Notice2022-15175
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 15, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 135 (Friday, July 15, 2022)</title>
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[Federal Register Volume 87, Number 135 (Friday, July 15, 2022)]
[Notices]
[Pages 42484-42485]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-15175]
[[Page 42484]]
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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.
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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 (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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>
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:
<bullet> To provide a source of information from which selected
measures can be publicly reported to beneficiaries as a decision aid
for dialysis facility selection.
<bullet> To aid facilities with their internal quality improvement
efforts and external benchmarking with other facilities.
<bullet> To provide CMS with information for monitoring and public
reporting purposes.
<bullet> 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
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</html>Indexed from Federal Register on July 15, 2022.
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