Notice2025-08307
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
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Published
May 12, 2025
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 90 Issue 90 (Monday, May 12, 2025)</title>
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[Federal Register Volume 90, Number 90 (Monday, May 12, 2025)]
[Notices]
[Pages 20166-20169]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08307]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-209, CMS-R-52, CMS-10538, CMS-10171, and CMS-
10780]
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
[[Page 20167]]
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 June 11, 2025.
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, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: <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: Revision of a currently
approved collection; Title of Information Collection: Laboratory
Personnel Report (CLIA) and Supporting Regulations; Use: The
information collected on this survey form is used in the administrative
pursuit of the Congressionally-mandated program with regard to
regulation of laboratories participating in CLIA. The surveyor will
provide the laboratory with the CMS-209 form. While the surveyor
performs other aspects of the survey, the laboratory will complete the
CMS-209 by recording the personnel data needed to support their
compliance with the personnel requirements of CLIA. For this
submission, we are making minor revisions to the collection instrument.
We revised the instructions for clarity and removed the references to
specific regulations. Form Number: CMS-209 (OMB control number 0938-
0151); Frequency: Biennially; Affected Public: Private Sector--State,
Local, or Tribal Governments; and Federal Government; Number of
Respondents: 16,404; Total Annual Responses: 8,202; Total Annual Hours:
4,101. (For policy questions regarding this collection contact Penny
Keller at 410-786-2035.)
2. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: End Stage Renal Disease (ESRD) Conditions for Coverage and
Supporting Regulations; Use: The Centers for Medicare and Medicaid
Services (CMS) is requesting reinstatement of OMB Control number 0938-
0386 (CMS-R-52) in compliance with the Paperwork Reduction Act (PRA).
This package applies to existing Medicare End-stage Renal Disease
(ESRD) conditions for coverage (CfCs) at 42 CFR 494. Section 299I of
the Social Security Amendments of 1972 (Pub. L. 92-603) originally
extended Medicare coverage to insured individuals, their spouses, and
their dependent children with ESRD who require dialysis or
transplantation. Subsequently, the ESRD Amendments of 1978 (Pub. L. 95-
292) amended title XVIII of the Social Security Act (the Act) by adding
section 1881. Section 1881(b)(1) of the Act authorizes the Secretary to
prescribe health and safety requirements (known as conditions for
coverage) that a facility providing dialysis and transplantation
services to patients must meet to qualify for Medicare reimbursement.
Final regulations were published June 3, 1976. Subsequent to the
publication of the final regulations, the ESRD Amendments of 1978 were
enacted to amend title XVIII of the Act to include section 1881(c).
This section establishes ESRD network areas and Network organizations
to assure the effective and efficient administration of ESRD program
benefits. The requirements from section 1881(b) and (c) are implemented
in regulations at 42 CFR part 405, subpart U, Conditions for Coverage
for dialysis facilities.
On April 7, 1986, the Consolidated Omnibus Budget Reconciliation
Act of 1975 (COBRA) (P.L. 99-272) was enacted which requires the
Secretary to maintain renal disease Network organizations as authorized
under section 1881(c) of the Act, and not merge the Network
organizations into other organizations or entities. On April 15, 1986,
we published a notice of proposed rulemaking to implement section 9214
of Public Law 99-272. A final rule (HSQ-115) was published August 26,
1986, which included information collection requirements at Sec.
405.2112(e). This rule revised the requirements in regulations
pertaining to the ESRD networks and organizations and establishes new,
more efficient Network organizations.
Revisions resulting from two additional rules: HSQ-137--ESRD:
Responsibilities of Network Organizations, published January 21, 1988;
and BERC-434--Medicare Program: Standards for the Reuse of Hemodialyzer
Filters and Other Dialysis Supplies, published October 2, 1987, are
also included. HSQ-137-ESRD approved information collection
requirements at Sec. Sec. 405.2112(f) and (j). BERC-434 approved
information collection requirements stemming from the following
historical sections of the CFR including Sec. Sec. 405.2136(b),
405.2138(a), 405.2139(a), and 405.2140(b) and (c).
Major revisions to the CFR established new ESRD CfCs at 42 CFR 494
issued in a final rule, ``Medicare and Medicaid Programs; Conditions
for Coverage for End-Stage Renal Disease Facilities,'' published on
April 15, 2008 (CMS-3818-F). This rule modified, removed, added, and
redesigned CfCs that dialysis facilities must meet to be certified
under the Medicare program. This rule approved information collection
requirements at Sec. Sec. 494.30, 494.40, 494.50, 494.60, 494.70,
494.80, 494.90, 494.100, 494.110, 494.120, 494.150, 494.170, and
494.180.
An additional revision to the ESRD CfCs at 42 CFR 494 was
precipitated by CMS-3818-F at 414.330(a)(2)(iii)(C). The burden to ESRD
home dialysis suppliers associated with this requirement would be the
time and effort necessary to collect all data for each patient
receiving home dialysis care with respect to services and items
furnished. However, the payment method that covered these suppliers
[[Page 20168]]
was eliminated in 2011 and there are no longer any such entities. See
42 CFR parts 410, 413 and 414 Medicare Program; End-Stage Renal Disease
Prospective Payment System; Final Rule and Proposed Rule at the
following link Federal Register <a href="https://www.govinfo.gov/content/pkg/FR-2010-08-12/pdf/2010-18466.pdf">https://www.govinfo.gov/content/pkg/FR-2010-08-12/pdf/2010-18466.pdf</a>. Therefore, there are no actual costs
associated with this requirement; we removed it from this package.
An additional revision to the ESRD CfCs at 42 CFR 494 was
precipitated by interim final rule, ``Medicare Program; Conditions for
Coverage for End-Stage Renal Disease Facilities-Third Party Payment,''
published on December 14, 2016 (CMS-3337-IFC). This rule established
new requirements for Medicare-certified dialysis facilities that make
payments of premiums for individual market health plans. This interim
final rule established additional burden associated with Sec. Sec.
494.70(c) and 494.180(k); these were quantified in the preceding
information collection which expired in 2024 (OMB control number 0938-
0386). Since these regulations were not finalized due to litigation,
they are no longer in effect. Therefore, we took out these sections
from this package as they do not impose any burden.
An additional revision to the ESRD CfCs at 42 CFR 494 was
precipitated by final rule, ``Medicare and Medicaid Programs; Emergency
Preparedness Requirements for Medicare and Medicaid Participating
Providers and Suppliers,'' published September 16, 2016 (CMS-3178-F).
This rule established the creation and maintenance of an Emergency
Preparedness Plan at 494.62(a), an Emergency Preparedness Policies and
Procedures document at 494.62(b), an Emergency Preparedness
Communication Plan at 494.62(c), a training program 494.62(d), and
documentation of training exercises 494.62(e). These information
collections are in separate package, OMB Control number 0938-1325.
On July 5, 2024, revisions to the CfC were proposed in ``Medicare
Program; End-Stage Renal Disease Prospective Payment System, Payment
for Renal Dialysis Services Furnished to Individuals with Acute Kidney
Injury, Conditions for Coverage for End-Stage Renal Disease Facilities,
End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal
Disease Treatment Choices Model,'' (CMS-1805-P). This rule proposed to
expand coverage of home dialysis services to patients with acute kidney
injury (AKI). Since the ESRD CfCs apply to dialysis facilities, not to
people with ESRD, this rule proposes to revise language in the CfCs to
allow beneficiaries with AKI to utilize home dialysis. Specifically, we
refer to facilities abiding by the ESRD CfCs as `dialysis facilities'
opposed to `ESRD facilities and all patients seeking services from
dialysis facilities as `patients' rather than `ESRD patients.' There is
no ICR burden associated with these changes however we made confirming
changes to the language in this package.
The CfCs are used by Federal (CMS), State surveyors (employed by
State survey agencies), or CMS authorized accrediting organizations as
a basis for determining whether a dialysis facility qualifies for
approval or re-approval under Medicare. Surveyors make an in-person
visit to the dialysis facility to perform the complete survey.
The preceding information collection, which expired on March 31,
2024, estimated the total annual hourly burden as 1,260,491 hours at a
cost of $64,839,657. We revise this to 800,621 hours at a cost of
$49,638,502. The reduction in hours and cost is largely due to removing
the burden estimates that no longer apply. Form Number: CMS-R-52 (OMB
control number: 0938-0386); Frequency: Annually; Affected Public:
Private sector--Business or other for-profit; Number of Respondents:
8,048; Total Annual Responses: 215,591; Total Annual Hours: 800,621
(For policy questions regarding this collection contact Claudia Molinar
at 410-786-8445.)
3. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: Hospice Information for Medicare Part D Plans; Use: The
Social Security Act in section 1861(dd) and Federal regulations in 42
CFR 418.106 and Sec. 418.202(f) require hospice programs to provide
individuals under hospice care with drugs and biologicals related to
the palliation and management of the terminal illness as defined in the
hospice plan of care. Medicare payment is made to the hospice for each
day an eligible beneficiary is under the hospice's care, regardless of
the amount of services provided on any given day. Because hospice care
is a Medicare Part A benefit, drugs provided by the hospice and covered
under the Medicare payment to the hospice program are not covered under
Part D.
The form would be completed by the prescriber or the beneficiary's
hospice, or if the prescriber or hospice provides the information
verbally to the Part D sponsor, the form would be completed by the
sponsor. Information provided on the form would be used by the Part D
sponsor to establish coverage of the drug under Medicare Part D. Per
statute, drugs that are necessary for the palliation and management of
the terminal illness and related conditions are not eligible for
payment under Part D. The standard form provides a vehicle for the
hospice provider, prescriber or sponsor to document that the drug
prescribed is ``unrelated'' to the terminal illness and related
conditions. It also gives a hospice organization the option to
communicate a beneficiary's change in hospice status and/care plan to
Part D sponsors. Form Number: CMS-10538 (OMB control number: 0938-
1296); Frequency: Yearly; Affected Public: Private Sector (business or
other for-profits); Number of Respondents: 319; Number of Responses:
57,027; Total Annual Hours: 2,329. (For policy questions regarding this
collection, contact Chad Buskirk at (410) 786-1630 or
<a href="/cdn-cgi/l/email-protection#73101b12175d110600181a011833101e005d1b1b005d141c05"><span class="__cf_email__" data-cfemail="6b08030a0f45091e18000219002b08061845030318450c041d">[email protected]</span></a>.)
4. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: Part D Coordination of Benefits Data; Use: Sections 1860D-
23 and 1860D-24 of the Act require the Secretary to establish
requirements for prescription drug plans to promote effective
coordination between Part D plans and SPAPs and other payers. These
Part D Coordination of Benefits (COB) requirements have been codified
into the Code of Federal Regulations at 42 CFR 423.464. In particular,
CMS' requirements relate to the following elements: (1) enrollment file
sharing; (2) claims processing and payment; (3) claims reconciliation
reports; (4) application of the protections against high out-of-pocket
expenditures by tracking TrOOP expenditures; and (5) other processes
that the Secretary determines.
This information collection request assists CMS, pharmacists, Part
D plans, and other payers coordinate prescription drug benefits at the
point-of-sale and track beneficiary True out-of-pocket (TrOOP)
expenditures using the Part D Transaction Facilitator (PDTF). Form
Number: CMS-10171 (OMB control number: 0938-0978); Frequency: Yearly;
Affected Public: State, Local, or Tribal Government; Number of
Respondents: 67,043; Total Annual Responses: 935,730,342; Total Annual
Hours: 1,011,740. (For policy questions regarding this collection
contact Chad Buskirk at 410-786-1630 or <a href="/cdn-cgi/l/email-protection#3e5d565f5a105c4b4d55574c557e5d534d1056564d10595148"><span class="__cf_email__" data-cfemail="35565d54511b5740465e5c475e755658461b5d5d461b525a43">[email protected]</span></a>.)
5. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Requirements
[[Page 20169]]
Related to Surprise Billing: Qualifying Payment Amount, Notice and
Consent, Disclosure on Patient Protections Against Balance Billing, and
State Law Opt-in; Use: On December 27, 2020, the Consolidated
Appropriations Act, 2021 (Pub. L. 116-260), which included the No
Surprises Act, was signed into law. The No Surprises Act provides
Federal protections against surprise billing and limits out-of-network
cost sharing under many of the circumstances in which surprise medical
bills arise most frequently. The July 13, 2021 interim final rules
``Requirements Related to Surprise Billing; Part I'' (86 FR 36872, July
2021 interim final rules) issued by the Department of Health and Human
Services, the Department of Labor, the Department of the Treasury, and
the Office of Personnel Management, implement provisions of the No
Surprises Act that apply to group health plans, health insurance
issuers offering group or individual health insurance coverage, and
carriers in the Federal Employees Health Benefits (FEHB) Program that
provide protections against balance billing and out-of-network cost
sharing with respect to emergency services, non-emergency services
furnished by nonparticipating providers related to patient visits to
certain types of participating health care facilities, and services
furnished by nonparticipating providers of air ambulance services. The
July 2021 interim final rules prohibit nonparticipating providers,
emergency facilities, and providers of air ambulance services from
balance billing participants, beneficiaries, and enrollees in certain
situations unless they satisfy certain notice and consent requirements.
The No Surprises Act and the July 2021 interim final rules require
group health plans and issuers of health insurance coverage to provide
information about qualifying payment amounts (QPAs) to nonparticipating
providers and facilities and to provide disclosures on patient
protections against balance billing to participants, beneficiaries and
enrollees. Self-insured plans opting in to a specified State law are
required to provide a disclosure to participants. Certain
nonparticipating providers and nonparticipating emergency facilities
may provide participants, beneficiaries, and enrollees with notice and
obtain their consent to waive balance billing protections, provided
certain requirements are met. In addition, certain providers and
facilities are required to provide disclosures on patient protections
against balance billing to participants, beneficiaries and enrollees.
The No Surprises Act requires the Secretary of HHS to audit no more
than 25 group health plans and health insurance issuers offering group
or individual health insurance coverage annually, and permits
additional audits based on complaints, to ensure that such plans and
coverage are in compliance with the requirement of applying a QPA and
that the QPA applied satisfies the definition under the No Surprises
Act with respect to the year involved. Form Number: CMS-10780 (OMB
control number: 0938-1401); Frequency: On Occasion; Affected Public:
Individuals, State, Local, or Tribal Governments, Private Sector;
Number of Respondents: 2,477,197; Total Annual Responses: 85,148,199;
Total Annual Hours: 6,006,654. (For policy questions regarding this
collection, contact Russell Tipps at 667-290-9640.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-08307 Filed 5-9-25; 8:45 am]
BILLING CODE 4120-01-P
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