CMS-367c DDR Product Data Specifications

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

DDR Screenshots for CMS-367a_b_c_CLEAN_updated_7.12.16

DDR Product Data Specifications (CMS-367c)

OMB: 0938-0578

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Online Quarterly Pricing Data Entry Screen (CMS-367a)



File Transfer Quarterly Pricing Layout (CMS-367a)



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

Initial Drug Available for LE

1

60-60

Y, N, X or Z

Initial Drug

9

61-69

9 digits alpha-numeric



Online Monthly Pricing Data Entry Screen (CMS-367b)



File Transfer Monthly Pricing Layout (CMS-367b)



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





Online Product Data Entry Screen – Screenshot #1 with Narrow Exception Indicator added (CMS-367c)

Note that the “Narrow Exception Indicator” will only appear in DDR if it has first been checked in MDR by CMS. This is not a field that manufacturers will have access to edit.



Online Product Data Entry Screen – Screenshot #2 with burden hours updated (CMS-367c)



File Transfer Product Layout (CMS-367c)



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

Line Extension Drug Indicator

1

183 – 183

See Data Element Definitions







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