Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)

Centers for Medicare & Medicaid Services
Center for Medicare (CM)
Hospital and Ambulatory Policy Group
7500 Security Blvd
Baltimore, MD 21244-1850

Average Sale Price (ASP) Data Collection
Template/Data Validation Macro

User Manual
Version: 1.4
Last Modified: June 8, 2011

TABLE OF CONTENTS
1

OVERVIEW............................................................................................................................ 1
Explanatory Messaging .......................................................................................................................... 1
Secondary Validation Check .................................................................................................................. 1

2

NAVIGATING THE TEMPLATE ....................................................................................... 2

3

FIELD DEFINITIONS ........................................................................................................... 5

4 TEMPLATE REQUIREMENTS ......................................................................................... 16
4

ACRONYMS ......................................................................................................................... 16

User Manual Version 1.0 / September 1, 2010

ii

LIST OF FIGURES
Figure 1: Example of validation macro error message .................................................................. 1
Figure 2: Screenshot of Run ASP Validation Button ..................................................................... 2
Figure 3: Screenshot of Security Warning section ......................................................................... 2
Figure 4: Screenshot of detailed security alert macro ..................................................................... 3
Figure 5: Screenshot of validation macro error message ................................................................ 3
Figure 6: Screenshot of highlighted cell with error ........................................................................ 3
Figure 7: Screenshot of the Run ASP Validation Button ............................................................... 4

User Manual Version 1.0 / September 1, 2010

iii

1 OVERVIEW
The Average Sales Price Data Form Addendum A Excel template (available at:
http://www.cms.gov/McrPartBDrugAvgSalesPrice/) provides a framework for drug manufacturers to submit
their ASP data for current Medicare Part B drugs to CMS. Such data consists of financial, sales, and descriptive
data elements.
The Addendum A Excel template has been enhanced to include a
validation macro which will ensure that the Center for Medicare (CM)/
Hospital and Ambulatory Policy Group (HAPG) receives complete and
correctly formatted data from each manufacturer. The validation macro
performs a quality check on the formatting of manufacturers‟ ASP
information.

The ASP Macro does not edit for the
validity of data or of calculations,
only for whether the contents of the
field are correctly formatted. Users
are responsible for ensuring that
the data entered is technically
correct.

Explanatory Messaging
Each cell within the data entry area of the template has been
programmed to validate data formatting upon entry. If an invalid format is entered, an error message will be
displayed, and the cell will remain highlighted until the error is corrected. Additionally, if a required field is left
blank, the macro will provide a message to the user upon exiting that required field (refer to Figure 1 below for
sample error message).

Figure 1: Example of validation macro error message

Secondary Validation Check
The user initiates a secondary validation check by clicking the [Run ASP Validation] button located above the
first row of the field descriptions. This prompts the macro to scan all cells that contain data.
Note: The secondary validation check can be run at any time during the data entry process. It can be run more
than once.
The secondary check provides an alternate method of data validation in MS Excel. Data that are copied and
pasted into the template will override many of the individual cell validations. Therefore, the validation macro
should be run after pasting data into the template.
Page 1 of 19

Figure 2: Screenshot of Run ASP Validation Button

2 NAVIGATING THE TEMPLATE
Open the Addendum A template in Microsoft Excel.
The first time the template is accessed, the user must accept the digital signature to utilize the validation
macro.
To accept the digital signature, look for the security warning at the top of the page (see Figure 3).

Figure 3: Screenshot of Security Warning section
If a user’s system security
policies do not allow the use of
macros, even if from trusted
sources, notify CMS in writing
as a part of your submission’s
cover letter or “Assumptions”
document. All submissions
must still conform to the data

Select the Options button to the right of the security
warning message. When the next window appears, select the
“Trust all documents from this publisher” option and select the
“OK” button at the bottom of the screen (see Figure 4). This
will enable the macro and enable the spreadsheet to accept data
entries. Selection of the “Enable this content” option is also
acceptable, but this selection must be made each time the
spreadsheet is open.
Note: Once you‟ve accepted the option to “Trust all documents
from this publisher”, you will not have to perform this step
again.

“Field Definitions” described in
Section 3.

Page 2 of 19

Figure 4: Screenshot of detailed security alert macro
Enter data into each cell. If the user enters an invalid format or leaves a required field or field
combination blank, an error message will be displayed (see Figure 5) and the cell(s) with the incorrect
format will be highlighted until the user corrects the error(s) (see Figure 6).

Figure 5: Screenshot of validation macro error message

Figure 6: Screenshot of highlighted cell with error
Upon completion of data entry, select the [Run ASP Validation] button located above the first row of
the field descriptions to determine if data pass the preliminary validation checks (see Figure 7).

Page 3 of 19

Figure 7: Screenshot of the Run ASP Validation Button
The user shall correct any highlighted errors before proceeding. Upon completion of all corrections, the
user shall run the full validation macro again to confirm there are no additional errors.
Once the entered data are error free, the user shall submit the template to CMS per the submission
instructions at: http://www.cms.gov/McrPartBDrugAvgSalesPrice/.

Page 4 of 19

3 FIELD DEFINITIONS
The validation macro identifies the values listed below as acceptable for each field. All required fields shall
contain appropriately formatted data. If no data are present in a required field, the cell with the missing data
will be highlighted and an error message will appear. The user must enter properly formatted data before
additional data entry can be completed. Fields identified as not required may be left blank.
Depending on the type of product, manufacturers must submit ASP data according to one of the following
sets of field definitions.

1. Table 1 contains the field definitions for drugs and biologicals reported on the NDC
or CMS-specified unit level.
Most ASP reporting is done at the NDC level where the ASP corresponds to the amount of drug represented
by that NDC. However, for a limited number of products, reporting at the NDC unit level is not appropriate
and must be done at a CMS-specified unit level. A list of such drug products is maintained on the CMS
website at: http://www.cms.gov/McrPartBDrugAvgSalesPrice/. For these drugs and biologicals,
manufacturers will still submit ASP sales data for an NDC, but will do so on an ASP unit level specified in
this list.

Table 1: Field Definitions for Drugs and Biologicals
Field Name
Field Definition
Valid Values
Manufacturer's Name
11-Digit National Drug Code
(NDC1)

The reporting
manufacturer‟s name.
The NDC1 is the first 5
digits of the 11 digit
National Drug Code that
identifies the labeler.
The 11 digit NDC
consists of the NDC1,
NDC2, and NDC3,
which identifies the
labeler, product, and
package size.

11-Digit National Drug Code
(NDC2)

The NDC2 is the sixth
through the ninth digits
of the 11 digit National
Drug Code that identifies
the product.
The 11 digit NDC

Free form field. Alpha and
numeric values accepted.
NDC1 values should be
formatted as a 5 digit
number. Use a preceding
zero(s) as needed (ex:
labeler code 1234 shall be
reported as 01234).

Required
Field
Yes

Yes, if
Alternate ID
has NOT
been entered

NDC2 values should be
formatted as a 4 digit
number.
Use a preceding zero as
needed (ex: NDC2 123 shall
be reported as 0123).

Yes, if
Alternate ID
has NOT
Page 5 of 19

Field Name

Field Definition

Valid Values

consists of the NDC1,
NDC2, and NDC3,
which identify the
labeler, product, and
package size.
11-Digit National Drug Code
(NDC3)

The NDC3 is the last 2
digits of the 11 digit
National Drug Code that
identifies the package
size.
The 11 digit NDC
consists of the NDC1,
NDC2, and NDC3,
which identify the
labeler, product, and
package size.

been entered

NDC3 values should be
formatted as a 2 digit
number.
Use a preceding zero as
needed (ex: NDC3 1 shall be
reported as 01).

Alternate ID

Numeric or
alphanumeric alternate
identifier (ex: an NHRIC
or UPC number) used
when an 11 digit NDC is
not available.

An alphanumeric alternate
ID is 13 characters or less.

Manufacturer's Average Sales
Price

ASP for a corresponding
ASP unit rounded to 3 or
more decimal places.

Any positive or negative
numbers including zero.
Value must include at least
three decimal places. Do
not include dollar sign ($).
If no ASP, enter “0.000”.

The number of ASP units Any positive or negative
sold.
numbers including zero.
Value must include at least
three decimal places. If no
units sold, enter “0.000”.
Any positive or negative
Wholesale Acquisition Cost (WAC) The WAC for a
corresponding ASP unit
numbers including zero.
in effect on the last day
Value must include at least
of the reporting period.
three decimal places. Do
not include dollar sign ($).
WAC is defined in
If no WAC available, enter
Number of ASP Units

Required
Field

Yes, if
Alternate ID
has NOT
been entered

Yes, if
NDC1,
NDC2,
NDC3 have
NOT been
entered
Yes

Yes

Yes

Page 6 of 19

Field Name

Name of Drug or Biological

Strength of the Product Volume
Per Item

Volume Per Item

Number of Items Per NDC

Field Definition

Valid Values

Section 1847A(c)(6)(B)
as “the manufacturer‟s
list price for the drug or
biological to wholesalers
or direct purchasers in
the United States, not
including prompt pay or
other discounts, rebates
or reductions in price, for
the most recent month
for which the
information is available,
as reported in wholesale
price guides or other
publications of drug or
biological pricing data.”
CMS further clarified, in
70 FR 70221, that
manufacturers must
report WAC for all
single source drugs and
biologicals (including
new drugs) each
reporting period.
Manufacturers must
report the WAC in effect
on the last day of the
reporting period.
The trade or brand name
of the product or the
active ingredient name.
The dosage strength of
one item (e.x: 250 mg
tablet, 20 mg/ml
solution, 1 IU).

“0.000”.

Required
Field

This a free form field
limited to 100 alphanumeric
characters.
This a free form field
limited to 500 alphanumeric
characters.

Yes

The amount in one item
This a free form field
(ex: 10 ml in one vial, or limited to 12 alphanumeric
500 tablets in one bottle). characters. Enter “1” for
certain forms of drugs (e.g.
powders) when “Strength of
the Product” indicates the
amount of the product per
item.
The number of items in
Limited to 10 numeric
the 11-digit NDC (ex: if digits.
an NDC packaged as a

Yes

Yes

Yes

Page 7 of 19

Field Name

Expiration Date of Final Lot Sold

Date of First Sale

Number of CAP Units Excluded

FDA Application Number

FDA Application Supplement
Number

Field Definition
box contains 4 vials, the
number of items per
NDC is 4).
The expiration date of
the final lot sold must be
reported to CMS once at
the end of utilization of
the NDC or when there
are no sales for three
consecutive quarters.
For ASP purposes, “at
the end of utilization”
means the manufacturer
will not make sales of
that NDC to any
purchaser.
Report for NDCs first
sold on or after
04/01/2006. Report at
least once and no later
than with the first ASP
report.
Beginning with the
3Q2006 reporting period,
report the number of
whole or fractional units
administered to a
beneficiary by a Part B
Drug Competitive
Acquisition Program
participating physician
excluded from the ASP
calculation.
The application number
assigned by the Food and
Drug Administration
(FDA).

The application
supplement number
assigned by the Food and

Valid Values

Required
Field

Value should be in the date
format (MM/DD/YYYY).

No

Value should be in the date
format (MM/DD/YYYY).

Yes

Data must be numeric and
must include at least three
decimal places.

No

This field is limited to 6 or 7
characters. Data may
include a mixture of alpha
numeric and numeric values
(ex: A123456) or just
numeric values (ex:
123456). For entries with
only numeric values, use
leading zeros if necessary to
report 6 digits. Do not use
dashes or spaces.
This field is limited to 4
characters. Use the format
XXXX for the application

Yes

No

Page 8 of 19

Field Name

Field Definition

Valid Values
supplement number.

Additional FDA Application
Number #1

Drug Administration
(FDA).
The application number
assigned by the Food and
Drug Administration
(FDA).

Additional FDA Application
Supplement Number #1

Additional FDA Application
Number #2

The application
supplement number
assigned by the Food and
Drug Administration
(FDA).
The application number
assigned by the Food and
Drug Administration
(FDA).

If the product has more than
one FDA Application
Number, enter an additional
application number here.
This field is limited to 6 or 7
characters. Data may
include a mixture of alpha
numeric and numeric values
(ex: A123456) or just
numeric values (ex:
123456). For entries with
only numeric values, use
leading zeros if necessary to
report 6 digits. Do not use
dashes or spaces.
This field is limited to 4
characters. Use the format
XXXX for the supplemental
application number.
If the product has more than
one FDA Application
Number, enter an additional
application number here.

Required
Field
No

No

No

This field is limited to 6 or 7
characters. Data may
include a mixture of alpha
numeric and numeric values
(ex: A123456) or just
numeric values (ex:
123456). For entries with
only numeric values, use
leading zeros if necessary to
report 6 digits. Do not use
dashes or spaces.
Additional FDA Application
Supplement Number #2

FDA Final Pre-Marketing

The application
supplement number
assigned by the Food and
Drug Administration
(FDA).
This is the original date

This field is limited to 4
characters. Use the format
XXXX for the supplemental
application number.

No

Value should be in the date

Yes
Page 9 of 19

Field Name

Field Definition

Valid Values

Approval Date

that the FDA granted
approval for the drug
(NDA), biological
(BLA), or pre-marketing
application (PMA).

format (MM/DD/YYYY).

The type of FDA
approval for the product.

Choose a value from the
drop down menu (ANDA,
NDA, 510K, BLA, PMA,
Human Tissue, Vaccine,
Other).

FDA Approval Type

Description of FDA Approval Type If Other was specified in
the column „FDA
Approval Type,‟ please
specify the type.
To indicate that a data
Descriptive Data Corrected
element other than a
manufacturer‟s ASP or
number of ASP units has
changed since the last
report.

Required
Field

If there is no approval date,
baseline date should be set
to 01/01/1965.

If Other, specify the type in
the column „Description of
FDA Approval Type‟.
Free form field limited to
255 alphanumeric
characters.
Free form field limited to
255 alphanumeric
characters. Describe which
data element(s) have been
corrected.

Yes

Yes, if FDA
Approval
Type is
“Other”.
No

2. Table 2 contains the field definitions for dermal grafting products.
Some dermal grafting products are not assigned an NDC. Instead, manufacturers identify them using
Universal Product Codes (UPCs) or other similar but unique identifiers. If an NDC is not available, the
UPC or other unique identifier must be entered in the field “Alternate ID”. Manufacturers may not convert
a UPC or other alternative identifier to an NDC format by adding zeros or removing numbers. Additionally,
manufacturers must submit ASP sales data for dermal grafting products by square centimeter.

Table 2: Field Definitions for Dermal Grafting Products
Field Name
Field Definition
Valid Values
Manufacturer's Name
11-Digit National Drug Code
(NDC1)

The reporting
manufacturer‟s name.
The NDC1 is the first 5
digits of the 11 digit
National Drug Code that
identifies the labeler.

Free form field. Alpha and
numeric values accepted.
NDC1 values should be
formatted as a 5 digit
number. Use a preceding
zero(s) as needed (ex:
labeler code 1234 shall be

Required
Field
Yes

Page 10 of 19

reported as 01234).
Yes, if
Alternate ID
has NOT
been entered.

The 11 digit NDC
consists of the NDC1,
NDC2, and NDC3,
which identifies the
labeler, product, and
package size.
11-Digit National Drug Code
(NDC2)

The NDC2 is the sixth
through the ninth digits
of the 11 digit National
Drug Code that identifies
the product.
The 11 digit NDC
consists of the NDC1,
NDC2, and NDC3,
which identify the
labeler, product, and
package size.

11-Digit National Drug Code
(NDC3)

The NDC3 is the last 2
digits of the 11 digit
National Drug Code that
identifies the package
size.
The 11 digit NDC
consists of the NDC1,
NDC2, and NDC3,
which identify the
labeler, product, and
package size.

NDC2 values should be
formatted as a 4 digit
number.
Use a preceding zero as
needed (ex: NDC2 123 shall
be reported as 0123).

NDC3 values should be
formatted as a 2 digit
number.
Use a preceding zero as
needed (ex: NDC3 1 shall be
reported as 01).

Alternate ID

Numeric or
alphanumeric alternate
identifier (ex: an NHRIC
number or UPC) used
when an 11 digit NDC is
not available.

An alphanumeric alternate
ID is 13 characters or less.

Manufacturer's Average Sales
Price

ASP rounded to 3 or
more decimal places.

Any positive or negative
numbers including zero.
Value must include at least
three decimal places. Do
not include dollar sign ($).
If no ASP, enter “0.000”.
Any positive or negative
numbers including zero.
Value must include at least

Report the ASP per
square centimeter.
Number of ASP Units

Report the number of
square centimeters
represented by the NDC

Yes, if
Alternate ID
has NOT
been entered.

Yes, if
Alternate ID
has NOT
been entered

Yes, if
NDC1,
NDC2,
NDC3 have
NOT been
entered.
Yes

Yes

Page 11 of 19

or Alternate ID (ex: an
NDC or Alternate ID that
represents a box of five 2
cm x 3cm grafts contains
a total of 30 square cm or
30 ASP units).
Wholesale Acquisition Cost (WAC) The WAC in effect on
the last day of the
reporting period.
Report the WAC per
square centimeter.

Name of Drug or Biological

Strength of the Product Volume
Per Item

WAC is defined in
Section 1847A(c)(6)(B)
as “the manufacturer‟s
list price for the drug or
biological to wholesalers
or direct purchasers in
the United States, not
including prompt pay or
other discounts, rebates
or reductions in price, for
the most recent month
for which the
information is available,
as reported in wholesale
price guides or other
publications of drug or
biological pricing data.”
CMS further clarified, in
70 FR 70221, that
manufacturers must
report WAC for all
single source drugs and
biologicals (including
new drugs) each
reporting period.
Manufacturers must
report the WAC in effect
on the last day of the
reporting period.
The trade or brand name
of the product or the
active ingredient name.
The total square
centimeters in one item
(ex: a 6cm x 8cm item is
48 sq cm).

three decimal places. If no
units sold, enter “0.000”.

Any positive or negative
numbers including zero.
Value must include at least
three decimal places. Do
not include dollar sign ($).
If no WAC available, enter
“0.000”.

Yes

This a free form field
limited to 100 alphanumeric
characters.
This a free form field
limited to 500 alphanumeric
characters.

Yes

Yes

Page 12 of 19

Volume Per Item

The amount in one item.

Number of Items Per NDC

The number of items in
the 11-digit NDC or
Alternative ID (ex: for an
NDC or Alternate ID that
has 5 grafts in a pack, the
number of items per
NDC is 5).
The expiration date of
the final lot sold must be
reported to CMS once at
the end of utilization of
the NDC or Alternate ID
when there are no sales
for three consecutive
quarters. For ASP
purposes, “at the end of
utilization” means the
manufacturer will not
make sales of that NDC
or Alternate ID to any
purchaser.
Report for
NDCs/Alternate IDs first
sold on or after
04/01/2006. Report at
least once and no later
than with the first ASP
report.
Beginning with the
3Q2006 reporting period,
report the number of
whole or fractional units
administered to a
beneficiary by a Part B
Drug Competitive
Acquisition Program
participating physician
excluded from the ASP
calculation.
The application number
assigned by the Food and
Drug Administration
(FDA).

Expiration Date of Final Lot Sold

Date of First Sale

Number of CAP Units Excluded

FDA Application Number

This a free form field
limited to 12 alphanumeric
characters. Enter “1” for
powders and sheets.
Limited to 10 numeric
digits.

Yes

Value should be in the date
format (MM/DD/YYYY).

No

Value should be in the date
format (MM/DD/YYYY).

Yes

Data must be numeric and
must include at least three
decimal places.

No

This field is limited to 6 or 7
characters. Data may
include a mixture of alpha
numeric and numeric values
(ex: A123456) or just
numeric values (ex:

Yes

Yes

Page 13 of 19

FDA Application Supplement
Number

Additional FDA Application
Number #1

Additional FDA Application
Supplement Number #1

Additional FDA Application
Number #2

Additional FDA Application
Supplement Number #2

The application
supplement number
assigned by the Food and
Drug Administration
(FDA).
The application number
assigned by the Food and
Drug Administration
(FDA).

The application
supplement number
assigned by the Food and
Drug Administration
(FDA).
The application number
assigned by the Food and
Drug Administration
(FDA).

The application
supplement number

123456). For entries with
only numeric values, use
leading zeros if necessary to
report 6 digits. Do not use
dashes or spaces.
This field is limited to 4
characters. Use the format
XXXX for the application
supplement number.
If the product has more than
one FDA Application
Number, enter an additional
application number here.
This field is limited to 6 or 7
characters. Data may
include a mixture of alpha
numeric and numeric values
(ex: A123456) or just
numeric values (ex:
123456). For entries with
only numeric values, use
leading zeros if necessary to
report 6 digits. Do not use
dashes or spaces.
This field is limited to 4
characters. Use the format
XXXX for the supplemental
application number.
If the product has more than
one FDA Application
Number, enter an additional
application number here.
This field is limited to 6 or 7
characters. Data may
include a mixture of alpha
numeric and numeric values
(ex: A123456) or just
numeric values (ex:
123456). For entries with
only numeric values, use
leading zeros if necessary to
report 6 digits. Do not use
dashes or spaces.
This field is limited to 4
characters. Use the format

No

No

No

No

No

Page 14 of 19

FDA Final Pre-Marketing
Approval Date

FDA Approval Type

assigned by the Food and
Drug Administration
(FDA).
This is the original date
the FDA granted
approval for the drug
(NDA), biological
(BLA), or pre-marketing
application (PMA).
The type of FDA
approval for the product.

Description of FDA Approval Type If Other was specified in
the column „FDA
Approval Type,‟ please
specify the type.
To indicate that a data
Descriptive Data Corrected
element other than a
manufacturer‟s ASP or
number of ASP units has
changed since the last
report.

XXXX for the supplemental
application number.
Value should be in the date
format (MM/DD/YYYY).
If there is no approval date,
baseline date should be set
to 01/01/1965.
Choose a value from the
drop down menu (ANDA,
NDA, 510K, BLA, PMA,
Human Tissue, Vaccine,
Other).
If Other, specify the type in
the column „Description of
FDA Approval Type‟.
Free form field limited to
255 alphanumeric
characters.
Free form field limited to
255 alphanumeric
characters. Describe which
data element(s) have been
corrected.

Yes

Yes

Yes, if FDA
Approval
Type is
“Other”
No

Page 15 of 19

4 TEMPLATE REQUIREMENTS
1. To use this template, a user must have the ability to enable and execute MS Excel-based Visual Basics
for Applications (VBA) Macros.
If the user is not able to accept macros due to constraints in corporate security policies, CMS
should be notified in writing of the security limitations in the user‟s cover letter.
2. Users shall not add additional columns to the template.
3. Users shall not add, remove or otherwise change columns or column headings within the template.
4. Users shall not submit blank rows between data entries. All data must be submitted in contiguous rows.
5. Users shall not create multiple rows for one NDC or Alternative ID.

4

ACRONYMS

ASP

Average Sale Price

CMS

Centers for Medicare & Medicaid Services

CM

Center for Medicare

HAPG

Hospital and Ambulatory Policy Group

NDC

National Drug Code

NHRIC

National Health Related Items Code

MS

Microsoft

VBA

Visual Basics for Applications

WAC

Wholesale Acquisition Cost

FR

Federal Register

IU

International Units

ML

Milliliter

MG

Milligram

CAP

Competitive Acquisition Program

FDA

Food and Drug Administration

NDA

New Drug Application

BLA

Biologics License Application

PMA

Pre Marketing Approval

ANDA

Abbreviated New Drug Application

Page 16 of 19