Form CMS-10638 New Technology Application

Centers for Medicare & Medicaid Services
Center for Medicare Management
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Welcome to the New Technology Add-On Payments (NTAP)
Application Overview
Application Setup
Let's set up your NTAP application

You will not be able to change these selections in the application
Select which NTAP pathway you are applying under.
For additional information on the alternative pathways for transformative new devices and
certain antimicrobial products, please refer to the NTAP Criteria and Pathways information
above.
• Alternative
• Traditional

DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

Disclaimer

All content submitted as part of this application may be made public unless otherwise noted
below. Please see the FY 2023 IPPS final rule (87 FR 48986-48990) for a discussion of the
policy to publicly post NTAP applications.
Information that should not be made public is not taken into consideration when determining
whether a technology meets the NTAP criteria. Throughout this application, “made public”
refers to either posting application materials publicly or including information from an
application in our discussion in the Federal Register. If you would like to include information
that should not be made public as part of your application, please refer to the “Additional
Application Information - CONFIDENTIAL” section on the summary page at the end of the
application. We also note that we will not make public any contact information or dates included
in the “FDA Info” section related to FDA applications that are not yet approved or cleared, as
indicated in the application.
Please note that the following application sections are not included in the public application
posting. However, some of the information submitted within the following sections may still be
included in the proposed or final rules, as indicated:
Cost

For alternative pathway applications, information in this section may be included in the
proposed and final rules. The cost of the technology will be included in the proposed and
final rules.
• For traditional pathway applications, information in this section may be included in the
proposed and final rules. The cost of the technology will be only be included in the final
rule (for technologies approved for NTAP).
Volume
• The information in this section will only be included in the final rule (for technologies
approved for NTAP).
Cost Criterion
• The NTAP Cost Criterion Codes and MS-DRGs worksheet will be publicly posted.
• Other information in this section may be included in the proposed and final rules. Please
note that the numerical value of any charges in this section will not be made public, with
the exception of column S (Final Inflated Case Weighted Standardized Charge Per Case).
•

Please note that any data provided in this application may become subject to disclosure where
required by law. Where CMS has indicated that information won’t be made public, CMS will
attempt, to the extent allowed by law, to keep that information protected from public view.
Please also note that application tracking forms will be posted on the CMS website shortly after
the application deadline. Please refer to the NTAP Tracking Form Info above for additional
information.
☐ I certify that I have been duly authorized to submit this application on behalf of the applicant.
I acknowledge and agree that I have read the Disclaimer and understand that all of the
DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

information in this application may be made public, unless otherwise noted or included in the
“Additional Application Information - CONFIDENTIAL” section.
Copyrighted Information:
For supporting evidence uploaded in the Substantial Clinical Improvement (SCI) section of the application, you will
be asked if the applicant does not have the appropriate license or right to release each document to the public. At the
end of the SCI section, you will be asked to represent and warrant that the applicant owns the copyright or otherwise
has the appropriate license to make any copyrighted material releasable to the public, with the exception of those
materials for which the applicant indicates otherwise. Please be sure to select the appropriate checkboxes as you go
through the SCI section to provide a representation of whether the files can be included in the public posting. You
will also be asked to provide citations for the materials, and CMS will post those citations publicly. Documents that
cannot be publicly posted will still be considered by CMS and may be summarized in the proposed rule, and the
summary information provided by the applicant will be posted publicly.
☐ I certify that I have been duly authorized by the applicant to sign this acknowledgement on behalf of the
applicant. I acknowledge and agree that I have read this information regarding copyrighted information and
understand that I will be required to represent and warrant that, except for studies for which I indicate otherwise, the
applicant owns the copyright or otherwise has the appropriate license to make the studies included in the SCI section
available to the public. I understand that CMS may post publicly any study for which I indicate that the applicant
owns the copyright or otherwise has the appropriate license to make it public.

DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

Contact Information Stepper
Info: The information in this section (A) will not be made public, except the name of the party
requesting the NTAP. Please note that the MEARIS website can only be accessed by individuals
who are located in the US.
Who is the party requesting the NTAP? (e.g. manufacturer, distributor, healthcare
organization/entity)
Provide a contact for the applicant.
Applicant Contact:
• First Name
• Middle Name (optional)
• Last Name
• Phone number
• Organization
• Occupation / Job Title
• Extension (optional)
• Email Address
• Country
• Mailing Address 1
• Mailing Address 2 (optional)
• City
• State
• Zip
• Applicant Type (selections):
o Distributor, Manufacturer, Healthcare Organization, Other (explain)
Who is the primary contact?
• First Name
• Middle Name (optional)
• Last Name
• US phone number
• Organization
• Occupation / Job Title
• Extension (optional)
• Email Address
• Country
• Mailing Address 1
• Mailing Address 2 (optional)
• City
• State
• Zip
• Relationship (selections):
DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

o Consultant, Manufacturer, Other (explain)
Who is the secondary contact?
• First Name
• Middle Name (optional)
• Last Name
• US phone number
• Organization
• Occupation / Job Title
• Extension (optional)
• Email Address
• Country
• Mailing Address 1
• Mailing Address 2 (optional)
• City
• State
• Zip
• Relationship (selections):
o Consultant, Manufacturer, Other (explain)

Technology Info Stepper
Note: If one of the name fields do not apply or is TBD, please leave the field blank.
General Information
o Applicant
o Trade Name
o Generic Name
o Please provide a brief (1-2 sentence) description of the technology.
Describe the technology in detail, using general terminology
o What is the technology?
o What does the technology do?
o How is the technology used?
Upload relevant descriptive booklets, brochures, package inserts, or other supporting
materials as needed (optional). Note: Please note that attachments uploaded in this section
will not be included in the public posting. Please avoid referring to any attachments in the
responses provided in this section. If using references, please use in-text citations rather than
footnote numbering.
Additional Technology Information

DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

o Is there an Investigational Device Exemption (IDE) number from the FDA assigned to
the technology? (Yes/No)
o IF YES: IDE Number
o If the technology is a device, what class is assigned to the technology? (Class I, II, III,
unclassified, N/A)
o If the technology is a drug, is this a drug that can only be administered orally? (Yes/No
N/A)
o If the technology is a drug, what is the drug's dosage/administration information when
used in the inpatient setting? Please clearly indicate the average total dose per inpatient
stay.
o Has the technology ever been the subject of a recall or subject to any bulletins and/or
letters issued by the FDA regarding the safety of the technology? (Yes*/No)
o IF YES: Provide specific details regarding the recall, bulletins and/or letters
issued by the FDA.
Please upload the recall, bulletins, or other documentation (REQUIRED IF YES IS
SELECTED)
Have you completed any outpatient pass through applications for this technology? (Yes/No)
IF NO, skip to question 7
IF YES:
Additional Technology Information
Was this application submitted using MEARIS™? (Yes/No)
IF YES, provide application type (Device OR Drug/Biological Pass through)
 Application Confirmation Number
 Provide Details (text box 3000 characters)
IF NO, provide application type (Device OR Drug/Biological Pass through)
 Submission Date
 Provide Details

Alternative Pathway Stepper

Has the technology already received a Breakthrough Device/QIDP designation or LPAD
approval from FDA for the indication relevant to this application? (YES/NO)
Info: For additional information on the alternative pathways for transformative new devices
and certain antimicrobial products, please refer to the NTAP Criteria and Pathways
information above.
IF YES:
Alternative Pathway Designation

DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

Note: Only the marketing authorization indication in the FDA section of this
application that corresponds to the Breakthrough Device/QIDP/LPAD
designation is eligible for NTAP.
o Please provide details about the relevant designation/approval. Include the date
received and the full Breakthrough Device/QIDP designation or approved LPAD
indication on the FDA letter.
o Upload a copy of the Breakthrough Device/QIDP designation or LPAD approval
letter.
o If the indication in the FDA section of this application does not match the
Breakthrough Device/QIDP/LPAD designation in the attached letter, please
provide an explanation.
o If the name of the technology in this application does not match the technology
name in the attached letter, please provide an explanation.
o If the technology was granted Breakthrough Device designation, please indicate if
the device that is the subject of this application is the same device that was
granted the Breakthrough Device designation: (select one)
-Yes, this is the designated device (explanation optional)
-No, this is not the designated device (explanation required)
-Does not apply
IF NO:
7b. Alternative Pathway Designation Dates included in this response will not be made public.
Provide details regarding the Alternative Pathway designation and its status including the
type (Breakthrough Device/QIDP/LPAD) and date of the designation request submission
to FDA, the date of anticipated approval of the designation request, and the designation
indication.
Note: Only the marketing authorization indication in the FDA section of this application
that corresponds to the Breakthrough Device/QIDP/LPAD designation is eligible for
NTAP

FDA Information Stepper
FDA Status

o What is the indication for the technology for which the applicant is submitting an NTAP
application?
o List if the technology has received any designations from FDA or if it is being considered
under any particular pathways by FDA such as Fast Track, Breakthrough Therapy,
Accelerated Approval, Priority Review, etc. for this indication (optional)

Has the technology already received marketing authorization from the Food and Drug
Administration (FDA) for the indication relevant to this application?
DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

Info: To be considered for NTAP for FY 2025, alternative pathway devices (Breakthrough
Devices) will need to receive FDA approval or clearance before 5/1/2024. Alternative
pathway drugs (QIDP/LPAD) are eligible for conditional approval if they do not receive FDA
marketing authorization before 7/1/2024. Technologies conditionally approved for FY 2025
under this pathway will need to receive FDA approval or clearance before 7/1/2025 in order
to receive NTAP.
Choose 1:
• Yes
• No, but the marketing authorization request has been accepted/filed by FDA and
approval/clearance is expected before the FDA deadline (May 1, 2024 for Breakthrough
Devices / July 1, 2025 for QIDP/LPAD)
Yes Sequence
FDA Approval/Clearance Details
What is the type of the FDA application?
Examples: Premarket Notification 510(k), De Novo Classification, Premarket Approval
Application (PMA), Humanitarian Device Exemption (HDE), New Drug Application (NDA),
Biologic License Application (BLA)
□ Checkbox: “Select if this is a 510(k) FDA application”
o What is the date of FDA approval?
o Upload FDA approval letter (required). Note: Please note that attachments uploaded in
this section will not be included in the public posting. Please avoid referring to any
attachments in the responses provided in this section.
• Summarize the supporting information contained in the FDA approval letter.
IF 510(k) CHECKBOX IS SELECTED, answer the following question. If not, skip
to FDA contact.
Please provide additional information regarding the 510(k) clearance
o List the predicate device(s) for the technology.
o Describe any differences between the devices
FDA Contact The information provided below will not be made public.
Please provide contact information for the FDA reviewer most knowledgeable about your
application.
o First Name
o Middle Name (optional)
o Last Name
o US Phone Number
o Email Address
Market Availability
o Was this technology available on the market immediately after FDA approval? (Yes/No)
DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

IF YES, skip to “Additional FDA Information” Section
IF NO:
• Please describe the reason for the delay in market availability.
• When did the technology become available for sale, or when do you anticipate
the technology becoming available?
No Sequence
FDA Submission Details
Info: All of the FDA dates entered in this question will not be made public.
o What is the date of FDA submission?
o What is the type of the FDA application?
Examples: Premarket Notification 510(k), De Novo Classification, Premarket Approval
Application (PMA), Humanitarian Device Exemption (HDE), New Drug Application (NDA),
Biologic License Application (BLA) □ Checkbox: “Select if this is a 510(k) FDA application”
o What is the expected action date from FDA? (eg PDUFA date/MDUFA goal date)
o Provide additional information about your FDA application. Include the review status of
your application with FDA For example, indicate whether it is accepted/filed and under
review, on hold, denied, pending reapplication or submission of additional information,
etc.
Note: As finalized in the FY 2024 IPPS final rule, technologies must be under active
review by FDA at the time of NTAP application submission in order to be eligible for
consideration. For additional information regarding this NTAP eligibility requirement,
please see the regulations at § 412.87(e) and the FY 2024 IPPS final rule.
o Upload the FDA acceptance or filing letter for this submission.
Note: As finalized in the FY 2024 IPPS final rule, we are requiring the relevant
acceptance letter (such as for 510k applications or De Novo Classification requests) or
filing letter (such as for PMA, BLA, or NDA applications) from FDA which indicates that
FDA has determined that the application is sufficiently complete to allow for substantive
review by FDA.
FDA contact? The information provided below will not be made public.
Please provide contact information for the FDA reviewer most knowledgeable about your
application.
o
First Name
o
Middle Name (optional)
o
Last Name
o
US Phone Number
o
Email Address

DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

Do you anticipate that this technology will be available on the market immediately after
FDA approval? (Yes/No)
IF YES, skip to “Additional FDA Information” section
IF NO:
o Reason for the delay
Please describe the reason for the delay in market availability and provide the
anticipated release date.
Additional FDA Information
Please describe any previous US approvals/clearances for this technology. Include any additional
approvals (e.g. Pre-Market Approval, HDE or HUD approval, expanded access approval) the
technology received prior to submission of this application and/or is currently seeking, including
approvals for other indications or clearances for other versions of this technology. CMS
recommends a timeline if the technology has received multiple types of approvals from the FDA.

Coding and MS-DRGs Stepper

If the technology/device utilized in the performance of a procedure/service or the administration
of a drug/therapeutic agent were to receive add-on payment status approval, it would need to be
distinctly identifiable by a unique code, such as ICD-10-PCS procedure code(s), with or without
ICD-10-CM diagnosis codes, on the claim in order to receive the add-on payment. The ICD-10
Coordination and Maintenance (C&M) Committee is responsible for approving coding changes,
developing errata, addenda, and other modifications. Requests for coding changes are submitted
to the committee for discussion at either the Spring or Fall C&M meeting. If any coding changes
are necessary to distinctly identify your technology by ICD-10-CM diagnosis and/or ICD-10PCS procedure code(s), you MUST separately contact the ICD-10 C&M Committee to submit a
code request. For more details, including the deadlines to submit code requests, refer to
the New/Revised ICD-10-PCS Procedure Codes Requests
Maintenance Committee

and ICD-10 Coordination and

for diagnosis code requests.

ICD-10-CM Diagnosis Codes
o List the ICD-10-CM diagnosis codes, with titles, that may currently be used to identify the
indication/proposed indication relevant to the application under the ICD-10-CM coding
system:
Note: Please use standard formatting for ICD-10-CM/PCS codes in your response.
Standard formatting for ICD-10-CM/PCS codes has the descriptor following the code in
parentheses, and capitalizes only the first letter of the descriptor. Example: I21.A1
(Myocardial infarction type 2) (new textbox)

DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

o Explain why these diagnosis code(s) were included and whether they are specific to the
indication listed under the Breakthrough Device/QIDP/LPAD designation.
ICD-10-PCS Procedure Codes
o List the procedure codes that may currently be used to identify your technology under the
ICD-10-PCS coding system.
Note: Please use standard formatting for ICD-10-CM/PCS codes in your response. Standard
formatting for ICD-10-CM/PCS codes has the descriptor following the code in parentheses,
and capitalizes only the first letter of the descriptor. Example: I21.A1 (Myocardial infarction
type 2) (new textbox)
o Do these codes uniquely identify your technology under the ICD-10-PCS coding system?
(Yes/No) Please explain.
•

IF NO: Have you submitted or will you be submitting an application for a unique
ICD-10-PCS code?

Existing technologies using ICD-10-CM/ICD-10-PCS - List existing technologies that use the
same ICD-10-PCS codes or combination of the ICD-10-CM/PCS codes.
ICD-10 C&M Committee Request
a) Does this technology have an existing request pending with the ICD-10 C&M Committee
for a new code? (Yes/No)
b) Explain the reason for your answer above, and any details you have about status of
requests with the ICD-10 C&M Committee, if applicable.
MS-DRGs
o Under the MS-DRG grouper, list all of the MS-DRGs that the technology would currently
map to based on the indication (diagnosis) that is the subject of this NTAP application. Note:
Please refer to the latest version of the ICD-10 MS-DRGs list on the MS-DRG Webpage for
the current list of MS-DRGs and titles.
Note: Please use standard formatting for MS-DRGs in your response. Standard formatting
for MS-DRGs has the descriptor following the MS-DRG number in parentheses, and
capitalizes the first letter of each word, except for common words like “and, “with,” etc.
Example: 004 (Tracheostomy with MV >96 Hours or Principal Diagnosis Except Face
Mouth and Neck without Major O.R. Procedures).
[TEXT BOX]
• Comments related to the MS-DRGs listed above (optional)
o Have you made, or do you anticipate making, a request to map to a new or different
MS-DRG(s) for the upcoming Fiscal Year 2025? (Yes/No)
IF YES, please provide details.

F. Newness Criterion Stepper

o Current treatments for the disease or condition that this technology treats or diagnoses

DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

•
•

Are there any other treatments for the disease or condition that this technology
treats or diagnoses? (Yes/No)
Briefly describe current treatments for the disease or condition.

o Substantial Similarity Criteria
Info: To qualify for a new technology add-on payment, the technology or service
must not be reflected in the data used to establish the Medicare-Severity
Diagnosis Related Groups (MS-DRGs). CMS has established three substantial
similarity criteria to determine if a technology is similar to an existing
technology. (Refer to 70 FR 47351 through 47352 and 74 FR 43813 through
43814 for additional details.)
Note: A technology can be considered “new” as long as one of the three criteria
are NOT met.
• Does the technology use the same or a similar mechanism of action when
compared to existing technology to achieve a therapeutic outcome? (Yes/No)
• Explain why or why not?
• Has the technology been assigned to the same MS-DRG when compared to an
existing technology to achieve a therapeutic outcome? (Yes/No)
• Explain why or why not?
• Does the use of the technology involve treatment of the same or similar type
of disease and patient population when compared to an existing technology?
(Yes/No)
• Explain why or why not?
o Newness Criterion Summary: Please briefly summarize your previous responses
regarding how the technology meets the newness criterion overall.
o Upload files related to the newness criterion as needed (optional)

Cost and Volume Stepper

Info: The information in this section will not be included in the public posting but may be
included in the proposed and final rules.
Technology Cost
o What is the current or anticipated cost of this technology to the hospital per inpatient
stay?
Note: The cost of the technology will be included in the proposed and final rules.
o How was the total cost per inpatient stay determined? Please include all relevant details
and calculations to explain how the cost was determined.
Note: For devices, include the cost per unit and the average number of units per
inpatient stay or for technologies sold on a subscription basis, an explanation of
how the cost per case is calculated, including the list price of the technology and
utilization across subscribers. For drugs, include the cost per unit/vial as well as
the average dosage and number of vials per inpatient stay (whole vials if singleDISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

use) and/or units per patient (ml/kg/hr). Please provide specific details about how
that average was determined (e.g., how the drug is sold (such as x vials per box),
variables in the Medicare population that effects the dosage administration (body
weight, disease progression, etc.), whether and how the average is weighted
based on those variables, etc.).
•

Indicate if this is a device: Yes/No
If this is a device, you will be asked to provide a breakdown of the cost of each
component in the next question.

o Upload files or materials that support the cost of the technology and how it was
calculated (optional)
IF YES:
Cost Breakdown (for devices)
o Info: Include a breakdown of the cost of the device components used in the per inpatient
stay calculation (ie, relevant to the NTAP payment amount), clearly showing which
components are the "new" ones. Note: Capital costs are not included in new technology
add-on payments under the IPPS. (Refer to 72 FR 47307-47308 for further
details.)Provide a breakdown of how the cost of the technology is calculated and identify
if any components are capital costs. For each component, include the following:
• Name of Component
• Type of Cost (capital vs operating)
• Component Cost
• Is this component new? (Yes/No)
o You may provide comments regarding the cost breakdown here (optional)
Volume
Info: The information in this section will not be included in the public posting but will be
included in the final rule (for technologies approved for NTAP).
Note: The volume estimates should be based on the actual or projected sales of your technology,
not the total population eligible for the technology.
Current Fiscal Year: (10/01/2023 - 09/30/2024) Upcoming Fiscal Year: (10/01/2024 09/30/2025)
What is the anticipated inpatient Medicare volume of this technology for the current
and upcoming Fiscal Year?
o Current Fiscal Year Anticipated Inpatient Medicare Volume
• Please describe how you arrived at this estimate.
o Upcoming Fiscal Year Anticipated Inpatient Medicare Volume
• Please describe how you arrived at this estimate.
What is the anticipated inpatient non-Medicare volume of this technology for the
current and upcoming Fiscal Year?
o Current Fiscal Year Anticipated Inpatient Non-Medicare Volume
DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

• Please describe how you arrived at this estimate.
o Upcoming Fiscal Year Anticipated Inpatient Non-Medicare Volume
• Please describe how you arrived at this estimate.

Cost Criterion Stepper

Info: Information in this section (G) will not be included in the public posting, except for the
NTAP Cost Criterion Codes and MS-DRGs worksheet. The information in this section may be
included in the proposed and final rules. Please note that the numerical value of any charges in
this section will not be made public, with the exception of column S (Final Inflated Case
Weighted Standardized Charge Per Case).
Click here for guidance about the cost criterion.
Cost Analysis
Download Appendix A for an explanation of how to standardize charges per case if multiple MSDRGs are affected by the technology.
o Step 1: Download FY2025 NTAP Cost Analysis spreadsheet.xlsx
Using the table as demonstrated in the spreadsheet as a template, show how the
standardized charge per case (if applicable, case weighted) exceeds the threshold for the
cost criterion. Please be sure the formulas are retained in the cells, when using the
spreadsheet. You may add additional tabs for additional analyses or to provide supporting
data.
o Step 2: Upload the Completed Cost Analysis Spreadsheet.
o Step 3: Does the final inflated average case-weighted standardized charge per case
exceed the average case-weighted (if applicable) threshold for the cost criterion?
(Yes/No)
o Comments (optional)
Cost Analysis Methodology
o With regard to the cost analysis spreadsheet, please detail the ICD-10-PCS/CM codes and
MS-DRGs used to identify cases in your cost analysis/analyses.
• Step 1: Download the NTAP Cost Criterion Codes and MS-DRGs spreadsheet
and complete the tables as demonstrated in the spreadsheet.
• Step 2: Upload the completed “NTAP Cost Criterion Codes and MS-DRGs”
spreadsheet. This spreadsheet will be included in the public application posting,
and information from this spreadsheet may be included in the proposed and final
rules.
• Comments (optional)

DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

Cost Analysis Methodology
o Please provide the type of source data and year that was used to identify cases (such as
“FY 2022 MedPAR” or “100% sample FY 2022 SAF”). If you did not use the most
recently available claims data or if you used other types of source data, please also
explain why. Note: The most recent claims data for the upcoming application year would
be 3 years prior (for example, for FY 2025 applications, the most recent claims data
would be from FY 2022).
o Use the following questions A through S (which correspond to columns A through S of
the cost analysis spreadsheet) to explain in detail how each column was completed, stepby-step.
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A. MS-DRG
Explain how these MS-DRGs were determined, including any differences between
multiple analyses if applicable. Please also discuss relevant decision points in choosing to
include/exclude ICD-10-PCS/CM codes for identifying cases. If there are any other
inclusion/exclusion criteria please describe them here as well.
B. Cases
Note: In compliance with the CMS data use agreement, the aggregate amount of cases
listed for each MS-DRG in the table must indicate a minimum of 11; applicants should
impute a value of 11 for any MS-DRG included with a number under 11.
C. Case Weighted Amount
D. Threshold
Note: Please confirm the thresholds used were from the prior year’s final rule/correction
notice. For example: for FY 2025 applications, the thresholds from the FY 2024 final rule
(or correction notice, if applicable) should be used.
E. Case Weighted Threshold
F. Average Charge Per Case (Unstandardized with No Case Weight)
G. Average Charge Per Case (Unstandardized with Case Weight)
H. Charges Removed for the Prior Technology or Technology Being Replaced
Note: Please also discuss the assumptions behind removing (or not removing) charges
for prior technologies. For example, if a technology is replacing the implantation of a
different device, explain how the removal of charges for the previous device was
determined; do not remove related charges such as operating room (OR) and/or intensive
care unit (ICU) charges in this column.
I. Related Charges Removed for the Prior Technology or Technology Being Replaced
Note: Please also discuss the assumptions behind removing (or not removing) related
charges for prior technologies. For example, if the technology is replacing the
implantation of a different device and requires less or more OR time and ICU days,
explain how the removal of related charges such as OR/ICU charges were determined. J.
Adjusted Average Charge Per Case (Unstandardized with No Case Weight)
K. Adjusted Average Charge Per Case (Unstandardized with Case Weight)

DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

•
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L. Average Standardized Charge Per Case
Note: Please include sources for provider-specific factors used to standardize charges
(for example, use of the FY 2022 final rule/correction notice impact file).
M. Average Standardized Charge Per Case with Case Weight
N. Inflation Factor
Note: The inflation factor should be aligned with the year of claims data used, and the
year for which the applicant is applying for NTAP. For example, when using FY 2022
MedPAR data and applying for FY 2025 NTAP, a three-year inflation factor would be
appropriate.
O. Inflated Average Standardized Charges Per Case
P. Charges Added for the New Technology
Please explain how the current and/or anticipated charges for the technology by the
hospital, per patient, were determined. Please confirm that the most recent national cost
center CCRs (listed in the cost analysis spreadsheet) were used to convert cost to charges,
if applicable. Note: The charges here should be only based on direct costs of the
drug/device itself, and not related costs such as OR/ICU charges.
Q. Related Charges Added for the New Technology
Note: The charges here should be only based on indirect costs related to use of the
drug/device, such as OR/ICU charges. Please also discuss the assumptions behind
adding (or not adding) related charges for the new technology.
R. Final Average Inflated Standardized Charge Per Case
S. Final Inflated Case Weighted Standardized Charge Per Case

I. Substantial Clinical Improvement

Info: A summary on the substantial clinical improvement (SCI) criterion can be found in
Appendix B. Additional information on the SCI criterion can be found in the September 7, 2001
Federal Register (66 FR 46913-14), the FY 2010 IPPS Final Rule (74 FR 43808-43823) and
the FY 2020 IPPS Final Rule (84 FR 42288-42292)
. Additionally, the annual IPPS final
rule includes CMS' decision-making processes for each application.
Overview of the SCI Criterion
CMS uses the following in its evaluation of SCI for the purposes of the NTAP:
1. The new medical service or technology offers a treatment option for a patient population
unresponsive to, or ineligible for, currently available treatments.
2. The new medical service or technology offers the ability to diagnose a medical condition
in a patient population where that medical condition is currently undetectable or offers
the ability to diagnose a medical condition earlier in a patient population than allowed
by currently available methods. There must also be evidence that the use of the new
medical service or technology to make a diagnosis affects the management of the patient.
3. The use of the new medical service or technology significantly improves clinical
outcomes relative to services or technologies previously available.
DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

A technology must demonstrate that it meets at least one of these three in order to be eligible for
NTAP.
Overview of the SCI Section
As you navigate through the Substantial Clinical Improvement section, you will be asked how the
technology meets the SCI criterion. For each assertion made, you will be asked to explain why
you believe the technology meets the SCI criterion. Each reason the technology meets the SCI
criterion will need to be added as a separate claim, using supporting data as applicable.
• You will be able to enter one or more claims (i.e., reasons) for each assertion made.
• Each claim for an assertion must be added individually.
• If you have evidence to support a claim, you will be able to provide one or more pieces of
supporting evidence for each claim.
• For each piece of evidence uploaded, you will be asked to describe the upload and
summarize details related to the upload, such as the reason for inclusion/relevance to the
claim, citation, summary of the data source, and results from the study that support the
claim.
• CMS may include attachments provided in this section as part of the public application
posting. If any attachments are uploaded that cannot be made public due to copyright
restrictions or other reasons, you must indicate that by selecting the checkbox under the
upload.
• Once you provide responses for each of the SCI Criterion questions (including
supporting evidence if applicable), you will be asked to provide a brief summary of these
responses to explain overall why you believe the technology demonstrates a substantial
clinical improvement over existing technologies.
o Does the new medical service or technology offer a treatment option for a patient
population unresponsive to, or ineligible for, currently available treatments? (Y/N)
IF NO, skip to the next question
IF YES:
You stated that the new medical service or technology offers a treatment option for a
patient population unresponsive to, or ineligible for, currently available treatments.
Please provide an explanation for this assertion using supporting data. Add each reason
as a separate claim.
(i) Add Claim - Claim Title
(ii) Please provide a full explanation
(iii) Add Supporting Evidence, if applicable
a. Select an existing file or upload a new one
b. Upload file and answer the following questions related to each upload:
i. □ The applicant does not have the appropriate license or right to
release this document to the public. If this box is checked, this
document will not be included in the public posting.
ii. Title of the supporting evidence
DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

iii. Data Source category (choose one)
• Published, peer, reviewed studies using technology
• Unpublished studies, abstracts, or presentations using
technology
• Other data submissions using technology
• Data submissions as background (does not directly assess the
technology)
iv. Evidence Type (choose one)
• Case-control Study
• Case Reports and Case Series
• Cohort Study
• Cross-sectional Study
• Meta-Analysis
• Randomized Controlled Trial
• Systematic Review
• Other
v. Citation
vi. Study summary: Please clearly summarize the study in full, to include
(at minimum) the purpose of the study, number of patients treated,
study arms, demographics, inclusion/exclusion criteria, endpoints
tested, and outcomes (specify if statistically significant).
c. Please explain why this uploaded file was provided in support of this
claim
i. Reason for inclusion/relevance to claim
ii. What are the results/outcomes from this study that support this
claim? Please be sure to provide the specific
statistic(s)/value(s) in your response.
Provide the location of these results/outcomes (i.e. page number(s), paragraph, table number,
etc., as applicable.)
o Does the new medical service or technology offer the ability to diagnose a medical
condition in a patient population where that medical condition is currently
undetectable or offers the ability to diagnose a medical condition earlier in a patient
population than allowed by currently available methods? There must also be
evidence that use of the new medical service or technology to make a diagnosis
affects the management of the patient. (Y/N)
IF NO, skip to the next question
IF YES: (same questions as under previous SCI question)
o Does the use of the new medical service or technology significantly improve clinical
outcomes relative to services or technologies previously available? (Y/N)
IF NO, skip to the next question. NOTE: At least one of the 3 reponses must be a
Yes selection.
IF YES: (same questions as first SCI question)
DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.

SCI Criterion Summary and Attestation
a) Please briefly summarize your responses to this section regarding how the technology
meets the substantial clinical improvement criterion overall.
b) □ I represent and warrant, on behalf of the applicant, that except for those documents for
which I indicated otherwise, the applicant owns the copyright or otherwise has the
appropriate license to make available all of the documents uploaded in this section to the
public. I certify that I have been duly authorized to submit this representation on behalf of
the applicant.

I. Summary

Info: If there is any information that you wish to provide with your application that should not be
posted publicly, it must only be added in the "Additional Application Information CONFIDENTIAL" section below. Please note that we generally do not consider any information
that cannot be made public when determining whether a technology meets the NTAP criteria.
Additional Application Information – CONFIDENTIAL
Do you have any information that you wish to provide as part of your application that should not
be made public? Please note that the information in this section will not be considered when
determining whether a technology meets the NTAP criteria and will not be made public. (Y/N)
IF YES:
a) Select section and corresponding information below (add more than one if desired):
(CHOOSE RELEVANT APPLICATION SECTIONS
b) Confidential information about this section:
Note: Data provided in this section may become subject to disclosure where required by
law. CMS will attempt, to the extent allowed by law, to keep this information protected
from public view.
c) Upload any relevant files (optional)

DISCLAIMER: All content submitted as part of this application may be included in the public
application posting unless otherwise noted. Please see the summary page if you would like to
provide information that should not be made public.