CMS-367c - Crosswalk

CMS Form-367c_Product Data_Crosswalk_07.2021_508.pdf

Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 (CMS-367)

CMS-367c - Crosswalk

OMB: 0938-0578

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2019 (old version)

2020 (new version)

Type of Change

Reason for Change

Burden Change

File Format Header:
DDR PRODUCT DATA FILE FORMAT
FOR TEXT FILE SUBMISSIONS TO CMS

File Format Header:
MEDICAID DRUG REBATE PROGRAM
MDP PRODUCT DATA
FILE SUBMISSION TO CMS
Form CMS-367c
FILE FORMAT
Effective: July 1, 2021

Rev

To align Header with other Medicaid Drug 
Rebate Program documentation.

N/A

N/A

New File Format Column:
Ordinal Position
Coresponding Rows Numbered 1-21
File Format - Column Name Update:
Field Name (.TXT)
Header Row (.CSV

Add

To update File Format to include .CSV
Ordinal Numbering Column

N/A

Rev

To include .CSV Header Row in additon to
the .TXT Field Name

N/A

File Format - Column Name Update:
Field

File Format - Remarks Fields:
See Data Element Definitions

File Format - Remarks Fields:
See Data Definitions

Rev

To remove the word "Element" throughout all N/A
the Remarks as it is not relevant

File Format - Position Fields:
1 - 159

File Format - Position Fields:
1 - 162

Rev

File Format Field:
Therapeutic Equivalence Code (TEC)

File Format Field:
Therapeutic Equivalence Code

Rev

Field positions were adjusted due to the
N/A
deletion of the DRA Baseline AMP and ACA
Baseline AMP fields
To remove (TEC)
N/A

File Format Field:
OBRA'90 Baseline AMP
Size: 12
Position: 44 - 55
Remarks: 99999.999999
File Format Field:
Units Per Package Size (UPPS)
Position: 56 - 66

File Format Field:
OBRA'90 Baseline AMP
Size: 15
Position: 44 - 58
Remarks: 99999999.999999
File Format Field:
Units Per Package Size
Position: 59 - 69

Rev

Updated field size from 12 to 15 digits

Rev

To remove (UPPS), and to update field positions  N/A
due to OBRA '90 Baseline AMP increased field 
size

File Format Field:
FDA Product Name
Position: 67 - 129

File Format Field:
FDA Product Name
Position: 70 - 132

Rev

To update field positions due to OBRA '90 
Baseline AMP increased field size. 

File Format Field:
Package Size Intro Date (PSID)
Poisition: 130 - 137

File Format Field:
Package Size Intro Date
Position: 133 - 140

Rev

To remove (PSID), and to update field positions  N/A
due to OBRA '90 Baseline AMP increased field 
size

File Format Field:
Purchased Product Date (PPD)
Poistion: 138 - 145

File Format Field:
Purchased Product Date
Position: 141 - 148

Rev

To remove (PPD), and to update field positions  N/A
due to OBRA '90 Baseline AMP increased field 
size

File Format Field:
5i Drug Indicator
Poistion: 146 - 146

File Format Field:
5i Drug Indicator
Poistion: 149 - 149

Rev

To update field positions due to OBRA '90 
Baseline AMP increased field size. 

Type of Change: Rev = Revision, Del = Deletion, Add = Addition, and Red = Redesgnation.

N/A

N/A

N/A

2019 (old version)

2020 (new version)

Type of Change

Reason for Change

Burden Change

File Format Field:
5i Route of Administration
Poistion: 147 - 149

File Format Field:
5i Route of Administration
Poistion: 150 - 152

Rev

To update field positions due to OBRA '90 
Baseline AMP increased field size. 

File Format Field:
Covered Outpatient Drug (COD) Status
Poistion: 150 - 151

File Format Field:
Covered Outpatient Drug Status
Poistion: 153 - 154

Rev

To remove (COD), and to update field positions  N/A
due to OBRA '90 Baseline AMP increased field 
size

File Format Field:
FDA Application Number / OTC Monograph Number
Poistion: 152 - 158

File Format Field:
FDA Application Number / OTC Monograph Number
Poistion: 155 - 161

Rev

To update field positions due to OBRA '90 
Baseline AMP increased field size. 

N/A

File Format Field:
Line Extension Drug Indicator
Poistion: 159 - 159

File Format Field:
Line Extension Drug Indicator
Poistion: 162 - 162

Rev

To update field positions due to OBRA '90 
Baseline AMP increased field size. 

N/A

File Format Field:
*Reactivation Date
Size: *n/a
Poistion: *n/a
Remarks: *This field may only be submitted online via DDR.
See Data Element Definitions

File Format Field:
Reactivation Date
Size: n/a
Poistion: n/a
Remarks: See Data Definitions

Rev

Removed extra verbiage/punctuation

N/A

Data Definitions Header:
Drug Product (CMS 367c Form) Data Element Definitions

Data Definitions Header:
MEDICAID DRUG REBATE PROGRAM
MDP PRODUCT DATA
FILE SUBMISSION TO CMS
Form CMS-367c
DATA DEFINITIONS
Effective: July 1, 2021

Rev

To align Header with other Medicaid Drug 
Rebate Program documentation.

N/A

Data Definitions - Unit Type:

Data Definitions - Unit Type:

Rev

Added two additional Unit Types

N/A

Valid Values:
AHF = Injectable Anti-Hemophilic Factor
CAP = Capsule
EA = EACH
GM = Gram
ML = Milliliter
SUP = Suppository
TAB = Tablet
TDP = Transdermal Patch

Valid Values:
AHF = Injectable Anti-Hemophilic Factor
CAP = Capsule
EA = EACH
GM = Gram
ML = Milliliter
SUP = Suppository
TAB = Tablet
TDP = Transdermal Patch
mCi = Millicurie
µCi = Microcurie

Data Definitions - FDA Approval Date:
...For covered outpatient drugsfor which the FDA does not require
approval,…

Data Definitions - FDA Approval Date:
...For covered outpatient drugs (CODs) for which the FDA does not
require approval,…

Rev

To align verbiage with other Medicaid Drug 
Rebate Program documentation.

N/A

Type of Change: Rev = Revision, Del = Deletion, Add = Addition, and Red = Redesgnation.

N/A

2019 (old version)

2020 (new version)

Type of Change

Reason for Change

Burden Change

Data Definitions - Market Date:
...If a Market Date falls on a date that is earlier than 9/30/1990, CMS will
change it to 9/30/1990 in both the Medicaid Drug Rebate (MDR) system
and the Drug Data Reporting for Medicaid (DDR) system,…

Data Definitions - Market Date:
Rev
...If a Market Date falls on a date that is earlier than 9/30/1990, CMS will
change it to 9/30/1990 in the Medicaid Drug Programs (MDP) system,…

Updated verbiage to reference MDP not
DDR

N/A

Data Definitions - Termination Date:
...(Note: Initial termination date submissions may be provided via file
transfer; however, subsequent changes to this field may only be submitted
online via DDR.)

Data Definitions - Termination Date:
...(Note: Initial termination date submissions may be provided via file
transfer; however, subsequent changes to this field may only be
submitted online via MDP.)

Updated verbiage to reference MDP not
DDR

N/A

Data Definitions - Obra'90 Baseline AMP: ...Numeric values; 12-digit
field: 5 whole numbers, the decimal point (‘.’) and 6 decimal places; rightjustified; zero-padded for AMP values with fewer than 12 digits

Data Definitions - Obra'90 Baseline AMP: ...Numeric values; 15-digit Rev
field: 8 whole numbers, the decimal point (‘.’) and 6 decimal places; right
justified; zero-padded for AMP values with fewer than 15 digits

Rev

Updated verbiage to account for increased field  N/A
size from 12 ‐ 15 digits

Data Definitions - Line Extension Drug Indicator:
Data Definitions - Line Extension Drug Indicator:
...Labelers seeking an ADF exclusion at the time a drug is initially reported ...Labelers seeking an ADF exclusion at the time a drug is initially
in DDR should submit an initial value of “R” in this field for CMS review and reported in MDP should submit an initial value of “R” in this field for
approval.
CMS review and approval.

Rev

Updated verbiage to reference MDP not
DDR

N/A

Data Definitions - Reactivation Date:
Data Definitions - Reactivation Date:
...(Note: This field may only be submitted online via DDR and is NOT part ...(Note: This field may only be submitted online via MDP and is NOT
part of the actual File Format.)
of the actual File Format.)

Rev

Updated verbiage to reference MDP not
DDR

N/A

Type of Change: Rev = Revision, Del = Deletion, Add = Addition, and Red = Redesgnation.


File Typeapplication/pdf
File TitleCMS Form-367c_Product Data_Crosswalk_07.2021.xlsx
AuthorLOKG
File Modified2020-11-04
File Created2020-11-04

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