Manufacturers Webinar

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.

3. Webinar Schedule • May 4th, 2011 4:00-5:00 p.m. ET • June 1st, 2011 4:00-5:00 p.m. ET • July 6th, 2011 4:00-5:00 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 http://www.cms.gov/PrescriptionDrugCovGenIn/05_Pharma.asp#TopOfPage 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, 2011. 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 www.csscoperations.com under the TPA/Drug Manufacturer heading before 1st quarter invoices are distributed.

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.

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, 2011. 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 423.100 • 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 http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm • Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) New NDC Directory • FDA has scheduled for June 1, 2011. See: http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm • 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.

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.

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.

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.

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.

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.

20. Periodic Review of NDCs • FDA NDC Directory at http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm . • New NDC Directory (FDA Online Label Repository) at http://labels.fda.gov/ • Corrections and updates should promptly be made by electronically listing or contacting the FDA at eDRLS@fda.hhs.gov .

21. Timely Removal of NDCs not on Market • NDCs listed only through Form 2657 (paper), contact FDA at eDRLS@fda.hhs.gov . • 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.

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)

24. Dispute Reasons (part 2 of 2)

25. Detail Dispute Record 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

26. Question and Answer