Crosswalk

NTAP Crosswalk-2023
Paper
Application

Paper Application Language

Modifications

Burden

Question #

Applicants need to include this information in the
Throughout
paper
application.

Currently the pathway questions are split across the paper
application

current paper application narrative, but we have
consolidated on this screen to create the skip
patterns that allow the system to only display the
relevant questions to the specific pathway chosen.

No substantive change or
burden

Screenshot

Name, address, telephone, and email address of primary and
backup contact for the application.
1

If using a consultant, provide a contact from the manufacturer
in addition to the consultant’s

AS IS

No substantive change or
burden

contact information.

Alternative Screen

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Trade/brand name of the new technology.
2, 3

AS IS
Describe the technology in general terminology.

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Describe the technology in general terminology.
- What is it? What does it do? How is it used?
3

- Also, submit relevant descriptive booklets, brochures,
package inserts, as well as copies of
published peer-reviewed articles relevant to the new medical
services and technologies.)

AS IS

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Devices:
15

If the technology is a device, is there an investigational
device exemption (IDE) number from the

AS IS

FDA assigned to the device? If yes, please provide this code.

Whether the technology has ever been the subject of

Refer to

a recall or subject to any bulletins and/or letters

http://www.fda.gov/MedicalDevices/DeviceRegulationandGu issued by the FDA regarding the safety of the
idance/HowtoMarketYourDevice/Inve
technology has been added to this question set to
stigationalDeviceExemptionIDE/ucm051480.htm for more

ensure applicants do not forget to tell CMS about

details.

this. Currently, it is required to be included in the
narrative, and the vast majority of applicants do
include this information in their application. If they
do not include it, CMS currently asks the applicant
to provide the information during the review of the

Devices:
If the technology is a device, what class (I, II, or III) was/is
assigned to the device? Refer to
16

http://www.fda.gov/MedicalDevices/DeviceRegulationandGu
idance/overview/default.htm for more
details.

application.

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

AS IS

Drugs:
13

If the technology is a drug, is this a drug that can only be
administered orally?
Drugs:

14

If the technology is a drug, provide complete dosage
information.

Whether the technology has 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 has been added to this question set to
ensure applicants do not forget to tell CMS about

No substantive change or

this. Currently, it is required to be included in the

burden

narrative, and the vast majority of applicants do
include this information in their application. If they
do not include it, CMS currently asks the applicant
to provide the information during the review of the
application.

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Have you submitted an outpatient application for passthrough payments under the Medicare
outpatient prospective payment system? If so, please provide
4

the tracking number or, if it was
approved, please provide the date of approval. Refer to
http://www.cms.gov/Medicare/MedicareFee-for-ServicePayment/HospitalOutpatientPPS/index.html for more
information.

AS IS

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Question 4 (Continued)
Have you submitted an outpatient application for passthrough payments under the Medicare
4

outpatient prospective payment system? If so, please provide
the tracking number or, if it was
approved, please provide the date of approval. Refer to
http://www.cms.gov/Medicare/MedicareFee-for-ServicePayment/HospitalOutpatientPPS/index.html for more
information.

AS IS

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #
Alternative New Technology Pathway for Transformative
New Devices
Is the technology a device that has received a Breakthrough
Device designation from the Food
and Drug Administration (FDA)? If yes, skip questions 6
5

through 21 (newness) and 34-36
(substantial clinical improvement) and proceed to question 22
- 33 (cost criterion). For
additional details on the Alternative Pathway we refer
applicants to 84 FR xxxxx – xxxxx
for additional details.

AS IS

No substantive change or
burden

Screenshot

Alternative New Technology Pathway for Transformative
New Devices
Is the technology a device that has received a Breakthrough
Device designation from the Food
and Drug Administration (FDA)? If yes, skip questions 6
through 21 (newness) and 34-36
(substantial clinical improvement) and proceed to question 22
- 33 (cost criterion). For
additional details on the Alternative Pathway we refer
applicants to 84 FR xxxxx – xxxxx
for additional details.
Date of Food and Drug Administration (FDA) (or expected)
5,8

approval for the technology, service, or drug. Provide a copy
of the FDA approval/clearance letter. If approval has not yet
been granted, please provide a copy of the approval notice to
CMS immediately after it becomes available. Note: Include
all types of approvals (i.e. Pre-Market Approval, HDE or
HUD approval, expanded access approval) the technology,
service or drug received prior to submission of this
application and/or is currently seeking. CMS recommends a
timeline if the technology, service, or drug has received
multiple types of approvals from the FDA. Per § 412.87(c) of
the regulations, an applicant for new technology add-on
payments (NTAP) must receive FDA approval or clearance
for its new medical service or technology by July 1 prior to
the beginning of the fiscal year (FY) for which the NTAP
would be effective (for FY 2021, not later than July 1, 2020).

Components of this question are now specified, that
would have been required to be included in the
narrative response previously. Applicants also
currently provide this information in the FDA
approval letter.

No substantive change or
burden

Question 5 (Continued)
Alternative New Technology Pathway for Transformative
New Devices
Is the technology a device that has received a Breakthrough
Device designation from the Food
and Drug Administration (FDA)? If yes, skip questions 6
through 21 (newness) and 34-36
(substantial clinical improvement) and proceed to question 22
- 33 (cost criterion). For
additional details on the Alternative Pathway we refer
applicants to 84 FR xxxxx – xxxxx
for additional details.
5,8

Components of this question are now specified, that

Date of Food and Drug Administration (FDA) (or expected)

would have been required to be included in the

No substantive change or

approval for the technology, service, or drug. Provide a copy

narrative response previously. This information is

burden

of the FDA approval/clearance letter. If approval has not yet

also included in the FDA approval letter.

been granted, please provide a copy of the approval notice to
CMS immediately after it becomes available. Note: Include
all types of approvals (i.e. Pre-Market Approval, HDE or
HUD approval, expanded access approval) the technology,
service or drug received prior to submission of this
application and/or is currently seeking. CMS recommends a
timeline if the technology, service, or drug has received
multiple types of approvals from the FDA. Per § 412.87(c) of
the regulations, an applicant for new technology add-on
payments (NTAP) must receive FDA approval or clearance
for its new medical service or technology by July 1 prior to
the beginning of the fiscal year (FY) for which the NTAP
would be effective (for FY 2021, not later than July 1, 2020).

Paper
Application

Paper Application Language

Modifications

Burden

Question #
Is the technology a device that has received a Breakthrough
Device designation from the Food and Drug Administration
(FDA)?
Date of Food and Drug Administration (FDA) (or expected)
approval for the technology, service, or drug. Provide a copy
of the FDA approval/clearance letter. If approval has not yet
been granted, please provide a copy of the approval notice to
CMS immediately after it becomes available. Note: Include
5,8

all types of approvals (i.e. Pre-Market Approval, HDE or
HUD approval, expanded access approval) the technology,
service or drug received prior to submission of this
application and/or is currently seeking. CMS recommends a
timeline if the technology, service, or drug has received
multiple types of approvals from the FDA. Per § 412.87(c) of
the regulations, an applicant for new technology add-on
payments (NTAP) must receive FDA approval or clearance
for its new medical service or technology by July 1 prior to
the beginning of the fiscal year (FY) for which the NTAP
would be effective (for FY 2021, not later than July 1, 2020).

We have further broken out the breakthrough device
designation to include these subcategories, so that
applicants can skip questions that are not relevant.
This information is included in the FDA approval
letter.

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #
Based on: Is the technology a device that has received a
Breakthrough Device designation from the Food and Drug
Administration (FDA)?
Date of Food and Drug Administration (FDA) (or expected)
approval for the technology, service, or drug. Provide a copy
of the FDA approval/clearance letter. If approval has not yet

5, 8

been granted, please provide a copy of the approval notice to

Components of this question are now specified for

CMS immediately after it becomes available. Note: Include

applicants that receive a special designation from

all types of approvals (i.e. Pre-Market Approval, HDE or

the FDA only. Applicants are currently required to No substantive change or

HUD approval, expanded access approval) the technology,

provide this information to CMS in the narrative

service or drug received prior to submission of this

response in the paper application. This information

application and/or is currently seeking. CMS recommends a

is included in the FDA approval letter.

timeline if the technology, service, or drug has received
multiple types of approvals from the FDA. Per § 412.87(c) of
the regulations, an applicant for new technology add-on
payments (NTAP) must receive FDA approval or clearance
for its new medical service or technology by July 1 prior to
the beginning of the fiscal year (FY) for which the NTAP
would be effective (for FY 2021, not later than July 1, 2020).

burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #
Date of Food and Drug Administration (FDA) (or expected)
approval for the technology, service, or drug. Provide a copy
of the FDA approval/clearance letter. If approval has not yet
been granted, please provide a copy of the approval notice to
CMS immediately after it becomes available. Note: Include
all types of approvals (i.e. Pre-Market Approval, HDE or
HUD approval, expanded access approval) the technology,
8

service or drug received prior to submission of this

AS IS - This question is broken down throughout

No substantive change or

application and/or is currently seeking. CMS recommends a

the FDA section.

burden

timeline if the technology, service, or drug has received
multiple types of approvals from the FDA. Per § 412.87(c) of
the regulations, an applicant for new technology add-on
payments (NTAP) must receive FDA approval or clearance
for its new medical service or technology by July 1 prior to
the beginning of the fiscal year (FY) for which the NTAP
would be effective (for FY 2021, not later than July 1, 2020).

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #
Date of Food and Drug Administration (FDA) (or expected)
approval for the technology, service, or drug. Provide a copy
of the FDA approval/clearance letter. If approval has not yet
been granted, please provide a copy of the approval notice to
CMS immediately after it becomes available. Note: Include
all types of approvals (i.e. Pre-Market Approval, HDE or
HUD approval, expanded access approval) the technology,
service or drug received prior to submission of this
application and/or is currently seeking. CMS recommends a
timeline if the technology, service, or drug has received
multiple types of approvals from the FDA. Per § 412.87(c) of
8,12

the regulations, an applicant for new technology add-on
payments (NTAP) must receive FDA approval or clearance
for its new medical service or technology by July 1 prior to
the beginning of the fiscal year (FY) for which the NTAP
would be effective (for FY 2021, not later than July 1, 2020).
If the technology is a drug, was/is your FDA application
considered under Fast Track, Breakthrough Therapy,
Accelerated Approval, or Priority Review? Refer to
http://www.fda.gov/forconsumers/byaudience/forpatientadvo
cates/speedingaccesstoimportantne
wtherapies/ucm128291.htm for more details.

Request for indication has been added to this
question set to ensure applicants do not forget to
include this detail. Currently, it is required to be
included in the narrative, and the vast majority of
applicants include this. If an applicant does not
provide the information, CMS will obtain the
information from the applicant.

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Date of Food and Drug Administration (FDA) (or expected)
approval for the technology, service, or drug. Provide a copy
of the FDA approval/clearance letter. If approval has not yet
been granted, please provide a copy of the approval notice to
CMS immediately after it becomes available. Note: Include
all types of approvals (i.e. Pre-Market Approval, HDE or
HUD approval, expanded access approval) the technology,
8

service or drug received prior to submission of this

AS IS - This question is broken down throughout

No substantive change or

application and/or is currently seeking. CMS recommends a

the FDA section.

burden

timeline if the technology, service, or drug has received
multiple types of approvals from the FDA. Per § 412.87(c) of
the regulations, an applicant for new technology add-on
payments (NTAP) must receive FDA approval or clearance
for its new medical service or technology by July 1 prior to
the beginning of the fiscal year (FY) for which the NTAP
would be effective (for FY 2021, not later than July 1, 2020).

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #
Date of Food and Drug Administration (FDA) (or expected)
approval for the technology, service, or drug. Provide a copy
of the FDA approval/clearance letter. If approval has not yet
been granted, please provide a copy of the approval notice to
CMS immediately after it becomes available. Note: Include
all types of approvals (i.e. Pre-Market Approval, HDE or
HUD approval, expanded access approval) the technology,
8

service or drug received prior to submission of this

AS IS - This question is broken down throughout

No substantive change or

application and/or is currently seeking. CMS recommends a

the FDA section.

burden

timeline if the technology, service, or drug has received
multiple types of approvals from the FDA. Per § 412.87(c) of
the regulations, an applicant for new technology add-on
payments (NTAP) must receive FDA approval or clearance
for its new medical service or technology by July 1 prior to
the beginning of the fiscal year (FY) for which the NTAP
would be effective (for FY 2021, not later than July 1, 2020).

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Date of Food and Drug Administration (FDA) (or expected)
approval for the technology, service, or drug. Provide a copy
of the FDA approval/clearance letter. If approval has not yet
been granted, please provide a copy of the approval notice to
CMS immediately after it becomes available. Note: Include
all types of approvals (i.e. Pre-Market Approval, HDE or
HUD approval, expanded access approval) the technology,
8

service or drug received prior to submission of this

AS IS - This question is broken down throughout

No substantive change or

application and/or is currently seeking. CMS recommends a

the FDA section.

burden

timeline if the technology, service, or drug has received
multiple types of approvals from the FDA. Per § 412.87(c) of
the regulations, an applicant for new technology add-on
payments (NTAP) must receive FDA approval or clearance
for its new medical service or technology by July 1 prior to
the beginning of the fiscal year (FY) for which the NTAP
would be effective (for FY 2021, not later than July 1, 2020).

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Date of Food and Drug Administration (FDA) (or expected)
approval for the technology, service, or drug. Provide a copy
of the FDA approval/clearance letter. If approval has not yet
been granted, please provide a copy of the approval notice to
CMS immediately after it becomes available. Note: Include
all types of approvals (i.e. Pre-Market Approval, HDE or
HUD approval, expanded access approval) the technology,
8

service or drug received prior to submission of this

AS IS - This question is broken down throughout

No substantive change or

application and/or is currently seeking. CMS recommends a

the FDA section.

burden

timeline if the technology, service, or drug has received
multiple types of approvals from the FDA. Per § 412.87(c) of
the regulations, an applicant for new technology add-on
payments (NTAP) must receive FDA approval or clearance
for its new medical service or technology by July 1 prior to
the beginning of the fiscal year (FY) for which the NTAP
would be effective (for FY 2021, not later than July 1, 2020).

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Date of Food and Drug Administration (FDA) (or expected)
approval for the technology, service, or drug. Provide a copy
of the FDA approval/clearance letter. If approval has not yet
been granted, please provide a copy of the approval notice to
CMS immediately after it becomes available. Note: Include
all types of approvals (i.e. Pre-Market Approval, HDE or
HUD approval, expanded access approval) the technology,
8

service or drug received prior to submission of this

AS IS - This question is broken down throughout

No substantive change or

application and/or is currently seeking. CMS recommends a

the FDA section.

burden

timeline if the technology, service, or drug has received
multiple types of approvals from the FDA. Per § 412.87(c) of
the regulations, an applicant for new technology add-on
payments (NTAP) must receive FDA approval or clearance
for its new medical service or technology by July 1 prior to
the beginning of the fiscal year (FY) for which the NTAP
would be effective (for FY 2021, not later than July 1, 2020).

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Date of Food and Drug Administration (FDA) (or expected)
approval for the technology, service, or drug. Provide a copy
of the FDA approval/clearance letter. If approval has not yet
been granted, please provide a copy of the approval notice to
CMS immediately after it becomes available. Note: Include
all types of approvals (i.e. Pre-Market Approval, HDE or
HUD approval, expanded access approval) the technology,
8

service or drug received prior to submission of this

AS IS - This question is broken down throughout

No substantive change or

application and/or is currently seeking. CMS recommends a

the FDA section.

burden

timeline if the technology, service, or drug has received
multiple types of approvals from the FDA. Per § 412.87(c) of
the regulations, an applicant for new technology add-on
payments (NTAP) must receive FDA approval or clearance
for its new medical service or technology by July 1 prior to
the beginning of the fiscal year (FY) for which the NTAP
would be effective (for FY 2021, not later than July 1, 2020).

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

List the name and phone number of a contact at the FDA who
9

is knowledgeable about the premarket approval request for

AS IS

No substantive change or
burden

the new technology listed

Was the technology, service of drug available on the market
immediately after FDA approval? If
not, please provide the date that the medical service or
11

technology came on the market (i.e. first
sales or availability) and an explanation and documentation
of any delay (i.e. manufacturing
issues, shelf life concerns, or other reasons).

AS IS - This question is broken down throughout

No substantive change or

the FDA section.

burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Was the technology, service of drug available on the market
immediately after FDA approval? If
not, please provide the date that the medical service or
11

technology came on the market (i.e. first
sales or availability) and an explanation and documentation
of any delay (i.e. manufacturing
issues, shelf life concerns, or other reasons).

AS IS - This question is broken down throughout

No substantive change or

the FDA section.

burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #
8

Date of Food and Drug Administration (FDA) (or expected)
approval for the technology, service or
drug. Provide a copy of the FDA approval/clearance letter. If
approval has not yet been granted,
please provide a copy of the approval notice to CMS
immediately after it becomes available.
Note: Include all types of approvals (i.e. Pre-Market
Approval, HDE or HUD approval, expanded
access approval) the technology, service or drug received
prior to submission of this application
and/or is currently seeking. CMS recommends a timeline if
the technology, service or drug has
received multiple types of approvals from the FDA.
Per § 412.87(c) of the regulations, an applicant for new
technology add-on payments (NTAP)
must receive FDA approval or clearance for its new medical
service or technology by July 1 prior
to the beginning of the fiscal year (FY) for which the NTAP
would be effective (for FY 2021, not
later than July 1, 2020).

Please describe the (most recent, if applicable) type of
application and approval the technology,
service or drug has received or is seeking from the FDA (i.e.
10

Pre-Market Approval, HDE or HUD
approval, expanded access approval, New Drug Approval).

AS IS - This question is broken down throughout

No substantive change or

the FDA section.

burden

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Paper
Application

Paper Application Language

Modifications

Burden

Question #
Coding:
Note: If the technology, device, or drug (administered via
procedure) were to receive add-on payment
status approval, it would need to be distinctly identifiable by
ICD-10-CM/PCS diagnosis and/or procedure
code(s) 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
Coding Note

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/PCS diagnosis and or procedure code(s), you
MUST separately contact the ICD-10 C&M
Committee to submit a code request. Refer to
https://www.cms.gov/Medicare/Coding/ICD10/newrevisedco
des.html for more details including deadline
to submit code request.

AS IS

No substantive change or
burden

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Paper
Application

Paper Application Language

Modifications

Burden

Question #

Coding:
17

List the diagnosis and/or procedure codes that are currently or
will be used to identify your
technology under the ICD-10-CM/PCS coding system.

AS IS – this question has been broken down to
separate code types

No substantive change or
burden

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Paper
Application

Paper Application Language

Modifications

Burden

Question #

Coding:
List the diagnosis and/or procedure codes that are currently or
will be used to identify your
technology under the ICD-10-CM/PCS coding system.
17-18

Do the codes listed in question 17 distinctly identify your

AS IS with one exception: Request now specific to
indication to ensure clarity in applicants’ responses. No substantive change or
Currently, this detail is required to be included in

technology under the ICD-10-CM/PCS coding system? If not, the narrative.
please see the note above.

burden

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Paper
Application

Paper Application Language

Modifications

Burden

Question #
Coding:
Do the codes listed in question 17 distinctly identify your
technology under the ICD-10-CM/PCS
coding system? If not, please see the note above.
18
REQUIRED INFORMATION Applications must include a
response to each question below. Information must be entered
directly onto this form. Do not copy and paste questions and
answers into a different document. CMS may request other
information in order to evaluate specific requests. Note: A
separate application is required for each distinct technology
Preamble

or service included in a request. For example, if an applicant
requests add-on payments for two unique technologies or
services, a separate application is required for each
technology or service. A completed tracking form. (A
tracking form may be downloaded at
http://www.cms.gov/Medicare/Medicare-Fee-forServicePayment/AcuteInpatientPPS/newtech.html.)

AS IS

No substantive change or
burden

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Paper
Application

Paper Application Language

Modifications

Burden

Question #

Coding:
List any other technologies coded using the code(s) listed in
question 17. For example, if you
listed a single procedure code, what procedures use the code
19

listed in question 17 aside from the

AS IS

No substantive change or
burden

procedure used for your technology? Similarly, if you listed a
combination or multiple codes in
question 17, what other procedures or technologies use the
same combination of codes listed in
question 17 aside from your technology?

Coding:
20

Does the service or technology have an existing request
pending with the ICD-10 C&M
Committee?

AS IS

No substantive change or
burden

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Paper
Application

Paper Application Language

Modifications

Burden

Question #

If applicable, briefly describe current and/or alternative
6

treatments for the disease or condition
that your technology treats or diagnoses.

AS IS

No substantive change or
burden

Screenshot

Newness Criterion
Note: 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). As noted
above if the technology is a device has received a
Breakthrough Device designation from the FDA, skip
questions 5 through 20 (newness criterion).
AS IS

Newness

No substantive change or
burden

Criterion Note
CMS has established a 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.)
A technology is not “new”, if it meets all three of the criteria
below:
a. If a product uses the same or a similar mechanism of action
when compared to an existing
7

technology to achieve a therapeutic outcome; and
b. If a product is assigned to the same DRG when compared
to an existing technology; and
c. If the new use of the technology involves the treatment of
the same or similar type of disease
and the same or similar patient population when compared to
an existing technology.
Applicants must explain why they do not meet the criteria
above.

No substantive change or
AS IS

burden

Paper
Application

Paper Application Language

Modifications

Burden

Question #

7

Applicants must explain why they do not meet the criteria
above.

AS IS.

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Cost Information
22

What is the (current and/or anticipated) cost of the technology
to the hospital, per patient?

AS IS

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Cost Information
Provide a breakdown of how the cost of the technology is
calculated:
23

(e.g. For drugs, the average dosage or number of units per
patient (ml/kg/hr); For devices, a
breakdown of the cost of all of the components used per
patient, clearly showing which
components are the “new” ones).

AS IS

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Cost Information
Provide a breakdown of how the cost of the technology is
calculated:
23

(e.g. For drugs, the average dosage or number of units per

AS IS

No substantive change or
burden

patient (ml/kg/hr); For devices, a
breakdown of the cost of all of the components used per
patient, clearly showing which
components are the “new” ones).

Optional upload. In the old application, they could

No substantive change or

upload anything they deemed relevant.

burden

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Paper
Application

Paper Application Language

Modifications

Burden

Question #

Charge Information:
24

Under the MS-DRG grouper for FY 2020, list the MS-DRGs

AS IS

No substantive change or
burden

that the technology currently maps
to?

Charge Information:

25

Has the applicant made a request for the new technology to
map to a new or different
MS-DRG(s) for the upcoming fiscal year (2021) other than
the ones listed in question 24?

AS IS

No substantive change or
burden

Screenshot

Cost Criterion
Note: To qualify for a new technology add-on payment, the
technology or service must result in
average charges for cases using the technology in excess of
Cost Criterion
Note

the thresholds established for the FY
(lesser of 75 percent of the standardized amount increased to
reflect the difference between costs
and charges or 75 percent of 1 standard deviation beyond the
geometric mean standardized charge
for all cases in the MS-DRGs to which the new technology is
assigned) of the annual IPPS final rule.
The most recent version of the thresholds can be downloaded
at
http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/newtech.html

Charge Information:
(26) Using the table as demonstrated in the spreadsheet as a
template, show how the standardized
charge per case (if applicable, case weighted) exceeds the
26

threshold for the cost criterion.
Note: Refer to Appendix A for an explanation of how to
standardize charges. Refer to the
spreadsheet in the application packet how to case weight the
average standardize charge per
case if multiple MS-DRGs are affected by the technology.

AS IS

No substantive change or
burden

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Charge Information:

27

With regard to the spreadsheet in question 26, provide all
supporting data used to calculate
charges and standardized charges per case involving the new
technology (in electronic format).

AS IS

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

List a step by step explanation of how the data and
calculations in each column of the spreadsheet were
determined. For example, within the explanation applicants
must include the type of data used to calculate the average
28

standardized charge (i.e. Medicare and/or non[1]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.

This provides space for a column-by-column
explanation instead of an open field to standardize
applicant responses. Most applicants already used a
column-by-column approach in their narrative
response.

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

List a step by step explanation of how the data and
calculations in each column of the spreadsheet were
determined. For example, within the explanation applicants
must include the type of data used to calculate the average
28

standardized charge (i.e. Medicare and/or non[1]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.

This provides space for a column-by-column
explanation instead of an open field to standardize
applicant responses. Most applicants already used a
column-by-column approach in their narrative
response.

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

List a step by step explanation of how the data and
calculations in each column of the spreadsheet were
determined. For example, within the explanation applicants
must include the type of data used to calculate the average
28

standardized charge (i.e. Medicare and/or non[1]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.

This provides space for a column-by-column
explanation instead of an open field to standardize
applicant responses. Most applicants already used a
column-by-column approach in their narrative
response.

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

List a step by step explanation of how the data and
calculations in each column of the spreadsheet were
determined. For example, within the explanation applicants
must include the type of data used to calculate the average
28

standardized charge (i.e. Medicare and/or non[1]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.

This provides space for a column-by-column
explanation instead of an open field to standardize
applicant responses. Most applicants already used a
column-by-column approach in their narrative
response.

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #

Charge Information:
29

What is the (current and/or anticipated) charge of the
technology by the hospital, per patient?
Explain how this was determined.

AS IS

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #
Volume of Cases:
(30) What is the anticipated Medicare volume of this
technology for FY 2020 (October 1, 2019 –
30

September 30, 2020)? Please describe how you arrived at this
estimate. This estimate should be
based on the actual or projected sales of your technology, not
the total population eligible for the
technology.
AS IS
Volume of Cases:
(32) What is the anticipated Medicare volume of this
technology for FY 2021 (October 1, 2020 –

32

September 30, 2021). Please describe how you arrived at this
estimate. This estimate should be
based on the actual or projected sales of your technology, not
the total population eligible for the
technology.

No substantive change or
burden

Screenshot

Paper
Application

Paper Application Language

Modifications

Burden

Question #
Volume of Cases:
(31) What is the anticipated Non-Medicare volume of this
technology for FY 2020 (October 1, 2019 –
31

September 30, 2020). Please describe how you arrived at this
estimate. This estimate should be
based on the actual or projected sales of your technology, not
the total population eligible for the
technology.
AS IS
Volume of Cases:
(33) What is the anticipated Non-Medicare volume of this
technology for FY 2021 (October 1, 2020 –

33

September 30, 2021). Please describe how you arrived at this
estimate. This estimate should be
based on the actual or projected sales of your technology, not
the total population eligible for the
technology.

No substantive change or
burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Complete information on the substantial clinical
improvement criterion can be found in the
September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
Substantial

prior years includes CMS's decision

Clinical

making process on each application. As noted above if the

Improvement

technology is a device has received a

Criterion Note Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.
34, 35, 36
(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Complete information on the substantial clinical
improvement criterion can be found in the
September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
Substantial

prior years includes CMS's decision

Clinical

making process on each application. As noted above if the

Improvement

technology is a device has received a

Criterion Note Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.
34, 35, 36
(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Complete information on the substantial clinical
improvement criterion can be found in the
September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
Substantial
Clinical
Improvement
Criterion Note

prior years includes CMS's decision
making process on each application. As noted above if the
technology is a device has received a
Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.

34, 35, 36

(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Complete information on the substantial clinical
improvement criterion can be found in the
September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
Substantial
Clinical
Improvement
Criterion Note

prior years includes CMS's decision
making process on each application. As noted above if the
technology is a device has received a
Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.

34, 35, 36

(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Complete information on the substantial clinical
improvement criterion can be found in the
September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
Substantial

prior years includes CMS's decision

Clinical

making process on each application. As noted above if the

Improvement

technology is a device has received a

Criterion Note Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.
34, 35, 36
(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Complete information on the substantial clinical
improvement criterion can be found in the
September 7, 2001 Federal Register (66 FR 46913-14) and in
Substantial

the FY 2010 Final Rule

Clinical

(74 FR 43808-43823). Additionally, the annual final rule for

Improvement

prior years includes CMS's decision

Criterion Note making process on each application. As noted above if the
technology is a device has received a
Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.

34, 35, 36

(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Complete information on the substantial clinical
improvement criterion can be found in the
September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
Substantial

prior years includes CMS's decision

Clinical

making process on each application. As noted above if the

Improvement

technology is a device has received a

Criterion Note Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.
34, 35, 36
(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Complete information on the substantial clinical
improvement criterion can be found in the
September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
Substantial

prior years includes CMS's decision

Clinical

making process on each application. As noted above if the

Improvement

technology is a device has received a

Criterion Note Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.
34, 35, 36
(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Complete information on the substantial clinical
improvement criterion can be found in the
September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
Substantial

prior years includes CMS's decision

Clinical

making process on each application. As noted above if the

Improvement

technology is a device has received a

Criterion Note Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.
34, 35, 36
(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Complete information on the substantial clinical
improvement criterion can be found in the
September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
Substantial
Clinical
Improvement
Criterion Note

prior years includes CMS's decision
making process on each application. As noted above if the
technology is a device has received a
Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.

34, 35, 36

(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Complete information on the substantial clinical
improvement criterion can be found in the
September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
prior years includes CMS's decision
making process on each application. As noted above if the
Substantial
Clinical
Improvement
Criterion Note
34, 35, 36

technology is a device has received a
Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.

(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Complete information on the substantial clinical
improvement criterion can be found in the
September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
prior years includes CMS's decision
Substantial
Clinical
Improvement
Criterion Note

making process on each application. As noted above if the
technology is a device has received a
Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a

34, 35, 36

summary document of all posters.

(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Complete information on the substantial clinical
improvement criterion can be found in the
September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
Substantial

prior years includes CMS's decision

Clinical

making process on each application. As noted above if the

Improvement

technology is a device has received a

Criterion Note Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.
34, 35, 36
(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Substantial
Clinical
Improvement
Criterion Note

Complete information on the substantial clinical
improvement criterion can be found in the
September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
prior years includes CMS's decision
making process on each application. As noted above if the
technology is a device has received a
Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.

(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
34, 35, 36

diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
Substantial

criteria can be found in Appendix B.

Clinical

Complete information on the substantial clinical

Improvement

improvement criterion can be found in the

Criterion Note September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
prior years includes CMS's decision
making process on each application. As noted above if the
technology is a device has received a
Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.

(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
34, 35, 36

substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot

Substantial Clinical Improvement Criterion:
Note: A summary on the substantial clinical improvement
criteria can be found in Appendix B.
Complete information on the substantial clinical
improvement criterion can be found in the
Substantial
Clinical
Improvement
Criterion Note

September 7, 2001 Federal Register (66 FR 46913-14) and in
the FY 2010 Final Rule
(74 FR 43808-43823). Additionally, the annual final rule for
prior years includes CMS's decision
making process on each application. As noted above if the
technology is a device has received a
Breakthrough Device designation from the FDA, skip
questions 33 through 35 (substantial clinical
improvement criterion).
Convert posters to word documents or to provide a
summary document of all posters.

34, 35, 36

(34) Appendix B has descriptions of the substantial clinical
improvement criteria, which are associated with treatments,
diagnosis, and clinical outcomes. Using Appendix B, identify
and describe how the technology meets the criteria for
substantial clinical improvement over existing technologies.

(35) Provide an annotated list and copies of published peerreviewed articles relevant to the new service or technology.
In the annotation, please clearly summarize each article,

Reworded as individual questions to clarify for the
applicant and allow for a more straightforward
response. This also consolidates information that

No substantive change or

was required to be included in subsequent

burden

questions/tables. All information would have been
included previously.

Paper
Application

Paper Application Language

Question #
describe the purpose of the article, and the relevance to the
technology. Please indicate all literature that is referenced in
question #35 above.
Note: Indicate if any peer-reviewed articles will be released
after submission of this application.

(36) For each claim of substantial clinical improvement over
existing technologies, in table format (see Table 1 below), list
the claim of substantial clinical improvement and summarize
the supporting information to include relevant clinical trial(s)
or data. See sample table below. (Application is incomplete
without this table). Contact [email protected] with
questions concerning the table.

Modifications

Burden

Screenshot