CMS-367a - Track Changes

DDR QUARTERLY 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 “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
Average Manufacturer Price (AMP)	12	18 - 29	99999.999999
Best Price (BP)	12	30 - 41	99999.999999
Nominal Price (NP)	9	42 - 50	999999999
Customary Prompt Pay (CPP) Discount	9	51 - 59	999999999
Initial Drug Available for Line Extension	1	60 - 60	Y, N, X or Z
Initial Drug	9	61 - 69	See Data Elements Definition

Quarterly Pricing (CMS 367a Form) Data Element Definitions

Record ID: Constant of “Q”. The Q Record ID indicates that the information reported for this NDC represents quarterly 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.

Period Covered: Calendar quarter and year covered by the pricing data submission. Numeric 5-digit field; format: QYYYY.

Valid values for Q:

1 = January 1 - March 31

2 = April 1 - June 30

3 = July 1 - September 30

4 = October 1 - December 31

Valid values for YYYY: 4-digit calendar year equal to 1991 or later.

Average Manufacturer Price (AMP): The AMP per unit per product code for the period 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.

Best Price (BP): Per the statute and rebate agreement, the lowest price available per product code, regardless of package size. Compute to 7 decimal places and round to 6 decimal places. Zero or blank-filled for Non-Innovator Multiple Source drugs. Numeric values; 12-digit field: 5 whole numbers, the decimal point (‘.’) and 6 decimal places; right-justified; zero-padded for BP values with fewer than 12 digits.

Nominal Price (NP): Sales that meet the statutory/regulatory definition of NP. Labelers should determine an aggregate dollar amount (by adding up all package sizes), and report this aggregate NP dollar amount at the 9-digit NDC level. Total dollar figure, rounded to the nearest dollar. Zero or blank-filled if an NDC has no NP sales for the quarter/year being reported, and for every quarter/year in which an NDC is classified as a Non-Innovator Multiple Source drug. Numeric values; 9-digit field; 9 whole numbers; right-justified; zero-padded for NP values with fewer than 9 digits.

Customary Prompt Pay (CPP) Discount: Labelers should determine an aggregate dollar amount (by adding up all package sizes), and report this aggregate CPP dollar amount at the 9-digit NDC level. Total dollar figure, rounded to nearest dollar. Zero or blank-filled if the NDC has no CPP discount for the quarter/year being reported. Numeric values; 9-digit field; 9 whole numbers; right-justified; zero-padded for CPP Discount values with fewer than 9 digits.

Initial Drug Available for Line Extension: Identifies whether a line extension drug has an Initial Drug available for the quarter/year being reported. 1-character field.

Valid Values:

Y = Yes

N = No

X = X - Not an LE Drug

Z = Not Applicable (for quarters prior to 2Q2016, or for quarters in which the NDC or labeler was not active)

Initial Drug: Identifies the 9-digit NDC (from which a line extension drug is derived) with the highest additional rebate ratio (calculated as a percentage of AMP) for the quarter/year being reported. The Initial Drug’s additional rebate ratio is then used in the alternative URA calculation for the line extension drug. The Initial Drug should fall under the same corporation as the corresponding line extension drug, and must be active within the MDR Program at the time it is reported as an Initial Drug. Zero-filled if the Initial Drug Available for LE field contains a value of N, X, or Z. Numeric values; 9-digit field; right-justified; zero-padded.

Form CMS-367a (Exp. ) is used by manufacturers on a quarterly 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-367a on a quarterly 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 34.8 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.