1. Manufacturers Webinar
April 6, 2011

2. Announcements Quarter 1 Invoice Distribution
April 30th, 2011
Directions for Payment Confirmation Overview and Overpunch Character Mapping are posted on CSSC website.
Manufacturer with no quarterly report
Latest HPMS module from MDBG released.
Thank everyone who has established connectivity. For the few that have not completed connectivity we urge you to do so in order to receive test files.

3. Webinar Schedule May 4th, 2011 4:00-5:00 p.m. ET
June 1st, :00-5:00 p.m. ET
July 6th, :00-5:00 p.m. ET

4. Accomplishments Released EFT Data on March 16
Invoice Correction Online Form
HPMS Modules Released
Manufactures can update labeler codes

5. Agenda Invoice Correction Process FAQs
Overview: Part D Covered Drugs and Applicable Drugs
Dispute Follow-up

6. Invoice Correction Process
Manufacturers wishing to correct an invoice may do so only if they have been invoiced for NDCs with labeler codes not covered by their CGDP Manufacturer Agreements. CMS publishes the “Participating Manufacturer Labeler Codes” at which documents the current list of labeler codes covered by each Manufacturer.
Manufacturers submit their labeler codes at the time they sign the CGDP Manufacturer Agreement and maintain current labeler codes on an ongoing basis as described in the “Release of the Health Plan Management System (HPMS) Drug Manufacturer Module” guidance released on March 25, This guidance revises and supersedes the December 17th guidance for maintaining contact and labeler code information.
CMS uses “Participating Manufacturer Labeler Codes” to create the quarterly CGDP Invoice report. The quarterly report invoices Manufacturers for Labeler codes assigned to them as of the first business day following the end of the quarter.
The TPA will post the link to the Manufacturer Invoice Correction Request form at under the TPA/Drug Manufacturer heading before 1st quarter invoices are distributed.
Make sure Angela Reddix goes to the websites that we have listed here when going through presentations.

7. Manufacturer Invoice Correction Request (Draft)
Manufacturer Steps:
Complete this online form within 5 calendar days of the date the TPA distributes the CGDP Quarterly Invoice.
TPA will respond within 3 business days .
If the TPA confirms the invoice correction, the manufacturer shall not be responsible for paying NDCs with labeler codes invoiced incorrectly. Instead the Manufacturer shall pay all other labeler codes in the invoice.
Here is a draft of the Invoice correction form that will appear online.

8. Frequently Asked Question #1
Q: Will manufacturers be required to send 1099s to contracts they have paid? A: Yes. Manufacturers will produce 1099s for contracts to whom they have made Coverage Gap Discount payments. Use the 1099 name and address fields from the EFT file.

9. Frequently Asked Question #2
Q: How many quarterly invoices will Manufacturers receive for 2011 dates of service (DOS) A: There will be 17 quarterly invoices for 2011 dates of service. Generally, a quarterly invoice includes data submitted during the invoice quarter. For example, the invoice for Q4 of 2011 could include a PDE with a Jan 2011 DOS if the Part D sponsor submitted the PDE between Oct 1, 2011 and Dec 31, This Q & A corrects the “13 Quarter” information published during the Feb 4, 2011 webinar.

10. Covered Medicare Part D Drug
Social Security Act §§ 1927(k)(2) and 1860D-2
Dispensed only upon a prescription, including OTC insulin and supplies associated with the injection of insulin (e.g. syringes, needles, alcohol swabs, gauze).
Approved as an Abbreviated New Drug Application (ANDA), New Drug Application (NDA), or Biologic License Application (BLA) by the Food and Drug Administration (FDA).
Meets provisions regarding the Drug Amendments of 1962.
No payment is available under Medicare Parts A or Part B.*
Not excluded from coverage under SSA 1927(d)(2), except for smoking cessation agents.
42 CFR
Included in a Part D plan's formulary.
Treated as being included in a Part D plan's formulary as a result of a coverage determination or appeal (includes transition and emergency fills).
Obtained at a network pharmacy or an out-of-network pharmacy.
* Part D plans use prior authorizations to determine Part B versus Part D coverage on drugs such as injectables. Note, claims for non-Part-B-covered injectables whether usually self-administered or not, when dispensed and submitted by pharmacists could be covered under Part D.

11. Applicable Drugs Applicable Drug
The definition of an applicable drug can be found under SSA §1860D-14A(g)(2).
Meets the definition of a covered Medicare Part D drug.
Approved by the FDA under an NDA or BLA.
Applicable drugs may be covered under Part D only if the manufacturer has a signed agreement, unless through an exception under SSA 1860D-43(c).

12. Resources to Identify Applicable Drugs
FDA National Drug Code (NDC) Directory
FDA NDC Directory at
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
New NDC Directory
FDA has scheduled for June 1, See:
The new NDC Directory (FDA Online Label Repository) is expected to have downloadable data files that are efficient for plans and CMS to identify NDC marketing categories.
Currently, NDCs that are electronically listed show on the FDA Online Label Repository and eventually the NDC Directory.
Show links.
If you are not involved in listing NDCs with the FDA, make sure you relay the information going forward with the person/people in your organization that are responsible for listing NDCs with the FDA.

13. MEDICARE COVERAGE GAP DISCOUNT PROGRAM (CGDP) AGREEMENT
Manufacturers agree to: “To electronically list and maintain an up-to-date electronic FDA listing of all NDCs of the Manufacturer, including the timely removal of discontinued NDCs from the FDA NDC Directory, so that CMS and Part D sponsors can accurately identify applicable drugs (as defined in section I (c) of this Agreement).” “To list NDCs with the FDA in advance of commercial distribution of the drug product.”

14. Electronically Listing NDCs
Manufacturers are responsible for listing and maintaining listings of NDCs of drug products that are on the market, including drug products:
In commercial distribution.
With discontinued applications , but unexpired drug product may be on wholesaler/distributor or pharmacy shelves.
Commercial distribution has halted, but unexpired drug product may be on wholesaler/distributor or pharmacy shelves.
Acquired through manufacturer acquisition.

15. In Commercial Distribution
If a drug product is being distributed on the market, whether the manufacturer anticipates stopping distribution or not, the manufacturer needs to electronically list the NDC with the FDA.
Manufacturers need to look over their inventory and make sure that all marketed NDCs, including NDCs that could potentially be on the market are electronically listed with the FDA.
“ONE” Manufacturers are responsible for listing and maintaining listings of NDCs of drug products that are on the market, including drug products that are in commercial distribution.

16. Discontinued Applications
Application discontinued for reasons other than safety.
NDC was not recalled from the market.
Unexpired drug product may be on pharmacy shelves.
“TWO” Manufacturers are responsible for listing and maintaining listings of NDCs of drug products that are on the market, including drug products that have discontinued applications.

17. Commercial Distribution has Halted
NDC of a drug product not listed with the FDA.
Marketing has discontinued.
Unexpired drug product may be on pharmacy shelves.
“THREE” Manufacturers are responsible for listing and maintaining listings of NDCs of drug products that are on the market, including drug products where commercial distribution has halted, e.g. due to low market demand.

18. NDC Changes Manufacturer acquisition.
Includes NDCs no longer distributed on the market.
Includes NDCs where new manufacturer changed NDC.
Unexpired drug product may be on pharmacy shelves.
“Four” Manufacturers are responsible for listing and maintaining listings of NDCs of drug products that are on the market, including drug products acquired manufacturer acquisitions.
An example of this includes when a manufacturer acquired another manufacturer. The new manufacturer changes the NDC of a drug product belonging to the old manufacturer. If the NDC belonging to the old manufacturer is not listed and unexpired drug product may be on the market, the new manufacturer is responsible for listing the old NDC.

19. Important Notes
NDCs need to be listed for plans to identify applicable drugs.
Include the marketing start dates and end dates on Structured Product Labeling (SPL).
For NDC acquisitions, use the original marketing start date for that NDC, not the date acquired from another manufacturer.
The Marketing End Date is the expiration date of the last lot released to the marketplace.
NDCs should only be listed once with the correct application number.
Structured Product Labeling (SPL) is used to electronically list with the FDA.

20. Periodic Review of NDCs
FDA NDC Directory at .
New NDC Directory (FDA Online Label Repository) at
Corrections and updates should promptly be made by electronically listing or contacting the FDA at .
Manufacturers need to periodically review their listed drug products on the FDA NDC Directory and the FDA Online Label Repository ( to update or identify incomplete or inaccurate information.

21. Timely Removal of NDCs not on Market
NDCs listed only through Form 2657 (paper), contact FDA at .
NDCs listed by SPL, update SPL using the same set id and new id root and version.
Inform the FDA prior to the last lot expiration date to allow ample time to update the FDA website.
The CGDP does not look at data submitted to the Drug Date Reporting for Medicaid (DDR) System.
CMS will verify that the date the NDC no longer displays on the NDC Directory is not after the last lot expiration date.
NDCs that are no longer on the market need to be removed from the NDC Directory in a timely manner. This allows plans and CMS to identify applicable drug on the market.

22. Dispute Follow Up Updates to simplify dispute submission:
increase detail record length to 1024
expand “Additional Information” field to 800+ characters
remove comment record cross-reference in detail record
eliminate additional comment detail record
Approach for automating dispute processing: specify required fields for individual dispute reason codes

23. Dispute Reasons (part 1 of 2)
Dispute Reason code
Dispute
Reason
SUPPORTING DETAIL REFERENCE NUMBER
SUPPORTING DATE 1
SUPPORTING DATE 2
ADDITIONAL INFORMATION
D01
Duplicate Invoice Item
Reference Number of duplicate record
Provide additional supporting evidence (optional)
D02
Closed Pharmacy
NCPDP closed date
D03
Not PART D Covered Drug
Explain statutory exclusion for the drug (required)
D04
Excessive Quantity
Excessive quantity on individual invoice item. Provide proprietary benchmark used to identify excessive quantity. (required)
D05
Invalid Days Supply
Provide additional supporting information (Required)
D06
High Price of the drug

24. Dispute Reasons (part 2 of 2)
Dispute Reason code
Dispute Reason
SUPPORTING DETAIL REFERENCE NUMBER
SUPPORTING DATE 1
SUPPORTING DATE 2
ADDITIONAL INFORMATION
D07
Last Lot Expiration Date
NDC directory drop date
Last lot expiration date
Provide additional supporting information (optional)
D08
Early Fill
Reference number for early fill disputed
Provide additional supporting information (Required)
D09
Marketing category is not NDA or BLA
FDA update date
D10
Invalid Date of Service
(prior to 01/01/2011)
D11
Invalid Date of Service (invoiced after 17th quarter
for the benefit year)
D12
Invalid Prescription Service Reference Number
D99
Other
Provide additional supporting information (required)

25. Detail Dispute Record Draft format posted on CSSC website
Fields 1-16: Detail record (DETCG) from Data report
Fields 17–22: Information to support dispute; completed by manufacturer
Draft format posted on CSSC website
FIELD NO
FIELD NAME
POSITION
PICTURE
LENGTH
DEFINITION / VALUES 17
DISPUTE REASON CODE
X(3) 3
The reason for the manufacturers to dispute GAP discount amount.
D01 - Duplicate Invoice Item
D02 - Closed Pharmacy
D03 - Not PART D Covered Drug
D04 - Excessive Quantity
D05 - Invalid Days Supply
D06 - High Price of the drug
D07 - Last Lot Expiration Date
D08 - Early Fill
D09 - Marketing category is not NDA or BLA
D10 - invalid date of service (prior to 01/01/2011)
D11 - Invalid Date of Service (invoiced after 17th quarter for the benefit year)
D12 - Invalid Prescription Service Reference Number
D99 - Other 18
SUPPORTING DETAIL REFERENCE NUMBER
X(20) 20
Expected supporting detail reference number for related records. ( i.e. Duplicate PDEs, Early fill). If there is more than one reference number, then note them in the dispute explanation field. 19
SUPPORTING DATE 1
9(8) 8
Expected ‘CCYYMMDD’, if the dispute reason requires two dates, Use this date column as Primary for reporting the date.
SUPPORTING DATE 2
Expected ‘CCYYMMDD’, if the dispute reason requires two dates, use this date column as secondary for reporting the date. 21
ADDITIONAL INFORMATION
X(837)
836
Detailed explanation of the dispute.

26. Question and Answer