Attachment F 30 Day FRN 0935-0206

Federal Register / Vol. 90, No. 173 / Wednesday, September 10, 2025 / Notices
address the structural problems in the
underlying market. Gateway is a private
equity owned network of pet
crematoria,1 which describes itself as
the ‘‘largest pet aftercare provider in
North America.’’ 2 Its self-described
‘‘focus is to acquire and partner with
like-minded, leading pet aftercare
companies across all of North
America.’’ 3 In other words, Gateway
rolls up smaller providers. And with
fewer pet aftercare competitors,
Gateway is able to exert more control
over the options and prices pet owners
pay for services in their time of need;
and over the employment options, pay,
and working conditions available to
workers.
That underlying market structure is
part of what enables Gateway to execute
the noncompete strategy described in
the Commission’s complaint. But the
Commission’s order does nothing to
address or unwind it. Without touching
the structural issues in the market, a
non-compete remedy, however
meaningful, will not successfully
protect consumers or workers in the pet
aftercare market.
Finally, while I am glad to see the
Commission has not entirely abandoned
the important work on noncompetes
that began under Chair Khan’s
leadership,4 I would be remiss if I did
not point out, as I have for years, that
one-off enforcement is no substitute for
the FTC’s meaningful, marketwide
noncompete rule that will protect
workers across the country.5 That rule,
which received thousands of public
comments in support and is currently
being challenged in several separate
cases, deserves the Commission’s fullthroated defense in the courts.
[FR Doc. 2025–17416 Filed 9–9–25; 8:45 am]
BILLING CODE 6750–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the
reinstatement with change of the
currently approved information
collection project ‘‘Online Application
Order Form for Products from the
Healthcare Cost and Utilization Project
(HCUP),’’ OMB #0935–0206. This
information collection was previously
published in the Federal Register on
April 30, 2025 and allowed 60 days for
public comment. AHRQ received no
comments from members of the public.
The purpose of this notice is to allow an
additional 30 days for public comment.
DATES: Comments on this notice must be
received by October 10, 2025.
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. Copies of the proposed
collection plans, data collection
instruments, and specific details on the
estimated burden can be obtained from
the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Margie Shofer, AHRQ Reports Clearance
Officer, 301–427–1696 or by email at
REPORTSCLEARANCEOFFICER@
ahrq.hhs.gov.
SUMMARY:

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SUPPLEMENTARY INFORMATION:
1 See IMPERIAL CAPITAL, https://
www.imperialcap.com/investments/gateway (last
visited Sept. 4, 2025).
2 GATEWAY SERVICES, INC., https://
www.gatewayservicesinc.com/ (last visited Sept. 4,
2025).
3 Id.
4 See, e.g., Press Release, Fed. Trade Comm’n,
FTC Announces Rule Banning Noncompetes,
https://www.ftc.gov/news-events/news/pressreleases/2024/04/ftc-announces-rule-banningnoncompetes.
5 See, e.g., Statement of Chair Lina M. Khan
Joined by Comm’r Rebecca Kelly Slaughter and
Comm’r Alvaro M. Bedoya (Dec. 31, 2024) at 11.

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Proposed Project
Online Application Order Form for
Products From the Healthcare Cost and
Utilization Project (HCUP)
The Healthcare Cost and Utilization
Project is a vital resource helping AHRQ
achieve its research agenda, thereby
furthering its goal of improving the
delivery of health care in the United
States. HCUP is a family of health care
databases developed through a FederalState-Industry partnership and
sponsored by AHRQ. HCUP includes

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the largest collection of longitudinal
hospital care data in the United States,
with all-payer, encounter-level
information beginning in 1988. The
HCUP databases are annual files that
contain anonymous information from
hospital discharge records for inpatient
care and certain components of
outpatient care, such as emergency care
and ambulatory surgeries.
The project currently creates eight
types of restricted access public release
databases and related files that are
released to authorized users under the
terms of the HCUP Data Use Agreement
(DUA). These HCUP databases and files
are used by researchers for a broad range
of health issues, including cost and
quality of health services, medical
practice patterns, access to health care
programs, and outcomes of treatments at
the national, State, and local market
levels.
This project has the following goal:
• Allow restricted access public
release and tracking of the eight HCUP
databases.
To achieve this goal the following
data collections and activities are
required:
1. HCUP DUA Training Course—All
purchasers and users of HCUP data
must complete this training prior to
signing the DUA. This Web-based
training course outlines important terms
of the DUA. The purpose of the course
is to emphasize the importance of data
protection, reduce the risk of
inadvertent violations, and describe an
individual’s responsibility when using
HCUP data. After completing the
training course, an HCUP DUA Training
Course certification code is received.
This code is required to purchase or
gain access to HCUP data.
2. HCUP DUA for the Nationwide
Databases—The HCUP Nationwide
databases include the National
(Nationwide) Inpatient Sample (NIS),
Kids’ Inpatient Database (KID),
Nationwide Ambulatory Surgery
Sample (NASS), Nationwide Emergency
Department Sample (NEDS), and
Nationwide Readmissions Database
(NRD). Any person seeking permission
from AHRQ to access HCUP Nationwide
Databases must sign and submit this
Agreement to AHRQ.
3. HCUP DUA for the State
Databases—The HCUP State databases
include the State Inpatient Databases
(SID), State Ambulatory Surgery and
Services Databases (SASD), and State
Emergency Department Databases
(SEDD). Any person seeking permission
from AHRQ to access HCUP State
Databases must sign and submit this
Agreement to AHRQ.

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43612

Federal Register / Vol. 90, No. 173 / Wednesday, September 10, 2025 / Notices

4. Online Application Form—The
application form collects relevant
applicant information, shipping and
billing address, and the payment
method.
This project is being conducted by
AHRQ through its contractors, National
Opinion Research Center and
TurningPoint-DS Federal J.V., L.L.C.,
pursuant to AHRQ’s statutory authority
to conduct and support research on
health care and on systems for the
delivery of such care, including
activities with respect to the outcomes,
cost, cost-effectiveness, and use of
health care services and access to such
services. 42 U.S.C 299a(a)(3).
Proposed Revisions:
Revisions include a redesigned HCUP
application form and reducing the
number of DUAs to one state and one
nationwide version. The current
expiration date for 0935–0206 was 5/31/
2025 and AHRQ is requesting a new
expiration date, 3 years from approval of
this information collection request.

Method of Collection

Estimated Annual Respondent Burden

Information collected in the HCUP
Online Application Form process will
be used for two purposes only:
1. Business Transaction: In order to
deliver the HCUP databases to the
applicants, contact information is
necessary for shipping the data on disk
(or any other media used in the future)
and payment collection.
2. Enforcement of the HCUP Data Use
Agreement (DUA): The HCUP DUA
contains several restrictions on use of
the data. Most of these restrictions have
been put in place to safeguard the
privacy of individuals and
establishments represented in the data.
For example, data users can only use the
data for research, analysis, and aggregate
statistical reporting and are prohibited
from attempting to identify any persons
in the data. Contact information on
HCUP DUAs is retained in the event
that a violation of the HCUP DUA takes
place requiring legal remedy.

Exhibit 1 shows the estimated
annualized burden associated with the
applicants’ time to order any of the
HCUP databases. An estimated 1,800
persons will order HCUP data annually.
To complete the ordering process, each
of these persons will complete the
HCUP DUA Training Course, review
and sign both DUAs, and complete the
HCUP Data Purchase Ordering Form.
The total burden to complete these four
steps to purchase HCUP data is
estimated to be 1,050 hours annually.
Exhibit 2 shows the estimated
annualized cost burden associated with
the applicants’ time to purchase HCUP
data. There are changes in the total
burden cost as per Exhibit 2 in the 60
Day FRN due to a transcription error, a
new requirement to base cost burden on
adjusted hourly wages and updating
wages to the most recent available
estimates (from May 2023 to May 2024).
These changes resulted in the cost
burden increasing from $78,252 to
$102,921.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name
1.
2.
3.
4.

HCUP
HCUP
HCUP
HCUP

DUA
DUA
DUA
Data

Number of
responses per
respondent

Hours per
response

Total burden
hours

Training Course ...........................................................................
for the Nationwide Databases .....................................................
for the State Databases ..............................................................
Purchase Ordering Form .............................................................

1,800
1,800
1,800
1,800

1
1
1
1

15/60
5/60
5/60
10/60

450
150
150
300

Total ..............................................................................................................

1,800

NA

NA

1,050

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Total
burden hours
1.
2.
3.
4.

HCUP
HCUP
HCUP
HCUP

DUA
DUA
DUA
Data

Average
hourly
wage rate *

Adjusted
hourly
wage rate **

Total cost
burden

Training Course ...........................................................................
for the Nationwide Databases .....................................................
for the State Databases ..............................................................
Purchase Ordering Form .............................................................

450
150
150
300

$49.01
49.01
49.01
49.01

$98.02
98.02
98.02
98.02

$44,109
14,703
14,703
29,406

Total ..............................................................................................................

1,050

NA

NA

102,921

* Based upon the mean of the average wages for Life Scientists, All Other (19–1099), National Compensation Survey: Occupational Employment Statistics, May 2024 National Occupational Employment and Wage Estimates United States, U.S. Department of Labor, Bureau of Labor
Statistics. https://data.bls.gov/oes/#/industry/000000.
** The Adjusted Hourly Rate was estimated at 200% of the hourly wage.

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Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the

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information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of

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automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.

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Federal Register / Vol. 90, No. 173 / Wednesday, September 10, 2025 / Notices
Dated: September 5, 2025.
Mamatha Pancholi,
Deputy Director.C
[FR Doc. 2025–17323 Filed 9–9–25; 8:45 am]
BILLING CODE 4160–90–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1840–N]

Medicare Program; Town Hall Meeting
on the Fiscal Year 2027 Applications
for New Technology Add-On Payments
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:

This notice announces a town
hall meeting in accordance with section
1886(d)(5)(K)(viii)(III) of the Social
Security Act (the Act) to discuss fiscal
year (FY) 2027 applications for add-on
payments for new medical services and
technologies under the hospital
inpatient prospective payment system
(IPPS). Interested parties are invited to
this virtual meeting to present their
comments, recommendations, and data
regarding whether the FY 2027
applications for new technology add-on
payments meet the substantial clinical
improvement criterion.
DATES:
Meeting Dates: The New Technology
Town Hall meeting announced in this
notice will be held virtually on
Wednesday, December 10, 2025, and
Thursday, December 11, 2025 (the
number of presentations will determine
if a second day for the meeting is
necessary; see the SUPPLEMENTARY
INFORMATION section for details
regarding the second day of the meeting
and the posting of the final schedule).
The New Technology Town Hall
meeting will begin each day at 9:00 a.m.
Eastern Standard Time (EST) and online
check-in will begin at 8:30 a.m. EST.
Deadline for Registration of Presenters
at the New Technology Town Hall
Meeting: The deadline to register to
present at the New Technology Town
Hall meeting is 5:00 p.m. EST on
Monday, November 3, 2025.
Deadline for Submission of Agenda
Item(s) or Written Remarks for the New
Technology Town Hall Meeting: Written
remarks and agenda items for discussion
at the New Technology Town Hall
meeting, including agenda items by
presenters (presentation slide decks),
must be received by 5:00 p.m. EST on
Thursday, November 13, 2025.

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SUMMARY:

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Deadline for Requesting Special
Accommodations: The deadline to
submit requests for special
accommodations is 5:00 p.m. EST on
Thursday, November 13, 2025.
Deadline for Submission of Written
Comments after the New Technology
Town Hall Meeting for Consideration in
the FY 2027 Inpatient Prospective
Payment System/Long-Term Care
Hospital PPS (IPPS/LTCH PPS)
Proposed Rule: Individuals may submit
written comments after the New
Technology Town Hall meeting, as
specified in the ADDRESSES section of
this notice, on whether the service or
technology represents a substantial
clinical improvement. These comments
must be received by 5:00 p.m. EST on
Monday, December 15, 2025, to ensure
consideration in the FY 2027 IPPS/
LTCH PPS proposed rule.
ADDRESSES:
Meeting Location: The New
Technology Town Hall meeting will be
held virtually via live stream technology
or webinar and listen-only via toll-free
teleconference. Live stream or webinar
and teleconference dial-in information
will be provided through an upcoming
listserv/email notice to registered
presenters, and will appear on the final
meeting agenda which will be posted on
the New Technology website when
available at: http://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
newtech.html. Continue to check the
website for updates.
Registration and Special
Accommodations: Individuals wishing
to present at the meeting must follow
the instructions located in section III. of
this notice. Individuals who need
special accommodations should send an
email to NTAP@cms.hhs.gov.
Submission of Agenda Item(s) or
Written Remarks for the New
Technology Town Hall Meeting: Each
presenter must submit at least one
agenda item for presentation regarding
whether a FY 2027 application for new
technology add-on payments meets the
substantial clinical improvement
criterion. Agenda items must be
submitted via email, by the previously
specified deadline, to: NTAP@
cms.hhs.gov.
Submission of Written Comments for
the New Technology Town Hall Meeting:
Written comments must be submitted
via email, by the previously specified
deadline, to: NTAP@cms.hhs.gov.
Comments should be limited to
information or material regarding
whether the application(s) for new
technology add-on payments meet the
substantial clinical improvement

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criterion. Information and studies
previously submitted in the application
do not need to be resubmitted in Town
Hall comments, even if they are cited
within the comment.
FOR FURTHER INFORMATION CONTACT:
Drew Kasper, (410) 786–8926,
drew.kasper@cms.hhs.gov and NTAP@
cms.hhs.gov.
SUPPLEMENTARY INFORMATION:

I. Background on the Add-On Payments
for New Medical Services and
Technologies Under the IPPS
Effective for discharges beginning on
or after October 1, 2001, section
1886(d)(5)(K)(i) of the Act requires the
Secretary to establish (after notice and
opportunity for public comment) a
mechanism to recognize the costs of
new services and technologies under the
hospital IPPS. For discussion on the
new technology add-on payment
criteria, we refer readers to the new
technology add-on payment final rule
(66 FR 46912, September 7, 2001), as
well as the FY 2012 IPPS/LTCH PPS
final rule (76 FR 51572 through 51574),
the FY 2020 IPPS/LTCH PPS final rule
(84 FR 42288 through 42300), and the
FY 2021 IPPS/LTCH PPS final rule (85
FR 58736 through 58742).
As finalized in the FY 2020 and FY
2021 IPPS/LTCH PPS final rules,
technologies that are eligible for the
alternative pathway for certain
transformative new devices or the
alternative pathway for certain
antimicrobial products do not need to
meet the requirement under 42 CFR
412.87(b)(1) that the technology
represent an advance that substantially
improves, relative to technologies
previously available, the diagnosis or
treatment of Medicare beneficiaries. See
the FY 2020 IPPS/LTCH PPS final rule
(84 FR 42292 through 42297) and the FY
2021 IPPS/LTCH PPS final rule (85 FR
58737 through 58739) for additional
information.
In the FY 2020 IPPS/LTCH PPS final
rule (84 FR 42289 through 42292), we
codified in our regulations at § 412.87
the following aspects of how we
evaluate substantial clinical
improvement for purposes of new
technology add-on payments under the
IPPS to determine if a new technology
meets the substantial clinical
improvement criterion:
• The totality of the circumstances is
considered when making a
determination that a new medical
service or technology represents an
advance that substantially improves,
relative to services or technologies
previously available, the diagnosis or
treatment of Medicare beneficiaries.

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