Form CMS-367 CMS Record Specifications DDR

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

CMS-367 Record File Layout

Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534

OMB: 0938-0578

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CMS RECORD SPECIFICATION

DDR QUARTERLY PRICING DATA

TEXT FILE FOR TRANSFER TO CMS


Source: Drug Manufacturers

Target: CMS


Field


Size


Position


Remarks

Record ID


1


1 - 1


Constant of “Q”

Labeler Code


5


2 - 6


NDC #1

Product Code


4


7 - 10


NDC #2

Package Size


2


11 – 12


NDC #3

Period Covered


5


13 – 17


QYYYY (Qtr/Yr)

Average Mfr Price


12


18 – 29


99999.999999

Best Price


12


30 – 41


99999.999999

Nominal Price

9

42 – 50

999999999

Customary Prompt Pay Disc.

9

51 – 59

999999999














CMS-367a (Exp. )


OMB No. 0938-0578

CMS RECORD SPECIFICATION

DDR MONTHLY PRICING DATA

TEXT FILE FOR TRANSFER TO CMS


Source: Drug Manufacturers

Target: CMS


Field


Size


Position


Remarks

Record ID


1


1 - 1


Constant of “M”

Labeler Code


5


2 - 6


NDC #1

Product Code


4


7 - 10


NDC #2

Package Size


2


11 - 12


NDC #3

Month

2

13 – 14

MM

Year

4

15 – 18

YYYY

Average Mfr Price (AMP)


12


19 – 30


99999.999999

AMP Unit


14


31 – 44


99999999999.99

Filler


21


45 – 51


spaces











CMS-367b (Exp. )


OMB No. 0938-0578

CMS RECORD SPECIFICATION

DDR DRUG PRODUCT DATA

TEXT FILE FOR TRANFER TO CMS


Source: Drug Manufacturers

Target: CMS


Field


Size


Position


Remarks


Record ID


1


1 – 1


Constant of “P”


Labeler Code


5


2 – 6


NDC #1


Product Code


4


7 – 10


NDC #2


Package Size Code


2


11 - 12


NDC #3


Drug Category


1


13 - 13


See Data Element Definitions


Unit Type


3


14 - 16


See Data Element Definitions


FDA Approval Date


8


17 - 24


MMDDYYYY


FDA Thera. Eq. Code


2


25 - 26


See Data Element Definitions


Market Date


8


27 - 34


MMDDYYYY


Termination Date


8


35 - 42


MMDDYYYY


DESI Indicator


1


43 - 43


See Data Element Definitions


Drug Type Indicator


1


44 - 44


See Data Element Definitions


OBRA ‘90 Baseline AMP


12


45 - 56


99999.999999


Units Per Pkg Size


11


57 - 67


9999999.999


FDA Product Name


63


68 – 130


FDA Drug Listing Name

DRA Base AMP

12

131-142

99999.999999

Package Size Intro. Date

8

143-150

MMDDYYYY

Purchase Product Date

8

151-158

MMDDYYYY

Pediatric Exclusivity Ind.

1

159-159

Y or N

ACA Base AMP

12

160 – 171

99999.999999

Filler

17

172 - 175

spaces






CMS-367c (Exp. )


OMB No. 0938-0578

MEDICAID DRUG REBATE AGREEMENT

ENCLOSURE B (PAGE 1 OF 2)

SUPPLEMENTAL DATA SHEET




LABELER CODE (as assigned by FDA)






LABELER NAME (Corporate name associated with labeler code)




LEGAL CONTACT – Person to contact for legal issues concerning the rebate agreement



NAME OF CONTACT



AREA PHONE NUMBER EXTENSION





NAME OF CORPORATION







STREET ADDRESS






CITY

STATE

ZIP CODE




INVOICE CONTACT – Person responsible for processing invoice utilization data



NAME OF CONTACT



AREA PHONE NUMBER EXTENSION





NAME OF CORPORATION







STREET ADDRESS






CITY

STATE

ZIP CODE

Note: This sheet is to be returned with the signed rebate agreement. If more than one labeler code, attach one sheet for each code.

CMS-367d (Exp. )

OMB No. 0938-0578

MEDICAID DRUG REBATE AGREEMENT

ENCLOSURE B (PAGE 2 OF 2)

SUPPLEMENTAL DATA SHEET



LABELER CODE (as assigned by FDA)






LABELER NAME (Corporate name associated with labeler code)




TECHNICAL CONTACT – Person responsible for sending and receiving data



NAME OF CONTACT



AREA PHONE NUMBER EXTENSION

FAX #


______________________________



EMAIL Address:


______________________________



NAME OF CORPORATION







STREET ADDRESS






CITY

STATE

ZIP CODE












Note: This sheet is to be returned with the signed rebate agreement. If more than one labeler code, attach one sheet for each code.


CMS-367d (Exp. )

OMB No. 0938-0578


File Typeapplication/msword
AuthorCMS
Last Modified ByCMS
File Modified2010-08-25
File Created2010-08-25

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