[Federal Register Volume 87, Number 135 (Friday, July 15, 2022)]
[Notices]
[Pages 42484-42485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15175]



[[Page 42484]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10511, CMS-10788, CMS-10052, CMS-460 and 
CMS-10105]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

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 (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 a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate 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 on the collection(s) of information must be received by 
the OMB desk officer by August 15, 2022.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    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 website address at: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-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 that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Reinstatement without 
change; Title of Information Collection: Medicare Coverage of Items and 
Services in FDA Investigational Device Exemption Clinical Studies--
Revision of Medicare Coverage; Use: Section 1862(m) of the Social 
Security Act (and regulations at 42 CFR Subpart B (sections 405.201-
405.215) allows for payment of the routine costs of care furnished to 
Medicare beneficiaries in a Category A investigational device exemption 
(IDE) study and authorizes the Secretary to establish criteria to 
ensure that Category A IDE trials conform to appropriate scientific and 
ethical standards. Medicare does not cover the Category A device itself 
because Category A (Experimental) devices do not satisfy the statutory 
requirement that Medicare pay for devices determined to be reasonable 
and necessary. Medicare may cover Category B (Non-experimental) 
devices, and associated routine costs of care, if they are considered 
reasonable and necessary and if all other applicable Medicare coverage 
requirements are met. Under the current centralized review process, 
interested parties (such as study sponsors) that wish to seek Medicare 
coverage related to Category A or B IDE studies have a centralized 
point of contact for submission, review and determination of Medicare 
coverage IDE study requests. In order for CMS (or its designated 
entity) to determine if the Medicare coverage criteria are met, as 
described in our regulations, CMS (or its designated entity) must 
review documents submitted by interested parties or study sponsors. 
Such information submitted will be a FDA IDE approval letter, IDE study 
protocol, IRB approval letter, National Clinical Trials (NCT) number, 
and Supporting materials as needed. Form Number: CMS-10511 (OMB control 
number: 0938-1250); Frequency: Yearly; Affected Public: Private Sector 
(Business or other for-profits, Not-for-Profit Institutions); Number of 
Respondents: 116; Total Annual Responses: 116; Total Annual Hours: 232. 
(For policy questions regarding this collection contact Xiufen Sui at 
410-786-3136.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Prescription Drug 
and Health Care Spending; Use: On December 27, 2020, the Consolidated 
Appropriations Act, 2021 (CAA) was signed into law. Section 204 of 
Title II of Division BB of the CAA added parallel provisions at section 
9825 of the Internal Revenue Code (the Code), section 725 of the 
Employee Retirement Income Security Act (ERISA), and section 2799A-10 
of the Public Health Service Act (PHS Act) that require group health 
plans and health insurance issuers offering group or individual health 
insurance coverage to annually report to the Department of the 
Treasury, the Department of Labor (DOL), and the Department of Health 
and Human Services (HHS) (collectively, ``the Departments'') certain 
information about prescription drug and health care spending, premiums, 
and enrollment under the plan or coverage. This information will 
support the development of public reports that will be published by the 
Departments on prescription drug reimbursements for plans and coverage, 
prescription drug pricing trends, and the role of prescription drug 
costs in contributing to premium increases or decreases under the plans 
or coverage. The 2021 interim final rules, ``Prescription Drug and 
Health Care Spending'' issued by the Departments and the Office of 
Personnel Management (OPM) implement the provisions of section 9825 of 
the Code, section 725 of ERISA, and section 2799A-10 of the PHS Act, as 
enacted by section 204 of Title II of Division BB of the CAA. OPM 
joined the Departments in issuing the 2021 interim final rules, 
requiring Federal Employees Health Benefits (FEHB) carriers to report 
information about prescription drug and health care spending, premiums, 
and plan enrollment in the same manner as a group health plan or health 
insurance

[[Page 42485]]

issuer offering group or individual health insurance coverage. Form 
Number: CMS-10788 (OMB control number: 0938-1405); Frequency: Annual; 
Affected Public: Private Sector; Number of Respondents: 356; Total 
Annual Responses: 356; Total Annual Hours: 1,684,080. (For policy 
questions regarding this collection, contact Christina Whitefield at 
301-492-4172.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Recognition of 
Pass-Through Payment for Additional (New) Categories of Devices under 
the Outpatient Prospective Payment System and Supporting Regulations; 
Use: The transitional pass-through provision provides a way for 
ensuring appropriate payment for new technologies whose use and costs 
are not adequately represented in the base year claims data on which 
the outpatient PPS is constructed as required by law. Categories of 
medical devices will receive transitional pass-through payments for 2 
to 3 years from the date payments are initiated for the category. 
However, the underlying provision is permanent and provides an on-going 
mechanism for reflecting timely introduction of new items into the 
payment structure.
    Interested parties such as hospitals, device manufacturers, 
pharmaceutical companies, and physicians apply for transitional pass-
through payment for certain items used with services covered in the 
outpatient PPS. After we receive all requested information, we evaluate 
the information to determine if the creation of an additional category 
of medical devices for transitional pass-through payments is justified. 
We may request additional information related to the proposed new 
device category, as needed. We advise the applicant of our decision, 
and update the outpatient PPS during its next scheduled quarterly 
payment update cycle to reflect any newly approved device categories. 
We list below the information that we require from all applicants. The 
following information is required to process requests for additional 
categories of medical devices for transitional pass-through payments. 
Form Number: CMS-10052 (OMB control number: 0938-0857); Frequency: 
Annually; Affected Public: Private Sector, Business or other for-
profits; Number of Respondents: 10; Number of Responses: 10; Total 
Annual Hours: 160. (For questions regarding this collection contact 
Kimberly A. Campbell at 410-786-2289.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection: Title of Information Collection: Medicare 
Participating Physician or Supplier Agreement; Use: Form CMS-460 is the 
agreement a physician, supplier, or their authorized official signs to 
become a participating provider in Medicare Part B. By signing the 
agreement to participate in Medicare, the physician, supplier, or their 
authorized official agrees to accept the Medicare-determined payment 
for Medicare covered services as payment in full and to charge the 
Medicare Part B beneficiary no more than the applicable deductible or 
coinsurance for the covered services. For purposes of this explanation, 
the term ``supplier'' means certain other persons or entities, other 
than physicians, that may bill Medicare for Part B services (e.g., 
suppliers of diagnostic tests, suppliers of radiology services, durable 
medical suppliers (DME) suppliers, nurse practitioners, clinical social 
workers, physician assistants). Institutions that render Part B 
services in their outpatient department are not considered 
``suppliers'' for purposes of this agreement. Form Number: CMS-460 (OMB 
control number: 0938-0373); Frequency: Annually; Affected Public: 
Private Sector, Business or other for-profits; Number of Respondents: 
36,000; Number of Responses: 36,000; Total Annual Hours: 9,000. (For 
questions regarding this collection contact Mark G. Baldwin at 410-786-
8139.)
    5. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: National 
Implementation of the In-Center Hemodialysis CAHPS Survey; Use: The 
national implementation of the ICH CAHPS Survey is designed to allow 
third-party, CMS-approved survey vendors to administer the ICH CAHPS 
Survey using mail-only, telephone-only, or mixed (mail with telephone 
follow-up) modes of survey administration. Experience from previous 
CAHPS surveys shows that mail, telephone, and mail with telephone 
follow-up data collection modes work well for respondents, vendors, and 
health care providers. Any additional forms of information technology, 
such as web surveys, is under investigation as a potential survey 
option in this population.
    Data collected in the national implementation of the ICH CAHPS 
Survey are used for the following purposes:
     To provide a source of information from which selected 
measures can be publicly reported to beneficiaries as a decision aid 
for dialysis facility selection.
     To aid facilities with their internal quality improvement 
efforts and external benchmarking with other facilities.
     To provide CMS with information for monitoring and public 
reporting purposes.
     To support the ESRD Quality Improvement Program.
    Form Number: CMS-10105 (OMB control number: 0938-0926); Frequency: 
Semi Annually; Affected Public: Individuals and Households; Number of 
Respondents: 103,500; Total Annual Responses: 621,000; Total Annual 
Hours: 55,890. (For policy questions regarding this collection contact 
Israel H. Cross at 410-786-0619.)

    Dated: July 12, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2022-15175 Filed 7-14-22; 8:45 am]
BILLING CODE 4120-01-P