[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Pages 73720-73722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25598]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10764, CMS-10454, CMS-R-71, CMS-370/CMS-377, 
CMS-1572 and CMS-10332]


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 January 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 __, Room C4-26-05,

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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.
    2. 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-10764 Evaluation of Risk Adjustment Data Validation (RADV) Appeals 
and Health Insurance Exchange Outreach Training Sessions
CMS-10454 Disclosure of State Rating Requirements
CMS-R-71 Quality Improvement Organization (QIO) Assumption of 
Responsibilities and Supporting Regulations
CMS-370/CMS-377 ASC Forms for Medicare Program Certification
CMS-1572 Home Health Agency Survey and Deficiencies Report
CMS-10332 Disclosure Requirement for the In-Office Ancillary Services 
Exception

    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: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Evaluation of Risk Adjustment Data Validation (RADV) Appeals and Health 
Insurance Exchange Outreach Training Sessions; Use: CMS recognizes that 
the success of accurately identifying risk-adjustment payments and 
payment errors is dependent upon the data submitted by Medicare 
Advantage Organizations (MAOs), and is strongly committed to providing 
appropriate education and technical outreach to MAOs and third-party 
administrators (TPAs). In addition, CMS is strongly committed to 
providing appropriate education and technical outreach to States, 
issuers, self-insured group health plans and TPAs participating in the 
Marketplace and/or market stabilization programs mandated by the 
Affordable Care Act (ACA).
    CMS will strengthen outreach and engagement with MAOs and 
stakeholders in the Marketplace through satisfaction surveys following 
contract-level (CON) RADV audit and Health Insurance Exchange training 
events. The survey results will help to determine stakeholders' level 
of satisfaction with trainings, identify any issues with training and 
technical assistance delivery, clarify stakeholders' needs and 
preferences, and define best practices for training and technical 
assistance. Form Number: CMS-10764 (OMB control number: 0938-NEW); 
Frequency: Occasionally; Affected Public: Private Sector; Number of 
Respondents: 4,270; Total Annual Responses: 4,270; Total Annual Hours: 
1,068. (For questions regarding this collection contact Melissa Barkai 
at 410-786-4305.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of information Collection: Disclosure of 
State Rating Requirements; Use: The final rule ``Patient Protection and 
Affordable Care Act; Health Insurance Market Rules; Rate Review'' 
implements sections 2701, 2702, and 2703 of the Public Health Service 
Act (PHS Act), as added and amended by the Affordable Care Act, and 
sections 1302(e) and 1312(c) of the Affordable Care Act. The rule 
directs that states submit to CMS certain information about state 
rating and risk pooling requirements for their individual, small group, 
and large group markets, as applicable. Specifically, states will 
inform CMS of age rating ratios that are narrower than 3:1 for adults; 
tobacco use rating ratios that are narrower than 1.5:1; a state-
established uniform age curve; geographic rating areas; whether 
premiums in the small and large group market are required to be based 
on average enrollee amounts (also known as composite premiums); and, in 
states that do not permit any rating variation based on age or tobacco 
use, uniform family tier structures and corresponding multipliers. In 
addition, states that elect to merge their individual and small group 
market risk pools into a combined pool will notify CMS of such 
election. This information will allow CMS to determine whether state-
specific rules apply or Federal default rules apply. It will also 
support the accuracy of the federal risk adjustment methodology. Form 
Number: CMS-10454 (OMB control number 0938-1258); Frequency: 
Occasionally; Affected Public: State, Local, or Tribal Governments; 
Number of Respondents: 3; Total Annual Responses: 3; Total Annual 
Hours: 17. (For policy questions regarding this collection contact 
Russell Tipps at 301-869-3502.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Quality 
Improvement Organization (QIO) Assumption of Responsibilities and 
Supporting Regulations; Use: The Peer Review Improvement Act of 1982 
amended Title XI of the Social Security Act to create the Utilization 
and Quality Control Peer Review Organization (PRO) program which 
replaces the Professional Standards Review Organization (PSRO) program 
and streamlines peer review activities. The term PRO has been renamed 
Quality Improvement Organization (QIO). This information collection 
describes the review functions to be performed by the QIO. It outlines 
relationships among QIOs, providers, practitioners, beneficiaries, 
intermediaries, and carriers. Form Number: CMS-R-71 (OMB control 
number: 0938-0445); Frequency: Yearly; Affected Public: Business or 
other for-profit and Not-for-profit institutions; Number of 
Respondents: 6,939; Total Annual Responses: 972,478; Total Annual 
Hours: 1,034,655. (For policy questions regarding this collection 
contact Kimberly Harris at 401-837-1118.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Titles of Information Collection: ASC Forms for 
Medicare Program Certification; Use: The form CMS-370 titled ``Health 
Insurance Benefits Agreement'' is used for the purpose of establishing 
an ASC's eligibility for payment under Title XVIII of the Social 
Security Act (the ``Act''). This agreement, upon acceptance by the 
Secretary of Health & Human Services, shall be binding on the ASC and 
the Secretary. The agreement may be

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terminated by either party in accordance with regulations. In the event 
of termination of this agreement, payment will not be available for the 
ASC's services furnished to Medicare beneficiaries on or after the 
effective date of termination.
    The CMS-377 form is used by ASCs to initiate both the initial and 
renewal survey by the State Survey Agency, which provides the 
certification required for an ASC to participate in the Medicare 
program. An ASC must complete the CMS-377 form and send it to the 
appropriate State Survey Agency prior to their scheduled accreditation 
renewal date. The CMS-377 form provides the State Survey Agency with 
information about the ASC facility's characteristics, such as, 
determining the size and the composition of the survey team on the 
basis of the number of ORs/procedure rooms and the types of surgical 
procedures performed in the ASC. Form Numbers: CMS-370 and CMS-377 (OMB 
control number: 0938-0266); Frequency: Occasionally; Affected Public: 
Private Sector--Business or other for-profit and Not-for-profit 
institutions; Number of Respondents: 1,567; Total Annual Responses: 
1,567; Total Annual Hours: 1,012. (For policy questions regarding this 
collection contact Caroline Gallaher at 410-786-8705.)
    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Home Health 
Agency Survey and Deficiencies Report; Use: In order to participate in 
the Medicare Program as a Home Health Agency (HHA) provider, the HHA 
must meet federal standards. This form is used to record information 
and patients' health and provider compliance with requirements and to 
report the information to the federal government. Form Number: CMS-1572 
(OMB control number: 0938-0355); Frequency: Yearly; Affected Public: 
State, Local or Tribal Government; Number of Respondents: 3,833; Total 
Annual Responses: 3,833; Total Annual Hours: 1,917. (For policy 
questions regarding this collection contact Tara Lemons at 410-786-
3030.)
    6. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Disclosure 
Requirement for the In-Office Ancillary Services Exception; Use: 
Section 6003 of the Affordable Care Act (ACA) established a new 
disclosure requirement that a physician must perform for certain 
imaging services to meet the in-office ancillary services exception to 
the prohibition of the physician self-referral law. This section of the 
ACA amended section 1877(b)(2) of the Act by adding a requirement that 
the referring physician informs the patient, at the time of the 
referral and in writing, that the patient may receive the imaging 
service from another supplier.
    Physicians who provide certain imaging services (MRI, CT, and PET) 
under the in-office ancillary services exception to the physician self-
referral prohibition are required to provide the disclosure notice as 
well as the list of other imaging suppliers to the patient. The patient 
will then be able to use the disclosure notice and list of suppliers in 
making an informed decision about his or her course of care for the 
imaging service.
    CMS would use the collected information for enforcement purposes. 
Specifically, if we were investigating the referrals of a physician 
providing advanced imaging services under the in- office ancillary 
services exception, we would review the written disclosure in order to 
determine if it satisfied the requirement. Form Number: CMS-10332 (OMB 
control number: 0938-1133); Frequency: Occasionally; Affected Public: 
Private Sector, Business or other for-profits, Not-for-profits 
institutions; Number of Respondents: 2,239; Total Annual Responses: 
989,971; Total Annual Hours: 18,694. (For questions regarding this 
collection contact Laura Dash at 410-786-8623.)

    Dated: November 16, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-25598 Filed 11-18-20; 8:45 am]
BILLING CODE 4120-01-P