Regulations

    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 currently 
approved collection; Title of Information Collection: Granting and 
Withdrawal of Deeming Authority to Private Nonprofit Accreditation 
Organizations and CLIA Exemption Under State Laboratory Programs; Use: 
The information required is necessary to determine whether a private 
accreditation organization/State licensure program standards and 
accreditation/licensure process is at least equal to or more stringent 
than those of the Clinical Laboratory Improvement Amendments of 1988 
(CLIA). If an accreditation organization is approved, the laboratories 
that it accredits are ``deemed'' to meet the

[[Page 26922]]

CLIA requirements based on this accreditation. Similarly, if a State 
licensure program is determined to have requirements that are equal to 
or more stringent than those of CLIA, its laboratories are considered 
to be exempt from CLIA certification and requirements. The information 
collected will be used by HHS to: Determine comparability/equivalency 
of the accreditation organization standards and policies or State 
licensure program standards and policies to those of the CLIA program; 
to ensure the continued comparability/equivalency of the standards; and 
to fulfill certain statutory reporting requirements. Form Number: CMS-
R-185 (OMB control number: 0938-0686); Frequency: Occasionally; 
Affected Public: Private Sector--Business or other for-profits and Not-
for-profit institutions; Number of Respondents: 9; Total Annual 
Responses: 9; Total Annual Hours: 5,464. (For policy questions 
regarding this collection contact Arlene Lopez at 410-786-6782.)
    2. Type of Information Collection Request: Reinstatement without 
change of a currently approved collection; Title of Information 
Collection: Fee-for-Service Improper Payment Rate Measurement in 
Medicaid and the Children's Health Insurance Program; Use: The 
information collected from the selected States will be used by Federal 
contractors to conduct Medicaid and CHIP FFS data processing and 
medical record reviews on which State-specific improper payment rates 
will be calculated. The quarterly FFS claims and payments will provide 
the contractor with the actual claims to be sampled. The systems 
manuals, provider policies, and other supporting documentation will be 
used by the federal contractor when conducting the FFS data processing 
and medical record reviews. Further, the FFS claims and payments 
sampled for data processing and medical record reviews will serve as 
the basis for the eligibility reviews. Individuals for whom the state 
made the FFS claim or payments will have their underlying eligibility 
reviewed.
    In addition to the Federal Review Contractor conducting a data 
processing and medical record review of the FFS claims and payments, 
the FFS sample selected from the state-submitted universe will also be 
leveraged to support the PERM eligibility reviews. The Federal 
Eligibility Review Contractor will review the underlying eligibility of 
individuals whose FFS claims and payments were sampled as part of the 
PERM FFS sample. Form Number: CMS-10166 (OMB control number: 0938-
0974); Frequency: Quarterly; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 17; Total Annual Responses: 34; 
Total Annual Hours: 56,100. (For policy questions regarding this 
collection contact Daniel Weimer at 410-786-5240.)
    3. Type of Information Collection Request: Reinstatement without 
change of a currently approved collection; Title of Information 
Collection: Medicaid and Children's Health Insurance (CHIP) Managed 
Care Payments and Related Information; Use: The information collected 
from the selected States will be used by Federal contractors to conduct 
Medicaid and CHIP managed care data processing reviews on which State-
specific improper payment rates will be calculated. The quarterly 
capitation payments will provide the contractor with the actual claims 
to be sampled. The managed care contracts, rate schedules, and updates 
to both, will be used by the federal contractor when conducting the 
managed care claims reviews. Further, the managed care capitation 
payments sampled for data processing reviews will serve as the basis 
for the eligibility reviews. Individuals for whom the state made the 
managed care capitation will have their underlying eligibility 
reviewed.
    Section 2(b)(1) of IPERA clarified that, when meeting IPIA and 
IPERA requirements, agencies must produce a statistically valid 
estimate, or an estimate that is otherwise appropriate using a 
methodology approved by the Director of the OMB. IPERIA further 
clarified requirements for agency reporting on actions to reduce 
improper payments and recover improper payments. The collection of 
information is necessary for CMS to produce national improper payment 
rates for Medicaid and CHIP as required by Public Law 107-300. Form 
Number: CMS-10178 (OMB control number: 0938-0994); Frequency: 
Quarterly; Affected Public: State, Local, or Tribal Governments; Number 
of Respondents: 17; Total Annual Responses: 34; Total Annual Hours: 
19,550. (For policy questions regarding this collection contact Daniel 
Weimer at 410-786-5240.)
    4. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Payment Error Rate Measurement--State Medicaid and CHIP 
Eligibility; Use: The Payment Error Rate Measurement (PERM) program was 
developed to implement the requirements of the Improper Payments 
Information Act (IPIA) of 2002 (Pub. L. 107-300), which requires the 
head of federal agencies to annually review all programs and activities 
that it administers to determine and identify any programs that are 
susceptible to significant erroneous payments. If programs are found to 
be susceptible to significant improper payments, then the agency must 
estimate the annual amount of erroneous payments, report those 
estimates to the Congress, and submit a report on actions the agency is 
taking to reduce improper payments. IPIA was amended by Improper 
Payments Elimination and Recovery Act of 2010 (IPERA) (Pub. L. 111-
204), the Improper Payments Elimination and Recovery Improvement Act of 
2012 (IPERIA) (Pub. L. 112-248), and the Payment Integrity Information 
Act of 2019 (PIIA) (Pub. L. 116-117).
    The eligibility case documentation collected from the States, 
through submission of hard copy case files and through access to state 
eligibility systems, will be used by CMS and its federal contractors to 
conduct eligibility case reviews on individuals who had claims paid on 
their behalf in order to determine the improper payment rate associated 
with Medicaid and CHIP eligibility to comply with the IPIA of 2002. 
Prior to the July 2017 Final Rule being published in response to the 
Affordable Care Act, states provided CMS only with information about 
their sampling and review process as well as the final review findings, 
which CMS has used in each PERM cycle to calculate IPIA-compliant state 
and federal improper payment rate for Medicaid and CHIP. Given changes 
brought forth in the July 2017 Final Rule, states will no longer be 
required to develop eligibility-specific universes, conduct case 
reviews, and report findings to CMS. A federal contractor will utilize 
the claims (fee-for-service and managed care universes) to identify a 
sample of individuals and will be responsible for conducting case 
reviews to support the PERM measurement. Form Number: CMS-10184 (OMB 
control number: 0938-1012); Frequency: Quarterly; Affected Public: 
State, Local, or Tribal Governments; Number of Respondents: 17; Total 
Annual Responses: 34; Total Annual Hours: 25,500. (For policy questions 
regarding this collection contact Daniel Weimer at 410-786-5240.)
    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare Fee-for-
Service Prepayment Review of Medical Records; Use: The Medical Review 
program is designed to prevent improper payments in the Medicare FFS 
program. Whenever possible, Medicare Administrative Contractors (MACs) 
are

[[Page 26923]]

encouraged to automate this process; however, it may require the 
evaluation of medical records and related documents to determine 
whether Medicare claims are billed in compliance with coverage, coding, 
payment, and billing policies. Addressing improper payments in the 
Medicare fee-for-service (FFS) program and promoting compliance with 
Medicare coverage and coding rules is a top priority for the CMS. 
Preventing Medicare improper payments requires the active involvement 
of every component of CMS and effective coordination with its partners 
including various Medicare contractors and providers. The information 
required under this collection is requested by Medicare contractors to 
determine proper payment, or if there is a suspicion of fraud. Medicare 
contractors request the information from providers/suppliers submitting 
claims for payment when data analysis indicates aberrant billing 
patterns or other information which may present a vulnerability to the 
Medicare program. Form Number: CMS-10417; Frequency: Occasionally; 
Affected Public: Private Sector, State, Business, and Not-for Profits; 
Number of Respondents: 485,632; Number of Responses: 485,632; Total 
Annual Hours: 242,816. (For questions regarding this collection, 
contact Christine Grose at (410-786-1362).
    6. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Annual Report on 
Home and Community Based Services Waivers and Supporting Regulations; 
Use: We use this report to compare actual data to the approved waiver 
estimates. In conjunction with the waiver compliance review reports, 
the information provided will be compared to that in the Medicaid 
Statistical Information System (MSIS) (CMS-R-284; OMB control number: 
0938-0345) report and FFP claimed on a state's Quarterly Expenditure 
Report (CMS-64; OMB control number: 0938-1265), to determine whether to 
continue the state's home and community-based services waiver. States' 
estimates of cost and utilization for renewal purposes are based upon 
the data compiled in the CMS-372(S) reports. Form Number: CMS-372(S) 
(OMB control number: 0938-0272); Frequency: Yearly; Affected Public: 
State, Local, or Tribal Governments; Number of Respondents: 48; Total 
Annual Responses: 253; Total Annual Hours: 11,132. (For policy 
questions regarding this collection contact Ralph Lollar at 410-786-
0777.)

    Dated: May 13, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-10453 Filed 5-17-21; 8:45 am]
BILLING CODE 4120-01-P