Crosswalk

Device Pass-through Web Application Crosswalk

Web
Application

Web Application Content

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Burden

Modification

Section
15

Additional FDA

We do not

Information from the

anticipate any

already required FDA

additional burden.

clearance

The answers to

documentation:

these questions are

New

in the FDA clearance

FDA Info

Note: Utilizing slide

documentation the

format but will tweak

applicant is required

questions to read: List

to attach to their

the indication for which

application under

the Device Pass through

the current process.

is being submitted.
If the device received a
breakthrough indication
from the FDA then list
the indication for which
the designation was
received. (optional)
27

Substantial Clinical

added that

Please Note: Utilizing

was in the

application with
modifications to the first

Clinical
Improvements

Question

Improvement Criterion
slide format from NTAP

Substantial

None

paragraph to make it
relevant for OPPS Device
P-T purposes. CMS

original
paper
application
that was
inadvertent

determines that a device

ly not

to be included in the

included in

category will

the MEARIS

substantially improve

system

the diagnosis or

when

treatment of an illness or

originally

injury or improve the

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Application

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Burden

Modification

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functioning of a

implement

malformed body part

ed.

compared to at least one
other currently available
and appropriate
treatment or diagnostic
test (ie. considered a
standard of care,
currently in use and
utilized by the Medicare
population). Whether a
candidate device
provides substantial
clinical improvement is
evaluated by one or
more of the following: a.
The device offers a
treatment option for a
patient population
unresponsive to, or
ineligible for, currently
available treatments.
Refer to the interim final
rule with comment
period in the November
2, 2001 Federal Register
and the final rule with
comment period in the
November 1, 2002
Federal Register (67 FR
66781) and the
modifications to certain
criteria in the November
10, 2005 (70 FR 68628)
final rule with comment
period for a full
discussion of the criteria
for establishing
additional pass-through

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Burden

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Section
categories for medical
devices.
• Does the new medical
service or technology
offer a treatment option
for a patient population
unresponsive to, or
ineligible for, currently
available treatments?
•

Yes / No

• Please explain why the
technology does or does
not meet this criterion
using supporting data.
• Text Box: Explanation
0/3000
28

None
Current treatments for

added that

the disease or condition

was in the

that this technology

original

treats or diagnoses

paper

• Are there any other

application

treatments for the
Newness
Criterion

Question

disease or condition that
this technology treats or
diagnoses?

that was
inadvertent
ly not
included in

o Yes / No
• Briefly describe current

the MEARIS

treatments for the

system

disease or conditions

when

o Text Box: Provide

originally

response

implement

0/3000

ed.