Crosswalk

Drug Pass Through Crosswalk
Paper
Application
Question #

Paper Application Language

Modifications

As Is

Web Application Content

1

The trade name and generic name of the
product.
Page: 2

Provide information about the drug
• Drug Trade Name
• Generic Name
• Drug Type (dropdown)
o Biological
o Radiopharmaceutical
o Viscosupplements
o Other

2a.

A detailed description of the product including As Is
the following:
Composition and clinical indication(s).
Page: 2

Provide information about the drug
What is the composition and clinical indication(s) of the
drug? (Text area, max character length: 2000)

2b.

The form in which it is supplied (e.g.,
solution, tablet, etc.).
Page: 2

As Is

Provide information about the drug
What is the drug's form? (radio button)
• Solution
• Tablet
• Other
If other: Describe other (free text)

2c.

Method of administration (e.g.,
intramuscularly, intravenously, orally,
subcutaneously, sublingually, etc.).
Page: 2

As Is

Provide administration and dosage information about the
drug
Administration (dropdown)
• Intramuscularly
• Intravenously
• Orally
• Subcutaneously
• Sublingually
• Other
If other: Describe "other"

2d.

Manner of packaging (e.g., volume, dosages,
concentrations per ml, per tablet, per mCi,
etc.).
Page: 2

As Is

Provide information about the drug
What is the manner of packaging (e.g., volume, dosages,
concentrations per ml, per tablet, per mCi, etc.)? (Text
area, max character limit: 2000)

2e.

The usual minimum dosage per
administration for one patient.
Page: 2

As Is

Provide administration and dosage information about the
drug
• Minimum dosage per patient (Text field)

Comments

Paper
Application
Question #

Paper Application Language

Modifications

Web Application Content

2f.

The usual maximum dosage per
administration for one patient
Page: 2

As Is

Provide administration and dosage information about the
drug
• Maximum dosage per patient (Text field)

2g.

The typical dosage per administration for a
As Is
Medicare patient in the hospital outpatient
department per one day. Specifically, based
on a 70kg Medicare patient, what would be
the typical dosage for this drug in the hospital
outpatient setting for one day?
Page: 2

Provide administration and dosage information about the
drug
• The typical dosage per administration for a
Medicare patient in the hospital outpatient
department per one day. Specifically, based on
a 70kg Medicare patient, what would be the
typical dosage for this drug in the hospital
outpatient setting for one day? (Text area, max
character limit: 2000)

2h.

How dosages are measured.
Page: 2

As Is

Provide administration and dosage information about the
drug
• How are dosages measured? (Text area, max
character limit: 2000)

3.

A copy of the most recently published AWP
and Wholesale Acquisition Cost (WAC),
including the date of publication and
compendium where published (please
include either RED BOOK™ or Medi-Span
Price Rx among the compendium in which
the price is published).
Page: 2

As Is

Please upload a copy of the most recently published
Average Wholesale Price (AWP) and Wholesale
Acquisition Cost (WAC)
• What date was publication? (Date picker)
• What is the compendium where published?
(please include either RED BOOKTM or MediSpan Price Rx among the compendium in which
the price is published) (Text field)
Provide some details about the selected file
• Page number(s) (Text field)
• Summarize the supporting information contained
in this file (Text area, max character limit: 500)

4.

Average Sales Price (ASP) for specified units As Is
of the drug.
Page: 2

If available, what is the average sales price (ASP) for
each unit of the drug?
Enter unit cost details and click to add them to the list
(optional)
• Unit (Text field)
• $ Current cost (numeric entry)

Comments

Paper
Application
Question #

Paper Application Language

Modifications

Web Application Content

5.

The current cost of the drug, biological or
radiopharmaceutical to hospitals, that is, the
actual cost paid by hospitals net of all
discounts, rebates, and incentives in cash or
in kind. In other words, submit the best and
latest information available that provides
evidence of the actual cost to hospitals for a
specific product specified in terms of dosage
and concentration.
Page: 2

As Is

What is the current cost of the drug to hospitals?
• Current total cost (numeric entry)
• Minimum dosage cost (numeric entry)
• Maximum dosage cost (numeric entry)
• Typical dosage cost (numeric entry)

6.

The date of commercial market availability or
date of sale of first unit.
Page: 3

As Is

Provide information about the drug
What is the date of commercial market availability or date
of sale of first unit? (Date picker)

7.

List the Healthcare Common Procedure
Coding System (HCPCS) code(s) associated
with the product.
a. CPT or Level II HCPCS code that reflects
the drug administration procedure code(s) or
other procedure code associated with the
product.
b. Level II HCPCS code that currently
identifies the product/item, including an
unlisted HCPCS code (e.g., A, C, J, or Q
code). Note: Approval of a drug, biological or
radiopharmaceutical for a transitional passthrough payment under the hospital OPPS is
not contingent on prior assignment of a
national HCPCS code. If no HCPCS code is
currently available, please specify the
requested code descriptor, including dosage
units.
Page:3

As Is

List all Healthcare Common Procedure Coding System
(HCPCS) code(s) or CPT codes associated with the drug
• Enter HCPCS or CPT codes below (Text field)

Comments

Paper
Application
Question #

Paper Application Language

Modifications

Web Application Content

8.

Usage: Projected units/volume by site of
service that reflects one full year of utilization
based on the drug’s package size. Indicate
the specific projected timeframe for the
utilization (e.g., Jan 1–Dec 31, 2015, or April
1, 2015–March 30, 2016, etc.). If a drug is
packaged in multiple sizes, list projections for
every single package size. List projected
units separately by the following categories
for every single package size:
a. Medicare Inpatient Hospital
b. Medicare Outpatient Hospital
c. Medicare Physician’s Office
d. Medicare Ambulatory Surgical Center
e. Other sites of services (e.g., Federally
Qualified Health Centers, Rural Health
Clinics, Veterans Administration Hospitals,
etc.).
Page: 3

As Is

Identify all projected units/volume by site of service that
reflects one full year of utilization based on the drug’s
package size.
Indicate the specific projected timeframe for the utilization
•
Date (from) (Date picker)
•
Date (to)
(Date picker)
Packaging Size (units) (Text field)
Hospital Outpatient - Amount
(numeric entry)
Hospital Inpatient - Amount
(numeric entry)
Ambulatory Surgical Center (ASC) - Amount (numeric
entry)
Physician Office - Amount (numeric entry)
Other (optional) - Amount
(numeric entry)
• If user enters a value for other: Define what the
"Other" utilization category is
Explanation (Text field)

9.

A copy of the FDA New Drug Application or
Biologics License Application approval letter.
Only for viscosupplements for osteoarthritis
may a Premarket Approval (PMA) letter be
submitted.
Page: 3

As Is

Upload your FDA approval letter
FDA approval letter
Provide some details about the selected file
• Page numbers(s) (Text field)
• Summarize the supporting information contained
in this file: (Text area, max character limit: 2000)
What date was the FDA approval?
Approval date (date picker)

10.

A copy of the FDA label (package insert).
Page: 3

As Is

- Not specifically listed in application. Users can attach
documentation throughout the application. -

Comments

The applicant can
attach this item in the
Attachments section
at the end of the
application, but
CARIS does not
specifically ask for
this document.

Paper
Application
Question #

Paper Application Language

11.

Applicant name(s), company name,
address(es), e-mail address(es) 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
applicant name, company name, address, email address, and telephone number of the
person that CMS should contact for any
additional information that may be needed to
evaluate the application.
Page: 3

12.

Other information as CMS may require or
that the applicant believes CMS may need to
evaluate the application.
Page: 3

Modifications

As Is

Web Application Content

Who is the primary contact? & Who is the secondary
contact?
• First name (Text field)
• Middle Name (optional) (Text field)
• Last name (Text field)
• Phone number (Text field)
• Email address (Text field)
• Mailing Address line1 (Text field)
• Mailing address line2 (optional) (Text field)
• City (Text field)
• State (dropdown)
• Zip code (Text field)
• Organization (Text field)
• Relationship (dropdown)
o Consultant
o Manufacturer
o Other
§ If other: Describe
"other" (Text field)
- Not specifically listed in application. Users can attach
documentation throughout the application. -

Comments

Paper
Application
Question #

Paper Application Language

Modifications

Web Application Content

List all referencing files and documents
• Provide some details about the selected file
• 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
Marketing Materials
• Booklets, pamphlets, and brochures
• Product catalogs
• Price lists and package inserts
• Case Studies
FDA Documentation
• FDA decision letter
• FDA New Drug application
• Biologics License application approval letter
• Premarket Approval (PMA) letter
• FDA label
• Package insert
• Carton label
Cost Documentation
• Itemized cost lists
• Manufacturing invoices
• Pricing guides
This item is not included in the paper
application.

New in
MEARIS

Have you applied for a Healthcare Common Procedure
Coding System (HCPCS) code?
What are the details of your HCPCS application
• Submission date (date picker)
• What is the status (optional) (Radio button)
o Approved
o Pending

Comments

Paper
Application
Question #

Paper Application Language

This item is not included in the paper
application.

Modifications

New in
MEARIS

Web Application Content

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