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

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

CMS-367 - Instructions to Labelers -CLEAN - updated.3 25 16

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

OMB: 0938-0578

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Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c



The following data fields are required for the relevant collections:


QUARTERLY PRICING DATA FIELDS – CMS-367a


Labeler Code: First segment of National Drug Code that identifies the labeler. Numeric values only, 5-digit field, right-justified and zero-filled.


Product Code: Second segment of National Drug Code. Alpha-numeric values, 4-digit field, right justified, zero-filled.


Package Size Code: Third segment of National Drug Code. Alpha-numeric values, 2-digit field, right justified, zero-filled.


Period Covered: Calendar quarter and year covered by data submission. Numeric 5-digit field, 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.


Average Manufacturer’s Price (AMP): The AMP per unit per product code for the period covered. 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 place (‘.’) and 6 decimal places; right-justified, zero-filled.


Best Price: 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-fill for Non-Innovator Multiple Source drugs. Numeric values, 12-digit field: 5 whole numbers, the decimal (‘.’) and 6 decimal places; right-justified, zero-filled.


Nominal Price (NP): Sales that meet the statutory/regulatory definition of NP. Total dollar figure per 11-digit NDC, rounded to nearest dollar. 9-digit field; 9 whole numbers; right-justified, 0-filled. If no sales for a package size, fill with all zeroes.


Customary Prompt Pay Discount (CPP): Labelers may 1) allocate an individual CPP discount dollar amount per 11-digit NDC in each package size’s record, or 2) report an aggregate discount dollar amount, by adding up all package sizes, and report this aggregate CPP discount dollar amount in one package size record and zero-fill the remaining package sizes.  9-digit field; 9 whole numbers; right-justified, 0-filled.


Initial Drug Available for LE: Identifies whether a line extension drug has an Initial Drug available for the quarter/year being reported.

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 drug (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. Numeric values only, 9-digit field, right-justified and zero-filled.



MONTHLY PRICING DATA FIELDS – CMS-367b


Labeler Code: First segment of National Drug Code that identifies the labeler. Numeric values only, 5-digit field, right-justified and zero-filled.


Product Code: Second segment of National Drug Code. Alpha-numeric values, 4-digit field, right justified, zero-filled.


Package Size Code: Third segment of National Drug Code. Alpha-numeric values, 2-digit field, right justified, zero-filled.


Month: Calendar month covered by data submission. Numeric 2-digit field, MM.

Valid values for MM:


01 = January 07 = July

02 = February 08 = August

03 = March 09 = September

04 = April 10 = October

05 = May 11 = November

06 = June 12 = December


Year: Calendar year covered by data submission. Numeric 4-digit field, YYYY. Valid values for YYYY: 4-digit calendar year.

Average Manufacturer Price (AMP): The AMP per unit per product code for the period covered. 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 place (‘.’) and 6 decimal places; right-justified, zero-filled.


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


5i Threshold: A manufacturer enters “Y” in this field if the AMP of the 5i drug is calculated using the alternate 5i AMP methodology, or a manufacturer enters “N” in this field if the AMP of the 5i drug is calculated using the standard (non-5i) methodology. A manufacturer enters “X” in this field if the drug was not classified as a 5i drug for the monthly reporting period. For months prior to the month in which the 5i Threshold field was implemented, or for months in which the NDC or labeler was not active, a manufacturer enters “Z” in this field to indicate the field was not applicable. Alpha-numeric values, 1-digit field.


Valid Values:


Y = Yes

N = No

X = Not a 5i drugZ = Not Applicable


DRUG PRODUCT DATA FIELDS – CMS-367c


Labeler Code: First segment of National Drug Code that identifies the labeler. Numeric values only, 5-digit field, right-justified and zero-filled.


Product Code: Second segment of National Drug Code. Alpha-numeric values, 4-digit field, right justified, zero-filled.


Package Size Code: Third segment of National Drug Code. Alpha-numeric values, 2-digit field, right justified, zero-filled.


Drug Category: Alpha-numeric values, 1 character.


Valid values:


S = Single source

I = Innovator multiple source

N = Non-innovator multiple source


Unit Type: One of the 8 unit types by which the drug is dispensed. Alpha-numeric values, 3-character field, left justified.


Valid values:


AHF = Injectable Anti-Hemophilic Factor

CAP = Capsule

SUP = Suppository

GM = Gram

ML = Milliliter

TAB = Tablet

TDP = Transdermal Patch

EA = EACH


FDA Approval Date: NDA or monograph approval date. Numeric values, 8-digit field, format: MMDDYYYY.


FDA TEC: FDA-assigned Therapeutic Equivalence Codes. Alpha-numeric values, 2 character field.



Valid values:


AA BC BS

AB BD BT

AN BE BX

AO BN NR - Not rated

AP BP A1 thru A9 = AB value

AT BR


Market Date: For S and I drugs, the date the drug was first marketed by the original labeler (i.e., NDA holder). For N drugs, the date the drug was first marketed under the labeler’s rebate agreement. If a Market Date falls on a date that is earlier than 9/30/1990, CMS will change it to 9/30/1990 in both the Medicaid Drug Rebate (MDR) system and the Drug Data Reporting for Medicaid (DDR) system since dates earlier than the start of the Drug Rebate Program have no bearing on the program. Numeric values, 8-digit field, format: MMDDYYYY.


Termination Date: The date a drug is withdrawn from the market or the drug’s last lot expiration date. (Note: Initial termination date submissions may be provided via file transfer; however, subsequent changes to this field may only be submitted online via DDR.) Zero or blank fill if not present. Numeric values, 8-digit field, format: MMDDYYYY.


Drug Type Indicator: Identifies a drug as prescription (Rx) or over-the-counter (OTC).


Valid Values:

1 = Rx

2 = OTC


OBRA’90 Baseline AMP: The AMP per unit for the period that establishes the OBRA’90 Baseline AMP for innovator drugs. There will be one weighted baseline AMP for the product, which will be 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 (‘.’) and 6 decimal places; right-justified, zero-filled.


Units Per Package Size: Total number of units in the smallest dispensable amount for the 11-digit NDC. Numeric values, 11-digit field: 7 whole numbers, the decimal (‘.’) and 3 decimal places; right-justified, zero-filled.


FDA Product Name: Drug name as it appears on FDA listing form. Alpha-numeric values, 63 characters, left justified, blank-fill unused positions.


DRA Baseline AMP (optional):  For active innovator drugs with a Market Date less than July 1, 2007, the OBRA’90 or OBRA ’93 Baseline AMP revised in accordance with relevant regulations and program guidance.  There will be one weighted DRA Baseline AMP for the product, which will be the same for all package sizes.  Per CMS-2238-FC, labelers had 4 quarters (i.e., January 2, 2008 – October 30, 2008) to report this optional field.  Numeric values, 12-digit field; 5 whole numbers, the decimal (‘.’) and 6 decimal places, right- justified, zero-filled.  Compute to 7 decimal places and round to 6 decimal places.


Package Size Introduction Date: The date the package size is first available on the market. Numeric values, 8-digit field, format: MMDDYYYY


Purchased Product Date: The date the company currently holding legal title to the NDC first markets the drug under this NDC (this date can result, for example, from the purchase of an NDC from one company by another company, the re-designation of an NDC from one of a company’s labeler codes to another of that same company’s labeler codes, cross-licensing arrangements, etc.). Zero or blank fill if not applicable. Numeric values, 8-digit field, format: MMDDYYYY


5i Drug Indicator: Identifies whether a product is a 5i Drug. Alpha-numeric values; 1-digit field.

Valid Values:


Y = Yes

N = No


5i Route of Administration: Identifies the method by which the 5i drug is administered to a patient. If a product is not a 5i drug, a value of “000” (Not Applicable) should be entered. Numeric values; 3-digit field.

Valid Values:


000 =

Not Applicable

001 =

Implanted

002 =

Infused

003 =

Inhaled

004 =

Injected

005 =

Instilled


ACA Baseline AMP (Optional):  For active innovator drugs, the OBRA ’90, OBRA ’93 or DRA Baseline AMP revised in accordance with the statute and relevant program guidance.  There will be one weighted ACA Baseline AMP for the product, which will be the same for all package sizes.  Numeric values, 12-digit field; 5 whole numbers, the decimal (‘.’) and 6 decimal places; right-justified; zero-filled.  Compute to 7 decimal places and round to 6 decimal places.


Covered Outpatient Drug (COD) Status:  A category that identifies whether or not a product meets the statutory definition of a covered outpatient drug in accordance with sections 1927(k)(2) to 1927(k)(4) of the Social Security Act. Numeric values, 2-character field.

Valid Values:


01 = Abbreviated New Drug Application (ANDA)

02 = Biological License Application (BLA)

03 = New Drug Application (NDA)

04 = NDA Authorized Generic

05 = DESI 5* – LTE/IRS drug for all indications

06 = DESI 6* – LTE/IRS drug withdrawn from market

07 = Prescription Pre-Natal Vitamin or Fluoride

08 = Prescription Dietary Supplement/Vitamin/Mineral (Other than Prescription
Pre-Natal Vitamin or Fluoride)

09 = OTC Monograph Tentative

10 = OTC Monograph Final

11 = Unapproved Drug – Drug Shortage

12 = Unapproved Drug – Per 1927(k)(2)(A)(ii)

13 = Unapproved Drug – Per 1927(k)(2)(A)(iii)


*NDCs with a COD Status of DESI 5/6 are not eligible for coverage or rebates under the Medicaid Drug Rebate Program.

FDA Application Number/OTC Monograph Number: For drugs with a COD status of ANDA, BLA, NDA, or NDA Authorized Generic, this is the seven-digit application number that is assigned by the FDA for approval to market a generic drug or new drug in the United States. Numeric field; 7 characters, fill with leading zeros as needed.


For drugs with a COD status of OTC Monograph Tentative or Final, this is the FDA’s regulatory citation for the OTC. 7 alpha-numeric characters. For drugs with a COD Status of OTC Monograph Final, the first four characters are a constant of “PART”; the last three characters are the numeric values for the appropriate regulatory citation for the product (e.g., “225”). For drugs with a COD Status of OTC Monograph Tentative, the first four characters are a constant of “PART”; the last three characters are the numeric values for the appropriate regulatory citation for the product, or 3 zeros if a Monograph Number is not available.


For drugs with a COD Status other than ANDA, BLA, NDA, NDA Authorized Generic, OTC Monograph Final, or OTC Monograph Tentative, the FDA Application No./OTC Monograph No. field should be zero-filled.


Reactivation Date: The date on which a terminated product is re-introduced to the market. (Note: This field may only be submitted online via DDR and is NOT part of the actual File Transfer Layout.)


Line Extension Drug Indicator: Identifies whether a product is a line extension drug as defined in Section 1927 (c)(2)(C)

Valid Values:


Y = Yes

N = No

Edits & Alerts


Labelers will have two data reporting options within DDR: first, they may key their data online on an NDC-by-NDC basis; second, they may transfer a saved file to DDR (certain fields must be keyed online). Labelers that key their data online will have an interactive “pop-up” help function when the DDR has detected a potential data error. Labelers that opt to transfer their data via a file to DDR can check the system periodically for a report that outlines any errors detected, as well as alerts for potential errors or data issues. These File Transfer Edit Reports include the following error/alert messages, along with instructions to the labeler to correct each data issue:



New Message

Type

Reason For Occurrence

E1

Product record contains a missing or invalid labeler code

Error

Labeler code (NDC1) on the product record is blank or does not exist in the database.

E2

Pricing record contains a missing or invalid labeler code

Error

Labeler code (NDC1) on the price record is blank or does not exist in the database.

E3

Missing or incorrect product code

Error

Product code (NDC2) is blank or incorrect format or value.

E4

Missing or incorrect package size

Error

Package size code (NDC3) is blank or incorrect format or value.

E5

Deleted product - rejected by CMS

Error

Product or package size has been deleted by CMS.

E6

Drug Category is blank or is not S, I or N

Error

Drug Category field may not be blank and must be S, I or N.

E7

Missing or invalid TEC

Error

TEC is blank or is invalid code.

E8

Missing Drug Type or drug type is not 1 or 2

Error

Drug Type cannot be blank and must be 1 or 2.

E9

OBRA ’90 Base AMP required

Error

Base AMP cannot be blank or contains zero when the drug category is S or I and the market date is earlier than 10/01/1993.

E10

Base AMP change is rejected

Error

Pricing changes after 12 quarters are not allowed.

E11

Base AMP is less than 6 decimal places and/or is not numeric

Error

Base AMP must be both numeric and 6 decimal places.

E12

Reserved

Error

Reserved

E13

Term Date is invalid and/or earlier than the Package Size Intro. Date

Error

Termination Date must be a valid date, must be greater than or equal to the Package Size Intro. Date, and should be zero or blank-filled if not present.

E14

Missing or invalid Unit Type

Error

Unit Type is blank or not a valid value.

E15

UPPS is less than 3 decimal places and/or is not numeric and/or is missing or invalid

Error

Units Per Package Size must be both numeric and 3 decimal places and cannot be blank.

E16

Future FDA Approval Date not allowed

Error

FDA Approval Date must be equal to current quarter or earlier.

E17

Missing or invalid Market Date

Error

Market Date cannot be blank and must be a valid date.

E18

Market Date not allowed

Error

Market Date cannot be greater than current quarter plus one.

E19

Invalid FDA Approval Date

Error

FDA Approval Date must be a valid date.

E20

Market Date is less than FDA Approval Date

Error

Market Date must be equal to or greater than the FDA Approval Date.

E21

Missing FDA Drug Name

Error

FDA Drug Name cannot be blank.

E22

Missing or invalid DESI

Error

DESI cannot be blank and must equal 2, 3, 4, 5 or 6.

E23

Product code does not exist

Error

Product code (NDC2) not found - pricing rejected.

E24

Missing year and/or quarter

Error

Quarter and/or year is blank (QYYYY).

E25

Quarter must be 1, 2, 3, or 4

Error

Quarter is not equal to 1, 2, 3 or 4.

E26

Invalid year

Error

Year reported is not numeric or is greater than current year.

E27

Year earlier than start of rebate program

Error

Year on the price record cannot be earlier than 1991.

E28

Future quarterly pricing not allowed

Error

Pricing quarter cannot be greater than current quarter.

E29

Best Price must contain 6 decimal places

Error

Best Price is less than 6 decimal places.

E30

Best Price must be present, numeric and greater than zero for category S or I drugs

Error

Best Price is blank, non-numeric, or zero.

E31

AMP must contain 6 decimal places

Error

AMP is less than 6 decimal places.

E32

AMP must be present, numeric, and greater than zero

Error

AMP is blank, non-numeric, or zero.

E33

Package size code does not exist

Error

Package size code (NDC3) not found - pricing rejected.

E34

Pricing change rejected

Error

Pricing changes not allowed after 12 quarters.

E35

AMP change not approved by CMS

Error

Only Best Price change approved by CMS.

E36

Best Price change not approved by CMS

Error

Only AMP change approved by CMS.

E37

Monthly pricing data rejected

Error

Monthly pricing changes not allowed after report period ends.

E38

UPPS cannot contain decimals when Unit Type is EA

Error

UPPS cannot contain decimals when Unit Type is EA.

E39

Pricing data submitted for a period more than 4 quarters after Termination Date

Error

Labeler submitted pricing data greater than 4 quarters after Termination Date. Review for accuracy.

E40

Missing month and/or year

Error

Month and/or year is blank (MMYYYY).

E41

Month must be a two-digit numeric value

Error

Month must be equal to 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, or 12.

E42

Year earlier than start of monthly data collection

Error

Year on the price record cannot be earlier than 2007.

E43

Future monthly pricing not allowed

Error

Pricing month cannot be greater than current month.

E44

Package size is terminated

Error

Pricing record cannot be used to change AMP and/or Best Price because package size was terminated for the quarter specified. Only active package sizes can be used to change pricing.

E45

Monthly pricing data submitted for monthly periods beyond Termination Date

Error

Labeler submitted monthly pricing data greater than Termination Date. Review for accuracy.

E46

Reserved

Error

Reserved

E47

Reserved

Error

Reserved

E48

Reserved

Error

Reserved

E49

Pricing change submitted after expiration date

Error

Labeler submitted change after specified date.

E50

Product code access denied

Error

User does not have access to this product code.

E51

Labeler code access denied

Error

User does not have access to this labeler code.

E52

Reserved

Error

Reserved

E53

Reserved

Error

Reserved

E54

Reserved

Error

Reserved

E55

Reserved

Error

Reserved

E56

DRA Base AMP submitted outside allowable timeframe

Error

The submission of DRA Base AMP is subject to requirements of CMS-2238-FC.

E57

Multiple package size error – labeler submitted different DRA Base AMPs across multiple package sizes of the same product

Error

DRA Base AMP was not weighted as required. Review/Correct.

E58

Market Date change requires additional pricing

Error

Market Date change to earlier date results in additional pricing due from labeler. If Market Date change is correct, labeler must process the change online in DDR.

E59

Market Date change invalidates labeler pricing

Error

Market Date change to later date causes submitted pricing for earlier quarters to become invalid. If Market Date change is correct, labeler must process the change online in DDR.

E60

Purchased Product Date field not properly reported

Error

Purchased Product Date must be supplied. If Market Date is within current reporting period, or if the product is being reported late and there is no Purchased Product Date, then the Purchased Product Date should be blank or zero-filled.

E61

Purchased Product Date entry must be performed manually online via DDR

Error

Purchased Product Date entered is later than the Market Date or previously entered Purchased Product Date; therefore, prior period pricing may exist. This action will cause the removal/deletion of previously calculated URA values for the submitted pricing. Change/entry of Purchased Product Date must be performed manually in DDR.

E62

Changing a Purchased Product Date to an earlier date results in additional pricing due from labeler

Error

Purchased Product Date entered is earlier than the previous Purchased Product Date; therefore, additional pricing is due from the labeler. If the new Purchased Product Date is correct, labeler must process the change online in DDR.

E63

Purchased Product Date is less than the Market Date

Error

Purchased Product Date must be equal to or greater than the Market Date.

E64

Purchased Product Date not allowed

Error

Purchased Product Date cannot be greater than current quarter plus one.

E65

Package Size Intro Date not allowed

Error

Package Size Intro Date cannot be greater than current quarter plus one.

E66

Package Size Intro Date is less than Market Date or Purchased Product Date (if PPD present)

Error

Package Size Intro Date must be equal to or greater than the Market Date or the Purchased Product Date (if PPD present).

E67

Missing or Invalid Package Size Intro Date

Error

Package Size Intro Date cannot be blank and must be a valid date.

E68

Invalid Package Size Intro Date

Error

At least one Package Size Introduction Date must be equal to Market Date or Purchased Product Date.

E69

Changing a Package Size Introduction Date to an earlier date results in additional pricing due from labeler

Error

Package Size Introduction Date entered is earlier than the previous Package Size Introduction Date; therefore, additional pricing is due from the labeler. If the new Package Size Introduction Date is correct, labeler must process the change online in DDR.

E70

Package Size Introduction Date entry must be performed manually online via DDR

Error

Package Size Introduction Date entered is later than the previously entered Package Size Introduction Date; therefore, prior period pricing may exist. This action will cause the removal/deletion of previously submitted AMP values. Change/entry of Package Size Introduction Date must be performed manually in DDR.

E71

Termination Date change invalidates existing labeler data

Error

Termination Date change to an earlier date causes submitted pricing for earlier months and/or quarters to become invalid. If Termination Date is correct, labeler must process the change online in DDR.

E72

Multiple package size error – labeler submitted different Market Dates across multiple package sizes of the same product

Error

Market Date was not the same across all package sizes for the same product. Review/Correct.

E73

Multiple package size error – labeler submitted different FDA Approval Dates across multiple package sizes of the same product

Error

FDA Approval Date was not the same across all package sizes for the same product. Review/Correct.

E74

Multiple package size error – labeler submitted different Purchased Product Dates across multiple package sizes of the same product

Error

Purchased Product Date was not the same across all package sizes for the same product. Review/Correct.

E75

Pricing quarter prior to Market Date and/or Purchased Product Date

Error

Pricing quarter must be after the Market Date or Purchased Product Date if one is present unless pricing quarter is being submitted to establish the product’s OBRA ’93 Baseline AMP.

E76

AMP Units must contain 2 decimal places

Error

AMP Units value is less than 2 decimal places.

E77

AMP Units must be present, numeric and greater than or equal to zero

Error

AMP Units value is blank, non-numeric or less than zero.

E78

Monthly pricing change rejected

Error

Monthly pricing changes not allowed after 36 months.

E79

Multiple package sizes – AMP Units problem

Error

AMP Units must be the same value across all package sizes.

E80

The Submitted Best Price is Greater Than AMP

Error

Best Price cannot be greater than AMP. Please review and correct the submitted pricing.

E81

Product Record is Missing Required 5i Drug Information

Error

The product record you submitted cannot be updated without including a valid value in the required 5i Drug Indicator and 5i Route of Administration fields.

E82

Product requires 5i Drug Indicator and 5i Route of Administration field data

Error

Monthly pricing data cannot be submitted until the 5i Drug Indicator and 5i Route of Administration fields have been updated in the NDCs product file and then certified.

E83

Product requires 5i Drug Indicator and 5i Route of Administration field data

Error

Quarterly pricing data cannot be submitted until the 5i Drug Indicator and 5i Route of Administration fields have been updated in the NDCs product file and then certified.

E84

Change to 5i Drug Indicator field not allowed via file transfer

Error

Changes to 5i Drug Indicator are not permitted via file transfer. They must be performed online.

E85

Change to 5i Drug Indicator field not allowed

Error

Changes to 5i Drug Indicator are not permitted beyond four quarters after the effective date of the final rule. If you believe that the 5i Drug Indicator originally entered for this product is incorrect, please contact [email protected].

E86

Value missing or invalid value submitted

Error

5i Drug Indicator value must be submitted in accordance with the record layout and data definitions as specified in the DDR User’s Guide and the DDR file transfer tab in DDR.

E88

Value missing or invalid value submitted

Error

5i Route of Administration field must be submitted in accordance with the record layout and data definitions as specified in the Labeler Data Guide and the DDR file transfer tab in DDR.

E89

Value missing or invalid value submitted

Error

The 5i Monthly Threshold value must be submitted in accordance with the record layout and data definitions as specified in the DDR User’s Guide and the DDR File Transfer tab in DDR.

E90

Incorrect value submitted for 5i Monthly Threshold field

Error

NDC was reported with a value of “N” in the 5i Drug Indicator field during this month/year; therefore, “X-Not a 5i Drug” is the only valid value in the 5i Monthly Threshold field for this time period.

E91

Incorrect value submitted for 5i Monthly Threshold field

Error

NDC was reported with a value of “Y” in the 5i Drug Indicator field during this month/year; therefore, “Y-Yes” or “N-No” are the only valid values for the 5i Monthly Threshold field for this time period.

E92

Incorrect value submitted for 5i Monthly Threshold field

Error

This reporting period was prior to the implementation of the 5i Monthly Threshold field; therefore, “Z—Not Applicable” is the only valid value.

E94

ACA Base AMP is invalid

Error

ACA Base AMP must be a valid value (5 whole positive numbers and 6 decimal numbers) or zero-filled when the drug category is S or I and the market date is less than 1/1/2014.

E95

Multiple package size error – Labeler submitted different ACA Base AMPs across multiple package sizes of the same product

Error

ACA Base AMP was not weighted as required. Review/Correct.

E96

ACA Base AMP submitted outside allowable timeframe

Error

The submission of ACA Base AMP is subject to requirements of CMS-2345-F.

E97

ACA Base AMP change rejected

Error

The timeframe for reporting changes to the ACA Base AMP field has closed.

E98

COD Status/Drug Category combination is invalid

Error

Only certain Drug Categories are allowed in conjunction with COD Status selections. Please review, correct and re-submit. For a list of allowable values for each COD Status, please refer to the COD Status lookup table, which can be accessed online via DDR under Documents-->Lookup Tables-->COD Status.

E99

COD Status/Drug Type combination is invalid

Error

Only certain Drug Types are allowed in conjunction with COD Status selections. Please review, correct and re-submit. For a list of allowable values for each COD Status, please refer to the COD Status lookup table, which can be accessed online via DDR under Documents-->Lookup Tables-->COD Status.

E100

Change to COD Status field not allowed.


Error

Changes to COD Status are not permitted. If you believe that the COD Status originally entered for this product is incorrect, please contact [email protected].


E101

Invalid value submitted.


Error

The COD Status field must contain one of the values in the COD Status lookup table, which can be accessed online via the DDR Documents tab.


E103

AMP and Best Price must be greater than zero.


Error

This pricing record requires the submission of the quarterly AMP and Best Price values for [insert Base AMP quarter/year in q/yyyy format] in order to establish the NDC’s OBRA ’93 Base AMP value. Please provide the required quarterly AMP and Best Price values in order to submit this record.


E104

Drug Category Change Requires Submission of an OBRA ’90 Base AMP.


Error

The submitted product record contained a Drug Category change from “Non-innovator” to “Innovator Multiple Source” or “Single Source.” Therefore, the submission of a value greater than zero is required in the OBRA ’90 Base AMP field.


E107

BP must be a value greater than zero.


Error

The Drug Category of this NDC has been updated from “N” to “S/I”. Therefore, the BP for [insert OBRA ’93 Base AMP quarter/year in format of q/yyyy] is required.


E108

AMP must be a value greater than zero.


Error

The Drug Category of this NDC has been updated from “N” to “S/I”. Therefore, the quarterly AMP for [insert OBRA ’93 Base AMP quarter/year in format of q/yyyy] is required and must be greater than zero in order to establish this product’s OBRA ’93 Base AMP.


E109

The submitted BP and the AMP values must be greater than zero.


Error

The Drug Category of this NDC has been updated from “N to “S/I”. Therefore, the quarterly AMP and BP for [insert OBRA ’93 Base AMP quarter/year in format of q/yyyy] are required and must be greater than zero in order to establish this product’s OBRA ’93 Base AMP.


E112

Removal of or change to existing termination date rejected.


Error

Termination Date cannot be removed or changed via file transfer. It can only be removed or changed online in DDR

E113

Product Data Fields Must Be Submitted Before Monthly Pricing Can Be Reported


Error

Monthly pricing data cannot be reported until the product data fields have been updated in the NDC’s product file and then certified. Refer to the Labeler Status screen for more information on these data fields.


E114

Product Data Fields Must Be Submitted Before Quarterly Pricing Can Be Reported


Error

Quarterly pricing data cannot be reported until the product data fields have been updated in the NDC’s product file and then certified. Refer to the Labeler Status screen for more information on these data fields.


E115

Change to COD Status Not Allowed


Error

Changes to a previously reported COD Status are not allowed without CMS permission. Please contact CMS at [email protected] to request a change.

E116

Missing or Invalid FDA Application No./OTC Monograph No.


Error

This record was submitted with a COD Status of ANDA, NDA, BLA, or Authorized Generic. Therefore, the FDA Application No./OTC Monograph No. field must contain the 6-digit number assigned by the FDA for approval to market the product in the U.S., preceded by a leading zero.


E117

COD Status of “OTC Monograph Final” Requires an FDA Application No./OTC Monograph No.


Error

This record was submitted with a COD Status of OTC Monograph Final. Therefore, the FDA Application No./OTC Monograph No. field must contain the word “PART” followed by a 3-digit numeric value that identifies the FDA’s regulatory citation for the OTC.


E118

COD Status of “OTC Monograph Tentative” Requires an FDA Application No./OTC Monograph No.


Error

This record was submitted with a COD Status of OTC Monograph Tentative. Therefore, the FDA Application No./OTC Monograph No. field must contain the word “PART” followed by a 3-digit numeric value that identifies the FDA’s regulatory citation for the OTC. If a 3-digit numeric value is not available, enter “000” following “PART”.


E119

The submitted COD Status requires the FDA Application No./OTC Monograph No. to be zero-filled.


Error

This record was submitted with a COD Status of something other than ANDA, NDA, BLA, NDA Authorized Generic, OTC Monograph Final, or OTC Monograph Tentative. Therefore, the FDA Application No./OTC Monograph No. field must be zero-filled.


E121

Incorrect COD Status value of “ANDA” submitted. (This message will only be received through 10/30/15.)


Error

The selection of a COD Status category of “ANDA” requires a Drug Category of “N”; however, this NDC currently has a Drug Category of “S” or “I”. Please review, correct, and re-submit.


E122

Incorrect COD Status value of “ANDA” submitted.


Error

The selection of a COD Status category of “ANDA” requires a Drug Category of “N”; however, this NDC currently has a Drug Category of “S” or “I”. Please contact CMS at [email protected] for assistance in making the initial COD Status selection for this NDC, and to request the corresponding Drug Category change (if applicable).


E123

Incorrect COD Status value of “NDA Authorized Generic” submitted. (This message will only be received through 10/30/15.)


Error

The selection of a COD Status category of “NDA Authorized Generic” requires a Drug Category of I; however, this NDC currently has a Drug Category of “N”. Please review, correct, and re-submit. Also note that a Drug Category of “S” or “I” requires a Base AMP pricing record.


E124

Incorrect COD Status value of “NDA Authorized Generic” submitted.


Error

The selection of a COD Status category of NDA Authorized Generic requires a Drug Category of “I”; however, this NDC currently has a Drug Category of “N”. Please contact CMS at [email protected] for assistance in making the initial COD Status selection for this NDC, and to request the corresponding Drug Category change (if applicable).


E125

Incorrect COD Status value of “NDA” submitted. (This message will only be received through 10/30/15.)



Error

The selection of a COD Status category of "NDA" requires a Drug Category of S or I; however, this NDC currently has a Drug Category of "N". Please review, correct, and re-submit.

E126

Incorrect COD Status value of "NDA" submitted.

Error

The selection of a COD Status category of "NDA" requires a Drug Category of S or I; however, this NDC currently has a Drug Category of "N". Please contact CMS at [email protected] for assistance in making the initial COD Status selection for this NDC, and to request the corresponding Drug Category change (if applicable).

E127

Incorrect COD Status value of “BLA” submitted. (This message will only be received through 10/30/15.)


Error

The selection of a COD Status category of "BLA" requires a Drug Category of "S"; however, this NDC currently has a Drug Category of "N". Please review, correct, and re-submit.


E128

Incorrect COD Status value of "BLA" submitted.

Error

The selection of a COD Status category of "BLA" requires a Drug Category of "S"; however, this NDC currently has a Drug Category of "N". Please contact CMS at [email protected] for assistance in making the initial COD Status selection for this NDC, and to request the corresponding Drug Category change (if applicable).

E129

Incorrect COD Status value of “Prescription Dietary Supplement” submitted. (This message shall only be applicable through 10/30/2015.)


Error

The selection of a COD Status category of “Prescription Dietary Supplement” requires a Drug Type of “Rx”; however, this NDC currently has a Drug Type of “OTC”. Please review, correct, and re-submit.


E130

Incorrect COD Status value of “OTC Monograph Tentative” submitted. (This message shall only be applicable through 10/30/2015.)


Error

The selection of a COD Status category of “OTC Monograph Tentative” requires a Drug Type of “OTC”; however, this NDC currently has a Drug Type of “Rx”. Please review, correct, and re-submit.


E131

Incorrect COD Status value of “OTC Monograph Final” submitted. (This message shall only be applicable through 10/30/2015.)


Error

The selection of a COD Status category of “OTC Monograph Final” requires a Drug Type of “OTC”; however, this NDC currently has a Drug Type of “Rx”. Please review, correct, and re-submit.


E132

Incorrect COD Status value of “Unapproved Drug – Drug Shortage” submitted. (This message shall only be applicable through 10/30/2015.)


Error

The selection of a COD Status category of “Unapproved Drug – Drug Shortage” requires a Drug Type of “Rx”; however, this NDC currently has a Drug Type of “OTC”. Please review, correct, and re-submit.


E133

Incorrect COD Status value of “Prescription Prenatal Vitamin or Fluoride” submitted. (This message shall only be applicable through 10/30/2015.)


Error

The selection of a COD Status category of “Prescription Prenatal Vitamin or Fluoride” requires a Drug Type of “Rx”; however, this NDC currently has a Drug Type of “OTC”. Please review, correct, and re-submit.


E134

Incorrect COD Status value of "Unapproved Drug – Per 1927(k)(2)(A)(ii)" submitted. (This message will only be received through 4/30/15.)


Error

The selection of a COD Status category of "Unapproved Drug – Per 1927(k)(2)(A)(ii)" requires a Drug Category of "N"; however, this NDC currently has a Drug Category of "S" or "I". Please review, correct, and re-submit.


E135

Incorrect COD Status value of "Unapproved Drug – Per 1927(k)(2)(A)(ii)" submitted.


Error

The selection of a COD Status category of "Unapproved Drug – Per 1927(k)(2)(A)(ii)" requires a Drug Category of "N"; however, this NDC currently has a Drug Category of "S" or "I". Please contact CMS at [email protected] for assistance in making the initial COD Status selection for this NDC, and to request the corresponding Drug Category change (if applicable).


E136

Incorrect COD Status value of "Unapproved Drug – Per 1927(k)(2)(A)(iii)" submitted.


Error

The selection of a COD Status category of "Unapproved Drug – Per 1927(k)(2)(A)(iii)" requires a Drug Category of "N"; however, this NDC currently has a Drug Category of "S" or "I". Please review, correct, and re-submit.


E137

Incorrect COD Status value of "Unapproved Drug – Per 1927(k)(2)(A)(iii)" submitted.


Error

The selection of a COD Status category of "Unapproved Drug – Per 1927(k)(2)(A)(iii)" requires a Drug Category of "N"; however, this NDC currently has a Drug Category of "S" or "I". Please contact CMS at [email protected] for assistance in making the initial COD Status selection for this NDC, and to request the corresponding Drug Category change (if applicable).


A1

Pricing submission equals current price

Alert

Submitted pricing data equaled the pricing data already in the database.

A2

Drug Category change not allowed

Alert

Drug Category has a different value than the current value. Cannot change from S/I to N or vice versa without CMS approval.

A3

Warning: Unit Type changed

Alert

Unit Type change often requires changes to UPPS and price. Review and adjust as needed

A4

Base AMP must be zero-filled if Market Date is greater than 9/30/1993 or for N drugs

Alert

Database uses AMP submitted for Base AMP quarter. Base AMP not required for N drugs.

A5

Market Date changes are not allowed

Alert

Market Date cannot be changed after 12 quarters without prior CMS approval.

A6

DESI change not allowed

Alert

DESI cannot be changed from a value of 2, 3, or 4 to a value of 5 or 6 or vice-versa.

A7

FDA Approval Date may not be after Market Date

Alert

Previous FDA Approval Date remains in database.

A8

Multiple package size OBRA ’90 Base AMP problem

Alert

OBRA ‘90 Base AMP was not weighted as required. CMS used highest submitted Base AMP which will result in highest possible AMP. Review/correct.

A9

Reserved

Alert

Reserved

A10

Multiple package size AMP problem

Alert

AMP was not weighted as required. CMS used highest submitted AMP which will result in highest possible AMP. Review/correct.

A11

Multiple package size FDA Approval Date problem

Alert

Initial FDA Approval Date does not change when new package size is added.

A12

Multiple package size Market Date problem

Alert

Initial Market Date does not change when new package size is added.

A13

Drug Category change made

Alert

Drug Category changed from S to I or vice-versa.

A14

Terminated package size - latest active Best Price used

Alert

When all package sizes are terminated, the best price from the last active quarter is used.

A15

Best Price greater than AMP

Alert

Best Price cannot be greater than AMP. CMS changed Best Price to equal AMP. Review/correct

A16

Multiple package size – Best Price problem

Alert

Best Price must be lowest price regardless of package size and the same value across all package sizes. CMS used lowest submitted Best Price which will result in highest possible URA. Review/correct.

A17

DRA Base AMP must be zero-filled if Market Date > 6/30/2007 or when drug category is “N”

Alert

DRA Base AMP is not required for NDCs with Market Dates > 6/30/2007 or for N drugs.

A18

Reserved

Alert

Reserved

A19

DRA Base AMP must be a valid numeric value with no blanks or special characters

Alert

DRA Base AMP, if supplied, must be numeric; 5 whole positive number and 6 decimals or must be zero-filled.

A20

Terminated package size – latest active AMP used

Alert

When all package sizes are terminated, the AMP from the last active quarter is used.

A21

Best Price not required for N drugs

Alert

Best Price not required for N drugs.

A22

Reserved

Alert

Reserved

A23

Reserved

Alert

Reserved

A24

Nominal Price invalid

Alert

For all active package sizes, Nominal Price must be a positive dollar value or zero.

A25

Multiple Package Size – AMP not submitted for all package sizes

Alert

AMP value for all package sizes not submitted. AMP for submitted package size will be stored for all active packages. Review/Correct.

A26

Product Record requires the submission of a quarterly pricing record (QYYYY) to establish the Baseline AMP

Alert

A new S or I product record with a Market Date earlier than the current quarter requires the submission of the quarterly AMP value needed to establish the product’s OBRA ’93 Baseline AMP.

A27

Nominal Price submitted for N drug – price will not appear in DDR

Alert

Nominal Price is not required for an N drug; therefore, the submitted price will not appear in DDR.

A28

Customary Prompt Pay Discount and/or Nominal Price submitted for terminated package size

Alert

When the last active package size of a product is terminated and it is within four quarters after the Termination Date, the Customary Prompt Pay Discount and/or Nominal Price field should be zero-filled for those four quarters.

A29

Valid Purchased Product Date value in database

Alert

Purchased Product Date exists in the database. Removal of PPD can be performed through the online system.

A30

Submitted Package Size Introduction Date is earlier than current reporting period

Alert

The Package Size Introduction Date submitted is earlier than the current reporting period; therefore, prior period monthly AMP values were automatically populated and prior quarterly NP and CPP values were zero-filled. These populated values all require certification – please review, correct where appropriate, and certify.

A31

Product Termination Date removed/changed to a later date

Alert

Removing or changing a product Termination Date to a later date results in additional pricing due from labeler. Review, enter missing pricing and certify any entered pricing.

A32

Reserved

Alert

Reserved

A33

Monthly AMP Units increased/decreased by 40% from last month.

Alert

Monthly AMP Units increased/decreased by 40% from last month, please review/correct.

A34

Monthly AMP increased/decreased by 40% from last month.

Alert

Monthly AMP increased/decreased by 40% from last month, please review/correct.

A35

AMP Units not required prior to October 2010

Alert

AMP Units are not required for periods prior to October 2010. Unit information not kept.

A36

AMP reported as 0.000001

Alert

AMP reported as 0.000001. Verify this is the actual AMP value for the NDC. If the AMP equals 0.000001 because the calculated AMP is negative or zero, report the most recent prior AMP.

A37

ACA Base AMP is invalid

Alert

For N drugs, the ACA Base AMP must be zero-filled with no blanks or special characters.

A38

ACA Base AMP must be zero-filled if Market Date is on or after 1/1/2014 or when drug category is N

Alert

ACA Base AMP is not required for NDCs with Market Dates on or after 1/1/2014 or for N drugs.

A39

ACA Base AMP must be a valid numeric value with no blanks or special characters

Alert

ACA Base AMP, if supplied, must be numeric; 5 whole positive numbers and 6 decimals or must be zero-filled.

A40

Change to 5i Indicator Results in Monthly 5i Threshold Changes

Alert

Changing the 5i Indicator from a value of “Y” to “N” results in the monthly 5i Threshold value changing to a value of “X” (i.e., not a 5i drug) for all previously reported monthly pricing records back to April 2014. These changes to the monthly 5i Threshold require certification in DDR.

A43

OBRA ’93 Base AMP quarterly pricing record accepted. Submitted Best Price not stored since a Purchased Product Date was provided.


Alert

Because a Purchased Product Date was reported for this NDC, the submission of a BP for this quarter (i.e., the OBRA ’93 Base AMP Quarter) is not needed. Therefore, the submitted Best Price value will be blanked out.


A44

Base AMP quarter AMP and BP are required.


Alert

The Drug Category of this NDC has been updated from “N” to “S/I”. Therefore, a pricing record containing the quarterly AMP and BP for [insert OBRA ’93 Base AMP quarter/year in format of q/yyyy] is required in order to establish this product’s OBRA ’93 Base AMP.




Disclosure Statement


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 128.6 hours per response (CMS-367a = 34.8 hours, CMS-367b = 44.8 hours, CMS-367c = 43.5 hours, and CMS-367d = 1.0 hour), 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.





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File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleInstructions to Labelers for CMS-367a, CMS-367b and CMS-367c
AuthorCMS
File Modified0000-00-00
File Created2021-01-24

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