Form CMS-10495 General-Research-Ownership Submission Data Elements and

Open Payments Change Summary:
Program Year 2021 and Onwards
Submission Data Mapping Document
Centers for Medicare & Medicaid Services

August 2020
Version 1.0

OP Change Summary: Submission Data Mapping Document v1.0

August 2020

Contents
1

Introduction .......................................................................................................................................... 1

2

Changes Made in August 2020.............................................................................................................. 1
2.1

Changes to the Submission Data Mapping Document ................................................................. 1

2.1.1

General Updates ................................................................................................................... 2

2.1.2

Changes to the General Payments (Non-Research) Tab ....................................................... 2

2.1.3

Changes to the Research Payment Tab.................................................................................6

2.1.4

Changes to the Physician Ownership Tab ...........................................................................20

2.1.5 Allowed Special Characters Tab ................................................................................................. 20
3

Changes Made to CSV Templates ....................................................................................................... 20

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1 Introduction
This document lists the changes made to the Submission Data Mapping Document and/or CSV templates
(also known as sample files) for program years 2021 and onwards compared to Program Year 20162020 Submission Data Mapping Document/CSV templates for this version.
These changes are being provided to Applicable Manufacturers and Applicable Group Purchasing
Organizations (GPOs) to aid in data collection activities for Program Years 2021 and onwards. The
changes described in this document should not be implemented for the Program Years 2013 – 2015
Submission Data Mapping Document/CSV templates nor for the Program Years 2016-2020 Submission
Data Mapping Document/CSV templates.
This document is organized into the following sections:
·

General updates;

·

Changes to the four tabs of the Submission Data Mapping Document (General Payments tab,
Research Payments tab, Physician Ownership tab, and Allowed Special Characters); and

·

Changes to CSV templates/sample files.

To understand changes to the Submission Data Mapping Document, follow the steps below:
1. Note which tab in the Submission Data Mapping Document is affected. Then, note the Data
Element Name and the Data Element Number (DE#) for a specific entry.
The change to the Data Element is listed below the Data Element Name and Data Element
Number.
2. In the Submission Data Mapping Document, select the affected tab and then find the
corresponding Data Element Number, located in Column A. and the Data Element Name listed in
Column B.
3. Once you have located the Data Element Name and Data Element Number in the Submission
Data Mapping Document, you can match it to the update(s) noted in this document.

2 Changes Made in August 2020
2.1 Changes to the Submission Data Mapping Document
This section of the Change Summary Document lists the changes that are being made to the Submission
Data Mapping Document in August 2020. This will create version 1.0 of the Program Year 2021 and
Onwards Submission Data Mapping Document, as shown in its Revision Log tab.

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August 2020

This Submission Data Mapping Document should be used when submitting payments or other
transfers of value for Program Year 2021-Onwards. To submit payments or other transfers of value for
a previous program year, refer to the Program Years 2016-2020 Submission Data Mapping Document
and 2013-2015 Submission Data Mapping Document.

2.1.1 General Updates
·

The Submission Data Mapping Document and Change Summary File on the CMS Open payments
Resources page are named as below:
o PY 2021 and Onwards Submission Data Mapping Document [XLSX]
o Change Summary: PY 2021 and Onwards Submission Data Mapping Document [PDF]

2.1.2 Changes to the General Payments (Non-Research) Tab
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Data Element Name: Covered Recipient Type (DE#06)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner i.e. physician assistant, nurse practitioner, clinical nurse specialist,
certified registered nurse anesthetist or anesthesiologist assistant, certified
nurse-midwife.
o Updated “Format” (Column E) to include: "10" = Non-Physician Practitioner
o Updated “Required?” (Column F) to include: Select value "10" if covered
recipient type is physician assistant, nurse practitioner, clinical nurse specialist,
certified registered nurse anesthetist or anesthesiologist assistant, certified
nurse-midwife.
o Updated “Field Size” (Column G) to delete: 1
o Updated “Field Size” (Column G) to include: ≤ 2
Data Element Name: Teaching Hospital Name (DE#07)
o Updated “Required?” (Column F) to delete: IF DE# 6 Covered Recipient Type =
"1" (Physician), this field must be blank.
o Updated “Required?” (Column F) to include: IF DE# 6 is any other value, this
field must be blank.
Data Element Name: Teaching Hospital Tax ID Number (TIN) (DE#08)
o Updated “Required?” (Column F) to delete: IF DE# 6 Covered Recipient Type =
"1" (Physician), this field must be blank.
o Updated “Required?” (Column F) to include: IF DE# 6 is any other value, this
field must be blank.
Data Element Name: Covered Recipient First Name (DE#09)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Covered Recipient
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner (covered recipient) in first bullet.
o Updated “Required?” (Column F) to include: OR "10" (Non-Physician
Practitioner) in second bullet.
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT
Data Element Name: Covered Recipient Middle Name (DE#10)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Covered Recipient
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Updated “Definition/Description” (Column C) to include: or non-physician
practitioner (covered recipient) in first bullet.
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT
Data Element Name: Covered Recipient Last Name (DE#11)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Covered Recipient
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner (covered recipient) in first bullet.
o Updated “Required?” (Column F) to include: OR "10" (Non-Physician
Practitioner)
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT
Data Element Name: Covered Recipient Name Suffix (DE#12)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Covered Recipient
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner (covered recipient) in first bullet.
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT
Data Element Name: Recipient Primary Business Street Address Line 1 (DE#13)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
Data Element Name: Recipient Primary Business Street Address Line 2 (DE#14)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
Data Element Name: Recipient City (DE#15)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
Data Element Name: Recipient State (DE#16)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
Data Element Name: Recipient Zip Code (DE#17)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
Data Element Name: Recipient Country (DE#18)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
Data Element Name: Recipient Province (DE#19)
o Updated “Definition/Description” (Column C) to delete: or teaching hospital
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
Data Element Name: Recipient Postal Code (DE#20)
o Updated “Definition/Description” (Column C) to delete: or teaching hospital
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
Data Element Name: Covered Recipient Primary Type (DE#22)
o

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Updated “Data Element Name” (Column B) to delete: Physician
Updated “Data Element Name” (Column B) to include: Covered Recipient
Updated “Definition/Description” (Column C) to include:
• or non-physician practitioner in first bullet
• NOTE: For non-physician practitioners, you may select multiple Primary
Types as applicable based on your knowledge and the relevant
definitions in the Final Rule as second bullet.
o Updated “Format” (Column E) to include:
• "101" = Physician assistant
• "102" = Nurse practitioner
• "103" = Clinical nurse specialist
• "104" = Certified registered nurse anesthetist or Anesthesiologist
Assistant
• "105" = Certified nurse-midwife
o Updated “Required?” (Column F) to include: then enter only one value between
Covered Recipient Primary Type= "1" and Covered Recipient Primary Type= "6"
as applicable OR IF DE# 6 Covered Recipient Type ="10" (Non-Physician
Practitioner) then enter up to 5 comma separated values between Covered
Recipient Primary Type= "101" and Covered Recipient Primary Type= "105" as
applicable
o Updated “Field Size” (Column G) to delete: 1
o Updated “Field Size” (Column G) to include: ≤ 20
o Updated “Validation Rules” (Column H) to include:
• IF DE# 6 Covered Recipient Type = "1" (Physician)
• Allowed comma separated multiple values between "101", "102",
"103", "104", or "105" IF DE# 6 as second bullet.Covered Recipient Type
= "10" (Non-Physician Practitioner) as second bullet.
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT
Data Element Name: Covered Recipient NPI (DE#23)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Covered Recipient
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
o Updated “Required?” (Column F) to include: OR Non-Physician Practitioner has
an NPI in second bullet.
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT
Data Element Name: Covered Recipient Specialty (DE#24)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Covered Recipient
o Updated “Definition/Description” (Column C) to include: or the non-physician
practitioner's specialty
o Updated “Required?” (Column F) to include: OR "10" (Non-Physician
Practitioner) in second bullet in second bullet.
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT
o
o
o

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Updated “Additional Notes” (Column K) to include: and Non-Physician
Practitioner
Data Element Name: Covered Recipient License State and License Number (DE#25)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Covered Recipient
o Updated “Definition/Description” (Column C) to include: or the covered
recipient non-physician practitioner at the end of first sentence.
• “Covered Recipient prior to License State and License Number” in the
second sentence.
• “If the covered recipient physician or the non-physician practitioner”
prior to “is licensed in multiple states” in the second sentence.
o Updated “Required?” (Column F) to include: OR "10" (Non-Physician
Practitioner)
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN from all five bullets.
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT in all five
bullets.
Data Element Name: Marketed Name of Drug, Device, Biological, or Medical Supply
(DE#30)
o Updated “Required?” (Column F) to delete: and Indicate Drug, Device,
Biological, or Medical Supply (DE#28) is "1" or "3" from first bullet.
Updated “Required?” (Column F) to include: OR Related Product Indicator (DE #26) is
"Yes", Covered or Non-covered Product Indicator (DE #27) is "Non-covered", Indicate
Drug, Device, Biological, or Medical Supply (DE#28) is "2" or "4" and an Associated
Primary Device Identifier (DE#32) has been provided.Updated “Validation Rules”
(Column H) to include: Validated against the CMS approved Device and Medical Supply
Names and Primary Device Identifier dataset. Data Element Name: Primary Device
Identifier (DE#32)
o Added “Data Element Name” (Column B) to include: Primary Device Identifier
o Added “Definition/Description” (Column C) to include: For each covered device
or covered medical supply listed in relation to the payment or other transfer of
value, provide the associated Primary Device Identifier (DI) (if applicable). The
device identifier is the mandatory, fixed portion of a unique device identifier
(UDI) that identifies the specific version or model of a device and the labeler of
that device. Up to 5 Primary Device Identifiers can be provided. Primary Device
Identifiers are required for all devices and medical supplies that have Primary
Device Identifiers. If the reported device or medical supply does not have a
Primary Device Identifier this field may be left blank. Report this element for
devices and medical supplies only. Do not report this element if the payment or
other transfer of value is not related to any products.
o Added “Data Type” (Column D) to include: Alpha-numeric Text
o Added “Format” (Column E) to include: Free form text
o Added “Required?” (Column F) to include: Yes IF, Related Product Indicator (DE
#26) is "Yes" and Covered or Non-covered Product Indicator (DE #27) is
"Covered" or "Non-Covered", Indicate Drug, Device, Biological, or Medical
Supply (DE#28) is "2" or "4" and when the reported device or medical supply
has a Primary Device Identifier. IF DE# 26 = "N" or if DE# 28 = “1" or "3", this
field must be blank.
o

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Added “Field Size” (Column G) to include: < 100 Char
Added “Validation Rules” (Column H) to include: Validated against format and
field size (columns E and G). If a device or medical supply named in the record
(DE#30) has a Primary Device Identifier, the Primary Device Identifier must be
reported with the same record. The order of Primary Device Identifiers provided
must match the order of named devices or medical supplies in DE#30. If no
Primary Device Identifier exists for a named device or medical supply in DE#30,
leave the corresponding Primary Device Identifier field blank for that device or
medical supply. Validated combination of Name of Associated Covered Device
or Medical Supply (DE#30) and Associated Device or Medical Supply Primary
Device Identifier (DE#32) against the CMS approved GUDID Device/Medical
Supply Names and Primary Device Identifier dataset.
o Added “Publicly Displayed” (Column I) to include: Yes
o Added “CSV Field Name” (Column J) to include: PRIMARY_DEVICE_IDENTIFIER_1
PRIMARY_DEVICE_IDENTIFIER_2 PRIMARY_DEVICE_IDENTIFIER_3
PRIMARY_DEVICE_IDENTIFIER_4 PRIMARY_DEVICE_IDENTIFIER_5
o Added “Additional Notes” (Column K) to include: No notes
o Added “Allowed Special Characters” (Column L) to include: no, only values
given in Format Column E are allowed
Data Element Number: Due to the addition of new Data Element of Primary Device
Identifier (DE #32), all other data element numbers (Column A) are amended to reflect
the impact of the addition of DE #32. For example, the data element labeled
“Applicable Manufacturer or Applicable GPO Making Payment Name” is renumbered
from DE #32 to DE #33. Further, all other fields that refer back to any data elements DE
#32 to DE #50 have been amended to refer to the new numbering.Data Element Name:
Nature of Payments or Transfer of Value (DE#40)
o Updated “Format” (Column E) to delete: “12” = Compensation for serving as
faculty or as a speaker for a non-accredited and noncertified continuing
education program and “13” = Compensation for serving as faculty or as a
speaker for an accredited or certified continuing education program.
o Updated “Format” (Column E) to include: "16" = Compensation for serving as
faculty or as a speaker for a medical education program, "17" = Debt
forgiveness, "18" = Long term medical supply or device loan, "19" = Acquisition.
o Updated “Validation Rules” (Column H) to delete: characters 1 through 15
o Updated “Validation Rules” (Column H) to include: characters 1 through 19 with
exception of 12 and 13
Data Element Name: Physician Ownership Indicator (DE#44)
o Updated “Required?” (Column F) to include: OR IF DE# 6 Covered Recipient Type
= "10" (Non-Physician Practitioner) as second bullet.
Data Element Name: Third Party Payment Recipient Indicator (DE#45)
o Updated “Definition/Description” (Column C) to include: non-physician
practitioner or
o
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2.1.3 Changes to the Research Payment Tab
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Data Element Name: Covered Recipient Type (DE#06)
o Updated “Definition/Description” (Column C) to include: or a covered recipient
non-physician practitioner i.e. physician assistant, nurse practitioner, clinical
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August 2020

nurse specialist, certified registered nurse anesthetist or anesthesiologist
assistant, certified nurse-midwife.
o Updated “Format” (Column E) to include: or "10" = Covered Recipient NonPhysician Practitioner
o Updated “Required?” (Column F) to include: Select value "10" if covered
recipient type is physician assistant, nurse practitioner, clinical nurse specialist,
certified registered nurse anesthetist or anesthesiologist assistant, certified
nurse-midwife.
o Updated “Field Size” (Column G) to delete: 1
o Updated “Field Size” (Column G) to include: ≤ 2
o Updated “Validation Rules” (Column H) to include: or 10
Data Element Name: Covered Recipient First Name (DE#10)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Covered Recipient
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner (covered recipient) in first bullet.
o Updated “Required?” (Column F) to include: OR "10" (Covered Recipient NonPhysician Practitioner) in second bullet.
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT
Data Element Name: Covered Recipient Middle Name (DE#11)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Covered Recipient
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner (covered recipient) in first bullet.
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT
Data Element Name: Covered Recipient Last Name (DE#12)
o Updated “Data Element Name” (Column J) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Covered Recipient
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner (covered recipient) in first bullet.
o Updated “Required?” (Column F) to include: OR "10" (Covered Recipient Nonphysician practitioner)
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT
Data Element Name: Covered Recipient Name Suffix (DE#13)
o Updated “Data Element Name” (Column J) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Covered Recipient
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner (covered recipient) in first bullet.
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT
Data Element Name: Recipient Business Street Address Line 1 (DE#14)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner

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Updated “Required?” (Column F) to include: OR "10" (Covered Recipient NonPhysician Practitioner)
Data Element Name: Recipient Business Street Address Line 2 (DE#15)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
Data Element Name: Recipient City (DE#16)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
o Updated “Required?” (Column F) to include: OR "10" (Covered Recipient NonPhysician Practitioner)
Data Element Name: Recipient State (DE#17)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
Data Element Name: Recipient Zip Code (DE#18)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
Data Element Name: Recipient Country (DE#19)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
o Update “Required?” (Column F) to include: OR "10" (Covered Recipient NonPhysician Practitioner)
Data Element Name: Recipient Province (DE#20)
o Updated “Definition/Description” (Column C) to delete: or teaching hospital
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
Data Element Name: Recipient Postal Code (DE#21)
o Updated “Definition/Description” (Column C) to delete: or teaching hospital
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
o Update “Required?” (Column F) to delete: OR "2"
o Update “Required?” (Column F) to include: OR "10"
Data Element Name: Recipient Email Address (DE#22)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
Data Element Name: Covered Recipient NPI (DE#23)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Covered Recipient
o Updated “Definition/Description” (Column C) to include:
• Or non-physician practitioner in the first sentence.
• Or non-physician practitioner has an NPI in the second sentence.
o Updated “Required?” (Column F) to include: or Covered Recipient Non-Physician
Practitioner
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT
Data Element Name: Covered Recipient Primary Type (DE#24)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Covered Recipient
o

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Updated “Definition/Description” (Column C) to include:
• Or the covered recipient non-physician practitioner in first bullet.
• NOTE: For covered recipient non-physician practitioners, you may select
multiple Primary Types as applicable based on your knowledge and the
relevant definitions in the Final Rule as second bullet.
o Updated “Format” (Column E) to include:
• "101" = Physician assistant
• "102" = Nurse practitioner
• "103" = Clinical nurse specialist
• "104" = Certified registered nurse anesthetist or Anesthesiologist
assistant
• "105" = Certified nurse-midwife
o Updated “Required?” (Column F) to include: then enter only one value between
Covered Recipient Primary Type= "1" and Covered Recipient Primary Type= "6"
as applicable OR "10" (Covered Recipient Non-Physician Practitioner) then enter
up to 5 comma separated values between Covered Recipient Primary Type=
"101" and Covered Recipient Primary Type= "105" as applicable
o Updated “Field Size” (Column G) to delete: 1
o Updated “Field Size” (Column G) to include: ≤ 20
o Updated “Validation Rules” (Column H) to include:
• If DE# 6 Covered Recipient Type = "1" (Covered Recipient Physician) in
first bullet.
• Allowed comma separated multiple values between "101", "102",
"103", "104", or "105" if DE# 6 in second bullet.
• Covered Recipient Type = "10" (Covered Recipient Non-Physician
Practitioner) in third bullet.
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT
Data Element Name: Covered Recipient Specialty (DE#25)
o Updated “Data Element Name” (Column B) to delete: PhysicianUpdated “Data
Element Name” (Column B) to include: Covered RecipientUpdated
“Definition/Description” (Column C) to include: or the non-physician
practitioner's specialty
o Updated “Required?” (Column F) to include: OR "10" (Covered Recipient NonPhysician Practitioner)
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT
o Update “Additional Notes” (Column K) to include: Non-Physician Practitioner
Data Element Name: Covered Recipient License State and License Number (DE#26)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Covered Recipient
o Updated “Definition/Description” (Column C) to include: “or the covered
recipient non-physician practitioner” in the first sentence.
• “If the covered recipient physician or the non-physician practitioner is
licensed in multiple states” at the end of second sentence.
o Updated “Required?” (Column F) to include: OR "10" (Covered Recipient NonPhysician Practitioner)
o

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Updated “CSV Field Name” (Column J) to delete: PHYSICIAN from all bullets
Updated “CSV Field Name” (Column J) to include: COVERED_RECIPIENT_LICENSE
in all five bullets
Data Element Name: Marketed Name of Drug, Device, Biological, or Medical Supply
(DE#31)
o Updated “Required?” (Column F) to delete: and Indicate Drug, Device,
Biological, or Medical Supply (DE#29) is "1" or "3" from first bullet.
o Updated “Required?” (Column F) to include: OR Related Product Indicator (DE
#27) is "Yes", Covered or Non-covered Product Indicator (DE #28) is "Noncovered", Indicate Drug, Device, Biological, or Medical Supply (DE#29) is "2" or
"4" and an Associated Device or Medical Supply Primary Device Identifier
(DE#33) has been provided.
o Updated “Validation Rules” (Column H) to include: Validated against the CMS
approved Device and Medical Supply Names and Primary Device Identifier
dataset
Data Element Name: Primary Device Identifier (DE#33)
o Added “Data Element Name” (Column B) to include: Primary Device Identifier
o Added “Definition/Description” (Column C) to include: For each covered device
or covered medical supply listed in relation to the payment or other transfer of
value, provide the associated Primary Device Identifier (DI) (if applicable).
• The device identifier is the mandatory, fixed portion of a unique device
identifier (UDI) that identifies the specific version or model of a device
and the labeler of that device.
• Up to 5 Primary Device Identifiers can be provided. Primary Device
Identifiers are required for all devices and medical supplies that have
Primary Device Identifiers. If the reported device or medical supply does
not have a Primary Device Identifier this field may be left blank. Report
this element for devices and medical supplies only. Do not report this
element if the payment or other transfer of value is not related to any
products.
o Added “Data Type” (Column D) to include: Alpha-numeric Text
o Added “Format” (Column E) to include: Free form text
o Added “Required?” (Column F) to include: Yes IF Related Product Indicator (DE
#27) is "Yes" and Covered or Non-covered Product Indicator (DE #28) is
"Covered" or "Non-Covered", Device, Biological, or Medical Supply (DE#29) is
"2" or "4", and when the reported device or medical supply has a Primary
Device Identifier. IF DE# 27 = "N" or if DE# 29 = "1" or "3", this field must be
blank.
o Added “Field Size” (Column G) to include: 100 Characters
o Added “Validation Rules” (Column H) to include: Validated against format and
field size (columns E and G). If a device or medical supply named in the record
DE#31 has a Primary Device Identifier, the Primary Device Identifier must be
reported with the same record. The order of Primary Device Identifiers provided
must match the order of named devices or medical supplies in DE#31. If no
Primary Device Identifier exists for a named device or medical supply in DE#31,
leave the corresponding Primary Device Identifier field blank for that device or
medical supply Validated combination of Name of Associated Covered Device or
o
o

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OP Change Summary: Submission Data Mapping Document v1.0

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·

August 2020

Medical Supply (DE#31) and Associated Device or Medical Supply Primary
Device Identifier (DE#33) against the CMS approved GUDID Device/Medical
Supply Names and Primary Device Identifier dataset.
o Added “Publicly Displayed” (Column I) to include: Yes
o Added “CSV Field Name” (Column J) to include: PRIMARY_DEVICE_IDENTIFIER_1
PRIMARY_DEVICE_IDENTIFIER_2 PRIMARY_DEVICE_IDENTIFIER_3
PRIMARY_DEVICE_IDENTIFIER_4 PRIMARY_DEVICE_IDENTIFIER_5
o Added “Additional Notes” (Column K) to include: No notes
o Added “Allowed Special Characters” (Column L) to include: no, only values given
in Format Column E are allowed
Data Element Name: Principal Investigator Covered Recipient Indicator (DE#46)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
o Updated “Validation Rules” (Column H) to delete: Physician from first bullet.
o Updated “Validation Rules” (Column H) to include: “or non-physician
practitioners” prior to “can be entered” in the first sentence of the first bullet.
“Or non-physician practitioner” prior to “cannot be entered as a principal
investigator” in the second sentence of the first bullet. “Or non-physician
practitioner” prior to “receiving the payment is also the only Principal
Investigator,” in the first sentence of third bullet.
• “Or non-physician practitioner's” prior to “information.” in the last
sentence of forth bullet.
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
Data Element Name: Principal Investigator Covered Recipient Type (DE#47)
o Added “Data Element Name” (Column B) to include: Principal Investigator
Covered Recipient Type
o Added “Definition/Description” (Column C) to include: Indicator showing if the
Principal Investigator covered recipient of the payment or other transfer of
value is a covered recipient physician, or a covered recipient non-physician
practitioner i.e. physician assistant, nurse practitioner, clinical nurse specialist,
certified registered nurse anesthetist or anesthesiologist assistant, certified
nurse-midwife.
o Added “Data Type” (Column D) to include: Enumeration
o Added “Format” (Column E) to include: "1" = Covered Recipient Physician or
"10" = Covered Recipient Non-Physician Practitioner
o Added “Required?” (Column F) to include: Yes IF DE# 46, "Principal Investigator
Covered Recipient Indicator" = "Y" Select value "1" if principal investigator is a
Covered Recipient Physician OR select value "10" if principal investigator is a
Covered Recipient Non-Physician Practitioner.
o Added “Field Size” (Column G) to include: ≤ 2 Char
o Added “Validation Rules” (Column H) to include: Validates that only 1 or 10 is
provided
o Added “Publicly Displayed” (Column I) to include: Yes
o Added “CSV Field Name” (Column J) to include:
PRINCIPAL1_INVESTIGATOR_COVERED_RECIPIENT_TYPE
o Added “Additional Notes” (Column K) to include: No Notes
11

OP Change Summary: Submission Data Mapping Document v1.0

Added “Allowed Special Characters” (Column L) to include: No, only values given
in Format Column E are allowed.
Data Element Name: Principal Investigator First Name (DE#48)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
o Updated “Required?” (Column F) to delete: Physician
o Updated “Required?” (Column F) to include: AND DE # 47, "Principal
Investigator Covered Recipient Type" = "1" or "10"
Data Element Name: Principal Investigator Middle Name (DE#49)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Last Name (DE#50)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
o Updated “Required?” (Column F) to delete: Physician
o Updated “Required?” (Column F) to include: AND DE # 47, "Principal
Investigator Covered Recipient Type" = "1" or "10"
Data Element Name: Principal Investigator Name Suffix (DE#51)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Business Street Address Line 1 (DE#52)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
o Updated “Required?” (Column F) to delete: Physician
o Updated “Required?” (Column F) to include: AND DE # 47, "Principal
Investigator Covered Recipient Type" = "1" or "10"
Data Element Name: Principal Investigator City (DE#54)
o Updated “Required?” (Column F) to delete: Physician
o Updated “Required?” (Column F) to include: AND DE # 47, "Principal
Investigator Covered Recipient Type" = "1" or "10"
Data Element Name: Principal Investigator State (DE#55)
o Updated “Required?” (Column F) to delete: Physician from first bullet.
• 56 from third bullet.
o Updated “Required?” (Column F) to include:
• AND DE # 47, "Principal Investigator Covered Recipient Type" = "1" or
"10" as second bullet
• 57 in third bullet.
Data Element Name: Principal Investigator Zip Code (DE#56)
o Updated “Required?” (Column F) to delete: Physician from first bullet.
• 56 from third bullet.
o Updated “Required?” (Column F) to include:
• AND DE # 47, "Principal Investigator Covered Recipient Type" = "1" or
"10" in second bullet
• 57 in third bullet.
o Updated “Validation Rules” (Column H) to delete: 54
o Updated “Validation Rules” (Column H) to include: 55
Data Element Name: Principal Investigator Country (DE#57)
o

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August 2020

12

OP Change Summary: Submission Data Mapping Document v1.0

Updated “Required?” (Column F) to delete: Physician from first bullet
Updated “Required?” (Column F) to include: AND DE # 47, "Principal
Investigator Covered Recipient Type" = "1" or "10" as second bullet.
Data Element Name: Principal Investigator Postal Code (DE#59)
o Updated “Required?” (Column F) to delete: 55
o Updated “Required?” (Column F) to include: 56
Data Element Name: Principal Investigator Physician Primary Type (DE#60)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Definition/Description” (Column C) to include: NOTE: For covered
recipient non-physician practitioners, you may select multiple Primary Types as
applicable based on your knowledge and the relevant definitions in the Final
Rule as second bullet.
o Updated “Format” (Column E) to include:
• "101" = Physician assistant
• "102" = Nurse practitioner
• "103" = Clinical nurse specialist
• "104" = Certified registered nurse anesthetist or Anesthesiologist
assistant
• "105" = Certified nurse-midwife
o Updated “Required?” (Column F) to delete: Physician from first bullet.
o Updated “Required?” (Column F) to include:
• AND DE # 47, "Principal Investigator Covered Recipient Type" = "1" or
"10" in second bullet.
• IF DE # 47, "Principal Investigator Covered Recipient Type" = "1" then
enter only one value between Principal Investigator Primary Type= "1"
and Principal Investigator Primary Type= "6" as applicable is third bullet.
• IIF DE # 47, "Principal Investigator Covered Recipient Type" = "10" then
enter up to 5 comma separated values between Principal Investigator
Primary Type= "101" and Principal Investigator Primary Type= "105" as
applicable in third bullet.
o Updated “Field Size” (Column G) to delete: 1
o Updated “Field Size” (Column G) to include: ≤ 20
o Updated “Validation Rules” (Column H) to include:
• If the Principal Investigator is a Covered Recipient Physician in first
bullet.
• Allowed comma separated multiple values between "101", "102",
"103", "104", or "105" if the Principal Investigator is a Covered Recipient
Non-Physician Practitioner in second bullet.
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
Data Element Name: Principal Investigator NPI (DE#61)
o Updated “Definition/Description” (Column C) to include: or non-physician
practitioner
o Updated “Required?” (Column F) to include: or Non-Physician Practitioner
Data Element Name: Principal Investigator Specialty (DE#62)
o Updated “Required?” (Column F) to delete: Physician from first bullet.
o Updated “Required?” (Column F) to include: AND IF DE # 47, "Principal
Investigator Covered Recipient Type" = "1" or "10" in second bullet.
o
o

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OP Change Summary: Submission Data Mapping Document v1.0
·

·

·

·

·

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August 2020

Data Element Name: Principal Investigator License State and License Number (DE#63)
o Updated “Definition/Description” (Column C) to delete: Physician from first
bullet.
o Updated “Definition/Description” (Column C) to include:
• “non-physician practitioner covered recipient” in the first sentence.
• “or Non-Physician Practitioner” in the second sentence.
o Updated “Required?” (Column F) to delete: Physician
o Updated “Required?” (Column F) to include: AND IF DE # 47, "Principal
Investigator Covered Recipient Type" = "1" or "10"
Data Element Name: Principal Investigator Covered Recipient Type (DE#64)
o Added “Data Element Name” (Column B) to include: Principal Investigator
Covered Recipient Type
o Added “Definition/Description” (Column C) to include: Indicator showing if the
Principal Investigator covered recipient of the payment or other transfer of
value is a covered recipient physician, or a covered recipient non-physician
practitioner i.e. physician assistant, nurse practitioner, clinical nurse specialist,
certified registered nurse anesthetist or anesthesiologist assistant, certified
nurse-midwife.
o Added “Data Type” (Column D) to include: Enumeration
o Added “Format” (Column E) to include: "1" = Covered Recipient Physician or
"10" = Covered Recipient Non-Physician Practitioner
o Added “Required?” (Column F) to include: No, unless indicating multiple
Principal Investigators
o Added “Field Size” (Column G) to include: ≤ 2 Char
o Added “Validation Rules” (Column H) to include: Validated against data type,
format, and field size (columns D, E, G)
o Added “Publicly Displayed” (Column I) to include: Yes
o Added “CSV Field Name” (Column J) to include:
PRINCIPAL2_INVESTIGATOR_COVERED_RECIPIENT_TYPE
o Added “Additional Notes” (Column K) to include: No Notes
o Added “Allowed Special Characters” (Column L) to include: No, only values given
in Format Column E are allowed.
Data Element Name: Principal Investigator First Name (DE#65)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Middle Name (DE#66)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Last Name (DE#67)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Name Suffix (DE#68)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Business Street Address Line 1 (DE#69)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
14

OP Change Summary: Submission Data Mapping Document v1.0
·

·

·

·

·

·

August 2020

Data Element Name: Principal Investigator Postal Code (DE#76)
o Updated “Required?” (Column F) to delete: 71
o Updated “Required?” (Column F) to include: 74
Data Element Name: Principal Investigator Primary Type (DE#77)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Principal Investigator
Primary Type
o Updated “Definition/Description” (Column C) to include: NOTE: For covered
recipient non-physician practitioners, you may select multiple Primary Types as
applicable based on your knowledge and the relevant definitions in the Final
Rule.
o Updated “Format” (Column E) to include:
• "101" = Physician assistant
• "102" = Nurse practitioner
• "103" = Clinical nurse specialist
• "104" = Certified registered nurse anesthetist or Anesthesiologist
assistant
• "105" = Certified nurse-midwife
o Updated “Field Size” (Column G) to delete: 1 Char
o Updated “Field Size” (Column G) to include: ≤ 20
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include:
PRINCIPAL2_INVESTIGATOR_PRIMARY_TYPE
Data Element Name: Principal Investigator NPI (DE#78)
o Updated “Definition/Description” (Column C) to include: or Non-Physician
Practitioner.
Data Element Name: Principal Investigator Specialty (DE#79)
o Updated “Additional Notes” (Column K) to include: and Non-Physician
Practitioner
Data Element Name: Principal Investigator License State and License Number (DE#80)
o Updated “Definition/Description” (Column C) to include:
• Or Non-Physician Practitioner in the first sentence.
• Or Non-Physician Practitioner in the second sentence.
Data Element Name: Principal Investigator Covered Recipient Type (DE#81)
o Added “Data Element Name” (Column B) to include: Principal Investigator
Covered Recipient Type
o Added “Definition/Description” (Column C) to include: Indicator showing if the
Principal Investigator covered recipient of the payment or other transfer of
value is a covered recipient physician, or a covered recipient non-physician
practitioner i.e. physician assistant, nurse practitioner, clinical nurse specialist,
certified registered nurse anesthetist or anesthesiologist assistant, certified
nurse-midwife.
o Added “Data Type” (Column D) to include: Enumeration
o Added “Format” (Column E) to include: "1" = Covered Recipient Physician or
"10" = Covered Recipient Non-Physician Practitioner
o Added “Required?” (Column F) to include: No, unless indicating multiple
Principal Investigators
15

OP Change Summary: Submission Data Mapping Document v1.0

Added “Field Size” (Column G) to include: ≤ 2 Char
Added “Validation Rules” (Column H) to include: Validated against data type,
format, and field size (columns D, E, G)
o Added “Publicly Displayed” (Column I) to include: Yes
o Added “CSV Field Name” (Column J) to include:
PRINCIPAL3_INVESTIGATOR_COVERED_RECIPIENT_TYPE
o Added “Additional Notes” (Column K) to include: No Notes
o Added “Allowed Special Characters” (Column L) to include: No, only values given
in Format Column E are allowed.
Data Element Name: Principal Investigator First Name (DE#82)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Middle Name (DE#83)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Last Name (DE#84)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Name Suffix (DE#85)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Business Street Address Line 1 (DE#86)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Primary Type (DE#94)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Principal Investigator
Primary Type
o Updated “Definition/Description” (Column C) to include: NOTE: For covered
recipient non-physician practitioners, you may select multiple Primary Types as
applicable based on your knowledge and the relevant definitions in the Final
Rule.
o Updated “Format” (Column E) to include:
• "101" = Physician assistant
• "102" = Nurse practitioner
• "103" = Clinical nurse specialist
• "104" = Certified registered nurse anesthetist or Anesthesiologist
assistant
• "105" = Certified nurse-midwife
o Updated “Field Size” (Column G) to delete: 1 Char
o Updated “Field Size” (Column G) to include: ≤ 20
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include:
PRINCIPAL3_INVESTIGATOR_PRIMARY_TYPE
Data Element Name: Principal Investigator NPI (DE#95)
o Updated “Definition/Description” (Column C) to include: or Non-Physician
Practitioner.
o
o

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August 2020

16

OP Change Summary: Submission Data Mapping Document v1.0
·

·

·

·

·

·

·

·

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August 2020

Data Element Name: Principal Investigator Specialty (DE#96)
o Updated “Additional Notes” (Column K) to include: and Non-Physician
Practitioner
Data Element Name: Principal Investigator License State and License Number (DE#97)
o Updated “Definition/Description” (Column C) to include: or Non-Physician
Practitioner
Data Element Name: Principal Investigator Covered Recipient Type (DE#98)
o Added “Data Element Name” (Column B) to include: Principal Investigator
Covered Recipient Type
o Added “Definition/Description” (Column C) to include: Indicator showing if the
Principal Investigator covered recipient of the payment or other transfer of
value is a covered recipient physician, or a covered recipient non-physician
practitioner i.e. physician assistant, nurse practitioner, clinical nurse specialist,
certified registered nurse anesthetist or anesthesiologist assistant, certified
nurse-midwife.
o Added “Data Type” (Column D) to include: Enumeration
o Added “Format” (Column E) to include: "1" = Covered Recipient Physician or
"10" = Covered Recipient Non-Physician Practitioner
o Added “Required?” (Column F) to include: No, unless indicating multiple
Principal Investigators
o Added “Field Size” (Column G) to include: ≤ 2 Char
o Added “Validation Rules” (Column H) to include: Validated against data type,
format, and field size (columns D, E, G)
o Added “Publicly Displayed” (Column I) to include: Yes
o Added “CSV Field Name” (Column J) to include:
PRINCIPAL4_INVESTIGATOR_COVERED_RECIPIENT_TYPE
o Added “Additional Notes” (Column K) to include: No Notes
o Added “Allowed Special Characters” (Column L) to include: No, only values given
in Format Column E are allowed.
Data Element Name: Principal Investigator First Name (DE#99)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Middle Name (DE#100)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Last Name (DE#101)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Name Suffix (DE#102)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Business Street Address Line 1 (DE#103)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Primary Type (DE#111)
o Updated “Data Element Name” (Column B) to delete: Physician

17

OP Change Summary: Submission Data Mapping Document v1.0
o
o

o

Updated “Data Element Name” (Column B) to include: Principal Investigator
Primary Type
Updated “Definition/Description” (Column C) to include: NOTE: For covered
recipient non-physician practitioners, you may select multiple Primary Types as
applicable based on your knowledge and the relevant definitions in the Final
Rule.
Updated “Format” (Column E) to include:
• "101" = Physician assistant
• "102" = Nurse practitioner
• "103" = Clinical nurse specialist
• "104" = Certified registered nurse anesthetist or Anesthesiologist
assistant
• "105" = Certified nurse-midwife

Updated “Field Size” (Column G) to delete: 1 Char
Updated “Field Size” (Column G) to include: ≤ 20
Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
Updated “CSV Field Name” (Column J) to include:
PRINCIPAL4_INVESTIGATOR_PRIMARY_TYPE
Data Element Name: Principal Investigator NPI (DE#112)
o Updated “Definition/Description” (Column C) to include: or Non-Physician
Practitioner
o Updated “Additional Notes” (Column K) to include: and Non-Physician
Practitioner
Data Element Name: Principal Investigator License State and License Number (DE#114)
o Updated “Definition/Description” (Column C) to include: or Non-Physician
Practitioner
Data Element Name: Principal Investigator Covered Recipient Type (DE#115)
o Added “Data Element Name” (Column B) to include: Principal Investigator
Covered Recipient Type
o Added “Definition/Description” (Column C) to include: Indicator showing if the
Principal Investigator covered recipient of the payment or other transfer of
value is a covered recipient physician, or a covered recipient non-physician
practitioner i.e. physician assistant, nurse practitioner, clinical nurse specialist,
certified registered nurse anesthetist or anesthesiologist assistant, certified
nurse-midwife.
o Added “Data Type” (Column D) to include: Enumeration
o Added “Format” (Column E) to include: "1" = Covered Recipient Physician or
"10" = Covered Recipient Non-Physician Practitioner
o Added “Required?” (Column F) to include: No, unless indicating multiple
Principal Investigators
o Added “Field Size” (Column G) to include: ≤ 2 Char
o Added “Validation Rules” (Column H) to include: Validated against data type,
format, and field size (columns D, E, G)
o Added “Publicly Displayed” (Column I) to include: Yes
o Added “CSV Field Name” (Column J) to include:
PRINCIPAL5_INVESTIGATOR_COVERED_RECIPIENT_TYPE
o Added “Additional Notes” (Column K) to include: No Notes
o
o
o
o

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18

OP Change Summary: Submission Data Mapping Document v1.0

Added “Allowed Special Characters” (Column L) to include: No, only values given
in Format Column E are allowed.
Data Element Name: Principal Investigator First Name (DE#116)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Middle Name (DE#117)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Last Name (DE#118)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Name Suffix (DE#119)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Business Street Address Line 1 (DE#120)
o Updated “Definition/Description” (Column C) to include: or Covered Recipient
Non-Physician Practitioner.
Data Element Name: Principal Investigator Primary Type (DE#128)
o Updated “Data Element Name” (Column B) to delete: Physician
o Updated “Data Element Name” (Column B) to include: Principal Investigator
Primary Type
o Updated “Definition/Description” (Column C) to include: NOTE: For covered
recipient non-physician practitioners, you may select multiple Primary Types as
applicable based on your knowledge and the relevant definitions in the Final
Rule.
o Updated “Format” (Column E) to include:
• "101" = Physician assistant
• "102" = Nurse practitioner
• "103" = Clinical nurse specialist
• "104" = Certified registered nurse anesthetist or Anesthesiologist
assistant
• "105" = Certified nurse-midwife
o Updated “Field Size” (Column G) to delete: 1 Char
o Updated “Field Size” (Column G) to include: ≤ 20
o Updated “CSV Field Name” (Column J) to delete: PHYSICIAN
o Updated “CSV Field Name” (Column J) to include:
PRINCIPAL5_INVESTIGATOR_PRIMARY_TYPE
Data Element Name: Principal Investigator NPI (DE#129)
o Updated “Definition/Description” (Column C) to include: or Non-Physician
Practitioner
o Updated “Additional Notes” (Column K) to include: and Non-Physician
Practitioner
Data Element Name: Principal Investigator License State and License Number (DE#131)
o Updated “Definition/Description” (Column C) to include: or Non-Physician
Practitioner
Data Element Number: Due to the addition of new data element of Primary Device
Identifier (DE #33), Principal Investigator Covered Recipient Type (DE#47, DE#64, DE#81,
o

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OP Change Summary: Submission Data Mapping Document v1.0

August 2020

DE#98, DE#115), all other data element numbers (Column A) are amended to reflect the
impact of the addition of DE #33. For example, the data element labeled “Applicable
Manufacturer or Applicable GPO Making Payment Name” is renumbered from DE #33 to
DE # 146. Further, all other fields that refer back to any data elements DE #33 to DE
#126 have been amended to refer to the new numbering.

2.1.4 Changes to the Physician Ownership Tab
·

No changes were made to the Physician Ownership tab

2.1.5 Allowed Special Characters Tab
·

No changes were made to the Allowed Special Characters tab

3 Changes Made to CSV Templates
·

The CSV sample files to be used for submitting payments are named on the CMS Open payments
Resources page as below:
o PY 2021 and Onwards CSV Sample File: General Payments [CSV]
o PY 2021 and Onwards CSV Sample File: Research Payments [CSV]

·

The CSV templates to be used for submitting payments are renamed within the Open
payments system Resources tab as below:
o
o

PY 2021 and Onwards CSV Template File: Research Payments [CSV]
PY 2021 and Onwards CSV Template File: General Payments [CSV]

20