MEARIS Non-Substantive Crosswalk

New Tech APC Crosswalk
Paper
Application
Question #

Paper Application Language

Modifications

Web Application Content

1.

The name by which the service is most commonly known.
Page 5

As Is

Provide information about the service.
Service Name (Text field)

2.

A clinical vignette, including patient diagnoses that the service is
intended to treat, the typical patient, and a description of what
resources are used to furnish the service by both the facility and
the physician. For example, for a surgical procedure this would
include staff, operating room, and recovery room services, as
well as equipment, supplies, and devices, etc.
Page 5

As Is

Provide information about the service.
1) What diagnoses does the service intend to
treat? (Text area, max character limit: 2000)
2) What are the resources used to furnish the
service by both the facility and the
physician? (Text area, max character limit:
2000)

3.

A list of any drugs or devices used as part of the service that
As Is
require approval from the Food and Drug Administration (FDA)
and information to document receipt of FDA approval/clearances
and the date obtained, including a copy of the FDA approval or
clearance letter. NOTE: Applicants are advised not to apply for a
New Technology APC assignment until any required FDA
approvals or clearances are received. An application is not
complete without the required FDA information.
Page 5

Are there any drugs or devices used as part of the
service that require approval from the Food and
Drug Administration (FDA)? Yes/No
If yes: List your devices and/or drugs that require
FDA approval
List of items used as part of the service:
1) Item name (Text field)
2) Select your most recent FDA Marketing
Pathway (dropdown)
a) Premarket Notification 510 (k)
b) Premarket Approval (PMA)
c) De Novo Classification Request
d) HD Exemption
e) FDA Exemption
f) Other
3) Enter the FDA decision date (date picker)
4) Attach the FDA decision letter

4.

A description of where the service is currently being performed
(by location) and the approximate number of patients receiving
the service in each location.
Page: 5

As Is

Provide information about the service.
Where is the service performed (by location) and
how many patients receive the service in each
location? (Text area, max character limit: 2000)

5.

An estimate of the number of physicians who are furnishing the
service nationally and the specialties they represent.
Page: 5

As Is

Provide information about the service.
How many physicians provide this service
nationally and what are their specialties? (Text
area, max character limit: 2000)

6.

Information about the clinical use and efficacy of the service,
such as peer-reviewed articles.
Page: 5

As Is

CARIS does not have a field or screen specifically
requesting this document. Peer reviewed articles
are noted in the list of items to include on the
Attachments page at the end of the application.

Comments

This question is broken
down into different fields
for the applicant to
describe the diagnoses
and the resources
separately.

See Attachments field at
the end of the
crosswalk.

Paper
Application
Question #

Paper Application Language

Modifications

Web Application Content

7.

The CPT or HCPCS Level II code(s) that are currently being
used to report the service and an explanation of why use of
these HCPCS codes is inadequate to report the service under
the OPPS
Page: 5

As Is

List the Healthcare Common Procedure Coding
System (HCPCS) code(s) and title(s) that are
currently being used to report the service.
• Enter HCPCS codes & titles (Text fields)
• Why are the use of these HCPCS codes
inadequate to report the service under the
OPPS? (Text area, max character
limit:2000)

8.

A list of the CPT or HCPCS Level II codes for all items and
procedures that are an integral part of the service. This list
should include codes for all procedures and services that, if
coded in addition to the code for the service under consideration
for new technology status, would represent unbundling.
Page: 5

As Is

List the CPT or HCPCS Level II codes for all items
and procedures that are an integral part of the
service.
• Item / Procedure (Text field)
• Enter CPT or HCPCS codes and
titles (Text fields)

9.

A list of all CPT and HCPCS Level II codes that would typically
be reported in addition to the service
Page: 5

As Is

List all CPT and HCPCS Level II codes that would
typically be reported in addition to the service.
• Enter CPT or HCPCS codes and titles:

10.

A proposal for a new HCPCS code, including a descriptor and
rationale for why the descriptor is appropriate. The proposal
should include the reason why the service does not have a CPT
or HCPCS Level II code, and why the CPT or HCPCS Level II
code or codes currently used to describe the service are
inadequate.
Page: 5

As Is

What do you propose for a new HCPCS code,
including a descriptor and rationale for why the
descriptor is appropriate?
Enter proposed code(s) and descriptor (Text
fields)
What is your rationale for the above? (Text area,
max character limit: 2000)

11.

An itemized list of the costs incurred by a hospital to furnish the
new technology service, including labor, equipment, supplies,
overhead, etc.
Page: 5

As Is

List itemized costs incurred by a hospital to furnish
the new service
Enter cost details below and click to add them to
the list
Item (Text field)
Cost (numeric entry)

Comments

Paper
Application
Question #

Paper Application Language

Modifications

Web Application Content

12.

Name(s), address(es), e-mail addresses and telephone
number(s) of the party or parties making the request and
responsible for the information contained in the application. If
different from the requester, give the name, address, e-mail
address, and telephone number of the person that CMS should
contact for any additional information that may be needed to
evaluate the application.
Page: 6

As Is

Who is the primary contact? & Who is the
secondary contact?
1) First name (Text field)
2) Middle Name (optional) (Text field)
3) Last name (Text field)
4) Phone number (Text field)
5) Email address (Text field)
6) Mailing Address line1 (Text field)
7) Mailing address line2 (optional) (Text field)
8) City (Text field)
9) State (dropdown)
10) Zip code (Text field)
11) Organization (Text field)
12) Relationship (dropdown)
a) Consultant
b) Manufacturer
c) Other
i) If other: Describe "other" (Text field)

13.

Other information as CMS may require to evaluate specific
requests or that the applicant believes CMS may need to
evaluate the application.

Minor
modification

List all referencing files and documents
1) Provide some details about the selected file
2) Page number(s) (Text field)
Summarize the supporting information contained
in this file (Text area, max character limit: 500)
Note: Click to view important files and documents
to include (opens in a pop up window)
Items to Include
Informative Materials
• Booklets, pamphlets, and brochures
• Peer Reviewed Articles
• Clinical Vignettes
• Case Studies
FDA Documentation
• FDA decision letter
• FDA clearance letter
Cost Documentation
• Itemized cost lists
• Manufacturing invoices
• Pricing guides

This item is not included in the paper application.

New in
MEARIS

Describe the service. (Text area, max character
limit: 2000)

Comments

Leveraging capability to
add reference
documents as
attachments in addition
to entered data

Paper
Application
Question #

Paper Application Language

Modifications

Web Application Content

This item is not included in the paper application.

New in
MEARIS

Have you applied for a Healthcare Common
Procedure Coding System (HCPCS)
code? Yes/No
If yes: What are the details of your HCPCS
application?
• Submission date (date picker)
• What is the status (optional) (Radio
button)
o Approved
o Pending

This item is not included in the paper application.

New in
MEARIS

Have you completed other CARIS applications for
this technology? Yes/No
If yes:
Please provide information about your previous
applications
Enter an application details below and click to add
them to the list
Application Type (dropdown list, options as follows)
• NTAP
• New & Revised Medicare Severity
Diagnosis Related Groups
• Device PTP
• Drug PTP
• WIA
• New Tech APC
• GME
• HCPCS
• HOP Nomination
• HOP Presentations
Application status (optional):
• Approved
• Pending
• Denied
• Withdrawn
Description
Submission Date (optional) (calendar picker)

Comments