CMS-367a, 367b, 36 CMS Record Specification and Rebate Agreement

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

Document [doc]
Download: doc | pdf


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

5i Threshold

1

60-60

Y or N or X




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

5i Threshold

1

45 - 45

Y or N or X

Filler


15


46 – 60


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

Package Size Intro. Date

8

131 - 138

MMDDYYYY

Purchased Product Date

8

139 - 146

MMDDYYYY

ACA Base AMP

12

147 - 158

99999.999999

5i Drug Indicator

1

159 - 159

Y or N

5i Route of Administration

3

160 - 162

See Data Element Definitions

Line Extension Indicator

1

163 - 163

See Data Element Definitions

Initial Brand Name Listed NDC

9

164 - 172

See Data Element Definitions

COD Status

2

173 - 174

See Data Element Definitions

FDA Approval Number

30

175 - 204

See Data Element Definitions

Filler

6

205 - 210

Spaces


CMS-367c (Exp. )

OMB No. 0938-0578



ENCLOSURE B (PAGE 1 OF 2)

SUPPLEMENTAL DATA SHEET



LABELER CODE



LABELER NAME




LEGAL CONTACT



NAME OF CONTACT


AREA PHONE NUMBER EXTENSION


NAME OF CORPORATION





STREET ADDRESS


CITY STATE ZIP CODE


EMAIL ADDRESS (Optional)



INVOICE CONTACT



NAME OF CONTACT


AREA PHONE NUMBER EXTENSION


NAME OF CORPORATION





STREET ADDRESS


CITY STATE ZIP CODE


EMAIL ADDRESS (Optional)


CMS-367d (Exp. )

OMB No. 0938-0578




ENCLOSURE B (PAGE 2 OF 2)

SUPPLEMENTAL DATA SHEET



LABELER CODE



LABELER NAME




TECHNICAL CONTACT



NAME OF CONTACT


PHONE NUMBER EXTENSION


FAX NUMBER


NAME OF CORPORATION





STREET ADDRESS


CITY STATE ZIP CODE


EMAIL ADDRESS (should match DDR user account email address)



Notes:

  • If you are amending existing contact information for more than one labeler, provide a form for each labeler code. Do not send a copy of your rebate agreement(s) with this form.

  • It is your responsibility to ensure that your contact information is the same for all labeler codes in the MDR program.



CMS-367d (Exp. )

OMB No. 0938-0578




File Typeapplication/msword
File Modified2012-07-27
File Created2012-07-27

© 2025 OMB.report | Privacy Policy