Crosswalk

NTAP Crosswalk-FY 2025 Program
Application
Section
Application
Setup

Application Language

Modifications

Burden

Let's set up your NTAP application
You will not be able to alter or change these selections in the application

The question regarding
No change
drugs/devices will be removed,
Which of the following describes the new technology for which you are applying for as we are moving from 4
application types (alternative
NTAP?
drugs, alternative devices,
• Medical Device or Service
traditional drugs, traditional
• Drug
devices) to just 1 for each
pathway (traditional app,
Select which NTAP pathway you are applying under.
alternative app). The detail
For additional information on the alternative pathways for transformative new
regarding type of Alternative
devices and certain antimicrobial products, please refer to the NTAP Criteria and
application will also be
Pathways information above.
removed for the same reason.
• Alternative (QIDP/LPAD) or (Breakthrough Device)
• Traditional

1

Revised Application Language
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

Application
Section

Disclaimer

Application Language
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 traditional pathway applications, information in this section may be
included in the proposed rule and final rules. However, the cost of the
technology will only be included in the final rule (for technologies
approved for NTAP).
• 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.
Charge (Cost Analysis)
• 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).
Volume
• The information in this section will only be included in the final rule (for
technologies approved for NTAP).
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.

Modifications

Burden

Minor text changes: The
volume bullet was moved up
to reflect the revised section
order of the application, and
the ‘Charge (Cost Analysis)’
header was revised to ‘Cost
Criterion’ to match the new
stepper name and bullet added
for accuracy.

No change

Revised Application Language
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 traditional pathway applications, information in this section may be included in the
proposed rule and final rules. However, the cost of the technology will only be included in
the final rule (for technologies approved for NTAP).
• 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.
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 information in this
application may be made public, unless otherwise noted or included in the “Additional Application
Information - CONFIDENTIAL” section.

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 information in this application may be made public, unless otherwise noted
or included in the “Additional Application Information - CONFIDENTIAL” section.
2

Application
Section

Application Language

Disclaimer (only Copyrighted Information:
displays for
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
traditional
applications)
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.

Contact
Information

Modifications

Burden

Revised Application Language

No change

As is

☐ 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.
Info: The information in this section (A) will not be made public.
Question added to clarify that a No change
contact from the applicant is
Who is the primary contact?
required.
• 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)

3

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

Application
Section

Application Language

Modifications

Burden

Revised Application Language
•
•

Zip
Applicant Type (selections):
o
Distributor, Manufacturer, Healthcare Organization,
Other (explain)

Who is the primary contact?
Note: this section will autopopulate if the contact is the same as the Applicant 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)
Contact
Information

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)

As is

No change

4

Application Language

Application
Section

Technology Info General Information
a) Applicant
b) Trade Name
c) Generic Name
d) Provide a brief description of the technology.

Technology Info Describe the technology in detail, using general terminology
• What is the technology?
• What does the technology do?
• How is the technology used?

Modifications

Burden

A note was added to clarify a No change
name field can be left blank.
Minor edit to clarify that a
brief description is 1-2
sentences. The Applicant
question will now autopopulate
from the previously provided
Applicant Contact Information.
A note was added to clarify
No change
instructions for this section and
uploader.

Upload relevant descriptive booklets, brochures, package inserts, or other
supporting materials as needed (optional).
Technology Info Additional Technology Information (Drug
Flow)
• Is this a drug that can only be administered orally? (Yes/No)
• What is the drug's dosage/administration information?
• 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.
o

Please upload the recall, bulletins, or other documentation (REQUIRED IF
YES IS SELECTED)

Minor revisions to existing
question text to incorporate
the transition from separate
application flows for drugs
and devices to one flow for
both. All applications will
now display the same
questions for this section.
Additional minor revisions to
existing question text for
accuracy and clarification.

Additional Technology Information (Device
Flow)
• Is there an Investigational Device Exemption (IDE) number from the FDA
assigned to the technology? (Yes/No)
o IF YES: IDE Number
• What class is assigned to the technology? (Class I, II, III)
• 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.
o

No change

Revised Application Language
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
• What is the technology?
• What does the technology do?
• 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
• Is there an Investigational Device Exemption (IDE) number from the FDA assigned to the
technology? (Yes/No)
o IF YES: IDE Number
• If the technology is a device, what class is assigned to the technology? (Class I, II, III,
unclassified, N/A)
• If the technology is a drug, is this a drug that can only be administered orally? (Yes/No N/A)
• 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.
• 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.
o

Please upload the recall, bulletins, or other documentation (REQUIRED IF
YES IS SELECTED)
5

Please upload the recall, bulletins, or other documentation (REQUIRED IF YES IS
SELECTED)

Application
Section

Application Language

Modifications

Burden

Technology Info Have you completed any outpatient pass through applications for this
As is
technology? (Yes/No)
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

Revised Application Language

No change

(Alternative Drug flow)
No change
•
Has the technology received a QIDP designation or approval under the LPAD
Text from both Alternative
pathway from FDA for the indication relevant to this application? Info: For
application flows was
additional information on the alternative pathways for transformative new devices
combined to create one set
and certain antimicrobial products, please refer to the NTAP Criteria and
of questions for all
Pathways information above.
Alternative pathway
Choose 1:
applications. Questions
were also simplified for the
• QIDP designation (sequence 7a)
“YES” flow.
• LPAD approval (sequence 7b)
• Both QIDP and LPAD (sequence 7c)
• Has not yet received a QIDP designation or LPAD approval (sequence 7d) 3 questions also were
added; responses were
previously expected to be
Please answer the subsequent questions only for the sequence selected:
provided within the
a: QIDP Designation Sequence
application (under “What is
a) When was the technology granted the QIDP designation?
the designation for”). Some
Date:
applicants provided this
b) What is the QIDP designation for?
information and others did
Note: The marketing authorization indication in the FDA section of this
not. Adding questions to
application must be the same as the QIDP/LPAD designation.
ensure applicants provide
c) Upload a copy of the QIDP designation letter.
the information to minimize
b: LPAD Approval Sequence
follow-up.
a) When was the technology granted the LPAD approval?
Date:
b) What is the LPAD indication for?
Note: The marketing authorization indication in the FDA section of this
application must be the same as the QIDP/LPAD designation.
c) Upload a copy of the LPAD approval letter.
c. Both QIDP and LPAD Sequence
a) When was the technology granted the QIDP designation?
Date:
b) When was the technology granted the LPAD approval?
6

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

•
•
•
•
•

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.
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
Upload a copy of the Breakthrough Device/QIDP designation or LPAD approval letter.
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.
If the name of the technology in this application does not match the technology name in the
attached letter, please provide an explanation.
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:
-Yes, this is the designated device (text box for optional explanation)
-No, this is not the designated device (text box for required explanation)
-Does not apply

IF NO:
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.

Application
Section

Application Language

Modifications

Burden

Date:
c) What is the QIDP designation/LPAD indication for?
Note: The marketing authorization indication in the FDA section of this
application must be the same as the QIDP/LPAD designation.
d) Upload a copy of the QIDP/LPAD letter.
d. Has not yet received QIDP designation or LPAD approval sequence
a) Provide additional details regarding the QIDP designation or approval
under the LPAD pathway from FDA and its status. Note: The marketing
authorization indication in the FDA section of this application must be the
same as the QIDP/LPAD designation.

Revised Application Language
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

(Alternative Device flow)
Has the technology already received a Breakthrough Device designation 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:
a: Alternative Pathway Designation
a) When was the technology granted the Breakthrough Device designation?
Date:
b) What is the Breakthrough Device designation for?
Note: The marketing authorization indication in the FDA section of this
application must be the same as the Breakthrough Device designation.
c) Upload a copy of the Breakthrough Device designation letter.

FDA
Information

IF NO:
b. Alternative Pathway Designation
Provide details regarding the Alternative Pathway designation and its
status.
Note: The marketing authorization indication in the FDA section of this
application must be the same as the Breakthrough Device designation.
Has the technology received marketing authorization from the Food and Drug
Administration (FDA) for the indication relevant to this application?
Info: To be considered for NTAP 2024 the technology will need to receive FDA
approval or clearance before 07/01/2023.
Choose 1:
• Approved (sequence 7a)
• Pending Approval (sequence 7b)
• Have not applied yet (sequence 7c)

2 existing questions will be
moved up to before the skip
pattern. Responses to create
skip pattern were simplified
from 3 to 2 options. Dates
and “No” response modified
to reflect recent finalized
policy.
There is slightly different
language for applications
under the alternative pathway
to reflect different dates for
7

No change

FDA Status
• What is the indication for the technology for which the applicant is submitting an NTAP
application?
• 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?
Info: To be considered for NTAP for FY 2025, the technology will need to receive FDA approval or
clearance before 05/01/2024.
.

Application
Section

Application Language

Modifications

Burden

Breakthrough Devices and
QIDP/LPADs under the
recently finalized policy

Revised Application Language
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 applications under the alternative pathway, this will read:
Has the technology already received marketing authorization from the Food and Drug
Administration (FDA) for the indication relevant to this application?
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.

D. FDA
Information

D. FDA
Information

Approved Sequence
NTAP Indication
• What is the indication for the technology for which the applicant is submitting
an NTAP application?
• 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)
FDA Approval/ Clearance Details
o □ Checkbox: “Select if this is a 510(k) FDA application”
• What is the type of the FDA application?
Examples: New Drug Application (NDA), Biologic License Application
(BLA)
• What is the date of FDA approval?
• Upload FDA approval letter (required)
• Summarize the supporting information contained in the FDA approval letter.
IF CHECKBOX ABOVE IS SELECTED, answer the following question.
Please provide additional information regarding the 510(k) clearance:
• List the predicate device(s) for the technology.
• Describe any differences between the devices
Who is the FDA Contact? This information will not be made public.
• First Name
• Middle Name (optional)
• Last Name
• US Phone Number
• Email Address

The questions are re-ordered
and additional detail added
regarding FDA application
examples

No change

Note added to clarify who
should be listed as the FDA
contact

No change

8

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.
o Summarize the supporting information contained in the FDA approval letter.
IF 510(k) CHECKBOX ABOVE IS SELECTED, answer the following question:
• 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.
• First Name
• Middle Name (optional)
• Last Name
• US Phone Number

Application
Section

D. FDA
Information

FDA
Information

Application Language

Modifications

Burden

Revised Application Language
•

Was this technology available on the market immediately after FDA
approval? (Yes/No)
IF NO:
Reason for the delay
• 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?
Pending Approval Sequence
• NTAP Indication
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)
• FDA Submission Details
Info: All of the FDA dates entered in this question (7b.b) will not be made
public.
o What is the type of the FDA application?
Examples: New Drug Application (NDA), Biologic License
Application (BLA) What is the date of FDA submission?
o Have you received an action date from FDA? (Yes/No)
 IF YES: What is the action date from FDA?
 IF NO: What is the anticipated approval date?
o Provide additional information about your FDA application
o Upload any FDA related documents (optional)
• Do you anticipate that this technology will be available on the market
immediately after FDA approval? (Yes/No)
IF NO: Reason for the delay
Please describe the reason for the delay in market availability and
provide the anticipated release date.

As is

Email Address

No change

The ‘pending approval’ and
No change
‘have not yet applied’
sequences will be combined
into one ‘no’ sequence.
’NTAP indication’ questions
were moved up to before the
skip pattern. Some additional
detail added to existing
questions for clarity.
Language modified to reflect
recent finalized policy.

Have Not Applied Yet Sequence
• NTAP Indication
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
9

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.
• Do you anticipate that this technology will be available on the market immediately after
FDA approval? (Yes/No)
IF NO:
Reason for the delay
Please describe the reason for the delay in market availability and provide the
anticipated release date.

Application
Section

FDA
Information

Coding and
MS-DRGs

Application Language

Burden

Fast Track, Breakthrough Therapy, Accelerated Approval, Priority
Review, etc. for this indication (optional)
• When do you plan to submit your FDA application?
Info: Dates entered here will not be made public.
o Anticipated Submission date
o Anticipated Approval date
o Provide additional information about your FDA application
o Upload any FDA related documents (optional)
Additional FDA Information
Existing question text
Include all types of approvals (e.g. Pre-Market Approval, HDE or HUD approval,
reordered and slightly
modified for clarity.
expanded access approval) the technology received prior to submission of this
application and/or is currently seeking. CMS recommends a timeline if the technology
has received multiple types of approvals from the FDA.
• Please describe any previous US approvals/clearances for this technology.
Coding Information
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-10PCS 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-10-PCS 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
and ICD-10 Coordination and Maintenance Committee
diagnosis code requests.

Coding and
MS-DRGs

Modifications

No change

Section name revised to
No change
describe existing questions as
well as questions from a
different section that were
moved into this section; no
other text changes

Revised Application Language

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
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-10-PCS 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
requests

for

Are there any diagnosis codes that may currently be used to identify the
indication/proposed indication relevant to the application under the ICD-10-CM
coding system? (Yes/No)

Question removed to avoid
confusion; applicants should
not be responding ‘no’

IF YES:
ICD-10-CM Diagnosis Codes - List the diagnosis codes that may currently be used to
identify the indication/proposed indication relevant to the application under the ICD10-CM coding system:
a) Provide ICD-10-CM codes and titles
Explain why the diagnosis code(s) were included (and whether they are specific to
the indication listed under the Breakthrough Device designation)

Note added, as current
method of inserting codes
and descriptors individually
has been revised to a
standard text box for
simplification.

10

No change

and ICD-10 Coordination and Maintenance Committee

for diagnosis code

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)
Explain why these diagnosis code(s) were included (and whether they are specific to the indication
listed under the Breakthrough Device/QIDP/LPAD designation.)

Application
Section

Coding and
MS-DRGs

Application Language
ICD-10-PCS Procedure Codes - List the procedure codes that may currently be used
to identify your technology under the ICD-10-PCS coding system.
• Provide ICD-10-PCS codes and titles
• Do these codes uniquely identify your technology under the ICD-10-PCS
coding system? (Yes/No) Please explain.
o

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

Modifications

Burden

Note added, as current
method of inserting codes
and descriptors individually
has been revised to a
standard text box for
simplification.

No change

Revised Application Language
ICD-10-PCS Procedure Codes
o List the procedure codes that may currently be used to identify your technology under the ICD-10PCS 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.
•

Coding and
MS-DRGs

Coding and
MS-DRGs

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
o Does this technology have an existing request pending with the ICD-10 C&M
Committee for a new code? (Yes/No)
o 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.
(Existing application includes these questions under the ‘Charge’ section)
MS-DRGs
Under the MS-DRG grouper, list all of the MS-DRGs that the technology
currently maps to based on the indication (diagnosis) for which the technology
has received or is seeking FDA approval. 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.
o List MS-DRGs and titles
o Comments related to the MS-DRGs listed above (optional)
o Have you made a request to map to a new or different MS-DRG(s) for
the upcoming Fiscal Year 2024? (Yes/No)
i. IF YES, please provide details.

Newness
Criterion (only
displays for
traditional
applications)

o

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

As is

No change

Questions moved up from
current ‘Charge’ section
(which is now renamed as
‘Cost Criterion’section).

No change

Minor text modifications for
clarity. Note added, as
current method of inserting
MS-DRGs and titles
individually has been revised
to a standard text box for
simplification.

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 MSDRGs and titles.
Note: Please use standard formatting for MS-DRGs in your response. Standard formatting for MSDRGs 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

As is

No change

11

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

Have you made, or do you anticipate making, a request to map to a new or different MSDRG(s) for the upcoming Fiscal Year 2025? (Yes/No)
IF YES, please provide details.

Application Language

Application
Section

Modifications

Burden

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)

12

Revised Application Language

Application
Section

Cost and
Volume

Cost and
Volume

Application Language
Cost

Technology Cost (device flow)
• What is the current or anticipated cost of this technology to the hospital, per
patient?
Note: The cost of the technology will be included in the proposed and final
rules.
• How was the cost determined? (e.g., the number of units per patient; for
technologies sold on a subscription basis, include an explanation of how the
cost per case is calculated, including the list price of the technology and
utilization across subscribers)
Note: You will be asked to provide a breakdown of the cost of each component
in the next question.
Technology Cost (drug flow)
• What is the current or anticipated cost of this technology to the hospital, per
patient?
Note: The cost of the technology will be included in the proposed and final
rules.
• How was the cost determined?
Note: Include the average dosage and number of vials per patient (whole vials if
single-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.).

Modifications

Burden

This section has been revised No change
to incorporate the existing
‘Volume’ section; section
title revised to describe all
questions now within the
section

Examples/notes revised to
incorporate into one set of
questions (as the separate
drug/device flows were
eliminated)
Minor text revisions to
existing questions for clarity.
Skip pattern question added
for the existing devices-only
related question since the
different flows were
eliminated

No change

Revised Application Language
Cost and Volume

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 single-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

13

Upload files or materials that support the cost of the technology and how it was calculated
(optional)

Application
Section

Cost and
Volume

Application Language
•

Modifications

Burden

Revised Application Language

Upload files or materials that support the cost of the technology and how it
was calculated (optional)

Cost Breakdown (for devices)
Minor text revisions for
Info: Include a breakdown of the cost of all of the components used per patient, clearly clarification
showing which components are the "new" ones.
a) 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 Upload files or materials that support the cost of the technology and how it
was calculated (optional)

No change

14

IF YES:
Cost Breakdown (for devices)
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.)
o 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)

Application
Section

Cost and
Volume

Application Language
(Existing application includes these questions under its own ‘Volume’ section)
Volume of Cases
Info: The information in this section (H) 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: (10/01/2022 - 09/30/2023) Upcoming Fiscal Year:
(10/01/2023 - 09/30/2024)
•

•

Modifications

Burden

Existing questions moved out No change
of the ‘Volume’ section to be
included within the revised
‘Cost and Volume’ section.
No modifications to the text
except updated dates.

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
o Please describe how you arrived at this estimate.
o Upcoming Fiscal Year Anticipated Inpatient Medicare Volume
o 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?
a) Current Fiscal Year Anticipated Inpatient Non-Medicare Volume
o Please describe how you arrived at this estimate.
b) Upcoming Fiscal Year Anticipated Inpatient Non-Medicare Volume

MS-DRGs
Under the MS-DRG grouper, list all of the MS-DRGs that the technology currently
maps to based on the indication (diagnosis) for which the technology has received or is
seeking FDA approval. Note: Please refer to the latest version of the ICD-10 MS-

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?
a) Current Fiscal Year Anticipated Inpatient Medicare Volume
o Please describe how you arrived at this estimate.
b) Upcoming Fiscal Year Anticipated Inpatient Medicare Volume
o Please describe how you arrived at this estimate.

Cost Criterion Charge
Info: The information in this section (G) will not be included in the public posting but
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).

Revised Application Language

Section renamed ‘Cost
Criterion’

No change

MS-DRG questions moved
up to another section
(‘Coding and MS-DRGs)

DRGs list on the MS-DRG Webpage
for the current list of MS-DRGs and titles.
a) List MS-DRGs and titles
b) Comments related to the MS-DRGs listed above (optional)
c) Have you made a request to map to a new or different MS-DRG(s) for the
upcoming Fiscal Year 2024? (Yes/No)
ii. IF YES, please provide details.

15

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

Cost Criterion
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).

Application Language

Application
Section

Cost Criterion Cost Criterion
Click here for guidance about the cost criterion.
Download Appendix A for an explanation of how to standardize charges per case if
multiple MS-DRGs are affected by the technology.

Modifications

Burden

Some text removed (and
incorporated into a later
question)

No change

Step 1: Download FY2024 New_Technology Cost Spreadsheet Example.xlsx
(available for download on the CMS webpage).
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. In compliance with the CMS data use agreement, case volumes for
MS-DRGs listed in the table must have a minimum value of 11; applicants should
impute a value of 11 for those cells with a lower value. 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.
• Step 2: Upload the Completed Cost Analysis Spreadsheet.
• 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)
With regard to the cost analysis spreadsheet, please upload
summary/aggregate data used to calculate charges and standardized charges
per case involving the new technology. You may include lists of ICD-10PCS/CM codes (for identifying cases), and/or other data that was used in the
development of the cost analysis spreadsheet.
In the box below, please list and briefly describe each upload, including
information about the source and time periods of the data, any decision
points in what data was used, and other relevant information.

Cost Criterion

Cost Criterion

Cost Analysis Methodology
For columns A to S of the cost analysis spreadsheet, as represented in the
following questions A-S, list a step by step explanation for how the data and
calculations were determined.
Info: For example, applicants must include the type of data used to calculate the
average standardized charge (i.e. Medicare and/or non-Medicare, number of
providers, time period from which data was collected) and/or the inflation factor
used to inflate the charges etc. An application is NOT complete without a complete
step by step explanation of the applicant’s charge methodology.
A. MS-DRG
Note: If you have not included cases in DRGs that CMS might expect to see cases

Cost Analysis
Click here for guidance about the cost criterion.
Download Appendix A for an explanation of how to standardize charges per case if multiple MS-DRGs
are affected by the technology.
• 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.
• Step 2: Upload the Completed Cost Analysis Spreadsheet.
• 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 Criterion

Revised Application Language

Questions and uploader
reworked to separate the
existing text into separate
distinct questions for
improved understanding. No
new information is being
requested.

No change

Text revised to improve
understanding of the
question, info note removed

No change

Notes and examples added
throughout this section to

No change

16

Cost Analysis Methodology
o With regard to the cost analysis spreadsheet, please detail the ICD-10-PCS/CM codes and MSDRGs 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)
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).
Cost Analysis Methodology
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, step-by-step.

A. MS-DRG
Explain how these MS-DRGs were determined, including any differences between multiple analyses if

Application
Section

Application Language
present for your technology, please address this in detail (e.g., a CAR-T charge
analysis that doesn’t include cases from DRG-018).
B. Cases
Note: Please discuss relevant decision points in choosing to include/exclude ICD10-PCS/CM codes (for identifying cases).
C. Case Weighted Amount
D. Threshold
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 discuss the assumptions behind removing (or not removing) charges
for prior technologies.
I. Related Charges Removed for the Prior Technology or Technology Being
Replaced
J. Adjusted Average Charge Per Case (Unstandardized with No Case Weight)
K. Adjusted Average Charge Per Case (Unstandardized with Case Weight)
L. Average Standardized Charge Per Case
Note: Please include provider-specific factors used to standardize charges
M. Average Standardized Charge Per Case with Case Weight
N. Inflation Factor
O. Inflated Average Standardized Charges Per Case
P. Charges Added for the New Technology
Q. Related Charges Added for the New Technology
R. Final Average Inflated Standardized Charge Per Case
S. Final Inflated Case Weighted Standardized Charge Per Case

Modifications

Burden

clarify the expected
information to be provided,
no new information is being
requested

17

Revised Application Language
applicable. Please also discuss relevant decision points in choosing to include/exclude ICD-10PCS/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)
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.

Application
Section

Cost Criterion

Substantial
Clinical
Improvement
(displays only
for traditional
applications)

Application Language

Modifications

Burden

Revised Application Language
R. Final Average Inflated Standardized Charge Per Case
S. Final Inflated Case Weighted Standardized Charge Per Case

Charge of the Technology
Redundant question removed No change
What is the current and/or anticipated charge of the technology by the hospital, per
patient? Explain how this was determined.
Info: A summary on the substantial clinical improvement (SCI) criterion can be found Minor text revisions for
in Appendix B. Additional information on the SCI criterion can be found in the
accuracy and clarity
September 7, 2001 Federal Register (66 FR 46913-14), the FY 2010 IPPS Final Rule

No change

(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.

N/A

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.
A technology must demonstrate that it meets at least one of these three in order to be eligible for NTAP.

Overview of the SCI Criterion
CMS uses the following criteria 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.
A technology must demonstrate that it meets at least one of these three SCI criteria 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.

Overview of the SCI Section
As you navigate through the Substantial Clinical Improvement section, you will be
asked which of these 3 criteria the technology meets. For each criterion you assert
that the technology meets, you will be asked to explain why you believe the technology
meets that criterion, using supporting data as applicable. Each reason the technology
meets a particular criterion will need to be added as a separate claim.
• You will be able to enter one or more claims (i.e., reasons) for each criterion
that you assert that the technology meets.
• Each claim for a criterion 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.
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Application Language

Application
Section

Burden

Revised Application Language

•

Substantial
Clinical
Improvement
(displays only
for traditional
applications)
Substantial
Clinical
Improvement
(displays only
for traditional
applications)

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 criteria 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.
Substantial Clinical Improvement Criterion 1: 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 YES:
a) Please provide a reason this technology meets this criterion using supporting
data. Add each reason for meeting this criterion as a separate claim.
i. Add claim – title of claim (add as many claims as desired)
ii. Provide a full explanation as to why this technology meets Criterion 1
iii. Add Supporting Evidence, if applicable. (Add as many as desired for each
claim)
Upload file and answer the following questions related to each upload:
Title of the supporting evidence
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 backgrounds (does not directly assess the technology)
Evidence Type (eg meta-analysis, case report, RCT)
Uploaded File
□ 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.
Page Number(s)
Citation
Reason for inclusion/relevance to the claim
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).
Results from the study that support this claim: Please provide the specific
statistic(s)/outcome(s) from the study and the page/paragraph within the study
where it can be found.

Modifications

o
o




o
o








Minor text revisions for
accuracy

No change

Existing questions reordered
and minor text revisions for
clarification; no new
information is being
requested

No change

19

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 YES:
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
o

(iii) Add Claim - Claim Title
(iv) Please provide a full explanation
(v) Add Supporting Evidence, if applicable
o Select an existing file or upload a new one
o Upload file and answer the following questions related to each upload:
• □ 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.
• Title of the supporting evidence
• Data Source category (choose one)
o Published, peer, reviewed studies using technology
o Unpublished studies, abstracts, or presentations using technology
o Other data submissions using technology
o Data submissions as background (does not directly assess the technology)
• Evidence Type (choose one)
o Case-control Study
o Case Reports and Case Series
o Cohort Study
o Cross-sectional Study
o Meta-Analysis
o Randomized Controlled Trial
o Systematic Review
o Other
• Citation
• 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).
o Please explain why this uploaded file was provided in support of this claim
• Reason for inclusion/relevance to claim
• 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.

Application
Section

Substantial
Clinical
Improvement
(displays only
for traditional
applications)
Substantial
Clinical
Improvement
(displays only
for traditional
applications)
Substantial
Clinical
Improvement
(displays only
for traditional
applications)

Summary

Application Language

Modifications

Burden

Revised Application Language
Provide the location of these results/outcomes (i.e. page number(s), paragraph, table number,
etc., as applicable.)

Substantial Clinical Improvement Criterion 2: Does the new medical service or
Text added for accuracy to
technology offer the ability to diagnose a medical condition in a patient population
mirror the regulations
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?

No change

Substantial Clinical Improvement Criterion 3: Does the use of the new medical
service or technology significantly improve clinical outcomes relative to services or
technologies previously available?

As is

No change

SCI Criterion Summary and Attestation
Please briefly summarize your responses to the previous slide regarding how the
technology meets the substantial clinical improvement criterion overall.

Minor clarifying edit to
change “the previous slide”
to “this section”

No change

□ 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.
Info: If there is any information that you wish to provide with your application that
As is
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.

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.

SCI Criterion Summary and Attestation
Please briefly summarize your responses to this section regarding how the technology meets the
substantial clinical improvement criterion overall.
□ 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.

No change

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.
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Application
Section

Application Language

Modifications

Burden

c) Upload any relevant files (optional)

21

Revised Application Language