CMS-367b - Track Changes

DDR MONTHLY PRICING DATA FILE FORMAT

FOR TEXT FILE SUBMISSIONS 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 Manufacturer Price (AMP)	12	19 – 30	99999.999999
AMP Units	14	31 – 44	99999999999.99
5i Threshold	1	45 - 45	Y, N, X, or Z

Monthly Pricing (CMS 367b Form) Data Element Definitions

Record ID: Constant of “M”. The M Record ID indicates that the information reported for this NDC represents monthly pricing data.

Labeler Code: First segment of the National Drug Code (NDC) that identifies the labeler. Numeric values; 5-digit field; right-justified; zero-padded.

Product Code: Second segment of the NDC. Alpha-numeric values; 4-digit field; right-justified; zero-padded.

Package Size: Third segment of the NDC. Alpha-numeric values; 2-digit field; right-justified; zero-padded.

Month: Calendar month covered by the pricing data submission. Numeric values; 2-digit field; format: MM.

Valid values for MM:

01 = January

02 = February

03 = March

04 = April

05 = May

06 = June

07 = July

08 = August

09 = September

10 = October

11 = November

12 = December

Year: Calendar year covered by the pricing data submission. Numeric values; 4-digit field; format: YYYY.

Valid values for YYYY: 4-digit calendar year equal to 2007 or later.

Average Manufacturer Price (AMP): The AMP per unit per product code for the month/year covered, based on sales. If a drug is distributed in multiple package sizes, there will be one “weighted” AMP for the product, which is the same for all package sizes. Compute to 7 decimal places and round to 6 decimal places. Numeric values; 12-digit field: 5 whole numbers,

the decimal point (‘.’) and 6 decimal places; right-justified; zero-padded for AMP values with fewer than 12 digits.

AMP Units: The total sum of all units included in the calculation of the AMP per product code for the monthly reporting period. If a drug is distributed in multiple package sizes, there will be one AMP unit value for the product, which is the same for all package sizes. Numeric values; 14-digit field: 11 whole numbers, the decimal point (“.”) and 2decimal places; right-justified; zero-padded.

5i Threshold: A value indicating whether the reported AMP was calculated using the alternate 5i AMP methodology (i.e., a 5i Threshold value of “Y”), or using the standard (non-5i) methodology (i.e., a 5i Threshold value of “N”). A 5i Threshold value of “X” should be reported if the NDC was not classified as a 5i drug for the month/year combination being reported. For months prior to July 2014 (i.e., the month in which the 5i Threshold field was implemented), a 5i Threshold value of “Z” should be reported to indicate the field was not applicable. 1-character field.

Valid Values:

Y = Yes

N = No

X = Not a 5i drug

Z = Not Applicable

Form CMS-367b (Exp. ) is used by manufacturers on a monthly basis, to transmit pricing data for each of their covered outpatient drugs to CMS either electronically or via file transfer. The use of Form CMS-367b on a monthly basis by manufacturers is considered mandatory under the authority of Section 1927 of the Social Security Act and the National Drug Rebate Agreement. Under the Privacy Act of 1974 any personally identifying information obtained will be kept private to the extent of the law.

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-0578. The time required to complete this information collection is estimated to average 44.8 hours per response, including the time to review instructions, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore, Maryland 21244-1850.