CMS-367 Record File Specification

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

CMS-367 for OMB - Record Specification - CLEAN - 4.1.14

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

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. 09/30/2016 )

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


12


19 – 30


99999.999999

AMP Units

14

31 – 44

99999999999.99

5i Threshold

1

45 - 45

Y, N, X, or Z


CMS-367b (Exp. 09/30/2016)

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


Drug Type Indicator


1

43 – 43


See Data Element Definitions


OBRA’90 Baseline AMP


12

44 – 55


99999.999999


Units Per Pkg Size


11

56 – 66


9999999.999


FDA Product Name


63

67 – 129


FDA Product Name

DRA Baseline AMP

12

130 – 141

99999.999999

Package Size Intro Date

8

142 – 149

MMDDYYYY

Purchased Product Date

8

150 – 157

MMDDYYYY

5i Drug Indicator

1

158 – 158

See Data Element Definitions

5i Route of Administration

3

159 – 161

See Data Element Definitions

ACA Baseline AMP

12

162 - 173

99999.999999

COD Status

2

174 – 175

See Data Element Definitions

FDA Appl. No./OTC Mono. No.

7

176 – 182

See Data Element Definitions

*Reactivation Date

*n/a

*n/a

*This field may only be submitted online via DDR.

See Data Element Definitions



CMS-367c (Exp. 09/30/2016)

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

EMAIL ADDRESS:


______________________________



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

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. 09/30/2016)

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. 09/30/2016)

OMB No. 0938-0578


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