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pdfRevisions Crosswalk (CMS-10419)
DE#
revised
n/a
DE#
n/a
Data element
name
n/a
Action to be
performed
Edit
Changes to the submission file
specifications
The name of this document is changed from
data templates to submission file
specifications.
n/a
n/a
n/a
Edit
The column header row # is changed to DE
#, data element.
n/a
n/a
n/a
Edit
The value column is broken into two
columns, data type and format.
n/a
n/a
n/a
Edit
The data element size is changed to field
size.
n/a
n/a
n/a
Addition
A CMS validation column was added.
n/a
n/a
n/a
Edit
References made to NPPTP are changed to
OPEN PAYMENTS.
General Payments (Non-Research)
2.
2.
Applicable
Edit
1. The description field is edited to: OPEN
Reason for the Change
Submission file specifications is an accurate term for
applicable manufactures and applicable GPOs to use
as guidance to build systems to support data
collection.
Data element accurately reflects the information
contained in that row for the submission file
specifications.
Presenting this information in two columns will
assist applicable manufacturers and applicable GPOs
in implementing the submission file specifications in
their systems by understanding the data type and
format that the OPEN PAYMENTS system will collect.
Based on comments requesting clarification
regarding character lengths to ensure accurate
reporting, the data element size is edited to reflect
field size, which describes the field. Additional, the
field size includes references to less than or equal to
a specific character size, if applicable. This provides
guidance for applicable manufacturers and
applicable GPOs to not include more characters than
what was originally specified.
The validation column explains to applicable
manufactures and applicable GPOs how their data
will be validated in the OPEN PAYMENTS system to
help eliminate errors when submitting reports.
Documents disseminated to the public now reference
OPEN PAYMENTS, rather than NPPTP, therefore the
data submission specifications are edited for
consistency.
The description is edited to provide guidance to
Page 1 of 62
DE#
revised
DE#
Data element Action to be
name
performed
manufacturer
or applicable
GPO
registration ID
submitting file
6.
6.
Covered
Recipient
Type
Edit
7.
7.
Teaching
Hospital
Name
Edit
Changes to the submission file
specifications
PAYMENTS system generated
identifier used to identify the Applicable
Manufacturer or GPO (populated only
with CMS provided identifier). If this
file contains 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.
2. The field size is edited to: system
generated.
1. The description field is edited to:
Indicator showing if recipient of the
payment or transfer of value is a
physician covered recipient or a teaching
hospital. Standardized list of covered
Teaching Hospital names and
information will be provided.
2. The field size is edited to: 1 character.
1. The description field is edited to: The
name of Teaching Hospital receiving the
payment or transfer of value.
Standardized list of covered Teaching
Hospital names and information will be
Reason for the Change
collect the information required for to reporting.
The field size is edited to reflect the registration ID
will be system generated.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to collect the appropriate
characters designated in the format column.
The description is edited to provide guidance to
collect the information required for to reporting.
Page 2 of 62
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revised
DE#
Data element
name
Action to be
performed
8.
8.
Edit
9.
9.
Teaching
Hospital Tax
ID Number
(TIN)
Physician first
name
10.
10.
Physician
middle name
Edit
11.
11.
Physician last
name
Edit
12.
12.
Physician
name suffix
Edit
Edit
Changes to the submission file
specifications
provided.
1. The field size is edited to: 9 characters.
Reason for the Change
1. The description field is edited to: textual
first name, as listed in the National Plan
& Provider Enumeration System
(NPPES) of the physician (covered
recipient) receiving the payment or
transfer of value.
2. The field size is limited to less than or
equal to 20 characters.
1. The description field is edited to: 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.
2. The field size is limited to less than or
equal to 20 characters.
1. The description field is edited to: textual
last name, as listed in the National Plan
& Provider Enumeration System
(NPPES) of the physician (covered
recipient) receiving the payment or
transfer of value.
2. The field size is limited to less than or
equal to 35 characters.
1. The description field is edited to: suffix,
as listed in the as listed in the National
Plan & Provider Enumeration System
(NPPES) of the physician (covered
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES.
The field size is edited to collect the appropriate
characters designated in the format column.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES.
Page 3 of 62
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revised
13.
14.
15.
DE#
Data element
name
Action to be
performed
13. Recipient
Edit
Primary
(practice
location)
Business
Street Address
Line 1
14. Recipient
Edit
Primary
(practice
location)
Business
Street Address
line 2
15. Recipient City Edit
17.
17. Recipient Zip
Code
Edit
19.
19. Recipient
Province
Edit
Changes to the submission file
specifications
recipient) receiving the payment or
transfer of value chosen from a
constrained list of values. (Examples:
Jr., Sr., III).
2. The field size is limited to less than or
equal to five characters.
1. The data element name was edited to:
Recipient Primary (practice location)
Business Street Address Line 1.
2. The field size is limited to less than or
equal to 55 characters.
Reason for the Change
1. The data element name was edited to:
Recipient Primary (practice location)
Business Address Line 2.
2. The field size is limited to less than or
equal to 55 characters.
The data element name is edited to clarify the
information required for to reporting. The field size
is edited to be consistent with data collection in
NPPES.
1. The field size is limited to less than or
equal 40 characters.
1. The description field is edited to: The 9
digit zip code for the primary practice
location of the physician or teaching
hospital (covered recipient) receiving
the payment or transfer of value if the
primary practice address is in the United
States.
2. The field size is edited to less than or
equal to 9 characters.
1. The description field is edited to: The
primary practice province name of the
The field size is edited to be consistent with data
collection in NPPES.
Based on comments received the field size is
increased to accommodate a 5 digit zip code with an
option to report the additional 4 digits.
The data element name is edited to clarify the
information required for to reporting. The field size
is edited to be consistent with data collection in
NPPES.
The description is edited to provide guidance to
collect the information required for to reporting.
Page 4 of 62
DE#
revised
20.
21.
DE#
Data element
name
Action to be
performed
20. Recipient
Edit
Postal Code
21. Recipient
Edit
Email Address
22.
22. Physician
Primary Type
Edit
23.
23. Physician NPI
Edit
24.
24. Physician
Specialty
Edit
25.
25. Physician
License State
and License
Number
Edit
Changes to the submission file
specifications
physician or teaching hospital (covered
recipient) receiving the payment or
transfer of value if the primary practice
address is outside the United States, and
if applicable.
2. The required field is edited to: no.
1. The field size is less than or equal to 20
characters.
1. The field size is increased to less than or
equal to 100 characters.
1. The description field is edited to:
Primary type of medicine practiced by
the physician covered recipient.
2. The field size is limited to 1 character.
1. The description field is edited to:
Individual NPI for Physician (not NPI of
any group physician belonging to),
required if applicable.
2. The required field is changed to: no.
1. The description field is changed to:
Physician’s single specialty chosen from
the standardized “provider taxonomy”
list.
2. The field size is edited to be limited to
10 characters.
1. The data element name is changed to:
Physician License State and License
Number
2. The description field is changed to:
Paired state and state license number of
the covered physician; the pairing
Reason for the Change
The required field is edited to no because based on
comments received not all countries outside the
United States necessarily have provinces.
The field size is edited to be consistent with data
collection in NPPES.
The field size is increased to allow applicable
manufacturers and applicable GPOs to accurately
report a recipient’s email address.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is limited to accurately collect
characters in the format column.
The required filed is changed to no because
applicable manufacturers and applicable GPOs are
only required to report a physician’s NPI if
applicable.
Based on comments received the “provider
taxonomy” list from the Washington Publishing
Company will be provided. This is the same list that
can be retrieved through the NPPESS website. The
field size is edited to accurately reflect the characters
for collection.
The physician’s license number and state are
combined in order to reflect the appropriate state
with the license number because multiple license
numbers and states may be reported. The field size
is edited to accurately reflect the characters for
collection.
Page 5 of 62
DE#
revised
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DE#
Data element
name
26. Physician
License State
Action to be
performed
Changes to the submission file
Reason for the Change
specifications
includes the 2 letter state abbreviation
followed by the state license number and
may include up to 5 "Physician License
State and License Number" pairs.
3. The field size is edited to: less than or
equal to 13 characters.
Delete
1. This data element was deleted.
This data element was combined with Physician
Licenses State(s) and License Number(s) for
simplification.
Page 6 of 62
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revised
26.
27.
DE#
-------
Data element
name
Product
Indicator
27. Name of
Associated
Covered Drug
Action to be
performed
Addition
Edit
Changes to the submission file
specifications
1. The description field is: Indicator allows
the Applicable Manufacturer or GPO to
select whether the payment or other
transfer of value is associated with
ONLY covered drugs, devices,
biologicals or medical
supplies("Covered"), ONLY noncovered drugs, devices, biologicals or
medical supplies ("Non-covered"),
neither covered or non-covered drugs,
devices, biologicals or medical
supplies("None"), or both covered
and/or non-covered drugs, devices,
biologicals or medical supplies
("Covered" or "Combination"). 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 may 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.
2. The required field is: yes.
3. The field size is: 1 character.
1. The data element name is changed to:
Name of Associated Covered Drug or
Biological.
Reason for the Change
Based on comments requesting clarification how
applicable manufacturers and applicable GPOs will
report “None”, “Non-Covered”, or report covered
products and have the ability to indicate “NonCovered” the product indicator data element was
added. This data element provides clarification for
applicable manufacturers’ and applicable GPOs’
options for when payments or other transfer of value
were associated with covered or non-covered
products. The Product Indicator should be “None”
if the payment or other transfer of value was not
associated with any products. The Product Indicator
should be “Non-covered” if the payment or transfer
of value was only associated with non-covered
products. The Product Indicator should be
“Combination” if the payment or other transfer of
value was associated with at least one covered
product and one non-covered product. The payment
indicator should be “Covered” if the payment or
other transfer of value was associated with only
covered products. However, applicable
manufacturers and applicable GPOs also have the
option to indicate “Covered” if the payment or other
transfer of value was associated with at least one
covered and one non-covered product and choose to
not report that the payment or other transfer of value
was also associated with a non-covered product.
Based on comment received the Name of Associated
Covered Drug or Biological data element is separate
from the Name of Associated Covered Device or
Page 7 of 62
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revised
28.
DE#
Data element
name
or Biological
28. NDC of
Associated
Drug or
Biological
Action to be
performed
Edit
Changes to the submission file
specifications
2. The description field is changed to: The
marketed name of the drug or biological
associated with this payment or transfer
of value; may report the marketed name
of up to 5 covered drugs, devices,
biologicals, or medical supplies
provided in either line 27 or line 29. 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.
3. The required field is changed to: Yes IF
the "Product Indicator" (line 26) is
"Covered" or "Combination" AND there
is not at least 1 covered device or
medical supply listed in line 29 "Name
of Associated Covered Device or
Medical Supply".
1. The date element name is edited to:
NDC of Associated Drug or Biological.
2. The description is edited to: The
National Drug Code, if any, of the
drug(s) or biological(s) associated with
the payment or other transfer of value.
If no NDC for any named covered drug
or biological in line 27, enter, "null." 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
Reason for the Change
Medical Supply data element. The required filed is
edited because this data element is only required
based on the product indicator chosen by the
applicable manufacturer or applicable GPO, as well
as, if the applicable manufacturer or applicable
GPOs did not provide at least one covered device or
medical supply in the data element Name of
Associated Covered Device or Medical supply. A
covered product is required for reporting when an
applicable manufacturer or applicable GPO indicates
either Covered or Combination in the product
indicator.
The data name and description are changed to
accurately define that an NDC is collected for an
associated drug or biological, if applicable. The
requirement is edited to reflect an NDC of
Associated Drug or Biological is only collected if
applicable. The field size is edited to limit the
character size to 10 characters per NDC.
Page 8 of 62
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revised
29.
DE#
Data element
name
Action to be
performed
29.
Name of
Associated
Covered
Device or
Medical
Supply
Edit
Changes to the submission file
specifications
"null."
3. The requirement field is edited to: Yes
IF the Drug(s) or Biological(s) reported
in Line 27 (Name of Associated Drug or
Biological) has (have) an associated
NDC.
4. The field size is edited to: 10 characters.
1. The data element name is: Name of
Associated Covered Device or Medical
Supply
2. The description is: The marketed name
of the device or medical supply
associated with this payment or transfer
of value; may report the marketed name
of up to 5 covered drugs, devices,
biologicals, or medical supplies
provided in either line 27 or line 29.
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 provided.
3. The required field is: Yes IF
the "Product Indicator" (line 26) is
"Covered" or "Combination" AND there
is not at least 1 covered drug or
biological listed in line 27 "Name of
Associated Covered Drug or Biological"
4. The field size is: 100 characters.
Reason for the Change
Based on comment received the Name of Associated
Covered Device or Medical Supply data element is
separate from the Name of Associated Covered
Drug or Biological data element. This will allow for
accurate data collection when applicable
manufactures or applicable GPOs are choosing how
to report a covered device or medical supply,
marketed name, therapeutic are or product category.
The required filed is edited because this data
element is only required based on the product
indicator chosen by the applicable manufacturer or
applicable GPO, as well as, if the applicable
manufacturer or applicable GPOs did not provide at
least one covered drug or biological in the data
element Name of Associated Covered Drug or
Biological. A covered product is required for
reporting when an applicable manufacturer or
applicable GPO indicates either Covered or
Combination in the product indicator.
Page 9 of 62
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revised
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DE#
Data element
name
Entity making
Indirect
Payment
Action to be
performed
Delete
Changes to the submission file
specifications
1. This data element is deleted.
32.
33.
Resubmitted
Payment
Record ID
Edit
1. The field size is edited to: system
generated.
2. The required field is edited to: no.
33.
34.
Total Amount
of Payment
Edit
1. The description field is edited to: U.S.
Dollar amount of payment or transfer of
value to recipient (manufacturer must
convert to dollar currency if necessary).
The “total amount of payment” should
be tied to a singular transaction or a
singular purchased service (items listed
in “Nature of Payment” line 37).
------
38.
Details
Regarding
Form of
Payment
Delete
1. This data element is deleted.
42.
44.
Payment
Recipient
Indicator
Edit
1. The description is edited to: 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
32.
Reason for the Change
Based on comments received, this data element is
deleted because applicable manufacturers and
applicable GPOs are not required to distinguish
between direct and indirect payments. If an indirect
payment is provided to a covered recipient,
physician owner or physician investor applicable
manufacturers and applicable GPOs are required to
report the indirect payment amount in the name of
the covered recipient, physician owner or physician
investor.
The field size is edited to reflect the Resubmitted
Payment Record ID will be system generated. The
required field is changed to no indicating this field is
only required when applicable.
The description is edited to provide guidance to
collect the information required for to reporting
The Details Regarding Form of Payment is deleted
because is not required. The Contextual Information
field provides applicable manufacturers and
applicable GPOs the opportunity to provide a
statement with additional context for the payment or
other transfer of value.
Based on comments received the description is
edited to provide guidance for applicable
manufactures and applicable GPOs to indicate when
a payment or other transfer of value was provided to
Page 10 of 62
DE#
revised
43.
44.
DE#
45.
---
Data element
name
Action to be
performed
Name of third
party Entity
Receiving the
Payment or
Transfer of
Value
Edit
Charity
Indicator
Addition
Changes to the submission file
specifications
recipient (physician or teaching
hospital).
2. The field size is edited to: 1 character
1. The description is edited to: The name of
the entity that received the payment or
other transfer of value.
2. The required field is edited to: Yes if
Payment Recipient Indicator is 1.
1.
2.
45.
---
Third Party
Equals
Covered
Recipient
Indicator
Addition
3.
4.
1.
2.
3.
4.
46.
46. Contextual
Information
Edit
1.
2.
Reason for the Change
a third party. The field size is edited to accurately
collect the characters required from the formal
column.
Based on comments received the description is
edited to provide guidance for applicable
manufactures and applicable GPOs to indicate the
name of third party entity that received the payment
or transfer of value. The required field is edited to
determine when applicable manufactures and
applicable GPOs are required to provide the name of
the third party entity.
The data element name is: Charity
The Charity Indicator, which was previously
Indicator.
included in the Name of Third Party Entity
The description is: Indicates the third
Receiving Payment or Transfer of Value, in order to
party entity that received the payment or allow applicable manufactures and applicable GPOs
other transfer of value is a charity.
when covered recipients opted to donate their
The field size is: 1 character.
payment or other transfer of value to a charity.
The requirement field is: no.
The data element name is: Third Party
This data element is added to indicate if the third
Equals Covered Recipient Indicator
party receiving the payment or other transfer of
The description field is: The Indicator
value is a covered recipient. This indicator prevents
showing the third party that received the the OPEN PAYMENTS system from counting the same
payment or transfer of value is a
payment or transfer of value provided twice because
covered recipient.
the payment or other transfer of value is reported
The field size is: 1 character.
under distinct covered recipients.
The requirement field is: yes, if the
Payment Recipient Indicator equals “1”
or “2”.
The required field is edited to: yes, if
The required field is edited to all the OPEN
the Delay in Publication of Research
PAYMENTS system to associate payments for delayed
Payment Indicator equals “1” or “2”
publication to a research report. The field size is
The field size is edited to: 500
edited to match contextual information data element
characters.
in the general payments data file specification.
Page 11 of 62
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revised
47.
DE#
---
Data element
name
Delay in
Publication of
Research
Payment
Indicator
Action to be
performed
Addition
Changes to the submission file
specifications
1. The data element name is: Delay in
Publication of Research Payment
Indicator
2. The description field is: Indicator
showing if an Applicable
Manufacturer/GPO is requesting a delay
in publication of a payment or 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." 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.
3. The field size is: 1 character.
4. The requirement field is: yes.
Reason for the Change
This data element allows applicable manufacturers
and applicable GPOs to indicate a payment or
transfer of value that was outside to the research
protocol or agreement should be delayed for
publication.
Page 12 of 62
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revised
Research
6.
6.
Data element
name
Action to be
performed
Changes to the submission file
specifications
Reason for the Change
Recipient
Type
Edit
1. The description field is edited to:
Indicator showing if recipient of the
payment or transfer of value is a
physician covered recipient, teaching
hospital covered recipient, non-covered
recipient entity or non-covered recipient
individual. Standardized list of covered
Teaching Hospital names and
information will be provided.
2. The field size is edited to: 1 character
The description field is edited to provide applicable
manufactures with four options to indicate the
recipient type that is receiving the research payment.
This data element is added in order for applicable
manufactures to provide the name of the noncovered recipient that received the research payment
or other transfer of value. The required field is
edited because applicable manufacturers are
required to provide the non-covered recipient entity
name if the recipient type is a non-covered recipient.
The data element name is edited to indicate the
information that is being collected. The required
field is edited to determine when applicable
manufactures are required to provide the teaching
hospital name. The required field is edited because
applicable manufacturers are required to provide the
teaching hospital name if the recipient type is a
teaching hospital covered recipient.
The data element name is edited to indicate the
information that is being collected. The description
is edited to provide guidance to collect the
information required for to reporting. The field size
is edited to collect the information required in the
format column. The required field is edited because
7.
-------
Non-covered
Recipient
Entity Name
Addition
1. The description field is: The name of
the non-covered recipient entity
receiving the payment or transfer of
value.
2. The required field is: Yes if line 6 is
equal to non-covered recipient, “3”.
8.
7.
Covered
Recipient
Teaching
Hospital
Name
Edit
1. The data element name is edited to:
Covered Recipient Teaching Hospital
Name.
2. The required field is edited to: Yes if
line 6 is equal to Covered Recipient
Teaching Hospital Name, “2”.
9.
8.
Covered
Recipient
Teaching
Hospital Tax
ID Number
(TIN)
Edit
1. The data element name is edited to:
Covered Recipient Teaching Hospital
Tax ID Number (TIN)
2. The description filed is edited to: Tax
Identification number of Teaching
Hospital receiving the payment or
The field size is edited to collect the appropriate
characters in the format column.
Page 13 of 62
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revised
DE#
Data element
name
Action to be
performed
10.
9.
Covered
Recipient
Physician
First Name
Edit
11.
10.
Covered
Recipient
Physician
Middle Name
Edit
12.
11.
Covered
Recipient
Edit
Changes to the submission file
specifications
transfer of value. Standardized list of
covered Teaching Hospital names and
information will be provided.
3. The required field is edited to: Yes if 6 is
equal to covered recipient teaching
hospital, “2”.
3. The field size is edited to: 9 characters
1. The data element name is edited to:
Covered Recipient Physician First Name
2. The description field is edited to: textual
first name, as listed in the National Plan
& Provider Enumeration System
(NPPES) of the physician (covered
recipient) receiving the payment or other
transfer of value.
3. The required field is edited to: Yes if
line 6 equals “1” covered recipient
physician.
4. The field size is limited to less than or
equal to 20 characters.
1. The data element name is edited to:
Covered Recipient Physician Middle
Name.
2. The description field is edited to: 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 other transfer of value.
3. The field size is limited to less than or
equal to 20 characters.
1. The data element name is edited to:
Covered Recipient Physician Last
Reason for the Change
applicable manufacturers are required to provide the
teaching hospital name TIN if the recipient type is a
teaching hospital covered recipient.
The data element name is edited to indicate the
information that is being collected. The description
is edited to provide guidance to collect the
information required for to reporting. The field size
is edited to be consistent with data collection in
NPPES. The required field is edited because
applicable manufactures are required to provide the
first name of the physician covered recipient if the
recipient type is a covered recipient physician.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES.
The description is edited to provide guidance to
collect the information required for to reporting.
Page 14 of 62
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Data element Action to be
name
performed
Physician Last
Name
13.
12.
Covered
Recipient
Physician
Name Suffix
Edit
14.
13.
Recipient
Business
Address Line
1
Edit
15.
14.
Recipient
Edit
Changes to the submission file
specifications
Name.
2. The description field is edited to: textual
last name, as listed in the National Plan
& Provider Enumeration System
(NPPES) of the physician (covered
recipient) receiving the payment or other
transfer of value.
3. The required field is edited to: Yes if
line 6 equals “1” covered recipient
physician.
4. The field size is limited to less than or
equal to 35 characters.
1. The data element name is edited to:
Covered Recipient Physician Name
Suffix.
2. The description field is edited to: name
suffix, as listed in the as listed in the
National Plan & Provider Enumeration
System (NPPES) of the physician
(covered recipient) receiving the
payment or other transfer of value
chosen from a constrained list of values.
(Examples: Jr., Sr., III).
3. The field size is limited to less than or
equal to five characters.
1. The field size is edited to: less than or
equal to 55 characters.
2. The required field is edited to: Yes if
Line 6 is equal to “1” covered recipient
physician. “2” covered recipient
teaching hospital, or “3” non-covered
recipient entity.
1. The field size is edited to: less than or
Reason for the Change
The field size is edited to be consistent with data
collection in NPPES. The required field is edited
because applicable manufacturers are required to
provide a physician’s last name if the recipient type
is a covered recipient physician.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES.
The field size is edited to be consistent with data
collection in NPPES. The required field is edited
because applicable manufacturers are required to
provide the address if the recipient type is a covered
recipient physician, covered recipient teaching
hospital, or non-covered recipient entity.
The data element name is edited to clarify the
Page 15 of 62
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Data element
name
Business
Address Line
2
Recipient City
Action to be
performed
16.
15.
Edit
17.
18.
Recipient
State
Edit
18.
17.
Recipient Zip
Code
Edit
19.
16.
Recipient
Country
Edit
20.
19.
Recipient
Province
Edit
Changes to the submission file
specifications
equal to 55 characters.
2. The required field is edited to: no.
1. The field size is edited to: less than or
equal to 40 characters.
2. The required field is edited to: Yes if
Line 6 is equal to “1” covered recipient
physician. “2” covered recipient
teaching hospital, or “3” non-covered
recipient entity.
1. The required field is edited to: Yes if
Recipient Country Line 19 is the United
States.
1. The description field is edited to: The 9
digit zip code for the primary practice of
the physician, teaching hospital, or noncovered recipient entity receiving the
payment or transfer of value if the
primary practice address is in the United
States.
2. The required field is edited to: Yes if
Recipient Country Line 19 is the United
States.
3. The field size is edited to less than or
equal to 9 characters.
1. The required field is edited to: Yes if
Line 6 is equal to “1” covered recipient
physician. “2” covered recipient
teaching hospital, or “3” non-covered
recipient entity.
1. The required field is edited to: no.
Reason for the Change
information required for to reporting. The field size
is edited to be consistent with data collection in
NPPES.
The field size is edited to be consistent with data
collection in NPPES. The required field is edited
because applicable manufacturers are required to
provide the address if the recipient type is a covered
recipient physician, covered recipient teaching
hospital, or non-covered recipient entity.
The required field is edited because applicable
manufacturers are required to provide the state if the
address is in the United States.
Based on comments received the field size is
increased to accommodate a 5 digit zip code with an
option or reporting the additional 4 digits. The
required field is edited because applicable
manufacturers are required to provide the zip code if
the country is the United States.
The required field is edited because applicable
manufacturers are required to provide the address if
the recipient type is a covered recipient physician,
covered recipient teaching hospital, or non-covered
recipient entity.
The required field is edited to no because based on
comments received not all countries outside the
Page 16 of 62
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Data element
name
Action to be
performed
Changes to the submission file
specifications
21.
20.
Recipient
Postal Code
Edit
22.
21.
Recipient
Edit
Email Address
23.
23.
Covered
Recipient
Physician NPI
Edit
24.
22.
Covered
Recipient
Physician
Primary Type
Edit
1. The required field is edited to: Yes if
Line 6 is equal to “1” covered recipient
physician. “2” covered recipient
teaching hospital, or “3” non-covered
recipient entity and if Recipient Country
Line 19 is the United States.
2. The field size is less than or equal to
20 characters.
1. The description field is edited to: The
primary email address for physician,
teaching hospital, or non-covered
recipient entity to be used
communication purposes.
2. The field size is edited to: less than or
equal to 100 characters.
1. The data element name is edited to:
Covered Recipient Physician or
Teaching Hospital NPI.
2. The description field is edited to:
Individual NPI for Physician (not NPI of
any group physician belonging to)
required if, applicable.
3. The required field is edited to: no.
1. The data element name is edited to:
Covered Recipient Physician Primary
Type.
2. The description field is edited to:
Primary type of medicine practiced by
the covered recipient physician.
3. The required field is edited to: Yes if
line 6 recipient type is equal to “1”
covered recipient physician.
Reason for the Change
United States necessarily have provinces.
The field size is edited to be consistent with data
collection in NPPES. The required field is edited
because applicable manufacturers are required to
provide the address if the recipient type is a covered
recipient physician, covered recipient teaching
hospital, or non-covered recipient entity.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is increased to allow applicable
manufacturers and applicable GPOs to accurately
report a recipient’s email address.
The required filed is changed to no because
applicable manufacturers and applicable GPOs are
only required to report a physician’s NPI if
applicable.
The description is edited to provide guidance to
collect the information required for to reporting.
The required field is edited because applicable
manufacturers are required to provide the physician
primary type if the recipient type is a covered
recipient physician. The field size is limited to
accurately collect characters in the format column.
Page 17 of 62
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Data element
name
Action to be
performed
25.
24.
Covered
Recipient
Physician
Specialty
Edit
26.
25.
Covered
Recipient
Physician
License State
and License
Number
Edit
Changes to the submission file
specifications
4. The field size is edited to: 1 character.
1. The data element name is edited to:
Covered Recipient Physician Specialty.
2. The required field is edited to: Yes if
line 6 recipient type is equal to “1”
covered recipient physician.
3. The field size is edited to be limited to
10 characters.
1.
2.
3.
3.
--------
26.
27.
------
Recipient/
Physician
State
Product
Indicator
Reason for the Change
Based on comments received the “provider
taxonomy” list from the Washington Publishing
Company will be provided. The required field is
edited because applicable manufacturers are
required to provide the physician primary type if the
recipient type is a covered recipient physician.
This is the same list that can be retrieved through the
NPPESS website. The field size is edited to
accurately reflect the characters for collection.
The data element name is changed to:
The recipient/physician’s license number and state
Covered Recipient Physician Licenses
are combined in order to reflect the appropriate state
State and License Number.
with the license number because multiple license
The description field is changed to:
numbers and states may be reported. The required
Paired state and state license number of
field is edited because applicable manufacturers are
the covered physician; the pairing
required to provide the physician primary type if the
includes the 2 letter state abbreviation
recipient type is a covered recipient physician. The
followed by the state license number and field size is edited to less than or equal to 20
may include up to 5 “Physician License characters per state and license number.
State and License Number” pair.
The required field is edited to: Yes if
line 6 recipient type is equal to “1”
covered recipient physician.
The field size is edited to: less than or
equal to 20 characters.
Delete
1. This data element was deleted.
Addition
1. The description field is: Indicator allows
the Applicable Manufacturer to select
whether the payment or other transfer of
value is associated with ONLY covered
This data element was combined with Physician
Licenses State(s) and License Number(s) for
simplification.
Based on comments requesting clarification how
applicable manufacturers will report “None”, “NonCovered”, or report covered products and have the
ability to indicate “Non-Covered” the product
Page 18 of 62
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revised
28.
DE#
27.
Data element
name
Name of
Associated
Drug or
Biological
Action to be
performed
Edit
Changes to the submission file
specifications
drugs, devices, biologicals or medical
supplies("Covered"), ONLY noncovered drugs, devices, biologicals or
medical supplies ("Non-covered"),
neither covered or non-covered drugs,
devices, biologicals or medical
supplies("None"), or both covered
and/or non-covered drugs, devices,
biologicals or medical supplies
("Covered" or "Combination").
2. The required field is: yes.
3. The field size is: 1 character.
1. The data element name is changed to:
Name of Associated Covered Drug or
Biological.
2. The description field is changed to: The
marketed name of the drug or biological
associated with this payment or transfer
of value; may report the marketed name
of up to 5 covered drugs, devices,
biologicals, or medical supplies
provided in either line 27 or line 29. If
the drug or biological associated with
Reason for the Change
indicator data element was added. This data element
provides clarification for applicable manufacturers’
options for when payments or other transfer of value
were associated with covered or non-covered
products. The Product Indicator should be “None”
if the payment or other transfer of value was not
associated with any products. The Product Indicator
should be “Non-covered” if the payment or transfer
of value was only associated with non-covered
products. The Product Indicator should be
“Combination” if the payment or other transfer of
value was associated with at least one covered
product and one non-covered product. The payment
indicator should be “Covered” if the payment or
other transfer of value was associated with only
covered products. However, applicable
manufacturers also have the option to indicate
“Covered” if the payment or other transfer of value
was associated with at least one covered and one
non-covered product and choose to not report that
the payment or other transfer of value was also
associated with a non-covered product.
Based on comment received the Name of Associated
Covered Drug or Biological data element is separate
from the Name of Associated Covered Device or
Medical Supply data element. The required filed is
edited because this data element is only required
based on the product indicator chosen by the
applicable manufacturer or applicable GPO, as well
as, if the applicable manufacturer or applicable
GPOs did not provide at least one covered device or
medical supply in the data element Name of
Associated Covered Device or Medical supply. A
Page 19 of 62
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revised
29.
DE#
28.
Data element
name
NDC of
Associated
Drug or
Biological
Action to be
performed
Edit
Changes to the submission file
specifications
this payment or transfer does not have a
marketed name, report the drug or
biological name as it is registered on
clinicaltrials.gov.
3. The required field is changed to: Yes IF
the "Product Indicator" (line 26) is
"Covered" or "Combination" AND there
is not at least 1 covered device or
medical supply listed in line 29 "Name
of Associated Covered Device or
Medical Supply".
1. The date element name is edited to:
NDC of Associated Drug or Biological.
2. The description is edited to: The
National Drug Code (NDC), if any, of
the drug or biological associated with
the payment or other transfer of value (if
applicable; up to 5 NDCs). If no NDC
for any named covered drug or
biological in line 28, enter, "null." If
more than one NDC provided, order
must match order of named covered
drugs or biologicals in line 28, "Name of
Associated Covered Drug or
Biological;" if no NDC for any named
drug or biological, enter "null."
3. The requirement field is edited to: Yes
IF "Product Indicator" line 27 is "1" =
"Covered" OR is "2" = "Combination"
AND there is not at least 1 covered
device or medical supply provided in
line 30 "Name of Associated Covered
Device or Medical Supply"
Reason for the Change
covered product is required for reporting when an
applicable manufacturer or applicable GPO indicates
either Covered or Combination in the product
indicator.
The data name and description are changed to
accurately define that an NDC is collected for an
associated drug or biological, if applicable. The
requirement is edited to reflect an NDC of
Associated Drug or Biological is only collected if
applicable. The field size is edited to limit the
character size to less than or equal to 12 characters
per NDC.
Page 20 of 62
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30.
--------
DE#
Data element
name
Action to be
performed
29.
Name of
Associated
Device or
Medical
Supply
Edit
52.
Date of
Payment
Multiyear
Payment
Structure
Indicator
Edit
Changes to the submission file
specifications
4. The field size is edited to: less than or
equal to 12 characters.
1. The data element name is: Name of
Associated Covered Device or Medical
Supply
2. The description is: If the payment or
other transfer of value is associated with
at least one (1) covered device or
medical supply that has a marketed
name, report the marketed name (or
names up to 5) of only the covered
device or medical supply. 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 provided.
3. The required field is: Yes IF "Product
Indicator" line 27 is "1" = "Covered" OR
is "2" = "Combination" AND there is
not at least 1 covered drug or biological
provided in line 28 "Name of Associated
Covered Drug or Biological".
4. The field size is: less than or equal to
100 characters.
1. The required field is edited to: no
Delete
This data element is deleted.
53.
Reason for the Change
Based on comment received the Name of Associated
Covered Device or Medical Supply data element is
separate from the Name of Associated Covered
Drug or Biological data element. This will allow for
accurate data collection when applicable
manufactures or applicable GPOs are choosing how
to report a covered device or medical supply,
marketed name, therapeutic are or product category.
The required filed is edited because this data
element is only required based on the product
indicator chosen by the applicable manufacturer or
applicable GPO, as well as, if the applicable
manufacturer or applicable GPOs did not provide at
least one covered drug or biological in the data
element Name of Associated Covered Drug or
Biological. A covered product is required for
reporting when an applicable manufacturer or
applicable GPO indicates either Covered or
Combination in the product indicator.
Based on comments received this data element is not
required.
Based on comments received this data element is
deleted.
Page 21 of 62
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-------
DE#
54.
-------
55.
-------
56.
35.
-----
36.
64.
Data element
name
Total Number
of Years for
this Research
Payment
Total Number
of Years for
this Research
Project
Total
Research
Budget of this
Project
Form of
Payment or
Other Transfer
of Value
Action to be
performed
Delete
Changes to the submission file
specifications
This data element is deleted.
Reason for the Change
Delete
This data element is deleted.
Based on comments received this data element is
deleted.
Delete
This data element is deleted.
Based on comments received this data element is
deleted.
Addition
This data element is added to align with the
information that is also required in data collection
for payment or other transfers of value that are not
related to research.
Expenditure
Category
Edit
1. The data element name is: Form of
Payment or Other Transfer of Value.
2. The description field is edited to: The
method of payment used to pay the
covered recipient or to make the transfer
of value.
3. The required field is: yes.
4. The field size is: 1 character
1. The description field is edited to:
Contextual category for this research
payment or transfer of value chosen
from an enumerated list to be provided.
There can be multiple contextual
categories for this research reported;
however, for every Expenditure
Category reported, an Expenditure
Category percentage must also be
reported.
2. The data element size is edited to: less
than or equal to 5 characters per
category and percentage.
Based on comments received this data element is
deleted.
The description field is edited to provide to provide
guidance that for each expenditure category is
required to be followed by the percent for that
category.
Page 22 of 62
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revised
-----
38.
DE#
65.
61.
Data element
name
Expenditure
Category
Percentage
Delay in
Publication
Research
Payment
Indicator
Action to be
performed
Delete
Changes to the submission file
specifications
This data element is deleted.
Reason for the Change
Edit
1. The description field is edited to:
Indicator showing if an Applicable
Manufacturer/GPO is requesting a delay
in publication of a payment or 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). 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.
Based on comments received the data element
description is edited to reflect the reasons an
applicable manufacturer may indicate a delay in
publication. If an applicable manufacturer is not
indicating a delay in publication research by
choosing either (1) or (2) the applicable
manufacturer is required to choose (3) alerting the
OPEN PAYMENTS system the information is available
for publication. The data element size is edited to
accurately reflect the character size.
Based on comments received this data element is
deleted.
2. The data element size is edited to: 1
character.
------
62.
Lift in Delay
in Publication
Indicator
Delete
This data element is deleted.
Based on comments received this data element is
deleted.
Page 23 of 62
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DE#
66.
39.
58.
40.
59.
43.
30.
44.
31.
Data element
name
Physician
Ownership
Indicator
Name of
Study
Action to be
performed
Delete
Changes to the submission file
specifications
This data element is deleted.
Reason for the Change
Edit
1. The data element size is edited to: less
than or equal to 500 characters.
Context of
Research
Principal
Investigator
Covered
Recipient
Physician
Indicator
Edit
1. The required field is edited to: no.
Based on comments received this data element size
is edited to less than or equal to 500 characters in
order to accurately capture the name of a study.
Based on comments received the context of research
data element is optional.
Edit
Principal
Investigator
First Name
Edit
1. The description field is edited to:
Indicator showing the Principal
Investigator of the research study is a
covered recipient physician. If there are
multiple Principal Investigators, indicate
"Yes" if at least one (1) is a covered
recipient physician and provide the
identifiers (data elements 45-60) for
each Principal Investigator (up to 5),
who is a covered recipient physician. If
the Principal Investigator is the same as
the Covered Recipient Physician
receiving the payment (identified in data
elements 10-13), it is not necessary to
duplicate the information for the
Principal Investigator fields (Data
Elements 45-60).
2. The required field is edited to: yes.
1. The description field is changed to:
Textual first name of the Principal
Investigator(s) of the research study, if
the Principal Investigator is a Covered
Recipient Physician. If the Principal
Investigator is the same as the Covered
Recipient Physician receiving the
Based on comments received this data element is
deleted.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES. The required field is edited
because applicable manufactures are required to
report information regarding principal investigator if
they indicated there is a principal investigator.
Page 24 of 62
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Data element
name
Action to be
performed
45.
32.
Principal
Investigator
Middle Name
Edit
46.
33.
Principal
Investigator
Last Name
Edit
47.
34.
Principal
Investigator
Name Suffix
Edit
Changes to the submission file
specifications
payment (identified in data elements 1013), it is not necessary to duplicate the
information for the Principal
Investigator fields (Data Elements 4560).
2. The required field is edited to: Yes IF
Line 43, "Principal Investigator
Physician Covered Recipient Indicator"
= "Y"
3. The field size is edited to: less than or
equal to 20 characters.
1. The description field is edited to:
Textual middle initial or middle name of
the Principal Investigator of the research
study, if the Principal Investigator is a
Covered Recipient Physician.
2. The field size is edited to: is less than or
equal to 20 characters.
1. The description field is edited to:
Textual last name of the Principal
investigator of the research study, if the
Principal Investigator is a Covered
Recipient Physician.
2. The required field is edited to: Yes IF
Line 43, "Principal Investigator
Physician Covered Recipient Indicator"
= "Y"
3. The field size is edited to: less than or
equal to 35 characters.
1. The description field is edited to: Suffix
of the Principal Investigator of the
research study chosen from a
constrained list of values (Examples: Jr.,
Reason for the Change
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES. The required field is edited
because applicable manufactures are required to
report information regarding principal investigator if
they indicated there is a principal investigator.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES.
Page 25 of 62
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Data element
name
Action to be
performed
48.
35.
Principal
Edit
Investigator
Business
Street Address
Line 1
49.
36.
Principal
Edit
Investigator
Business
Street Address
Line 2
50.
37.
Principal
Investigator
City
Edit
Changes to the submission file
specifications
Sr, III), if the Principal Investigator is a
Covered Recipient Physician.
2. The field size is edited to: less than or
equal to 5 characters.
1. The description field is edited to: The
first line of the primary business street
address of the Principal Investigator of
the research study, if the Principal
Investigator is a Covered Recipient
Physician. If the Principal Investigator
is the same as the Covered Recipient
Physician receiving the payment
(identified in data elements 10-13), it is
not necessary to duplicate the
information for the Principal
Investigator fields (Data Elements 4560).
2. The required field is edited to: Yes IF
Line 44, "Principal Investigator
Physician Covered Recipient Indicator"
= "Y"
3. The field size is edited to: less than or
equal to 55 characters.
1. The description field is edited to: The
second line of the primary business
street address of the Principal
investigator of the research study.
2. The required field is edited to: no.
3. The field size is edited to: less than or
equal to 55 characters.
1. The description field is edited to: The
primary business address city of the
Principal investigator of the research
Reason for the Change
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES. The required field is edited
because applicable manufactures are required to
report information regarding principal investigator if
they indicated there is a principal investigator.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
Page 26 of 62
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revised
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Data element
name
Action to be
performed
51.
40.
Principal
Investigator
State
Edit
52.
39.
Principal
Investigator
Zip Code
Edit
53.
38.
Principal
Investigator
Country
Edit
54.
41.
Principal
Investigator
Province
Edit
Changes to the submission file
specifications
study.
2. The required field is edited to: Yes IF
Line 43, "Principal Investigator
Physician Covered Recipient Indicator"
= "Y"
3. The field size is edited to: less than or
equal to 40 characters.
1. The required field is edited to: Yes IF
Line 43, "Principal Investigator
Physician Covered Recipient Indicator"
= "Y" and recipient country, line 53 is
the United States.
1. The description field is edited to: The 9
digit zip code of the primary business
address location of the Principal
investigator of the research study, if the
primary practice address is in the
United States.
2. The required field is edited to: Yes IF
Line 43, "Principal Investigator
Physician Covered Recipient Indicator"
= "Y"
3. The field size is edited to: less than or
equal to 9 characters.
1. The required field is edited to: Yes IF
Line 43, "Principal Investigator
Physician Covered Recipient Indicator"
= "Y"
2. The field size is edited to: less than or
equal to 40 characters.
1. The required field is edited to: no.
Reason for the Change
collection in NPPES. The required field is edited
because applicable manufactures are required to
report information regarding principal investigator if
they indicated there is a principal investigator.
The required field is edited because applicable
manufactures are required to report information
regarding principal investigator if they indicated
there is a principal investigator and state is only
required if the country is the United States.
Based on comments received the description is
edited to provide guidance to collect the information
required for to reporting. The field size is edited to
be consistent with data collection in NPPES. The
required field is edited because applicable
manufactures are required to report information
regarding principal investigator if they indicated
there is a principal investigator.
The field size is edited to be consistent with data
collection in NPPES. The required field is edited
because applicable manufactures are required to
report information regarding principal investigator if
they indicated there is a principal investigator.
Based on comments received the required field is
edited to no because not all countries necessarily
have provinces.
Page 27 of 62
DE#
revised
55.
DE#
42.
Data element
name
Principal
Investigator
Postal Code
Action to be
performed
Edit
56.
44.
Principal
Investigator
Physician
Primary Type
Edit
57.
43.
Principal
Investigator
NPI
Edit
58.
45.
Principal
Edit
Changes to the submission file
specifications
1. The required field is edited to: Yes IF
Recipient Country Line 53 is outside
the United States
2. The field size is edited to: less than or
equal to 20 characters.
1. The description field is edited to:
Primary type of medicine practiced by
the Principal Investigator. If the
Principal Investigator is the same as the
Covered Recipient Physician receiving
the payment (identified in data
elements 10-13), it is not necessary to
duplicate the information for the
Principal Investigator fields (Data
Elements 45-60).
2. The required field is edited to: Yes IF
Line 44, "Principal Investigator
Physician Covered Recipient Indicator"
= "Y"
3. The field size is edited to: 1 character.
1. The description field is edited to:
Individual NPI for Physician (not NPI
of any group physician belonging to)
required, if applicable. If the Principal
Investigator is the same as the Covered
Recipient Physician receiving the
payment (identified in data elements
10-13), it is not necessary to duplicate
the information for the Principal
Investigator fields (Data Elements 4560).
2. The required field is edited to: no.
1. The description field is edited to:
Reason for the Change
The required field is edited because the postal code
is only required if the country is outside the United
States.
The description is edited to provide guidance to
collect the information required for to reporting.
The required field is edited because applicable
manufactures are required to report information
regarding principal investigator if they indicated
there is a principal investigator.
The description is edited to provide guidance to
collect the information required for to reporting.
The required filed is changed to no because
applicable manufacturers are only required to report
a physician’s NPI if applicable.
Based on comments received the “provider
Page 28 of 62
DE#
revised
59.
DE#
46.
Data element
name
Investigator
Specialty
Action to be
performed
Principal
Investigator
License State
and License
Number
Edit
Changes to the submission file
specifications
Principal Investigator's single specialty
chosen from "provider taxonomy" code
list. If the Principal Investigator is the
same as the Covered Recipient
Physician receiving the payment
(identified in data elements 10-13), it is
not necessary to duplicate the
information for the Principal
Investigator fields (Data Elements 4560).
2. The required field is edited to: Yes IF
Line 43, "Principal Investigator
Physician Covered Recipient Indicator"
= "Y"
3. The field size is edited to: 10 characters
1. The description field is edited to: Paired
state and state license number of the
Principal Investigator, who is a
physician covered recipient; the pairing
includes the 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 Principal
investigator is licensed in multiple
states, provide only one state and
license number pair.
2. The required field is edited to: Yes IF
Line 43, "Principal Investigator
Physician Covered Recipient Indicator"
= "Y"
3. The field size is edited to: less than or
equal to 20 characters per state and
Reason for the Change
taxonomy” list from the Washington Publishing
Company will be provided. This is the same list that
can be retrieved through the NPPESS website. The
field size is edited to accurately reflect the characters
for collection. The required field is edited because
applicable manufactures are required to report
information regarding principal investigator if they
indicated there is a principal investigator.
The physician’s license number and state are
combined in order to reflect the appropriate state
with the license number because multiple license
numbers and states may be reported. The field size
is edited to accurately reflect the characters for
collection.
Page 29 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
------
47.
Delete
60.
------
Principal
Investigator
License State
Principal
Investigator
First Name
61.
------
Principal
Investigator
Middle Name
Addition
Addition
Changes to the submission file
specifications
license number.
This data element is deleted.
Reason for the Change
1. The data element name is: Principal
Investigator First Name
2. The description is: Textual first name of
the Principal Investigator(s) of the
research study; required, if the Principal
Investigator is a Covered Recipient
Physician. If the Principal Investigator
is the same as the Covered Recipient
Physician receiving the payment
(identified in data elements 10-13), it is
not necessary to duplicate the
information for the Principal
Investigator fields (Data Elements 4560).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters.
1. The data element name is: Principal
Investigator Middle Name
2. The description is: Textual middle
initial or middle name of the Principal
Investigator of the research study, if the
Principal Investigator is a Covered
Recipient Physician.
3. The required field is: no, unless
indicating multiple principal
investigators
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
This data element is deleted because the license state
is combined with the license number.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 30 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
62.
------
Principal
Investigator
Last Name
Addition
63.
------
Principal
Investigator
Name Suffix
Addition
64.
------
Principal
Addition
Investigator
Business
Street Address
Line 1
Changes to the submission file
specifications
4. The field size is: less than or equal to 20
characters.
1. The data element name is: Principal
Investigator Last Name
2. The description is: Textual last name of
the Principal investigator of the
research study; required if, the Principal
Investigator is a Covered Recipient
Physician.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 35
characters.
1. The data element name is: Principal
Investigator Name Suffix
2. The description is: Suffix of the
Principal Investigator of the research
study chosen from a constrained list of
values (Examples: Jr., Sr, III), if the
Principal Investigator is a Covered
Recipient Physician.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 5
characters.
1. The data element name is: Principal
Investigator Business Street Address
Line 1
2. The description is: The first line of the
primary business street address of the
Principal Investigator of the research
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 31 of 62
DE#
revised
65.
DE#
Data element
name
Action to be
performed
------
Principal
Addition
Investigator
Business
Street Address
Line 2
Changes to the submission file
specifications
study, if the Principal Investigator is a
Covered Recipient Physician. If the
Principal Investigator is the same as the
Covered Recipient Physician receiving
the payment (identified in data
elements 10-13), it is not necessary to
duplicate the information for the
Principal Investigator fields (Data
Elements 45-60).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 55
characters.
1. The data element name is: Principal
Investigator Business Street Address
Line 2
2. The description is: The first line of the
primary business street address of the
Principal Investigator of the research
study, if the Principal Investigator is a
Covered Recipient Physician. If the
Principal Investigator is the same as the
Covered Recipient Physician receiving
the payment (identified in data
elements 10-13), it is not necessary to
duplicate the information for the
Principal Investigator fields (Data
Elements 45-60).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 55
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 32 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
66.
------
Principal
Investigator
City
Addition
67.
------
Principal
Investigator
State
Addition
68.
------
Principal
Investigator
Zip Code
Addition
Changes to the submission file
specifications
characters.
1. The data element name is: Principal
Investigator City
2. The description is: The primary
business address city of the Principal
investigator of the research study.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 40
characters
1. The data element name is: Principal
Investigator State
2. The description is: The primary
business address state or territory
abbreviation of the Principal
investigator of the research study, if the
primary practice address is in the
United States.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 2 characters
1. The data element name is: Principal
Investigator Zip Code
2. The description is: The 9 digit zip code
of the primary business address
location of the Principal investigator of
the research study, if the primary
practice address is in the United States.
3. The required field is: no, unless
indicating multiple principal
investigators
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 33 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
69.
------
Principal
Investigator
Country
Addition
70.
------
Principal
Investigator
Province
Addition
71.
------
Principal
Investigator
Postal Code
Addition
Changes to the submission file
specifications
4. The field size is: less than or equal to 9
characters
1. The data element name is: Principal
Investigator Country
2. The description is: The primary
business address country name of the
Principal investigator of the research
study.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 40
characters
1. The data element name is: Principal
Investigator Province
2. The description is: The primary
business address province name of the
Principal investigator of the research
study, if the primary practice address is
outside the United States.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters
1. The data element name is: Principal
Investigator Postal Code
2. The description is: The international
postal code of the primary business
location of the Principal investigator of
the research study if the primary
practice address is outside the United
States.
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 34 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
72.
------
Principal
Investigator
Physician
Primary Type
Addition
73.
------
Principal
Investigator
NPI
Addition
Changes to the submission file
specifications
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters.
1. The data element name is: Principal
Investigator Physician Primary Type
2. The description is: Primary type of
medicine practiced by the Principal
Investigator. If the Principal
Investigator is the same as the Covered
Recipient Physician receiving the
payment (identified in data elements
10-13), it is not necessary to duplicate
the information for the Principal
Investigator fields (Data Elements 4560).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 1 character.
1. The data element name is: Principal
Investigator NPI
2. The description is: Individual NPI for
Physician (not NPI of any group
physician belonging to) required, if
applicable. If the Principal Investigator
is the same as the Covered Recipient
Physician receiving the payment
(identified in data elements 10-13), it is
not necessary to duplicate the
information for the Principal
Investigator fields (Data Elements 45-
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 35 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
74.
------
Principal
Investigator
Specialty
Addition
75.
------
Principal
Investigator
License State
and License
Number
Addition
Changes to the submission file
specifications
60).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 10 characters
1. The data element name is: Principal
Investigator Specialty
2. The description is: Principal
Investigator's single specialty chosen
from "provider taxonomy" list. If the
Principal Investigator is the same as the
Covered Recipient Physician receiving
the payment (identified in data
elements 10-13), it is not necessary to
duplicate the information for the
Principal Investigator fields (Data
Elements 45-60).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 10 characters
1. The data element name is: Principal
Investigator License State and License
Number
2. The description is: Paired state and state
license number of the Principal
Investigator, who is a physician
covered recipient; the pairing includes
the 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 Principal
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 36 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
76.
------
Principal
Investigator
First Name
Addition
77.
------
Principal
Investigator
Middle Name
Addition
Changes to the submission file
specifications
investigator is licensed in multiple
states, provide only one state and
license number pair.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters per state and license number.
1. The data element name is: Principal
Investigator First Name
2. The description is: Textual first name of
the Principal Investigator(s) of the
research study; required, if the Principal
Investigator is a Covered Recipient
Physician. If the Principal Investigator
is the same as the Covered Recipient
Physician receiving the payment
(identified in data elements 10-13), it is
not necessary to duplicate the
information for the Principal
Investigator fields (Data Elements 4560).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters.
1. The data element name is: Principal
Investigator Middle Name
2. The description is: Textual middle
initial or middle name of the Principal
Investigator of the research study, if the
Principal Investigator is a Covered
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 37 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
78.
------
Principal
Investigator
Last Name
Addition
79.
------
Principal
Investigator
Name Suffix
Addition
80.
------
Principal
Investigator
Addition
Changes to the submission file
specifications
Recipient Physician.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters.
1. The data element name is: Principal
Investigator Last Name
2. The description is: Textual last name of
the Principal investigator of the
research study; required if, the Principal
Investigator is a Covered Recipient
Physician.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 35
characters.
1. The data element name is: Principal
Investigator Name Suffix
2. The description is: Suffix of the
Principal Investigator of the research
study chosen from a constrained list of
values (Examples: Jr., Sr, III), if the
Principal Investigator is a Covered
Recipient Physician.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 5
characters.
1. The data element name is: Principal
Investigator Business Street Address
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
Page 38 of 62
DE#
revised
81.
DE#
------
Data element Action to be
name
performed
Business
Street Address
Line 1
Principal
Addition
Investigator
Business
Street Address
Line 2
Changes to the submission file
specifications
Line 1
2. The description is: The first line of the
primary business street address of the
Principal Investigator of the research
study, if the Principal Investigator is a
Covered Recipient Physician. If the
Principal Investigator is the same as the
Covered Recipient Physician receiving
the payment (identified in data
elements 10-13), it is not necessary to
duplicate the information for the
Principal Investigator fields (Data
Elements 45-60).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 55
characters.
1. The data element name is: Principal
Investigator Business Street Address
Line 2
2. The description is: The first line of the
primary business street address of the
Principal Investigator of the research
study, if the Principal Investigator is a
Covered Recipient Physician. If the
Principal Investigator is the same as the
Covered Recipient Physician receiving
the payment (identified in data
elements 10-13), it is not necessary to
duplicate the information for the
Principal Investigator fields (Data
Elements 45-60).
Reason for the Change
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 39 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
82.
------
Principal
Investigator
City
Addition
83.
------
Principal
Investigator
State
Addition
84.
------
Principal
Investigator
Zip Code
Addition
Changes to the submission file
specifications
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 55
characters.
1. The data element name is: Principal
Investigator City
2. The description is: The primary
business address city of the Principal
investigator of the research study.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 40
characters
1. The data element name is: Principal
Investigator State
2. The description is: The primary
business address state or territory
abbreviation of the Principal
investigator of the research study, if the
primary practice address is in the
United States.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 2 characters
1. The data element name is: Principal
Investigator Zip Code
2. The description is: The 9 digit zip code
of the primary business address
location of the Principal investigator of
the research study, if the primary
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 40 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
85.
------
Principal
Investigator
Country
Addition
86.
------
Principal
Investigator
Province
Addition
87.
------
Principal
Investigator
Postal Code
Addition
Changes to the submission file
specifications
practice address is in the United States.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 9
characters
1. The data element name is: Principal
Investigator Country
2. The description is: The primary
business address country name of the
Principal investigator of the research
study.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 40
characters
1. The data element name is: Principal
Investigator Province
2. The description is: The primary
business address province name of the
Principal investigator of the research
study, if the primary practice address is
outside the United States.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters
1. The data element name is: Principal
Investigator Postal Code
2. The description is: The international
postal code of the primary business
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 41 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
88.
------
Principal
Investigator
Physician
Primary Type
Addition
89.
------
Principal
Investigator
NPI
Addition
Changes to the submission file
specifications
location of the Principal investigator of
the research study if the primary
practice address is outside the United
States.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters.
1. The data element name is: Principal
Investigator Physician Primary Type
2. The description is: Primary type of
medicine practiced by the Principal
Investigator. If the Principal
Investigator is the same as the Covered
Recipient Physician receiving the
payment (identified in data elements
10-13), it is not necessary to duplicate
the information for the Principal
Investigator fields (Data Elements 4560).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 1 character.
1. The data element name is: Principal
Investigator NPI
2. The description is: Individual NPI for
Physician (not NPI of any group
physician belonging to) required, if
applicable. If the Principal Investigator
is the same as the Covered Recipient
Physician receiving the payment
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 42 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
90.
------
Principal
Investigator
Specialty
Addition
91.
------
Principal
Investigator
License State
and License
Number
Addition
Changes to the submission file
specifications
(identified in data elements 10-13), it is
not necessary to duplicate the
information for the Principal
Investigator fields (Data Elements 4560).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 10 characters
1. The data element name is: Principal
Investigator Specialty
2. The description is: Principal
Investigator's single specialty chosen
from "provider taxonomy" list. If the
Principal Investigator is the same as the
Covered Recipient Physician receiving
the payment (identified in data
elements 10-13), it is not necessary to
duplicate the information for the
Principal Investigator fields (Data
Elements 45-60).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 10 characters
1. The data element name is: Principal
Investigator License State and License
Number
2. The description is: Paired state and state
license number of the Principal
Investigator, who is a physician
covered recipient; the pairing includes
the 2 letter state abbreviation, followed
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 43 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
92.
------
Principal
Investigator
First Name
Addition
93.
------
Principal
Investigator
Addition
Changes to the submission file
specifications
by a hyphen, followed by the state
license number and may include up to 5
"Physician License State and License
Number" pairs. If a Principal
investigator is licensed in multiple
states, provide only one state and
license number pair.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters per state and license number.
1. The data element name is: Principal
Investigator First Name
2. The description is: Textual first name of
the Principal Investigator(s) of the
research study; required, if the Principal
Investigator is a Covered Recipient
Physician. If the Principal Investigator
is the same as the Covered Recipient
Physician receiving the payment
(identified in data elements 10-13), it is
not necessary to duplicate the
information for the Principal
Investigator fields (Data Elements 4560).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters.
1. The data element name is: Principal
Investigator Middle Name
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
Page 44 of 62
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DE#
Data element
name
Middle Name
Action to be
performed
94.
------
Principal
Investigator
Last Name
Addition
95.
------
Principal
Investigator
Name Suffix
Addition
Changes to the submission file
specifications
2. The description is: Textual middle
initial or middle name of the Principal
Investigator of the research study, if the
Principal Investigator is a Covered
Recipient Physician.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters.
1. The data element name is: Principal
Investigator Last Name
2. The description is: Textual last name of
the Principal investigator of the
research study; required if, the Principal
Investigator is a Covered Recipient
Physician.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 35
characters.
1. The data element name is: Principal
Investigator Name Suffix
2. The description is: Suffix of the
Principal Investigator of the research
study chosen from a constrained list of
values (Examples: Jr., Sr, III), if the
Principal Investigator is a Covered
Recipient Physician.
3. The required field is: no, unless
indicating multiple principal
investigators
Reason for the Change
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 45 of 62
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DE#
Data element
name
Action to be
performed
96.
------
Principal
Addition
Investigator
Business
Street Address
Line 1
97.
------
Principal
Addition
Investigator
Business
Street Address
Line 2
Changes to the submission file
specifications
4. The field size is: less than or equal to 5
characters.
1. The data element name is: Principal
Investigator Business Street Address
Line 1
2. The description is: The first line of the
primary business street address of the
Principal Investigator of the research
study, if the Principal Investigator is a
Covered Recipient Physician. If the
Principal Investigator is the same as the
Covered Recipient Physician receiving
the payment (identified in data
elements 10-13), it is not necessary to
duplicate the information for the
Principal Investigator fields (Data
Elements 45-60).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 55
characters.
1. The data element name is: Principal
Investigator Business Street Address
Line 2
2. The description is: The first line of the
primary business street address of the
Principal Investigator of the research
study, if the Principal Investigator is a
Covered Recipient Physician. If the
Principal Investigator is the same as the
Covered Recipient Physician receiving
the payment (identified in data
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 46 of 62
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DE#
Data element
name
Action to be
performed
98.
------
Principal
Investigator
City
Addition
99.
------
Principal
Investigator
State
Addition
100.
------
Principal
Investigator
Addition
Changes to the submission file
specifications
elements 10-13), it is not necessary to
duplicate the information for the
Principal Investigator fields (Data
Elements 45-60).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 55
characters.
1. The data element name is: Principal
Investigator City
2. The description is: The primary
business address city of the Principal
investigator of the research study.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 40
characters
1. The data element name is: Principal
Investigator State
2. The description is: The primary
business address state or territory
abbreviation of the Principal
investigator of the research study, if the
primary practice address is in the
United States.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 2 characters
1. The data element name is: Principal
Investigator Zip Code
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
Page 47 of 62
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DE#
Data element
name
Zip Code
Action to be
performed
101.
------
Principal
Investigator
Country
Addition
102.
------
Principal
Investigator
Province
Addition
Changes to the submission file
specifications
2. The description is: The 9 digit zip code
of the primary business address
location of the Principal investigator of
the research study, if the primary
practice address is in the United States.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 9
characters
1. The data element name is: Principal
Investigator Country
2. The description is: The primary
business address country name of the
Principal investigator of the research
study.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 40
characters
1. The data element name is: Principal
Investigator Province
2. The description is: The primary
business address province name of the
Principal investigator of the research
study, if the primary practice address is
outside the United States.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters
Reason for the Change
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 48 of 62
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revised
103.
DE#
Data element
name
Principal
Investigator
Postal Code
Action to be
performed
Addition
104.
------
Principal
Investigator
Physician
Primary Type
Addition
105.
------
Principal
Investigator
NPI
Addition
------
Changes to the submission file
specifications
1. The data element name is: Principal
Investigator Postal Code
2. The description is: The international
postal code of the primary business
location of the Principal investigator of
the research study if the primary
practice address is outside the United
States.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters.
1. The data element name is: Principal
Investigator Physician Primary Type
2. The description is: Primary type of
medicine practiced by the Principal
Investigator. If the Principal
Investigator is the same as the Covered
Recipient Physician receiving the
payment (identified in data elements
10-13), it is not necessary to duplicate
the information for the Principal
Investigator fields (Data Elements 4560).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 1 character.
1. The data element name is: Principal
Investigator NPI
2. The description is: Individual NPI for
Physician (not NPI of any group
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 49 of 62
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DE#
Data element
name
Action to be
performed
106.
------
Principal
Investigator
Specialty
Addition
107.
------
Principal
Investigator
License State
and License
Addition
Changes to the submission file
specifications
physician belonging to) required, if
applicable. If the Principal Investigator
is the same as the Covered Recipient
Physician receiving the payment
(identified in data elements 10-13), it is
not necessary to duplicate the
information for the Principal
Investigator fields (Data Elements 4560).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 10 characters
1. The data element name is: Principal
Investigator Specialty
2. The description is: Principal
Investigator's single specialty chosen
from "provider taxonomy" list. If the
Principal Investigator is the same as the
Covered Recipient Physician receiving
the payment (identified in data
elements 10-13), it is not necessary to
duplicate the information for the
Principal Investigator fields (Data
Elements 45-60).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 10 characters
1. The data element name is: Principal
Investigator License State and License
Number
2. The description is: Paired state and state
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 50 of 62
DE#
revised
DE#
Data element
name
Number
Action to be
performed
108.
------
Principal
Investigator
First Name
Addition
Changes to the submission file
specifications
license number of the Principal
Investigator, who is a physician
covered recipient; the pairing includes
the 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 Principal
investigator is licensed in multiple
states, provide only one state and
license number pair.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters per state and license number.
1. The data element name is: Principal
Investigator First Name
2. The description is: Textual first name of
the Principal Investigator(s) of the
research study; required, if the Principal
Investigator is a Covered Recipient
Physician. If the Principal Investigator
is the same as the Covered Recipient
Physician receiving the payment
(identified in data elements 10-13), it is
not necessary to duplicate the
information for the Principal
Investigator fields (Data Elements 4560).
3. The required field is: no, unless
indicating multiple principal
investigators
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 51 of 62
DE#
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DE#
Data element
name
Action to be
performed
109.
------
Principal
Investigator
Middle Name
Addition
110.
------
Principal
Investigator
Last Name
Addition
111.
------
Principal
Investigator
Name Suffix
Addition
Changes to the submission file
specifications
4. The field size is: less than or equal to 20
characters.
1. The data element name is: Principal
Investigator Middle Name
2. The description is: Textual middle
initial or middle name of the Principal
Investigator of the research study, if the
Principal Investigator is a Covered
Recipient Physician.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters.
1. The data element name is: Principal
Investigator Last Name
2. The description is: Textual last name of
the Principal investigator of the
research study; required if, the Principal
Investigator is a Covered Recipient
Physician.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 35
characters.
1. The data element name is: Principal
Investigator Name Suffix
2. The description is: Suffix of the
Principal Investigator of the research
study chosen from a constrained list of
values (Examples: Jr., Sr, III), if the
Principal Investigator is a Covered
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 52 of 62
DE#
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DE#
Data element
name
Action to be
performed
112.
------
Principal
Addition
Investigator
Business
Street Address
Line 1
113.
------
Principal
Addition
Investigator
Business
Street Address
Line 2
Changes to the submission file
specifications
Recipient Physician.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 5
characters.
1. The data element name is: Principal
Investigator Business Street Address
Line 1
2. The description is: The first line of the
primary business street address of the
Principal Investigator of the research
study, if the Principal Investigator is a
Covered Recipient Physician. If the
Principal Investigator is the same as the
Covered Recipient Physician receiving
the payment (identified in data
elements 10-13), it is not necessary to
duplicate the information for the
Principal Investigator fields (Data
Elements 45-60).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 55
characters.
1. The data element name is: Principal
Investigator Business Street Address
Line 2
2. The description is: The first line of the
primary business street address of the
Principal Investigator of the research
study, if the Principal Investigator is a
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 53 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
114.
------
Principal
Investigator
City
Addition
115.
------
Principal
Investigator
State
Addition
Changes to the submission file
specifications
Covered Recipient Physician. If the
Principal Investigator is the same as the
Covered Recipient Physician receiving
the payment (identified in data
elements 10-13), it is not necessary to
duplicate the information for the
Principal Investigator fields (Data
Elements 45-60).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 55
characters.
1. The data element name is: Principal
Investigator City
2. The description is: The primary
business address city of the Principal
investigator of the research study.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 40
characters
1. The data element name is: Principal
Investigator State
2. The description is: The primary
business address state or territory
abbreviation of the Principal
investigator of the research study, if the
primary practice address is in the
United States.
3. The required field is: no, unless
indicating multiple principal
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 54 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
116.
------
Principal
Investigator
Zip Code
Addition
117.
------
Principal
Investigator
Country
Addition
118.
------
Principal
Investigator
Province
Addition
Changes to the submission file
specifications
investigators
4. The field size is: 2 characters
1. The data element name is: Principal
Investigator Zip Code
2. The description is: The 9 digit zip code
of the primary business address
location of the Principal investigator of
the research study, if the primary
practice address is in the United States.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 9
characters
1. The data element name is: Principal
Investigator Country
2. The description is: The primary
business address country name of the
Principal investigator of the research
study.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 40
characters
1. The data element name is: Principal
Investigator Province
2. The description is: The primary
business address province name of the
Principal investigator of the research
study, if the primary practice address is
outside the United States.
3. The required field is: no, unless
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 55 of 62
DE#
revised
DE#
Data element
name
Action to be
performed
119.
------
Principal
Investigator
Postal Code
Addition
120.
------
Principal
Investigator
Physician
Primary Type
Addition
Changes to the submission file
specifications
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters
1. The data element name is: Principal
Investigator Postal Code
2. The description is: The international
postal code of the primary business
location of the Principal investigator of
the research study if the primary
practice address is outside the United
States.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters.
1. The data element name is: Principal
Investigator Physician Primary Type
2. The description is: Primary type of
medicine practiced by the Principal
Investigator. If the Principal
Investigator is the same as the Covered
Recipient Physician receiving the
payment (identified in data elements
10-13), it is not necessary to duplicate
the information for the Principal
Investigator fields (Data Elements 4560).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 1 character.
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 56 of 62
DE#
revised
121.
DE#
122.
------
------
Data element
name
Principal
Investigator
NPI
Action to be
performed
Addition
Principal
Investigator
Specialty
Addition
Changes to the submission file
specifications
1. The data element name is: Principal
Investigator NPI
2. The description is: Individual NPI for
Physician (not NPI of any group
physician belonging to) required, if
applicable. If the Principal Investigator
is the same as the Covered Recipient
Physician receiving the payment
(identified in data elements 10-13), it is
not necessary to duplicate the
information for the Principal
Investigator fields (Data Elements 4560).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 10 characters
1. The data element name is: Principal
Investigator Specialty
2. The description is: Principal
Investigator's single specialty chosen
from "provider taxonomy" list. If the
Principal Investigator is the same as the
Covered Recipient Physician receiving
the payment (identified in data
elements 10-13), it is not necessary to
duplicate the information for the
Principal Investigator fields (Data
Elements 45-60).
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: 10 characters
Reason for the Change
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
Page 57 of 62
DE#
revised
123.
DE#
------
Data element
name
Principal
Investigator
License State
and License
Number
Action to be
performed
Addition
Physician Ownership/Investment Record
2.
2.
Applicable
Edit
manufacturer
or applicable
GPO
registration ID
submitting file
6.
6.
Ownership/
Edit
Changes to the submission file
specifications
1. The data element name is: Principal
Investigator License State and License
Number
2. The description is: Paired state and state
license number of the Principal
Investigator, who is a physician
covered recipient; the pairing includes
the 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 Principal
investigator is licensed in multiple
states, provide only one state and
license number pair.
3. The required field is: no, unless
indicating multiple principal
investigators
4. The field size is: less than or equal to 20
characters per state and license number.
Reason for the Change
1. The description field is edited to: Open
Payments System generated identifier
used to identify the Applicable
Manufacturer or GPO (populated only
with CMS provided identifier). If this
file contains a single AM/GPO's set of
payment/transfer of value records, this
AM/GPO ID will be used for all records
in the file.
2. The field size is edited to: system
generated.
1. The description field is edited to: textual
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to reflect the registration ID
will be system generated.
Based on comments received additional data
elements were added to allow applicable
manufactures to report multiple principal
investigators that are covered recipients.
The description is edited to provide guidance to
Page 58 of 62
DE#
revised
DE#
Data element
name
Investment
Physician’s
Frist Name
Action to be
performed
7.
7.
Ownership/
Investment
Physician’s
Middle Name
Edit
8.
8.
Ownership/
Investment
Physician’s
Last Name
Edit
9.
9.
Ownership/
Investment
Physician’s
Name Suffix
Edit
Changes to the submission file
specifications
first name, as listed in the National Plan
& Provider Enumeration System
(NPPES) of the physician (covered
recipient) receiving the payment or
transfer of value.
2. The field size is limited to less than or
equal to 20 characters.
1. The description field is edited to: 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.
2. The field size is limited to less than or
equal to 20 characters.
1. The description field is edited to: textual
last name, as listed in the National Plan
& Provider Enumeration System
(NPPES) of the physician (covered
recipient) receiving the payment or
transfer of value.
2. The field size is limited to less than or
equal to 35 characters.
1. The description field is edited to: suffix,
as listed in the 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).
2. The field size is limited to less than or
equal to five characters.
Reason for the Change
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES.
The description is edited to provide guidance to
collect the information required for to reporting.
The field size is edited to be consistent with data
collection in NPPES.
Page 59 of 62
DE#
revised
10.
DE#
10.
11.
11.
12.
12.
14.
14.
15.
------
Data element
name
Ownership/
Investment
Physician’s
Business
Street Address
Line 1
Ownership/
Investment
Physician’s
Business
Street Address
Line 2
Ownership/
Investment
Physician’s
City
Ownership/
Investment
Physician’s
Zip Code
Action to be
performed
Edit
Changes to the submission file
specifications
1. The field size is limited to less than or
equal to 55 characters.
Reason for the Change
Edit
1. The field size is limited to less than or
equal to 55 characters.
The field size is edited to be consistent with data
collection in NPPES.
Edit
1. The field size is limited to less than or
equal 40 characters.
The field size is edited to be consistent with data
collection in NPPES.
Edit
Based on comments received the field size is
increased to accommodate a 5 digit zip code with an
option to report the additional 4 digits.
Ownership/
Investment
Physician’s
Country
Addition
1. The description field is edited to: The 9
digit zip code for the primary practice
location of the physician or teaching
hospital (covered recipient) receiving
the payment or transfer of value if the
primary practice address is in the United
States.
2. The field size is edited to less than or
equal to 9 characters.
1. The data element name is: Ownership/
Investment Physician’s Country
2. The description field is: The primary
practice/business address country name
of the physician.
3. The required field is: yes
4. The field size is: less than or equal to 20
characters.
The field size is edited to be consistent with data
collection in NPPES.
This data element is added match information
collected in general and research data specifications.
Page 60 of 62
DE#
revised
16.
DE#
------
Data element
name
Ownership/
Investment
Physician’s
Province
Action to be
performed
Addition
Addition
17.
------
Ownership/
Investment
Postal Code
18.
15.
19.
------
Ownership/
Edit
Investment
Physician’s
Email Address
Ownership/
Addition
Investment
Physician’s
Primary Type
Changes to the submission file
specifications
1. The data element name is: Ownership/
Investment Physician’s Province
2. The description field is: The primary
business address province name of the
Physician Owner/Investor, if the primary
practice address is outside the United
States.
3. The required field is: no
4. The field size is: less than or equal to 20
characters.
1. The data element name is: Ownership/
Investment Physician’s Postal Code
2. The description field is: The
international postal code of the primary
business location of the Principal
investigator of the research study if the
primary practice address is outside the
United States.
3. The required field is: yes, if country is
not the United States.
4. The field size is: less than or equal to 20
characters.
1. The field size is increased to less than or
equal to 100 characters.
Reason for the Change
1. The data element name is: Ownership/
Investment Physician’s Primary Type
2. The description field is: Primary type of
medicine practiced by the physician
covered recipient.
3. The required field is: yes
4. The field size is: 1 character
This data element is added match information
collected in general and research data specifications.
This data element is added match information
collected in general and research data specifications.
This data element is added match information
collected in general and research data specifications.
The field size is increased to allow applicable
manufacturers and applicable GPOs to accurately
report a recipient’s email address.
Page 61 of 62
DE#
revised
20.
DE#
17.
Data element
name
Ownership/
Investment
Physician’s
NPI
Action to be
performed
Edit
21.
16.
Ownership/
Investment
Physician’s
Specialty
Edit
22.
18.
Ownership/
Investment
Physician’s
License State
and License
Number
Edit
-----
19.
Ownership/
Investment
Physician’s
License State
Delete
Changes to the submission file
specifications
1. The description field is edited to:
Individual NPI for Physician (not NPI of
any group physician belonging to),
required if applicable.
2. The required field is changed to: no.
1. The description field is changed to:
Physician's single specialty chosen from
the standardized "provider taxonomy"
code list.
2. The field size is edited to be limited to
10 characters.
1. The data element name is changed to:
Ownership/ Investment Physician’s
License State and License Number
2. The description field is changed to:
Paired state and state license number of
the covered physician; the pairing
includes the 2 letter state abbreviation
followed by the state license number and
may include up to 5 "Ownership/
Investment Physician License State and
License Number" pairs.
3. The field size is edited to: less than or
equal to 20 characters per state and
license number.
1. This data element is deleted.
Reason for the Change
The required filed is changed to no because
applicable manufacturers and applicable GPOs are
only required to report a physician’s NPI if
applicable.
Based on comments received the “provider
taxonomy” list from the Washington Publishing
Company will be provided. This is the same list that
can be retrieved through the NPPESS website. The
field size is edited to accurately reflect the characters
for collection.
The physician’s license number and state are
combined in order to reflect the appropriate state
with the license number because multiple license
numbers and states may be reported. The field size
is edited to accurately reflect the characters for
collection.
This data element was combined with Physician
Licenses State(s) and License Number(s) for
simplification.
Page 62 of 62
| File Type | application/pdf |
| File Title | Issue # |
| Author | CMS |
| File Modified | 2013-05-01 |
| File Created | 2013-05-01 |