CMS-10419 General Payments (Non-Research) Template

General Payments (Non-Research) Template

General Payments (Non-Research) Submission File Specification
DE #
Data Element Name
Definition / Description
Submission File Information (this section contains data elements which are reported once per submission file)
1

Applicable Manufacturer or
Applicable GPO Submitting
File Name

Textual proper name of either the Submitting Applicable Manufacturer or Submitting Applicable Group
Purchasing Organization (GPO) .

Data Type

Format

Required?

Field Size

Validation

Publicly
Displayed

Text

Free form text

Yes

≤ 100 Char

Match the name
on file for
associated
Registration ID

Yes

System generated

System generated

Yes

System
generated

Match the
Registration ID on
file

No

If this file is a single Applicable Manufacturer/GPO's set of payment(s) and/or transfer(s) of value records,
this Applicable Manufacturer/GPO name will be used for all records in the file.
If this file contains a Consolidated Report, this Applicable Manufacturer/GPO Name will be used as the
Consolidated Reporter and the Applicable Manufacturer/GPO Names and OPEN PAYMENTS system IDs
of the sub-companies making the payments/transfers of value will be recorded with every payment or
transfer of value record in the file.
2

Applicable Manufacturer or
Applicable GPO
Submitting File Registration
ID

OPEN PAYMENTS system generated identifier used to identify the Applicable Manufacturer or GPO
(populated only with CMS provided identifier).
If this file is a single Applicable Manufacturer/GPO's set of payment/transfer of value records, this
Applicable Manufacturer/GPO ID will be used for all records in the file.
If this file contains a Consolidated Report, this Applicable Manufacturer/GPO ID will be used as the
Consolidated Reporter and the Applicable Manufacturer/GPO Names and OPEN PAYMENTS System IDs
of the sub-companies making the payments/transfers of value will be recorded with every
payment/transfer of value record in the file.

3

Consolidated Report
Indicator

Indicator showing if this submission file constitutes a Consolidated Report.

Boolean

"Y" = Yes;
"N" = No

Yes

1 Char

Limited to
characters Y or N

No

4

Resubmission File Indicator

Indicator showing if this submission file contains payment(s) and/or transfer(s) of value that are
amended or corrected versions of previously submitted records.

Boolean

"Y" = Yes;
"N" = No

Yes

1 Char

Limited to
characters Y or N

No

5

Original File Submission ID

OPEN PAYMENTS system generated identifier used to identify the original file submission. This data will System generated

System generated

Yes IF

System
generated

Matches Original
File Submission ID
on file for
associated
Registration ID

No

be reported to the submitter after a successful submission and should only be reported back in a
resubmission for file identification purposes.

Line 4
Resubmission File Indicator
= "Y"

Submission Record Information (all sections from here to end of template contain data elements that are reported once per payment/transfer of value)
Recipient Demographic Information
6

Covered Recipient Type

Indicator showing if recipient of the payment or transfer of value is a physician covered recipient or a
teaching hospital.

Enumeration

"1" = Physician
"2" = Teaching Hospital

Yes

1 Char

Allowed values
limited to: "1" or
"2"

Yes

Text

Text from Standardized Selection

Yes IF

≤ 100 Char

Matches the
hospital name
provided in list for
a given TIN

Yes

9 Char

Matches a TIN
provided on
teaching hospital
list

No

Standardized list of covered Teaching Hospital names and information will be provided.
7

Teaching Hospital Name

The name of the Teaching Hospital receiving the payment or transfer of value.
Standardized list of covered Teaching Hospital names and information will be provided.

8

Teaching Hospital Tax ID
Number (TIN)

Tax Identification number of Teaching Hospital receiving the payment or transfer of value.

Line 6 is Covered Recipient
Type = "2" (Teaching
Hospital)
Text

XXXXXXXXX

Standardized list of covered Teaching Hospital names and information will be provided.

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW

Yes IF
Line 6 is Covered Recipient
Type = "2" (Teaching
Hospital)

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General Payments (Non-Research) Template

DE #
9

Data Element Name
Physician First Name

Definition / Description

Data Type

Textual first name, as listed in the National Plan & Provider Enumeration System (NPPES) of the physician Text
(covered recipient) receiving the payment or transfer of value.

Format
Free form text

Required?
Yes IF

Field Size
≤ 20 Char

Validation

Publicly
Displayed

Validation by CMS

Yes

Line 6
Covered Recipient Type =
"1" (Physician)
10

Physician Middle Name

Textual middle initial or middle name, as listed in the National Plan & Provider Enumeration System
(NPPES) of the physician (covered recipient) receiving the payment or transfer of value.

Text

Free form text

No

≤ 20 Char

11

Physician Last Name

Textual last name, as listed in the National Plan & Provider Enumeration System (NPPES) of the physician Text
(covered recipient) receiving the payment or transfer of value.

Free form text

Yes IF

≤ 35 Char

Yes

Validation by CMS

Yes

Line 6
Covered Recipient Type =
"1" (Physician)
12

Physician Name Suffix

Name suffix, as listed in the National Plan & Provider Enumeration System (NPPES) of the physician
(covered recipient) receiving the payment or transfer of value chosen from a constrained list of values
(Examples: Jr., Sr, III).

Text

Free form text

13

Recipient Primary Business
Street Address Line 1

The first line of the primary practice/business street address of the physician or teaching hospital
(covered recipient) receiving the payment or transfer of value.

Text

14

Recipient Primary Business
Street Address Line 2

The second line of the primary practice/business street address of the physician or teaching hospital
(covered recipient) receiving the payment or transfer of value.

Text

15

Recipient City

16

Recipient State

17

Recipient Zip Code

No

≤ 5 Char

Yes

Two line address format;
Yes
First line contains building number,
street name, street identifier

≤ 55 Char

Yes

Two line address format;
No
Second line contains suite number,
apartment number, post office box
number or other qualifying
information

≤ 55 Char

Yes

The primary practice/business city of the physician or teaching hospital (covered recipient) receiving the Text
payment or transfer of value.

Free form text

Yes

≤ 40 Char

Yes

The primary practice/business state or territory abbreviation of the physician or teaching hospital
Enumeration
(covered recipient) receiving the payment or transfer of value, if the primary practice/business address is
in the United States.

2 character U.S. state or territory
alpha abbreviation

Yes IF

2 Char

Limited to list of
state
abbreviations and
territories per US
Postal Service

Yes

The 9 digit zip code for the primary practice/business location of the physician or teaching hospital
Text
(covered recipient) receiving the payment or transfer of value, if the primary practice/business address is
in the United States.

9 digit numeric zip code

≤ 9 Char

Either exactly 5 or
exactly 9 numeric
digits

Yes

Recipient Country, Line 18
is the United States
Yes IF
Recipient Country, Line 18
is the United States

18

Recipient Country

The primary practice/business address country name of the physician or teaching hospital (covered
recipient) receiving the payment or transfer of value.

Text

Free form text

Yes

≤ 20 Char

Yes

19

Recipient Province

The primary practice/business province name of the physician or teaching hospital (covered recipient)
Text
receiving the payment or transfer of value, if the primary practice/business address is outside the United
States, and if applicable.

Free form text

No

≤ 20 Char

Yes

20

Recipient Postal Code

The international postal code for the primary practice/business location of the physician or teaching
hospital (covered recipient) receiving the payment or transfer of value, if the primary practice/business
address is outside the United States.

Text

Alphanumeric

Yes IF

≤ 20 Char

Proper length and
format validated
for each country

Yes

The primary email address for this payment recipient to be used for communication purposes.

Text

≤ 100 Char

Proper email
format enforced

No

21

Recipient Email Address

Recipient Country Line 18
is outside the United
States
Email Address

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW

No

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General Payments (Non-Research) Template

DE #
22

Data Element Name
Physician Primary Type

Definition / Description
Primary type of medicine practiced by the physician covered recipient.

Data Type
Enumeration

Format

Required?

"1" = Medical Doctor (MD);
"2" = Doctor of Osteopathy (DO);
"3" = Doctor of Dentistry (DDS);
"4" = Doctor of Podiatric Medicine
(DPM);
"5" = Doctor of Optometry (OD);
"6" = Chiropractor (DCP)

Yes IF

Field Size

Validation

Publicly
Displayed

1 Char

Allowed values
limited to "1", "2",
"3", "4", "5", or
"6"

Yes

Line 6
Covered Recipient Type =
"1" (Physician)

23

Physician or Teaching
Hospital NPI

Individual NPI for Physician (not NPI of any group physician belonging to) or NPI of Teaching Hospital;
required, if applicable.

Text

Numeric digits only

Yes IF
the Physian has an NPI

10 Char

Validation by CMS

No

24

Physician Specialty

Physician's single specialty chosen from the standardized "provider taxonomy" code list.

Text

Text from Standardized Selection

Yes IF

10 Char

Validation by CMS

Yes

Line 6
Covered Recipient Type =
"1" (Physician)
25

Physician License State and
License Number

Paired state and official state license number of the covered recipient physician; the pairing includes the Alphanumeric
2 letter state abbreviation, followed by a hyphen, followed by the state license number and may include
up to 5 "Physician License State and License Number" pairs, if a physician is licensed in multiple states.

Associated Drug, Device, Biological, or Medical Supply Information
26 Product Indicator
Indicator allows the Applicable Manufacturer or GPO to select whether the payment or other transfer of Enumeration
value is associated with ONLY covered drugs, devices, biologicals or medical supplies("Covered"), ONLY
non-covered drugs, devices, biologicals or medical supplies ("Non-covered"), neither covered or noncovered drugs, devices, biologicals or medical supplies("None"), or both covered and/or non-covered
drugs, devices, biologicals or medical supplies ("Covered" or "Combination").

Maximum of 5 comma
separated pairs of the state
and license number; AAXXXXXXXXXXXXXXXXX

Yes IF

"1" = "Covered"
"2" = "Non-covered"
"3" = "None"
"4" = "Combination"

Yes

Maximum of 5 comma
separated covered drugs or
biologicals

Yes IF

Line 6
Covered Recipient Type =
"1" (Physician)

≤ 20 Char per Proper length and
comma
format validated
separated item for each state

1 Char

Yes, for the
State
AND
No, for the
License #

Allowed values
limited to "1", "2",
"3", or "4"

Yes

≤ 100 Char per Validation by CMS
comma
"Product Indicator" line 26 separated item
is "1" (Covered) OR is "2"
(Combination)
AND
there is not at least 1
covered device or medical
supply provided in line 29
(Name of Associated
Covered Device or Medical
Supply)

Yes

If the payment or other transfer of value is associated with both covered drugs, devices, biologicals or
medical supplies AND non-covered drugs, devices, biologicals or medical supplies, the Applicable
Manufacturer must choose either "Covered" or "Combination", where:
(1) “Covered” represents covered ≥ 1 AND non-covered product ≥ 0 AND that "Combination" is not
selected
OR
(2) “Combination” to represent covered ≥ 1 AND non-covered product ≥ 1 AND that "Covered" is not
selected.

27

Name of Associated Covered The marketed name of the drug or biological associated with this payment or transfer of value; may
Drug or Biological
report the marketed name of up to 5 covered products (drugs, devices, biologicals, or medical supplies)
provided in either line 27 or line 29.

Text

If the drug or biological associated with this payment or transfer does not have a marketed name, report
the drug or biological name as it is registered on clinicaltrials.gov
A standardized list based on validated industry lists (drug names, etc.) will be available for guidance.

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW

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General Payments (Non-Research) Template

DE #
28

Data Element Name
NDC of Associated Covered
Drug or Biological

Definition / Description

Data Type

The National Drug Code, if any, of the drug(s) or biological(s) associated with the payment or other
Alphanumeric
transfer of value (if applicable; up to 5 NDCs). If no NDC for any named covered drug or biological in line
27, enter, "null."

Format
Free form text; Maximum of 5 No
comma separated NDCs

Required?

Field Size

Validation

Publicly
Displayed

10 Char per
Number of NDCs
comma
is same as
separated item number of names
(line 27)

Yes

Yes IF
100 Char per Validation by CMS
Maximum of 5 comma
comma
separated covered devices or
"Product Indicator" line 26 separated item
medical supplies

Yes

Free form text

Yes

≤ 100 Char

Matches AM/GPO
names specified
at registration for
associated
Registration IDs

Yes

System generated

Yes

System
generated

Matches
Registration ID(s)
on file

No

Alphanumeric string

System generated

No

System
generated

If reported,
matches Initial
Payment Record
ID for given
Original File
Submission ID

No

Fixed point

Currency (US dollars)
##########.##

Yes

≤ 12 Char

Date

YYYYMMDD

Yes

8 Char

If more than one NDC provided, order must match order of named covered drugs or biologicals in line 27,
"Name of Associated Covered Drug or Biological;" if no NDC for any named drug or biological in line 27,
enter "null."
29

Name of Associated Covered The marketed name of the device or medical supply associated with this payment or transfer of value;
Device or Medical Supply
may report the marketed name of up to 5 covered products (drugs, devices, biologicals, or medical
supplies) provided in either line 27 or line 29.

Text

is "1" (Covered) OR is "2"
(Combination)
AND
there is not at least 1
covered drug or biological
provided in line 27 (Name
of Associated Covered
Drug or Biological)

Applicable Manufacturer or GPO may provide either (1) the marketed name under which the device or
medical supply is or was marketed OR (2) the Therapeutic Area or Product Category.
A list of Therapeutic Area or Product Category will be available for guidance.

Transfer of Value (Payment) Information
30

Applicable Manufacturer or
Applicable GPO Making
Payment Name

Textual proper name of either the Applicable Manufacturer or Applicable GPO making the payment or
transfer of value being reported in this record.

Text

If this file contains a single Applicable Manufacturer/GPO's set of payment(s) and/or transfer(s) of value
records (i.e. is not a consolidated report), this data element will be the same as reported in data element
#1 for each record.
31

Applicable Manufacturer or
Applicable GPO Making
Payment Registration ID

CMS issued generated alphanumeric identifier for this Applicable Manufacturer or GPO issued during the Alphanumeric string
registration process.
If this file contains a single Applicable Manufacturer/GPO's set of payment(s) and/or transfer(s) of value
records (i.e. is not a consolidated report), this data element will be the same as reported in data element
#2 for each record.

32

Resubmitted Payment
Record ID

This data element will be blank for initial file submissions.
For resubmission files - this data element will either be blank (indicating an omitted record is being
submitted in the Resubmission file) or will contain the original payment/transfer of value record ID
(indicating which record is to be corrected). The original payment/transfer of value record ID is provided
by the CMS OPEN PAYMENTS System.

33

Total Amount of Payment

U.S. dollar amount of payment or transfer of value to recipient (manufacturer must convert to dollar
currency if necessary).

Yes

The “total amount of payment” should be tied to a singular transaction or purchased service (items listed
in “Nature of Payment” line 37).

34

Date of Payment

If reporting a singular payment, report the actual date the payment was issued.

Is within correct
reporting year

Yes

If reporting EITHER a series of payments or an aggregated set of payments, record the date of the first
payment to the covered recipient in this reporting year.

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW

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General Payments (Non-Research) Template

DE #
35

Data Element Name
Number of Payments
Included in Total Amount

Definition / Description

Data Type

The number of discrete payments being reported in the "Total Amount of Payment" data element (#33). Integer

Format

Required?

Field Size

Validation

Publicly
Displayed

Integer

Yes

3 Char

Yes

Yes

1 Char

Allowed values
limited to "1", "2",
"3", or "4"

Yes

Limited to
numeric
characters 1
through 15

Yes

Report 1 in this data element if this is a singular payment to the covered recipient.
Report the actual number of payments made to the covered recipient in this reporting year if the
amount of payment reported is EITHER a series of payments or an aggregation of a set of payments.
36

Form of Payment or Transfer The method of payment used to pay the covered recipient or to make the transfer of value.
of Value

Enumeration

"1" = Cash or cash equivalent;
"2" = In-kind items and services;
"3" = Stock, stock option, or any
other ownership interest;
"4" = Dividend, profit or other
return on investment

37

Nature of Payment or
Transfer of Value

The nature of payment used to pay the covered recipient or to make the transfer of value.

Enumeration

"1" = Consulting Fee;
Yes
"2" = Compensation for services
other than consulting, including
serving as faculty or as a speaker at
a venue other than a continuing
education program;
"3" = Honoraria;
"4" = Gift;
"5" = Entertainment;
"6" = Food and Beverage;
"7" = Travel and Lodging;
"8" = Education;
"9" = Charitable Contribution;
"10" = Royalty or License;
"11" = Current or prospective
ownership or investment interest;
"12" = Compensation for serving as
faculty or as a speaker for a nonaccredited and noncertified
continuing education program;
"13" = Compensation for serving as
faculty or as a speaker for an
accredited or certified continuing
education program;
"14" = Grant;
"15" = Space rental or facility fees
(teaching hospital only);

≤ 2 Char

38

City of Travel

For "Travel and Lodging" payments, destination city where covered recipient traveled.

Text

Free form text

≤ 20 Char

Yes IF

Yes

Line 37 Nature of Payment
= "7" Travel and Lodging
39

State of Travel

For "Travel and Lodging" payments, destination state where covered recipient traveled.

Enumeration

2 character U.S. state or territory
alpha abbreviation

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW

Yes IF
2 Char
Line 37 Nature of Payment
= "7" Travel and Lodging
and Line 40 Country of
Travel = "USA"

Limited to list of
state
abbreviations and
territories per US
Postal Service

Yes

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General Payments (Non-Research) Template

DE #
40

Data Element Name
Country of Travel

Definition / Description
For "Travel and Lodging" payments, destination country where covered recipient traveled.

Data Type
Text

Format
Free form text

Required?
Yes IF

Field Size

Validation

≤ 30 Char

Publicly
Displayed
Yes

Line 37 Nature of Payment
= "7" Travel and Lodging

General Record Information
41

Physician Ownership
Indicator

If Recipient type = "Physician", does the physician hold ownership or investment interest in the
applicable manufacturer?

Boolean

"Y" = Yes;
"N" = No

Yes IF

1 Char

Limited to
characters "Y" or
"N"

Yes

Limited to
numeric
characters "1,"
"2," or "3"

Yes

Line 6 Covered Recipient
Type = "1" (Physician)

This indicator is limited to physician's ownership, not physician's family members' ownership.
42

Third Party Payment
Recipient Indicator

Indicates if a payment or transfer of value was paid to a third party entity or individual at the request of
or on behalf of a covered recipient (physician or teaching hospital).

Enumeration

"1" = "Entity"
"2" = "Individual"
"3" = "No Third Party Payment"

Yes

1 Char

43

Name of Third Party Entity
Receiving Payment or
Transfer of Value

The name of the entity that received the payment or other transfer of value.

Text

Free form text

Yes IF

≤ 50 Char

44

Charity Indicator

Indicates the third party entity that received the payment or other transfer of value is a charity.

Boolean

"Y" = Yes;
"N" = No

No

1 Char

If reported, Third
Party Payment
Recipient
Indicator = 1
(Entity)

Yes

45

Third Party Equals Covered
Recipient Indicator

Indicator showing the "Third Party" that received the payment or transfer of value is a Covered Recipient. Boolean

"Y" = Yes;
"N" = No

Yes IF

1 Char

Limited to
numeric
characters Y or N

Yes

Yes

Line 42, Third Party
Payment Recipient
Indicator = "1" (Entity)

Line 42, Third Party
Payment Recipient
Indicator = "1" (Entity) or
"2" (Individual)
46

Contextual Information

Any free text which the reporting entity deems helpful or appropriate regarding this payment or transfer Text
of value.

47

Delay in Publication of
Indicator showing if an Applicable Manufacturer/GPO is requesting a delay in publication of a payment or Enumeration
Research Payment Indicator other transfer of value when the payment or transfer of value is made in connection with: (1) research
on or development of a new product (drug, device, biological, or medical supply) or (2) clinical
investigation regarding a new product (drug, device, biological, or medical supply). If the Delay in
Publication of Research Payment Indicator equals “1” or “2”, indicate the name of the related research
study in line 46, "Contextual information."

Free form text

"1" = R &D on New Product
"2" = Clinical Investigation on New
Product
"3" = No Delay Requested

Yes IF
≤ 500 Char
the Delay in Publication of
Research Payment
Indicator equals “1” or “2”
Yes

1 Char

Yes

Validated by CMS

Yes

Applicable Manufacturers/GPOs not requesting a delay in publication of a payment or other transfer of
value should select (3) not requesting a delay in publication to indicate that no delay is requested.
CMS will display payments or other transfers of value no later than four years after the initial request for
delay in publication of the [payment or transfer of value. Further details regarding notification to CMS of
FDA approval will be forthcoming in guidance.

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW

6